EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Director

Brussels, 1st March 2004

VADEMECUM ON EUROPEAN STANDARDISATION

FOREWORD

Twenty years ago, the Community set out the legal basis for its cooperation with the European Standardisation structures in Directive 83/189/EEC. Since then few things have changed in legal terms. However, there has been evolution; a wealth of changes has occurred and a wealth of experience has been accumulated.

Standardisation has proven its potential as a tool in support of Community law and policies. The positive results of this huge task have been recognised. European standardisation policy has grown from the hand-in-hand cooperation between public authorities and standardisation bodies. It is a great success story of the European Union.

I believe that a compilation of the texts that both make and back up this policy can aid the officials of the European institutions in understanding European standardisation and how it relates to their own areas of responsibility. Such a compilation can help these officials make better and broader use of standardisation and guide them in following the appropriate procedures. The texts to be included would include official documents or documents agreed with Member States at the level of the Committee on Standards and Technical Regulations (Directive 98/34/EC) or the Senior Officials Group for Standardisation and Conformity Assessment (SOGS).

The primary target group for this compilation – the “Vademecum” – is therefore the officials of the European institutions. However, Member States officials, European and national standardisation organisations and stakeholders could also find important information helping them to understand the “mechanics” of the system and to contribute to its further evolution.

By its very nature the Vademecum is destined to be updated continually. It has still gaps. The standardisation policy Unit of the Enterprise Directorate General has the responsibility of seeing to its timely revision in coming years. Any suggestions for its improvement and completion would be welcomed.

I would like to thank all those who, over the pastyears, have contributed to the development of European standardisation policy and especially those who have contributed to the compilation of this first edition of the Vademecum.

Michel Ayral

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EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Standardisation

Vademecum on European Standardisation

Part I General Framework

Chapter 1.1

Standardisation and the Directive 98/34/EC Historical background

15 November 2003

Status of the document: Final

Author: E. Vardakas

Director ENTR/G For further information : entr-standardisation@cec.eu.int

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TECHNICAL REGULATIONS AND STANDARDS IN EUROPE:

A HISTORICAL BACKGROUND1 THE SEARCH FOR THE ABOLITION OF TECHNICAL BARRIERS TO TRADE IN EUROPE

The European Union (EU) is the largest group of independent countries in the world, which has continually made efforts to abolish technical barriers to trade (TBTs). These efforts are based on the very Treaty establishing the EU and they are supported by a legal dispute settlement system (the European Court of Justice), which can be used as a last resort. The dispute settlement system is accessible, in most cases, to individuals as well as to countries and the resulting decisions are directly enforceable.

Efforts for developing technical regulations applicable to the markets of all Member states also started very early. However, it quickly became evident that a new method was needed to advance these development efforts after examining the procedures, the decision making process in relation to laws of similar character, the qualifications of the persons involved in this process, and the large volume of TBTs that needed to be tackled.

On closer examination, it also became apparent that the range of areas covered by each country’s technical regulations system did not coincide. Something that was regulated in one Member state was not necessarily regulated in another. Theoretically the (European) technical regulations should cover the totality of areas covered in every single Member state. The volume of questions to be tackled reinforced the need for another solution.

The first breakthrough: the Low Voltage Directive

In 1973, the Council of Ministers adopted the Directive 73/23/EEC better known as the “Low Voltage Directive.” It covered the free movement of goods operating between 50 and 1000 Volts AC or between 75 and 1500 Volts DC. Obviously, governments could not imagine subjecting every single electrotechnical product to a special law in such a large trade area. The situation was even more difficult since, at that time, the agreement of nine governments was needed on the technical requirements for these products.

Thanks to the advancement of International standardisation through the International Electrotechnical Commission (IEC), a large number of safety related international standards on electrotechnical products were already available and implemented (in some cases, with minor modifications) in the individual European countries. This made it possible, after numerous meetings with experts, to adopt the directive, which

1 Based on a yet not published article of Mr Ev.Vardakas

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made open reference to these standards, once the standards bodies of the countries of the European Communities had commonly adopted them.

In Article 5, the Directive stipulated that:

“The Member States shall take all appropriate measures to ensure that, in particular, electrical equipment which complies with the safety provisions of harmonized standards shall be regarded by their competent administrative authorities as complying with the provisions of [the present Directive].

Standards shall be regarded as harmonized once they are drawn up by common agreement between the bodies notified by the Member States in accordance with the procedure laid down in Article […], and published under national procedures. The standards shall be kept up to date in the light of technological progress and the developments in good engineering practice in safety matters.

For purposes of information the list of harmonized standards and their references shall be published in the Official Journal of the European Communities.”

This text introduced several important innovations:

• The notion of “harmonized standards,” which were defined as identical standards for all Member states that conformed to the “safety objectives” of the legislator.

• The elegant solution of “presumption of conformity,” which considered that products designed and produced in accordance with these (harmonized) standards also met the legal requirements. This gave an advantage to these standards without making them mandatory.

• The text also pre-empted and politically supported the establishment of CENELEC as the place to produce “by common agreement” the harmonized standards.

The second breakthrough: the “Cassis de Dijon” ruling

The Treaty establishing the European Union has amongst its principles, at least regarding the free movement of goods, that of “mutual recognition.” This principle remained vague until the Court of Justice of the European Communities (ECJ), in one of the most important of its judgements, concluded in 1979 that:

“Obstacles to movement within the Community resulting from disparities between the national laws relating to the marketing of the products in question must be accepted in so far as those provisions may be recognized as being necessary in order to satisfy mandatory requirements relating in particular to the effectiveness of fiscal supervision, the protection of public health, the fairness of commercial transactions and the defence of the consumer.”

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This case was brought before the ECJ because of the legal difficulties encountered when one company attempted to export a French liqueur called “Cassis de Dijon” to Germany.

The repercussions of this ruling were tremendous:

• It would not give any advantage to a certain Member state by allowing it to introduce technical regulations—and therefore, to create technical barriers to trade—if the (national) regulation could not fulfil the conditions imposed by the ruling (i.e. “…being necessary in order to satisfy mandatory requirements relating in particular to the effectiveness of fiscal supervision, the protection of public health, the fairness of commercial transactions and the defence of the consumer”).

• All previously adopted national technical regulations imposing requirements on products outside of these areas could not be used to block the marketing of nonconforming products.

• The Community does not need to legislate on the free movement of goods, except when addressing the previously mentioned subjects.

• Any product that does not fall within these areas and is legally circulating in one of the Member states can automatically circulate freely in all of the Member states.

The “transparency” Directive

The 98/34/EC Directive (initially adopted in 1983 as 83/189/EEC) sets up a procedure that imposes an obligation upon the Member states to notify the Commission and each other of all draft technical regulations concerning products and, with its 1998 extension, Information society services before they are adopted into national law. This procedure aims at providing transparency (thus its name in the European Community’s jargon is “the transparency Directive”) and control with regard to those regulations. This transparency procedure is also voluntarily extended to the EFTA countries and (even before their entrance to the European Union) to a large number of acceding countries. As of today, some 26 countries participate in this exchange.

In reality, this Directive imposes limitations on the freedom of national legislators (including Parliaments) to introduce national technical regulations before the other participating countries and the Commission verifies their compatibility with the Treaty principles and the Community legislation. Since they could create unjustified barriers to trade between countries, notification in the draft form and subsequent evaluation of their content during the procedure help to diminish this risk. It should be noted that the national draft laws notification system in the framework of the

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WTO/TBT agreement is largely based on the principles and mechanisms of this Directive.

Apart from the technical regulations, this Directive deals with national (voluntary) standards. It creates the basis of the relationship between the European Union and European Standards bodies by listing the “recognized” national and European standards bodies and obliging the national standards bodies to publish not only their draft standards but also their annual standardisation programs in advance. For the time being, it is the basic (yet minimal) legal document covering the activities of the European standards bodies and their relations with the Union.

Its adoption served as a first impetus for strengthening the co-operation between the national standards bodies in the framework of CEN (CENELEC was earlier reinforced through the Low Voltage Directive –“LVD”). ETSI was created much later (in 1988) and included in the list of recognized European bodies.

The “Single Market” project

In June 1985 the Commission President Delors and the Commissioner Lord Cockfield drafted a white paper on the completion of the internal market. It set out a comprehensive list, largely based on the “Cassis de Dijon” ruling, of what needed to be done to abolish borders in Europe and introduced the ambitious deadline for Internal Market completion by the end of 1992.

This project created a major change in the mentality of all actors and put important pressure on the European legislation. The list of measures considered necessary in this white paper was rather long. New methods had to be followed in order to be able to produce the vast legislative body. The Community no longer had the luxury of discussing and negotiating legislative proposals for an infinite number of years.

For the free movement of goods, the “method” had already been invented approximately one month earlier, in May 1985, when the Council of Ministers agreed to the “New Approach to technical harmonization and standards.”

THE “NEW APPROACH”

The new regulatory technique, the “New Approach to technical harmonization and standards” was laid down in a Council Resolution of 7 May 1985. It established that legislative harmonization should be limited to essential requirements that products have to meet in order to freely circulate within the Community. In other words, the legislator should establish in a concise but precise enough form the objectives (regarding, for example, safety) to be satisfied by the products. The laws shall not describe design specifications but specify the performances of the products in a way that they can be uniformly enforced in the Community. They shall also require the

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manufacturer to perform a risk analysis and elaborate the design specifications to satisfy the corresponding essential (performance based) requirements. Furthermore, the laws define one or more conformity assessment procedures, which manufacturers have to apply to demonstrate compliance.

The affixing of the CE marking, being obligatory for the free movement of products falling in the field of application of every law (Directive), means the manufacturer declares that the product conforms to the essential requirements and other stipulations of the Directive (including conformity assessment requirements).

The New Approach intends to reduce regulatory intervention to the minimum necessary to protect the public interest whilst maintaining the high standards of safety and legislative quality. However this legislative technique is not easy to develop.

Standardisers within the European Standards bodies were asked to interpret these requirements in a more concrete form. But again, the application of the “harmonized standards” produced in this way remained voluntary.

The essential requirements - the Legislator’s objectives

Elaborating on the “essential requirements” presents the most difficult part of the New Approach legislation. As seen in the 20 or so Directives that have followed the pattern of the New Approach so far, the “essential requirements” are not always perfect in their conception and expression. This is because creating concise and concrete descriptions of the legislator’s objectives requires a deep knowledge of the sector and a distance from the traditional practice for drafting technical specifications in laws. The additional feature requested from well-written essential requirements (i.e., to be uniformly and directly enforceable) presents the most difficulties, as they must enable direct assessment of the product conformity.

The Council Resolution introducing the New Approach took care to give the enterprises a valid, more detailed interpretation of these requirements. This was especially helpful to small and medium-sized enterprises, which do not usually possess the technical capacity for designing their products “ex ovo.” The Council gave a privileged position to European standardisation by assigning the non-exclusive task of interpreting these essential requirements in their standards to the European standards bodies.

The interpretative function of harmonised European standards

As stated before, New Approach directives do not contain the definitive technical detail needed to make a product; they contain broad safety requirements. Manufacturers therefore need to translate these essential requirements into technical solutions. One of the best ways to achieve this translation or “interpretation” is

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through European standards. To this end, mandates (i.e., official requests) are issued by the European Commission to the relevant European Standards bodies for the development of necessary standards including, where necessary, guidance from public authorities on specific aspects of these standards.

European standards allow technical solutions to be developed by all those with an interest in the product sector—they are open, transparent, and lead to the sharing of innovation and best practices. Most importantly, European standards ensure that different manufacturers have a uniform interpretation of the essential requirements in the Directives and, therefore, a level playing field is ensured.

Something that is very often forgotten by those who do not know the legal situation well and, therefore, is necessary to repeat here is the fact that they are not obligatory. If a manufacturer wishes, it may use its own solution. The only burden it then faces is the obligation to prove that his solution conforms to the essential requirements of the law. In other words, the introduction of the standards in the New Approach only inverses the burden of the proof. If a manufacturer has produced according to the relevant standards, the public authority controlling the market has to prove that the product is not in conformity.

The success

The New Approach has been praised often for its success at the European level. It has already been used as a basis for creating an international model for WTO/TBT’s conforming technical regulations in the framework of the United Nations Economic Commission for Europe (UNECE). It has provided a common basis for nearly 30 countries that enables the free trade of sensitive products with a volume of some thousands of billions of Euros, providing a fair place for those directly involved to influence the system under a transparent, cost-efficient, politically credible, and democratic route such as the standardisation process.

In a recent reflection document, which the Enterprise Directorate General of the European Commission presented at a Seminar in 2003, important possibilities for expanding the New Approach (including areas outside of the free movement of goods) were identified:

“The implicit conclusion of the Council Resolution of 1985 is that any industrial or entrepreneurial activity operating within the Internal market could adopt the New Approach as it is currently applied, as long as the public interest is adequately protected. Such activities could range throughout the product cycle, from research and innovation to market.”

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THE EUROPEAN STANDARDISATION SYSTEM: ACHIEVEMENTS AND SOME BASIC PROBLEMS

The “New Approach” brought a tremendous tension to the standardisation system in Europe. No legislator would naturally agree to give a blank check to the standardisers without a minimum degree of confidence in them and their system. The case was relatively easy in Europe—in practically every country one (and only one) national standardisation system was recognized. In some countries (like Germany) this recognition was based on a contractual relation, called “Normenvertrag”, between the government and the standards body. In other countries, the recognition was more direct since it was included in or based on a law (this was, for example, the case in Greece, Portugal, France, and, in a similar way, a royal charter in the UK).

At the European level, recognition was made without significant problems through the “transparency Directive.”

Learning to” work together”

The national standards bodies in Europe, among them some of the strongest in the world such as AFNOR, BSI and DIN, had a tradition of working independently and competing in the world market. Over the years, different philosophies were developed on several aspects including the way standards are written and presented. For example, the German philosophy emphasizes “thin” content for each standard to allow for easy revisions while the British prefer self-standing documents that provide the maximum amount of possible information to their users.

Franco-German standards disputes at the end of the 1970s and efforts to diminish them, supported by top-level politicians of both countries at the time, led to the experiment of recognizing equivalence between them. The fruits of these efforts were mediocre. It became evident that the only solution was to work together and jointly develop standards. This belief arrived at the same moment that the New Approach was being prepared at the Community level.

The most difficult part of the agreements was the requirement for every national standards organization to adopt the agreed upon European Standard—even if an organization voted against it—and to withdraw all conflicting standards from its standards collection. The experience in CENELEC, which had implemented such a rule about a decade before, made its acceptance easier.

The arrival of mandates (i.e., official requests) from the Community for joint development of European Standards made necessary, especially between 1985 and 1990, the massive establishment of European Technical Committees for a large number of sectors. Their encouraging results stimulated further stakeholder interest in entirely voluntary standardisation efforts (i.e., work not having a connection with the

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European Union’s mandates or legislation). Today, according to statistics made available by the European Standards Bodies, about two-thirds of their work are initiated and adopted independently of the European Union’s mandates.

This change is not only quantitative. It contains a deep qualitative change in the approach for standardisation by the national industry and other stakeholders’ associations. They are abolishing the old-fashioned approach to work alone in their own corner. The internal market in Europe as well as the world market does not offer serious opportunities for “own” solutions. Politically seen, this change of behaviour is the genuine implementation of the European ideal at the level of standardisation. From the trade point of view, it can also be considered the result of what is now more visible through surveys and other means in Europe (i.e., that national standards are potential—if not already real—technical barriers to trade).

This also explains the position of Europeans regarding the international standards bodies (ISO, IEC, and ITU). They have traditionally supported international standards bodies loyally, seriously and consistently implemented the results of their work to their fullest potential, and continue to support them.

As a result, the European Union now has the privilege and advantage of having all of its national standards bodies, including those being traditionally recognized as “big powers” in their area and those from co-operating nations (EFTA), working together. They represent one-fifth of ISO’s membership and a very important part of the world in terms of trade.

Accelerating the “production” of Standards

After the first difficult years of adaptation to the new situation, European standardisation is now at a cruising speed. The European collection already serves as a “critical mass” and it is unlikely that European standardisation is vulnerable from the point of view of standards content. However, risks exist and new challenges are faced daily.

Current efforts to improve the efficiency of the European standardisation system must consider conflicting factors. On one hand, the quality of consensus building and the requirements of openness and transparency imply that there is a minimum amount of time needed. On the other hand, ever-decreasing product life cycles demand speedier standards production. This is why there is a need to focus efforts on applying sound project management to the development of each standard, and the bits that are controllable should be well managed. For example, from the start one needs to think carefully about the impact, users, and purpose of the standard; planning and thinking about problems that may occur during development is needed (for example, will there be a laboratory validation needed of the test method). Only when this is done will we

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have standards that are needed, reflect market needs, and are within the timescales desired by the market.

The “selling less and influencing more” paradox

The major source of the national standards bodies’ income is the sale of their documents. Since all European standards have to be implemented as national standards with identical content, European Standardisation has, by definition, resulted in the creation of fewer standards overall. With the exception of the need for translations (something extremely important in Europe for the accessibility of small and medium size enterprises), the national standards bodies, as the sole distributors of their standards, obviously sell less. On the other hand, the adoption of a European standard in a given subject brings with it the possibility of more broadly influencing not only intra-European but also international trade.

A paradox is therefore created: the volume of the standards sold is decreasing while their influence (and through them that of the relevant technology) is increasing significantly. But the (national) standards bodies cannot live on influence; they have to sell in order to stay alive and continue to serve their constituencies. The added influence of the resulting standards does not seem to be transformed into an additional financial contribution from their (qualitatively) better-served constituencies.

A similar situation, although caused by different reasons, also exists elsewhere. The Standards Developing Organizations (SDOs) in the USA also survive on their sales. Their standards are, very often, of high quality and serve as “carriers” of important technologies. However, in cases where their standards are considered appropriate to become International standards (and logically, to be exposed to broader “ownership”), the SDOs hesitate because of the risk sales losses. The paradox here is that in an effort to prevent some income loss, they limit the potential for the technologies represented in the standards to become more influential. In order to stay alive, they have to limit the influence of the technologies embedded by their constituencies in their standards.

It is obvious that in both cases we are facing a serious problem—the standardisers are obliged, in order to survive, to avoid loyally serve their constituencies. A way has to be found to transform this influence into resources and someone has to provide them.

REFERENCE TO STANDARDS IN “TRADITIONAL” EUROPEAN LEGISLATION

Standards are not only used in the framework of the “New Approach-based” legislation. Hundreds of references to standards are made in the European legislative corpus. Ironically, very few of them are European standards. Most of them are

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national standards that are often superseded or withdrawn. Furthermore, a large number of cases even refer to standards that do not originate in Europe.

The most important problem for these references is the constant need for updating. A recent document published by the Enterprise Directorate General exemplifies this problem clearly.

It is obvious that the European Commission must still do important work to develop a more organized system and monitoring technique for this extra “New Approach” use of standards. This would not only help the quality of the legislation but also facilitate its synchronization with technology.

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EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Standardisation

Vademecum on European Standardisation

Part II European Standardisation in support of European Policies

Chapter 1 Standardisation Setting and Governance

15 November 2003

Status of the document: Final version of the speech given at MIT/Boston on 11 December 2002 Author: Evangelos Vardakas

Director Enterprise DG Directorate G For further information : entr-standardisation@cec.eu.int

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The role of government in standards setting; a European View

Evangelos Vardakas

European Commission Enterprise Directorate-General1

Note on terminology2 For a number of years, intensive discussions on standardization have taken place between the US and the other regions of the world. Indeed, formal agreement has been achieved on the definition of a standard3. However there are still considerable differences regarding the very nature of what a ‘standard’ really is. These differences are often the result of legislation and/or jurisprudence. This paper will not try to bridge these differences.

Some features of standardization – hierarchy of rules Standardization is a form of self-regulation. Interested parties come together and agree voluntarily on (usually technical) matters, which permit them to compete in the market more efficiently. Whether or not to abide by these agreements is a matter for the stakeholders themselves to decide. Although there is an absence of conclusive scientific evidence about the impact of standards on the economy4, it would be difficult for anyone to claim that they do not have a positive influence on overall efficiency5. In order to reach the agreements needed to produce standards, one needs rules and a specific set of procedures to be applied. In this way, we can ensure that a standard only results after a series of logical steps have been followed. Every participant in the standardization effort then has the right to object if the agreed rules have not been correctly followed. There are, however, some higher-level rules, usually imposed by law or business ethos, which put some limits to the freedom of companies and individuals to come to their agreements. The laws on competition and IPRs come to mind in this respect. This is why it is so important that the set of procedures for standardization, which I have just mentioned, remain accessible and open. If they are not, they will fall out of line with the higher-level rules. Of course whilst talking about the law, it should be mentioned that the agreements achieved within the standards themselves must never be in conflict with existing legislation or ethical values.

1 The views expressed here are those of the author; they do not necessarily represent those of his employer. 2 For abbreviations used see the end of the paper 3 For example, in the framework of ISO/IEC, of the UN/ECE and of WTO/TBT Agreement. 4 Several efforts have been made worldwide in order find a model for evaluating the impact of standardization on the economy. This paper does not enter in this discussion; it assumes that standardization has positive influence in the economy as a whole. 5 A recent study commissioned by DIN concludes that for Germany standardization has a positive impact of the order of 1 % of GDP.

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Government interest in standardization Today, governments act on several levels. For example:

• They procure products or services • They aim to boost the competitiveness of their economy • They propose or adopt rules and regulations which support the interests of the public (for

example safety, health, consumer protection, and protection of the environment) • They promote trade on national, cross-border and international level • They make sure that agreements they have entered into (at bi- or multi-lateral level) are

honored • They try, as a general rule, to simplify and reduce the unnecessary regulatory burdens on

their citizens and on enterprises

The potential of standardization Standardization can assist governments with all of these activities, for example:

• Standards, when agreed voluntarily by the interested parties, can be used in a non-controversial way for the government’s procurement

• The technical agreements which standards provide can facilitate the interaction, co-operation and competition between economic actors. This promotes efficiency and competitiveness in the market

• The network of national, regional and international (worldwide6) organizations is now allowing the standardizing bodies to act as “technical diplomacy” bodies. It is, however, questionable in some cases if private bodies (such as the standardising bodies) trying to secure their financial survival can -and really do- act in the interest of their constituency without guidance and/or their government’s support7.

• In WTO/TBT Agreement, clear reference is made to the obligation of WTO members to base their technical regulations on international standards8 except if these standards are ineffective or inappropriate for the pursuit of legitimate objectives.

Standards can also be used by government to support policies even more directly:

• Standards can be used to support a wide range of governments policy, legislative and other. Obviously this needs to be done in an appropriate legislative framework so that governments are then freed from a continuous effort to update their technical rules. Using standards in this way imposes some additional, and usually unknown, challenges. It is a new way to make laws and to design policies - it assumes a certain level of confidence in the standardization structures9.

6 Such as ISO, IEC and ITU 7 See also in footnote 11. 8 It should however be noted that there is no clear agreement on the meaning of “international standards” 9 See for example: “Methods of referencing standards in legislation with an emphasis on European legislation”, European Commission, [2002], Enterprise Guides. Also accessible on http://europa.eu.int/comm/enterprise/library/enterprise-guides/doc/guide_standards_en.pdf

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• If governments are ready to confine themselves to essential issues in their legislation, then they can leave free space to the economic actors to agree on the technical details; the standardization structures can offer one of the possible solutions for compliance with the law.

The benefits of formal standardization for governments The statements just made are clearly valid for what is called “formal” standardization. However, other forms of co-operation have developed over the years such as Fora and Consortia. The primary aim of such groups is to produce agreements (“standards”). To do this they have had to tailor their procedures and conditions to suit the specific situation they are working on. The result has been a multitude of efficient but sometimes overlapping, contradicting or competing groups. Governments have to check the compatibility of these activities with the law, e.g. in relation to competition rules. But if they need to use the results of these activities in their regulatory activities, the governments also have to check the results i.e. the content of the agreements resulting from these groups.

It is confusing when all documents, regardless of where and how they are developed, take the form and/or the name of a standard. It is difficult for the user of a document to understand the difference between a document that has been developed by a group of narrow interests and one that has been developed by a larger sphere. The user has to understand the different levels of legitimacy and validation between formal standardization and consortia standardization. Only then can they make an informed decision on when to use which type of document.

It is therefore important to distinguish between standardization structures, which aim at producing deliverables just for the authors (as is usually the case in consortia), and those standardization structures, which produce deliverables for the wider ‘unknown’ audience. In other words, the problem of every document having the form or name of a ‘standard’ is that its real value (moral, economic and technical) cannot be evaluated. The non-expert user would have to examine the originating body of the standard before being able to decide on its value.

However, the motivation behind every ad hoc standardization structure such as a forum or consortium is not always easy to find. Their ‘standards’ are a means to an aim, which is not usually known to the user. This is the reason why accountability and transparency of standardization structures are essential requirements for public authorities if they are to accept, and in some way use, the results.

How do we deal with standardization in Europe? The European Union is a special case. It should not be compared with a single country. Member States remain independent and only act together on subjects they have agreed upon.

We believe that standardization offers the same benefits at the European level as it does to the national governments (as highlighted earlier). The same potential exists for standards to play a positive role in a wealth of European policy areas including those affecting our economic, social and environmental situations. In other words, we think that standardization can play a role in helping us to achieve the European goal of sustainable development.

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In the European Commission, we have a dedicated unit dealing specifically with standardization policy for the EU. The other institutions such as the European Parliament and the Council of Ministers give political support to the work of this department. The existence of this department is not an attempt to change the European standardization system in any way but; instead, it has two approaches:

− Firstly, we try to support the European Standards Bodies in their efforts to maintain an open, and transparent system, which satisfies the needs of all stakeholders. In other words we continually check and help to enhance their accountability and transparency.

− Secondly, we can then confidently promote the voluntary use of their work (i.e. European Standards) into a wide range of European policy areas.

A very common fallacy outside Europe is that the European Commission is dictating or even drawing up the European Standards. The European Commission plays no role in relation to the technical choices made in the European Standards; it is only interested in ensuring that the standardization structures and procedures remain efficient, accountable and transparent.

Should governments invest in (formal) standardization? Maintaining a rather complicated machinery which is able to produce good standards is a costly operation. Such a machinery is difficult to be financed solely through the sales of ‘products’ i.e. the standards and related services. The size of the relevant market10, and the need to satisfy the obligation of accountability and transparency, usually makes this impossible. In Europe where 20 or so different national standards have to be superseded by a single European one, the possibilities of the standards bodies to generate income are even more reduced. Nevertheless, as it is made clear earlier, there are important governmental interests, which can be supported and served by these same standardization structures11. This is the reason why the financial viability of these structures is carefully monitored in Europe. In1999, the European Council of Ministers discussed and arrived at some conclusions on the future financing of the standardization activities in Europe. Based on these conclusions, one of the three European standardization organisations, CEN has commissioned a study12 on the subject and the graphic13 is an extract from the resulting report. It is interesting to see here that the European Commission (together with the EFTA Secretariat) “invested” an amount equivalent to 2 % of the total costs in CEN in 1999. This amount can be practically interpreted as the material encouragement, given to the national standards bodies to work together instead of continuing in an individual nation-based ‘mode’14. Other data from the study reveals that, on a national level, the Member States of the European Union support the work of their national standards bodies and express this in the form of some

10 The major limiting factors being language, size of the relevant economy, the varying behaviour of the economic actors vis-à-vis standardization, the need for proximity etc. 11 It is for example questionable if the role of ‘technical diplomacy’ can be best served by the standards organizations if they have to jealously protect their IPRs on their standards by not permitting their broader use in the framework of other (e.g. international) standardization bodies. 12 To the consulting firm Ronald Berger & Partners 13 At the end of this paper. 14 There is however also a ‘legal’ motivation since Directive 83/189/EEC obliges them to exchange their annual work programmes and give the possibility to every national standards body to ask that a given standardization project is carried out jointly at European level.

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kind of financial support. What is particularly interesting is that, between the Member States, there are widely varying degrees of funding for their national standards systems.

Some Member States fund their national standards body to a value of 50% of the costs; others are below 10%. This variation is, no doubt, due to a number of historical, political and economic reasons. However it means that in Europe, collectively, there is a wide experience of the advantages and disadvantages of different levels of government support to standardization.

In any case, it is evident that the investment of the European taxpayer in European standardization represents good value. Standardization done at the European level mobilizes other resources (up to 50 times more). This, in turn, allows more scope for Member States to work together therefore promoting the harmonization of technical requirements throughout the European Union and EFTA.

Is ICT standardization a special case? ICT industry has some well-known characteristics. The most relevant ones in the context of the discussion on standardization are its high innovation rate and the short lifetime of its products. ICT industry cannot, in the majority of the cases, be well served by standardization structures needing extremely long time to produce a standard, by far longer than the expected lifetime of the relevant products. However, this statement has to be qualified. Not all products have a short lifetime; especially those dealing with aspects of the infrastructure of ICT. The GSM standard, for example, is born to stay for long and, to be historically correct, it took long time to be established15. Therefore, the importance of short elaboration periods for a standard lays more in the need of (short) ‘time to market’ than in the reality of the short lifetime of products. Standardization in ICT takes therefore more the form of agreements on choices of technologies than the traditional form of ‘consolidation of technologies’. The products in ICT usually do not exist in the market before a standard has covered them. Standardization in ICT is therefore anticipative.

Fortunately, the ICT sector is rather unregulated. Thus there is only a limited need for public authorities to use ICT standards in support of legal requirements. This clearly distinguishes ICT standardization from other areas, where the protection of citizen's safety and health plays a crucial role. As a result there are fewer incentives to develop formal standards in support of public interest. But this is only one reason that makes ICT standardization rather special. Others are the following: • Although limited, there are nevertheless in Europe some legal frameworks that make use of

ICT standards to be effectively and efficiently implemented such as the Directive on Radio and Telecommunications Terminal Equipment, R&TTE. But in most cases, the reference to ICT standards is usually different from that used in the field of internal market legislation. The e-Signature Directive, for example, calls for standards without, however, specifying which standards shall be developed and by whom. However, it is evident that legal effect can only be given to those standards that result from an open, transparent and inclusive standardization process. In response, the private sector launched in co-operation with CEN and the European Telecommunication Standardisation Institute, ETSI the “European Electronic Signatures Standards Initiative” (EESSI), to produce the required consensus

15 Work on mobile telephony started in Europe at the beginning of 80’s in the framework of CEPT with the establishment of the ‘Groupe Spécial Mobile’.

7

documents. The results of this voluntary standardization initiative will now be referenced by the Commission as an acceptable solution to implement the legal requirements of the e-Signature Directive. However, it should be born in mind that by this reference the legislator “approves” for application the contents of the standard. This constitutes an interesting case of “co-regulation”.

• The high innovation rate and the usually short lifetime of the products of ICT do not necessarily call for formal standards. There is, however, a well-identified need for consensus as demonstrated by the existence of consortia and fora. The ESO's have recently identified a list of active consortia in the ICT domain; there are some 200 consortia on the list16! This may result in a lack of interoperability between various solutions and applications. But not all problems call necessarily for policy action. The consumers are free to choose whatever solution they may want. And if they are too confused none of them will find a market. Where standardization fails, the normal competition rules apply. However, in some cases the lack of interoperability may become also a matter of political concern, as for example in the field of Digital TV. The Digital TV case is a border case. Public Authorities should not select “winning technologies" but leave it to the private sector to define open standards that can guarantee user's freedom of access to those new services. But in order to create favourable conditions for investments in this future technology the need for interoperable solutions has to be ensured by legal provisions or other government intervention.

• ICT has become ubiquitous; a part of business processes in general. Nearly all enterprises are now using PC’s and e-business is increasingly becoming the norm. Technical interoperability is no longer the only problem to be addressed; the issue has become more complex. For instance, in the domain of e-business there is an urgent need to establish e-catalogues for products and services in order to buy and sell online. ICT standardization is therefore leaving the traditional area of technologies and is increasingly dealing also with e-business processes and practises. Consequently, ICT solution providers are not anymore the main players. More and better involvement of IT user industries is needed in order to allow electronic business to flourish, integrating IT fully into the process of ordering, fulfilment and payment. This may result in new organisational forms of standardization and a new balance between generic solutions such as the use of XML as the new business language for the transmission of data (which has to be standardised at global level) and specific IT applications (which have to be tailored to sectoral needs).

Contrary to other areas of technology, Intellectual Property Rights play a crucial role in most of the ICT standards. The existence of carefully followed and applied rules on IPRs becomes an extremely important factor with regard to the accountability and, in some cases the very legality of the relevant standards developing structure. It is however questionable if a standardization structure with a limited membership can fully satisfy the needs related to IPRs since its IPR rules, if any, apply to its members only. The effort to solve the IPR questions in a standardization structure seems to be, at least in theory, contradictory to the very need to have standards not stifling innovation. In every grouping one member has the IPR on a specific aspect and the others ‘have not’. This could naturally guide the ‘have nots’ –being the majority- to include in the standard, probably non-essential requirements in order to have easier access (on the basis of the ‘fair, reasonable and non-discriminatory conditions’ imposed by all IPRs rules) to the IPRs of the member who has it. This may be one explanation of the usually voluminous ICT standards…

16 It is therefore questionable if these fora and consortia better serve the participating interests than the more traditional concentrated standardization structures.

8

From what was said above, it seems evident that in the ICT area standardization has been used to give solutions to problems it was not designed for. On the other hand, no better system has been found for it yet.

Conclusion – The role of government The question of the session is “A proper role of government: follow or lead?”. There is no single answer. Governments can be users of standards both for their procurement and in support for their legislative or other policies. They are therefore interested in having good standards available for use.

The quality of the standards is not based only in their technical content. It is also built on their broad acceptance, on their accessibility for implementation (including IPR questions), on their simplicity, and on their market potential. The governments, as users, have every interest in ensuring that standards originate from structures, which are able to guarantee that all of these qualities are built into the system. Governments, on the other hand, hardly have the required expertise for fully influencing the actual contents of the standards. Therefore, in order for governments to use standards, they have to be the leaders when it comes to the accountability of the system. They have to ensure, through encouragement or motivation, that the standardization bodies have the broadest possible constituency, the widest possible consultation structures, a more balanced representation of interests, and, of course, the most efficient elaboration procedures.

The role of leader, in this respect, is however a delicate one. There should be safety valves in case the power of government can start influencing the very content of the standards.

The solution found in the European Union, through the legislative technique of the ‘New Approach’, demonstrates perfectly that the responsibility for safety and other public interest matters lies with governments. It is for the government alone to define the objectives on these issues and to show the essential targets. However, it is for all the interested parties, together, to find the ways to achieve these and thus define the content of the standards.

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Financing of European standardization in CEN in 1999

1) Including other organizations 2) Industry, trade, consumer organizations, etc. 3) Including other organization EUR 37 m Source: BSI; Roland Berger & Partners analysis

35

15

31

4

70

10

Total EC/EFTA contributions

National Government

Fees

Industry/ interested Parties 3)

100 2 5 93

65,4

Mirror committees

Technical committees

Sales

Expert participation

Cash Fees/memberships1)

of which: through NSBs1)

% of total

18

10

Abbreviations BSI British Standards Institution CEN « Comité Européen de Normalisation » – European Committee for

Standardisation CENELEC « Comité Européen de Normalisation Electrotechnique » – European

Committee for Electrotechnical Standardisation CEPT Conférence Européenne des Postes et Télécommunications DIN « Deutsches Institut für Normung » – German Institute for Standardization EESSI European Electronic Signatures Standards Initiative EFTA European Free Trade Association ESO European Standardization Organization ETSI European Telecommunications Standards Institute EU European Union GDP Gross Domestic Product GSM Initially: Groupe Spécial Mobile (french) ICT Information and Communication Technology IEC International Electrotechnical Commission IPR Intellectual Property Rights ISO International Organization for Standardization ITU International Telecommunications Union NSB National Standards Body R&TTE Radio and Telecom Terminal Equipment TBT Technical Barriers to Trade UN/ECE United Nations’ Economic Commission for Europe WTO World Trade Organization

This report was prepared by Dr Gerhard Leibrock of the Standardisation unit of Directorate G– Single market: regulatory environment, standardisation & new approach – of the EnterpriseDirectorate-General, European Commission.

For further information, contactEuropean CommissionEnterprise Directorate-GeneralStandardisation unitB-1049 Brussels

Fax: (32-2)299 1675E-mail: entr-standardisation@cec.eu.int

A great deal of additional information on the European Union is available on the internet.It can be accessed through the Europa server (http://europa.eu.int).

���� European Communities, 2002Reproduction is authorised provided the source is acknowledged.

1

ForewordThe European legislator makes broad use of standards tosupport Community legislation. Taking into account thecurrent reflections about governance and better regulationwhich recommend an increased use of co-regulatory and self-regulatory practices, it may be expected that the use ofstandards to support legislation will increase as well.

The methods applied while making reference to standards inlegislation vary significantly. The following document givesan overview of the different methods showing concreteexamples with their advantages and disadvantages. It isgeared at all legislators at European, Member State andcountry candidate level and aims to provide recommendationsfor ‘best practice’ to be applied if, while draftinglegislation, the option of using standards is chosen.

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IntroductionStandards are technical documents, prepared by allinterested parties (companies, consumers, workers, publicauthorities) on the basis of a number of principles (e.g.consensus, openness and transparency). Unlike regulations,they are not adopted by an authorised public authority butwithin private, independent and - in the case of Europeanstandards - officially recognised standards organisations.1Standards are a priori not binding and their application isvoluntary.

Standards can also play an important role in legislation, inparticular in technical regulation. If a legislator includesstandards in a legal act or makes reference to them in oneway or another standards can obtain legal quality. Thestandards thus become a part of the requirements of aspecific legislative act or of the system.

The advantages to legislators of making use of standards inlegislation are manifold. Instead of being obliged to findsolutions for difficult technical questions themselves,legislators can rely on the technical expertise of thestandards developers and at the same time save public money.Moreover, thanks to the consensus-based, open andtransparent procedure of setting standards and thesubsequent broad acceptance of standards, the legislator canexpect a broad acceptance of his legislation as well.Finally, standards reflect the latest ‘state of the art’i.e. the latest technical developments. However, in order tofollow the latest technical developments, standards must beregularly revised.2 Accordingly, a legislator making use ofstandards to support legislation should take that intoaccount and choose a legislative option allowing him toavoid having to adapt the whole legal act every time astandard is revised.

At European level, the Community, in its legislation, makesbroad use of the option of referencing standards. This isconfirmed by a recent study3 in which all Community acts inwhich reference is made to standards are listed. Standardsto which reference is made are international standards,European standards and, to a lesser extent, nationalstandards. The methods used vary significantly, depending onthe political will of the legislator. The Europeanlegislator makes direct and indirect reference to standards. 1 Directive 98/34/EC of the European Parliament and the Council laying down a procedure for the provisionof information in the fields of standards and technical regulations (OJ L 204 of 21.7.1998) recognises CEN,CENELEC and ETSI as the official European Standards Organisations.2 The statutes of the European standards organisations foresee a regular revision at least every five years.3 Falke, Internationale Normen zum Abbau von Handsdelshemmnissen, July 2001.

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Direct references can be dated or undated. The legislatorcan allow the use of standards to remain voluntary or makethem mandatory.

The different possibilities for making use of standards inlegislation may be combined, thus establishing a largevariety of ways of referencing standards in legislation.

Based on an analysis of the different combinations appliedby the European legislator, this note intends to presentexamples of the different types of references used by theEuropean legislator and the procedures chosen by him toadapt legislation to technical developments in standards. Itfurther aims to examine their advantages and disadvantagesin the light of legal certainty, and the proceduralimplications of the legislator's obligation to adaptlegislation if a referenced standard is revised.

I . Direct references to standardsDirect references can be established by the primary Europeanlegislator (the European Parliament and the Council), butthe task to carry out necessary adjustments can be delegatedto the administrative authority (Commission, sometimessupported by a Committee). In this case, a specific standardis directly quoted within a legal text. There are two typesof direct references: the dated direct reference and theundated direct reference. By way of a direct reference, inmany cases, a standard is made mandatory. Thus, depending onthe level of the referenced standard (national, European,international), barriers to trade may be created. Moreover,direct references require regular adaptations of thelegislative act in order to remain in line with technicaldevelopment. Finally, a detailed ex-ante control by thelegislator is necessary as to the technical content of thestandard.

A) The dated reference

A reference to a standard is dated if the legislative actquotes the standard by its number and by its date.

General advantages of the dated reference

The major advantage of a direct, dated reference is itslegal certainty. The legislator is the ‘master of theprocedure’ in autonomously choosing exactly the technical

5

solution he wants to be applied. On the other side, theaddressee of the legal act knows exactly which technicalsolution he has to apply in order to comply with thelegislation. In addition, he can recognise the imposedtechnical solution in the legal act itself.

General disadvantages of the dated reference

Nevertheless, the disadvantages of such a method prevail. Asmentioned above, every time a standard is adjusted to thelatest state of the art or even entirely replaced,legislation using that standard will also have to follow ifit wants to respond to the latest state of the art. Thiswill require complicated and time-consuming legislativeprocedures especially if the right of adaptation of thelegal act is not delegated by the primary Europeanlegislator (the European Parliament and the Council).

Examples of dated references

The abovementioned procedural disadvantages of datedreferences are most often avoided in European legislation.While examining the abovementioned study with regard todated standards used in European legislation, one canrecognise that specific procedures are introduced whichsimplify the adaptation of the legal act to revisedstandards.

1) Such a procedure can consist in delegating the adaptationof the legislative act to the Commission supported by acommittee (‘comitology’).

For example Art. 2(2) of Council Directive 79/196/EEC of 6February 1979 on the approximation of the laws of the MemberStates concerning electrical equipment for use in potentialexplosive atmospheres employing certain types of protection4(complementing Directive 76/117/EEC) holds that ‘harmonisedstandards in the meaning of Article 4(4) of the (basic)Directive 76/117/EEC shall mean standards listed in annex Ihereto’. These standards are quoted as ‘EN 50 014/Electrical Equipment for Use in Potentially ExclusiveAtmospheres/1/ March 1977’.

Article 5 of the same Directive then states that ‘thecontents of the harmonised standards referred to in annex Imay be amended by following the procedure laid down in

4OJ No. L 43 of 1979, p. 20 ff, to be abrogated.

6

Article 7 of the (basic) Directive 76/117/EEC’, establishinga management committee following the comitology rules.

Accordingly, in the case of an adaptation, it is notnecessary to trigger the whole legislative process(Commission proposal, discussion in and adoption by theCouncil/Parliament) but instead, to consult a managementcommittee and to find a final solution as foreseen by thecomitology procedure. A further advantage is that, in thecase of dated references which might in this situation beused more often, the legitimated authority remains the‘master of the procedure’. Constitutional problems can beavoided. Legal certainty for the addressee is ensured aswell. Nevertheless, Article 7 of the abovementioneddirective is badly formulated: it is not the legislatingauthority itself which decides on ‘the amendments to thecontents of harmonised standards’ but the respectivestandard organisation. The legislating authority decideswhether to adapt the annex to the Directive to the amendedstandard.

Nevertheless, a committee still needs to be consulted. Thelegal act does not automatically follow the development ofthe ‘state of the art’. 2) The right for adaptation can also be delegated to theCommission alone.

For instance, Commission Regulation (EC) No 2316/1999 of 22October ‘laying down detailed rules for the application ofCouncil Regulation (EC) No 1251/ 1999 establishing a supportsystem for producers of certain arable crops’,5 by which theCommission was entitled to regulate the details, quotes inits Article 4 EN ISO 9167-1: 1995 and EN ISO 5508: 1999 asthe applicable testing methods.

This type is similar to the delegation to a committee andmaintains the advantages of a dated reference, at the sametime removing complicated and time-consuming adaptationproceedings. Nevertheless, a permanent adaptation of thelegal act remains necessary as well.

3) An example of a means to avoid such an obligation isprovided by Directive 94/2/EC of the Commission of 21January19946 implementing Council Directive 92/75/EEC withregard to energy labelling of household electricrefrigerators, freezers and their combinations. Therein,Art. 1(2) establishes that ‘the information required by thisDirective shall be measured in accordance with EN 153 of May 5 OJ L 280 of 30 October 1999.6OJ in 1994 L 45, p. 1 ff.

7

1990 or with harmonised standards the reference s of whichhave been published in the OJ’. This alternative combinesthe clear dated reference with the option to use othermethods, thus removing the obligation of regularadaptations. Nevertheless, the wording of the above Articlemay easily lead to confusion with the user since he mightnot know which standard to use if EN 153 of May 1990 isreplaced but still quoted in the Directive.

B) Undated references

In the case of an undated reference, the European legislatoronly quotes the number of a specific standard, not the date.

General advantages of the undated reference

Compared to the dated reference, this method is certainlymore flexible. In the case of a revision of a referencedstandard, the legal act itself does not need to be adapted.The reference still corresponds to the state of the art.

General disadvantages of the undated reference

The undated reference comprises many negative aspects. Thetext allows the use of subsequent revised versions of thesame standard. The question arises as to what will happen ifthe standards are entirely replaced or if the quoted pre-standard has in the meantime become a standard. In such acase, an adaptation of the legal text with all itsprocedural impact might be necessary as well. Moreover, withundated references, the legislator loses its position as the‘master of the procedure’ and shifts his authority forreference to standards organisations that are notlegitimised for this. Constitutional questions may arise.

Examples of undated references

1) Council Decision 93/465/EEC of 22 July 1993 concerningthe modules for the various phases of the conformityassessment procedure and the rules for the affixing and useof the EC conformity marking, which are intended to be usedin the technical harmonisation Directives7 says under pointA(m) that ‘notified bodies which can prove their conformitywith harmonised standards (EN 45000 series) are presumed toconform to the requirements of Directives’. 7 OJ L 220 of 30 August 1993.

8

This practical example demonstrates the flexibility of theundated reference type. If the EN 45000 series is updated,no adjustment of the Decision should be necessary. Doubtsremain however, if the EN 45000 series are not only updatedbut completely replaced as is currently the case with ENISO/ IEC 17025. For reasons of clarity and certainty, anadjustment of the Decision seems preferable.

2) In many cases, the wording ‘or later modified version’,‘or revised version’ or ‘in the valid version’ are added tothe number of the undated standard. Thus Art. 1 of theCommission Decision of 16 January 2001 establishing tworeference methods of measurement for PCBs pursuant toArticle 10(a) of Council Directive 996/59/EC on the disposalof polychlorinated biphenyls and polychlorinated terphenyls8stipulates that ‘European standards EN 12766-1 and prEN12766-2 and subsequently upgraded versions shall be appliedas the reference method for the determination of PCB inpetroleum products and used oils’.

Here again, the question remains what should happen if thestandards are completely replaced or, in the case of thequoted prEN, have become a formal standard.

II. Indirect references to standardsUnlike direct references, indirect references to standardsare generally made where the legislator intends to allow orpromote their voluntary use. Barriers to trade are avoided.Moreover, indirect references may allow the technicaldevelopment to be followed more easily. In this case, arevision of the relevant standard does not require acorresponding adaptation of the basic legal act.

A) New Approach

Within the New Approach legislation aiming at harmonisingtechnical regulation in the Single Market, standards playan important role. Within the New Approach, the Europeanlegislator clearly defines his political objectives bydefining detailed essential requirements (mostly on healthand safety) which a manufacturer must meet in order tocomply with the legislation. No reference to specific

8OJ 2001 No. L 203, p. 31.

9

standards is made in the legislation itself, the NewApproach is operational without standards.

However, pursuant to the aforementioned Directive 98/34/EC,the Commission can request the European standardsorganisations to elaborate harmonised European standardsnecessary to comply with the essential requirements definedin the respective legislation. Standards thus complementlegislation as they provide technical specifications of theessential requirements set up by the European legislator.Any manufacturer who wants to market his products withinthe Single Market must meet the essential requirements. Oneway of doing this is to comply with harmonised Europeanstandards, the references of which are published in the OJ.In this case, the New Approach Directives conferpresumption of conformity of a product with thelegislation.

Thus, the New Approach leaves the technical workcomplementing and specifying legislation to bodies withoutlegislative authority. Unlike in the case of directreferencing, an ex- ante control of the technical work bythe legislator does not take place. The European legislatorhas faith in the accountability of the European standardssystem. This system does and must, according toconsideration n° 24 of Directive 98/34 ensure that ‘Europeanstandardisation system is organised by and for the partiesconcerned, on the basis of coherence, transparency,openness, consensus, independence of special interests,efficiency and decision making based on nationalrepresentation’. Nevertheless, there is the opportunity ofan ex- post control. By introducing the possibility offormal objections against a harmonised European standard,the New Approach has also established a system allowing boththe Commission and the Member States to control theconformity of a harmonised European standard with the legalrequirements defined by legislation.

General advantages of the New Approach

The way in which standards are used in the framework of theNew Approach avoids most of the disadvantages demonstratedwith the other solutions mentioned above. Thus:

� The legislator can request the European StandardsOrganisations to carry out technical work which isnecessary to support technical regulation. The Europeanstandards system is accountable. An ex- ante control ofthe result of the standardisation work is not necessary.Nevertheless, the European legislator maintains control

10

of the final results as he needs to publish thereferences of these standards in the OJ in order for thestandards to have legal effect (presumption ofconformity). Constitutional doubts that a non-legitimisedactor is carrying out legislation cannot emerge;

� If there is a revision of the standard, no revision ofthe legislative act itself is necessary, the referencesof the revised standards just need to be published. TheNew Approach legislation always corresponds to the ‘Stateof the Art’;

� The addressee of the legislation has certainty about therequirements he has to meet since the references ofrelevant standards are published in the OJ.

General disadvantages

Despite the above mentioned advantages it must be admittedthat the legislator has less influence on the final outcomethan in the case where he can himself choose a standard. Anex-post procedure of safeguard cannot provide the samequality of control as an ex-ante legislative procedure.Therefore, it must be ensured that the system of Europeanstandardisation remains as accountable as it presently is9.

A New Approach example

The essential rules are more or less the same in all NewApproach Directives. The recent Directive 1999/5/EC of theEuropean Parliament and of the Council of 9 May 1999 onradio equipment and telecommunication equipment and mutualrecognition of their conformity is a good example amongmany.10

Article 2(h) of this Directive defines a ‘harmonisedstandard as a technical specification adopted by arecognised standards body under a mandate from theCommission in conformity with the procedures laid down inDirective 98/34 for the purpose of establishing a Europeanrequirement, compliance with which is not compulsory.’

Article 5 of the same Directive stipulates that ‘whereapparatus meets the relevant harmonised standards or partsof it whose reference numbers have been published in the 9 This was only recently confirmed by the Council in its resolution of 28 October 1999 on the role ofstandardisation in Europe (OJ 141 of 19 May 2000).10 OJ L 091 of 7 April 1999.

11

Official Journal of the European Communities, Member Stateshall presume compliance with the essential requirementsreferred to …..’

Article 9§3 of the Directive establishes a procedure offormal objections against shortcomings of harmonisedstandards not complying with the essential requirements ofthe Directive.

B) ‘State of the art’

A further method of making use of standards to supportlegislation but not to quote them directly is the so-calledreference to the ‘state of the art’ or ‘acknowledged rulesof technology’ within legislation. State of the art in thiscase means that if a manufacturer meets the latest standardswhich, however, are in no way specified, the law presumesthat this manufacturer complies with the relevantprovisions. The state of the art model is somewhat similarto the New Approach. Community legislation does not havesuch a type of reference whereas Member States' legislationdoes11. The mere reference to the state of the art isproblematic. The only advantage to this solution is that itis not necessary to adjust legislation in case of a revisionof the relevant standard. The disadvantages prevail. Thelegislator leaves complementary legislative work to non-legitimised organisations without having any possibility ofcontrol. A manufacturer has no certainty which standardexactly corresponds to the state of the art.

SummaryThe analysis has demonstrated that Community legislationmainly makes use of two methods of using standards tosupport legislation: the direct reference either dated orundated and the indirect reference in the New Approach. Theexamples mentioned above have shown that the directreferences contain disadvantages per se (barriers to trade,need to adjust legislation) which the primary Europeanlegislator tries to reduce partly by delegating the task ofadjustment to the administrative authorities. Nevertheless,there remain different types of delegations. Moreover, thereis no coherent application of the method of directreferences. Sometimes, direct referencing is confusing(dated and undated reference) and raises constitutionalproblems (undated reference). 11 Schepel, Falke; ‘Legal Aspects of standardisation in the Member States of the EC and EFTA, Vol. 1, pp.187, 188.

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In the New Approach method, the European legislator combinesthe advantages of direct referencing (legal certainty) withthose of indirect referencing (avoiding barriers to trade,no adjustment of legislation necessary). In addition, theNew Approach Directives have a coherent construction and arebased on the same principles. Making use of the accountableEuropean standardisation system renders an ex-ante controlof the technical results unnecessary. The risk of confusingthe addressee of legislation can be more easily avoided.

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL New Approach Industries, Tourism and CSR Standardisation

Vademecum on European Standardisation

Part II

European Standardisation in support of European policies

Chapter 3

Models of articles on standardisation issues to be included in drafts of New Approach directives

15 October 2009

Status of the document: Final Author: DG ENTR I/3 For further information: entr-standardisation@cec.eu.int

2

MODELS OF ARTICLES ON STANDARDISATION ISSUES TO BE INCLUDED IN DRAFTS OF NEW APPROACH DIRECTIVES

I. New Approach legislation

1. The New Approach as a legislative technique The “New Approach” was born on 7 May 1985. It moved away from the “Old Approach” of prescriptive detailed technical requirements written into the legislation. The New Approach is a legislative technique which limits harmonisation to essential requirements. These “essential requirements” are in particularly health and safety requirements for products. This simplification was a step forward in the legislative provisions, allowing all the technical elements for product specification to be covered in harmonised European standards, not the legislation itself; thus providing a flexible, technology-neutral and non-prescriptive means of regulation. A manufacturer therefore has the flexibility in how to conform to the requirements and to demonstrate compliance. The final step is that the manufacturer applies the CE marking to identify that the product complies with the law. The New Approach is a legislative technique used in the area of free movement of goods, particularly of industrial products. Parallel to its legislative programme, the Community also developed a policy to reinforce European standardisation in order to develop voluntary harmonised European standards, conformity with which gives presumption of conformity with relevant legislative provisions. 2. New Legal Framework In 2008, a new package of measures which are intended to boost intra-community trade in industrial goods was adopted. These measures will ensure that the internal market does indeed become a reality for all manufacturers and producers, and will make it easier for companies, especially SMEs, to trade their products in the Union. High quality safe products will continue to be the goal, whilst ensuring market access for goods. This new package of measures includes also Decision No 768/2008/EC on a common framework for the marketing of products1. Decision No 768/2008/EC provides a toolbox of measures which will, in future, be integrated into the legal framework as sectoral specific New Approach directives are adopted, revised or updated. This will give the means to clarify commonly used terms (which today are often used differently) such as manufacturer, distributor and authorised representative so that all stakeholders can be clear on relative responsibilities. Decision No 768/2008/EC also provides the following definitions of terms related to standardisation: a. Harmonised standard Decision No 768/2008/EC introduces a common definition of a harmonised standard in Annex I Chapter R1 in order to clarify this commonly used term.

1 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common

framework for the marketing of products, and repealing Council Decision 93/465/EEC, OJ L 218/82, 13.08.2008, p. 82

3

ANNEX I

REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS

Chapter R1

Definitions

Article R1

Definitions 9. "Harmonised standard" shall mean a standard adopted by one of the European

standardisation bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that Directive.

b. Formal objections The New Approach directives contain a clause according to which a harmonised standard can be challenged through a formal objection. Decision No 768/2008/EC provides in Article in Annex I, Chapter R3, Article R9 for a “standard” text of such a clause to be applied in all future New Approach Directives:

Formal objection against harmonised standards

1. When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements which it covers and which are set out in … [reference to the relevant part of the legislation], the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, hereinafter the "Committee", giving its arguments. The Committee shall deliver its opinion without delay.

2. In the light of the Committee’s opinion, the Commission shall decide to publish,

not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.

3. The Commission shall inform the European standardisation body concerned and,

if necessary, request the revision of the harmonised standards concerned. II. Other legislation

For information on how to refer to standards in other European legislation, please consult also the document “Methods of referencing standards in legislation with an emphasis on European legislation“ (see Part II, Chapter 2 of the Vademecum).

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL New Approach Industries, Tourism and CSR Standardisation

Vademecum on European Standardisation

Part II

European standardisation in support of European policies

Chapter 4.1

Role and preparation of mandates

15 October 2009 Status of the document: Draft Author: DG ENTR I/3 For further information: entr-standardisation@ec.europa.eu

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL New Approach Industries, Tourism and CSR Standardisation

Role and preparation of mandates

Contents Introduction Chapter I - Role of mandates

1. Basis 2. Status of mandates

Chapter II - Preparation and issue of mandates 1. Types of mandates 2. Requirements with regard to the contents of a mandate 3. Procedure for preparing a draft mandate 4. Procedure for consulting the Standing Committee 5. Procedure for transmission to the European standardisation bodies and

acceptance by these bodies Annex 1 - Basic documents laying down the concept of a mandate Annex 2 – Template mandate with typical clauses

2

Introduction

The original verison of this document (from 2003) followed a request from the Council in its 1999 Resolution1: "The Council calls upon the Commission

- to ensure that standardisation mandates under the new approach are prepared accurately and efficiently, affording Member States and the European standards bodies sufficient opportunity to contribute;

- to ensure that standardisation activities covered by mandates are subject to

thorough monitoring and that appropriate measures are examined with the European standards bodies in order to ensure proper progress".

The aim of this revised document remains to describe, on the basis of the "acquis", the common understanding by all parties directly concerned of the role of mandates. The document also establishes the guidelines for the preparation and adoption of mandates. The term "parties directly concerned" means the Commission services, the Member States, the European standardisation bodies2, and the New Approach consultants. The involvement of other various parties (industrial, social partners, consumers, environmentalists, etc.) and their role in the initiation and the preparation of mandates is also reflected and recognised in this document. The original version of this document of 2003 has been reviewed by the Commission services in order to bring it up to date and to recognise changes in practice, in the agreements between the Commission and the European standardisation bodies (e.g. on the Annex ‘Z’) and the shift of emphasis in the mandates issued away from the New Approach sectors and toward new areas, such as support to environmental policies and legislation. This document is applicable as guide for mandates under the New Approach directives, in fields relating to legislation other than the New Approach and in general in support of European policies outside European legislation. However, legislation other than New Approach directives (for example Directive 2001/95/EC on General Product Safety3) can contain partly differing provisions, for instance with regard to the setting and consultation of mandates. The document is divided into two sections: - Chapter I deals with the role and place of mandates as an instrument for public authorities. - Chapter II gives an exhaustive account of the elements designed to respond to the

Council’s first request relating to the accurate and efficient preparation of mandates.

1 OJ C 141 of 19.05.2000 2 see Annex I of the Directive 98/34/EC (OJ L 204, 21.7.1998, p. 37–48) 3 OJ L 11 of 15.01.2002, p.4

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A separate part of the Vademecum deals with the monitoring of mandates, as stated in the Council’s second request, and to information on mandates and on their implementation.

Chapter I - Role of mandates 1. Basis 1.1 Reference documents Standardisation is a process based, in principle, on the needs of the market. One of the specific actors in this market is the public authorities, which require technical specifications in order to implement European legislation and/or policy. These needs should be given close attention because they safeguard public interests. The development of technical specifications increasingly requires expertise as well as the involvement of the various parties concerned (industrial, social partners, consumers, environmentalists, etc.). This led to the idea that appeared in the 1980s of asking the standards bodies to draw up technical specifications required by the public authorities. This concept was incorporated in three basic documents: a. Directive 98/34/EC4. The provisions of this Directive form the legal basis for the

mandates, the Commission’s requests to the European standardisation bodies to draw up European standards or to carry out some other standardisation work (cf. Annex 1: Article 6(3) and (4)(d)). The committee established by this Directive must be consulted on these requests.

b. The general guidelines on cooperation signed between the Commission and EFTA on the

one hand and CEN, CENELEC and ETSI on the other hand5. c. Council Resolution of 7 May 1985 on the New approach to technical harmonisation and

standardisation6. This involves a fundamental principle of the New Approach, which stipulates that, for the directives based on this method, the task of preparing technical specifications is entrusted to the competent standardisation bodies. This resolution also specifies that the quality of the harmonised standards must be ensured by the standardisation mandates, "the execution of which must conform to the general guidelines on cooperation” (cf. also Annex 1).

Currently more than 30 directives, in particular the "New Approach" directives, entrust mandates to the European standardisation bodies, after consultation of the Standing Committee7. The

4 OJ L 204, 21.07.98, p. 37. The Directive 98/34/EC is a codification of the Directive 83/189/EEC and its amendments 5 OJ C 91, 16.04.2003. These general guidelines replaced the original General Guidelines of 1984 6 OJ C 136 , 04/06/1985 P. 0001 - 0009 7 The Standing Committee set up by Article 5 of Directive 98/34/EC (OJ L 204, 21.7.1998, p. 37–48), also known as the ’98/34 Committee‘ or the ’Committee on Standards and Technical Regulations‘

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Decision on financing of European standardisation8 stipulates that mandates are eligible for financing only if they have been consulted in the Standing Committe. Several of these directives also refer to the general guidelines on cooperation and to harmonised standards which, by their definition, are elaborated on the basis of a standardisation mandate. In the meantime, several mandates have already been issued in the framework of directives inspired by the New Approach concepts, where general reference to standards is made. This is for example the case for the directives on energy labelling, general product safety, as well as the Interoperability Regulation concerning the Single European Sky. A number of mandates have also been issued in support of other European Community legislation than the New Approach legislation (e.g. mandates for development of test methods in support of the Community legislation on foodstuffs). In addition, a large number of mandates have already been issued outside the purely legislative framework in support of European policy. 1.2 Concept 1.2.1 The concept of a mandate is based on the principle of partnership, cooperation and the clear division of tasks between the public authorities and the duly recognised European standardisation bodies. Through a mandate, the public authorities ask the European standardisation bodies to draw up technical specifications of a normative nature that meet "their" requirements. In practice, these standards must enable manufacturers to design and manufacture products that comply with the legal requirements. On the one hand, it is up to the public authorities to lay down strict requirements in order to safeguard the public interest. On the other hand, it is up to those responsible for preparing the standards to draw up suitable standards that meet these requirements and take account of "the state of the art". Therefore, it is not a question of delegating power but of recognising the specific competencies of each operator. It is the mandates which describe and justify, case by case, the tasks that the public authorities assign to the European standardisation bodies. It is on these mandates that the clarity of each party's role, the complementarity between regulations and standards and the quality of European standardisation depend. 1.2.2 The choice of standards bodies is justified by the fact that these bodies have an appropriate structure and work according to clearly defined and recognised procedures. In the standards bodies several basic principles are applied, such as the participation of all the interested parties, transparency, the establishment of consensus, the public enquiry and the vote. The standardisation work required must also be achievable for the European standardisation bodies within a reasonable time period. This condition is assessed in light of their potential technical capability and their ability to apply the basic principles of standardisation mentioned above. 1.2.3 Experience shows that those who draw up standards are not in a position to provide high-quality standards or are even blocked in their work if, in a previous stage, the regulatory/essential9

requirements are not sufficiently precise and/or if "political" choices are left

8 OJ L 315, 15.11.2006, p. 9 9 The expression "essential requirements" is a specific expression used for the regulatory requirements in the framework of New Approach directives.

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open. "Political" choices cannot therefore be left to the standards bodies. When a new directive based on the New Approach is being drawn up, close attention must be paid to the detailed and precise establishment of the essential requirements. 1.3 Areas in which mandates can be used The method of referring to standards, applied for the first time systematically in the New Approach directives later became more common in certain other fields. This approach was formally encouraged, in the first instance, by the Council Resolution of 18 June 199210

(points 17 and 21) calling on the Commission to apply this method, where necessary, in future European draft legislation. Moreover, this Council Resolution (point 17) also encouraged the use of European standards as an instrument for economic and industrial integration in the single market. This involves promoting European standardisation in this European policy, even in cases where it is not based on legislation, as in the field of new technologies. The Council Resolution of 28 October 199911 also emphasises in point 10 "the role of European standardisation as a means to meet specific needs of the European market, to serve the public interest, in particular in support of the European policies, to provide standards in new domains...". In its Resolution of 10 November 200312, the Council acknowledged the importance of the New Approach as an appropriate and efficient regulatory model allowing technological innovation and enhancing the competitivness of European industry, and confirmed the necessity of extending the application of its principles to new areas. According to the Commission Communication on the role of European standardisation in the framework of European policies and legislation of 18 October 200413, "the extension of making use of standards in areas of Community legislation beyond the Single Market is highly desirable, taking of course into account the specificities of the ares concerned, in accordance with the Commission proposals on governance and better regulation". 1.4 Practical benefit of a mandate for the European standardisation bodies Mandates enable the European standardisation bodies to have precise details on the common expectations of the public authorities, to draw up a well defined number of standards and to plan their work. Mandates should be regarded as reference documents for the standardisation activities.

10 OJ C 173 of 09.07.1992 11 OJ C 141 of 19.05.2000 12 Council Resolution of 10 November 2003 on the Communication of the European Commission "Enhancing the Implementation of the New Approach Directives" (OJ C 282 25.11.2003 p. 3) 13 COM (2004) 674 final

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Recommendations A 1. Experience has shown that referral in legislation to standards and thus the use of mandates in legislation is a tried and tested technique which should be continued and even promoted in new fields. 2. The use of the mandating method outside European legislation also ought to be encouraged if it fits in with European policy. However, this method should not be considered as a substitute for regulations which have failed. 3. When a New Approach-type directive is being drawn up or revised, the Commission services must ensure that the essential requirements are as precise as possible. 2. Status of mandates 2.1 Reference framework Mandates specify the public authorities’ expectations towards the European standardisation bodies. They indicate the general context of the standardisation work, as regards a given European policy and/or the legislation concerned. It is a unilateral act inviting the European standardisation bodies to draw up standards, responding to certain conditions - such as the risks to be covered - and assuming certain tasks. Mandates must be regarded as the framework which refers to the public interest requirements and which enables the standards bodies to develop quality standards that meet these requirements. Under the New Approach, if there is any doubt about a standard, reference should be made to the essential requirements of the directive concerned. These requirements must be regarded as the only legal reference points. The Commission services have examined the question of the legal status of a mandate and the result of this examination is presented in a separate document. 2.2 Commitment of the European standardisation bodies Although in theory the European standardisation bodies can refuse a mandate, in practice these cases are rare. Nevertheless the European standardisation bodies sometimes ask for changes to the mandates with the view of their acceptance. The acceptance of the mandate by an European standardisation body must, however, be regarded as a commitment on its part and on the part of its members to complete the work required within the time agreed. If an European standardisation body is not in a position to fulfil this commitment, it must inform the public authorities (namely the Commission and, if necessary, the Member States through Standing Committee) clearly stating the reasons. The support of these public authorities must be obtained in order to be able to amend or, if necessary, cancel this commitment.

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This commitment should be distinguished from the possible contract (grant agreement) which may be signed between the Commission and a European standardisation body following a mandate and which stipulates the European financing requirements as well as the methods for supplying the documents/reports. Recommendations B 1. A standardisation mandate is a request from the Commission to the European standardisation bodies, after having received the opinion of the Standing Committee, to draw up and adopt European standards or alternative standardisation deliverables or to carry out some other standardisation work. A mandate must specify the needs of the public authorities, indicating the context of the European policy and, where appropriate, referring to the requirements of the legislation concerned. 2. If there is any doubt regarding the validity of a harmonised standard, reference must be made to the essential requirements of the legislation on which the mandate is based. 3. A mandate accepted by the European standardisation bodies should be regarded as a firm commitment on their part with respect to the public authorities. If the European standardisation bodies are unable to meet this commitment, detailed reasons should be given to enable the public authorities to consider an amendment of the mandate including the timetable for completion.

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Chapter II - Preparation and issue of mandates

This chapter is devoted to the aspects that make it possible to draw up mandates with greater accuracy and efficiency. Before defining the contents of a mandate it is necessary to outline the various types of mandates, which have different functions. This chapter then sets out the current and possible elements of the three procedures, namely the preparation of draft mandates, the consultation of the Standing Committee and transmission of the mandate to the European standardisation bodies. 1. Types of mandates 1.1 Study, programming and standardisation mandates In principle, there are three types of mandates: study mandates, programming mandates and standardisation mandates. a. The study mandate aims to determine if European standardisation is relevant and feasible in a specific field or for a certain subject. This type of mandate is most common in non-regulatory fields or for new sectors. b. The programming mandate asks the European standardisation bodies to draw up a standardisation programme in a given time. This programme has to contain inter alia the subjects to be standardised, the relevant technical organisations as well as the completion dates laid down. It can also include an inventory of the existing standards to be revised in order to meet the set requirements. c. A standardisation mandate calls on those drawing up standards or other alternative standardisation deliverables to prepare and adopt within a given time European standards in a specific field, possibly on specific subjects. It can also include the verification, and, if necessary, the revision of existing standards. The list of the subjects and/or standards (new standards and existing standards to be revised) that the European standardisation bodies will draw up on the basis of this mandate should be regarded as the work programme under the mandate. It makes it possible to follow the work that is planned and to monitor the progress made in executing the mandate. Apart from these three types of mandates, there are also "combined" mandates. This involves mandates asking the European standardisation bodies to prepare in a first phase a work programme and in a second phase the implementation of this programme. This normally happens in the case of major standardisation work where several families of products and/or several issues (safety, for instance) need to be dealt with. At the end of the first phase, a "right of inspection" by the public authorities (the Commission and possibly the Member States through Standing Committee) can be included, according to needs, in the standardisation programme. This right of inspection may be under various formats: for information, for opinions or for approval (in this case with possibility of removing or adding subjects).

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In principle, any type of publication by the European standardisation bodies may be the subject of a standardisation mandate. However, in practice, and a fortiori for the directives under the New Approach, it is mostly limited to European standards (ENs) in order to ensure that the various principles of European standardisation (such as identical transposition at national level) are applied. Indeed, it is necessary that within the framework of the various European policies, there are identical standards throughout the European Union. In order to avoid any misunderstanding, it is therefore necessary to specify in each mandate the type of document to be provided. 1.2 Closed and open mandates The first important mandates contained the detailed inventory of the standards to be worked out or the subjects to be standardised. These were what are called closed mandates, which resulted in the need to amend the initial request when those drawing up the standards deemed it appropriate, in the course of their work, either to combine the specifications in another way or to add other subjects to be standardised, in the field referred to by the mandate. Now the important mandates are open. The European standardisation bodies may, during standardisation work, add or modify to a certain extent the subjects referred to in the programme submitted, after having informed the Commission services and, in the event of a major amendment, the Standing Committee. 1.3 Mandates of limited or unlimited duration Once the standards are adopted and submitted to the Commission, it is considered that the mandate has been completed. However, the mandates must not be regarded as closed, but as being "dormant". Indeed, the revision of a European standard to adapt it to technical progress (cf. the internal rules of CEN and CENELEC) must in principle be regarded as having to be carried out under the terms of reference of the mandate in question. In particular for the revision of the harmonised standards drawn up under the New Approach directives, the same standardisation principles and the same procedures valid for the first version of the harmonised standard continue to apply (inter alia the procedure for publishing the standard references in the OJ, as well as the formal objection procedure). The question of possibly maintaining the standstill14

does not arise. A national standardisation body may in fact never begin work on a subject that has already been the subject of European harmonisation. It is clear that revision of a standard in response to a formal objection15

should require a specific request, in other words a supplementary mandate, from the public authorities. Even if a European standardisation body is already in the process of revising the standard in question, a commitment on its part will be useful as regards the aspects to be improved and the deadlines for completing this revision.

14 See Article 7 of Directive 98/34/EC: the national standardisation bodies should not take any action which could prejudice the harmonisation intended. 15 For details on formal objections see Vademecum on European standardisation, part II, document 6: „Formal objection to a harmonised standard - Guidelines for the administrative procedure“

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Recommendations C 1. For important standardisation work, it is recommended that firstly a programming phase be provided for, either through a separate programming mandate or through a combined mandate. In the case of the New Approach directives, it is advised that the standardisation programme be submitted to the Commission services for their approval, before proceeding to the implementation stage. 2. Even without a specific programming mandate, the response from the European standardisation bodies should contain a work programme, which will also make monitoring easier. 3. The mandates drawn up under the New Approach directives continue to be valid in order to ensure and provide a framework for adapting the harmonised standards to technical progress. 4. The revision of a harmonised standard following a formal objection requires in principle a specific request, i.e. a supplementary mandate, from the public authorities. 5. It is advisable that public authorities' requests to the European standardisation bodies for any type of normative document should be drawn up in the form of a mandate. 2. Requirements with regard to the contents of a mandate As indicated above, the mandate defines the public authorities' expectations of the European standardisation bodies. It is therefore important to pay close attention to the contents of a mandate. Indeed, the quality of a mandate has a significant influence on the standardisation activities and therefore also on the quality of the standards drawn up. Several elements should be included in a mandate. The mandate should answer clearly the following questions in relation to the standardisation work requested:

Why? What? How? When? Who?

2.1 Title of a mandate The title should contain the key elements of the description of a mandate. It should specify the type of the mandate (study mandate, programming mandate or standardisation mandate).

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It must state to which of the European standardisation bodies it is addressed and which specific subject it covers. Mandates are in principle sent to the three European standardisation bodies, except if it is evident that only one or two bodies will be responsible for its implementation. The systematic issue of mandates to the three European standardisation bodies avoids the public authorities intervening in the division of tasks between the European standardisation bodies. The fact of sending a mandate to a single European standardisation body cannot be considered as barring the participation and/or contribution of other European standardisation bodies. Optionally, it may make a reference to the legislation or policy area under or in which it is to be developed. 2.2 Justification and indication of the framework of the European and regulatory policy A mandate can be issued on the basis of: - either legislation (e.g. a New Approach directive that foresees the use of harmonised

standards or the Single European Sky Interoperability Regulation that foresees the development of standards that will become Community Specifications),

- or policy (e.g. to support the creation of lead markets or to promote policy objectives such

as accessibility). It can also be a combination of these two elements. A mandate must firstly set out the context of the relevant European policy, the basic legislation and the specific legislation. Moreover, if necessary, reference should be made to the other European policies to be taken into account, as well as to the corresponding legislation. This document therefore has to describe the framework in which the standards are required to support a policy and/or legislation. It should be stressed that, even for mandates outside European legislation, it is necessary to specify the political framework for the requested standardisation by drawing attention, for instance, to documents of a "political" nature. References to mandates already approved in this field or for the products concerned are also useful. The mandate must also justify the need for the harmonised technical specifications as well as the goals to be met when these are available and used. These elements should be regarded both as justification of the public authorities' request and as a framework within which the European standardisation bodies are supposed to work. The mandate text does not, however, need to explain the legal basis for the issuing of mandates under Directive 98/34/EC. This is assumed for standardisation requests.

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2.3 Reference to and clarification of the requirements It is also important for the mandate to be precise as regards the regulatory/essential requirements and conditions imposed on European standards (for example, the aspects - such as risks - to be covered by these standards). In the case of legislation, and specifically in the case of the New Approach directives, the mandate must at least refer in detail to the essential requirements quoted in that legislation. When these essential requirements are very general, it is useful to clarify and explain them, while taking care not to restrict or expand them. The more precise a mandate, the easier it is to verify at a later stage the conformity of the standards drawn up under this mandate with these regulatory/essential requirements. Where there is a specific need, it will be possible and even necessary to draw up a very precise mandate. This may be the case when it becomes evident, following the introduction of a formal objection, that a standard does not comply entirely with the essential requirements and/or that there is a need to revise the standard. However, serious consideration should be given to the level of detail of the request. As the mandate forms the terms of reference for the work the European standardisation bodies are to do for the Commission, the mandate should give the European standardisation bodies a sufficient level of detail. An insufficiently precise mandate will lead to differences in interpretation and the possibility that the European standardisation bodies will deliver work that is not well targeted to Commission needs. However, the mandate should not be too detailed as this may mean that it will need to be amended on several occasions if it transpires during the standardisation process that certain elements cannot be delivered in the precise way envisaged. This question of the level of precision should be discussed with the European standardisation bodies as part of the informal consultation of the draft mandate. Mandates relating to safety and/or health aspects not covered by the New Approach should refer to one or more risk assessments of the products concerned and may include data on actual accidents. These mandates must also take account of the existing standardisation and regulatory situation in the most up-to-date manner possible. The services developing the mandate should consider making a request to the European standardisation bodies to take into account any environmental impacts that would arise from the work to be carried out. 2.4 Involvement of the parties concerned The question arises as to whether it is essential to specify in a mandate certain basic principles of standardisation which are normally applied, such as openness to the various parties involved and their possible participation and the need for standardisation to be based on a consensus between all the parties. In general this is not necessary, except if there is a desire to stress explicitly the specific collaboration and involvement of certain interested parties, such as environmental bodies or consumer associations. Where appropriate, it is also necessary to specify the need or usefulness of collaborating with specific bodies, which are competent in the area concerned.

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2.5 Completion dates A mandate also specifies the dates of adoption of the standards and if possible the dates on which these documents must be ready for public survey. These details are included either in the body of the mandate or in the attached work programme. 2.6 "Standard" clauses Lastly, each mandate must contain "standard" clauses, such as the standstill for national activities and the close cooperation between European standardisation bodies (see Annex 2 for more information). Two remarks can be made on the subject of the standstill arrangement: - the standstill arrangement must be taken to refer to Article 7(1) of Directive 98/34/EC, - in the case of blockage of standardisation work at European level, this standstill cannot be

lifted unilaterally by the standardisers. Each individual issue related to lifting the standstill must be discussed with the public authorities, taking into account the solution being considered for the suspended work covered by the mandate.

As regards work at international level, it should be noted that in principle nothing prevents the European standardisation bodies from applying the agreements with the ISO/IEC so that work under a mandate is carried out in these bodies. However, the European standardisation bodies must ensure that the standards resulting from this work correspond to the requirements of European legislation and the mandate, including the completion dates and conform to the cooperation guidelines. This means that the clause in the mandate which allows specific work to be transferred to the international level must contain particulars which make it possible to verify after the event that these criteria have been met. 2.7 Relationship between content of the standard and essential requirements for harmonised standards for New Approach Directives For each harmonised standard for a New Appproach Directive, there should be a clear and precise indication of the relationship between its content and the essential requirements covered. It should preferably be contained in the standard itself (e.g. as annex thereof). This indication is very useful for a number of reasons: - it enables the Commission services to check whether this standard actually covers in an

appropriate manner the essential requirements indicated, and, where appropriate, if the standard covers aspects outside legislation;

- it provides manufacturers using the standard with a working tool enabling them to comply

with the essential requirements of a directive.

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The indication of this relationship during the preparation phase of a standard allows all parties concerned to assess the work in progress and check that the work does indeed correspond to both the Directive and the mandate. In particular, this information should allow the users of a standard to establish to which level this standard provides presumption of conformity with the essential requirements covered. Recommendations D 1. A mandate is only justified if there is a need on the part of the public authorities. Such a request must specify as far as possible the political expectations and the requirements of the public authorities. 2. In addition, a mandate must, if possible, clarify and explain the requirements in cases where they are too general in European legislation, while remaining consistent with the regulatory/essential requirements. A mandate must guide the standardisers, without imposing constraints at the level of the elaboration of the technical solutions. 3. A mandate must spell out a number of elements, which allow it to be monitored, and the standards supplied to be formally verified. 4. Any amendment to a mandate has to undergo the same procedure as the mandate itself. In order to avoid such amendments, the Commission services have to pay special attention to the formulation of draft mandates. In particular, the level of precision and detail has to be considered here, this should be discussed with the European standardisation bodies already as part of the informal consultation of the draft mandate. 3. Procedure for preparing a draft mandate The mandate is normally drawn up at the initiative of a Commission department. However, Article 6(3) of Directive 98/34 stipulates that the Standing Committee may ask the Commission to invite the European standardisation bodies to draw up a European standard. The initiative for a mandate stems from the public authorities. This does not prevent the various players on the market, such as consumers, from contacting these authorities to demonstrate the value of having a mandate, and so of having European standards, in a particular area. Before a mandate is submitted to the Standing Committee, the various parties involved must be consulted informally in order to make sure that this mandate will be accepted and will produce results that are acceptable. This provision makes it possible to respond to the Council’s invitation of 28 October 199916 to afford "Member States and the European standards bodies sufficient opportunity to contribute" (cf. point 25, indent 1).

16 OJ C 141 of 19.05.2000

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It must however be ensured that these informal consultations take place within a reasonable time. A correct balance has to be struck between the requirement to consult the various parties concerned in advance and the need to issue a mandate quickly. One must also take account of constraints such as the lack of availability at this stage of the three language versions. Moreover, the role of the Standing Committee and its members, as stipulated in Article 6(4)(e) of Directive 98/34/EC, cannot be overlooked. A mandate with a very broad scope or on a difficult subject requires a more in-depth consultation. Moreover, apart from internal consultation within the Commission, as indicated above, certain other guidance has already proved useful, such as: 3.1 Stable legislative text In the case of new legislation, it is not always essential to await its final adoption before issuing a mandate. However, a stable text must already be available in order to begin standardisation work. A mandate based on the "common position" makes it possible to save time as regards standardisation and even as regards the implementation of the legislation concerned. In some cases it may be useful to issue a mandate, and particularly a programming mandate, as early as the moment of the adoption of the draft directive by the Commission. 3.2 Consultation of the national administrations concerned It is useful for the service responsible for a mandate to firstly consult its usual contacts in the Member States in order to verify if a mandate adequately meets the needs of the European policy and/or legislation concerned. The existence of a specific sectoral framework composed of the Member States, in charge of the implementation of this policy/legislation is an asset in consulting the competent national public authorities in the field concerned. Where this consultation occurs, it should be mentioned in the mandate text. 3.3 Informal consultation of the European standardisation bodies

It is recommended that the responsible service, makes informal contact at the same time with the European standardisation bodies, and even, through their central secretariat, with the technical committee concerned, in order to verify whether it is possible for the standards to be completed within the desired time frame. This enables the technical committee to programme the necessary work even if the mandate has not yet been formally accepted. 3.4 Consultation of the other stakeholders Depending on the field concerned, direct consultation of the other interested parties (social partners, consumers, SMEs, relevant industry associations, etc.) should also be provided for. For example, in the case of a mandate relating to consumer health and/or protection, it is clear that the association ANEC should be consulted directly.

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Recommendations E 1. In the case of new legislation, it may be useful not to await its final adoption before issuing a mandate; however the text must already be stable. 2. Before submitting a mandate to Standing Committee, it is recommended that the issuing Commission service consults informally all the parties involved in the field concerned, and particularly the competent administration in the Member States and the European standardisation bodies, while trying to strike a balance between the duration of this consultation and its "democratic"nature. It is advisable to attach to the draft mandate a simple list of the parties involved that have been consulted. 4. Procedure for consulting the Standing Committee 4.1 When the issuing service has consulted the various interested parties informally, the draft mandate is submitted to the Committee for formal consultation, as stipulated in Article 6(4)(d) of Directive 98/34/EC. This consultation is required for mandates under the New Approach directives, but also for any other request for standardisation to the European standardisation bodies. The draft mandates must be submitted to the Standing Committee in 3 language versions, in English, French and German. The translations must be prepared by the sectoral Commission service developing the mandate. The mandate will be submitted to the Standing Committee through the CIRCA server. The consultation of the Standing Committee is not just a formality. The aim of this consultation is to reach a consensus between the public authorities on what they expect from the standards bodies. This consensus is first sought through the national consultation, initiated by each member of the Standing Committee and then between the Member States at the meetings of the Standing Committee in close cooperation with the Commission. In the absence of a consensus the Chairman can call for a vote. Because the committee is an advisory committee, this vote will always be a simple majority vote. 4.2 There must therefore be time for the members of the Standing Committee to carry out consultations at national level. This means that the Commission must be in a position to provide the documents in time. On several occasions the members of Committee 98/34 have expressed this requirement. A period of at least three weeks should be allowed. It should be noted that there might be an argument for extending this period to four weeks in the case of a fairly broad mandate on which it is difficult to achieve a consensus. The committee can deliver its opinion through a written procedure, thus without waiting until the date of the next meeting. The CIRCA server, a forum for the electronic exchange of comments, between the members of the Standing Committee and the Commission is used for the communication within the written procedure.

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4.3 It should be noted that the participation of the representatives of the European standardisation bodies in the meetings of the Standing Committee makes it possible to obtain an initial response to this mandate on their behalf. 4.4 As a rule, three meetings of the Standing Committee take place a year. Over the last few years, the written procedure has been increasingly used for the consultation on mandates. Recommendations F 1. The draft mandates must be transmitted in good time to the members of the Standing Committee in order to enable them to hold appropriate consultations at national level and to deliver their opinion within the required time. 2. The increased use of a written procedure for consultation of the Standing Committee makes it possible to accelerate the procedure for approving a mandate, thereby increasing efficiency. 5. Procedure for transmission to the European standardisation bodies and acceptance by these bodies 5.1 Transmission to the European standardisation bodies When the mandate has received a favourable opinion by the Standing Committee, the issuing service draws up the final version of the mandate, taking into account as far as possible the comments submitted by the members of the Standing Committee. This final version is then forwarded in English, French and German to the European standardisation bodies by official letter, followed by a transmission by electronic means. This final version is also provided to the members of the Committee through the CIRCA server and is uploaded to the database of mandates. 5.2 Acceptance of the mandate by the European standardisation bodies - Mandates are accepted or refused by the European standardisation bodies according to

their own internal rules, through the CEN and CENELEC Technical Boards and the ETSI Board. Acceptance/refusal by the European standardisation bodies can last several months depending inter alia on these procedures, the opinion of the technical committee and the resources available.

- The practice with respect to the acceptance/refusal of the mandates is different for each

European standardisation body. No rules on the communication of this decision to the Commission exist. CEN’s practice is now to send a formal letter of acceptance to the Commission. CENELEC appears also to have started this practice, whereas ETSI has not. The decision usually takes 6-8 weeks, but in some cases is taking several months. In order

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to bring more coherence and certainty into this process, it should be considered as a good practice that all the European standardisation bodies should communicate the acceptance (with possible reservations)/refusal of the mandate to the Commission.

- The acceptance of the standardisation mandate begins the standstill period, as specified in

Article 7.1 of Directive 98/34/EC. From this moment the national standardisation bodies do not take "any action which could prejudice the harmonisation intended".

- The acceptance of a mandate should lead to the submission of a work programme, even if

the mandate does not explicitly ask for a programme. Such a work programme should facilitate the monitoring of the execution of the mandate.

- A mandate sent to the three European standardisation bodies supposes that either a

common response or an explicit response from each of the three bodies will be given on the action to be taken by them, even if one of the European standardisation bodies takes the view that it is not concerned. It will be useful to spell out in the reply the detail for the “cooperation modes” applied between the European standardisation bodies for the mandate in question.

- In the event of refusal, it will, in the first instance, be for the Commission's services,

together with the European standardisation body concerned, to analyse the situation and find a solution. In a second step the Standing Committee should be consulted.

- The withdrawal of a mandate by the Commission must be subject to a consultation with

the Standing Committee. 5.3 Beginning of work In principle, the programming and standardisation work only start after the acceptance of the mandate. In certain cases work only starts when there is an agreement on financing between the European standardisation bodies and the Commission. The latter condition can in practice lead to a considerable delay in the standardisation work. Therefore, the European standardisation bodies can request that the financing of work already begins before the conclusion of the contract, however not before the receipt of the request by the Commission. The decision whether to accept such a request lies with the Commission and financing is only confirmed once a contract is signed by both parties.

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Recommendations G 1. Enhanced consultation of the European standardisation bodies during the preparation of

the mandate should make it possible to speed up acceptance of this mandate and the beginning of work.

2. The possibilities of forwarding mandates sooner to the European standardisation bodies

must be examined. Direct processing of the comments and the use of electronic means can accelerate its acceptance by them.

3. It should become practice that the European standardisation bodies communicate the

acceptance of the mandate (with possible reservations) to the Commission. 4. The acceptance of a mandate should give rise to the submission of a work programme

which will form the basis of the commitment of the European standardisation bodies and which will allow monitoring of the mandate.

5. The negotiations on the possible financing of standardisation work should not delay the initiation of this work. Where appropriate, negotiations on the possible financing of standardisation work should start as early as possible in order to ovoid potential delays in the execution of the work.

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Annex 1 - Basic documents laying down the concept of a mandate 1. Directive 98/34/EC 1.1 Article 6(3), first indent "The Committee.... may in this connection propose in particular that the Commission request the European standards institutions to draw up a European standard within a given time limit..." 1.2 Article 6(4)(d) "The Committee must be consulted by the Commission... on the requests to the standards institutions referred to in the first indent of paragraph 3..." 2. Commission/European standardisation bodies General guidelines on cooperation of 28 March 2003 (OJ C 91 of 16 April 2003) Point 5 second indent "…the European standards organisations expect the European Commission and EFTA to make use of European standards where they are appropriate in support of European regulations and other policies, and continue to pursue a policy of broader use of standards". 3. Council Resolution of 7 May 1985 (OJ C 136 of 4.6.85) 3.1 Annex II - Second fundamental principle on which the New Approach is based: " the task of drawing up the technical specifications needed for the production and placing on the market of products conforming to the essential requirements established by the Directives… is entrusted to organisations competent in the standardisation area." 3.2 Annex II, paragraph 9 "The quality of harmonised standards must be ensured by standardisation mandates, conferred by the Commission, the execution of which must conform to the general guidelines which have been the subject of agreement between the Commission and the European standardisation organisations." 4. Council Resolution of 18 June 1992 Point 17 “The Council considers that the use of European standards should be further encouraged... as a technical basis in support of legislation, in particular in defining technical specifications for products and services... to be used in other areas falling within the scope of European legislation.” 5. Decision No 768/2008/EC " harmonised standard" shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that Directive"

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Annex 2 - Template mandate with typical clauses The structure of a mandate should be as follows: 1. Title 2. Objective 3. Policy and/or legal framework 4. Description of the mandated work 5. Execution of the mandate 6. Organisations to be involved 1. Title This should contain the key elements of the description of the mandate:

1. Whether it is a standardisation, programming or study mandate 2. To which European standardisation body (-ies) it is addressed 3. Under which legislation/in which policy area it is to be developed (optional) 4. Which specific subject it covers

EXAMPLE:

1. Standardisation mandate… 2. …to CEN and CENELEC… 3. …under Directive 2007/47/EC relating to medical devices… 4. …for standards concerning graphical symbols for use in the labelling of medical devices.

‘Standardisation mandate to CEN and CENELEC under Directive 2007/47/EC relating to medical devices for standards concerning graphical symbols for use in the labelling of medical devices.’ 2. Objective This section should contain a very brief summary of key purpose of the mandate. EXAMPLE: The Commission requests CEN to revise standard EN ISO 4254-1 “Agricultural machinery – Safety – Part 1: General requirements” in order to take account of hazards caused by the PTO drive-shaft between the tractor and the recipient machinery in line with the essential health and safety requirement 3.4.7 of Annex I to the Machinery Directive on the transmission of power between self-propelled machinery (or tractor) and recipient machinery. 3. Policy and/or legal framework The mandate text should set out briefly and clearly (1.5 pages maximum) the background to the work, either in terms of European policy or legislation (or both). The title of this section of the mandate should reflect the basis of which it is given (e.g. it should be ‘Legal framework’ in the case of a mandate for a New Approach directive).

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4. Description of the mandated work This is the key section of the mandate as it includes the detail of the request from the Commission to the European standardisation bodies. The text should clearly state what is expected in terms of:

Deliverables – is the Commission requesting European standards or other deliverables, such as workshop agreements?

Phasing of the work – is there to be a first phase in order to make cooperation

arrangements between the European standardisation bodies or for programming work? Will this be followed by a standardisation phase? Will there be a period of scrutiny by the Commission services in between?

Support to legislation – if this is the case, specific references to the legislation should be

made, such as to the essential requirements of New Approach directives.

Some mandates may use an annex to set out in detail what is expected, in which case this section of the mandate generally states, ‘The European standardisation bodies are requested to carry out the standardisation programme in accordance with the Annex’. In such cases, it is particularly important to consider the level of detail. 5. Execution of the mandate This section should contain certain key elements:

The timetable for the mandated work, divided as necessary into the separate phases and the separate deliverables. This may be done in a tabular format if appropriate. It is important that the timetable is consulted with the European standardisation bodies in advance. The timetable should be given in the format ‘acceptance of mandate + x months’ rather than in the form of an actual date.

Any interim reporting requirements. This would not usually be required for a short programming mandate, but is important for longer mandates. Again, the requirement should be in the form ‘every 12 months after acceptance of the mandate’.

Any break in the work for consideration by the Commission services. A requirement to take into account other ongoing standardisation work, in particular to

take into account the work of the recognised international standards organisations. An indication of technical committees/working groups to be potentially involved.

A requirement where necessary to develop the standards in full cooperation with the Commission services.

A clause requesting the European standardisation bodies to take the needs of SMEs into account when developing standards.

If it is a standardisation mandate requests European standards, then this statement must be included:

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‘Acceptance by [add name of European standardisation body here] of this mandate starts the standstill period referred to in Article 7 of Directive 98/34/EC of 22 June 1998 (Of N° L 204/37 of 21 July 1998).’ If the mandate requests European standards from CEN and/or CENELEC then this text must be included: ‘The text of the European standards shall be delivered to the Commission in the three working languages of [CEN/CENELEC] (German, English and French).’ If the references of the standards produced are to be published in the Official Journal, then the following text must be included: ‘[CEN/CENELEC/ETSI} will provide the titles of the standards in all the official languages of the European Union.’ 6. Organisations to be involved The text must include the following statement: ‘As appropriate, CEN, CENELEC and ETSI will invite the representative organisations of consumers’ interests (ANEC), environmental protection (ECOS), workers (ETUI-REHS) and small and medium-size enterprises (NORMAPME) to take part in the standardisation work.’

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL New Approach Industries, Tourism and CSR Standardisation

Vademecum on European Standardisation

Part II

European standardisation in support of European policies

Chapter 4.2

Follow-up of Mandates

15 October 2009 Status of the document: Final Author: DG ENTR I/3 For further information: entr-standardisation@cec.eu.int

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL New Approach Industries, Tourism and CSR Standardisation

Follow-up of mandates

Contents Introduction 1. Context

2. Analysis of the request of the Council as seen in item 25 indent 2 of the Resolution of 28 October 1999 Chapter I Mission „To ensure the follow-up of standardisation activities“

1. Basic elements of an effective follow-up 2. Measures to ensure an effective follow-up

Chapter II Mission „To ensure that standardisation work progresses regularly“ 1. Basic elements of an administrative follow-up of work 2. Measures to ensure the administrative follow-up of work

Annex 1 Tasks and responsibilities of New Approach Consultants

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Introduction

1. Context The original version of this document was drafted to answer the request of the Council formulated in item 25 indents 1 and 2 of its Resolution of 28 October 19991, relating to the development and follow up of standardisation mandates in the framework of European policies and especially under the New Approach: "The Council asks the Commission: – to ensure that standardisation mandates under the new approach are prepared accurately

and efficiently, affording Member States and the European standards bodies sufficient opportunity to contribute;

– to ensure that standardisation activities covered by mandates are subject to thorough

monitoring and that appropriate measures are examined with the European standards bodies in order to ensure proper progress".

Item 25 indent 1 is treated in a separate part of the Vademecum which deals with the role and development of the mandates. The subject of this document corresponds to item 25 indent 2, which concerns the follow-up of the mandates. The invitation from the Council to the Commission "to ensure" the follow-up of the execution of the mandates first requires a common clarification and interpretation of the various terms used. Moreover, the different basic elements of an effective follow-up are examined and supplemented with recommendations to determine the concrete means. These must take account of the fact that the European standarisation bodies2 which accept a mandate are responsible for the execution of the mandate and therefore also its daily follow-up. It should be noted that just describing recommendations is not sufficient. They must also be implemented, which implies concrete actions by entities remaining to be specified. In any case, this implementation should be carried out in close cooperation with the European standardisation bodies. 2. Analysis of the request of the Council as given in item 25 indent 2 of the Resolution of 28 October 1999 In order to answer precisely the request of the Council, it is necessary to analyse the request as well as the missions and tasks that result from it. We can distinguish two missions in the invitation quoted in item 25 indent 2 of the Council Resolution, each one being made up of two aspects:

1 OJ C 141 of 19.05.2000 2 see Annex I of the Directive 98/34/EC (OJ L 204, 21.7.1998, p. 37–48)

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a. "Ensure that standardisation activities covered by mandates are subject to thorough monitoring". This request to the Commission aims to ensure that measures are set up to check that the activities of standardisation, as well as the resulting standards themselves, satisfactorily fulfil the terms of a mandate and the regulatory/essential requirements3 of the directive involved. Therefore we shall deal here with the follow-up on the qualitative level. Moreover we should make a distinction between the task of ensuring the existence and application of means of checking and the task of checking itself.

b. "Ensure that appropriate measures are examined with the European standards bodies in

order to ensure proper progress ". Here, the Council asks the Commission to ensure, along with the European standardisation bodies, that measures are set up to see that standardisation work progresses in good time. Here we shall deal with the administrative and organisational follow-up. Again, a distinction needs to be made between ensuring the existence of means to do this and the administrative follow-up of the work.

3 The expression "essential requirements" is a specific expression used for the regulatory requirements in the framework of New Approach directives.

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Chapter I

The mission "To ensure the follow-up of standardisation activities” As pointed out above, we should make a clear distinction between the task of the Commission to ensure the existence and application of measures for follow-up and checking and the task of follow-up and checking itself. We firstly need to analyse the basic elements of a close follow-up before being able to determine what measures the Commission should implement. 1. Basic elements of an effective follow-up of standardisation activities In order to define the nature and characteristics of the measures to be set up by the Commission, it is firstly necessary to lay down the conditions for an effective follow-up. The following elements should be specified: - the scope of the follow-up, namely, what we understand by "a thorough monitoring of

standardisation activities"; - the stages, that is, at what moment should checking and/or examination be carried out; - the actors who are in a position to carry out such a follow-up; - information and methods of communication. 1.1 Scope of the follow-up A correct follow-up of the execution of a mandate from the content point of view assumes that, at appropriate stages there is an examination or check of each mandate with regards to the work programme, the standards or alternative standardisation deliverables being developed or adopted as well as the standardisation process. We can therefore quote the following points on monitoring and checking: - the standardisation programme and each component of this programme must fit in with the Community legislation and policy to which the mandate refers; - where the subject of the mandate is a request to develop harmonised standards, the standardisation programme has to cover in a coherent way the categories of products and the risks mentioned, as well as the regulatory/essential requirements of the directive concerned; - the standardisation programme has to be coherent with existing programmes of the same organisation and its sister organisations; - where the subject of the mandate is a request to develop harmonised standards, each harmonised standard being developed or adopted has to treat in a satisfactory way one or more regulatory/essential requirements. Here it will be useful to check, if possible, that a high level of safety is ensured;

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- where the subject of the mandate is a request to develop harmonised standards, for each

harmonised standard there should be a clear and precise indication with regard to the relationship between its content and the essential requirements covered. More precisely, it is advisable that the relationship is being established, if possible, prior to the stage of public enquiry, and that it is made available, together with the draft standard, at that stage;

- the other requirements of the mandate, for example, the request that the European standardisation bodies consult specific organisations, have to be fulfilled by the standardisation process itself. We might ask whether some systematic check should be made to see if the activities of standardisation carried out under this mandate comply with the general principles of standardisation (openness, transparency, independence etc.) and the general guidelines on cooperation signed between the European standardisation bodies and the Commission4. At first sight, we can limit ourselves here to management and follow-up "by exception". Recommendations H 1. It is necessary to check that the programme of standardisation itself integrates well into the Community policy (or policies) quoted in the mandate, and in the case of the mandate requesting to develop harmonised standards which of the regulatory/essential requirements of the directive concerned are covered. 2. Each harmonised standard has to treat satisfactorily the regulatory/essential requirements that it claims to cover.

4 OJ C 91, 16.04.2003

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1.2 Stages at which checking should be carried out The checking of the above-mentioned elements can be carried out at one and/or at several of the following stages: - drawing up of the work programme; - development of the preliminary draft of the standard or alternative standardisation

deliverables; - the public enquiry; - the vote and/or publication of the standard or alternative standardisation deliverables by

an European standardisation bodies; - the request for publication of the references of a harmonised standard in the OJ. Since there is a possibility of checking at these stages, we have to assume that there are also some opportunities for communicating and dealing with the comments at these times. These possibilities should form an integral part of the stages, as is already the case with the public enquiry. Recommendation I 1. Checking of the documents (programmes, draft standards or alternative standardisation deliverables and standards) produced by the European standardisation bodies is necessary at certain formal stages. 1.3 Entities likely to be in charge of monitoring and checking The actors that carry out monitoring and checking are in the first place: - the responsible European standardisation body (bodies); - the public authorities at national level; - the sectoral department of the Commission responsible for the mandate. It is useful to clearly define the role and tasks of each entity, taking into account, among other factors, the resources available. The cooperation methods between these entities also remain to be determined. For example, we can envisage the creation of an ad hoc group composed of the representatives of the European standardisation bodies concerned, a "New Approach" consultant and the Commission representatives.

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Recommendations J 1. The role and the tasks of each entity in charge should to be defined clearly, as well as the cooperation between these entities. 2. A first check should be carried out by persons in charge of the execution of the mandate. The existence of a quality control system within the European standardisation bodies could represent an asset. 3 The "New Approach" consultant has a key role in checking the harmonised standards produced, especially whether relevant essential requirements are covered in an adequate way. 4. The sectorial committee or group of experts of the directive concerned should play a real role in the follow-up of the execution of the mandates, even if this directive does not stipulate it. 1.4 Information and the methods of communication Each check and follow-up requires an examination comparing the assignment (the mandate) with the resulting product (the programme and/or standards or alternative standardisation deliverables). A communication procedure should be developed taking account of the comments arising from these checks. Moreover, easy access to this information has to be ensured for the parties directly concerned. Among others, the following elements should be examined and taken into account: - information (the terms of reference, the documents forming the object of checking, comments on these documents); - the availability of this information as well as the means to achieve it (such as databases accessible by Internet); - the methods for dialogue and treatment of the comments (meetings, electronic newsgroups for exchanges of information etc.). In particular, we need to examine whether it is possible or useful to set up a procedure for communicating fundamental comments on behalf of the official authorities, in order to avoid formal objections against the standards at a later date. Indeed, the procedure for dealing with these objections is not simple, because there must be a detailed examination of the case, as well as consultations with the various parties, a formal consultation of the Standing Committee5 and a

5 The Standing Committee set up by Article 5 of Directive 98/34/EC (OJ L 204, 21.7.1998, p. 37–48), also known as the ’98/34 Committee‘ or the ’Committee on Standards and Technical Regulations‘

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Commission Decision. This "Early Warning" system will moreover make it possible to comply with the request expressed by the Council in Item 21 of its Resolution of 28 October 1999. Recommendations K 1. A clear procedure should be envisaged for communication and taking charge of the comments arising from the checks. 2. A possibility for early warning should be set up, as requested by the Council Resolution item 21. This system should make it possible to avoid subsequent formal objections against the harmonised standards or the application of the safeguard clause. 3. Consideration must be given to the question of the availability of information on mandates as well as the standardisation programmes and the draft standards to the various interested parties. 2. Measures to ensure an effective follow-up As mentioned in the introduction, this involves formulating, and if necessary setting up, measures on behalf of the Commission for ensuring the effective follow-up of standardisation work. It should be remembered that European standardisation bodies initially have the responsibility of ensuring the proper execution of the accepted mandates as well as the conformity of the (harmonised) standards or alternative standardisation deliverables adopted with the mandate and the directive concerned (see also Recommendation J2). Currently, there are already several measures in force on behalf of the Commission. The main ones are as follows: - the mandates themselves. It is important that each mandate should contain elements allowing the effective follow-up of its implementation; - the possibilities of creating Working Parties, such as those in the fields of construction products, machines and pressure equipment; - the meetings of the normal and enlarged Standing Committee; - the role allocated to the sectorial services of the Commission. In the first instance, it is appropriate to maintain these methods, but also to improve and strengthen them. If necessary, supplementary measures could also be introduced. A presentation of the actions launched by the European standardisation bodies to strengthen their own follow-up

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procedure could be envisaged. This presentation could be made to the sectorial committee, to the group of experts of the directive concerned or the normal and/or enlarged Standing Committee. The existing means are described below with, if necessary, some proposals for improvement and/or reinforcement. 2.1 Mandates Each mandate should not solely describe which requirements and which criteria of the standards or alternative standardisation deliverables need to be satisfied, but must also include the elements allowing and facilitating the monitoring of its implementation. This makes it possible to detect possible gaps in the standardisation work compared with the mandate and the related New Approach Directive. In a separate document of the Vademecum dealing with the role and elaboration of mandates (Part 1 Chapter II par. 2), the various requirements are stipulated regarding the contents of a mandate. 2.2 Role and tasks of the "New Approach" consultants "New Approach" consultants play a very important role in the various phases of the execution of mandates, from explaining the essential requirements to checking the harmonised standards that will be submitted to the Commission for publication of their references in the OJEU. The reports established by the "New Approach" consultants and communicated amongst others by the European standardisation bodies to the Commission services should be mentioned here. These reports allow all concerned parties (technical and managerial entities of CEN, sectorial services of the Commission) to detect possible problems and to start, if necessary, correctives measures. It is essential that the sectorial services of the Commission use these reports with the aim of a systematic follow-up of the mandated standardisation activities. 2.3 Ad hoc groups In the event of major problems in the execution of the mandates in a given field, an ad hoc Working Group (Task Force) can be created, as was done in the past for some mandates, e.g. mandates concerning construction products, machines or pressure equipment. It should be noted that the creation of such an ad hoc group has to be justified, because the participation in meetings of an ad hoc group requires human resource mobilisation in an already difficult context. 2.4 Normal Standing Committee Up to now, the normal Standing Committee has not dealt systematically with the follow-up of the mandates. However, as is stipulated in several "New Approach" directives, this committee can be referred to "when a Member State or the Commission considers that the harmonised standards... do not entirely satisfy the essential requirements dealt with... ". In this case, the document on the

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administrative procedure in the event of a formal objection against a harmonised standard clearly specifies the role of the Standing Committee as well as the role of the sectorial committee of the directive concerned. As indicated in this document, it is unnecessary to await publication of the references of harmonised standards in the Official Journal. It is possible, and even useful for a Member State or the Commission to inform the Standing Committee on probable major objections against a harmonised standard. Such an intervention could be useful even at the draft stage of a harmonised standard, particularly if the regulatory aspects are in danger of not being taken into account in an adequate manner. However, the Standing Committee cannot be used as an appeal authority. In the formal and informal process mentioned above, the usefulness of the participation of "New Approach" consultants should be examined. 2.5 Sectoral services of the Commission Generally, it is the task of the sectoral service to follow the mandated work that they have requested. ENTR-Standardisation unit is only involved in the follow-up of mandates at the level of the Technical Boards of CEN and CENELEC and ETSI Board and in financial matters when there is a grant agreement. The Commission department originating a mandate has to follow its execution in close cooperation with the persons in charge of the European standardisation body and the "New Approach" consultant(s). It is advisable that a representative of this service follows the part dealing with the aspects of the directive and/or the mandate at the meetings of the technical committee concerned. Such a follow-up makes it possible to note the possible problems on this level at an early stage. It should be noted that the sectoral service representatives of the Commission already participate actively in the periodic meetings mentioned in item 2.4 and in the meetings of the enlarged Standing Committee. It has to be underlined that the sectoral services have to check if the terms of references of the mandate are respected. The checking system must be based on a continuous process throughout the development of the standards or alternative standardisation deliverables. It is up to the European standardisation bodies to ensure, where appropriate by asking the help of the "New Approach" consultants, that the harmonised standards cover correctly the regulatory requirements. It is therefore not necessary, as a general rule, for the Commission services to check the technical content of the harmonised standards (cf. the procedure to follow in case of a formal objection against a harmonised standard).

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2.6 Service Level Agreement

The Service Level Agreement is concluded between the unit DG ENTR-Standardisation unit and Commission services initiating mandates in the case that the European standardisation bodies request the co-funding by the Commission for the mandated work. The objective of this document is to optimise the co-operation of these services. It aims to provide each of them with a clear understanding of the tasks related to the awarding of standardisation-related grants proposed by the European Standards Organisations and their follow up.

2.7 Availability of the texts of mandates With the aim of better transparency of the mandates addressed to the European standardisation bodies, the Commission has established a database of mandates on the Internet in which the final texts of the mandates as transmitted to the European standardisation bodies are publicly available. This database contains all mandates issued by the European Commission to the European Standards Organisations since June 2002. It also has a significant number of earlier mandates in the numbering system M/xxx. No mandates with other numbering systems are in this database.

From M/3xx onwards, the text of the mandates is available in English, French and German. The earlier mandates are at present available in English only, but the other linguistic versions will be uploaded in due course. The availability of this information facilitates the follow-up of the work by all concerned parties.

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Chapter II Mission "To ensure that standardisation work progresses regularly" This chapter relates to the administrative and organisational follow-up of the work. As in the previous chapter, a distinction must be made between ensuring the means, a task, which falls mainly on the Commission, and the actual task of administrative monitoring of work, for which European standardisation bodies are mainly responsible. The latter task has to be carried out as the follow-up of a project, to be executed within a certain time and according to a previously defined timetable. Techniques of project management and monitoring should be applied by the European standardisation bodies. 1. Basic elements of the administrative monitoring of work As stated by the Council in its Resolution of 28 October 1999, this involves carrying out a task in close cooperation with the European standardisation bodies. In fact, the planning of standardisation work, as well as its follow-up, is actually carried out by the European standardisation bodies, which must set up the means necessary to achieve these goals and perform regular reporting. The European standardisation bodies have already taken several initiatives to improve this follow-up. The Commission Report in the Council and in the European Parliament6 describes the efforts of the European standardisation bodies to increase their efficiency. In its Conclusions of 1 March 20027, the Council welcomes the initiatives of the European standardisation bodies, particularly those related to reducing the time to produce standards. Without wishing to intervene in the working methods of the European standardisation bodies, the following principles should be applied: - the execution of a mandate should to be regarded as the execution of a project. Suitable tools should be applied for the management and monitoring of the projects (such as the detailed planning of resources, monitoring and evaluation); - the programme of the European standardisation body concerned represents the basic element of the follow-up. This programme should indicate all the subjects forming the object of standardisation as well as the completion dates; - the development of each individual standard should be regarded as the execution of a project, so a separate workplan should therefore normally be advised for each standard; - a systematic use of IT is required to facilitate the planning of work and its follow-up. These resources should also lead to a more transparent process of development of the standards process, making it accessible to all interested parties:

6 COM (2001) 527 final of 26.09.2001 7 OJ C 66 of 15.03.2002

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- a certain degree of harmonisation between the three European standardisation bodies is desirable in the terminology used for the follow-up of the mandates as well as the presentation of the programmes and their state of progress (for example: the completion time of a standard). This should also make it possible to obtain consistent statistics; - care should nevertheless be taken not to intervene in the specific working methods of each European standardisation body, in view of the autonomy of these organisations and the fact that they are responsible for the organisation of their own work; - the technical and administrative follow-up of the stages has to go together with a financial

follow-up of the grant agreement (if any) for the execution of tasks related to the mandate concerned and vice versa.

Recommendations L 1. The execution of a mandate and the development of standards have to be regarded as an actual project. Therefore, the techniques of project management must be applied, such as work planning, active follow-up, the introduction of corrective measures in the event of problems and project evaluation. 2. The independence of the European standardisation bodies must however be respected. We should be aware that they are entirely responsible for the execution of the accepted mandates and for the development of the necessary standards. 2. Measures to ensure the administrative monitoring of work In principle it is advisable to use the same measures as already established for the follow-up when dealing with the contents and the standardisation activities (see Item 2 of the previous chapter). These measures comprise: - the requirements given in the mandate (programme request, indication of the completion

dates, regular reporting request); - the use, if necessary, of ad hoc groups; - the Standing Committee in its normal and enlarged configuration; - the role of the sectoral services within the Commission. The use of tools for the follow-up of projects should enable a clear presentation of the progress of standardisation work for all the interested parties.

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If necessary, the Commission can examine in even greater detail, together with the European standardisation bodies, those measures that could be strengthened or set up in order to increase the efficiency of this administrative follow-up.

* * *

15

Annex 1

Tasks and responsibilities of the New Approach Consultants

Edition 1 / April 2009

CEN/CENELEC Guide 15

Tasks and responsibilities of the New Approach consultants

The present guide provides guidance on the tasks and responsibilities of the New Approach consultants working with CEN and CENELEC. It was approved by CENELEC BT decision D134/C056 and by CEN Resolution BT C072/2008.

European Committee for Standardization

European Committee for

Electrotechnical Standardization

Avenue Marnixlaan 17 B – 1000 Brussels

Tel: +32 2 550 08 11 Fax: +32 2 550 08 19

Tel: +32 2 519 68 71 Fax: +32 2 519 69 19

www.cen.eu

www.cenelec.eu

CEN/CENELEC Guide 15 Tasks and responsibilities of the New Approach Consultants

Edition 1 / April 2009 3

Tasks and responsibilities

of the New Approach consultants

1 Scope

This document is the CEN/CENELEC guide on the tasks and responsibilities of the New Approach consultants working with CEN and CENELEC.

It deals with the:

• Role and profile of the consultant

• Main tasks and responsibilities of the consultant

• Consultant’s involvement in the development of standards

o Involvement from the time of the creation of the NWI

o Comments at enquiry stage

o Advice and comments following the enquiry stage

o Formal assessment prior to formal vote/UAP

o Resolution of disputes

• Selection of a new consultant

• Induction and introduction of a new consultant

• Handover from previous consultant

• Reporting and evaluation of consultant's work

• Treatment of complaints

2 Background

European Directives (hereinafter called directives) contain essential requirements. These essential requirements shall be fulfilled by the product before it may be placed on the market.

Standardisation work related to directives is described in Mandates to the ESO’s.

European Standards provide a means for manufacturers to demonstrate conformity to the essential requirements of directives. Such European Standards are referenced as harmonised standards.

Tasks and responsibilities of the New Approach Consultants CEN/CENELEC Guide 15

4 Edition 1 / April 2009

The relevant technical body of CEN or CENELEC is responsible for deciding which technical requirements will be included in a European Standard.

The references and titles of harmonised European Standards are published by the European Commission in the Official Journal of the European Union (OJEU).

The European Commission and EFTA request that CEN and CENELEC assess the conformity of all candidate harmonised standards to the relevant essential requirements of relevant directives.

CEN, CENELEC and the European Commission/EFTA appoint independent consultants to carry out this assessment and to provide assistance and guidance to the technical bodies developing these European Standards in relation to the relevant directives and their respective essential requirements. Mandates can influence this work in particular ways. Consultants may also explain some elements of the relevant Mandates.

Many harmonised European Standards are based on international standardization according to the Vienna or Dresden Agreements. In such cases the consultant shall also be consulted with the development of such standards.

3 Role and profile of the consultant

3.1 Role of the consultant

The consultant is responsible for assisting experts to prepare harmonised standards and provides the necessary recommendations, explanation and support in relation to the relevant directive(s) and the respective essential requirements.

The consultant shall be involved with the technical bodies from the earliest possible stage in the development of a European Standard at the latest when a working draft is available in order that his/her comments may be taken into account from the beginning.

When requested by a technical body, the consultant shall obtain clarification on the scope of the directive or mandate from the Commission.

The consultant shall examine if the work programme of the relevant technical bodies covers all aspects indicated in the related directives and mandates (i.e. essential requirements, product families…) and identify any gaps which may be bridged by standards.

The consultant is not responsible for deciding or choosing which technical requirements will be included in a European Standard. This is the responsibility of the technical bodies.

The consultant informs the technical body on the compliance of a draft standard with the provisions of the relevant directive1); during development of the draft from the creation of the work item, through the preparation of the draft standard, during the public enquiry and before the Formal Vote or UAP.

1) Directive has to be understood in its broad sense (e.g. TSI’s in case of Railway Interoperability,

RID/ADR/AND agreements in the case of dangerous goods, …).

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3.2 Competence of the consultant

A consultant is required to be impartial and independent.

In order to fulfil his/her tasks, the consultant shall have:

• a deep technical understanding of the field of work of the relevant technical bodies and a recent state of the art experience of the subject;

• extensive knowledge and experience of relevant directives;

• experience of developing and implementing standards;

• knowledge of the main rules (e.g. CEN/CLC Internal Regulations, ISO/IEC Directives, different timeframes within the drafting process);

• knowledge of the Vienna Agreement, Dresden Agreement;

• social competence/interpersonal skills.

4 Main tasks and responsibilities of the consultant

The consultant's main tasks and responsibilities are:

• to explain to the technical bodies the different elements of the relevant directive(s) and mandate(s), especially the essential requirements, as far as necessary;

• to give recommendations to the technical bodies during the development of a standard with the consistency of the draft standard to the relevant directive(s);

• to identify shortcomings in the technical requirements chosen by the technical body in relation to the essential requirements in the relevant directive(s), and where possible suggest remedies, noting that the responsibility for the choice of technical requirement remains with the technical body;

• to advise whether the work programme of the technical body covers all aspects indicated in the relevant directive(s) (i.e. essential requirements, product families, risks…);

• to provide formal assessments on draft standards prior to formal vote/UAP in relation to the relevant directive(s) as requested and strictly by the deadline requested by the central secretariat2);

• to keep up to date with the latest developments of the directive(s) they are contracted for;

• to identify new standardization needs and check for duplication of work.

2) In this document “central secretariat” refers to CEN Management Centre (CMC) and/or CENELEC Central

Secretariat (CLC/CS).

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In particular, the consultant shall:

• ensure that candidate harmonised standards comply with the relevant essential requirements laid down by the relevant directive(s). This activity is to be maintained for the entire duration of the development of the standard, at the latest starting with the first working draft, during the enquiry (prEN) and before the formal vote/UAP;

• comment on all draft standards under his/her responsibility during the Enquiry Stage;

• give a formal assessment to all final drafts prior to the Formal Vote/UAP under his responsibility;

• check each draft standard, that is under his/her responsibility and that is in support of directive(s), for the existence and the contents of an annex (Annex Z) giving the relation between the standard and the essential requirements in the relevant directive(s);

• by mutual agreement attend meetings of technical bodies;

• be available to the European Commission (usually DG Enterprise and Industry) and the relevant Standing Committee(s) for questions related to the preparation of the standards;

• co-operate and co-ordinate with other consultants who are advising the technical body in relation to other directives or aspects of directives;

• co-operate and co-ordinate with the central secretariat for the setting of work and priorities;

• identify the need for formal assessment of draft standards by consultants responsible for other sectors.

Additionally the consultant may:

• help the technical body to identify new harmonised standards to be prepared;

• give recommendations to technical bodies in the light of what standards are being prepared or are planned in other technical bodies in order to avoid duplication of work and contradictions;

• be asked to support the central secretariat in tasks related to standardization in the field of his/her competence;

5 Consultant’s involvement in the development of standards

A flowchart in Annex A is outlining the procedures described in this clause.

Each time a standard is drafted in the framework of the Vienna Agreement, the guidelines for the implementation of the Vienna Agreement apply for the involvement of the consultant.

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For standards drafted in the framework of the Dresden Agreement:

• CENELEC/CS asks for the formal assessment from the consultant at CDV and FDIS stage for all projects associated with directives;

• In order to allow possible "corrective" action at IEC level, it is recommended that CENELEC should also ask an informal advice from the consultant on the CD;

• When there is a CENELEC technical body mirroring the IEC activities, it is the responsibility of this body to manage the alignment of their (upcoming) standards to the ERs of the directive. This includes possible requests for informal advice (e.g. on CD) from the consultant;

• When there is no CENELEC technical body mirroring the IEC activities - and as a support to the Reporting Secretariat – CENELEC/CS would in the future also ask for the informal advice from the consultant on the CD3).

5.1 Involvement from the time of the creation of the NWI

The consultant shall be involved with the technical body , e.g. by giving written comments or attending meetings, from the earliest possible stage in the development of a European Standard and at the latest when a working draft is available in order to provide advice to the technical body in relation to the essential requirements of the directive(s).

5.2 Comments at enquiry stage

The central secretariat ensures that all relevant draft standards that are submitted to the enquiry4) are given to the respective consultant(s).

The consultant(s) shall provide comments to the relevant technical bodies on all draft standards submitted to enquiry under his/her responsibility.

The technical body shall then take into account the consultant’s comments along with all comments made as a result of the enquiry in order to further develop and consolidate the technical requirements contained in the draft standard.

5.3 Advice and comments following the enquiry stage

Following the closure of the enquiry the technical body reviews all comments received, including those from the consultant, and revises the draft standard accordingly.

If agreed by the technical body the consultant receives the resulting revised draft standard and further versions as necessary and provides additional comments and guidance to the technical body.

The goal of both the consultant and the technical body should be to achieve a final draft standard that when presented for formal vote or UAP will receive a positive assessment from the consultant.

3) EMC issues are exempted, as these are duly coordinated through installed provisions by CLC/TC 210. 4) For standards being developed in parallel by IEC/CENELEC under the Dresden Agreement commenting at

the CD stage might be appropriate.

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It is important that the technical body and the consultant work together efficiently at this stage to avoid introducing delays into the development timeframe for the standard.

To support this aim the technical body is advised to provide the final draft standard to the consultant for ‘informal assessment’ and take into account the consultant comments before submitting revised final draft to the central secretariat to launch the formal vote or UAP.

5.4 Formal assessment prior to formal vote/UAP

When the technical body decides that a draft standard is sufficiently mature and that there is consensus within the technical body on its technical content, it sends the draft standard to the central secretariat for submission to formal vote or UAP.

The rules require that all relevant consultants formally assess the draft standard prior to the launch of the vote.

The formal assessment provided by a consultant establishes the clear and unambiguous opinion of that consultant on whether or not the draft standard, if adopted as a European Standard, would adequately provide presumption of conformity to the addressed essential requirements of the relevant directive(s). (Template to be found on CEN BOSS and CENELEC TISS servers).

The consultant’s decision to give a positive or a negative assessment shall be based solely on whether or not the technical requirements presented in the draft standard would provide an appropriate means of conforming to the essential requirements of the relevant directive. The consultant may have general and editorial comments on the draft standard but these shall not contribute to the result of the assessment.

In particular the consultant checks the information contained in the Annex ZA (for CEN) or Annex ZZ (for CENELEC).

The consultant shall provide the formal assessment within the set timescale5).

When all the consultants´ assessments of the draft are positive, it will be submitted for formal vote/UAP (however, see 4th paragraph of 5.5). With such a positive assessment the consultant supports that the European Standard when ratified, is submitted as a Harmonised Standard for publication of its reference in the Official Journal of the European Union under the directive(s) under which it has been assessed.

If one consultant submits a negative assessment on the draft standard, further processing is suspended, the vote is not launched and the draft standard is returned to the responsible technical body along with the negative assessment of the consultant.

The technical body (chairperson, secretary, the WG convenor and WG secretary, Reporting Secretariat, as appropriate), shall then consider the reasons given by the consultant for the negative assessment along with any proposals provided by the consultant to resolve the comments. This might imply a dialogue with the consultant.

The technical body should seek, and the consultant must provide, any clarification and explanation of the comments that lead to the negative assessment and the necessary solutions. 5) 28 days for CEN. The consultant is given the ”voting period minus 1 month” to provide his/her formal

assessment in due time to CENELEC.

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Subsequently, following resolution of the comments made by the consultant in the negative assessment the technical body may submit a modified draft standard to the central secretariat which then requests new assessments from all relevant consultants.

The consultants shall refrain from raising any new issues or concerns in any second or subsequent assessment of a draft standard.

Only when all the assessments of the draft standard by of all consultants involved (multiple directives) are positive, shall it be submitted for vote.

If, however, the technical body and the consultant cannot agree on how to resolve a negative assessment then one or both parties should seek to resolve the dispute as foreseen in 5.5 (Resolution of disputes).

At all times the technical body and the consultant shall work together to find agreement, whilst respecting each other’s particular roles and responsibilities.

5.5 Resolution of disputes

It is important that technical bodies and the consultants work together to find appropriate agreement on the wording of draft standards. Either party can contact the central secretariat for help and guidance at any time on issues and points of difference.

In the rare instances when a consultant and a technical body cannot agree on how to resolve a negative assessment on a draft European Standard, the technical body or the consultant shall elevate the issue to the Technical Board for decision.

In this case, the consultant and/or the technical body should raise the matter with the central secretariat that will obtain the necessary positions of both parties and present them to the Technical Board with a proposal on how to proceed to facilitate the further development of the draft standard.

The often quoted “veto”-right of the consultant does not exist. As an outcome of the discussion within the Technical Board the final draft might be send to formal vote as agreed by the technical body while not adopting the consultant’s comments given at the negative assessment.

There is no mandatory obligation for the technical body to adopt all comments given by a consultant.

N.B.: The Commission or the Member States may raise a Formal Objection if they consider that the standard does not comply with the essential requirements. This may end up in stopping the referencing of the standard in the OJEU.

6 Selection of consultants

CEN and CENELEC are responsible for managing the selection procedure to appoint a consultant.

The European Commission and EFTA participate in the selection process along with the central secretariats of CEN and CENELEC and representatives of the sector and/or technical bodies.

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For each field the central secretariat of CEN or CENELEC launch a ‘’call for candidates” to initiate the selection procedure. The national members publicize the calls e.g. to national (mirror) technical bodies and/or on web sites and/or in national publications.

Applicants are asked to submit details of their knowledge and experience of the relevant directive(s), the development and application of relevant standards and the daily remuneration rate sought.

The central secretariats manage the selection process consulting the

• European Commission,

• EFTA Secretariat,

• Sector representative,

and review the applications using the criteria given in 3.2, prepare a shortlist of applicants, interview selected applicants and decide the final choice of a consultant.

CEN and CENELEC appoint consultants initially for one year, renewable annually. After four years the central secretariats must launch a new call for candidates for each consultant position. Currently individual consultants must not be contracted for more than eight years in total.

7 Induction and introduction of new consultants

Following the appointment of a new consultant the central secretariat ensures that he or she is given the appropriate information in order to perform the role as a consultant and is introduced to the technical committees for which he or she will be responsible. Important information relating to discussions and decisions on draft standards in preparation is made available to the new consultant, including feedback from the previous consultant.

7.1 Induction

The central secretariat ensures that the new consultant receives information about:

• the role of a consultant and his/her rights and duties;

• the working procedures of a consultant and relevant deadlines given for his/her work;

• details of the technical bodies and their work programmes for which the new consultant will be responsible (including access to relevant database tools);

• the contact details of the technical body secretaries;

• contractual reporting requirements.

In particular, the central secretariat provides pertinent information in the form of a ‘handover dossier’ (see Clause 8).

The provision of information about outstanding negative assessments is essential to allow the new consultant and the responsible technical body to resolve the issues raised in the assessment in the most efficient manner.

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If possible and appropriate the central secretariat tries to ensure that the new consultant can meet with the outgoing consultant to achieve a good handover of information and knowledge.

The central secretariat arranges (a) meeting(s) with other consultants (if any) working under the same directive. A common understanding of the consultants’ tasks and responsibilities, especially of the relevant directive and the respective essential requirements should exist among the consultants working under the same directive.

7.2 Introduction to technical bodies

The central secretariat ensures that the relevant technical bodies are informed of the appointment of a new consultant at the earliest moment, including the date when the new consultant will begin work (and take over from any outgoing consultant), his/her contact details and any other information that will enhance the smooth introduction of the new consultant to these technical bodies.

As stated above, the central secretariat provides the new consultant with relevant information about the technical bodies, their work programmes and the contact details of the technical bodies secretaries.

The central secretariat facilitates initial contact between the new consultant and the technical bodies in accordance with the priorities dictated by the work programme, including outstanding negative assessments and the status of draft standards.

The central secretariat helps the new consultant to establish an initial list of missions that the consultant will undertake in order to address the priority issues and also to introduce him/herself to the technical bodies.

8 Handover from previous consultant

Whenever possible, the central secretariat tries to ensure that the outgoing or previous consultant provides a ‘handover dossier’ which will be given to the new consultant to help him/her to assume responsibility for the relevant work programme with the fullest knowledge of the current status of discussions and the history of relevant agreements and decisions.

Before the contract of the outgoing consultant expires, the central secretariat asks the outgoing consultant to provide a ‘handover dossier’ which shall include details of:

• all comments and assessments made by the outgoing consultant on draft standards that have not been adopted as European Standards at that time;

• a full and clear explanation of the basis and justification for all outstanding negative assessments;

• details of any draft standards undergoing public enquiry for which the outgoing consultant has not yet provided comments;

• particular issues, positions and agreements that were made during the development of currently adopted standards that would be essential for the new consultant for future revisions or amendments of those standards;

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• ‘horizontal’ issues relevant to the field covered by the directive, or the technical bodies for which the new consultant will be responsible;

• particular decisions and/or policies made by the relevant EC committee of the directive.

The central secretariat provides the ‘handover dossier’ to the new consultant and provides additional information and support for his or her understanding, as necessary.

The incoming consultant should respect any former positive position and decision taken by the outgoing consultant on any ongoing draft work, in order not to unnecessarily delay the work.

9 Reporting and evaluation of consultant's work

9.1 Reporting

Every four months the consultant shall submit activity reports on the templates provided to the central secretariat based on the contractual requirements.

9.2 Evaluation of consultant’s work

Towards the end of each annual contract the central secretariat carries out an evaluation of the performance of a consultant over the period of the contract and provides it to the European Commission/EFTA together with a recommendation on whether or not the consultant should be offered a new contract (in accordance with the overall timescales, see Clause 6).

The central secretariat monitors the development of harmonised European Standards and the performance of a consultant, in particular the:

• adherence to the planned timescales for provision of formal assessments;

• the provision of comments during the public enquiry;

• positive and negative assessments;

• compliance with Clause 4 of this Guide.

The central secretariat also takes into account the ongoing monitoring of progress of the relevant work programmes and feedback from technical body officers, other players in the standards system and organizations participating in the development of European Standards.

10 Treatment of complaints

Whenever there are complaints from either side (the consultant or the technical body) these shall be brought to the attention of the central secretariat. The central secretariat shall then try together with the involved parties to solve the problem.

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Annex A Flowchart

Technical Body creates a work item

Cons. provides comments at earliest possible stage, at latest when first draft is

available (see 5.1)

CEN/CLC National Members implement EN

Titles to EC

Technical Body resolves comments

CMC or CLC/CS conducts CEN/CLC enquiry

Technical Body drafts & builds consensus

Start

End

Cons. examines WP in relation to EU

Directive(s)/Mandate(s)

Technical Body establishes/reviews work

programme (WP)

Cons. information

Cons. provides comments on public enquiry draft

(see 5.2)

Cons. Comments

Cons. Comments

Cons. provides comments (informal assessment is

advisable, see 5.3)

Technical Body finalizes draft

Cons. Comments

Cons. assesses final draft (formal assessment, see

5.4)

AssessmentNo

Positive

CMC or CLC/CS prepares Formal Vote (FV)

Requests assessment

Yes

Positive

Negative

(see 5.5 in case of dispute between Technical Body and Cons.)

CEN/CLC National Members vote

No

Yes

Negative

Enterpriseand Industry

The ‘Blue Guide’on the implementation of EU product rules 2014

Ref. Ares(2014)1025242 - 02/04/2014

2

1. REGULATING THE FREE MOVEMENT OF GOODS ..........................................................................................................6

1.1. A historical perspective .............................................................................................................................................................................................................6 1.1.1. The ‘Old Approach’ .......................................................................................................................................................................................................................6 1.1.2. Mutual Recognition ......................................................................................................................................................................................................................6 1.1.3. The ‘New Approach’ and the ‘Global Approach’ ...........................................................................................................................................................7 1.2. The ‘New Legislative Framework’........................................................................................................................................................................................9 1.2.1. The concept ......................................................................................................................................................................................................................................9 1.2.2. The legal nature of the NLF acts and their relationship to other EU legislation ...................................................................................10 1.2.3. Howthesystemfitstogether .............................................................................................................................................................................................10 1.3. The General Product Safety Directive ............................................................................................................................................................................11 1.4. The legislation on product liability ...................................................................................................................................................................................11 1.5. Scope of the Guide ...................................................................................................................................................................................................................12

2. WHEN DOES UNION HARMONISATION LEGISLATION ON PRODUCTS APPLY? ........15

2.1. Product coverage .......................................................................................................................................................................................................................15 2.2. Making available ........................................................................................................................................................................................................................17 2.3. Placing on the market .............................................................................................................................................................................................................17 2.4. Products imported from countries outside the EU .................................................................................................................................................18 2.5. Putting into service or use (and installation) .............................................................................................................................................................19 2.6. Simultaneous application of Union harmonisation acts ......................................................................................................................................19 2.7. Intended use / misuse .............................................................................................................................................................................................................20 2.8. Geographical application (EEA EFTA states, Overseas Countries and Territories (OCTs), Turkey) ................................................21 2.8.1. Member States and Overseas countries and territories ......................................................................................................................................21 2.8.2. EEA EFTA states ..........................................................................................................................................................................................................................21 2.8.3. Monaco, San Marino and Andorra ....................................................................................................................................................................................22 2.8.4. Turkey ...............................................................................................................................................................................................................................................22 2.9. Transitional periods in the case of new or revised EU rules .............................................................................................................................23

3. THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS ...................24

3.1. Manufacturer ...............................................................................................................................................................................................................................24 3.2. Authorised Representative ...................................................................................................................................................................................................26 3.3. Importer ..........................................................................................................................................................................................................................................27 3.4. Distributor ......................................................................................................................................................................................................................................28 3.5. End-user .........................................................................................................................................................................................................................................30

4. PRODUCT REQUIREMENTS ...........................................................................................................................................................................32

4.1. Essential product requirements ........................................................................................................................................................................................32 4.1.1. Definitionofessentialrequirements ..............................................................................................................................................................................32 4.1.2. Conformity with the essential requirements: Harmonised standards .........................................................................................................33 4.1.3. Conformity with the essential requirements: Other possibilities ....................................................................................................................42 4.2. Traceability requirements .....................................................................................................................................................................................................43 4.2.1. Why does traceability matter? ...........................................................................................................................................................................................43 4.2.2. Traceability provisions ............................................................................................................................................................................................................43 4.3. Technical documentation ......................................................................................................................................................................................................46 4.4. EU Declaration of conformity .............................................................................................................................................................................................47 4.5. Marking requirements .............................................................................................................................................................................................................48 4.5.1. CE marking ....................................................................................................................................................................................................................................48 4.5.2. Other mandatory markings .................................................................................................................................................................................................53

5. CONFORMITY ASSESSMENT ......................................................................................................................................................................54

5.1. Modules for conformity assessment ..............................................................................................................................................................................54 5.1.1. What is conformity assessment? ......................................................................................................................................................................................54 5.1.2. The modular structure of conformity assessment in Union harmonisation legislation.....................................................................54 5.1.3. Actors in conformity assessment - Positioning of conformity assessment in the supply chain ..................................................55

TABLE OF CONTENTS

3

5.1.4. Modules and their variants ..................................................................................................................................................................................................58 5.1.5. One- and two-module procedures - Procedures based on type (EU-type examination) ..................................................................58 5.1.6. Modules based on quality assurance .............................................................................................................................................................................58 5.1.7. Overview of modules ..............................................................................................................................................................................................................59 5.1.8. Overview of procedures .........................................................................................................................................................................................................61 5.1.9. Rationale for selecting the appropriate modules ....................................................................................................................................................63 5.2. Conformity assessment bodies .........................................................................................................................................................................................63 5.2.1. Conformityassessmentbodiesandnotifiedbodies ..............................................................................................................................................63 5.2.2. Roles and responsibilities .....................................................................................................................................................................................................64 5.2.3. CompetencesofNotifiedbodies .......................................................................................................................................................................................66 5.2.4. Coordinationbetweennotifiedbodies ...........................................................................................................................................................................66 5.2.5. Subcontractingbynotifiedbodies ....................................................................................................................................................................................67 5.2.6. Accredited in-house bodies ..................................................................................................................................................................................................68 5.2.7. Recognised Third-Party Organisations (RTPOs) and User Inspectorates ....................................................................................................68 5.3. Notification ....................................................................................................................................................................................................................................68 5.3.1. Notifying authorities ................................................................................................................................................................................................................68 5.3.2. Notificationprocess ..................................................................................................................................................................................................................69 5.3.3. Publication by the Commission – the NANDO web site .......................................................................................................................................71 5.3.4. Suspension – withdrawal – appeal ..................................................................................................................................................................................72

6. ACCREDITATION .............................................................................................................................................................................................................73 6.1. Why accreditation?....................................................................................................................................................................................................................73 6.2. What is accreditation?.............................................................................................................................................................................................................73 6.3. Scope of Accreditation ............................................................................................................................................................................................................74 6.4. Accreditation according to Regulation (EC) No 765/2008..................................................................................................................................75 6.4.1. National accreditation bodies .............................................................................................................................................................................................75 6.4.2. Non-competition and non-commerciality of national accreditation bodies .............................................................................................76 6.5. The European accreditation infrastructure .................................................................................................................................................................76 6.5.1. Sectoral accreditation schemes ........................................................................................................................................................................................77 6.5.2. Peer evaluation ...........................................................................................................................................................................................................................77 6.5.3. Presumption of conformity for national accreditation bodies .........................................................................................................................77 6.5.4. EA’s role in supporting and harmonising accreditation practice across Europe .....................................................................................78 6.6. Cross-border accreditation ...................................................................................................................................................................................................78 6.7. Accreditation in the international context ...................................................................................................................................................................79 6.7.1. Cooperation between accreditation bodies.................................................................................................................................................................79 6.7.2. TheimpactontraderelationsinthefieldofconformityassessmentbetweentheEUandThirdCountries ........................80

7. MARKET SURVEILLANCE ..................................................................................................................................................................................82 7.1. Why do we need market surveillance? ..........................................................................................................................................................................82 7.2. Market Surveillance activities .............................................................................................................................................................................................83 7.3. Member States responsibilities .........................................................................................................................................................................................85 7.3.1. National infrastructures.........................................................................................................................................................................................................85 7.3.2. National Market Surveillance Programmes (NMSP) ...............................................................................................................................................85 7.3.3. Control of products from third countries by customs: national organisation and coordination ...................................................86 7.3.4. Public information .....................................................................................................................................................................................................................87 7.3.5. Market surveillance procedures (including safeguard mechanisms) ...........................................................................................................88 7.3.6. Corrective measures – bans – withdrawals-recalls ...............................................................................................................................................89 7.3.7. Sanctions ........................................................................................................................................................................................................................................90 7.4. Safeguard mechanisms for Member States ..............................................................................................................................................................90 7.4.1. Objective and place of safeguard mechanisms in market surveillance process ...................................................................................90 7.4.2. The application of safeguard mechanisms step by step ....................................................................................................................................91 7.5. Cooperation and exchange of information between the Member States and the European Commission .............................93 7.5.1. Cooperation among Member States ...............................................................................................................................................................................93 7.5.2. RAPEX ...............................................................................................................................................................................................................................................95 7.5.3. ICSMS ...............................................................................................................................................................................................................................................96 7.5.4. Medical devices: vigilance system ...................................................................................................................................................................................97

8. FREE MOVEMENT OF PRODUCTS WITHIN THE EU .................................................................................................98 8.1. Free movement clause ...........................................................................................................................................................................................................98 8.2. Limits and restrictions ............................................................................................................................................................................................................98

4

9. INTERNATIONAL ASPECTS OF THE EU LEGISLATION ON PRODUCTS ....................................99 9.1. Agreements on Conformity Assessment and Acceptance (ACAAs) ...............................................................................................................99 9.2. Mutual recognition agreements (MRAs).....................................................................................................................................................................100 9.2.1. Main characteristics ..............................................................................................................................................................................................................100 9.2.2. EU-Swiss MRA ..........................................................................................................................................................................................................................101 9.2.3. EEA EFTA States: Mutual recognition agreements and Agreements on Conformity Assessment and Acceptance .........101

10. ANNEXES ............................................................................................................................................................................................................................102 10.1. Annex 1 - EU legislation referred to in the Guide (non-exhaustive list) ..................................................................................................103 10.2. Annex 2 - Additional guidance documents ..............................................................................................................................................................107 10.3. Annex 3 - Useful web addresses ...................................................................................................................................................................................108 10.4. Annex 4 - Conformity assessment procedures (modules from Decision No 768/2008/EC) ........................................................109 10.5. Annex 5 - Relation between ISO 9000 and modules requiring a quality assurance system ......................................................118 10.6. Annex 6 - Using Harmonised Standards to assess the competence of Conformity Assessment Bodies .............................119 10.7. Annex 7 - Frequently Asked Questions on CE marking .....................................................................................................................................123

5

The Guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) was published in 2000. Since then, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the New Legislative Framework.

Much of the 2000 edition of the “Blue Guide” is still valid but it requires updating to cover new developments and to ensure the broadest possible common understanding on implementation of the New Legislative Framework (NLF) for the marketing of products. It is also necessary to take account of the changes introduced by the Lisbon Treaty (in force since 1st December 2009) with regard to the legal references and terminology applicable to EU-related documents, procedures, etc.

This new version of the Guide will therefore build on the past edition, but include new chapters, for example on the obligations of economic operators or accreditation, or completely revised chapters such as those on standardisation or market surveillance. TheGuidehasalsobeengivenanewtitlereflectingthefactthattheNewLegislativeFramework is likely to be used, at least in part, by all types of Union harmonisation legislation and not only by the so-called “New Approach” directives.

This Guide is intended to contribute to a better understanding of EU product rules and to theirmore uniformand coherent application across different sectors andthroughout the single market. It is addressed to the Member States and others who need to be informed of the provisions designed to ensure the free circulation of products as well as a high level of protection throughout the Union (e.g. trade and consumer associations, standardisation bodies, manufacturers, importers, distributors, conformity assessment bodies and trade unions).

This is intended purely as a guidance document – only the text of the Union harmonisationactitselfhaslegalforce.Incertaincases,theremaybedifferencesbetween the provisions of a Union harmonisation act and the contents of this Guide, in particular where slightly divergent provisions in the individual Union harmonisation act cannot be fully described in this Guide. The binding interpretation of EU legislation is the exclusive competence of the Court of Justice of the European Union. The views expressed in this Guide cannot prejudge the position that the Commission might take before the Court of Justice. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information.

This Guide applies to the EU Member States but also to Iceland, Liechtenstein and Norway as signatories of the Agreement on the European Economic Area (EEA), as well as Turkey in certain cases. References to the Union or the single market are, accordingly, to be understood as referring to the EEA, or to the EEA market.

AsthisGuidereflectsthestateoftheartatthetimeofitsdrafting,theguidanceofferedmaybesubjecttolatermodification1.

PREFACE

IMPORTANT NOTICE

1 On 13 February 2013, the Commission adopted a proposal for a new stand-alone Market Surveillance Regulation, bringing together all market surveillanceprovisionsfromRegulation(EC)No765/2008,GPSDandsectorallegislation.COM(2013)75finalisavailableat: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2013:0075:FIN:EN:PDF

6

1. REGULATING THE FREE MOVEMENT OF GOODS

1.1. A HISTORICAL PERSPECTIVE

Theobjectivesofthefirstharmonisationdirectivesfocusedontheeliminationofbarriersandonthefreemovementofgoodsinthe single market. These objectives are now being complemented by a comprehensive policy geared to ensuring that only safe andotherwisecompliantproductsfindtheirwayontothemarket,insuchawaythathonesteconomicoperatorscanbenefitfromalevelplayingfield,thuspromotingatthesametimeaneffectiveprotectionofEUconsumersandprofessionalusersanda competitive single EU market.

Policies and legislative techniques have evolved over the last 40 years of European integration, especially in the area of the free movement of goods, thereby contributing to the success of the Single Market today.

Historically, EU legislation for goods has progressed through four main phases:

• the traditional approach or “Old Approach” with detailed texts containing all the necessary technical and administrative requirements;

• the “New Approach” developed in 1985, which restricted the content of legislation to “essential requirements” leaving the technical details to European harmonised standards. This in turn led to the development of European standardisation policy to support this legislation;

• the development of the conformity assessment instruments made necessary by the implementation of the various Union harmonisation acts, both New Approach and Old Approach;

• the “New Legislative Framework”2 adopted in July 2008, which built on the New Approach and completed the overall legislativeframeworkwithallthenecessaryelementsforeffectiveconformityassessment,accreditationandmarketsurveillance including the control of products from outside the Union.

1.1.1. THE ‘OLD APPROACH’

TheOldApproachreflectedthetraditionalmannerinwhichnationalauthoritiesdrewuptechnicallegislation,goingintogreatdetail-usuallymotivatedbya lackofconfidenceintherigourofeconomicoperatorson issuesofpublichealthandsafety.In certain sectors (e.g. legalmetrology) thiseven ledpublicauthorities todeliver certificatesof conformity themselves. Theunanimityrequiredinthisfielduntil1986madetheadoptionofsuchlegislationveryunwieldyandthecontinuedrecoursetothistechniqueinanumberofsectorsisoftenjustifiedforreasonsofpublicpolicy(e.g.foodlegislation)orbyinternationaltraditionsand/or agreements which cannot be changed unilaterally (e.g. automobile legislation or food again).

ThefirstattempttobreakoutofthissituationcamewiththeadoptionofDirective83/189/EEC3 on 28 March 1983 setting up an information procedure between the Member States and the Commission to avoid the creation of new technical barriers to the free movement of goods which would take a long time to correct through the harmonisation process.

UnderthatDirective,MemberStatesareobligedtonotifydraftnationaltechnicalregulationstootherMemberStatesandtheCommission(andnationalstandardisationbodies(NSB)wereobligedtonotifydraftnationalstandards4 to the Commission, to the European standardisation organisations (ESO) and to other national standardisation bodies). During a standstill period these technical regulations may not be adopted, leaving the Commission and the other Member States the possibility to react. In the absenceofreactionswithintheinitialstandstillperiodofthreemonths,thedrafttechnicalregulationsmaythenbeadopted.Otherwise, where objections are raised, a further three month standstill is imposed.

The standstill period is 12 months in the presence of a proposal for a Union harmonisation act in the area in question. However, the standstill period does not apply where a Member State is obliged to introduce technical regulations urgently to protect public health or safety, animals or plants.

1.1.2. MUTUAL RECOGNITION

Alongside legislative initiatives to prevent new barriers and promote the free movement of goods, the systematic application of the principle of mutual recognition enshrined in EU law was also pursued. National technical regulations are subject to the provisions of Articles 34 to 36 of the Treaty on the Functioning of the European Union (TFEU), which prohibit quantitative

2 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 and Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC3 Now superseded by Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of informationinthefieldoftechnicalstandardsandregulationsandofrulesonInformationSocietyservicesO.J.E.C.L217,5.8.19984 Since 1.1.2013 and under Regulation (EU) No 1025/2012 each national standardisation body is obliged to make its work programme publicly available and to notify the existence thereof to the other national standardisation bodies, to the European standardisation organisation and to the Commission.

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restrictionsormeasureshavingequivalenteffect.CaselawoftheEuropeanCourtofJustice,especiallycase120/78(the‘Cassisde Dijon’ case5),providesthekeyelementsformutualrecognition.Theeffectofthiscaselawisasfollows.

• Products lawfully manufactured or marketed in one Member State should in principle move freely throughout the Union where such products meet equivalent levels of protection to those imposed by the Member State of destination.

• In the absence of Union harmonisation legislation, Member States are free to legislate on their territory subject to the Treaty rules on free movement of goods (Arts. 34 – 36 TFEU).

• Barrierstofreemovementwhichresultfromdifferencesinnationallegislationmayonlybeacceptedifnationalmeasures:

‣arenecessarytosatisfymandatoryrequirements(suchashealth,safety,consumerprotectionand environmental protection);

‣servealegitimatepurposewhichjustifiesoverridingtheprincipleoffreemovementofgoods;and

‣canbejustifiedwithregardtothelegitimatepurposeandareproportionatewiththeaims.

To help implement these principles, the European Parliament and the Council adopted, in the 2008 goods package, Regulation (EC) 764/2008 of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision 3052/95/EC6.

However, while contributing greatly to the free movement of goods within the single market, the mutual recognition principle cannot solve all the problems and there remains, even today as underlined by the comments of the Monti Report7, room for further harmonisation.

1.1.3 THE ‘NEW APPROACH’ AND THE ‘GLOBAL APPROACH’

The Cassis de Dijon case is well known for its important role in promoting the mutual recognition principle but it also played an immense role in modifying the EU approach to technical harmonisation on three fundamental counts:

• in stating that Member States could only justify forbidding or restricting the marketing of products from other Member States on the basis of non-conformity with “essential requirements”, the Court opened a reflection on the contentof future harmonisation legislation: since non-respect of non-essential requirements could not justify restricting the marketingofaproduct,suchnon-essentialrequirementsneednolongerfigureinEUharmonisationtexts.ThisopenedthedoortotheNewApproachandtheconsequentreflectiononwhatconstitutesanessentialrequirementandhowtoformulate it in such a manner that conformity can be demonstrated;

• in stating this principle, the Court clearly placed the onus on national authorities to demonstrate where products did not conform to essential requirements but it also begged the question of the appropriate means for demonstrating conformity in a proportionate manner;

• by noting that Member States were obliged to accept products from other Member States except in circumscribed conditions,theCourtidentifiedalegalprinciplebutdidnotproducethemeanstocreatethetrustintheproductsthatcould help authorities to accept products they could not vouch for. This led to the need to develop a policy on conformity assessment.

• The New Approach legislative technique approved by the Council of Ministers on 7 May 1985 in its Resolution on a new approach to technical harmonisation and standards8 was the logical legislative follow up to the Cassis de Dijon case.

• This regulatory technique established the following principles:

• Legislative harmonisation should be limited to the essential requirements (preferably performance or functional requirements)thatproductsplacedontheEUmarketmustmeetiftheyaretobenefitfromfreemovementwithintheEU;

• Thetechnicalspecificationsforproductsmeetingtheessentialrequirementssetoutinlegislationshouldbelaiddowninharmonised standards which can be applied alongside the legislation;

5 Judgment of the Court of Justice of 20 February 1979. - Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein. Case 120/78. European Court reports 1979 Page 6496 OJEU L 218 of 13.8.2008.7 http://ec.europa.eu/bepa/pdf/monti_report_final_10_05_2010_en.pdf8 OJEC N° C 136 of 4.8.1985

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• Productsmanufacturedincompliancewithharmonisedstandardsbenefitfromapresumptionofconformitywiththecorrespondingessentialrequirementsoftheapplicablelegislation,and,insomecases,themanufacturermaybenefitfromasimplifiedconformityassessmentprocedure(inmanyinstancesthemanufacturer’sDeclarationofConformity,made more easily acceptable to public authorities by the existence of the product liability legislation9).

• The application of harmonised or other standards remains voluntary, and the manufacturer can always apply other technical specifications tomeet the requirements (but will carry the burden of demonstrating that these technicalspecificationsanswertheneedsoftheessentialrequirements,moreoftenthannot,throughaprocessinvolvingathirdparty conformity assessment body);

TheoperationofUnionharmonisationlegislationundertheNewApproachrequiresharmonisedstandardstoofferaguaranteedlevel of protection with regard to the essential requirements established by the legislation. This constitutes one of the major preoccupations of the Commission in pursuit of its policy for a strong European standardisation process and infrastructure. Regulation (EU) No 1025/2012 on European Standardisation10givestheCommissionthepossibilityofinviting,afterconsultationwith the Member States, the European standardisation organisations to draw up harmonised standards and it establishes procedures to assess and to object to harmonised standards.

Since the New Approach calls for common essential requirements to be made mandatory by legislation, this approach is appropriateonlywhereitispossibletodistinguishbetweenessentialrequirementsandtechnicalspecifications.Further,asthescopeofsuchlegislationisrisk-related,thewiderangeofproductscoveredhastobesufficientlyhomogeneousforcommonessential requirements to be applicable. The product area or hazards also have to be suitable for standardisation.

The principles of the New Approach laid the foundation for European standardisation in support of Union harmonisation legislation. Theroleofharmonisedstandardsandtheresponsibilitiesof theEuropeanstandardisationorganisationsarenowdefined inRegulation (EU) No 1025/2012 together with relevant Union harmonisation legislation.

The principle of reliance on standards in technical regulations has also been adopted by the World Trade Organisation (WTO). In its Agreement on Technical Barriers to Trade (TBT) it promotes the use of international standards11.

The negotiation of the first Union harmonisation texts under the New Approach immediately highlighted the fact that thedeterminationofessentialrequirementsandthedevelopmentofharmonisedstandardswerenotsufficienttocreatethenecessarylevel of trust between Member States and that an appropriate horizontal conformity assessment policy and instruments had to be developed. This was done in parallel to the adoption of the directives12.

Hence in 1989 and 1990 the Council adopted a Resolution on the Global Approach and Decision 90/683/EEC (updated and replaced by Decision 93/465/EEC)13 laying down the general guidelines and detailed procedures for conformity assessment. These have now been repealed and updated by Decision No 768/2008/EC of 9 July 2008 on a common framework for the marketing of products14.

The major thrust of these policy instruments was to develop common tools for conformity assessment across the board (for both regulated and non-regulated areas).

Thepolicyonproductstandardswasfirstdevelopedtoensurethatthestandardssettechnicalspecificationstowhichconformitycould be demonstrated. However, at the request of the Commission, CEN and CENELEC adopted the EN 45000 series of standards for the determination of the competence of third parties involved with conformity assessment. This series has since become the EN ISO/IEC 17000 harmonised series of standards. Under the New Approach directives a mechanism was set up whereby nationalauthoritiesnotifiedthethirdpartiestheydesignatedtocarryoutconformityassessmentsbasedonrecoursetothesestandards.

On the basis of ISO/IEC documentation, the Council in its Decisions developed consolidated conformity assessment procedures and the rules for their selection and use in directives (the modules). The modules are set out in a manner to favour their selection from the lightest (“internal control of production”) for simple products or products not necessarily presenting serious risks, moving to the most comprehensive (full quality assurance), where the risks are more severe or the products/technologies more complex. In order to face up to modern manufacturing processes, the modules foresee both product conformity assessment processes and quality management assessment, leaving the legislator to decide which are the most appropriate in each sector,

9 For more details on the product liability legislation see Section 1.4. 10 OJEU of 14.11.2012 L 316/1911 Article 2.4 of the WTO TBT Agreement12 Initially legislation adopted under the New Approach technique was essentially in the form of Directives.13 References 93/465/EEC: Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and therulesfortheaffixinganduseoftheCEconformitymarking,whichareintendedtobeusedinthetechnicalharmonisationdirectives.OJL220, 30.8.1993, p. 2314 OJEU L 218 of 1813.8.2008

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asitisnotnecessarilyeffectivetoprovideforindividualcertificationforeachmassproducedproduct,forexample.Toreinforcethetransparencyofthemodulesandtheireffectiveness,attherequestoftheCommission,theISO9001seriesofstandardsonquality assurance were harmonised at the European level and integrated into the modules. Thus, economic operators who use thesetoolsintheirvoluntaryqualitymanagementpoliciestoreinforcetheirqualityimageonthemarket,canbenefitfromtheuse of the same tools in the regulated sectors.

Thesedifferentinitiativeswereallgearedtodirectlyreinforcingtheassessmentofconformityofproductspriortotheirmarketing.Alongside these, the Commission, in close cooperation with the Member States and the national accreditation bodies, developed Europeancooperationinthefieldofaccreditationinordertoconstitutealastlevelofcontrolandreinforcethecredibilityofthethird parties involved in carrying out product and quality assurance conformity assessment. This remained a political, rather than alegislativeinitiative,butitwasneverthelesseffectiveincreatingthefirstEuropeaninfrastructureinthisarea,andinplacingEuropeanplayersverymuchintheleadinthisfieldatinternationallevel.

These developments led to some 27 directives being adopted on the basis of New Approach elements. They are far fewer in numberthantraditionaldirectivesinthefieldofindustrialproducts(some700),buttheirwidehazard-basedscopemeansthatentireindustrialsectorshavebenefitedfromfreemovementthroughthislegislativetechnique.

1.2. THE ‘NEW LEGISLATIVE FRAMEWORK’ 1.2.1 THE CONCEPT

Towardstheendofthe90’stheCommissionstartedtoreflectontheeffectiveimplementationoftheNewApproach.In2002,a wide consultation process was launched and on 7 May 2003 the Commission adopted a Communication to the Council and European Parliament suggesting a possible revision of certain New Approach elements. This in turn led to the Council Resolution of 10 November 2003 on the Communication of the European Commission ‘Enhancing the implementation of the New Approach Directives’15.

The consensus on the need for the update and review was clear and strong. The major elements needing attention were also clear:overallcoherenceandconsistency,thenotificationprocess,accreditation,theconformityassessmentprocedures(modules),CE marking and market surveillance (including revision of the safeguard clause procedures).

A Regulation and a Decision constituting part of the “Ayral goods package”16 were adopted by the European Parliament and the Council on 9 July 200817.

Regulation (EC) No 765/2008 and Decision No 768/2008/EC brought together, in the New Legislative Framework (NLF), all the elementsrequiredforacomprehensiveregulatoryframeworktooperateeffectivelyforthesafetyandcomplianceofindustrialproducts with the requirements adopted to protect the various public interests and for the proper functioning of the single market.

Regulation (EC) No 765/2008 established the legal basis for accreditation and market surveillance and consolidated the meaning oftheCEmarking,thusfillinganexistingvoid.DecisionNo768/2008/ECupdated,harmonisedandconsolidatedthevarioustechnicalinstrumentsalreadyusedinexistingUnionharmonisationlegislation(notonlyinNewApproachdirectives):definitions,criteriaforthedesignationandnotificationofconformityassessmentbodies,rulesforthenotificationprocess,theconformityassessment procedures (modules) and the rules for their use, the safeguard mechanisms, the responsibilities of the economic operators and traceability requirements.

The NLF takes account of the existence of all the economic operators in the supply chain –manufacturers, authorised representatives, distributors and importers – and of their respective roles in relation to the product. The importer now has clear obligationsinrelationtothecomplianceofproducts,andwhereadistributororanimportermodifiesaproductormarketsitunder their own name, they become the equivalent of the manufacturer and must take on the latter’s responsibilities in relation to the product.

TheNLFalsorecognisesthedifferentfacetsoftheresponsibilitiesofthenationalauthorities:theregulatoryauthorities,thenotificationauthorities,thosewhichoverseethenationalaccreditationbody,themarketsurveillanceauthorities,theauthoritiesresponsible for the control of products from third countries, etc., underlining that responsibilities depend on the activities carried out.

The NLF has changed the emphasis of EU legislation in relation to market access. Formerly the language of Union harmonisation legislation concentrated on the notion of “placing on the market” which is traditional free movement of goods language, i.e. itfocusesonthefirstmakingavailableofaproductontheEUmarket.TheNLF,recognisingtheexistenceofasingleinternal

15 OJEU N°C 282 of 25.11.2003, p. 316 So called by the European Parliament in memory of Michel Ayral, the Director in Directorate General Enterprise and Industry, responsible for putting the Package together.17 OJEU L 218 of 18.8.2008

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market,putstheemphasisonmakingaproductavailablethusgivingmoreimportancetowhathappenstoafteraproductisfirstmade available. This also corresponds to the logic of the putting into place of EU market surveillance provisions. The introduction of the concept of making available facilitates the tracing back of a non-compliant product to the manufacturer. It is important tonotethatcomplianceisassessedwithregardtothelegalrequirementsapplicableatthetimeofthefirstmakingavailable.

The most important change brought about by the NLF to the legislative environment of the EU was the introduction of a comprehensive policy on market surveillance. This has considerably changed the balance of EU legislative provisions from being fundamentally oriented at setting product related requirements to be met when products are placed on the market to an equal emphasis on enforcement aspects during the whole life-cycle of products.

1.2.2. THE LEGAL NATURE OF THE NLF ACTS AND THEIR RELATIONSHIP TO OTHER EU LEGISLATION

1.2.2.1. Regulation (EC) No 765/2008

Regulation (EC) No 765/2008 imposes clear obligations on Member States who do not have to transpose its provisions (although many may have to take national measures to adapt their national legal framework). Its provisions are directly applicable to the Member States, to all the economic operators concerned (manufacturers, distributors, importers) and to conformity assessment bodies and accreditation bodies. Economic operators now have not only obligations but direct rights that they can enforce through the national courts against both national authorities and other economic operators for non-respect of the provisions of the Regulation.

InthepresenceofotherEUlegislation,theRegulationappliesfirstandforemost,a)onthebasisofbeingdirectlyapplicablei.e.national authorities and economic operators must apply the provisions of the Regulation as such (most of the other legislation is contained in directives) and b) on the basis of the lex specialis rule i.e. whenever a matter is regulated by two rules, the more specificoneshouldbeappliedfirst.

Intheabsenceofmorespecificlegislationontheissuescoveredbyitsprovisions,Regulation(EC)No765/2008willapplyatthe same time, with, and as a complement to, existing legislation. Where existing legislation contains similar provisions as the Regulation,thecorrespondingprovisionswillhavetobeexaminedonaonetoonebasistodeterminewhichisthemostspecific.

In general terms, relatively few EU legislative texts contain provisions relating to accreditation, so it can be said that Regulation (EC) No 765/2008 is of general application in this area. In the area of market surveillance (including the control of products from third countries) the situation is more complex, as some Union harmonisation legislation does have various provisions relating to the issues covered by the Regulation (e.g. pharmaceuticals andmedical devices legislationwhich provides for a specificinformation procedure).

1.2.2.2. Decision No 768/2008/EC

Decision No 768/2008/EC is what is referred to as a sui generis decision, meaning that it has no addressees and therefore is neither directly nor indirectly applicable. It constitutes a political commitment on the part of the three EU institutions, European Parliament, Council and Commission.

This means that for its provisions to apply in Union law, they have to be either referred to expressis verbis (expressly) in future legislation or integrated into it.

The three institutions have indeed committed themselves to adhere to and to have recourse as systematically as possible to its provisions when drawing up product related legislation. Thus, relevant future proposals are to be examined in the light of the Decisionanddeparturesfromitscontents,dulyjustified.

1.2.3. HOW THE SYSTEM FITS TOGETHER

TheevolutionofEUlegislativetechniquesinthisareahasbeenprogressive,tacklingissuesoneafteranother,althoughsometimesin parallel, culminating in the adoption of the New Legislative Framework: essential or other legal requirements, product standards, standards and rules for the competence of conformity assessment bodies as well as for accreditation, standards for quality management, conformity assessment procedures, CE marking, accreditation policy, and lately market surveillance policy including the control of products from third countries.

TheNewLegislativeFrameworknowconstitutesacompletesystembringingtogetherallthedifferentelementsthatneedtobedealt with in product safety legislation in a coherent, comprehensive legislative instrument that can be used across the board in all industrial sectors, and even beyond (environmental and health policies also have recourse to a number of these elements), whenever EU legislation is required.

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In this system, the legislation has to set the levels of public protection objectives of the products concerned as well as the basic safety characteristics, it should set the obligations and requirements for economic operators, it has to set-where necessary-the level of competence of the third party conformity assessment bodies who assess products or quality management systems, as wellasthecontrolmechanismsforthesebodies(notificationandaccreditation),itmustdeterminewhicharetheappropriateconformity assessment processes (modules which also include the manufacturer’s Declaration of Conformity) to be applied, andfinally itmust imposetheappropriatemarketsurveillancemechanisms(internalandexternal) toensurethatthewholelegislativeinstrumentoperatesinaneffectiveandseamlessmanner.

Allthesedifferentelementsareinterlinked,operatetogetherandarecomplementary,forminganEUquality18 chain. The quality oftheproductdependsonthequalityofthemanufacturing,whichinmanyinstancesis influencedbythequalityoftesting,internal or carried out by external bodies, which depends on the quality of the conformity assessment processes, which depends onthequalityofthebodieswhichinturndependsonthequalityoftheircontrols,whichdependsonthequalityofnotificationor accreditation; the entire system depending on the quality of market surveillance and controls of products from third countries. They should all be treated in one way or another in any piece of EU product safety legislation. If one element goes missing or is weak,thestrengthandeffectivenessoftheentire“qualitychain”isatstake.

1.3. THE GENERAL PRODUCT SAFETY DIRECTIVE

Directive 2001/95/EC on general product safety (GPSD) is intended to ensure a high level of product safety throughout the EU forconsumerproductsthatarenotcoveredbysector-specificEUharmonisationlegislation.TheGPSDalsocomplementstheprovisions of sector legislation in some aspects. The key provision of the GPSD is that producers are obliged to place on the market only products which are safe for consumers19.

The GPSD has set up the rapid alert system, RAPEX, between Member States and the Commission. The RAPEX system ensures thattherelevantauthoritiesarerapidlyinformedofdangerousproducts.Subjecttocertainconditions,RAPEXnotificationscanalso be exchanged with non-EU countries. In the case of serious product risks, the GPSD provides for the possibility of taking temporary Decisions on Union-wide measures, so-called ‘emergency measures’. Under certain conditions, the Commission may adopt a formal Decision (valid for one year, but renewable) requiring the Member States to restrict or prevent the marketing of a product posing a serious risk to the health and safety of consumers. The RAPEX system has been subsequently extended to apply toallindustrialproductsirrespectiveofthefinaluser.

1.4. THE LEGISLATION ON PRODUCT LIABILITY

The concept of manufacturer according to Union harmonisation legislation as shaped by the New Legislative Framework is differentfromthatundertheDirectiveonconsumerproductliability85/374/EEC20. In the latter case, the concept of “producer”21 coversmoreanddifferentpersonsthantheconceptof“manufacturer”undertheNewLegislativeFramework.

Legal or administrative action may take place against any person in the supply or distribution chain who can be considered responsible for a non-compliant product. This may, in particular, be the case when the producer is established outside the Union. The Directive on product liability covers all movables22andelectricity,aswellasrawmaterialsandcomponentsoffinalproducts.Services as such are currently excluded from the scope. Secondly, the Directive applies only to defective products i.e. products not providingthesafetythatapersonisentitledtoexpect.Thefactthataproductisnotfitfortheuseexpectedisnotenough.TheDirectiveonlyappliesifaproductlackssafety.Thefactthatabetterproductismadeafterwardsdoesnotrenderoldermodelsdefective.

Liability,theresponsibilitytopayfordamages,isplacedontheproducer.Aproduceriseitheramanufacturerofafinishedproductoracomponentpartofafinishedproduct,producerofanyrawmaterial,oranypersonwhopresentshimselfasamanufacturer(forexamplebyaffixingatrademark).ImportersplacingproductsontheUnionmarketfromthirdcountriesareallconsideredtobeproducersundertheDirectiveonproductliability.Iftheproducercannotbeidentified,eachsupplieroftheproductbecomesliable, unless he informs the injured person within a reasonable time of the identity of the producer, or of the person who supplied him with the product. When several persons are liable for the same damage, they are all jointly and severally liable.

The producer must compensate damages caused by the defective product to individuals (death, personal injury) and private property (goods for private use). Howev er, the Directive does not cover any damage to property under EUR 50023 for a single incident.Nationallawmaygovernnon-materialdamages(suchaspainandsuffering).TheDirectivedoesnotcoverthedestructionof the defective product itself and, therefore, there is no obligation to compensate for it under the Directive on product liability.

18 The word « quality » is used to designate the level of safety and other public policy objectives which are aimed by the Union harmonisation legislation. Nottobeconfusedwiththemeaningoftheword“quality”inthecommercialcontextallowingdifferentiatingbetweendifferentlevelsofproductquality.19 SpecificguidanceonthepracticalapplicationoftheGPSDisavailableat:http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm20 L 210 of 07/08/198521 See Article 3 of Directive 85/374/EEC22 For comparison, Union harmonisation legislation may apply to “movables” such as electronic equipment, personal protective equipment etc. or ‘not movables”(e.g.aliftonceitisintegratedintoimmovableproperty)23 The equivalence in national currency is calculated at the exchange rate of 25 July 1985.

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This is without prejudice to national law.

TheDirectiveonproductliabilityallowsMemberStatestofixafinancialceilingforserialaccidentsataminimumofEUR70million24. However, most Member States have not used this possibility.

The producer is not automatically liable for damage caused by the product. The injured person, whether or not he is the buyer or user of the defective product, must claim his rights to obtain compensation. The victims will be paid only if they prove that they havesuffereddamage,theproductwasdefective,andthisproductcausedthedamage.Iftheinjuredpersoncontributestothedamage, the producer’s liability may be reduced or even eliminated. However, the victims do not need to prove that the producer was negligent because the Directive on product liability is based on the principle of no-fault liability. Thus, the producer will not be exonerated even if he proves he was not negligent, if an act or omission of a third person contributes to the damage caused, if he has applied standards, or if his product has been tested.

The producer will not have to pay, if he proves:

• he did not place the product on the market (for example the product was stolen);

• the product was not defective when he placed it on the market (thus he proves that the defect was caused subsequently);

• the product was not manufactured to be sold or distributed for economic purpose;

• the defect was caused due to compliance with mandatory regulations issued by the public authorities (which excludes national, European and international standards)25;

• thestateofscientificandtechnicalknowledgeatthetimewhentheproductwasputonthemarketcouldnotassuchenable the existence of the defect to be discovered (the development risks defence)26; or,

• whereheisasubcontractor,thatthedefectwasdueeithertothedesignofthefinishedproductortodefectiveinstructionsgiventohimbytheproducerofthefinishedproduct.

Tenyearsaftertheproductisplacedonthemarket,theproducerceasestobeliable,unlesslegalactionispending.Further,thevictimmustfileanactionwithinthreeyearsofthedamage,thedefectandtheidentityoftheproducerbeingknown.Nowaiversof liability in relation to the injured person may be agreed.

The Directive on product liability does not require Member States to repeal any other legislation on liability. In this respect, the Directive’sregimeaddstotheexistingnationalrulesonliability.Itisuptothevictimtochoosethegroundsonwhichtofiletheaction.

1.5. SCOPE OF THE GUIDE

This Guide discusses non-food and non-agricultural products referred to as industrial products or products whether for use by consumers or professionals. The product-related legislation that deals with these products will be referred throughout the text indistinctly as Union harmonisation legislation, sectoral Union harmonisation legislation or Union harmonisation acts.

The New Legislative Framework consists of a set of legal documents. In particular Decision No 768/2008/EC provides for elements, which are partially or totally implemented in product-related Union harmonisation legislation addressing various public interests. The guide gives guidance for the implementation of the provisions and concepts laid down in the New Legislative Framework27. Wherethereareproduct-specificdeviationsorprovisionstheguidereferstosectoralguides,whichexistforalmostallsectoralUnion harmonisation legislation.

ThepresentGuidehas theambitionofexplaining thedifferentelementsof theNewLegislativeFramework indetailandofcontributingtoabetteroverallunderstandingofthesystemsothatlegislationisimplementedproperlyandisthereforeeffectivefor the protection of public interests such as health and safety, consumers, the environment and public security, as well as the proper functioning of the internal market for economic operators. Furthermore, the Guide promotes the goals of the Commission’s better regulation policy by contributing to the development of more comprehensive, coherent and proportionate legislation.

Each of these chapters should be read in conjunction with the explanations set out above, in other words against the general background, and in conjunction with the other chapters, as they are all interlinked and should not be seen in isolation. 24 The equivalence in national currency is calculated at the exchange rate of 25 July 1985.25 Accordingly, harmonised standards– although they give a presumption of conformity – do not free from liability, but they may reduce the likelihood of damage. For the use of harmonised standards and presumption of conformity, see Point 4.1.2.26 According to the Court of Justice (case C-300/95) this refers to an objective state of knowledge, related not only to safety standards existing in a particular sector, but to any high standard the producer is presumed to be aware of and that was accessible to him. Liability for development risks exists in only two Member States.27 Decision No 768/2008/EC and Regulation (EC) No 765/2008

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This guide primarily relates to the Union legislation on:

• The restriction of the use of certain hazardous substances in electrical and electronic equipment (Directive 2011/65/EU)

• Appliances burning gaseous fuels (Directive 2009/142/EC)

• Ecodesign requirements for energy-related products (Directive 2009/125/EC)

• Simple pressure vessels (Directive 2009/105/EC)

• Toys’ safety (Directive 2009/48/EC)

• Electrical equipment designed for use within certain voltage limits (Directive 2006/95/EC)

• Machinery (Directive 2006/42/EC)

• Electromagnetic compatibility (Directive 2004/108/EC)

• Measuring instruments (Directive 2004/22/EC)

• Non-automatic weighing instruments (Directive 2009/23/EC)

• Cableway installations designed to carry persons (Directive 2000/9/EC)

• Radio equipment and telecommunications terminal equipment (Directive 1999/5/EC)

• Active implantable medical devices (Directive 90/385/EEC)

• Medical devices (Directive 93/42/EEC)

• In vitro diagnostic medical devices (Directive 98/79/EC)

• Pressure equipment (Directive 97/23/EC)

• Transportable Pressure equipment (Directive 2010/35/EU)

• Aerosol Dispensers (Directive 75/324/EEC as amended)

• Lifts(Directive95/16/EC)

• Recreationalcraft(Directive94/25/EC)

• Equipment and protective systems intended for use in potentially explosive atmospheres (Directive 94/9/EC)

• Explosives for civil uses (Directive 93/15/EEC)

• Pyrotechnics (Directive 2013/29/EU)

• Efficiencyrequirementsfornewhot-waterboilersfiredwithliquidorgaseousfuels(CouncilDirective92/42/EEC)

• Personal protective equipment (Directive 89/686/EEC)

• Marine equipment (Directive 96/98/EC)

• Noise emission in the environment by equipment for use outdoors (Directive 2000/14/EC)

• Emissions from non-road mobile machinery (Directive 97/68/EC as amended)

• Energy labelling (Directive 2010/30/EU)

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However, elements of this Guide might be relevant for other Union harmonisation legislation going even beyond the realm of industrial products. This is particularly true for the various definitions in the Guide as well as the chapters bearing onstandardisation, conformity assessment, accreditation and market surveillance. Although, it is neither correct nor desirable to dress an exhaustive list of relevant legislation, a larger list of legislation concerned is provided in Annex 1.

The Guide does not attempt to cover:

• the Directive on General Product Safety28.TheCommissionhasprovidedspecificguidanceonthepracticalapplicationof the GPSD29.

• the Union legislation on motor vehicles, construction products, REACH, and chemicals.

This guide addresses conformity assessment as laid down under Decision No 768/2008/EC.

28 TherearehoweverreferencestoGPSDinrelationtospecificsituationssuchassecond-handproducts.29 http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm

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2. WHEN DOES UNION HARMONISATION LEGISLATION ON PRODUCTS APPLY?

2.1 PRODUCT COVERAGE

• Union harmonisation legislation applies when the product is placed on the market and to any subsequent operation which constitutes making available until it reaches the end-user.

• Union harmonisation legislation applies to all forms of selling. A product offered in a catalogue or by means of electronic commerce has to comply with Union harmonisation legislation when the catalogue or website directs its offer to the Union market and includes an ordering and shipping system.

• The Union harmonisation legislation applies to newly manufactured products but also to used and second-hand products imported from a third country when they enter the Union market for the first time

• Union harmonisation legislation applies to finished products.

• A product which has been subject to important changes or overhauls aiming to modify its original performance, purpose or type may be considered as a new product. The person who carries out the changes becomes then the manufacturer with the corresponding obligations.

Union harmonisation legislation applies to products which are intended to be placed (or put into service30) on the market. Furthermore, Union harmonisation legislation applies when the product is placed on the market (or put into service) and to any subsequent making available until the product reaches the end-user31 32. A product still in the distribution chain falls under the obligations of the Union harmonisation legislation as long as it is a new product.33 Once it reaches the end-user it is no longer considered a new product and the Union harmonisation legislation no longer applies34. The end-user is not one of the economic operators who bear responsibilities under Union harmonisation legislation i.e. any operation or transaction by the end-user involvingtheproduct(e.g.givingtheproductasagiftordonationtootherpersons,transformingintoanotherproduct)isnotsubject to Union harmonisation legislation. However, such an operation or transaction might fall under another regulatory regime, in particular at national level.

The product must comply with the legal requirements that were in place at the time of its placing on the market.

Union harmonisation legislation applies to all form of supply, including distance selling and selling through electronic means. Hence, regardless of the selling technique products intended to be made available on the Union market must be in conformity with the applicable legislation.

AproductintendedtobeplacedontheUnionmarket,offeredinacatalogueorbymeansofelectroniccommerce,hastocomplywithUnionharmonisationlegislationwhenthecatalogueorwebsitedirectsitsoffertotheUnionmarketandincludesanorderingand shipping system35. Where a product is not intended for the Union market or is not compliant with the applicable Union legislation, this has to be clearly indicated (e.g. by providing a visual warning).

The Union harmonisation legislation applies to newly manufactured products but also to used and second-hand products imported fromathirdcountrywhentheyentertheUnionmarketforthefirsttime36 37. This applies even to used and second-hand products imported from a third country that were manufactured before the legislation became applicable38.

30 SomeUnionharmonisationlegislationcoversalso„puttingintoservice“(e.g.lifts)or„ownuse“(e.g.machinerytobeusedbythemanufacturerhimself)as beingequivalenttothe„placingonthemarket“.Productshavetofulfiltheessentialrequirementsoftheapplicablelegislationatthepointintimethey are put into service. 31 For placing on the market, making available on the market and putting into service, see Sections 2.2, 2.3 and 2.5.32 Directive 1999/44/ on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 07/07/1999, p. 12.) is beyond the interest of this Guide. According to this directive, sellers of consumer products within the EU are obliged to guarantee the conformity of the products with a con tract,foraperiodoftwoyearsaftertheirdelivery.Iftheproductsarenotdeliveredinconformitywiththesalescontract,consumerscanaskforthe productstoberepaired,replaced,andreducedinpriceorforthecontracttoberescinded.Thefinalseller,whoisresponsibletotheconsumer,canalso hold the producer liable in their business relationship.33 See chapter 3.3 Distributors. 34 ThisiswithoutprejudicetothelevelofsafetyorotherpublicinterestprotectionthataproductmustofferinrelationtotheapplicableUnion harmonisation legislation at the time it was placed on the market.35 Thisimpliesthattheeconomicoperatorthatofferstheproducthastobeinapositiontoprovidetheevidencethattheproductcomplieswiththe applicablerequirementsi.e.byprovidingthetechnicalfileonrequestofamarketsurveillanceauthority.36 Union harmonisation legislation does not prohibit the manufacture of products to meet the requirements of a non EU Member State, if such products will not be placed and put into service in the internal market. Union harmonisation does not prohibit the import of products that do not meet the requirements of the relevant Union harmonisation legislation, if such products are not intended to be placed on the market or put into service on theinternalmarket(bute.g.refined/processed/incorporatedintheinternalmarket)buttobeexportedoutsidetheEEA.37 In this context the Union should be considered to mean the present Member States, where free movement of used and second-hand products takes place according to Articles 34 and 36 of the EU Treaty.38 Used and second-hand products supplied to consumers are covered by the GPSD and have to be safe, unless they are supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier has clearly informed the person to whom he supplies theproducttothateffect.

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Unionharmonisationlegislationappliestofinishedproducts.Yet,theconceptofproductvariesbetweendifferentpiecesofUnionharmonisation legislation. The objects covered by legislation are referred to, for instance, as products, equipment, apparatus, devices,appliances,instruments,materials,assemblies,componentsorsafetycomponents,units,fittings,accessories,systemsorpartlycompletedmachinery.Thus,withinthetermsofaspecificUnionharmonisationact,componentsorsub-assembliesmayberegardedasfinishedproductsandtheirend-usemaybetheassemblyorincorporationintoafinishedproduct.Itistheresponsibility of the manufacturer to verify whether or not the product is within the scope of a given piece of legislation39.

Acombinationofproductsandparts,whicheachcomplywithapplicablelegislation,doesnotalwaysconstituteafinishedproductthat has to comply itself as a whole with a given Union harmonisation legislation40. However, in some cases, a combination ofdifferentproductsandpartsdesignedorputtogetherbythesamepersonisconsideredasonefinishedproductwhichhasto comply with the legislation as such. In particular, the manufacturer of the combination is responsible for selecting suitable products to make up the combination, for putting the combination together in such a way that it complies with the provisions ofthelawsconcerned,andforfulfillingalltherequirementsofthelegislationinrelationtotheassembly,theEUDeclarationofConformityandCEmarking.ThefactthatcomponentsorpartsareCEmarkeddoesnotautomaticallyguaranteethatthefinishedproductalsocomplies.Manufacturersmustchoosecomponentsandpartsinsuchawaythatthefinishedproductitselfcomplies.Thedecisionwhetheracombinationofproductsandpartshastobeconsideredasonefinishedproducthastobetakenbythemanufacturer on a case-by-case basis in relation with the relevant legislation.

A product, which has been subject to important changes or overhaul aiming to modify its original performance, purpose or type afterithasbeenputintoservice,havingasignificantimpactonitscompliancewithUnionharmonisationlegislation,maybeconsidered as a new product. This has to be assessed on a case-by-case basis and, in particular, in view of the objective of the legislation and the type of products covered by the legislation in question. Where a rebuilt41ormodifiedproductisconsideredasa new product, it must comply with the provisions of the applicable legislation when it is made available or put into service. This hastobeverified–asdeemednecessaryaccordingtotheriskassessment–byapplyingtheappropriateconformityassessmentprocedure laid down by the legislation in question. In particular, if the risk assessment leads to the conclusion that the nature ofthehazardhaschangedorthelevelofriskhasincreased,thenthemodifiedproducthastobetreatedasanewproducti.e.complianceofthemodifiedproductwiththeapplicableessentialrequirementshastobereassessedandthepersoncarryingoutthemodificationhastofulfilthesamerequirementsasanoriginalmanufacturer,forexamplepreparationofthetechnicaldocumentation,drawingupaEUdeclarationofconformityandaffixingtheCEmarkingontheproduct

In any case, amodifiedproduct sold under thenameor trademarkof a natural or legal persondifferent from theoriginalmanufacturer, should be considered as new and subject to Union harmonisation legislation. The person who carries out important changes to the product carries the responsibility for verifying whether or not it should be considered as a new product in relation to the relevant Union harmonisation legislation. If the product is to be considered as new, this person becomes the manufacturer with the corresponding obligations. Furthermore, in the case the conclusion is that it is a new product, the product has to undergo a full conformity assessment before it is made available on the market. However, the technical documentation has to be updated inasmuchasthemodificationhasanimpactontherequirementsoftheapplicablelegislation.Itisnotnecessarytorepeattestsandproducenewdocumentationinrelationtoaspectsnotimpactedbythemodification,aslongasthemanufacturerhascopies(or access to copies) of the original test reports for the unchanged aspects. It is up to the natural or legal person who carries out changes or has changes carried out to the product to demonstrate that not all elements of the technical documentation need to be updated.

Products which have been repaired or exchanged (for example following a defect), without changing the original performance, purpose or type, are not to be considered as new products according to Union harmonisation legislation. Thus, such products do notneedtoundergoconformityassessmentagain,whetherornottheoriginalproductwasplacedonthemarketbeforeorafterthe legislation entered into force. This applies even if the product has been temporarily exported to a third county for the repair operations.Suchoperationsareoftencarriedoutbyreplacingadefectiveorwornitembyasparepart,whichiseitheridentical,oratleastsimilar,totheoriginalpart(forexamplemodificationsmayhavetakenplaceduetotechnicalprogress,ordiscontinuedproduction of the old part) or the entire identical unit42. Thus, maintenance operations are basically excluded from the scope of the Union harmonisation legislation. However, at the design stage of the product the intended use and maintenance must be taken into account43.

Softwareupdatesorrepairscouldbeassimilatedtomaintenanceoperationsprovidedthattheydonotmodifyaproductalreadyplacedonthemarketinsuchawaythatcompliancewiththeapplicablerequirementsmaybeaffected.

39 In some situations the responsibilities of the original manufacturer are taken over by another person, see Chapter 3.40 Please note that in the case of measuring instruments, a measuring instrument, assembled from subassemblies or a measuring instrument in combination with a subassembly does not have to meet ht requirements of the directive on measuring instruments. It is national legislation that applies to the new measuring instrument.41 Under medical devices legislation, the term “fully refurbished” exists. “Fully refurbished” products are assimilated to new products.42 In addition to traditional repairs, it is the “state of technology” not to repair products but instead to exchange cards, components, sub-assemblies or even entire units.43 For products used at the workplace the employer must take all measures necessary to ensure that work equipment is suitable and safe and that repaired machinery is no less safe than the original. See Section 3.5.

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2.2. MAKING AVAILABLE

• A product is made available on the market when supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge

• The concept of making available refers to each individual product. A product is made available on the market when supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.44 Such supply includesanyoffer fordistribution,consumption or use on the Union market which could result in actual supply (e.g. an invitation to purchase, advertising campaigns).

Supplying a product is only considered as making available on the Union market, when the product is intended for end use on theUnionmarket.Thesupplyofproductsforfurtherdistribution,forincorporationintoafinalproduct,forfurtherprocessingorrefinementwiththeaimtoexportthefinalproductoutsidetheUnionmarketisnotconsideredasmakingavailable.Commercialactivityisunderstoodasprovidinggoodsinabusinessrelatedcontext.Non-profitorganisationsmaybeconsideredascarryingout commercial activities if they operate in such a context. This can only be appreciated on a case by case basis taking into account the regularity of the supplies, the characteristics of the product, the intentions of the supplier etc. In principle, occasional supplies by charities or hobbyists should not be considered as taking place in a business related context.

‘Use’referstotheintendedpurposeoftheproductasdefinedbythemanufacturerunderconditionswhichcanbereasonablyforeseen. Usually, this is the end use of the product.

The central role that the concept of making available plays in Union harmonisation legislation is related to the fact that all economic operators in the supply-chain have traceability obligations and need to have an active role in ensuring that only compliant products circulate on the Union market.

The concept of making available refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series.

Themakingavailableofaproductsupposesanofferoranagreement(writtenorverbal)betweentwoormorelegalornaturalpersons for the transfer of ownership, possession or any other right45 concerning theproduct inquestionafter thestageofmanufacture has taken place. The transfer does not necessarily require the physical handover of the product.

This transfer can be for payment or free of charge, and it can be based on any type of legal instrument. Thus, a transfer of aproductisconsideredtohavetakenplace,forinstance,inthecircumstancesofsale,loan,hire,leasingandgift.Transferofownership implies that the product is intended to be placed at the disposal of another legal or natural person.

2.3. PLACING ON THE MARKET

• A product is placed on the market when it is made available for the first time on the Union market.

• Products made available on the market must comply with the applicable Union harmonisation legislation at the moment of placing on the market.

AproductisplacedonthemarketwhenitismadeavailableforthefirsttimeontheUnionmarket.Theoperationisreservedeither for a manufacturer or an importer i.e. the manufacturer and the importer are the only economic operators who place products on the market46. When a manufacturer or an importer supplies a product to a distributor47oranend-userforthefirsttime, the operation is always labelled in legal terms as “placing on the market”. Any subsequent operation, for instance, from a distributortodistributororfromadistributortoanend-userisdefinedasmakingavailable.

As for “making available”, the concept of placing on the market refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series. Consequently, even though a product model or type has been supplied before new Union harmonisation legislation laying down new mandatory requirements entered into force, individual unitsofthesamemodelortype,whichareplacedonthemarketafterthenewrequirementshavebecomeapplicable,mustcomply with these new requirements.

Placingaproductonthemarketrequiresanofferoranagreement(writtenorverbal)betweentwoormorelegalornaturalpersons for the transfer of ownership, possession or any other property right concerning the product in question. This transfer could be for payment or free of charge. It does not require the physical handover of the product.

44 See Article 2 of Regulation (EC) No 765/2008 and Article R1 of Annex I of Decision No 768/2008/EC45 Excluding intellectual property rights46 TheLiftsDirective95/16/ECusesalsotheconceptof“installer”whoalsoplacesonthemarket47 The distribution chain can also be the commercial chain of the manufacturer or the authorised representative.

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Placing on the market is considered not to take place where a product is:

• manufactured for one’s own use. Some Union harmonisation legislation however covers products manufactured for own use in its scope48;

• bought by a consumer in a third country while physically present in that country;

• transferred from the manufacturer in a third country to an authorised representative in the Union whom the manufacturer has engaged to ensure that the product complies with the Union harmonisation legislation49;

• introduced from a third country in the EU customs territory and has not been released for free circulation. This includes the cases of products in transit, placed in free zones, warehouses or temporary storage50;

• manufactured in a Member State with a view to exporting it to a third country (this includes components supplied to a manufacturerforincorporationintoafinalproducttobeexportedintoathirdcountry);

• transferred for testing or validating pre-production units considered still in the stage of manufacture;

• displayed or operated under controlled conditions51 at trade fairs, exhibitions or demonstrations52; or

• in the stocks of the manufacturer ( or the authorised representative established in the Union) or the importer, where the product is not yet made available, unless otherwise provided for in the applicable Union harmonisation legislation.

The placing on the market is the most decisive point in time concerning the application of the Union harmonised legislation53. When made available on the market, products must be in compliance with the Union harmonisation legislation applicable at the time of placing on the market. Accordingly, new products manufactured in the Union and all products imported from third countries – whether new or used – must meet the provisions of the applicable Union harmonisation legislation when placed on themarketi.e.whenmadeavailableforthefirsttimeontheUnionmarket.Compliantproductsoncetheyhavebeenplacedonthemarket may subsequently be made available along the delivery chain without additional considerations, even in case of revisions to the applicable legislation or the relevant harmonised standards.

Member States have an obligation in the framework of market surveillance to ensure that only safe and compliant products are on the market54. Used products, which are on the Union market, are subject to free movement according to the principles laid down by Articles 34 and 36 TFEU. It must be noted that used products made available to consumers in the course of a commercial activity are subject to the GPSD.

2.4. PRODUCTS IMPORTED FROM COUNTRIES OUTSIDE THE EU

Irrespective of their origin products must be compliant with the applicable Union harmonisation legislation when placed on the market.

Union harmonisation legislation applies when the product is made available (or put into service55) on the Union market for the firsttime.Italsoappliestousedandsecond-handproductsimportedfromathirdcountrywhentheyentertheUnionmarketforthefirsttime,butnottosuchproductsalreadyonthemarket.Itapplieseventousedandsecond-handproductsimportedfroma third country that were manufactured before the Union harmonisation legislation became applicable.

The basic principle of EU product rules is that irrespective of the origins of the products, they need to be compliant with the applicable Union harmonisation legislation when placed on the market. Products manufactured in the EU and products from non EU countries are treated alike.

48 See for instance, the Directives on Machinery, Measuring Instruments, ATEX, Civil Explosives49 For authorised representative, see Section 3.2.50 See Council Regulation (EEC) No 2913/92 establishing the Community customs code. In accordance with this Regulation, non-Community goods placed underasuspensivecustomsprocedureorinafreezonearesubjecttocustomssupervisionanddonotbenefitfromthefreecirculationintheinternal market.Beforebenefitingfromthefreecirculationintheinternalmarket,thesegoodsmustbedeclaredforreleaseforfreecirculation.Thatentails application of commercial policy measures, completion of the other formalities laid down in respect of the importation of goods and the charging of any duties legally due.51 The prototype must be safe and under complete control and supervision. Controlled conditions would mean expert operators, restrictions to public con tact with the product, avoiding inappropriate interaction with other neighbouring products etc. 52 However, in such circumstances a visible sign must clearly indicate that the product in question may not be placed on the market or put into service until it has been made to comply.53 The design in accordance with the essential requirement of the applicable legal act, the following risk and conformity assessment, the issue of a DeclarationofConformity,themarkingrequirements(CEmarking,name,addressofthemanufactureretc.),thecompilationofthetechnicalfile,must have been completed by the manufacturer at the time of placing on the market.54 For market surveillance, see Chapter 7.55 For putting into service, see Section 2.5.

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For products imported from countries outside the EU, Union harmonisation legislation envisages a special role for the importer. The latter assumes certain obligations which to some extent mirror the obligations of manufacturers based within the EU56.

In the case of products imported from countries outside the EU, an authorised representative may carry out a number of tasks on behalf of the manufacturer57. If however, the authorised representative of a third country manufacturer supplies a product to a distributor or a consumer within the EU, he then no longer acts as a mere authorised representative but becomes the importer and is subject to the obligations of importers.

2.5. PUTTING INTO SERVICE OR USE (AND INSTALLATION)

• The moment of putting into service is relevant for some Union harmonisation legislation.

• Putting into service takes place at the moment of first use within the Union by the end user.

PuttingintoservicetakesplaceatthemomentoffirstusewithintheUnionbytheenduser58 59 60. The concept is used in the fieldofLifts,Machinery,MeasuringinstrumentsorproductscoveredbytheEMCorATEX-directivesandresultsinthescopeofUnion harmonisation legislation being extended beyond the moment of making available of a product. The relevant products must comply with the provisions of the applicable Union harmonisation legislation and other Union legislation when they are put into service.

Where the product is put into service by an employer for use by his employees, the employer is considered as the end-user.

Member States may not prohibit, restrict or impede the putting into service of products that meet the provisions of the applicable Union harmonisation legislation61. However, Member States are allowed to maintain and adopt, in compliance with the Treaty (in particular Articles 34 and 36 TFEU), additional national provisions regarding the putting into service, installation or use, of products which are intended for the protection of workers or other users, or other products. Such national provisions may notrequiremodificationsofaproductmanufacturedinaccordancewiththeprovisionsoftheapplicableUnionharmonisationlegislation.

In the framework of market surveillance62, the need to verify the compliance of products, and – if applicable – that they are correctly installed, maintained and used for the intended purpose, should be limited to products:

• whichcanbeusedonlyafteranassembly,aninstallationorothermanipulationhasbeencarriedout;or

• whosecompliancecanbeinfluencedbythedistributionconditions(forexamplestorageortransport).

2.6. SIMULTANEOUS APPLICATION OF UNION HARMONISATION ACTS• Essential and other requirements laid down in Union harmonisation legislation may overlap or complement each other,

depending on the hazards covered by these requirements that are related to the product in question.

• The making available or putting into service can only take place when the product complies with the provisions of all applicable Union harmonisation legislation at the time of its placing on the market.

• Where the same product or policy objective is covered by two or more Union harmonisation acts, the application of some of the acts can sometimes be excluded following an approach that includes a risk analysis of the product with a view to intended use as defined by the manufacturer.

Union harmonisation legislation covers a wide range of products, hazards and impacts63, which both overlap and complement each other. As a result, the general rule is that several pieces of legislation may have to be taken into consideration for one product, since the making available or putting into service can only take place when the product complies with all applicable

56 For the role of the importer, see Point 3.3. 57 Please note that in the area of medical devices, the role of the authorised representative is reinforced and he is the primary interlocutor of market surveillance authorities for products for third countries.58 The concept of “putting into service” is not relevant for all Union harmonisation legislation. For instance, in the case of explosives, there is no ‘putting into service’.59 Asregardsliftsandequivalentproducts,theputtingintoserviceshouldbeconsideredtotakeplaceatthemomentwhenthefirstusewithintheUnionis possible.60 Products not considered to be “placed on the market” (according to the bullet point list in chapter 2.3) are also not considered to be “put into service” as definedhere.61 AccordingtotheDirectiverelatingtohot-waterboilers,productscannotbeputintoserviceunlesstheymeet,inadditiontotheefficiencyrequirements laid down by the Directive, the national conditions for entry into service. However, such provisions may not prevent the free movement of boilers. In the case of the Directive on radio and telecommunications terminal equipment, Article 7 regulates restrictions to the putting into service. Member Statesmayrestricttheputtingintoserviceofradioequipmentforreasonsrelatedtotheeffectiveandappropriateuseoftheradiospectrum,avoidance of harmful interference or matters related to public health.62 For market surveillance, see Chapter 7.63 e.g. energy consumption

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provisions and when the conformity assessment has been carried out in accordance with all applicable Union harmonisation legislation.

HazardscoveredbytherequirementsofvariousUnionharmonisationactswouldtypicallyconcerndifferentaspectsthatinmanycases complement each other (for example the Directives relating to Electromagnetic Compatibility and Pressure Equipment cover phenomena not covered by the Directives relating to Low-voltage Equipment or Machinery). This calls for a simultaneous application of the various legislative acts. Accordingly, the product has to be designed and manufactured in accordance with all applicable Union harmonisation legislation, as well as to undergo the conformity assessment procedures according to all applicable legislation, unless otherwise provided for.

Certain Union harmonisation acts exclude from their scope products covered by other acts64 or incorporate the essential requirements of other acts65 which avoids simultaneous application of redundant requirements. In other instances, this is not the case and the general principle of simultaneous application still applies where the requirements of the Union harmonisation acts are complementary to each other.

Two or more Union harmonisation acts can cover the same product, hazard or impact. In such a case, the issue of overlap might be resolvedbygivingpreference to themorespecificUnionharmonisationact66. This usually requires a risk analysis of the product, or sometimes an analysis of the intended purpose of the product, which then determines the applicable legislation. In specifying the hazards relating to a product, the manufacturer may use the relevant harmonised standards for the product in question.

2.7. INTENDED USE / MISUSE

Manufacturers have to match a level of protection corresponding to the use they prescribe to the product under the conditions of use which can be reasonably foreseen.

Union harmonisation legislation applies in the case products made available or put into service 67on the market are used for their intended use. Intended use means either the use for which a product is intended in accordance with the information provided by the person placing it on the market, or the ordinary use as determined by the design and construction of the product.

Usually such products are ready for use, or require only adjustments that can be performed in view of their intended use. Products are “ready for use” if they can be used as intended without the insertion of additional parts. Products are also deemed ready for use if all parts from which they are to be assembled are placed on the market by one person only, or they only need to be mounted or plugged in, or they are placed on the market without the parts that are usually procured separately and inserted for the intended use (e.g. a cable for electric supply).

Manufacturers are required to match a level of protection for the users of the products which corresponds to the use that the manufacturer prescribes for the product in the product information. This is particularly relevant in the cases where a misuse of a product is at stake68.

As far as market surveillance activities are concerned, market surveillance authorities are required to check the conformity of a product:

• inaccordancewithitsintendedpurpose(asdefinedbythemanufacturer)and

• under the conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour.

The consequence for manufacturers is that they have to consider the conditions of use which can be reasonably foreseen prior to placing a product on the market.

64 For instance: the Directive relating to low voltage equipment is not applicable to electrical equipment for medical purposes, instead the legislation relatingtomedicaldeviceswillapply;theDirectiverelatingtoelectromagneticcompatibilityisnotapplicabletoproductscoveredbyspecificlegislation thatharmonisestheprotectionrequirementsspecifiedintheDirectiveonelectromagneticcompatibility;theDirectiverelatingtoliftsisnotapplicableto liftsconnectedtomachineryandintendedexclusivelyforaccesstotheworkplace,insteadtheDirectiverelatingtomachineryapplies;marineequipment, which is also within the scope of other directives than the Directive on marine equipment, is excluded from the application of such directives.65 E.g. The R&TTE Directive directly covers electromagnetic compatibility aspects and low voltage safety. In order to avoid double coverage R&TTE incorporates the essential requirements of EMCD and LVD (with no lower voltage limit) and allows a manufacturer to use some of their conformity assessmentprocedures.InadditionHarmonisedStandardsunderEMCDandLVDalsohavethatstatusundertheR&TTEDirective.TheLiftsDirective includes relevant requirements of the Machinery Directive.66 For example: the Machinery Directive covers all hazards that come from machinery, including electrical hazards. However, concerning the electrical hazards of machinery, the Machinery Directive is referring to the safety objectives of the Low Voltage Directive, to be applied solely.67 For making available, see Section 2.2.; for putting into service, see 2.5.68 Please note that the Machinery Directive requires the manufacturer to take account of “reasonably foreseeable misuse”.

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Manufacturers have to look beyond what they consider the intended use of a product and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product69.

It is also important that market surveillance authorities take into account that not all risks can be prevented by product design. The supervision and assistance of the intended users should be considered as part of the conditions which can be reasonably foreseen. For instance, some professional machine tools are intended for use by averagely skilled and trained workers under the supervision of their employer; the responsibility of the manufacturer cannot be engaged if such machine tools are rented by a distributor or third party service-provider for use by unskilled and untrained consumers.

In any case, the manufacturer is not obliged to expect that users will not take into consideration the lawful conditions of use of his product.

2.8. GEOGRAPHICAL APPLICATION (EEA EFTA STATES, OVERSEAS COUNTRIES AND TERRITORIES (OCTS), TURKEY)

• Union harmonisation legislation applies to the Member States of the EU and to certain European territories to the extent necessary to give effect to the arrangements set out in the Accession Treaty of the relevant Member States.

• The Agreement on the European Economic Area is established between the European Union and Iceland, Liechtenstein and Norway. The Agreement extends the internal market to these three EFTA States – commonly known as EEA EFTA States.

• The Customs Union Agreement between the EU and Turkey aims to ensure the free movement of products between the EU and Turkey, by eliminating import controls at the EU-Turkey border on such products.

2.8.1. MEMBER STATES AND OVERSEAS COUNTRIES AND TERRITORIES

The purpose of Union harmonisation legislation relating to goods adopted pursuant to Articles 114 and 115 TFEU is the establishment and functioning of the internal market for goods. Consequently, Union harmonisation legislation cannot be separated from Treaty provisions on free movement of goods and the territorial scope of application of Union harmonisation legislation should coincide with the territorial scope of application of Articles 30 and 34 to 36 TFEU.

Pursuant to Article 355 TFEU and in connection with the Article 52 of the Treaty establishing the European Union, the Treaty and consequently the Union harmonisation legislation applies to all Member States of the European Union. Pursuant to Article 355(4) TFEU it also applies to Guadeloupe, French Guyana, Martinique, Réunion, Saint-Barthélemy, Saint-Martin, the Azores, Madeira and the Canary Islands. Moreover, the Treaty and harmonisation legislation relating to products adopted on the basis of Articles 114 and115TFEUappliestocertainEuropeanterritoriestotheextentnecessarytogiveeffecttothearrangementssetoutintherelevant Accession Treaty70.

However, it applies neither to Faeroe Islands, Greenland, Akrotiri and Dhekelia, nor to those overseas countries and territories having special relations with the United Kingdom of Great Britain and Northern Ireland such as Gibraltar. The Union harmonisation legislation does not apply to overseas countries and territories, in particular: New Caledonia and Dependencies, French Polynesia, French Southern and Antarctic Territories, Wallis and Futuna Islands, Saint Pierre and Miquelon, Aruba, Curaçao, Sint Maarten, Caribbean Netherlands(Bonaire, Saba and Sint Eustatius), Anguilla, Cayman Islands, Falkland Islands, South Georgia and the South Sandwich Islands, Montserrat, Pitcairn, Saint Helena and Dependencies, British Antarctic Territory, British Indian Ocean Territory, Turks and Caicos Islands, British Virgin Islands, Bermuda.

2.8.2 EEA EFTA STATES

2.8.2.1. Basic elements of the Agreement on the European Economic Area

The Agreement on the European Economic Area, in force since 1 January 1994, covers all Union harmonisation legislation to which this Guide is applicable. Thus, Union harmonisation legislation covered by this Guide also applies to the so-called EEA EFTA States: Iceland, Liechtenstein and Norway.

The objective of the EEA Agreement is to establish a dynamic and homogeneous European Economic Area, based on common rules and equal conditions of competition.

69 Furthermore, a tool designed and intended to be used by professionals only, might eventually also be used by ordinary persons; consequently the design and instructions accompanied must take this possibility into account.70 In the UK, these are the Channel Islands and the Isle of Man.

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Rights conferred and obligations imposed upon the Member States, or their public entities, undertakings, or individuals in relation to each other, are, according to the EEA Agreement, understood to be conferred or imposed in the same way also upon the EEA EFTA States. This ensures that the EEA EFTA States, and their economic operators, are subject to the same rights and obligations as their counterparts in the Union. For instance, the New Approach directives and other Union harmonisation legislation are implemented and applied in exactly the same way in the EEA EFTA States as in the Member States — although the safeguard clauseismodified.Therefore,allguidanceapplicabletotheMemberStatesaccordingtothisGuideappliesalsototheEEAEFTAStates.

For the purpose of the EEA Agreement references to the Community (now Union) or the common market in the EU/EEA acts are understood to be references to the territories of the Contracting Parties. Accordingly, a product is not only placed on the Union market, but on the EEA market (i.e. the national markets of the Member States and Iceland, Liechtenstein and Norway).

The EEA Agreement is amended on a continuous basis through decisions of the EEA Joint Committee following changes in relevant Union legislation. To arrive at and maintain a uniform interpretation and application of the Agreement, an EFTA Court and an EFTA Surveillance Authority have been established.

The EEA Agreement ensures a close cooperation between the Commission and the administration of the EEA EFTA States. The Commission seeks informal advice from experts of these States in the same way as it seeks advice from experts of the Member States. As regards the committees assisting the Commission in its work, close cooperation has been established. The EEA Council meets biannually, and the EEA Joint Parliamentary Committee and the EEA Consultative Committee regularly.

2.8.2.1. Safeguard clause procedure

TheEFTASurveillanceAuthority is responsible for theexaminationof thesafeguardclausenotifications from theEEAEFTAStates. The Authority consults all parties concerned and exchanges information with the Commission on the proceedings of the case. The Authority transmits its decision to the EEA EFTA States and the Commission for further actions. If an EEA EFTA State does not follow the decision, the Surveillance Authority can initiate an infringement procedure.

In cases where a Member State triggers a safeguard clause, consultations between the Commission and the Surveillance Authority are envisaged. The Commission communicates its decision to the EFTA Surveillance Authority, which sends it to the EEA EFTA States for further actions. If an EEA EFTA State does not follow the decision, the Surveillance Authority can initiate an infringement procedure.

2.8.3. MONACO, SAN MARINO AND ANDORRA

Bilateral trade in products between the EU and the three small-sized countries - Monaco, San Marino and Andorra, is facilitated by customs union agreements: Monaco has customs union with France and is part of the customs territory of the EU; whereas San Marino and Andorra both have a customs union agreement with the EU.

However, in order to be placed on the Union market, products from these countries must comply with the EU acquis.71

2.8.4. TURKEY

Turkey and the EU established a Customs Union in 1995 (Decision 1/95 of the EU-Turkey Association Council, 96/142/EC). The Customs Union Agreement covers trade in manufactured products between Turkey and the EU, and entails alignment by Turkey with all EU product legislation. The Agreement aims to ensure the free movement of industrial products between the EU and Turkey, by eliminating import controls at the EU-Turkey border on such products.

Articles5to7oftheAgreementprovidefortheeliminationofmeasureshavinganeffectequivalenttocustomsdutiesbetweenthe European Union and Turkey, mirroring Articles 34-36 TFEU. Pursuant to Article 66, Articles 5 to 7 must, for the purposes of their implementation and application to products covered by the Customs Union Agreement, be interpreted in conformity with the relevant case law of the Court of Justice, most notably the Cassis de Dijon case on mutual recognition.

As a consequence, in the sectors for which Turkey has aligned its legislation with that of the EU, a product lawfully manufactured and/or marketed in Turkey should be treated equal to the EU originating products and should not be subject to import controls. The same reasoning would apply in the non-harmonised sectors where Turkey has aligned its legislation with Articles 34-36 TFEU.

The Agreement also requires Turkey to adopt European Union legislation on products and on quality infrastructure, notably on CEmarkingrequirements,notifiedbodies,marketsurveillance,accreditation,standardisation,metrologyandmutualrecognitionin the non-harmonised area.

71 Formoredetails,pleaseconsultCommissionStaffWorkingPaperonObstaclestoaccessbyAndorra,MonacoandSanMarinototheEU’sInternalMarket andCooperationinotherAreas(SWD(2012)388final)availableat:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0388:FIN:EN:PDF

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Another Agreement (Decision No 2/97 of the EC-Turkey Association Council) signed in 1997 lays down the list of the Union’s legal instruments, including part of the acquis on industrial products related to the removal of technical barriers to trade and the conditions and arrangements governing their implementation by Turkey. Annex I of this Agreement ensures that when Turkey adopted the legislation listed in Annex II of the Agreement, the same rules and procedures would apply in the EU and Turkey for products that fall within the scope of the legislation listed in Annex II of the Agreement. However, many of the legislative instruments set out in Annex II have been gradually replaced by new Union directives and regulations.

In2006,TurkeyandtheEUadoptedanewAssociationCouncilDecision(1/2006),providingforthedesignationofTurkishnotifiedbodiesandrecognitionofthetestreportsandcertificatesissuedbysuchbodiesinTurkey.ThePartieshavesignedstatementsconfirmingthatTurkey’slegislationisequivalenttothatoftheEUforanumberofNewApproachdirectivesandregulations.

In the non-harmonised area, the rights and obligations of economic operators supplying products to the EU market from Turkey have been laid down in the Commission’s interpretative communication on ‘facilitating the access of products to the markets of other Member States: the practical application of mutual recognition’ (2003/C 265/02).

The Turkish Accreditation Agency (TURKAK) is a member of European co-operation for Accreditation (EA) and has signed a numberofmutualrecognitionagreementswithEA.CertificatesissuedbyTurkishconformityassessmentbodiesaccreditedbyTURKAK should be deemed equivalent to those issued by conformity assessment bodies established in the EU and accredited by EU National Accreditation Bodies.

In the area of standardisation, both CEN and CENELEC granted full membership status to the Turkish Standards Institute (TSE) on 1st January 2012.

2.9. TRANSITIONAL PERIODS IN THE CASE OF NEW OR REVISED EU RULES

In the case of new or revised legislation, economic operators may be given additional time to adapt to the new rules which is called transitional period and correspond to the lapse of time between the entry into force of a new rule and the moment it starts applying

Transitional period means that the existing product rules remain applicable although new rules have been already adopted. Transitional period may be introduced by the legislator in the case EU product rules are being revised or come to replace national rules.

Theaimofthetransitionalperiodistoallowmanufacturersandnotifiedbodiestoadjustgraduallytotheconformityassessmentprocedures and the essential or other legal requirements set up by a new or a revised piece of legislation, and, thus, to avert the risk of blocking production. Further, manufacturers, importers and distributors need to be given time to exercise any rights they have acquired under any pre-existing, national or EU rules, for example to sell their stocks of products manufactured in line with the pre-existing rules. Finally, the transitional period provides for extra time for the adoption of harmonised standards, even though this is not a precondition for the application of Union harmonisation legislation.

Each Union harmonisation legislation providing for a transitional period sets the date for freezing the system in force. Generally, this is the date on which the legislation enters into force, but sometimes it is the date on which the legislation is adopted.

Afterthetransitionalperiod,productsmanufacturedbeforeorduringthisperiod,inlinewiththelegislationtoberepealed,mayno longer be placed on the market. A product, which is placed on the market before the end of the transitional period, should be allowed to be made available on the market or put into service.72.Nevertheless,specificUnionharmonisationlegislationcouldforbid the making available of such products if this is deemed necessary for safety reasons or other objectives of the legislation. Products which were not placed on the market before the end of the transposition period can only be placed on the market or put into service, if they fully comply with the provisions of the new legislation73.

According to the general rule, CE marking is an indication that products, which are subject to one or several pieces of Union harmonisationlegislationprovidingforitsaffixing,conformtotheprovisionsofalltheseapplicablelegislations.However,whereone or more of these pieces of legislation allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking is an indication of conformity only to the legal texts applied by the manufacturer. Consequently, during a transitional period, the CE marking does not necessarily indicate that the product conforms to all applicable pieces of legislation providingforitsaffixing.InthatcaseinformationconcerningallUnionharmonisationlegislationappliedbythemanufacturerhasto be found in the EU Declaration of Conformity74.

72 Forinstance,suchproductcanstillbesoldlegallyafterthetransitionalperiodiftheproductisonstockatthedistributors’warehouse,i.e.that the product has been already placed on the market and that a change of ownership has taken place.73 Since the Directive on pressure equipment sets no time limit for the putting into service, products covered by this Directive can be put into service at any time without being subject to further conditions according to this Directive. For placing on the market and putting into service, see Sections 2.2 and 2.5.74 For the EU declaration of conformity, see Section 4.4.; for the CE marking, see Section 4.5.1.

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3. THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONSUnionharmonisation legislationdefines themanufacturer, theauthorised representative, the importerandthedistributoras‘economic operators’75.

3.1. MANUFACTURER

• The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark.

• The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations in-cluding traceability requirements.

• When placing a product on the Union market, the responsibilities of a manufacturer are the same whether he is established outside the European Union or in a Member State.

• The manufacturer must cooperate with the competent national authorities in charge of market surveillance in case of a product presenting a risk or being non-compliant.

The manufacturer is any natural or legal person who is responsible for designing or manufacturing a product and places it on the market under his own name or trademark76.Thedefinitioncontainstwocumulativeconditions:thepersonhastomanufacture(or have a product manufactured) and to market the product under his own name or trademark. So, if the product is marketed under another person’s name or trademark, this person will be considered as the manufacturer.The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes or labels ready-made products and places them on the market under his own name or trademark. Further, the responsibility of the manufacturerisplacedonanypersonwhochangestheintendeduseofaproductinsuchawaythatdifferentessentialorotherlegalrequirementswillbecomeapplicable,orsubstantiallymodifiesorre-buildsaproduct(thuscreatinganewproduct),witha view to placing it on the market77.

The manufacturer may design and manufacture the product himself. As an alternative, he may have it designed, manufactured, assembled, packed, processed or labelled with a view to placing it on the market under his own name or trademark, and thus presenting himself as a manufacturer78. Where subcontracting takes place, the manufacturer must retain the overall control for theproductandensurethathereceivesalltheinformationthatisnecessarytofulfilhisresponsibilitiesaccordingtotherelevantUnion harmonisation act. The manufacturer who subcontracts some or all of his activities may in no circumstances discharge himself from his responsibilities, for example to an authorised representative, a distributor, a retailer, a wholesaler, a user or a subcontractor.

The manufacturer has sole and ultimate responsibility for the conformity of the product to the applicable Union harmonisation legislation, whether he designed and manufactured the product himself or is considered as a manufacturer because the product is placed on the market under his name or trademark.

Thus, when a product is transferred to a manufacturer for further measures such as assembling, packaging, processing or labelling, when placing the product on the market, he has the sole and ultimate responsibility for ensuring the conformity of the product to the applicable legislation, and must be able to do so.

The manufacturer is responsible for designing and manufacturing the product in accordance with essential or other legal requirements laid down by the relevant Union harmonisation legislation and for carrying out conformity assessment in accordance with the procedure(s) laid down by the Union harmonisation legislation79.

The manufacturer is obliged to understand both the design and construction of the product to be able to take the responsibility for the product being in compliance with all provisions of the relevant Union harmonisation legislation. This applies equally to situations where the manufacturer designs, manufactures, packs and labels the product himself, as to situations where some or all of these operations are carried out by a subcontractor.

75 See Article R1 (7) of Annex I of Decision No 768/2008/EC.76 See Article R1 (3) of Annex I of Decision No 768/2008/EC.77 See Article R6 of Annex I of Decision No 768/2008/EC.78 Thosemanufacturersareoftenreferredtoas“ownbrandlabellers”or“privatelabellers”.79 TheLiftsDirective95/16/ECusestheconceptofinstallertoimposeresponsibilitiesonthepersonwhomakesaproductoperationalandreadytouse. Theroleoftheinstallercombineselementsofmanufactureandputtingintoserviceandisseenasfundamentalfordeliveringthefinalproduct. TheLiftsDirective95/16/ECdefinestheinstallerofaliftas“thenaturalorlegalpersonwhotakesresponsibilityforthedesign,manufacture, installationandplacingonthemarketoftheliftandwhoaffixestheCEmarkinganddrawsuptheECdeclarationofconformity”. Hence, the installer is a person who assumes responsibilities which in the context of other Union harmonisation legislation are typically assigned to the manufacturer.

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Union harmonisation legislation does not require the manufacturer to be established in the European Union. Thus, when placing a product on the Union market, the responsibilities of a manufacturer are the same whether he is established outside the European Union or in a Member State.

As a general rule, when placing a product on the market the manufacturer must take all measures necessary to ensure that the manufacturing process assures compliance of the products80 and in particular:

1. carry out the applicable conformity assessment or have it carried out, in accordance with the procedure(s) laid down by the relevant Union harmonisation legislation; Depending on the Union harmonisation act, the manufacturer may be required to submittheproducttoathirdparty(usuallyanotifiedbody)tohavetheconformityassessmentcarriedout,ortohaveaqualitysystemapprovedbyanotifiedbody.Inanycase,themanufacturerbearsfullresponsibilityforproductconformity.

2. draw up the required technical documentation; 3. draw up the EU Declaration of Conformity;4. accompany the product with instructions and safety information81 82 83 as required by the applicable Union harmonisation

legislation, in a language easily understood by consumers and other end-users, as determined by the Member State con-cerned;

5. satisfy the following traceability requirements:• KeepthetechnicaldocumentationandtheEUDeclarationofConformityfor10yearsafter theproducthasbeen

placed on the market84orfortheperiodspecifiedintherelevantUnionharmonisationact.• Ensurethattheproductbearsatype,batchorserialnumberorotherelementallowingitsidentification.• Indicate the following three elements: his (1) name, (2) registered trade name or registered trade mark and (3) a sin-

gle contact postal address on the product or when not possible because of the size or physical characteristics of the products85, on its packaging86 and/or on the accompanying documentation87 88 89. The single contact point may be located in only one Member State and not necessarily the Member State where the product is placed on the market.

6. affix the conformitymarking (CEmarkingandwhere relevant othermarkings90) to theproduct in accordancewith theapplicable legislation,

7. ensure that procedures are in place for series production to remain in conformity. Changes in product design or charac-teristicsandchanges intheharmonisedstandardsor intechnicalspecificationsbyreferencetowhichconformityofaproduct is declared must be adequately taken into account. The kind of action to be taken by the manufacturer depends onthenatureofchangesintheharmonisedstandardsortechnicalspecifications,inparticularwhetherthesechangesarematerial with regard to the coverage of the essential or other legal requirements and whether they concern the product in question. This might require for instance to update the EU Declaration of conformity, change the product design, contact thenotifiedbody,91 etc.

8. Where relevant, certify the product and/or the quality system. Under certain Union harmonisation acts, the manufacturer may be required to perform sample testing at the end of the productionchainorofalreadymarketedproductsinviewofofferingadditionalprotectiontoconsumersorotherend-users92. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Union harmonisation legislation must immediately take the necessary corrective measures to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, manufacturers must immediately inform the competent national authorities of the Member States in which they made theproductavailabletothateffect,givingdetails, inparticular,ofthenoncomplianceandofanycorrectivemeasurestaken.

80 Article R2 (1) of Decision No 768/2008/EC81 The use of symbols according to international standards may be an alternative to written statements.82 Not all Union harmonisation legislation requires both instructions and safety information since not all Union harmonisation legislation is safety related.83 Insomespecificcases,whereseveralidenticalproductsarebundledinapackagingforuseinoneapplication(e.g.installationequipment),itissufficient to accompany the shipping unit with one set of instructions.84 To be understood as the last item of the product model placed on the market.85 This does not include esthetical reasons.86 Please note that some Union harmonisation legislation excludes the possibility to use the packaging to satisfy this requirement (e.g. Simple Pressure Vessels Directive)87 Manufacturer may add a website if they so desires. A website is additional information, but is not enough as an address. Normally an address consists of a street and number or post-box and number and the postal code and town, but some countries might deviate from this model.88 See Union harmonisation legislation relating to low voltage equipment, toys, machinery, non- automatic weighing instruments, active implantable medicaldevices,gasappliances,medicaldevices,potentiallyexplosiveatmospheres,recreationalcraft,lifts,pressureequipment,telecommunications terminal equipment, in vitro diagnostic medical devices, and radio and telecommunications terminal equipment. Further, according to the Directive on in vitro diagnostic medical devices, a manufacturer who places devices on the Union market under his own name is obliged to register in the Member State where he has his place of business.89 For more information on the name and address requirement, see Point 4.2.2.1. 90 e.g.ATEXmarking,ClassidentifierinaccordancewiththeR&TTEDirectiveorthesupplementarymetrologymarkinginthecaseofnon-automatic weighing machines and measuring instruments.91 FortheinformationobligationsinthecaseofEU-typeexaminationcertificates,seeAnnexIIofDecisionNo768/2008/EC,ModuleB,point7.92 E.g. The Directives on Simple pressure vessels and ATEX

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Upon a reasoned request93, the manufacturer has to provide the competent national authority with all the information and documentation necessary to demonstrate the conformity of a product, in a language which can be easily understood by that authority. Manufacturers must cooperate with the authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market. Manufacturers must on request by market surveillance authorities identify any economic operator to whom they have supplied a product. They must be able to present this information for a period of 10 years aftertheyhavesuppliedtheproduct.

The idea is that the national authoritymight accept a language they understand andwhich is different from the nationallanguage(s). The language chosen is subject to negotiation with the authority and could be a third language, if accepted by the authority.

Inthecaseofareasonedrequestitissufficientforthemanufacturertoprovidethepartofthetechnicaldocumentationrelatedto the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, any request for translation of technical documentation should be limited to these parts of the documentation. The request may indicate a deadline for the receipt of the requested documents, depending on the Union harmonisation legislation the product is subject to. A shorter deadline can be fixed if the national authority justifies the urgency on the basis of animmediate serious risk.

If the Union harmonisation legislation covers putting into service, the person who puts the product into service has the same responsibilities as a manufacturer who places a product on the market. He must ensure that the product complies with the Union harmonisation legislation, and that the appropriate conformity assessment procedure has been carried out94.

Furthermore, a person who places on the Union market second-hand products from a third country, or any product not designed or manufactured for the Union market, must assume the role of the manufacturer.

Finally,ifanimporterordistributormodifiesaproductorsuppliesitunderhisname,thenheistobeconsideredthemanufacturerand must undertake all the obligations incumbent on the manufacturer95. Accordingly, he must ensure that the product complies with the applicable Union harmonisation legislation and that the appropriate conformity assessment procedure has been carried out96.

3.2. AUTHORISED REPRESENTATIVE

Irrespectively of whether he is established in the EU or not, the manufacturer may appoint an authorised representative in the Union to act on his behalf in carrying out certain tasks.

Whether the manufacturer is established in the EU or not, he may appoint an authorised representative in the Union to act on his behalf in carrying out certain tasks required in the applicable Union harmonisation legislation97. A manufacturer established outside the European Union is not obliged to have an authorised representative98.

For the purposes of Union harmonisation legislation, to be able to act on behalf of the manufacturer, the authorised representative must be established inside the Union. Commercial representatives of the manufacturer (such as authorised distributors or agents), are not to be confused with the authorised representative in the meaning of Union harmonisation legislation.

The delegation of tasks from the manufacturer to the authorised representative must be explicit and set out in writing, in particulartodefinethecontentsandlimitsoftherepresentative’stasks.Thetasksthatmaybedelegatedtotheauthorisedrepresentative according to the Union harmonisation legislation are of an administrative nature. Thus, the manufacturer may neither delegate the measures necessary to ensure that the manufacturing process assures compliance of the products nor the drawing up of technical documentation, unless otherwise provided for. Further, an authorised representative cannot modify the product on his own initiative in order to bring it into line with the applicable Union harmonisation legislation.

93 The reasoned request does not necessarily mean a formal decision by an authority. According to Article 19 (1), paragraph 2 of Regulation (EU) No 765/2008, “market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities”.94 This is not applicable to products covered by the Union harmonisation legislation relating to toys, low voltage equipment, civil explosives and refrigerationappliances,sincethesedirectivesonlycovermakingavailableonthemarket.Further,thisisnotapplicabletorecreationalcraftbuiltforown use,providedthatitisnotsubsequentlyplacedonthemarketduringaperiodoffiveyears,ortocraftdesignedbefore1950.95 Article R6 of Annex I of Decision No 768/2008/EC96 Further,accordingtotheDirectivesrelatingtomachineryandlifts,obligationsregardingtheconformityassessmentprocedurefalltoanypersonplacing theproductonthemarket,whereneitherthemanufacturernortheauthorisedrepresentativeortheinstalleroftheliftfulfilstheseobligations.97 Please note that not all Union harmonisation legislation provides for an authorised representative (e.g. this is not allowed under the Pyrotechnic articles directive).98 As an exception, according to the Directives on medical devices (as regards certain types of devices) and in vitro diagnostic medical devices the manu facturer must designate a person who is established in the Union to be responsible for the marketing of medical devices, if he does not have a registered place of business in a Member State and he places devices on the Union market under his own name.

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Depending on the conformity assessment procedure and the Union harmonisation act in question, the authorised representative can, for instance, be appointed to perform tasks such as:

• affix the CE marking (and where relevant other markings) and the notified body’s number to the product,

• draw up and sign the EU Declaration of Conformity,

• keep the declaration and the technical documentation at the disposal of national surveillance authorities and cooperate with them at their request,

• upon a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product

• cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.

The authorised representative who is appointed by a manufacturer may be an importer or a distributor in the meaning of Union harmonisationlegislation,inwhichcasehemustalsotofulfiltheobligationsoftheimporterordistributor99.

3.3. IMPORTER

• The importer is a natural or legal person established in the Union who places a product from a third country on the EU market.

• His obligations build on the obligation of the manufacturer.

The importer is the economic operator established in the Union who places a product from a third country on the Union market. HehasimportantandclearlydefinedresponsibilitiesunderUnionharmonisationlegislation100101. To a large extent they build on the type of responsibilities which a manufacturer based in the EU is subjected to.

Theimportermustensurethatthemanufacturerhascorrectlyfulfilledhisobligations.Theimporterisnotasimplere-sellerofproducts, but has a key role to play in guaranteeing the compliance of imported products.

TheimporterisdefinedasanynaturalorlegalpersonwhoplacesaproductfromathirdcountryontheEUmarket.Asageneralrule, before placing a product on the market the importer must ensure:

1. that the appropriate conformity assessment procedure has been carried out by the manufacturer. If he has any doubt about the conformity of the product, he must refrain from placing it on the market. If the product has already been placed on the market, he has to take corrective actions.102 In both cases the manufacturer might need to be contacted to clarify any doubt about the conformity of the product.

2. thatthemanufacturerhasdrawnupthetechnicaldocumentation,affixedtherelevantconformitymarking(e.g.CEmarking),fulfilledhistraceabilityobligationsandaccompanied,whererelevant,theproductbytheinstructionsandsafety information in a language easily understood by consumers and other end-users, as determined by the Member State concerned.103

These obligations are meant to make sure that the importers are aware of their responsibility to place only compliant products on the market104. Neither do they imply the need for importers to systematically resort to additional control procedures or (third-party) testing, nor do they preclude them from doing so.

99 For the obligations of the importer see Section 3.3100 ForthepurposesofthisGuide,importsareproductsmanufacturedinthirdcountriesandplacedontheUnionmarketafterhavingbeenreleasedfor free circulation by customs authorities. Products manufactured in one Member State and placed on the market in another Member State do not constitute an “import” as the operation takes place within the Union internal market.101 The importer is not necessarily the person who transports the product, but can be the person on behalf of whom this logistic activity is performed.102 See the Chapter on Market Surveillance103 Not all Union harmonisation legislation requires both instructions and safety information since not all Union harmonisation legislation is safety related.104 In light of these obligations, it is generally considered good practice for importers to: refer to the applicable EU legislation in the contract with his supplier(mentioningtheobligationsofmanufacturersunderUnionlaw);ensurethathehasaccesstothetechnicalfile,orensurethatthemanufacturer has signed an obligation to provide the technical documentation if requested by market surveillance authorities.

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The importer also has to:

• Indicate the following three elements: his (1) name, (2) registered trade name or trade mark and (3) the address at which he can be contacted on the product or where not possible because of the size or physical characteristics of the product or because the packaging would need to be opened, on the packaging or/and105 on the accompanying documentation106. By doing so, he must not impede the visibility of any safety information printed on the product or the accompanying documents.

• Ensure that, while a product is under his responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in the applicable legislation.

• KeepacopyoftheEUDeclarationofConformityfor10yearsaftertheproducthasbeenplacedonthemarket107 or for theperiodspecifiedintherelevantUnionharmonisationact.

• Ensure that the technical documentation can be made available to the competent national authority upon request108. The importer has to cooperate with that authority and upon a reasoned request109, has to provide that authority with all the information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority. The idea is that the national authority might accept a language they understand and whichisdifferentfromthenationallanguage(s).Thelanguagechosenissubjecttonegotiationwiththeauthorityandcould be a third language, if accepted by the authority.

Inthecaseofareasonedrequest it issufficientfortheimportertoprovidethepartofthetechnicaldocumentationrelated to the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, any request for translation of technical documentation should be limited to these parts of the documentation.

• On request by market surveillance authorities, the importer must identify any economic operator who has supplied him andtowhomhehassuppliedtheproduct.Hemustbeabletopresentthisinformationforaperiodof10yearsafterhehasbeensuppliedwiththeproductandforaperiodof10yearsafterhehassuppliedtheproduct.

Further, under certain Union harmonisation acts, the importer, like a manufacturer, may be required to perform or have performed sample testing of products already placed on the market110.

Equally, importers who have reason to believe that a product which they have placed on the market is not in conformity with the Union harmonisation legislation applicable, shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, importers shall immediately inform the competent national authorities.

The importer needs neither a mandate from the manufacturer, nor a preferential relationship with the manufacturer like the authorised representative. However, the importermust ensure, in order to fulfil his responsibilities, that a contactwith themanufacturer can be established (e.g. to make the technical documentation available to the requesting authority).

The importer may wish to carry out administrative tasks on behalf of the manufacturer. In such a case, he has to be explicitly designated by the manufacturer in order to become an authorised representative.

3.4. DISTRIBUTOR

• The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.

• Distributors are subject to specific obligations and have a key role to play in the context of market surveillance.

Alongwithmanufacturersandimporters,distributorsarethethirdcategoryofeconomicoperatorswhoaresubjecttospecificobligations. The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.

105 Depends on the applicable Union harmonisation legislation106 Please note that some sectoral Union harmonisation legislation might provide for stricter requirements107 To be understood as the last item of the product model placed on the market.108 Even if there is no explicit obligation, the importer is advised to require formal assurance in writing from the manufacturer that the documents will be made available when requested by the surveillance authority.109 The reasoned request does not necessarily mean a formal decision by an authority. According to Article 19 (1), paragraph 2 of Regulation (EU) No 765/2008, “market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities”.110 Article R4(6) of Annex I of Decision No 768/2008/EC.

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Retailers, wholesalers and other distributors in the supply chain are not required to have a preferential relationship with the manufacturer like the authorised representative. A distributor acquires products for further distribution either from a manufacturer, from an importer, or from another distributor.

Distributor must act with due care111 in relation to the applicable requirements112. They have to know, for instance, which products must bear the CE marking, what information is to accompany the product (for example the EU Declaration of Conformity), what are the language requirements for labelling, user instructions or other accompanying documents, and what is a clear indication of the product being non-compliant. Distributors have an obligation to demonstrate to the national market surveillance authority that they have acted with due care and ensure that the manufacturer, or his authorised representative, or the person who provided him with the product has taken the measures required by the applicable Union harmonisation legislation as listed in the obligations for distributors.

Conformity assessment, drawing up and keeping the EU declaration of conformity and the technical documentation remain the responsibility of the manufacturer and/or importer in the case of products from third countries. It is not part of the distributor’s obligations to check whether a product already placed on the market is still in conformity with the legal obligations that are currently applicable in case these have changed. The obligations of the distributor refer to the legislation applicable when the productwasplacedonthemarketbythemanufacturerortheimporterunlessspecificlegislationprovidesotherwise.

The distributor must be able to identify the manufacturer, his authorised representative, the importer or the person who has providedhimwiththeproduct inordertoassist themarketsurveillanceauthority in itseffortstoobtaintheEUDeclarationof Conformity and the necessary parts of the technical documentation. Market surveillance authorities have the possibility to address their request for the technical documentation directly to the distributor. The latter is however not expected to be in possession of the relevant documentation.

Before making a product available on the market, the distributor must verify the following formal requirements113:

• that the product bears the required conformity marking(s)(e.g. CE marking);

• that the product is accompanied by the relevant documents (e.g. EU Declaration of Conformity114) and by instructions and safety information115 in a language which can be easily understood by consumers and other end-users if required by the applicable legislation;

• that the manufacturer and importer have indicated their (1) name, (2) registered trade name or trademark and (3) the address at which they can be contacted on the product or when not possible because of the size or physical characteristics of the products, on its packaging and/or on the accompanying documentation116, and that the product bearsatype,batchorserialnumberorotherelementallowingtheidentificationoftheproduct.

Distributor must not supply products that they know or should have assumed, on the basis of information in their possession and as a professional, not to be in compliance with the legislation. Further, they must cooperate with the competent authority in actions taken to avoid or minimise these risks, inform the manufacturer or the importer as well as the competent national authorities117.

Similar obligations bind distributors once a product is made available. If they have reasonable grounds to believe that a product is not in conformity, they have to make sure that corrective measures to bring the product into conformity are taken by the manufacturer or the importer and inform the competent national authorities. Distributors have to contact the importer or manufacturer to clarify any doubt about the conformity of the product.

In addition to controlling the conformity of the product with the formal requirements, the distributor must:

1. initiate corrective measures where there is suspicion of a non-conformity118;

2. assist market surveillance authorities in identifying the manufacturer or importer responsible for the product;

111 Duecarereferstotheeffortmadebyanordinarilyprudentorreasonablepartytoavoidharmtoanother,takingthecircumstancesintoaccount.Itrefers to the level of judgment, care, prudence, determination, and activity that a person would reasonably be expected to do under particular circumstances.112 Article R5(1) of Annex I of Decision No 768/2008/EC.113 Article R5(2), 1st paragraph of Annex I of Decision No 768/2008/EC.114 Where the Union harmonisation legislation explicitly requires that the product is accompanied by the EU declaration of conformity, the distributor has to ensure that this is the case.115 Not all Union harmonisation legislation requires both instructions and safety information since not all Union harmonisation legislation is safety related.116 See the obligations of the manufacturer in point 3.1.117 Article R5(2), 2nd paragraph, of Annex I of Decision No 768/2008/EC.118 Article R5(2), 2nd paragraph and article R5(4) of Annex I of Decision No 768/2008/EC.

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3. upon a reasoned request119 from a competent authority, cooperate with that authority and provide it with all the infor-mation and documentation necessary to demonstrate the conformity of a product120

4. on request by market surveillance authorities, identify any economic operator who has supplied them and to whom theyhavesuppliedtheproduct.Theymustbeabletopresentthisinformationforaperiodof10yearsaftertheyhavebeensuppliedwiththeproductandforaperiodof10yearsaftertheyhavesuppliedtheproduct121.

The distribution conditions (for example transport or storage) may have an impact on maintaining the compliance with the provisions of the applicable Union harmonisation legislation. Thus, the person in charge of the distribution conditions must take the necessary measures to protect the compliance of the product. This is to ensure that the product complies with the essential orotherlegalrequirementsatthemomentoffirstusewithintheUnion122.

The distribution conditions may, in the absence of Union harmonisation legislation, be regulated to some extent on the national levelinaccordancewithArticles34and36TFEU.Nationallegislationthatgrantstomembersofaspecificprofessiontheexclusiverighttodistributecertainproductsiscapable, insofarasitrestrictssalestocertainchannels,ofaffectingthepossibilitiesofmarketingimportedproducts.Accordingly,suchlegislationmayconstituteameasurehavinganeffectequivalenttoaquantitativerestrictiononimports.However,itcanbejustifiedforinstanceongroundsoftheprotectionofpublichealth,ifthemeasureisappropriate for the purpose and does not go beyond what is necessary to achieve it123.

3.5. END-USER

• Contrary to economic operators, end-users are not defined in Union harmonisation legislation and are not subject to obligations.

• Many products covered by Union product harmonisation legislation are used at work and thus also subject to Union safety at work legislation.

Union harmonisation legislation does not create obligations for the end-users of the products in their scope. Consequently, the termisnotdefinedinthatlegislation.Itiscertainhoweverthatthetermcoversbothprofessionalusersandconsumers.The use of a product as a component to be built into a new product that again is placed on the market is not considered end-use. The concept of “end use” by a professional or a consumer is intrinsically related to the concept of “intended use”124.

Many products covered by Union harmonisation legislation are used at work. According to legislation based on Article 153 TFEU, employers have obligations as regards the use of work equipment by workers at the workplace. An employer is considered to be any natural or legal person who has an employment relationship with a worker (that is any person employed by an employer), and has responsibility for the undertaking or establishment.

According to the Directive concerning the minimum safety and health requirements for the use of work equipment by workers at work (2009/104/EC), the employer must take all measures necessary to ensure that the work equipment (for example machinery and apparatus) made available to the workers is suitable for the work carried out, and may be used by workers without impairment to their safety or health. The employer may only obtain or use work equipment that complies with the provisions oftheapplicablelegislationatthetimeofitsfirstuse,or,ifnootherlegislationisapplicableorisonlypartiallyapplicable,theminimum requirements laid down in Annex I to Directive 2009/104/EC. The employer must also take the necessary measures to ensure that work equipment is kept at such a level. Further, the employer has an obligation to provide information and training for workers as regards the use of work equipment.

According to the Directive concerning the minimum health and safety requirements for the use of personal protective equipment by workers at the workplace (89/656/EEC), such equipment must comply with the relevant Union provisions on design and manufacture with respect to safety and health (that is the Union harmonisation act relating to personal protective equipment). Further, the equipment must be appropriate for the risk involved, correspond to existing conditions at the workplace, take into account ergonomic requirements and theworker’s state of health, fit thewearer correctly, and be compatiblewheremorethan one pieces of equipment must be used simultaneously. The employer is required, before choosing the personal protective equipment,toassessthatitsatisfiestherequirements.

According to the Directive on the minimum safety and health requirements for work with display screen equipment (90/270/EEC), employers are obliged to perform an analysis of workstations in order to evaluate the safety and health conditions, particularly regarding possible risks to eyesight, physical problems and problems of mental stress. The Directive also lays down the minimum requirements for the display screen and other equipment.

119 The reasoned request does not necessarily mean a formal decision by an authority. According to Article 19 (1), paragraph 2 of Regulation (EU) No 765/2008, “market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities”.120 Article R5(5) of Annex I of Decision No 768/2008/EC.121 Article R7(2) of Annex I of Decision No 768/2008/EC.122 Article R5(3) of Annex I of Decision No 768/2008/EC123 See Judgement of the Court: case C-271/92.124 For the concept of “intended use”, see above Section 2.7.

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According to the Directive on the introduction of measures to encourage improvements in the safety and health of workers at work (89/391/EEC), workers have a general responsibility to take care, as far as possible, of their own safety and health and thatofotherpersonsaffectedbytheiractsatwork.Inaccordancewiththetrainingandtheinstructionsgivenbytheiremployerthey must, for instance, make correct use of machinery, apparatus, and other means of production, and the personal protective equipment.

Directives 89/391/EEC, 2009/104/EC, 89/656/EEC and 90/270/EEC lay down minimum requirements. Therefore, Member States are allowed to adopt or retain more stringent provisions, as long as they are compatible with the TFEU. The provisions of Union harmonisationlegislationmustberespectedand,thus,additionalnationalprovisionsmayneitherrequestamodificationofaproductwithinthescopeofaUnionharmonisationact,norinfluencetheconditionsofthemakingavailableonthemarketofsuch products.

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4. PRODUCT REQUIREMENTS

4.1. ESSENTIAL PRODUCT REQUIREMENTS

4.1.1. DEFINITION OF ESSENTIAL REQUIREMENTS

• A large part of Union harmonisation legislation limits legislative harmonisation to a number of essential requirements that are of public interest.

• Essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so.

A fundamental feature of a large part of Union harmonisation legislation is to limit legislative harmonisation to the essential requirements that are of public interest. These requirements deal with the protection of health and safety of users (usually con-sumers and workers) but may also cover other fundamental requirements (for example protection of property, scarce resources or the environment).Essential requirements are designed to provide and ensure a high level of protection. They either arise from certain hazards associatedwith theproduct (for examplephysical andmechanical resistance, flammability, chemical, electrical orbiologicalproperties, hygiene, radioactivity, accuracy), or refer to the product or its performance (for example provisions regarding materials, design, construction, manufacturing process, instructions drawn up by the manufacturer), or lay down the principal protectionobjective(forexamplebymeansofanillustrativelist).Oftentheyareacombinationofthese.Asaresult,severalUnionharmonisationactsmaybeapplicabletoagivenproductatthesametime,sincetheessentialrequirementsofdifferentUnion harmonisation acts need to be applied simultaneously in order to cover all relevant public interests.

Essential requirements must be applied as a function of the hazard inherent to a given product. Therefore, manufacturers have to carry out risk analysis and determine the essential requirement applicable to the product. This analysis has to be documented and included in the technical documentation125, unless risk assessment is included in the harmonised standard. If only part of the harmonised standard is used, then the way risks not covered by it are dealt with, should be documented126.

Essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify the technicalsolutionsfordoingso.Theprecisetechnicalsolutionmaybeprovidedbyastandardorbyothertechnicalspecificationsatthediscretionofthemanufacturer.Thisflexibilityallowsmanufacturerstochoosethewaytomeettherequirements.Itallowsalsothat, for instance, the materials and product design may be adapted to technological progress. Accordingly, Union harmonisation legislation based on essential requirements does not necessitate regular adaptation to technical progress, since assessment of whether requirements have been met or not are based on the state of technical know-how at the moment the product is placed on the market.

The essential requirements are set out in relevant sections or annexes of a given piece of Union harmonisation legislation. Althoughnodetailedmanufacturingspecificationsareincludedintheessentialrequirements,thedegreeofdetailedwordingdiffersbetweendifferentUnionharmonisationacts127. The wording is intended to be precise enough to create, on transposition into national legislation, legally binding obligations that can be enforced, and to facilitate the setting up of standardisation requests by the Commission to the European standardisation organisations in order to produce harmonised standards. They are also formulated so to enable the assessment of conformity with those requirements, even in the absence of harmonised standards or in case the manufacturer chooses not to apply them.

125 For the technical documentation, see Point 4.3.126 Even where the manufacturer uses a harmonised standard (where its title is published in the OJEU and which aims to cover certain risks) to satisfy essential requirements, the risk assessment has to be carried out. This is because it cannot be assumed that the harmonised standard covers all requirementsofalllegislativeacts(or,indeed,alltherequirementsofthespecificactunderwhichithasbeendeveloped)orwhethertheproductin question introduces also other risks not considered in the harmonised standard.127 AccordingtotheDirective2008/57/EContheinteroperabilityoftherailsystemeachsub-systemiscoveredbyaTechnicalSpecificationof Inter-operability(TSI),whichspecifiestheessentialrequirements.AccordingtoRegulation(EC)No552/2004ontheinteroperabilityoftheEuropeanAir TrafficManagementnetwork,incaseofnecessity,theessentialrequirementsarerefinedorcomplementedbyimplementingrulesforinteroperability.

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4.1.2. CONFORMITY WITH THE ESSENTIAL REQUIREMENTS: HARMONISED STANDARDS

• The terms “standard”, “national standard”, “European standard”, “harmonised standard”, and “international standard” are subject to concrete definitions.

• Standards are of voluntary application.

• “Harmonised standards” are “European standards” adopted, upon a request made by the Commission for the application of Union harmonisation legislation.

• Harmonised standards provide a presumption of conformity with the essential requirements they aim to cover. 4.1.2.1. Definition of a harmonised standard

Regulation (EU) No 1025/2012128 provides definitions for the terms “standard”, “national standard”, “European standard”,“harmonised standard”, and “international standard”.

• “Standards” are defined as technical specifications, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory.

• “European standards” are “standards” adopted by the European standardisation organisations listed in Annex I of Regulation (EU) No 1025/2012129.

• Takingintoaccountthefirsttwodefinitionsmentionedabove,“harmonisedstandards”are“Europeanstandards”adopt-ed, upon a request made by the Commission for the application of Union harmonisation legislation. Harmonised stand-ards maintain their status of voluntary application.

Thedefinitionfora“harmonisedstandard”,withinthecontextofRegulation(EU)No1025/2012,isnotrestrictedtoharmonisedstandards supporting harmonised product legislation as the Regulation mainstreams the use of harmonised standards in harmonisation legislation for services in similar way as in Union harmonisation legislation for products.

4.1.2.2. Role of harmonised standards

Harmonised standards are developed and published like other European standards following the internal rules of European standardisation organisations. According to these rules, all European standards must be transposed at national level by the national standardisation bodies. This transposition means that the European standards in question must be made available as nationalstandardsinanidenticalway,andthatallconflictingnationalstandardsmustbewithdrawninagivenperiod.

Harmonised standards are European standards to which Regulation (EU) 1025/2012 and sectoral Union harmonisation legislation give a special meaning130. Harmonised standards maintain their status of voluntary application131. However it is important to note thatthedefinitionofaharmonisedstandarddoesnotcontainanyreferencetothepublicationofitstitleintheOJEU.Aslongas a title of a harmonised standard is not published in the OJEU the special role of a harmonised standard is not yet realised. The Commission formally requests the European standardisation organisations to present harmonised standards by issuing a standardisation request (mandate). Prior to this the Commission consults the Member States132. Obtaining standards based on consensus within the meaning of Regulation (EU)No 1025/2012133 implies a wide consultation of sectoral authorities at national level. Thus, the mandate provides a strong indication of the expectations of public authorities134.

128 L 316/12 of 14.11.2012129 CEN (European Committee for Standardisation); CENELEC (European Committee for Electrotechnical Standardisation); ETSI (European Telecommunication Standards Institute) 130 Exceptionally, harmonisation documents (HD) adopted by European standardisations organisations can also be regarded as harmonised standards (e.g. inthecaseoftheLowVoltageDirective).ThedifferencesbetweenEuropeanstandards(EN)andharmonisationdocumentsessentiallyrelatetothe degree of obligation on the part of the national stardardisation bodies. Harmonisation documents must be implemented at national level, at least by publicnotificationofthetitleandnumberofthedocument,andbythewithdrawalofconflictingnationalstandards.However,itisacceptabletoretain or publish a national standard dealing with a subject covered by the harmonisation document, provided that it has technically equivalent contents. In addition, harmonisation documents allow for national divergences under special conditions, which could create some application problems if they were accepted as harmonised standards.131 Voluntary nature of standards makes reference to the fact that standards as such and as published by standardisation organisations are always of voluntary application. This principle is also usually applied in legislation when referencing to standards. The legislator, however, may decide to make standards,includingharmonisedstandards,orpartsthereof,compulsorye.g.inordertoensureinteroperability,classificationofperformanceofproducts orverificationofcomplianceagainstlimitvaluesgiveninlegislation.Mostcommonlystandardsbecomemandatoryonthebasisofagreementsbetween economic operators. 132 Following consultation of the ESOs, stakeholders and sectoral experts (the latter through the committee set up under the legislation where it exists), the Commission consults the Member State Committee established under Regulation (EU) N°1025/2012 (Standardisation Regulation) in accordance with the examination procedure of Regulation 182/2011(OJEU of 28.2.2011 L 55/13). 133 See Article 10 of Regulation (EU) No 1025/2012134 The term ‘mandate’, although common, is not the only term used in this context. Rather than focusing on the terminology, it is important to consider that standardisation activities must be based on a formal invitation of the Commission, on which Member States were consulted.

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The European standardisation organisations will formally take a position on a mandate from the Commission in conformity with their internal rules. Acceptance of the mandate and the subsequent standardisation work initiate the standstill period for national standardisation bodies as provided for in their internal rules and, in the case of harmonised standards, also in Regulation (EU) No 1025/2012.

The elaboration and adoption of harmonised standards is based on Regulation (EU) No 1025/2012 and on the General Guidelines for cooperation between the European standardisation organisations and the Commission and EFTA from 28 March 2003135. There are a number of requirements, principles and commitments concerning standardisation, such as the participation of all interested parties (for example manufacturers, including SMEs, consumer associations, environmental stakeholders and trade unions), the role of public authorities, the quality of standards and a uniform transposition of European standards throughout the Union by national standardisation bodies.

The European standardisation organisations are responsible for identifying, in line with relevant mandates, and elaborating harmonised standards within the meaning of the relevant internal market legislation and for presenting a list of adopted harmonised standards to the Commission. The technical contents of such harmonised standards are under the entire responsibility of the European standardisation organisations. Once public authorities have agreed on a mandate, the search for technical solutionsshouldinprinciplebelefttotheinterestedparties.Incertainareas,suchastheenvironmentandhealthandsafety,theparticipation of public authorities on a technical level is important in the standardisation process. However, Union harmonisation legislation for products do not foresee a procedure under which public authorities would systematically verify or approve either at Union or national level the contents of harmonised standards, which have been adopted by European standardisation organisations136. The dialogue between standardisation bodies and public authorities and, when appropriate, their participation in the standardisation process should, nevertheless, help to ensure that the terms of the mandate are correctly understood and public concerns are properly taken into account in the process.

The European standardisation organisations decide on the mandated work programme for harmonised standards in line with the relevantmandate.Theymayalsoidentifyexistingstandardsthattheyjudge,afterexaminationandpossiblerevision,tomeettheterms of the mandate, or modify existing standards in order to meet those terms. In the same way, they may identify international or national standards and adopt them as European standards, and present them to the Commission as harmonised standards. It is also possible that sometimes only certain parts or clauses of a harmonised standard support essential requirement and then onlythosepartsorclauseswillprovidepresumptionofconformityafterthereferencesarepublishedintheOJEU.

A harmonised standard must match the relevant essential or other legal requirements of the relevant piece of legislation in line withtherelevantmandate.Aharmonisedstandardmaycontainspecificationsrelatingnotonlytoessentialrequirementsbutdealingwithothernon-regulatedissues. Insuchacase,thesespecificationsaretoclearlydistinguishedfromthosecoveringthe essential requirements. A harmonised standard does not necessarily has to cover all essential requirements but it must be always clear which requirement are “aimed to be covered”137 as otherwise a manufacturer complying with a harmonised standard, referenced in the OJEU, does not know against which requirements a “presumption of conformity” will apply and public authorities do not know against which essential requirements they must accept a presumption of conformity.

The relevant essential or other legal requirements aimed to be covered are usually indicated in a separate informative annex138 to a harmonised standard. In some cases the scope of a harmonised standard may also indicate the relevant requirements with sufficientclarity(e.g.whenthereisaclearreferencetocoveredsafetyrelatedrisks).Thisinformationonthe“aimedcoverageofessential or other requirements” given in a harmonised standard thereby determines the scope of the so-called “presumption of conformity with legal requirements”.

A clear distinction must be made between “conformity with a standard” and “presumption of conformity (when applying a harmonised standard)”. “Conformity with a standard” usually makes a reference to a situation where a standard is “fully applied”. Thisisforinstancethecaseofvoluntarycertificationagainstastandard.Forthepurposesof“presumptionofconformity”itissufficienttoapplyonlythoseprovisionsrelatingtotheessentialorotherlegalrequirementsaimedtobecovered.

Harmonisedstandardsneverreplacelegallybindingessentialrequirements.Aspecificationgiveninaharmonisedstandardisnot an alternative to a relevant essential or other legal requirement but only a possible technical means to comply with it. In risk related harmonisation legislation this means in particular that a manufacturer always, even when using harmonised standards, remains fully responsible for assessing all the risks of his product in order to determine which essential (or other) requirements areapplicable.Afterthisassessmentamanufacturermaythenchoosetoapplyspecificationsgiveninharmonisedstandardstoimplement “risk reduction measures”139whicharespecifiedbyharmonisedstandards.Inriskrelatedharmonisationlegislationharmonised standards most commonly provide certain means to reduce or remove risks while manufacturers remain fully

135 (2003/C 91/04)136 Still,theCommissiononthebasisofRegulation(EU)No1025/2012mustverifyandassessthatthetermsofthemandatearefulfilledinorder to ensure the proper functioning of the Single market (see Point 4.1.2.4).137 In reality European standardisation organisations may only declare an intention to cover certain requirements and this intention is further presumed (or removed) once a reference is published (or removed) in (from) the OJEU (see Points 4.1.2.4 and 4.1.2.5).138 European standardisation organisations usually name this annex as “Annex ZA, ZB or ZZ” etc.139 InthiscontextthistermisunderstoodasdefinedinISO/IECGuide51Safetyaspects-Guidelinesfortheirinclusioninstandards,whichisageneric guideline to develop standards addressing safety issues.

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responsible for risk assessment to identify applicable risks and to identify applicable essential requirements in order to select suitableharmonisedstandardsorotherspecifications.

The role of harmonised standards when complying with applicable essential requirements identified by a manufacturer

Where harmonised standards fail to indicate clearly the essential requirements aimed to be covered such standards may become less useful for manufacturers as there is less legal certainty on the real “scope of presumption of conformity”. An unclear or incorrect indication of the essential requirements aimed to be covered may also lead, in some cases, to formal objections against harmonised standards (see point 4.1.2.5). Where a harmonised standard covers only part of the essential requirements identifiedasapplicablebyamanufacturer,hehastouseotherrelevanttechnicalspecificationsinordertomeetalltheremainingessential requirements of the legislation in question or to apply directly relevant essential requirements. In a similar way when a manufacturer chooses not to apply all the provisions given in a harmonised standard, and which normally would provide presumption of conformity, he needs, on the basis of his own risk assessment, to indicate in his technical documentation how the compliance is reached or that relevant essential requirements are not applicable for his product.

Occasionallystandardsmaycontainerrorsorofferdifferentpossiblereadings.Ifamanufacturerfindssuchanerrororuncertainty,heshouldfirstmakecontactwithhisnationalstandardisationbodytoseekforclarification.

4.1.2.3. Process to harmonised standards providing presumption of conformity

The overall procedure leading to a harmonised standard giving a presumption of conformity is described in Flowchart 1.

Before a preparation of a mandate asking to develop harmonised standards may start there should be Union harmonisation legislation, or this legislation is under preparation140, which foresees the use of harmonised standards as a means to comply with essential or other legal requirements, i.e. the legislator has already given the political acceptance to the harmonised standards to be developed and published within the legal framework given in Regulation (EU) No 1025/2012.

1. Planning of the Commission mandates: The Commission publishes its plans on future standardisation requests in the Annual Union Work Programme for European standardisation according to Article 8 of Regulation (EU) No 1025/2012. This WorkProgrammealsoidentifiesstandardisationneedsunderfutureharmonisationlegislation.

2. Preparation of a mandate:TheCommissionprepares,accordingtoArticle10(1)ofRegulation(EU)No1025/2012,adraftmandate consulting European standardisation organisations, sectoral experts of the Member States and relevant stake-holders at European level according to Articles 10(2) and 12 of Regulation (EU) No 1025/2012.

3. Adoption and issue of a mandate:TheCommissionadoptsadecisiontosendamandatetotheESOsafterconsultingtheMember States in accordance with the procedure laid down in Article 22(3) of Regulation (EU) No 1025/2012. The man-dateisthennotifiedtotheEuropeanstandardisationorganisations.

140 Preparation of a mandate usually starts in parallel with the legislative process. However at the moment when a mandate is issued to the European standardisation organisations, there must be certainty on the legal requirements to be supported by harmonised standards

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4. Acceptance of a mandate: Relevant European standardisation organisation indicates its acceptance on the mandate141 within the time limit given in Article 10(3) of Regulation (EU) No 1025/2012. National standardisation bodies are obliged to respect standstill requirements according to Article 3(6) of Regulation (EU) No 1025/2012. Relevant European stand-ardisationorganisationmayapplyforUnionfinancing(anactiongrant)onthebasisofChapterVofRegulation(EU)No1025/2012. The Commission informs the relevant European standardisation organisation within the timeline given in Article 10 (4) of Regulation (EU) No 1025/2012 about the award of a grant.

5. Programming and agreement of a work programme: Relevant European standardisation organisation(s) elaborates a (joint) work programme in line with the relevant mandate and presents it to the Commission. When appropriate the Com-mission may inform on priorities for the standardisation work.

6. Draftingwork:ResponsibletechnicalcommitteeofaEuropeanstandardisationorganisation142elaboratesadraftEuro-pean standard. European standardisation organisations follow the principles recognised by the World Trade Organisation (WTO)inthefieldofstandardisation(coherence,transparency,openness,consensus,voluntaryapplicationandefficiency).In addition Regulation (EU) No 1025/2012 addresses directly applicable requirements on stakeholder participation and transparencyofworkprogrammesanddraftstandardsinitsArticles3to5.Theacceptedmandateisoneofthereferencedocumentstheresponsibletechnicalcommitteemustfollowduringdraftingwork.AccordingtoArticle10(5)ofRegulation(EU) No 1025/2012 relevant European standardisation organisation shall inform (reporting) the Commission on activities undertakenandhaveasuitablemeans143toassesscomplianceofthedraftedstandardswiththeinitialmandate.

7. Public Enquiry: European standardisation organisations together with national standardisation bodies organise a public enquiry where all stakeholders may submit comments through national standardisation bodies. Article 4(3) of Regulation (EU) No 1025/2012 provides a procedure if a national standardisation body receives comments indicating a possible neg-ative impact on the internal market.

8. Integrating comments received: Responsible technical committee considers comments received during public enquiry and preparesthefinaldraftEuropeanstandard.

9. Formal Vote:Nationalstandardisationbodiesvoteonthefinaldraftinaformalvotewherenationalstandardisationbodieshaveweightedvotes.Thefinaldraftisadoptedif71.00%ormoreoftheweightedvotescast(abstentionsnotcounted) are in favour.

10. RatificationandpublicationofanEN: Where the voting result is positive, the relevant European standardisation organi-sationratifiesandpublishestheEuropeanstandard(EN).AsinthiscasetherelevantENsupportsUnionharmonisationlegislationanditwasdraftedonthebasisofaCommissionmandate,thisENisaharmonisedstandardwiththemeaningof Article 2(1)(c) of Regulation (EU) No 1025/2012 – however it does not yet provide a presumption of conformity.

11. Submission of references to the Commission: Relevant European standardisation organisation transmits automatically references of a relevant harmonised standard to the Commission. This information includes in particular the reference numberandthetitleinallofficiallanguagesoftheEU.

12. VerificationoftheconditionsforpublicationintheOJEU: According to Article 10(5) of Regulation (EU) No 1025/2012 the Commissionhastoverifywhethertherelevantharmonisedstandardcomplieswiththeinitialmandate.Duringthisverifi-cation the Commission checks in particular that the harmonised standard is covered by the relevant mandate and whether essentialorotherlegalrequirements“aimedtobecovered”areclearlyindicatedbythestandard.Duringthisverificationthere is no need for a review of the technical content as the Commission does not, in general, accept the technical content or takes responsibility for it. However already during this step the Commission may also assess the adequacy of technical specificationsgiveninaharmonisedstandardinsatisfyingcorrespondingessentialrequirementsandthisassessmentmay lead to a formal objection (instead of publication in the OJEU).

13. Publication of references in the OJEU: According to Article 10(6) of Regulation (EU) No 1025/2012 the Commission pub-lishesthereferencesofaharmonisedstandardintheOJEU.Thispublicationfinallyinitiatesapresumptionofconformitywith essential or other legal requirements covered by the relevant harmonised standard. A presumption of conformity is usually valid from the date the publication is done in the OJEU and can be removed by a formal objection or when a revised version of the harmonised standard is referenced in the OJEU.

141 This is without prejudice to their right to refuse a mandate.142 Europeanstandardisationorganisationmayalsoco-operatewithotherbodieswhichareresponsibleforthedraftingwork.143 Article 10(5) indicates that consensus building process according to the internal rules of European standardisation organisations is not alone as such a sufficientguaranteetoassumethatrequirementsofamandatearefulfilled.

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14. National transposition: National standardisation bodies are obliged to transpose the relevant European standard144 as an identical national standard on the basis of the internal rules of the European standardisation organisations. According to Article3(6)ofRegulation(EU)No1025/2012theyalsoareobligedtowithdrawanynationalstandardswhichareconflict-ing with a harmonised standard.

15. Formal objection: According to Article 11145 of Regulation (EU) No 1025/2012 a Member State or the European Parliament may dispute the publication of the references of a harmonised standard in the OJEU. Through this process a Member StateortheEuropeanParliamentmayasktheCommissiontodraftaCommissionDecisioninordertopreventorremovethe presumption of conformity.

144 The transposition of the standard is a matter for the ESOs’ rules. It is usually carried out before the references of the harmonised standard are published in the OJEU. However national transposition is not a precondition to get a presumption of conformity. In practise harmonised standards are usually available as transposed nationally standards while the list of harmonised standards published in the OJEU and relevant Union harmonisation legislation make direct reference to original European standards. 145 According to Article 28 of Regulation (EU) No 1025/2012 formal objection articles given in some sectoral legislation continue to be valid for some time.

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Flowchart 1 – Process to harmonised standards and presumption of

conformity

Union harmonisation legislation

with essential requirements

1. Planning of the Commission mandates

2. Preparation of a mandate

3. Adoption and issue of a mandate

4. Acceptance of a mandate

5. Programming and agreement of a work

programme

6. Drafting work

7. Public Enquiry

8. Integrating comments received

9. Formal Vote

10. Ratification and publication of an EN

11. Submission of references to the

Commission

12. Verification of the conditions for the

publication in the OJEU

13. Publication of references in the OJEU

14. National transposition

15. Formal objection to

prevent or remove

presumption of

conformity

Presumption of conformity

I Preparation of a mandate (EC)

II Development of a harmonised standard (ESO)

III Publication of a title of a harmonised standard in the OJEU (EC)

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4.1.2.4 The Presumption of conformity

Harmonised standards provide a presumption of conformity with the essential requirements they aim to cover, if their references have been published in the Official Journal of the European Union. References of harmonised standards are published asCommission Communications in the C series of the OJEU146.

Europeanstandards, includingharmonisedstandards,areoftenbasedfullyorpartiallyoninternationalISOorIECstandards.Sometimes,however,thepresumptionofconformityispossibleonlywhenapplyingtheEuropeanversionbecauseofmodificationsintroduced in it.

TheobjectiveofpublishingthereferenceintheOfficialJournal istosetthedatefromwhichthepresumptionofconformitytakeseffect.Publicationof referencesofharmonisedstandards isanadministrative task for theCommissionwhich isdonewithout further consulting Member States or relevant sectoral Committees. It is the ultimate goal for a mandated harmonised standard and the end of the process which started when the relevant Commission mandate was issued. Before the Commission publishes the references, it must however assess, according to Article 10(5) of Regulation (EU) No 1025/2012, that the terms of therelevantmandatearefulfilledandthattheharmonisedstandardcoversindeedtheessentialorotherrequirementswhichitclaims147 to cover.

Publication of references is not an automatic action and the Commission must perform certain checks and assessments before publication takes place. The Commission may thus refuse to publish the references or may set certain limitations which are published together with the references.

In a situation where a formal objection procedure has been already initiated, there is a doubt whether a harmonised standard entirelysatisfiestherequirementsitaimstocoverwithinthemeaningofArticle11(1)ofRegulation(EU)No1025/2012.Becauseof this doubt, the Commission cannot publish the reference according to Article 10(6) of Regulation (EU) No 1025/2012 and a Commission Implementing Decision within the meaning of Article 11(1) must be taken.

There are also other situations where the references might not be published. The assessment according to Article 10(5) may revealthatthetermsoftherelevantmandatearenotproperlyfulfilledorthatthestandardcontainsobviouserrors.Inthosecases the conditions for initiating the objection procedure according to Article 11148 of Regulation (EU) No 1025/2012 are usually notfulfilled.

Examples of other reasons for non-publication include: the standard is not covered by the relevant mandate; products covered by the standard are not within the scope of relevant Union harmonisation legislation; the standard fails to indicate which legal (essential) requirements are covered149; the standard does not cover the legal (essential) requirements which it claims to cover; thestandardcontainsspecificationswhicharenotsupportingessentialrequirementsandwithoutclearlyseparatingthemfromspecificationssupportingessentialrequirements;thestandardclaimstosupportotherlegalrequirementsthanthoseaddressedinthemandate;thestandardcontainsnormativereferencestootherspecificationswhicharenotacceptablebecauseoftheirorigin or lack of proper consensus building process during their adoption; other reasons because of non-application of internal rules of European standardisation organisations or disregard of the requirement given in Regulation (EU) No 1025/2012 during the preparation of a relevant harmonised standard.

In these cases the Commission ensures by non-publication a correct application of relevant Union harmonisation legislation and a coherent and proper functioning of the Single Market. Here the Commission can merely ask the relevant European standardisation organisations to correct the relevant standards making reference to the agreed requirements given in the relevant mandate and to other recognised and agreed principles under which these organisations should work. In some cases the Commission may consider the publication of references with a limitation, however, keeping in mind that these limitations should not overlap with reasonswhereaproperobjectionprocedureshouldbeinitiated.Thejustificationfornon-publicationcomesfromtherelevantmandate itself but the Commission may refuse the publication also in order to protect the functioning of the Single Market.

The recourse to harmonised standards cited in the OJEU and which give a presumption of conformity remains voluntary150.The manufacturer can choose whether or not to refer to such harmonised standards. However, if the manufacturer chooses not to follow a harmonised standard, he has the obligation to demonstrate that his products are in conformity with essential requirements by the use of othermeans of his own choice (for example bymeans of any existing technical specificationsincluding all other available standards). If the manufacturer applies only a part of a harmonised standard or the applicable harmonised standard does not cover all applicable essential requirements, the presumption of conformity exists only to the extent the harmonised standard corresponds to the essential requirements. For that reason it is necessary that each harmonised standard contains clear and correct information on legal (essential) requirements covered.

146 AWebserviceprovidingaccesstothelatestlistsofreferencesofharmonisedstandardsandofotherEuropeanstandardspublishedintheOfficial Journal of the European Union (OJEU) is available at: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm147 This “claim” is usually in a dedicated informative annex to a harmonised standard.148 In some cases a piece of sectoral legislation may still contain an article of objection.149 A presumption of conformity would be meaningless if essential requirements covered are not known. 150 Directive 1999/5/EC relating to telecommunications terminal equipment allows harmonised standards to be transformed into common technical regulations,compliancewithwhichismandatory.Regulation(EC)No552/2004ontheinteroperabilityoftheEuropeanAirTrafficManagementnetwork requirestheapplicationofCommunityspecifications.

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Compliance with harmonised standards must, according to certain Union harmonisation acts, be performed according to the applicable conformity assessment procedure, which sometimes opens the possibility for conformity assessment without the intervention of a third party or for a larger choice of procedures151.

4.1.2.5 Withdrawal, restriction or prevention of the presumption of conformity

The Standardisation Regulation (EU) No 1025/2012 contains a provision according to which publication of titles of harmonised standards in the OJEU can be challenged152. This situation might arise prior to the publication of the reference of the harmonised standardintheOfficialJournaloftheEuropeanUnionorinthecaseofaharmonisedstandardthereferenceofwhichhasalreadybeenpublishedintheOfficialJournaloftheEuropeanUnion.

In both cases, where a Member State or the European Parliament153 considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union harmonisation legislation, it has to informtheCommissionthereof.AfterconsultingtheMemberStates154, the Commission can make an Implementing Decision:

• to publish, not to publish or to publish with restrictions the reference to the harmonised standard concerned in the OJEU, or

• to maintain, to maintain with restrictions or to withdraw the references to the harmonised standard concerned in or from the OJEU.

In all cases, the Commission needs to publish on its website155 information on the harmonised standards that have been subject to such Implementing Decisions.

As part of its responsibilities and duties according to Regulation (EU) No 1025/2012 and the relevant sectoral legislation, the CommissioncanalsodraftandproposesuchImplementingDecisionstoobjecttoharmonisedstandardsonitsowninitiative.Where a Member State has raised an action under a safeguard clause156 against a product which complies with a harmonised standardandwhere sucha safeguardaction is considered justified, theCommissionalsohasa responsibility to initiateanobjection against the relevant harmonised standard.

Theproceduretochallengeaharmonisedstandardanditsoutcomedoesnotaffectitsexistenceasaharmonisedstandardoras a European standard as only European standardisation organisations can make decisions on the revision or withdrawal of their deliverables. This objection procedure gives the legislator a possibility to control the presumption of conformity i.e. the legal effect,whichstemsfromthepublicationofthetitleofaharmonisedstandardintheOJEU.Itmayonlyleadtothewithdrawalor prevention of such a publication. In former case, this means that the standard in question will no longer give presumption of conformity with the essential requirements. In the latter, it means that the standard will not become a harmonised standard giving presumption of conformity.

ThefactthataharmonisedstandardcanbechallengedatanymomentafteritspublicationasaEuropeanstandard,insteadof conducting a formal approval procedure prior to the publication of its reference in the OJEU157, indicates that a systematic verificationofthetechnicalcontentsofharmonisedstandardsisnotprovidedfor158. Only in cases where a harmonised standard, after ithasbeenchallenged, is foundnot tosatisfyentirely the requirementsaimed tobecoveredandassetout inUnionharmonisation legislation, may its reference be withdrawn.

According to Regulation (EU) No 1025/2012 the Commission is obliged to inform stakeholders159 on all pending objections against harmonised standards before formal decisions are taken.

151 See the directives relating to simple pressure vessel, toys, electromagnetic compatibility, radio and telecommunications terminal equipment, machinery, liftsandrecreationalcraft.Thelackofharmonisedstandardsmayleadtotheapplicationofaspecificprocedure,seeforinstancethePressure equipment directive (the European approval may be granted to materials which are not covered by any harmonised standard and which are intended for repeated use in the manufacture of pressure equipment).152 Article11ofRegulation(EU)No1025/2012becomesgraduallyapplicableafterobjectionarticlescontainedinsectorallegislationareremoved. MeanwhilesomeUnionharmonisationlegislationmaystillcontainspecificprocedures,liketheDirectiverelatingtoradioandtelecommunications terminalequipmentprovidesapossibilityfortheCommission,inthecaseofshortcomingsofharmonisedstandards,topublishintheOfficialJournal guidelines to the interpretation of harmonised standards, or the conditions under which compliance is possible.153 The European Parliament can raise this concern in cases where Article 11 of Regulation (EU) No 1025/2012 applies. 154 In accordance with Article 11(1) and 11(4)-(5) of Regulation (EU) No 1025/2012155 http://ec.europa.eu/enterprise/policies/european-standards/standardisation-policy/notifications-systems/index_en.htm156 For the safeguard clause, see Section 7.4157 Only national standards, which may give a presumption of conformity according to certain Union harmonisation acts as a transitional measure before theareaiscoveredbyaharmonisedstandard,aresubjecttoaverificationprocedure.158 Article 10(5) of Regulation (EC) No 1025/2012 only provides for an assessment by the Commission together with the European standardisation organisationsofthecomplianceofthedocumentsdraftedbytheEuropeanstandardisationorganisationswithitsinitialrequest,butnotforaformal approval procedure.159 http://ec.europa.eu/enterprise/policies/european-standards/standardisation-policy/notifications-systems/index_en.htm

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4.1.2.6 Revision of harmonised standards

Harmonisedstandardstranslatetheessentialrequirementsintodetailedtechnicalspecifications,methodsofmeasurementtoassess and/or declare the compliance with the essential requirements and, in some cases, numerical values to allow compliance with the essential requirements. Like any technical document, they are subject to change, or in other words to a revision.

The formal decision to revise a harmonised standard is, in principle, taken by the European standardisation organisations. This takes place on the basis of their own initiative160, or following a standardisation request from the Commission directly or, indirectly, basedonaCommissiondecisionafteraformalobjection.TheneedforrevisioncanresultfromthechangesofthescopeoftheUnionharmonisationact(suchasanextensionofthescopetootherproductsoramodificationoftheessentialrequirements),from the fact that the Commission or a Member State challenges the contents of the harmonised standard, indicating that it could no longer give presumption of conformity with the essential requirements, or as a result of technological development.

When a harmonised standard is revised, the revision must be covered by a mandate to maintain the possibility of giving presumption of conformity. Unless the contrary can be deduced, the terms and conditions of the original mandate apply also for the revision of the harmonised standard. This does not exclude the possibility of a new mandate, in particular where the revision is related to shortcomings with respect to the essential requirements.

To give presumption of conformity, the revised standard must satisfy the general conditions according to the Union harmonisation legislation: the standard is based on a mandate, it is presented by the relevant European standardisation organisation to the CommissionanditsreferenceispublishedbytheCommissionintheOfficialJournal.

Following its internal rules, the relevant European standardisation organisation lays down the date of withdrawal of the superseded edition of the standard. The transitional period is normally the time period between the date of publication of the reference of the new edition of the standard in OJEU and the date of withdrawal of the superseded edition. During this transitional period both harmonisedstandardsmaygivepresumptionofconformity,providedthattheconditionsforthisaremet.Afterthistransitionalperiod, only the revised harmonised standard gives a presumption of conformity. However any dates for transitional periods are set by the Commission and published in the OJEU.

The Commission may consider that, for safety or other reasons, the superseded version of the harmonised standard must cease to give a presumption of conformity before its date of withdrawal, set by the European standardisation organisation in question, oratalaterdate.Insuchcases,theCommissionfixesanearlierorlaterdateafterwhichthestandardwillnolongergiveapresumptionofconformity,andpublishesthisinformationintheOfficialJournal.Ifcircumstancesallow,theCommissionmayconsult the Member States prior to taking a decision to reduce or extend the period during which both versions of the standard give a presumption of conformity.

Unless decided otherwise on the basis of a proposal by the Commission, the withdrawal of a harmonised standard does not invalidateexistingcertificatesissuedbynotifiedbodies;itonlyconcernstheconformitythatisconferredontonewconformityassessmentsthatfollowthenewharmonisedstandard.Productsproducedaccordingtotheoldcertificatestillbenefitfromthecontinuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity oftherelevantcertificatesissuedbynotifiedbodies.

The reference of the revised harmonised standard, the reference of the superseded version of the harmonised standard, and the datewhenthepresumptionofconformityofthesupersededversionofthestandardceasesarepublishedtogetherintheOfficialJournal. It is responsibility of the manufacturer to check every publication of the list of harmonised standards and to verify within it the validity of the harmonised standards he has applied in order to assess the conformity of his product.

A harmonised standard may contain normative references to other standards. Through these references those other standards or parts thereof, become indispensable for the application of a given harmonised standard. Internal rules of the European standardisation organisations are applicable when making these normative references to other standards. Because of the nature of harmonised standards undated references to other standards, where relevant clauses aim to support essential or other legal requirements, should not be normally used. Undated references may cause situations where changes in specifications contained in harmonised standards and providing presumption of conformity are uncontrolledand non-transparent - changes in normative references cannot be controlled within the meaning of Article 10(6) of the Regulation (EU) No 1025/2012 although by such changes a harmonised standard (a part of it) is de facto revised.

160 Under the terms of their internal rules, the European standardisation organisations review their standards – whether or not initially developed on thebasisofamandate–atintervalsnotexceedingfiveyears.Thisperiodicalreviewmayleadtoaconfirmation(noaction),arevisionorawithdrawalof a relevant standard.

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4.1.3. CONFORMITY WITH THE ESSENTIAL REQUIREMENTS: OTHER POSSIBILITIES

• The conformity of a product may be demonstrated not only by harmonised standards but also by other technical specifications.

• Other technical specifications however do not benefit from the presumption of conformity.

The application of harmonised standards is not the only means to demonstrate the conformity of a product – however only harmonised standards161, after publicationof references in theOJEU,mayprovideanautomatic presumptionof conformityagainst essential requirements covered by such standards.

According to some Union harmonisation acts, national standards may give a presumption of conformity – as a transitional measure – insofar as there is no harmonised standard covering the same area162. Member States may communicate to the Commissionthetextofthosenationalstandards,whichtheyconsidertomeettheessentialrequirements.AfterconsultingtheMember States163,theCommissionnotifiestheMemberStateswhetherornotthenationalstandardshouldenjoypresumptionof conformity. If the opinion is positive, Member States are required to publish the references of such standards. The reference is also published in the OJEU. This procedure has not been used so far in order to give full priority to the development of European standards.

The manufacturer can choose whether or not to apply and refer to harmonised standards. However, if the manufacturer chooses not to follow the harmonised standards, he has the obligation to demonstrate that his products are in conformity with essential requirements by the use of other means of his own choice that provide for at least an equivalent level of safety or protection. Thesecanbetechnicalspecificationssuchasnationalstandards,Europeanorinternationalstandardswhicharenotharmonisedi.e.notpublishedintheOJEUorthemanufacturer’sownspecifications.Inthesecasesthemanufacturerdoesnotbenefitfromthepresumptionofconformity,buthastodemonstratetheconformityhimself.Thisimpliesthathedemonstrates,inthetechnicalfileofarelevantproduct,inamoredetailedmannerhowthetechnicalspecificationsheusesprovideconformitywiththeessentialrequirements164.

It is important to stress that Union harmonisation legislation for products does not, as a general rule, impose the use of harmonised standards. Only essential requirements are legally binding and manufacturers may apply whatever standards and technicalspecifications–howeveronlyharmonisedstandardsprovideapresumptionofconformity.

Furthermore, even if the manufacturer has not used harmonised standards, a change in the relevant harmonised standard could mean a change in the state of the art that implies that his product may not be compliant.

161 SomeUnionharmonisationlegislationmayhowevergivealternativewaysforapresumptionofconformitybymeansofotherspecifications than harmonised standards, e.g. the possibility to use European Eco-label scheme in Eco-design Directive; in the in vitro diagnostic medical devices sector,compliancewithsocalled‘commontechnicalspecifications’(CTS)providespresumptionofconformitywiththerelevantessentialrequirements. Another example is the references to normative documents from the Organisation de Métrologie Légale (OIML) in Directive 2004/22/EC on measuring instruments.162 See, for instance, Directive relating to gas appliances.163 The Member States Committee under Regulation (EU) No 1025/2012 and, if provided for, the sectoral Committee164 InthecaseofRegulation(EC)No552/2004ontheinteroperabilityoftheEuropeanAirTrafficManagementnetwork,ifamanufacturerchoosesnotto follow a harmonised standard, the declaration is called declaration of suitability for use.

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4.2. TRACEABILITY REQUIREMENTS

• The traceability requirements allow tracing the history of the product and support market surveillance. It allows market surveillance authorities to find the liable economic operators and obtain evidence of the product compliance.

• The traceability requirements include labelling the product and identifying the economic operators in the distribution chain.

4.2.1 WHY DOES TRACEABILITY MATTER?

Traceability is the ability to trace the history of the product.

From a regulator’s perspective, traceability matters because it enables effective enforcement through market surveillancevia corrective measures including withdrawals and recalls. It enables unsafe or non-compliant products to be traced up the distributionchainandidentifiesrolesandresponsibilitiesoftheeconomicoperatorthroughoutthechain.Traceabilityenablesmarket surveillance authorities to trace products up to the factory gate and from factory to the end-user in certain cases.

From amanufacturer’s perspective traceabilitymatters because it enables effective control of the production process andsuppliersbeforethemarketingoftheproducts,andcontroloftheirdistributionchainaftertheplacingoftheproductonthemarket. In case of non-compliance, manufacturers are able to reduce the impact of recalls or withdrawals depending on the detail of their traceability system.

4.2.2 TRACEABILITY PROVISIONS

Union harmonisation legislation is prescriptive as to the ends but not as to the means to achieve those ends. This means that Union harmonisation legislation foresees requirements for the traceability of products placed on the market, without stipulating how to achieve or implement these requirements. Union harmonisation legislation is also technology-neutral, meaning it does not prescribe the technology to be used such as printing or moulding. Manufacturers should choose the traceability system which they deem most appropriate in relation to their products and their manufacturing and distribution system.

The indication of the manufacturer’s and for imported products also the importer’s, name and address on the product is a basic traceability requirement. In case of need, it allows market surveillance authorities to quickly get in contact with the economic operator responsible for the placing of an unsafe or non-compliant product on the Union market.

There is no explicit obligation that the addresses have to be preceded by the words “Manufactured by”, “Imported by” or “Represented by”. This information must however not mislead the end-user and the market surveillance authorities about the place of manufacture and the address of each economic operator165. If these words are not mentioned, market surveillance authorities will decide what the role of each economic operator is. It is then up to the economic operator to prove than that he hasadifferentrole.

There is no obligation to translate into all necessary languages the words “manufactured by”, “imported by” or “represented by”. ThesewordsareconsideredtobeeasilyunderstandableinallofficialEUlanguages.

Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and Decision No 768/2008/EC on a common framework for the marketing of products establish the current practices regardingtraceabilitybyrequiringspecifictraceabilitylabels.ThereferenceprovisionsofDecisionNo768/2008/ECreflectedinUnion harmonisation legislation require:

1. manufacturers to indicate the following three elements: their (1) name, (2) registered trade name or registered trade mark166 and (3) the address at which they can be contacted, on the product or, where that is not possible, on its pack-aging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted167;

2. importers to indicate the following three elements: their (1) name, (2) registered trade name or registered trade mark and (3) the address at which they can be contacted, on the product or, where that is not possible, on its packaging or in a document accompanying the product;168

165 Such confusion might occur for instance when the name of the distributor appears on the packaging while the manufacturer’s name is shown on the product inside.166 A trade mark is a distinctive sign or indicator used by an individual, business organisation, or other legal entity to identify that the products or services to consumers with which the trade mark appears originate from a unique source, and to distinguish the products or services in question from those of other entities. A trademark is a type of intellectual property, and typically a name, word, phrase, logo, symbol, design, image, or a combination of these elements.167 Article R2(6) of Annex I of Decision No 768/2008/EC168 Article R2(3) of Annex I of Decision No 768/2008/EC

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3. manufacturers to ensure that their products bear a type, batch, serial or model number or other element allowing their identification,or,wherethesizeornatureoftheproductdoesnotallowit,thattherequiredinformationisprovidedonthe packaging or in a document accompanying the product169 and

4. economic operators to identify any economic operator who has supplied them with a product and any economic opera-tor to whom they have supplied a product170.

4.2.2.1 The requirement to indicate name and address for manufacturers

The manufacturers must indicate the following three elements: their (1)name, (2) registered trade name or registered trade mark and (3) the address at which they can be contacted on the product, or, where that is not possible, on its packaging and / or in a document accompanying the product. This information has to be the same as the one on declaration of conformity and in the technical documentation.

Thenameandaddressmust,asarule,beaffixedtotheproduct.However,itmayexceptionallybemovedfromtheproductifthisrulecannotbefollowed.Thiswouldbejustifiedwhereaffixingittotheproductwasnotpossibleunderreasonabletechnicaloreconomic conditions excluding however esthetical reasons. It is up to the manufacturer to make this assessment. This assessment has to be done according to the size or nature of the product171. Some products e.g. hearing aids, sensors or the like are simply toosmalltocarrysuchinformation.Insuchcasestheorderofpriorityisthatasafirstalternativetheinformationshouldbeonthe packaging, as a second alternative on an accompanying document, except for the cases where sectoral Union harmonisation legislation requires the information to be on both the packaging and accompanying documents.

The manufacturer has to comply with this obligation regardless of his location (within or outside the EU). This provision implies that products sold without packaging or any accompanying documents, must bear the name and address of the manufacturer on the product itself.

The address must indicate a single point at which the manufacturer can be contacted. The legal text obliges the manufacturer to put a single contact point on the product. Only one single contact point in the EU is allowed. This is not necessarily the address where the manufacturer is actually established. This address can for example be the one of the authorised representative or of the customer services.

The single contact point does not need to be in every Member State where the product is made available. The manufacturer may however put other addresses172 provided that it is clear which one is the single contact point. The latter is then to be indicated on the product/documentation as the “single contact point”. The address or the country does not necessarily have to be translated into the language of the Member State where the product is made available on the market.

A website is additional information, but is not enough as an address. Normally an address consists of a street and number or post-box and number and the postal code and town, but some countries might deviate from this model.

4.2.2.2 The requirement to indicate name and address for importers

Importers must also indicate the following three elements: their (1) name, (2) registered trade name or registered trade mark and (3) the address at which they can be contacted on the product, or, where that is not possible, on its packaging or in a document accompanying the product. The provision refers to an address at which they can be contacted, so this is not necessarily the address where the importer is actually established. The information has to be the same as the one on declaration of conformity and in the technical documentation.

Asarule,the identificationandtheaddressof importermustbe indicatedontheproduct.Onlywhere it isnotpossible,theidentificationandaddressoftheimportermaybeindicatedonthepackagingand/orinadocumentaccompanyingtheproduct.This may be the case when the importer would have to open the packaging to put his name and address. The additional information from the importer shall not hide the information put on the product by the manufacturer.

A website is additional information, but is not enough as contact address. Normally an address consists of a street and number or post-box and number and the postal code and town, but some countries might deviate from this model.

The product must always bear the manufacturer’s name and address. Imported products must also bear the importer’s name and address. Hence, in conclusion, a product normally bears one or two addresses173:

169 Article R2(5) of Annex I of Decision No 768/2008/EC170 Article R7 of Annex I of Decision No 768/2008/EC171 see Recital 25 of Decision No 768/2008/EC172 For instance, an address serving as an information point for consumers and other users in the Member State where the product is made available 173 In the medical devices sector, the product must also bear the authorised representative’s name and address.

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‣IfthemanufactureriswithintheEuropeanUnion,theproductwillbearonlyone(manufacturer’s)addressasthereisnoimporter involved.

‣Ifthemanufacturer(declaringhimselfasamanufacturerbyputtinghisnameandaddressontheproduct)isoutsidetheEU and the products are placed on the Union market by an importer, the product will bear two addresses: the one of the manufacturer and the one of the importer.

‣IftheoriginalmanufacturerisoutsidetheEUandtheimporterplacestheproductonthemarketunderhisownnameor trademarkormodifies theproductalreadyplacedon themarket (insuchaway thatcompliancewith theapplicablerequirementsmaybeaffected),theimporterisconsideredthemanufacturer.Theonlyaddressthatinthiscasewillfigureonthe product (or packaging or accompanying document) is the address of the importer who is considered as the manufacturer.174

‣IfthemanufactureriswithintheEU(acompanylocatedintheEUdeclaringitselftobeamanufacturerbyputtingitsname and address on the product) although the products are manufactured outside the EU, that company is considered to be the manufacturer who places the product on the Union market, even if actual importation is done by another company. Inthiscasethereisnoimporterinthemeaningoftheimporter’sdefinitionanditissufficienttoputonlythemanufacturer’saddress.

4.2.2.3 Identification element

Theproductmustbearatype,batch,serialormodelnumberorotherelementallowingitsidentification.Theidentificationmust,asarule,beaffixedtotheproduct.However,itmayexceptionallybemovedfromtheproductifthisrulecannotbefollowed.Thiswouldbejustifiedwherethesizeand/orthenatureoftheproductmakestheindicationillegibleortechnicallyimpossible175. In such cases, the identificationhas to beaffixed to the packaging, if it exists, and/or to theaccompanyingdocument. Theidentificationontheproductmayneitherbeomittednorbemovedtothepackagingoraccompanyingdocumentsonpurelyaesthetic or economic grounds. It is up to the manufacturer to make this assessment.

Thisprovisionimpliesthatiftheproducthasnopackagingorisnotaccompaniedbyanydocument,theidentificationmustbeon the product itself.

Therequirementgivesthefreedomtothemanufacturerstochoosetheelementtheywanttouseasidentificationoftheproduct,aslongastraceabilityisensured.ThisidentificationelementoftheproductisidenticaltotheoneusedontheEUDeclarationofConformity.

In some cases, e.g. when a product consists of several parts or is an assembly of several parts, its nature does not allow for theaffixingoftheidentificationelement.Theidentificationoftheproducthasinthesecasestobeaffixedtothepackaging(oraccompanyingdocument). Inaddition to themarkingwithan identificationelementon thepackaging,additionalmarkingofindividual products/parts/components can be made based on the manufacturer’s internal rules and ambitions to minimise the extent of a potential recall by having an advanced system for traceability of individual items (e.g. batch codes, production dates).

According to some economic operators, one way to refer to products is to use an item number (a so-called “SKU”-“Stock keeping unit”)asidentification.ThisitemnumbercanalsobeusedasanidentifierontheEUDeclarationofConformity(DoC)togetherwith other elements allowing traceability.

The product consists of several parts/components

Each product is enclosed in one packaging but typically some parts/components could/would also be sold in another packaging as separate parts/components or in other combinations of parts/components. Some of the parts/components in these packages may be possible to mark, while others may be too small or have a shape which does not allow the marking to be on the part. For these reasons, it is allowed to give the set/packaging an item number and to use the same item number on the EU Declaration of Conformity.

Themainpurposeoftheidentificationelementistoenablemarketsurveillanceauthoritiestoidentifyanindividualproductandto link it to a EU Declaration of Conformity. If, when the market surveillance takes place, the product is still in its packaging, it will be easy to identify the element and thus ensure that the corresponding EU Declaration of Conformity regards the product-unit inquestion.Itwouldbemorecomplicatedtohavetoopenthepackagingandfindelementsontheindividualitemsandthenlinkthese to a particular EU Declaration of Conformity.

174 Iftheimporterisonlyaffixinghisnameandaddressandleavesthetrademarkoftheoriginalmanufacturer,heremainsimporter. The address of importer and manufacturer will appear on the product (or packaging or accompanying documents)175 In the case of toys, this might be the case for toys consisting of several parts or an assembly of several parts.

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The product consists of one assembled item

Also when a product consists of only one “item”, it is not uncommon that this item has been assembled by the manufacturer, usingseveralparts(butitisnotintendedtobedisassembledbytheconsumer).Thepartscomposingtheitem(product)areoftenusedinmorethanonedesignofproducts.Normally,somepartswouldnotbelargeenoughtobearanidentificationelementandyetotherpartsmightnotallowmarkingwithanidentificationelementfortechnicalreasons(unevensurface,sphericalshapedsurfaceetc.).AlsointhiscaseitisallowedtoaffixanitemnumberonthepackagingandtousethesamenumberontheEUDoC. The product consists of one item which has not been assembled of several parts

Thisisacasewhereitmayseemsimpletomarktheproductitselfwithanidentificationelementthatisidenticaltotheoneonthe EU DoC (i.e. an item number). However, the same product might be sold in combination with other products/items in a set. Since at the point of production, it is not known which of the items will be sold “alone” and which will be in a packaging together with other products, it is easier to mark the item number, corresponding to the EU DoC, on the packaging. This will also facilitate market surveillance authorities to link the product to the EU DoC.

4.2.2.4 Identification of economic operators

Economic operators are obliged to keep track of the economic operators they supplied their product to or from whom they bought products for a period of 10 years. Bear in mind that the end user (consumer) is not covered by this requirement as they are not considered to be economic operators.

The way to comply with this requirement by economic operators is not prescribed by Union harmonisation legislation, but it must be noted that market surveillance authorities can ask for relevant documents, including invoices, allowing the origin of the product to be traced. Hence, it could be useful to keep invoices for a longer period than envisaged in accounting legislation to comply with the requirements on traceability.

4.3. TECHNICAL DOCUMENTATION

• The manufacturer must draw up a technical documentation.

• The technical documentation is intended to provide information on the design, manufacture and operation of the product.

Union harmonisation legislation obliges the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements. This documentation may be part of the quality system documentation where the legislation provides for a conformity assessment procedure based on a quality system (modules D, E, H and their variants). The technical documentation must be available when the product is placed on the market, whatever its geographical origin or location176.

The technical documentation must be kept for 10 years from the date of placing the product on the market, unless the applicable Union harmonisation legislation expressly provides for any other duration177. This is the responsibility of the manufacturer or the authorised representative established within the Union. Since the concept of “placing on the market” refers to each individual product178, the time period needs to be calculated from the moment when the individual product that is covered by the technical documentation is placed on the market.

The contents of the technical documentation are laid down, in each Union harmonisation act, in accordance with the products concerned. As a rule, the documentation has to include a description of the product and of its intended use and cover the design, manufacture and operation of the product. The details included in the documentation depend on the nature of the product and on what is considered as necessary, from the technical point of view, for demonstrating the conformity of the product to the essential requirements of the relevant Union harmonisation legislation or, if the harmonised standards have been applied, to these by indicating the essential requirements covered by the standards. The requirements in Annex II of Decision No 768/2008/EC refer to the contents of the technical documentation that are relevant for proving the conformity of the product with the applicable harmonisation legislation. Furthermore, the requirement for an “adequate analysis and assessment of the risk(s)” does not oblige the manufacturer to conduct an additional risk assessment or to draw up additional documentation when he has applied harmonised standards, the development of which is based on an assessment of the relevant risk(s). Manufacturers may base their assessment on harmonised standards, which already include the risk analysis, but only as far as the risks are covered by that standard.

176 For placing on the market, see Section 2.3.177 According to the Directives relating to medical devices and in vitro diagnostic medical devices these documents must be kept for 5 years and in the case of implantable medical devices for 15 years.

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In the case where a product has been subject to re-designs and re-assessment of the conformity, the technical documentation mustreflectallversionsoftheproduct;describingthechangesmade,howthevariousversionsoftheproductcanbeidentifiedand information on the various conformity assessment. This is to avoid situations where during the whole life of a product, a market surveillance authority is faced with previous versions of the product for which the version of the technical documentation it is presented with, is not applicable.

SomeUnionharmonisationactsrequirethatthetechnicaldocumentationiswritteninalanguageacceptedbythenotifiedbody179. Inordertocarryouttheconformityassessmentproceduresrequiringthird-partyverificationinaproperway,thedocumentationshouldalwaysbeina languageunderstoodbythenotifiedbody,evenifthishasnotbeenexplicitlymentionedintheUnionharmonisation legislation.

4.4. EU DECLARATION OF CONFORMITY

• The manufacturer or the authorised representative established within the Union must draw up and sign an EU Declaration of Conformity as part of the conformity assessment procedure provided for in the Union harmonisation legislation.

• The EU Declaration of Conformity must contain all relevant information to identify the Union harmonisation legislation ac-cording to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonised standards or other technical specifications.

• A single declaration of conformity is required whenever a product is covered by several pieces of Union harmonisation legis-lation requiring an EU Declaration of Conformity.

• The single declaration of conformity can be made up of a dossier containing all relevant individual declarations of conformity.

Union harmonisation legislation imposes an obligation on the manufacturer to draw up and sign an EU Declaration of Conformity before placing a product on the market180. The manufacturer or his authorised representative established within the Union must draw up and sign an EU Declaration of Conformity as part of the conformity assessment procedure provided for in the Union harmonisation legislation. The EU declaration of conformity is the document that states that that the product satisfies theessential requirements of the applicable legislation.

By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product.

Just as it is the case for the technical documentation181, the EU Declaration of Conformity must be kept for ten years from the date of placing the product on the market, unless the legislation provides for any other duration182. This is the responsibility of the manufacturer or the authorised representative established within the Union. For imported products, the importer must take on this responsibility for the DoC183.

The contents of the EU Declaration of Conformity either refer to the model declaration contained in Annex III of Decision No 768/2008/EC or a model declaration directly annexed to the sectoral Union harmonisation legislation at stake. The standard EN ISO/IEC 17050-1 has been drawn up with the objective of providing the general criteria for the declaration of conformity, and it can also be used as a guidance document provided it is in line with the applicable Union harmonisation legislation. The declarationmaytaketheformofadocument,alabelorequivalent,andmustcontainsufficientinformationtoenableallproductscovered by it to be traced back to it.

The model declaration of Decision No 768/2008/EC contains:

1. A number identifying the product. This number does not need to be unique to each product. It could refer to a product, batch, type or a serial number184.Thisislefttothediscretionofthemanufacturer185.

2. The name and address of the manufacturer or the authorised representative issuing the declaration;

179 See the Directives relating to simple pressure vessels, machinery (for module B), non-automatic weighing instruments, active implantable medical devices,gasappliances,telecommunicationsterminalequipment,medicaldevices,potentiallyexplosiveatmospheres,lifts(formodulesB,C,D,G,H), pressure equipment, in vitro diagnostic medical devices, and radio and telecommunications terminal equipment.180 Please note that the Machinery Directive 2006/42/EC foresees the placing on the market of “partly completed machinery” to be accompanied by a so- calleddeclarationofincorporationwhichisdifferentfromtheEUDeclarationofconformity.AccordingtoRegulation(EC)No552/2004,constituentsof theEuropeanAirTrafficManagementnetworkareaccompaniedeitherbyadeclarationofconformityoradeclarationofsuitabilityforuse.181 For more information on the technical documentation, see Section 4.3.182 According to the Directives relating to medical devices and in vitro diagnostic medical devices the EU Declaration of Conformity must be kept for 5 years and in the case of implantable medical devices for 15 years. 183 For responsibilities of the manufacturer, the authorised representative and the importer, see Chapter 3.184 The “number” can be an alpha-numerical code too.185 In addition, whether this is expressly envisaged or not by the Union harmonisation legislation manufacturers are free to add a number identifying the EU Declaration of Conformity itself in line with EN ISO/IEC 17050-2.

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3. A statement that the declaration is issued under the sole responsibility of the manufacturer.

4. Theidentificationoftheproductallowingtraceability.Thisisbasicallyanyrelevantinformationsupplementarytopoint1describingtheproductandallowingforitstraceability.Itmaywhererelevantfortheidentificationoftheproductcontainanimage,butunlessspecifiedasarequirementintheUnionharmonisationlegislationthisislefttothe discretion of the manufacturer.

5. AllrelevantUnionharmonisationlegislationcompliedwith;thereferencedstandardsorothertechnicalspecifications(suchasnationaltechnicalstandardsandspecifications)inaprecise,completeandclearlydefinedway;thisimpliesthattheversionand/ordateoftherelevantstandardisspecified.

6. Thenameandidentificationnumberofthenotifiedbodywhenithasbeeninvolvedintheconformityassessmentprocedure186 187;

7. All supplementary information that may be required (for example grade, category), if applicable;

8. The date of issue of the declaration; signature and title or an equivalent marking of authorised person188 189; this could beanydateafterthecompletionoftheconformityassessment

Where several pieces of Union harmonisation legislation apply to a product, the manufacturer or the authorised representative has to provide a single declaration of conformity in respect of all such Union acts190. It is accepted that the single declaration may be a dossier made up of relevant individual Declarations of conformity.

The EU declaration of conformity must be made available to the surveillance authority upon request. Moreover, Union harmonisation legislation relating to machinery, equipment in potentially explosive atmospheres, radio and terminal telecommunication equipment,measuring instruments,recreationalcraft, lifts,high-speedandconventionalrailsystemsandconstituentsoftheEuropeanAirTrafficManagementnetworkrequireproductstobeaccompaniedbytheEUdeclarationofconformity.

The EU declaration of conformity must be translated into the language or languages required by the Member State in which the product is placed or made available on the market191. Union harmonisation legislation does not necessarily specify who has the obligation to translate. Logically, this should be the manufacturer or another economic operator making the product available.

4.5. MARKING REQUIREMENTS

4.5.1. CE MARKING

4.5.1.1 Definition and role of the CE marking

• The CE marking indicates the conformity of the product with the Union legislation applying to the product and providing for CE marking.

• The CE marking is affixed on products that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.

The CE marking is a key indicator (but not proof) of a product’s compliance with EU legislation and enables the free movement of products within the European market, whether they are manufactured in the EEA, Turkey or in another country.Member States of the European Economic Area (EEA - EU Member States and certain EFTA countries: Iceland, Norway, Liechtenstein) arenotallowedtorestricttheplacingonthemarketofCEmarkedproducts,unlesssuchmeasurescanbejustifiedonthebasisof evidence of the non-compliance of the product. This also applies to products made in third countries which are sold in the EEA.

CE marking does not indicate that a product was made in the European Union. The CE marking indicates conformity with the requirements laid down by the Union harmonisation text(s) in question. Therefore, it is to be considered as essential information to Member States’ authorities as well as other relevant parties (for example distributors). CE marking does not serve commercial purposes i.e. it is not a marketing tool.

186 NotallUnionharmonisationlegislationrequirestheinterventionofanotifiedbody.ForinstancetheLowvoltagedirectiveandtheToysdirectivedonot.187 The name and address of the person who keeps the technical documentation may also be required by some pieces of Union harmonisation legislation since according to those, not only the manufacturer shall keep the technical documentation.188 This could be the Managing Director of the company or another representative of the company to whom this responsibility has been delegated.189 It is not necessary for the signatory to be domiciled in the European Union. A manufacturer established outside the Union is entitled to carry out all the conformity assessment procedures at his premises and, to sign the EU Declaration of Conformity, unless otherwise provided for in the relevant Union harmonisation legislation.190 Article 5 from Decision No 768/2008/EC191 Article R10(2) of Annex I of Decision No 768/2008/EC

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CE marking is the visible consequence of a whole process comprising conformity assessment in a broad sense and indicates that a product is declared by the manufacturer as in conformity with Union harmonisation legislation.

4.5.1.2 Relationship to existing legislation

• Regulation (EC) No 765/2008 lays down the general principles governing the CE marking while Decision No 768/2008/EC provides for rules governing its affixing.

• Sectoral Union harmonisation texts providing for CE marking are based on Regulation (EC) No 765/2008 and Decision No 768/2008/EC.

Regulation(EC)No765/2008laysdownthedefinition,theformatandthegeneralprinciplesgoverningtheCEmarking.DecisionNo768/2008/ECprovidesforconformityassessmentproceduresthatleadtoitsaffixing.

ThesectoralUnionharmonisationlegislationprovidingfortheaffixingoftheCEmarkingmostlyfollowstheprinciplesoftheRegulation (EC) No 765/2008 and Decision No 768/2008/EC.

As a general rule192 the CE marking can be introduced in a Union legislative act as legal conformity marking if:

• the method of total harmonisation is used, which means that diverging national regulations that cover the areas as the legislative act in question are prohibited;

• the Union harmonisation act contains conformity assessment procedures according to Decision No 768/2008/EC. However there is an exception to this rule.

IndulyjustifiedcasesatotalharmonisationpieceoflegislationthatfollowsDecisionNo768/2008/ECmayprovideforadifferentmarking instead of the CE marking. For example the Directive on marine equipment does not provide for a CE marking, but for a specificconformitymarkduetotheapplicationofaninternationalagreementwhichprovideforsuchamarking193.

4.5.1.3 Who must (not) affix the CE marking

• The CE marking is affixed by the manufacturer (established inside or outside the Union), or by his authorised representative established within the Union.

• By affixing the CE Marking the manufacturer declares on his sole responsibility that the product conforms to all applicable Union legislative requirements, and that the appropriate conformity assessment procedures have been successfully com-pleted.

The manufacturer, whether established inside or outside the Union, is the entity ultimately responsible for the conformity of the productwiththeprovisionsoftheUnionharmonisationlegislationandfortheaffixingoftheCEmarking.ThemanufacturermayappointanauthorisedrepresentativetoaffixtheCEmarkingonhisbehalf.

ByaffixingtheCEmarkingonaproduct,amanufacturerisdeclaring,onhissoleresponsibility(andirrespectivelyofwhetherathird-party has been involved in the conformity assessment process), conformity with all of the legal requirements to achieve CE marking.

Iftheimporterordistributororanotheroperatorplacesproductsonthemarketunderhisownnameortrademarkormodifiesthem, he then takes over the manufacturer’s responsibilities. This includes the responsibility for the conformity of the product andtheaffixingoftheCEmarking.Inthiscasehemusthavesufficientinformationonthedesignandproductionoftheproduct,ashewillbeassumingthelegalresponsibilitywhenaffixingtheCEmarking.

4.5.1.4 Principles of affixing the CE marking

The CE marking must take the form below. If the CE marking is reduced or enlarged the proportions must be respected.

The CE marking must be affixed visibly, legibly and indelibly to the product or to its dataplate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and/or to the accompanying documents. The CE marking may not, in principle, be affixed until the conformity assessment procedure hasbeen completed to ensure that the product complies with all the provisions of the relevant Union

192 Conformity assessment according to the construction products legislation does not follow Decision No 768/2008/EC although construction products legislationprovidesfortheCEmarking.ThedifferenceisthattheCEmarkingunderconstructionproductslegislationindicatesthelevelofperformance of the product and not conformity in the stricter sense as it is the case for the other legislative acts providing for the CE marking.193 See the section 4.5.2 on other mandatory markings.

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harmonisation acts. This will usually be at the end of the production phase. This poses no problem if, for example, the CE marking isonadataplatethat isnotaffixedtotheproductuntilafterthefinal inspection.However, if (forexample)theCEmarkingisaffixedbystampingorcasting, themarkingcanbeaffixedatanyotherstageof theproductionphase,provided that theconformityoftheproductisverifiedaspartoftheproductionprocess.

TherequirementforvisibilitymeansthattheCEmarkingmustbeeasilyaccessibleforallparties.Itcould,forinstance,beaffixedon the back or underside of a product. A minimum height of 5 mm is required to ensure that it is legible. However according to the several pieces of legislation194 the minimum dimension of the CE marking may be waived for small devices or components.

TheCEmarkingcantakedifferentforms(e.g.colour,solid/hollow)aslongasitremainsvisible,legibleandrespectsitsproportions.It must also be indelible so that it cannot be removed under normal circumstances without leaving noticeable traces (for example some product standards provide for a rub test with water and petroleum spirits). Nevertheless, this does not mean that the CE marking must form an integral part of the product.

HoweverincertaincasesaffixingoftheCEmarkingtotheproductisimpossible(forexampleoncertaintypesofexplosives)ornot possible under reasonable technical or economic conditions. Furthermore there can be cases where the minimum dimensions fortheaffixingcannotberespected,oritcannotbeensuredthattheCEmarkingisvisibly,legiblyandindeliblyaffixed.

Insuchcases,theCEmarkingcanbeaffixedtothepackaging,ifitexists,and/ortotheaccompanyingdocument,wheretheUnion harmonisation legislation concerned provides for such documents. The CE marking on the product may neither be omitted nor be moved to the packaging or accompanying documents on purely aesthetic grounds.

Regulation (EC) 765/2008 and Decision 768/2008/EC lay down that the CE marking must have the dimensions, format and proportionsdefinedinAnnexIIofRegulation(EC)No765/2008andbelegibleandclearlyaffixed.Regulation(EC)765/2008andDecision No 768/2008/EC do not forbid any kind of design (e.g. “hollow” design) as long as the above conditions are respected. Electronic labelling however is not allowed.

4.5.1.5 Affixing CE marking together with the identification number of the notified body

Where a notified body is involved in the production control phase according to the applicable Union harmonisation legislation, its identification number must follow the CE marking. The manufacturer or the authorised representative affixes the identification number if the legislation so requires, under the responsibility of the notified body.

Anotifiedbodymaybeinvolvedintheproductionphase,dependingontheconformityassessmentproceduresapplied.TheCEmarkingmustbefollowedbytheidentificationnumberofthenotifiedbodyonlyifitisinvolvedintheproductionphase.Thus,theidentificationnumberofanotifiedbodyinvolvedinconformityassessmentinthedesignphaseaccordingtomoduleBdoesnotfollowtheCEmarking.Sometimesseveralnotifiedbodiesareinvolvedintheproductionphase,whichispossiblewheremorethanoneUnionharmonisationtextisapplicable.InthesesituationsseveralidentificationnumbersfollowtheCEmarking.Thus,iftheCEmarkingappearsonproductswithoutanidentificationnumber,thismeansthat:

• eithernonotifiedbodyintervenedinthedesignorproductionphase(moduleA);• or upon manufacturer’s choice the in-house accredited body intervened in the production phase (modules A1, A2);• oranotifiedbodyintervenedinthedesignphase(moduleB)butnonotifiedbodyintervenedintheproductionphase

(module C following module B);• oranotifiedbodyintervenedinthedesignphase(moduleB)anduponmanufacturer’schoicethein-houseaccredited

body intervened in the production phase (modules C1, C2 following module B).• IfhowevertheCEmarkingappearsonproductswithanidentificationnumber195, this means that:• eitheruponmanufacturer’schoiceanotifiedbodyintervenedintheproductionphase(modulesA1,A2);• oranotifiedbodyintervenedinthedesignphase(moduleB)anduponmanufacturer’schoiceanotifiedbody(notnec-

essarilythesameonebuttheonewhoseidentificationnumberappears)intervenedintheproductionphase(modulesC1, C2 following module B);

• oranotifiedbodyintervenedinthedesignphase(moduleB)andanotifiedbody(notnecessarilythesameonebuttheonewhoseidentificationnumberappears)intervenedintheproductionphase(modulesC1,C2,D,E,FfollowingmoduleB);

• oranotifiedbodyintervenedinthedesignandproductionphase(modulesD1,E1,F1,G1H,H1). TheCEmarkingandtheidentificationnumberofthenotifiedbodydonotnecessarilyhavetobeaffixedwithintheUnion.Theymaybeaffixedinathirdcountry,forexampleiftheproductismanufacturedthereandthenotifiedbodycarriedoutconformityassessmentinthatcountryinlinewiththerelevantUnionharmonisationlegislation.TheCEmarkingandtheidentificationnum-bercanalsobeaffixedseparately,aslongastheyremaincombined.SomeUnionharmonisationlegislationalsorequiresthatthe

194 Suchasmachinery,personalprotectiveequipment,activeimplantablemedicaldevices,medicaldevices,potentiallyexplosivesatmospheres,lifts-as regards safety components, in vitro diagnostic medical devices, radio and telecommunications terminal equipment or marine equipment195 PleasenotethatinthecasewhereseveralUnionharmonisationactsapplytoaproductandtheCEmarkingappearswithanidentificationnumber,this doesnotmeanthatthenotifiedbodyintervenesintheconformityassessmentprocessrequiredbyeachoftheapplicableacts.Someoftheapplicable Unionharmonisationlegislationmightnotrequiretheinterventionofanotifiedbody.

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lastdigitsoftheyearinwhichtheCEmarkingwasaffixedareindicated. 4.5.1.6 Which products must (not) be CE marked

• The CE marking must be affixed before any product subject to it, is placed on the market, save where specific Union harmo-nisation legislation requires otherwise.

• Where products are subject to several Union harmonisation acts, which provide for the affixing of the CE marking, the marking indicates that the products are declared to conform to the provisions of all these acts.

• A product may not be CE marked, unless it is covered by a Union harmonisation legislation providing for its affixing.

Not all products have to be CE marked196.TheobligationtoaffixtheCEmarkingextendstoallproductswithinthescopeoflegislativeactsprovidingforitsaffixing,andwhichareintendedfortheUnionmarket.Thus,theCEmarkingmustbeaffixed:

• to all newly manufactured products that are subject to legislation providing for CE marking, whether manufactured in the Member States or in third countries;

• to used and second-hand products imported from third countries that are subject to legislation providing for CE marking;

• tomodifiedproductsthat,asnew,aresubjecttolegislationprovidingforCEmarkingandwhichhavebeenmodifiedinawaythatcouldaffectthesafetyorthecomplianceoftheproductwiththeapplicableharmonisationlegislation.

Insomecases,aproductisdeemedfinalforthepurposesofaparticularUnionharmonisationactandhastobeCEmarked.ThissameproductthenisincorporatedinanotherfinalproductwhichisitselfsubjecttoanotherUnionharmonisationactwhichalsorequires CE marking. This produces a situation where more than one CE marking can be found on a product197.

Union harmonisation legislation providing in general for CE marking may exclude the application of the CE marking on certain products. As a general rule, such products are subject to free circulation, if:

a. They are accompanied by:• a Declaration of incorporation for partly completed machinery, according to the Machinery Directive;• aDeclarationofconformityinthecaseofpartlycompletedboatsreferredtointheDirectiveonrecreationalcraft.

b. TheyareaccompaniedbyanattestationofconformityinthecaseofcomponentsasdefinedintheDirectiveonequip-ment and protective systems intended for use in potentially explosive atmospheres (ATEX).

c. They are accompanied by a statement in the case of:• custom-made medical devices and devices intended for clinical investigations referred to in the Directives on

active implantable medical devices and medical devices; • devices intended for performance evaluation referred to in the Directive on in vitro diagnostic medical devices.

d. TheyareaccompaniedbyacertificateofconformityinthecaseoffittingsreferredtointheDirectiverelatingtogasappliances.

e. The product bears the manufacturer’s name and an indication of maximum capacity in the case of instruments not subject to conformity assessment according to the Directive relating to non-automatic weighing instruments.

f. The product is manufactured in accordance with sound engineering practice in the case of certain vessels referred to in the Directives relating to simple pressure ves sels and pressure equipment.

In addition, the Directive on pressure equipment entitles Member States to authorise, on their territory, the placing on the mar-ket and the putting into service by users, of pressure equipment of assemblies not bearing the CE marking, but that have been subjecttoaconformityassessmentcarriedoutbyauserinspectorateinsteadofanotifiedbody.

196 Regulation(EC)No552/2004ontheinteroperabilityoftheEuropeanAirTrafficManagementnetworkdoesnotprovideforCEmarking.197 The typical example can be a computer.

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4.5.1.7 CE marking and other markings

• The CE marking is the only marking of conformity indicating that a product is in conformity with Union harmonisation legis-lation that applies to it and provides for CE marking.

• Member States must refrain from introducing any reference to another conformity marking into their national regulations, which would overlap with the CE marking.

• A product may bear additional markings and marks, provided that they fulfill a different function from that of the CE marking, are not liable to cause confusion with it, and do not reduce its legibility and visibility.

The CE marking replaces all mandatory conformity markings having the same meaning, which existed before harmonisation took place. Such national conformity markings are incompatible with CE marking and would constitute an infringement of the applicable European legislation in question. When transposing Union harmonisation legislation, Member States are required to incorporate the CE marking into their national regulations and administrative procedures. They must also refrain from introducing any other conformity marking into their national legislation that has the same meaning as the CE marking.However, other markings may be used as long as they contribute to the protection of public interests, are not covered by Union harmonisationlegislationandtheiraffixingdoesnotimpairthevisibility,legibilityandmeaningoftheCEmarking.Theaffixingof additional markings (such as a protected trademark of a manufacturer or other private/national markings) is allowed to the extent that such markings do not create confusion with the CE marking. This confusion may either refer to the meaning or form of the CE marking.

Inthisrespect,othermarkingsadditionaltotheCEmarkingneedtofulfiladifferentfunctionfromthatoftheCEmarking.Thus,theyshouldprovideanaddedvalueinsignifyingconformitywithobjectivesthataredifferentfromthosetowhichtheCEmarkingrelates (for example environmental aspects not covered by the applicable Union harmonisation legislation).

Furthermore several Union harmonisation acts foresee additional markings that are complementary and non-overlapping to the CE marking (see under 4.5.2).

4.5.1.8 Sanctions

• Member States have to ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking.

• Member States have to also provide for penalties for infringements, which may include criminal sanctions for serious in-fringements

• A Member State must notify to the Commission and to the other Member States when it decides to restrict free movement due to incorrect affixing of the CE marking, or when it takes action against those who are responsible for a non-compliant product bearing the CE marking.

TheCEmarkingprovidesthefirstindicationthatthenecessarycontrolscanbeassumedtohavebeencarriedout,beforetheproduct in question is placed on the market, in order to ensure its compliance to the legislative requirements. Market surveillance authorities are entitled to proceed to additional controls for the protection of public interest. The action to be taken by market surveillance authorities should be decided on a case by case basis according to the principle of proportionality.

Member States must provide in their national legislation for appropriate measures both to prevent the abuse and misuse of CE marking,andtoredressthesituationifsuchabuseormisusetakesplace.Thosemeasuresneedtobeeffective,proportionatetotheseriousnessoftheoffenceanddissuasiveandmaybeincreasediftherelevanteconomicoperatorhaspreviouslycommittedasimilar infringement.Theymay includewithdrawal, recallofproducts,penaltiesandcriminalsanctions (suchasfinesandimprisonment) wherever necessary.

Themeasuresare imposedwithoutprejudicetoothermeasurestakenwherethemarketsurveillanceauthoritiesfindthataproduct presents a risk or does not comply with the applicable legislation. Furthermore Member States must ensure that the measures are implemented.

InthisrespecttheaffixingoftheCEmarkingtoaproductthat isnotcoveredbyanyoftheUnionharmonisationlegislationprovidingforitsaffixingisconsideredtobedeceivingbecauseconsumersorusers,forinstance,arelikelytogettheimpressionthat the product in question satisfies certain Union safety provisions. Competent authoritiesmust, therefore, have at theirdisposal legal instruments that enable them to act against the deceptive use of CE marking. Action must be taken also against those responsible for a non-compliant product bearing the CE marking.

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TheaffixingofmarkingsinadditiontotheCEmarkingissubjecttocertainrestrictions198. The surveillance authority has to take the necessary measures to ensure that these principles are respected and, where necessary, take appropriate action.

A Member State must inform the Commission and the other Member States of its decision to restrict free movement due toincorrectaffixingoftheCEmarking,andofitsactionagainstthepersonresponsibleforaffixingtheCEmarkingtoanon-compliant product. It is then up to the other Member States to decide whether or not similar action is necessary. In the case of undulyaffixedCEmarkingtoproductsnotsubjecttotheCEmarkingrequirement,MemberStateshouldinformtheCommissionand the other Member States about it.

4.5.2. OTHER MANDATORY MARKINGS

Several pieces of Union harmonisation legislation foresee additional markings that are complementary and non-overlapping to the CE marking

Pictograms or other markings indicating, for instance, the category of use are, according to some Union harmonisation legislation, complementary to the CE marking but do not form part of it or replace it. Some examples:

• the EU energy label for energy-related products;

• thespecificmarkingofexplosionprotectionrequiredforequipmentandprotectivesystemsintendedforuseinpoten-tially explosive atmospheres;

• thespecificconformitymark(intheformofaship’swheel)ofthemarineequipmentdirective(insteadoftheCEmark-ing)e

• theequipmentclassidentifierrequiredforradioequipment(Class2);

• the “Pi” marking required for transportable pressure equipment (instead of the CE marking);

• the supplementary metrology marking required for measuring instruments and non-automatic weighing instruments.

198 See under Points 4.5.1.7 and 4.5.2

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5. CONFORMITY ASSESSMENT

5.1. MODULES FOR CONFORMITY ASSESSMENT

5.1.1. WHAT IS CONFORMITY ASSESSMENT?

• Conformity assessment is the process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled.

• A product is subjected to conformity assessment both during the design and production phase. Two important elements of every legislative act (either Old or New Approach) covering products are:

• the legislative requirements governing the characteristics of the products covered;• and the conformity assessment procedures the manufacturer carries out in order to demonstrate that a product,

before it is placed on the market, conforms to these legislative requirements.

This guide addresses conformity assessment as this is laid down under Decision No 768/2008/EC (particularly for the Union harmonisation legislation under the ‘New Approach’ and now the New Legislative Framework).

A product is subjected to conformity assessment both during the design and production phase. Conformity assessment is the responsibility of the manufacturer. Should a manufacturer subcontract design or production, he still remains responsible for the execution of conformity assessment.

Conformity assessment must not be confused with market surveillance, which consists of controls by the national market surveillanceauthoritiesafter theproducthasbeenplacedon themarket.Howeverboth techniquesarecomplementaryandequally necessary to ensure the protection of the public interests at stake and the smooth functioning of the internal market.

The essential objective of a conformity assessment procedure is to demonstrate that products placed on the market conform to the requirements expressed in the provisions of the relevant legislation.

5.1.2. THE MODULAR STRUCTURE OF CONFORMITY ASSESSMENT IN UNION HARMONISATION LEGISLATION

• In Union harmonisation legislation, conformity assessment procedures cover both design and production phases. They are composed of one or two modules. Some modules cover both phases. In other cases, distinct modules are used for each phase.

• Decision No 768/2008/EC lays down the “horizontal menu” of conformity assessment modules and the ways procedures are built of modules.

• The legislator selects from the menu of conformity assessment modules/procedures (laid down under Decision No 768/2008/EC) the most appropriate ones for the concerned sector.

Under Union harmonisation legislation, conformity assessment procedures are composed of one or two conformity assessment modules. As products are subjected to conformity assessment both during the design and production phase, a conformity assess-ment procedure covers both design and production phases; while a module may cover:

• either one of these two phases (in this case a conformity assessment procedure is composed of two modules);• or both (in this case a conformity assessment procedure is composed of one module).

Decision No 768/2008/EC, lays down a “horizontal menu” of conformity assessment modules and the ways procedures are built of modules.

The legislator selects from the menu of conformity assessment modules/procedures (laid down under Decision No 768/2008/EC) themostappropriateone(s)inordertoaddressthespecificneedsoftheconcernedsector199. The least onerous modules should be selected taking into account the type of products and hazards involved, the impact on the protection of public interests, the economicinfrastructureofthegivensector,themethodsofproductionetc.,wherepossibleachoiceofinspection,certification,and/or QA modules should be provided.

199 UndertheEcodesigndirectivetheconformityassessmentprocedures(tobespecifiedintheimplementingmeasure)islaiddowninthedirectiveitselfas arule,butindulyjustifiedcasesthemodulesofDecisionNo768/2008areprescribed.

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Conformity assessment procedures are equivalent from a legal point of view but not technically identical in terms of methods. Theirapplicationinthesectorallegislationaimsatprovidinghighlevelofconfidenceasregardstheconformityofproductstothe relevant essential requirements.

The intention of the modules as laid down in the Decision No 768/2008/EC is to allow for a limited number of possible procedures. Nevertheless,thechoiceofferedneedstobesufficientlyvariedinordertobeapplicabletothewidestrangeofproductsconcerned.

Union harmonisation legislation establishes conformity assessment procedures by either leaving the manufacturer no choice or by establishing a range of procedures from which the manufacturer must choose. As conformity assessment procedures in Union harmonisation legislation originate from Decision No 768/2008/EC, they remain consistent and coherent. Thus the assessment of product conformity becomes more transparent especially in cases where more than one harmonisation legislative act applies to a product.

5.1.3. ACTORS IN CONFORMITY ASSESSMENT - POSITIONING OF CONFORMITY ASSESSMENT IN THE SUPPLY CHAIN

• Conformity assessment is the responsibility of the manufacturer, whether the legislation provides for the involvement of a notified or in-house accredited conformity assessment body, or not.

• The main actors in conformity assessment are the legislator, the manufacturer and (if provided for by the legislation) the notified or in-house accredited conformity assessment body.

• The modules used for both the design and the production phase or for each phase may or may not involve a notified body.

• In-house accredited conformity assessment bodies must demonstrate the same level of technical competence and impar-tiality as notified bodies.

Conformity assessment is a responsibility of the manufacturer. However, if required by the relevant legislation, a third party must be involved in the conformity assessment procedure.

In total there are three possibilities:

• There is no third-party involvement. This may concern the case where, according to the legislator, a declaration (ac-companied by the relevant technical examinations and documentation) of the manufacturer is enough to ensure the conformity of the product(s) in question against the relevant legislative requirements. In this case the manufacturer himself carries out all required controls and checks, establishes the technical documentation and ensures the conform-ity of the production process.

• Conformity assessment is performed with the involvement of an accredited in-house conformity assessment body that forms a part of the manufacturer’s organisation. However this in-house body must not have any activities other than conformity assessment and must be independent from any commercial, design and production entities (see for details Article R21 of Decision No 768/2008/EC). It has to demonstrate the same technical competence and impartiality as external conformity assessment bodies, through accreditation.Wheneverappropriateforaspecificsector,thelegislatormayacknowledgethefactthatmanufacturersoperateverywell equipped testing laboratories or premises and their competence is sometimes higher than the abilities of certain external bodies. This may be the case for new innovative complex products for which the testing know-how remains inside the manufacturers.

• However in some other cases the legislator may consider the intervention of a third party i.e. an external conformity assessment body, necessary. Such a body must be impartial and fully independent from the organisation or the prod-uctitassesses(seealsoArticleR17(3)ofDecisionNo768/2008/EC),itcannotengageinanyactivitythatmayconflictwith its independence (see also Article R21(2)(c) of Decision No 768/2008/EC) and thus it cannot have user or other interests in the product to be assessed.

It is the responsibility of the Member States to notify those third party conformity assessment bodies within their jurisdiction that they consider technically competent to assess the compliance of products with the requirements of the Union harmonisation legislation that applies to them. In-house bodies cannot be notified but they have still to demonstrate the same technicalcompetence as external bodies, through accreditation. Member States must also ensure that the (in-house or external) bodies permanently maintain their technical competence.

Taking the above into account, the stakeholders in a conformity assessment procedure are the following:

a) The legislator who:

• setsoutthelegalrequirementsthatproductshavetofulfil;

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• selects conformity assessment modules/procedures from the menu set out under Decision No 768/2008/EC. b) The manufacturer who:

• designs, manufactures and tests the product or has it designed, manufactured or tested;• draws up the technical documentation of the product;• takes all measures necessary to ensure compliance of the products;• uponpositiveassessmentoftheproducts,drawsuptheEUDeclarationofConformityandaffixestheCEmarkingon

the products if the legislation so requires;• uponinterventionofanotifiedbody,affixesthenotifiedbody’sidentificationnumbertotheproductifthelegislationso

requires.It must be clear that it is always the manufacturer who takes responsibility for the conformity of his products with the relevant legislative requirements.

c) The (in-house or external) conformity assessment body that:

• performs checks and assessments, if the legislation so provides;• uponpositiveassessmentissuestheapprovalcertificateorattestationasrequiredbytheapplicablelegislation.

A conformity assessment body wishing to carry out conformity assessment for one or several module(s) under a given piece ofUnionharmonisationlegislationhastobeassessedaccordingtoalltherequirementsforthedifferentmodulesitwishestoofferservicesfor(seeunder§5.2.3).AbodywishingtoofferconformityassessmentservicesunderaUnionharmonisationacthastoofferservicesforatleastonemodulefromthoseindicatedintheUnionharmonisationact.Itmustbenotedthatthereisnoobligationforabodytoofferservicesformorethanonemodule,butitmusttakeontheresponsibilityforawholemodule.

The exact position of conformity assessment in the supply chain is depicted under Flowchart 2

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97

1. The legislator sets out legislative requirements for products

2. The legislator selects conformity assessment modules/procedures

from the menu set out under Decision 768/2008

1. Manufacturer drafs technical documentation

2. Manufacturer takes all measures to ensure compliance

of the products to legislative requirements

Manufacturer

launches design,

production

processes

Conformity assessment is performed and

covers both design and production phase

Manufacturer’s choice

and /or legal provisions

No third-party

involvement.

Manufacturer carries

out all checks

Third-party carries out

checks and controls

specifed in the

legislation

Assessment

result?Negative

Positive

1. Manufacturer draws up declaration of conformity and declares on his sole

responsibility that the products concerned satisfy the legislative requirements

2. Manufacturer afxes CE marking and, upon intervention of a notifed body, the

latter’s identifcation number on the products

Products ready to be placed into the market

Flowshart 2: Conformity Assessement

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5.1.4. MODULES AND THEIR VARIANTS

There are eight modules. Some of them have variants.

There are eight modules (named with the letters from A to H). They lay down the responsibilities of the manufacturer (and his authorisedrepresentative)andthedegreeofinvolvementofthein-houseaccreditedornotifiedconformityassessmentbody.They are the components of the conformity assessment procedures laid down under Decision No 768/2008/EC, the “horizontal menu”.

Several modules have their variants. The reason for providing variants within modules (this applies for all variants of all modules laid down under Decision No 768/2008/EC) is to enable the necessary level of protection to be ensured for products presenting higher level of risk while avoiding the imposition of a heavier module. The idea is to minimise the burden on manufacturers to the extent possible.

5.1.5. ONE- AND TWO-MODULE PROCEDURES - PROCEDURES BASED ON TYPE (EU-TYPE EXAMINATION)

In some cases the conformity assessment procedure is in two steps:• first examination of the conformity of a specimen or the design of the concerned product;• then, determination of the conformity of the manufactured products against the approved specimen.

In some cases (e.g. mass production based on a type/specimen “representative of the production envisaged”) and where the product in question is of complex design, the EU legislation may lay down the conformity assessment procedure in two steps:

• firsttheexaminationofconformityofthetype/specimenagainsttherelevantlegalrequirements(socalledEU-Typeexamination - module B);

• and then the determination of the conformity of the manufactured products against the approved EU-type. Inthesecasesconformityassessmentproceduresarecomposedoftwomodules;thefirstmoduleisalwaysmoduleB.

Thismethodnotonlyreducesburdenandcostsbutisalsomoreefficientcomparedtoatraditionalexaminationoftheconformityproductsdirectlyagainstthelegalrequirements.Oncethetypeisapproved(andthisisdoneonlyonceforaspecificspecimen),it must be checked only whether the products to be placed on the market are in conformity with the approved type.

The conformity assessment body involved under module B is not necessarily the same as the one involved in the module that is used together with module B.

Furthermore, the manufacturer undertaking the modules200 that is used together with module B does not need to be the same personastheonehavingtheEU-typeexaminationcertificateundermoduleB.Yet,thatmanufacturerplacingthentheproductonthe market, takes the entire responsibility for the conformity assessment (design & production) of the product. Consequently, he mustbeinpossessionofbothcertificates,althoughtheEU-typeexaminationcertificatedoesnothavetobeinhisname,andthefull history of the product. He must have all the administrative and technical information and data, have type testing performed, manage the technical documentation related to the type testing and have batch testing performed.

In cases where there is no EU-type examination, conformity assessment procedures are composed of one two-phase (design & production) module.

5.1.6. MODULES BASED ON QUALITY ASSURANCE

• The use of quality assurance systems for the purpose of conformity assessment in the Union harmonisation legislation is described in modules D, E and H and their variants.

• For the purpose of complying with the applicable legislation the manufacturer must ensure that the quality system is im-plemented and applied in such a way that it ensures full compliance of the products with the legislative requirements in question.

• Compliance of the manufacturer with standards EN ISO 9000, EN ISO 9001, gives a presumption of conformity with the corresponding quality assurance modules as regards the legislative provisions covered by these standards.

• In addition the quality system must take into consideration the specificities of the concerned products.

200 The relevant modules are modules C, C1, C2, D, E and F

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Some modules and their variants are based on quality assurance techniques and are derived from the EN ISO 9000201, EN ISO 9001202 standards. The modules based on quality assurance techniques (modules D, E, H and their variants) describe the elementsamanufacturermust implement inhisorganisation inorder todemonstrate that theproduct fulfils theessentialrequirements of the applicable legislation.

This means that a manufacturer is given the possibility of using an approved quality system for the purpose of demonstrating compliancewithregulatoryrequirements.Thequalitysystemisassessedbythenotifiedbody.

A quality system implemented on the basis of the EN ISO 9000, EN ISO 9001 gives a presumption of conformity with the respective modules with regard to the provisions in the modules that these standards cover, provided that the quality system takesintoconsiderationthespecificitiesoftheconcernedproducts.

However, the manufacturer is free to apply other quality system models than those based on EN ISO 9001 for the purpose of complying with these modules.

Inanycasethemanufacturermustspecificallyaddressallregulatoryprovisionswhileapplyingitsqualitysystem,inparticular:

• The quality objectives, quality planning and quality manual must fully take on board the objective of delivering products that conform to the essential requirements.

• The manufacturer must identify and document the essential requirements that are relevant for the product and the harmonisedstandardsorothertechnicalsolutionsthatwillensurefulfilmentoftheserequirements.

• Theidentifiedstandardsorothertechnicalsolutionsmustbeusedasdesigninput,andasverificationthatdesign output ensures that the essential requirements will be met.

• Themeasurestakentocontrolmanufacturingmustensurethattheproductsconformtotheidentifiedessential requirements.

• Qualityrecords,suchasinspectionreportsandtestdata,calibrationdata,qualificationreportsofthepersonnel concerned,mustbesuitabletoensurethefulfilmentoftheapplicableessentialrequirements.

5.1.7. OVERVIEW OF MODULES

Modules Description

AInternal production control

Covers both design and production.The manufacturer himself ensures the conformity of the products to the legislative requirements (no EU-type examination).

A1Internal production control plus supervised product testing

Covers both design and production.A+testsonspecificaspectsoftheproductcarriedoutbyanin-houseaccreditedbodyorundertheresponsibilityofanotifiedbodychosenbythemanufacturer*:

A2Internal production control plus su-pervised product checks at random intervals

Covers both design and production.A+productchecksatrandomintervalscarriedoutbyanotifiedbodyorin-houseaccreditedbody*:

BEU-type examination

Covers design. It is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated.AnotifiedbodyexaminesthetechnicaldesignandorthespecimenofatypeandverifiesandatteststhatitmeetstherequirementsofthelegislativeinstrumentthatapplytoitbyissuinganEU-typeexaminationcertificate.Thereare3waystocarryout EU-type examination: 1)production type, 2) combination of production type and design type and 3) design type

CConformity to EU-type based on internal production control

Covers production and follows module B.The manufacturer himself ensures the conformity of the products to the approved EU-type.

C1Conformity to EU-type based on internal production control plus supervised product testing

Covers production and follows module B.C+testsonspecificaspectsoftheproductcarriedoutbyanin-houseaccreditedbodyorundertheresponsibilityofanotifiedbodychosenbythemanufacturer*

201 Quality management systems —- Fundamentals and vocabulary202 Quality management systems —- Requirements

*Thelegislatormayrestrictmanufacturer’schoice

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C2Conformity to EU-type based on internal production control plus su-pervised product checks at random intervals

Covers production and follows module B.C+productchecksatrandomintervalstestsonspecificaspectsoftheproductcar-riedoutbyanotifiedbodyorin-houseaccreditedbody*:

DConformity to EU-type based on quality assurance of the production process

Covers production and follows module B.Themanufactureroperatesaproduction(manufacturingpartandinspectionoffinalproduct) quality assurance system in order to ensure conformity to EU-type. The notifiedbodyassessesthequalitysystem.

D1Quality assurance of the production process

Covers both design and production.The manufacturer operates a production (manufacturing part and inspection of finalproduct)qualityassurancesysteminordertoensureconformitytolegislativerequirements(noEU-type,usedlikeDwithoutmoduleB).Thenotifiedbodyassessestheproduction(manufacturingpartandinspectionoffinalproduct)qualitysystem.

EConformity to EU-type based on product quality assurance

Covers production and follows module B.The manufacturer operates a product quality (=production quality without the man-ufacturingpart)assurancesystemforfinalproductinspectionandtestinginordertoensureconformitytoEU-type.Anotifiedbodyassessesthequalitysystem.The idea behind module E is similar to the one under module D: both are based on a qualitysystemandfollowmoduleB.TheirdifferenceisthatthequalitysystemundermoduleEaimstoensurethequalityofthefinalproduct,whilethequalitysystemunder module D (and D1 too) aims to ensure the quality of the whole production process(thatincludesthemanufacturingpartandthetestoffinalproduct).Eisthussimilar to module D without the provisions relating to the manufacturing process

E1Qualityassuranceoffinalproductinspection and testing

Covers both design and production.The manufacturer operates a product quality (=production quality without the man-ufacturingpart)assurancesystemforfinalproductinspectionandtestinginordertoensure conformity to the legislative requirements (no module B (EU-type), used like E withoutmoduleB).Thenotifiedbodyassessesthequalitysystem.The idea behind module E1 is similar to the one under module D1: both are based on aqualitysystem.TheirdifferenceisthatthequalitysystemundermoduleE1aimstoensurethequalityofthefinalproduct,whilethequalitysystemundermoduleD1aims to ensure the quality of the whole production process (that includes the manu-facturingpartandthetestoffinalproduct).E1isthussimilartomoduleD1withoutthe provisions relating to the manufacturing process.

FConformity to EU-type based on productverification

Covers production and follows module B.The manufacturer ensures compliance of the manufactured products to approved EU-type.Thenotifiedbodycarriesoutproductexaminations(testingofeveryproductor statistical checks) in order to control product conformity to EU-type.ModuleFislikeC2butthenotifiedbodycarriesoutmoresystematicproductchecks.

F1Conformitybasedonproductverifi-cation

Covers both design and production.The manufacturer ensures compliance of the manufactured products to the leg-islativerequirements.Thenotifiedbodycarriesoutproductexaminations(testingof every product or statistical checks) in order to control product conformity to the legislative requirements (no EU-type, used like F without module B)ModuleF1islikeA2butthenotifiedbodycarriesoutmoredetailedproductchecks.

GConformitybasedonunitverification

Covers both design and production.The manufacturer ensures compliance of the manufactured products to the legis-lativerequirements.Thenotifiedbodyverifieseveryindividualproductinordertoensure conformity to legislative requirements (no EU-type).

HConformity based on full quality assurance

Covers both design and production.The manufacturer operates a full quality assurance system in order to ensure conformitytolegislativerequirements(noEU-type).Thenotifiedbodyassessesthequality system.

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H1Conformity based on full quality assurance plus design examination

Covers both design and production.The manufacturer operates a full quality assurance system in order to ensure con-formitytolegislativerequirements(noEU-type).Thenotifiedbodyassessesthequal-itysystemandtheproductdesignandissuesanEUdesignexaminationcertificate.ModuleH1incomparisontomoduleHprovidesinadditionthatthenotifiedbodycarries out a more detailed examination of the product design.TheEU-designexaminationcertificatemustnotbeconfusedwiththeEU-typeexam-inationcertificateofmoduleBthatatteststheconformityofaspecimen“represent-ative of the production envisaged”, so that the conformity of the products may be checkedagainstthisspecimen.UnderEUdesignexaminationcertificateofmoduleH1,thereisnosuchspecimen.EUdesignexaminationcertificateatteststhattheconformityofthedesignoftheproducthasbeencheckedandcertifiedbyanotifiedbody

5.1.8 OVERVIEW OF PROCEDURES

The following procedures are possible:

• A - Internal production control

• A1 - Internal production control plus supervised product testing

• A2 - Internal production control plus supervised product checks at random intervals

• B+C - EU-type examination (B) followed by Conformity to EU-type based on internal production control (C)

• B+C1- EU-type examination (B) followed by Conformity to EU-type based on internal production control plus supervised product testing (C1)

• B+C2 - EU-type examination (B) followed by Conformity to EU-type based on internal production control plus super-vised product checks at random intervals (C2)

• B+D - EU-type examination (B) followed by Conformity to EU-type based on quality assurance of the production pro-cess (D)

• D1 - Quality assurance of the production process.

• B+E - EU-type examination (B) followed by Conformity to EU-type based on product quality assurance (E)

• E1-Qualityassuranceoffinalproductinspectionandtesting

• B+F-EU-typeexamination(B)followedbyConformitytoEU-typebasedonproductverification(F)

• F1-Conformitybasedonproductverification

• G-Conformitybasedonunitverification

• H - Conformity based on full quality assurance

• H1 - Conformity based on full quality assurance plus design examination

62105

Manufacturer

Design phase Production phase

Module A

Module A1

Module A2

Module B

Module C

Module C1

Module C2

Module D

Module D1

Module E

Module E1

Module F

Module F1

Module G

Module H

Module H1

C

O

N

F

O

R

M

I

T

Y

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5.1.9. RATIONALE FOR SELECTING THE APPROPRIATE MODULES

• The legislator should avoid modules too onerous for the objectives of the Union harmonisation legislation concerned, without however compromising the protection of the public interest.

• The complexity of the modules selected should be proportional to the risk (impact on public interest, health, safety, environ-ment) of the product, its design complexity, the nature of its production (large series vs small series, custom-made, simple vs complex production mechanism etc).

The legislator when selecting modules for his legislative instrument should follow the following principles:

• As a general rule, products are subject to both design and production modules before placed on the market.• When appropriate in terms of protection of public interest, the manufacturer must be given as wide a choice of mod-

ules as possible.• Ifitissufficientthatthemanufacturercarriesouthimselfallchecksinordertoensuretheconformityoftheproducts,

then the manufacturer may select module A. This can be the case of low complexity (simple design and production mechanism) products that present a low risk for the public interest.

• In cases of mass production based on a type/specimen and where the product in question is of complex design or presents higher risks of non-compliance for instance, the EU legislation may lay down the conformity assessment pro-cedureintwosteps:firsttheexaminationofconformityoftheprototype/specimenagainsttherelevantlegalrequire-ments (EU-type examination - module B) and then the determination of the conformity of the products against the approved EU-type (modules C and variants, D, E, F).

• In cases where the legislator has opted for the demonstration of conformity assessment against a specimen (module B),hemustexaminethepossibilityofwhetheritissufficientthatthemanufacturercancarryouthimselfallchecksinorder to ensure the conformity in the production phase. If this is the case, then the manufacturer may select module C. This method may be adequate when the products in question are of complex design (this is the reason of having already selected module B) but simple production mechanism and present a low risk for the public interest

• Inmanycasesthelegislatormustacknowledgethatquiteoften,manufacturersmanageverywellequippedtestinglaboratoriesorpremisesandtheircompetenceissometimeshigherthantheabilitiesofcertainnotifiedbodies.Thisis usually the case for new innovative complex products for which the testing know-how remains inside the manu-facturers. In such cases the legislator may consider selecting either modules A1, A2, or, C1, C2 (the latter two, if he has opted for the demonstration of conformity assessment against a specimen - module B) that allow the use of an accredited in-house body.

• IfthedemonstrationofconformityofproductsagainstanapprovedEU-typecannotbelefttothemanufacturerbutrequiresthatproductsaresupervisedbyanotifiedbodyduringtheproductionprocess,thenthelegislatormayrequirefrom the manufacturer either to operate an approved quality system (modules D, E) or that the conformity of his productsareverifiedbemeansoftests/checks(moduleF).Inthisrespect,iftheproductionmechanismisrelatively“simple”thenthelegislatormayconsiderthatitsufficientthatthequalitysystemofthemanufacturerfocusesonlyonthetestofthefinalproductwithoutincludingthepuremanufacturingpart.Ifthisisthecase,moduleEisthemostappropriate.

• In the case of products of simple design but complicated production/manufacturing, the legislator may consider se-lecting modules D1, E1, F1 and using thus the advantages of modules D, E and F respectively, without the necessity of recurring to a more formal specimen examination (as provided under module B that precedes modules D, E, F).

• For products, produced in small series the legislator may consider selecting module G.• In complex cases where it is necessary that the manufacturer must operate a full quality system covering both the

design and the production phase, the legislator may opt for module H.• Whenthemanufactureroperatesafullqualityassurancesystem,buttheverificationoftheconformityofdesignand

theissuanceofEUdesignexaminationcertificatebyanotifiedbodyisnecessary,thenthelegislatormayselectmod-ule H1.

5.2. CONFORMITY ASSESSMENT BODIES

5.2.1. CONFORMITY ASSESSMENT BODIES AND NOTIFIED BODIES

Notified bodies carry out the tasks pertaining to the conformity assessment procedures referred to in the applicable technical harmonisation legislation when a third party is required.

A conformity assessment body is a body that performs one or several elements of conformity assessment, including one or severalofthefollowingactivities:calibration,testing,certificationandinspection.NotifiedbodiesareconformityassessmentbodieswhichhavebeenofficiallydesignatedbytheirnationalauthoritytocarryouttheproceduresforconformityassessmentwithinthemeaningofapplicableUnionharmonisationlegislationwhenathirdpartyisrequired.Theyarecalled‘notifiedbodies’under EU legislation.

Notifiedbodiestakeresponsibilitiesinareasofpublicinterestand,therefore,mustremainaccountabletothecompetentnationalauthorities. To be eligible a body must be a legal entity established on the territory of a Member State and, thus, come under its

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jurisdiction. Otherwise Member States remain free to decide whether or not to notify a body which complies with the requirements laid down in the relevant Union harmonisation legislation.

5.2.2. ROLES AND RESPONSIBILITIES

• Notified bodies are free to offer their conformity assessment services, within their scope of notification, to any economic operator established either inside or outside the Union. They may carry out these activities also on the territory of other Member States or of third countries.

• Notified bodies must provide relevant information to their notifying authority, the market surveillance authorities and other notified bodies.

• Notified bodies must operate in a competent, non-discriminatory, transparent, neutral, independent and impartial manner.

• Notified bodies must employ the necessary personnel, which has sufficient and relevant knowledge and experience to carry out conformity assessment in accordance with Union harmonisation legislation in question.

• Notified bodies must make adequate arrangements to ensure confidentiality of the information obtained in the course of conformity assessment.

• Notified bodies must be adequately insured to cover their professional activities, unless liability is assured under the national legislation of the notifying Member State.

• Notified bodies may demonstrate their competence through accreditation, which is the preferred way to assess their tech-nical competence.

AlthoughthenotifiedbodymustbeestablishedontheterritoryofthenotifyingMemberState,itmayhaveactivitiesorpersonneloutsidetheMemberState,orevenoutsidetheUnion.Certificatesandotherconformityassessmentattestationsare,however,alwaysissuedbyandinthenameofthenotifiedbody203.Sincethenotifiedbodyalwayshastocarryoutitsassessmentfunc-tions within the jurisdiction of the designating Member State, it has to inform the notifying authority, which must be capable of ensuring the monitoring of the total body as it has to take the responsibility for its operations. If monitoring is not considered possible,thenotifyingauthorityshouldwithdraworlimitthescopeofthenotificationasdeemednecessary.Notifiedbodiesmustkeeptheirnationalnotifyingauthoritiesinformedoftheiractivities(forexampleconcerningtheconductofconformityassessments,availabilityofresources,subcontracting,situationsofconflictsofinterest),eitherdirectlyorviaanauthorised body (for example the national accreditation body). They must also be prepared to provide either at the request of their notifying authorities or of the Commission, all information concerning the proper implementation of the conditions under whichtheywerenotified.

Notifiedbodieshaveageneralobligation to informtheothernotifiedbodiesand thenationalmarketsurveillanceauthorityaboutallcertificatessuspendedorwithdrawnduetosafetyrelatednon-conformitiesand,onrequest,aboutcertificatesissuedorrefused. They must also provide the market surveillance authority and, according to some Union harmonisation legislation also the market surveillance authorities of other Member States, with relevant information for the purpose of market surveillance. NotifiedbodiesassucharenotresponsibleforprovidingtheEUDeclarationofConformityorthetechnicaldocumentation.Havingsaid that, in line with the applicable conformity assessment procedure, they might have to keep the technical documentation as partofthetechnicalfileandprovideittotheCommissionortheMemberStatesuponrequest204.Further,notifiedbodiesmustprovide, on request of the Commission department responsible for administering a safeguard clause, the necessary information related to the product or the conformity assessment.

Notifiedbodiesareandmustremainthirdpartiesindependentoftheirclientsandotherinterestedparties.Thelegalstatusofbodiesseekingnotification,whethertheyareprivateorstate-owned,isirrelevantaslongastheirindependence,impartialityandintegrityareensured,andtheyareidentifiableasalegalentitybearingrightsandobligations.

The requirement for independence covers the whole organisation, including the board or directors, and applies also for bodies belonging to business associations or professional federations.

Inorder toguarantee impartiality, thenotifiedbodyand its staffhave tobe free fromanycommercial, financialandotherpressurethatmightinfluencetheirjudgement.Thebodyalsohastoimplementprocedurestoensurethatitsworkcannotbeinfluencedfromoutside.Thestructureofthebodymustsafeguarditsimpartiality,especiallyifthebodyhasactivitiesotherthanthoseofanotifiedbody.

203 Forsubcontractingbynotifiedbodies,seeSection5.2.5204 See Annex II of Decision No 768/2008/EC, Module B, point 8, 3rd paragraph.

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Furthermore,thebodymusthavepoliciesandproceduresthatdistinguishbetweenthetasksitcarriesoutasanotifiedbodyandany other activity in which it is engaged, and it must make this distinction clear to its customers. Accordingly, marketing material must not give any impression that assessment or other activities carried out by the body are linked with tasks described in the applicable Union harmonisation legislation.

When a conformity assessment body delivers a test report it is in its capacity as a conformity assessment body; only in its capacity as notified body can it deliver EU-type examination certificates – a certificate bearing in particular the name andidentificationnumberofthenotifiedbody.Innocircumstancesmustthenotifiedbodyissueatestreportcarryingitsnotifiedbodynumber205inrelationtoteststhatarenotspecifiedinthelegislation,whetherthosetestswerecarriedoutbythebodyitselforbyanotherbody.Moreover,anotifiedbodymayonlyuseitsnumberinrelationtoconformityassessmentactivitiescarriedoutunderthespecificconformityassessmentmodulethatrequirestheinterventionofanotifiedbody,andforwhichithasbeennotified.

Anotifiedbodymustrequirethemanufacturertotakeappropriatecorrectivemeasureand,ifnecessarysuspendorwithdrawacertificateithasissued,ifinthecourseofthemonitoringofconformityfollowingtheissueofthecertificate,itfindsthattheproduct no longer complies206.

Intheircapacityofnotifiedbodies,theymustnotofferorprovideadditionalservicesunlesstheyhaveanaddedvaluefortheconformityassessmentof theproduct.However, notifiedbodiesmayofferany typeof conformityassessment servicesandmarkings where the products are intended for the markets of third countries outside the European Union, for example in the context of Mutual Recognition Agreements207. Such activities must be clearly separated from the activities of the body as a notifiedbody.Notifiedbodiesmustalsoensurethattheiractivitiesoutsidethescopeoftechnicalharmonisationlegislationdonotcompromiseordiminishconfidenceintheircompetence,objectivity,impartialityoroperationalintegrityasnotifiedbodies.Notifiedbodiescannotusetheirnotifiedbodynameandnumbertocarryouttheseactivities.

Anotifiedbodymaynotbe themanufacturer, theauthorised representative,a supplieror their commercial competitor, norofferorprovide(orhaveofferedorprovided)consultancyoradvicetoanyofthesepartiesasregardsthedesign,construction,marketing or maintenance of the products in question. However, this does not preclude the possibility of exchanging technical informationandguidancebetweenthemanufacturer,theauthorisedrepresentative,suppliersandthenotifiedbody.

Tosafeguardimpartialityandavoidconflictsofinterestitisimportanttomakeacleardistinctionbetweenconformityassessmentandmarket surveillance. Therefore, it is to be considered as inappropriate for notified bodies to be responsible formarketsurveillance208 209.Notifiedbodiesmusthavedocumentedproceduresfortheidentification,reviewandresolutionofallcaseswhereconflictofinterestissuspectedorproven.Thenotifiedbodyshouldalsorequireallstaffactingonitsbehalftodeclareanypotentialconflictofinterest.

Notifiedbodiesmusthaveundertheircontrolthenecessarypersonnel,whohavesufficientknowledgeandexperiencerelatingtothe products and conformity assessment procedure in question, and who have appropriate training. In particular, knowledge and experience should relate to relevant regulatory requirements and enforcement policies, European and international standardisation activities,relevanttechnologies,productionmethodsandverificationprocedures,andnormalconditionsofuseoftheproductin question. The body must be in a position to manage, control and be responsible for the performance of all its resources and maintaincomprehensiverecordsconcerningthesuitabilityofallthestaffitusesinparticularareas,whethertheyareemployees,employed on contract or provided by external bodies. The body must also have access to appropriate facilities and be able to test or re-test in the EU. Otherwise it will not be possible for the notifying authority to check its competence.

Notifiedbodiesmustensuretheconfidentialityofalltheinformationitobtainsinthecourseofconformityassessment.Itmustmake adequate arrangements to ensure that no results or other information is disclosed to any other party than the competent authority in question, and to the manufacturer or the authorised representative.

Notifiedbodiesmusthaveadequateinsurancetocovertheirconformityassessmentactivities.Thescopeandoverallfinancialvalueofliabilityinsurancemustcorrespondtothelevelofactivityofthenotifiedbody.Themanufacturerinparticularretains,however, the overall responsibility for the conformity of the product with all the requirements of the applicable legislation, even ifsomestagesoftheconformityassessmentarecarriedoutundertheresponsibilityofanotifiedbody.

Notifiedbodiesareobliged toparticipate incoordinationactivities210. They must also take part directly or be represented in European standardisation, or otherwise ensure that they know the situation of relevant standards211.

205 FormoreinformationonthenotifiedbodynumberinNANDO,seePoint5.3.3.206 Article R27(4) of Annex I of Decision No 768/2008/EC207 For Mutual Recognition Agreements, see Section 9.2.208 For market surveillance, see Chapter 7.209 Havingsaidthatitiscommonpracticeinsomesectors(e.g.explosivesandpyrotechnicsarticles)thatmarketsurveillanceauthoritiesrelyonnotified bodies’testingprovidedthatthereisnoconflictofinterests.210 Forthecoordinationbetweennotifiedbodies,seePoint5.2.4.211 Article R17(11) of Annex I of Decision No 768/2008/EC

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5.2.3. COMPETENCES OF NOTIFIED BODIES

The primary task of a notified body is to provide conformity assessment services on the conditions set out in the applicable Union harmonisation legislation. This is a service to the manufacturers in an area of public interest. Notifiedbodiesaredesignatedtoassessconformitywiththeessentialrequirements,andtoensureconsistenttechnicalapplica-tionoftheserequirementsaccordingtotherelevantproceduresintheapplicableUnionharmonisationlegislation.Thenotifiedbodiesmusthaveappropriatefacilitiesandtechnicalstaffthatenable themtocarryout technicalandadministrative tasksrelated to conformity assessment. They must also apply appropriate procedures of quality control in relation to such services provided.Manufacturersarefreetochooseanynotifiedbodythathasbeendesignatedtocarryouttheconformityassessmentprocedure in question according to the applicable Union harmonisation legislation.A notified body wishing to offer services according to several conformity assessment procedures must fulfil the relevantrequirementsfortherespectivetasks,andthishastobeassessedaccordingtotherequirementsforeachdifferentprocedurein question. However, since the scope of much technical harmonisation legislation can be relatively wide and heterogeneous, a notifiedbodydoesnotneedtobequalifiedtocoverallproductsfallingwithinthescopeofthatlegislation,butmaybenotifiedforadefinedrangeofproductsonly.

Notifiedbodiesmusthaveappropriatestructuresandprocedurestoensurethattheconductofconformityassessmentandtheissuingofcertificatesaresubjecttoareviewprocess.Relevantproceduresmust,inparticular,coverobligationsandresponsibilitiesinrelationtosuspensionandwithdrawalofcertificates,requestsaddressedtothemanufacturertotakecorrectivemeasures,and reporting to the competent authority.

Apartfromcarryingoutcertainresponsibilitiesinthefieldofpublicinterest,notifiedbodiesmustregardthemselvesasrenderingservices to industry. Thus, they should provide relevant information to the manufacturer and the authorised representative regarding the legislation in question, apply the conformity assessment procedure without unnecessary burdens for the economic operators,andrefrainfromproposingadditionalcertificationormarkingthathasnoaddedvaluefortheconformityassessmentoftheproduct.Thelatteractivitiesmustbeclearlyseparatedfromtheactivitiesofthebodyasanotifiedbody.Notifiedbodiescannotusetheirnotifiedbodynameandnumbertocarryouttheseactivities.

Toavoidunnecessaryburdensforeconomicoperatorsandhelp inensuringtheprotectionofconfidentialdataor intellectualpropertyrights,thetechnicaldocumentationprovidedtonotifiedbodieshastobelimitedtothatwhichisrequiredsolelyforthepurpose of assessing conformity to the legislation.

5.2.4. COORDINATION BETWEEN NOTIFIED BODIES

Inrecognitionofthefactthatnotifiedbodiesfulfiltasksdelegatedtothembypublicauthorities,theyareobligedtotakepartincoordination activities organised by the Commission. The latter, together with the Member States, ensures that coordination is organisedbetweenthenotifiedbodies.

AcoordinationgroupofnotifiedbodiesisestablishedforeachUnionharmonisationlegislativeactorforseveralrelatedacts,and its work is limited to technical problems relating to conformity assessment in order to ensure a uniform application of the technicalprovisionsoftheapplicablelegislation.Tothatend,itshouldbefreetodefineitsrulesofworkandconstitution.Eachgroupofnotifiedbodieshasatechnicalsecretariatandachairman.

Generally, the groups of notified bodies are composed of representatives of notified bodies. To achieve a higher degree ofefficiencyintheirworkthegroupscansetupsubgroupswitharestrictednumberofparticipantstodiscussspecifictechnicalquestions. The Commission is represented in the groups. Governmental experts and representatives of the authorities directly responsiblefortheeffectiveimplementationofUnionharmonisationlegislationcanparticipateasobserversinthegroups.TheEuropean standardisation organisations (CEN, CENELEC and ETSI) are represented in the groups when standards related issues arise.ThegroupsmayalsoinviterelevantEuropeanfederationsotherinterestedparties.Wherethegroupsofnotifiedbodieshavetotreatsubjectsofaconfidentialnature,theparticipationinmeetingsisrestrictedasdeemednecessary.

Ifabodyrefusestocooperate,thenotificationmaybewithdrawn.However,thenotifiedbodiesarenotobligedtoparticipateinmeetings at European level if they keep themselves informed of, and apply the administrative decisions and documents produced by their group. The relevant working documents, meeting reports, recommendations and guidelines produced by the sectoral and inter-sectoralgroupsofnotifiedbodiesortheirsubgroupsshouldbecirculatedtoallnotifiedbodiesformingpartofthosegroups,whether they have taken part in the meetings or not. The information exchange and communication can be enhanced by use of a platform such as CIRCABC, hosted by the Commission.

Nationalcoordinationgroupsarealsoencouragedandwherethoseexist,notifiedbodiesfromagivenMemberStatemightberequired to take part in their activities.

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5.2.5. SUBCONTRACTING BY NOTIFIED BODIES

• A notified body can have part of its work carried out by another body, whether a subcontractor or a subsidiary, on the basis of established and regularly monitored competence.

• Subcontracting must be based on a contract, which makes it possible to ensure the transparency of and have confidence in the notified body’s operations.

Anotifiedbodycanonlysubcontractataskforwhichithasthecompetenceitself.Itmustnotbethecasethatanotifiedbodysubcontracts a part of the work because it does not have the required competence and knowledge.

Thebodiesactingassubcontractorsforthenotifiedbodiesneednotbenotifiedassuch.Nevertheless,thenotifiedbodymustinform the Member State concerned of its intention to subcontract certain work. Consequently, the Member State may decide that it cannot take the overall responsibility as a notifying authority for such an arrangement, and withdraw or limit the scope of the notification.Thenotifiedbodymustkeeparegisterofallitssubcontractingactivities,andupdateitsystematically.

Thebodysubcontractedbythenotifiedbodymustbetechnicallycompetent,anddisplayindependenceandobjectivityaccordingtothesamecriteriaandunderthesameconditionsasthenotifiedbody.TheMemberStatethathasnotifiedthebodywhichsubcontractspartofitsworkmustbecapableofensuringeffectivemonitoringofthecompetenceofthebodysubcontractedbythenotifiedbody.Individualexternalauditorsorspecialistshavetofulfiltheconditionsofasubcontractor.

Thenotifiedbodymustensurethatitssubcontractorshavethenecessarycompetenceandthattheymaintainthiscompetence,for example by carrying out regular evaluations and by keeping itself regularly informed of the details regarding the performance oftheirtasks.Thenotifiedbodymustalsobeabletodemonstratethecomplianceofitssubcontractorswiththerequirementslaid down in the relevant Union harmonisation legislation.

Information on subcontracting activities and on the competence of the subcontractors and/or the subsidiaries must be readily available at all times, so that the notifying authority can take any necessary action, and communicate it without delay to the Commission and the other Member States on request. Compliance with the EN ISO/IEC 17000 series of standards entails a presumptionofconformityofthesubcontractorwithmostoftherequirements,asisthecasewiththenotifiedbodyitself.Whereaccreditation isnotused toassess thecompetenceofnotifiedbodies, theauthorityshouldundertakeon-sitechecksof thesubcontractor to the same extent as would be provided for under accreditation.

A further condition for subcontracting is that the conformity assessment procedure can be subdivided into technical operations andassessmentoperations,andthatthemethodologyusedtocarryoutthetechnicaloperationsissufficientlyprecise.Anotifiedbody can subcontract strictly limited technical tasks (such as tests and examinations), as long as these can be defined assubstantialandcoherentpartsofthetechnicaloperation.Thebodysubcontractedbythenotifiedbodymust,nevertheless,carryoutsubstantialandcoherentpartsofthesetechnicaloperations.Thenotifiedbodystaffhastobetechnicallyqualifiedtobeabletoassessthetestresultsofsubcontractors.Notifiedbodiesmustnotrestricttheiractivitiestopurelyadministrativefunctions.

Notifiedbodiesmay,forexample,subcontracttestswhilecontinuingtoassesstheirresultsand,inparticular,tovalidatethetestreport in order to evaluate whether the requirements of the Union harmonisation legislation are met. Similarly, subcontracting ispossibleinthefieldofcertificationofqualitysystemsprovidedthatthenotifiedbodycarriesouttheevaluationoftheauditresults.Thenotifiedbodycannotunderanycircumstancessubcontractallofitsactivities,asthatwouldmakethenotificationmeaningless.

Thesubcontractedworkmustbecarriedoutaccordingtopre-establishedtechnicalspecificationssettingoutadetailedprocedurebasedonobjectivecriteriatoguaranteetotaltransparency.Wherethebodysubcontractedbythenotifiedbodyisinvolvedinthe assessment of conformity to standards, these must be used if they lay down the procedures. If this body is involved in the assessmentofconformitytoessentialrequirements,theprocedurefollowedbythenotifiedbodyitselforaproceduredeemedbythenotifiedbodytobeequivalenttothatmustbeused.

Thenotifiedbodymustinallcaseshaveabindingagreementwithitssubcontractorstoensurethatitsgeneralresponsibilitiesare fulfilled212. Notifiedbodiesmustkeepat thedisposalof thenotifyingauthority the relevantdocumentsconcerning theassessmentofthequalificationsofthesubcontractororthesubsidiaryandtheworkcarriedoutbythemundertherelevantUnion harmonisation legislation213.

Asubcontractingnotifiedbodyremainsresponsibleforalltheactivitiescoveredbythenotification.Subcontractingdoesnotentailthedelegationofpowersorresponsibilities.Certificatesandotherattestationsofconformityarealwaysissuedinthenameandundertheresponsibilityofthenotifiedbody.Therefore,thesubcontractingnotifiedbodymustbecompetenttoreviewtheworkofthesubcontractorinallitselementsandmusttakethefinaldecision.

212 FortheroleandresponsibilitiesofnotifiedbodiesseePoint5.2.2.213 Article R20(4) of Annex I of Decision No 768/2008/EC

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TheconditionsforsubcontractingapplytoanysubcontractorwhetherornotestablishedwithintheEuropeanUnion.Thenotifiedbody remains entirely responsible for the work carried out for it by the subcontractor.

Inthecaseofsubsidiariesandsubcontractingtobodiesinthirdcountries,thenotifiedbodymusthaveappropriatefacilitiesandstafftobeabletoverifytestresultsintheEU.Furthermore,ifaccreditationisthechosenpathfornotification,itmustcoverthesubsidiarycompaniesofnotifiedbodiestowhichtheyhaverecourse.Accreditationbodiesmusttakethisintoaccount,eitherby properly applying the existing international guidance on cross-frontier accreditation or by specifying it in the accreditation documents.Ifnotificationisnotbasedonaccreditation,theninordertoensuretheproperandconsistentsupervisionofsuchsubsidiaries and subcontractors, the contents of the information to be provided to the notifying authority should be further specifiedbyaligningittotherelevantpracticesinaccreditation214.

5.2.6. ACCREDITED IN-HOUSE BODIES215

Only in the cases where sectoral Union harmonisation legislation provides for it, an accredited in-house body may be used to carry out conformity assessment activities for the undertaking of which it forms a part, for the implementation of the conformity assessment procedures, modules A1, A2, C1 or C2. That body must constitute a separate and distinct part of the undertaking and must not participate in the design, production, supply, installation, use or maintenance of the products it assesses.

An accredited in-house body has to meet a number of requirements. It must be accredited in accordance with Regulation (EC) No 765/2008.Thebodyanditspersonnelmustbeidentifiablewithinthestructureoftheorganisation,andhavereportingmethodswithin the undertaking of which they form a part which ensure their impartiality and demonstrate it to the relevant national accreditation body. Neither the body nor its personnel may be responsible for the design, manufacture, supply, installation, operation ormaintenance of the products they assess, normay they engage in any activity thatmight conflict with theirindependence of judgment or integrity in relation to their assessment activities. An accredited in-house body can supply its services only to the undertaking of which it forms a part.

An accredited in-house body cannot be notified to the Member States or the Commission, but information concerning itsaccreditation must be given by the undertaking of which it forms a part, or by the national accreditation body, to the notifying authority at the request of that authority.

5.2.7. RECOGNISED THIRD-PARTY ORGANISATIONS (RTPOS) AND USER INSPECTORATES

Most of the principles described in this Chapter also apply to recognised third-party organisations referred to in Article 13 (except Section 5.3) and to the user inspectorates referred to in Article 14 (only Sections 5.1 and 5.2) of the Directive on Pressure Equipment.Asageneralrule,itisconsideredinappropriatefornotifiedbodiestoberesponsibleformarketsurveillance216.

5.3. NOTIFICATION

5.3.1. NOTIFYING AUTHORITIES

A notifying authority is the governmental or public body that is tasked with designating and notifying conformity assessment bodies under Union harmonisation legislation. A notifying authority is the governmental or public body that is tasked with designating and notifying conformity assessment bodiesunderUnionharmonisationlegislation.MostoftenitisthenationaladministrationresponsiblefortheimplementationandmanagementoftheUnionharmonisationactunderwhichthebodyisnotified.EachMemberStatemustdesignateanotifyingauthoritytoberesponsiblefortheassessment,notificationandmonitoringofconformityassessmentbodies.Thenotifyingau-thorityassumesfullresponsibilityforthecompetenceofthebodiesitnotifies.

214 In particular, these are the requirements currently contained in section 14.2.b and c and 14.3 of the IAF/ILAC guidance on ISO/IEC 17020. Sections 14.2.b and c and 14.3 of the IAF/ILAC guidance on ISO/IEC 17020 stipulate:

14.2b: “Competence of a sub-contractor may be demonstrated either: by the sub-contractor having accreditation to ISO/IEC 17020 or ISO/IEC 17025 for the relevant inspections/tests and providing endorsed reports orcertificates;orbytheinspectionbodyitselfassessingthecompetenceofthesub-contractortotherequirementsofISO/IEC17020orISO/IEC 17025, as applicable.” 14.2c. “Where the assessment of the sub-contractor is carried out by the inspection body, it must be able to demonstrate that the assessment team is technically competent and knowledgeable in the application of ISO/IEC 17020 or ISO/IEC 17025.” 14.3a. “If the competence of the subcontractor is based partly or in full on its accreditation, the scope of its accreditation shall cover the activities to be subcontracted and the inspection body shall have records available to show that it has checked the status of the subcontractor. If the subcontractedbodiesarenotaccreditedaccordingtotherelevantstandardforthespecificactivitiestobesubcontracted,theinspectionbodyshallprovideappropriateevidenceofthesubcontractedbody’scompetence,suchasrecordsofevaluationperformedbyqualifiedpersonnel according to appropriate procedures.”

215 Please note that only a limited number of Union harmonisation legislation provides for accredited in-house bodies216 Havingsaidthatitiscommonpracticeintheexplosivesandpyrotechnicssectorsthatmarketsurveillanceauthoritiesrelyonnotifiedbodies’testing providedthatthereisnoconflictofinterests.

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EachMemberStatemustestablishitsnotifyingauthoritiesinsuchawaythatthereisnoconflictofinterestwithconformityassessment bodies. They must be organised and operated so as to safeguard the objectivity and impartiality of their activities. Eachdecisionrelatingtonotificationofaconformityassessmentbodymustbetakenbycompetentpersonsdifferentfromthosewho carried out the assessment.

Furtherrequirementsonanotifyingauthorityarethatitmustnotofferorprovideanyactivitiesthatconformityassessmentbodies perform, or consultancy services on a commercial or competitive basis. Itmust safeguard the confidentiality of theinformationitobtains,anditmusthaveasufficientnumberofcompetentpersonnelatitsdisposalfortheproperperformanceof its tasks.

MemberStatesmustinformtheCommissionoftheirproceduresfortheassessmentandnotificationofconformityassessmentbodiesandthemonitoringofnotifiedbodies.TheCommissionmakesthatinformationpubliclyavailableonitswebsite.

5.3.2. NOTIFICATION PROCESS

• Notification is the act of the notifying authority informing the Commission and the other Member States that a conformity assessment body has been designated to carry out conformity assessment according to a Union harmonisation act, and fulfils the requirements relating to notified bodies set out in that Union harmonisation act.

• Member States take the final responsibility for the competence of their notified bodies with respect to the other Member States and the EU institutions.

• Accreditation is the preferred way to assess the technical competence of notified bodies.

• The notification of a notified body is sent by the notifying authority to the Commission and the other Member States via NANDO - the electronic notification tool developed and managed by the Commission where a list of all notified bodies can be found.

5.3.2.1. Principles of notificationThestatusofNotifiedBodyisavailabletoconformityassessmentbodiesestablishedwithintheEuropeanUnion.MemberStatesareresponsibleforthenotificationofnotifiedbodiesandthechoiceofandresponsibilityfornotifiedbodiesrestswithnationalauthorities. They may choose the bodies they notify from those that are established on their territory which comply with the requirementsofthelegislation,andwhichhavethenecessarycompetencestobecomenotified.Notificationistheactofthenotifying authority informing the Commission and the other Member States that such a body has been designated to carry out conformityassessmentaccordingtoaUnionharmonisationact,andfulfilstherequirementsrelatingtonotifiedbodiessetoutin that Union harmonisation act.

While designation is considered as an act of the designating authority – which may be the same body as the notifying authority –onlytheactofnotifyingtheCommissionandtheotherMemberStatesallowsa‘designatedbody’tobecomea‘notifiedbody’.

Since notification fallswithin the discretion ofMember States, they are not obliged to notify all the bodies demonstratingtechnical competence. Neither are Member States obliged to notify bodies in respect of each procedure to be applied according toaspecificUnionharmonisationact.

MemberStatesarefreetonotifyabodyatanytimeafteraUnionharmonisationacthasbeenadopted.Theyshouldneverthelessconsider thepossibility ofnotifyingbefore theUnionharmonisationact startsapplying. This canmakeeffectiveuseof thetransitionalperiodprovidedforintheUnionharmonisationact,andallowforcertificatestobegrantedfromthedateoffirstapplicationoftheUnionharmonisationact.Itmustbenoted,however,thatinsuchcasesnotifiedbodiesarenotentitledtoissuecertificatesbeforetheUnionharmonisationlegislationstartsapplyingunlesssectorlegislationprovidesotherwise.

5.3.2.2. Assessment of conformity assessment bodies

Theassessmentofaconformityassessmentbodyseekingnotificationdeterminesifitistechnicallycompetentandcapableofcarrying out the conformity assessment procedures in question, and if it can demonstrate the necessary level of independence, impartiality and integrity.

MemberStatestakethefinalresponsibilityforthecompetenceoftheirnotifiedbodieswithrespecttotheotherMemberStatesandtheEUinstitutions.Theymustthereforeverifythecompetenceofthebodiesseekingnotification,basedonthecriterialaiddown in the applicable Union harmonisation legislation in conjunction with essential requirements and the conformity assessment procedure(s) in question. In general, the competence criteria set out in the Union harmonisation acts cover:

• availability of personnel and equipment;• independence and impartiality in relation to those directly or indirectly concerned with the product (such as the design-

er, the manufacturer, the manufacturer’s authorised representative, the supplier, the assembler, the installer, the user);

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• technical competence of personnel that is relevant to the products and conformity assessment procedure in question;• maintenance of professional secrecy and integrity; and• subscription to civil liability insurance, unless that liability is covered by the state under national law.

Notifyingauthoritiesoraccreditationbodiesmustperformperiodicalverificationtoassessthecontinuityofthecompetenceofnotifiedbodiesaftertheyarenotified.

5.3.2.3. Accreditation under Regulation (EC) No 765/2008

Accreditation, performed according to the EN ISO/IEC 17000 series of standards by nationally recognised accreditation bodies that are members of the European Co-operation for Accreditation (EA), is a technical assessment of the competence of the conformity assessmentbodyseekingnotification.Althoughit isnotarequirement, itremainsanimportantandfavouredinstrumentforevaluating thecompetenceand integrityof thebodies tobenotified.For this reason,accreditationshouldbeconsideredbynational notifying authorities as the most favoured technical basis for the assessment of conformity assessment bodies so as to reducedifferencesinthecriteriaappliedfornotification.

Accreditation provides an authoritative statement of the competence, professional integrity and impartiality of the bodies to be notifiedtotheCommissionandtheotherMemberStates.Italsoentailsregularmonitoringandsurveillanceoftheaccreditedbodies. Whenever a national accreditation body ascertains that the conformity assessment body to which it has issued an accreditationcertificateisnolongercompetentordoesnotfulfilitsobligations,theaccreditationcertificatecanbewithdrawn.Inthiscasethebodyshouldbede-notifiedandnolongerallowedtocarryoutconformityassessmentactivitiesundertherelevantlegislation.

Althoughaccreditationisthefavouredinstrumentfortheverificationofcompetenceofconformityassessmentbodies,MemberStates can carry out the evaluation themselves. Following the entry into force of Regulation (EC) No 765/2008 on 1 January 2010, in such cases evidence must be given to the Commission and other Member States that the evaluated body complies withalltheapplicableregulatoryrequirements.Further,thenotifiedbodymustbesubjecttoregularsurveillancesimilartothepractice established by the accreditation organisations.

5.3.2.4. Article 5(2) of Regulation (EC) No 765/2008

AccordingtoArticle5(2)ofRegulation(EC)No765/2008,whenaMemberStatedoesnotbaseitsnotificationonaccreditation,“itshallprovidetheCommissionandtheotherMemberStateswithallthedocumentaryevidencenecessaryfortheverificationof the competence of the conformity assessment bodies it selects for the implementation of the Union harmonisation legislation in question”.

Inordertoensurethenecessarylevelofconfidenceintheimpartialityandtechnicalcompetenceofconformityassessmentbodiesandinthereportsandcertificatesissuedbythem,nationalauthorities,whencarryingouttheassessmentwithoutaccreditation,shouldgivedetailedandcomprehensiveinformationdescribinghowthecandidateNotifiedBodyhasbeenassessedasqualifiedtocarryoutthetasksforwhichitisnotifiedandshowingthatitfulfilstheapplicablecriteriarelatingtonotifiedbodies.Thisinformation,linkedtoagivennotification,ismadeavailabletotheCommissionandtheotherMemberStatesusingtheNANDOelectronicnotificationtool.

The evaluation procedure should be based on at least the following elements:

• a formal application procedure • assessment against applicable requirements. • production of an assessment report• clear decision-making process• existence of a systematic surveillance and related sanction mechanism, providing for periodic surveillance including

on-sitevisits,inordertoverifythecontinuedfulfilmentofrequirementsbythenotifiedbody• demonstration of the national authority’s own technical competence for assessing conformity assessment bodies for

thepurposeofnotificationundertechnicalharmonisationlegislation.Thisdemonstrationmustgiveequivalentassur-ance as the EA217 peer evaluation system.

• thecandidatenotifiedbodiesshouldbemadeawareofgeneralconditions,oftheirrightsandobligations,andoftherequirementsrelatingtoassessmentcarriedoutwithaviewtonotification

The assessment itself should consist of:

• a review of documents verifying the completeness and appropriateness from a substantial point of view with regard to conformity to the applicable requirements

217 On EA’s role, see 6.5.2 and 6.5.4.

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• an on-site audit to check technical and procedural aspects - such as the availability and appropriateness of facilities andequipment,thetechnicalcompetenceofstaff,theexistenceofanappropriatemanagementsystem-andtocheckother aspects demonstrating that conformity to requirements is properly implemented. The assessment must include witnessing technical activities.

When choosing an assessment process other than formal accreditation, notifying authorities must indicate the reasons why accreditationisnotchosentobackupthenotificationprocess.Moreover,notifyingauthoritiesmaynotoutsourcetothenationalaccreditationbodytheassessmentofunaccreditedconformityassessmentbodiesthatseektobecomenotifiedbodies,withoutfulfillingthewholeaccreditationprocessincludingthedeliveryoftheaccreditationcertificate.

Whenaccreditationisnotused,thenotifyingauthoritiesmustperformperiodicalverificationstoensurethecontinuouscompetenceofthenotifiedbody,inthesamewayasnationalaccreditationbodiesdo.

5.3.2.5. Steps in the notification of a notified body

Toobtainnotification,aconformityassessmentbodysubmitsanapplicationfornotificationtothenotifyingauthorityoftheMember State in which it is established. That application should be accompanied by a description of the conformity assessment activities, the conformity assessment procedures or modules and the product or products for which that body claims to be competent,aswellasbyanaccreditationcertificate,whereoneexists,issuedbythenationalaccreditationbodyattestingthattheconformityassessmentbodyfulfilstherequirementslaiddownintherelevantharmonisationlegislation.

Where the body concerned cannot provide an accreditation certificate, it must provide the notifying authority with all thedocumentaryevidencenecessaryfortheverification,recognitionandregularmonitoringofitscompliancewiththerequirementslaiddownintherelevantharmonisationlegislation.AfterverificationtheMemberStateinformstheCommissionandtheotherMember States of the details of the body.

ThenotificationofanotifiedbodyissentbythenotifyingauthoritytotheCommissionandtheotherMemberStatesviaNANDO(NewApproachNotifiedandDesignatedOrganisations),which is the electronic notification tool developedandmanagedbythe Commission. It should include full details of the body, its conformity assessment activities, the conformity assessment proceduresormodulesandproductorproductsconcerned,andtherelevantattestationofcompetence.Shouldthenotificationbelimitedintimebythenotifyingauthorities,thedurationofthenotificationmustalsobeindicated.

Whereanotificationisnotbasedonanaccreditationcertificate,thenotifyingauthoritymustprovidetheCommissionandtheother Member States with documentary evidence which demonstrates the conformity assessment body’s competence, how it has been assessed, and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements.

ThenotificationtakeseffectafteranotificationemailfromNANDOhasbeensenttotheCommissionandtheotherMemberStatesandpublishedontheNANDOwebsite.Thebodyconcernedmaythenperformtheactivitiesofanotifiedbody.UnderlegislationthatisalignedwithDecisionNo768/2008/EC,thenotificationispublishedfollowingaperiodallowedforobjectionsbyother Member States or the Commission - two weeks where accreditation is used, two months where accreditation is not used - and then only where no such objections have been raised.

TheCommissionandtheotherMemberStatesmustbenotifiedinsimilarmannerofanysubsequentrelevantchangestothenotification,suchasachangeinthescopeorvalidityperiodofthenotification,orchangestothedetailsofthebodyitself.

5.3.3. PUBLICATION BY THE COMMISSION – THE NANDO WEB SITE

Forinformationpurposes,theCommissionmakesthelistsofnotifiedbodies(andothercategoriesofconformityassessmentbodies such as User Inspectorates and Recognised Third Party Organisations) publicly available on the NANDO web site on its Europaserver.Thelistsareupdatedasandwhenthenotificationsarepublished,andthewebsiteisrefresheddailytokeepitup-to-date.

Withitsinitialnotification,anotifiedbodyisassignedanidentitynumberintheNANDOsystem.ThisnumberisautomaticallygeneratedbythesystematthemomentofpublicationofthenotificationontheNANDOwebsite.Alegalentitymaycarryonlyonenotifiedbodyidentitynumber,regardlessofthenumberofUnionharmonisationactsforwhichitisnotified.Allocationofthenumberisapurelyadministrativeactdesignedtoensuretheconsistentmanagementofthelistsofnotifiedbodies,anddoesnot confer rights or commit the Commission in any way. The numbering system in NANDO is sequential, and numbers are not re-usedwhenanotifiedbodyiswithdrawnfromthelist.Incasesofsuspensionorwithdrawalofanotification,thedetailsofthenotificationremaininthedatabase,andaremovedtothe‘Withdrawn/ExpiredNotifications/NBs’partofthewebsite218.

218 Formoreinformationonwithdrawalandde-notification,seePoint5.3.4.

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Amendments(extensionorreduction)tothescope,modificationsofthevaliditythenotification,orcancellationofthenotificationarelikewisepublishedontheNANDOwebsite.ThewebsitecanbesearchedbyUnionharmonisationact,bycountry,bynotifiedbody number or using keywords.

5.3.4. SUSPENSION – WITHDRAWAL – APPEAL

Withdrawalofnotificationtakesplacewhenthenotifiedbodyceasestofulfiltherequirementsoritsobligations.Thismaybedone at the instigation of the notifying Member State, during the periodical surveillance (done by the accreditation body or thenotifyingauthority)whereithasreceivedevidenceregardingthefailureofthenotifiedbodytomeetitsrequirementsorcomplaintsaboutthenotifiedbody’scompetenceorbehaviour.ItmayalsobearesultofactionbytheCommission,wherethelatterhasreasontodoubtthatanotifiedbodymeetsorcontinuestomeettherequirementsforitsnotification.Insuchcasesthe Commission informs the notifying Member State accordingly and requests it to take the necessary corrective measures, includingde-notificationifnecessary.Thenotifyingauthoritymusttakeappropriatemeasures.Furthermore,acommonreasonforwithdrawalofanotificationmightbetherequestofanotifiedbodyitself,for instanceduetoplannedchangesinpolicy,organisation or ownership of the body.

TheCommissionandtheMemberStateshavetheresponsibilitytoactwhendoubtarisesaboutthecompetenceofanotifiedbody,eitheratthemomentofnotificationorthereafter.ShouldtheCommissionconsider,onitsowninitiativeoraftercomplaint,that anotifiedbodydoesnot complywith the requirementsor fulfil its responsibilities, itwill inform thenational notifyingauthorityandaskforappropriatedocumentedevidenceconcerningthebasisforthenotificationandthemaintenanceofthecompetence of the body. Should a Member State not provide such information, the Commission may bring this to the attention of the other Member States for discussion or initiate the procedure under Article 258 TFEU against the notifying Member State.

Whereanotifyingauthorityhasascertainedorhasbeeninformedthatanotifiedbodynolongermeetstherequirementslaiddownintherelevantlegislation,orthatitisfailingtofulfilitsobligations,thenotifyingauthoritymust-dependingontheseriousnessofthefailure-suspendorwithdrawthenotificationafterimmediatelycontactingthebodyinquestion.Ithastoimmediatelyinform the Commission and the other Member States accordingly. The Member State must also have this information published, andinformtheCommissionandtheotherMemberStatesfollowingaproceduresimilartothatofthenotification.Thebodyinquestionshouldhavethepossibilitytoappealagainstsuchadecision.Whetherthisappealpostponesthede-notificationornotdepends on national legislation.

Withdrawal is the responsibility of the notifying Member State. It can also be the end result of an infringement procedure. Only thenationalauthorityisentitledtowithdrawanotification.TheCommissioncanwithdrawanotifiedbodyfromtheNANDOlistonlywhenthenotifyingauthorityofaMemberStateitselfwithdrawsitsnotificationorwhen,attheendofaninfringementprocedure under Article 258 TFEU, the Court declares a Member State to be in infringement of a given Union harmonisation actand, consequently, declaresanotification tobe invalid. Inall such cases theCommissionwill ensure thatany sensitiveinformationobtainedinthecourseofitsinvestigationsistreatedconfidentially.

Withoutprejudicetosectoralspecificities,thesuspensionorwithdrawalofanotificationdoesnotaffectcertificatesissuedbythenotifiedbodyuptothatpoint,untilsuchtimeasdemonstrationcanbemadethatthecertificatesshouldbewithdrawn.Inordertoensurecontinuityintheeventofthesuspensionorwithdrawalofanotification,orwherethenotifiedbodyhasceaseditsactivity,thenotifyingMemberStatemustensurethatthefilesofthatbodyareeitherprocessedbyanothernotifiedbodyorkept available for the responsible notifying and market surveillance authorities at their request.

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6. ACCREDITATIONRegulation (EC) No 765/2008 provides a legislative framework for accreditation at the national and EU levels and puts into place an overall policy with its rules, procedures and infrastructures. The reinforcement of accreditation as a means of underpinning thecompetenceofconformityassessmentbodiesandhencethecredibilityandacceptanceofcertificatesandotherattestations,required to ensure the free movement of goods, has been a preoccupation of the Commission since the end of the 1970s. In the 1990s there was a trend towards accreditation becoming a commercial and competitive activity, hence reducing its credibility as thelastlevelofcontrol.TheNLFhoweverconfirmedthatintheEU,accreditationisanon-commercialandnon-competitivepublicactivity which is accountable to both national and European authorities. .

The reinforced EU accreditation system thus put in place is in line with the standards, rules and practices of the international organisationsinthefield.Regulation(EC)No765/2008aimstoensurethataccreditationservesthepublicinterest.EuropeanCooperation for Accreditation (EA), the European organisation of national accreditation bodies, is recognised by the Regulation, by theguidelinessignedwiththeMemberStates(EFTAincluded)andtheCommissionon1April2009,andbenefitsfromaprivilegedrelationship with the Commission through the signature of a Framework Partnership Agreement. Within this framework, the primary role of EA is to contribute to the harmonisation of European accreditation services to support the mutual recognition and acceptanceofaccreditationcertificatesthroughouttheUnion,andtooperatearigorouspeerevaluationsystemthatcontrolsthecompetence of the national accreditation bodies and the equivalence of their services.

In thefieldofaccreditation,Regulation (EC)No765/2008hasestablishedasingleEuropeansystemwhichcoversboth theregulated domain where accreditation is required by legislation as well as for the non-regulated sphere. In the latter case, where a body voluntarily wishes to be accredited it can only go the accreditation bodies which operate under Regulation (EC) No 765/2008, thus avoiding the existence of competing systems.

6.1. WHY ACCREDITATION?

Accreditation provides the last level of public control in a quality chain underpinning the free movement of goods in the Union.

Regulation (EC)No 765/2008 introduced a legal framework for accreditation for the first time. Accreditation of conformityassessment bodies had previously been used in both the regulated and non-regulated domains, but it was not governed by a legal framework at European level.

The idea of regulating accreditation at European level is twofold. On the one hand a comprehensive European framework for accreditation provides the last level of public control in the European conformity assessment chain and is therefore an important element in ensuring product conformity – on the other it enhances the free movement of products and services across the EU by underpinning trust in their safety and compliance with other issues of public interest protection.

Before the entry into force of the Regulation, the lack of common rules for accreditation across Member States meant that accreditationwasbeingusedverydifferently,withtheresultthataccreditationcertificateswerenotnecessarilyrecognisedbydifferentnationalauthoritiesandmarketoperators-leadingtomultipleaccreditationandthereforeincreasedcosttobusinessandconformityassessmentbodieswithoutproducingthebenefitsdescribedabove.

Introducing the legal framework for accreditation therefore reduced administrative burdens in the single market and enhanced public control over accreditation so that it serves as an essential tool for the functioning of the internal market.

The accreditation framework set up by the Regulation explicitly applies both to the regulated and to the voluntary spheres. This is so, because the distinction between the two can become blurred as conformity assessment bodies are active, and products are used,inbothfields.Adifferentiationwouldthereforeleadtounnecessaryburdensforpublicauthoritiesandmarketactorswhileleading to contradictions between the voluntary and regulated domains.

6.2. WHAT IS ACCREDITATION?

Accreditation is the attestation by a national accreditation body based on harmonised standards that a conformity assessment body has the technical competence to perform a specific conformity assessment activity.

Accreditation is the attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes,tocarryoutaspecificconformityassessmentactivity.A wide range of products are subject to third party conformity assessment. This includes unregulated products as well as products regulated at national or at EU level. For products regulated at EU level i.e. in the harmonised area, this usually means that nationallydesignatedconformityassessmentbodies–notifiedbodies–testtheproductandissueanattestationofconformitybefore the product can be placed on the market.

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More precisely, for there to be accreditation, there has to be an accreditable conformity assessment activity.

Accreditation is the standards-based activity to ensure and attest that conformity assessment bodies have the technical competence to perform their duties as is required by the relevant regulations and standards. It assesses conformity assessment bodies’competencetoperformtheirdutiesinspecificfields,asaccreditationisalwayslinkedtoaspecificscopeofactivityofthe conformity assessment body. Operating in the public interest, accreditation assesses the technical competence, reliability and integrity of conformity assessment bodies. It does this through a process of transparent and impartial evaluation against internationally recognised standards and other requirements. Regulation (EC) No 765/2008 obliges national accreditation bodies to verify that conformity assessments are carried out in an appropriate manner and that account is taken of the size and structure of undertakings and the degree of complexity of the product technology in question and the nature of the production process.

Accreditation is based on the international standards for conformity assessment bodies that have been harmonised in the New LegislativeFrameworkandthereferencesofwhichhavebeenpublishedintheOfficialJournaloftheEU.Itistheattestationbyanational accreditation body that a conformity assessment body meets the requirements set by harmonised standards and where applicable any additional requirements, including those set out in relevant sectoral schemes. With Regulation No 765/2008, only national accreditation bodies are allowed to provide accreditation of conformity assessment bodies.

The reliance on harmonised standards, based on corresponding international standards, is intended to create the necessary levelof transparencyandconfidence in thecompetenceofconformityassessmentbodies,andtoensure that theEuropeanaccreditation system set up by Regulation (EC) No 765/2008 is compatible with the international accreditation system – therefore facilitating international trade.

6.3. SCOPE OF ACCREDITATION

Accreditation is always sought and granted for a defined scope i.e. for specific conformity assessment activities.

Accreditation is the standards-based method of assessing and attesting the competence of conformity assessment bodies. Union policyhasmadeuseofaccreditationasaninstrumentthatisdesignedtocreatetheconditionsformutualconfidencebecauseofitsrelianceonconsensusstandards.Mutualconfidencecanonlybeachievedthroughrelianceoncriteriathatcanbeobjectivelyverified, thus allowing transparency and comparability of conformity assessment. The relevant standards for conformityassessment bodies219 were produced with the intention of supporting the introduction of the conformity assessment procedures set out in Union harmonisation legislation220. These standards are conceived to cover the general competence requirements for bodiesperformingconformityassessmenttospecifiedrequirements,irrespectiveofwhetherthesearecontainedinregulations,standardsorothertechnicalspecificationsorwhethersuchspecificationsareperformance-basedorproduct-specific.Thisconceptsupports the role of accreditation as a tool to facilitate the free movement of products within the internal market and has been taken over by the ISO/IEC 17000 standards at international level.

As stated in the respective clauses covering their scope, the standards specify criteria for bodies irrespective of the sector concerned.However,accreditationisalwayssoughtandgrantedforadefinedscope,i.e.forspecificconformityassessmentactivityand, where applicable, the types of test performed and methods used (e.g. “Body X is competent to undertake inspections as a type A body in the area of pressure equipment categories of Directive 97/23”) and is never restricted to the mere compliance with the general EN 45000/17000 standards. Therefore, accreditation on the basis of compliance with the EN 45000/17000 standards alwaysimpliestheneedforthesegeneralcriteriatobecomplementedandfurtherspecifiedbyalltechnicalspecificationsthatare relevant for the specific technical area for which the applicant conformity assessment body seeks accreditation. Thus,accreditationimpliesverificationofcompetencewithregardtothecurrentstateoftheart,andincludesassessmentonthebasisof the standards for conformity assessment bodies and all relevant product- and/or technology-related regulations, standards andotherspecifications.

219 Originally, the EN 45000 series of standards which have been revised and superseded by the EN ISO/IEC 17000 series of standards.220 ThesetofconformityassessmentprocedurestobeusedbyUnionharmonisationlegislationwasfirstsetoutinCouncilDecision93/465/EEC (the so-called “modules Decision”).

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6.4. ACCREDITATION ACCORDING TO REGULATION (EC) NO 765/2008

• Each Member State may appoint one single national accreditation body.

• Accreditation is to be operated as a public authority activity.

• The responsibilities and tasks of the national accreditation body have to be clearly distinguished from those of other na-tional authorities.

• Accreditation is to be provided on a not-for-profit basis.

• Within the EU, accreditation bodies are not allowed to compete with other accreditation bodies.

• Within the EU, accreditation bodies are only to be active on the territory of their own Member State.

6.4.1. NATIONAL ACCREDITATION BODIES

The Regulation foresees that each Member State may appoint one single national accreditation body. Only the national accreditation bodies are allowed to perform accreditation of conformity assessment bodies. This provision is central to the functioning of accreditation in the EU and to the framework of accreditation set up by the Regulation. Member States are not obliged to set up their own national accreditation body, should they consider it not economically viable to do so or should they notdeemitusefultoofferaccreditationforallactivities.Thismeansthatatnotimemorethanoneaccreditationbodymaybe active on the territory of a Member State for a given activity. In order to ensure transparency, Member States are therefore obliged to inform the Commission and other Member States to which national accreditation body of another Member State they are having recourse.

A list of national accreditation bodies is available online221. National accreditation bodies have to make the activities for which they perform accreditation publicly available.

The Regulation does not prescribe the legal form a national accreditation body should take. This means that the national accreditation body may operate from within a ministry, be a governmental agency or be organised as a private company. The Regulationis,however,veryclearinthataccreditationistobeoperatedasapublicauthorityactivityand,tothiseffect,hastobeformally recognised by the Member State.

Furthermore, the responsibilities and tasks of the national accreditation body have to be clearly distinguished from those of other national authorities. This provision aims to enhance the independence of the national accreditation body and the impartiality and objectivity of its activities. Should the national accreditation body be part of a larger public structure, such as a ministry, other departmentsarenotallowedtoinfluenceaccreditationdecisions.Theprocessofaccreditationhastoremainseparatefromotherfunctions.Itisabsolutelyessentialtoavoidaconflictofinterestofthenationalaccreditationbody.Thisalsoappliestocertaintasks that the national accreditation body may take on. While Decision No 768/2008/EC foresees that the national accreditation body may function as a notifying authority222, the delegation of powers has to be clearly documented and the conditions for impartiality, namely the separation of tasks within the accreditation body ensured.

In addition, when providing accreditation, the national accreditation body has to fulfil a number of conditions in terms ofstakeholder representation, its internal management and internal controls. Decisions on assessment have to be taken by a differentpersontotheonewhocarriedouttheassessmentoftheconformityassessmentbody.Theaccreditationbodyhastohave enough competent personnel at its disposal to ensure that it can perform its tasks. Procedures have to be in place to make sure that the personnel performs adequately and is competent to carry out its tasks. Also, adequate arrangements to ensure the confidentialityoftheinformationobtainedfromconformityassessmentbodieshavetobeinplaceandtheaccreditationbodyisobliged not to impose unnecessary burdens on its clients. Accreditation bodies must also have a complaint handling mechanism in place.

Furthermore,theRegulationstatesthatthenationalaccreditationbodyhastohavesufficientresourcestofulfilitstasks;thisincludesontheonehandasufficientnumberofcompetentpersonnel,butalsospecialtaskssuchasactivitiesforEuropeanandinternationalaccreditationcooperationandactivitiesthatarerequiredinsupportofpublicpolicyandwhicharenotself-financing.In this respect adequate participation in EA, its committees and the peer evaluation process are of foremost importance. Member States should facilitate the participation of their national accreditation bodies in this kind of activities.

221 NANDO website: http://ec.europa.eu/enterprise/newapproach/nando/ as well as EA website: http://www.european-accreditation.org/ 222 Article R14(2) of Annex I of Decision No 768/2008/EC

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In this vein, national accreditation bodies are also obliged to publish their annual audited accounts. The intentions of this provisiongobeyonddemonstratingsoundfinancialmanagement,forthepurposesofpeerevaluation.Nationalaccreditationbodiesmustthereforeclearlydemonstratethattheguidingprinciplesofnon-commercialityandsufficientresourcesforensuringits competence in all activities are respected. Bearing in mind the overall objective of the Regulation of establishing accreditation as the last level of control in the conformity assessment system, in those cases where the accreditation body is part of a larger structure, this requirement should thus be understood to be a tool to demonstrate compliance with these principles, rather than being used to create unnecessary bureaucratic burdens for Member States. Thus the accreditation bodies situated in ministerial departmentsmustbeinapositiontopresentatleasttheiroverallbudgetaryandfinancialfigurescoveringoverallresourcesandtheirglobalandoperationalexpenses;togetherwithanyfinancialpoliciesthatapplytotheminordertobeabletodemonstratethattheyhavesufficientresourcestoperformtheirtasksadequatelywhilesafeguardingtheprincipleofnon-commerciality.

Member States have the responsibility to ensure that their national accreditation bodies meet the requirements foreseen by the Regulation on an on-going basis and to take corrective action if this should not be the case. For this reason they are to take the utmost account of the results of the peer evaluation organised by the European accreditation infrastructure.

6.4.2. NON-COMPETITION AND NON-COMMERCIALITY OF NATIONAL ACCREDITATION BODIES

The Regulation’s aim of setting up a coherent framework for accreditation that establishes accreditation as the last level of control is underpinned by the principles of non-commerciality and non-competition.

Forthisreason,whileaccreditationissupposedtobeaself-supportingactivity, it istobeprovidedonanot-for-profitbasis.Thismeansthatnationalaccreditationbodiesdonothavetheobjectiveofmaximisinggainsordistributingprofits.Theymayprovide their services in return for payments or receive income, but any excess revenue is to be invested in further developing their accreditation activities as long as these correspond to the overall tasks of the accreditation bodies. The primary objective ofaccreditationremainsnottoproduceanygainbuttofulfilataskinthepublicinterest.

Following the same logic, accreditation is to be established as a clearly distinct activity from any conformity assessment activities. Anationalaccreditationbodyisthereforenotallowedtoofferorprovideanyactivitiesorservicesthataconformityassessmentbodyoffersorprovides.Neithermayitprovideconsultancyservices,ownsharesinorotherwisehaveafinancialinterestinaconformityassessmentbodyorcompetewithconformityassessmentbodies,soastoavoidanykindofconflictofinterest.

Furthermore, to safeguard the principle of non-commerciality the Regulation also foresees that accreditation bodies are not allowed to compete with other accreditation bodies. Within the EU, they are only to be active on the territory of their own Member State.Onlyinexceptionalcases,specifiedinArticle7.1oftheRegulation(EC)765/2008iscross-borderaccreditationforeseen.Unless these conditions are met, conformity assessment bodies have to seek accreditation with the national accreditation body of the Member State they are established in. This applies for all conformity assessment activities that take place in Europe and concern products or services that are to be placed on the market223.

6.5. THE EUROPEAN ACCREDITATION INFRASTRUCTURE

• The European Cooperation for Accreditation (EA) is the organisation of European national accreditation bodies.

• EA is central to the implementation of the Regulation (EC) 765/2008 and one of its most important tasks is the organisation of the peer evaluation system of national accreditation bodies.

• EA’s tasks may also include the development or the recognition of sector schemes.

The Regulation provides for the recognition of a European accreditation infrastructure. For the time being, this is the European Cooperation for Accreditation (EA), the regional organisation of European national accreditation bodies. EA is central to the implementation of the Regulation and through the peer evaluation system is the body that has the closest oversight of the practical functioning of accreditation in Europe. The Commission and EA have concluded a framework partnership agreement on the basis of which EA carries out its tasks. One of EA’s primary tasks is to operate a peer evaluation of national accreditation bodies, in line with international standards and practice, but it also contributes to the wider development, maintenance and implementation of accreditation in the EU.

223 See point 6.6 on cross-border accreditation.

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6.5.1. SECTORAL ACCREDITATION SCHEMES

At the request of the Commission, EA’s tasks may include the development or the recognition of sector schemes. Asectorschemeisanaccreditationconformityassessmentschemethatisbasedonarelevantstandardforaspecificproduct,process,serviceetc.andadditionalrequirementsthatarespecifictotherelevantsectorand/orspecificlegislation.Accreditationmay be called upon to assess the competence of conformity assessment bodies to carry out assessments with regard to such schemes.

EA may contribute to the development of sector schemes and their corresponding evaluation criteria and peer evaluation procedures. EA may also recognise already existing schemes that lay down their evaluation criteria and peer evaluation procedures.

In the case of sector schemes that are linked to EU legislation, the Commission has to ensure that the proposed scheme meets thenecessaryrequirementsofthelegislationinquestionintermsofthepublicinterestexpressedbythisspecificlegislation.

Itneedstobenoted,however,thatsectorschemesareonlynecessaryorevendesirableinveryspecificcases.Accreditationisalwaysgearedtowardsanactivityinaspecificandwell-definedfieldevenifitisperformedonthebasisofageneralconformityassessment body standard and peer evaluation is performed on the basis of this standard. Sector schemes should therefore ratherbeconsideredanexceptionthantherule.Whenintroducingsuchspecificschemesacarefulanalysisshouldthereforebeconductedwhethertherelevantrequirementswarrantaspecificschemeorwhethertheycanbemetwithoutone.

An uncontrolled proliferation of accreditation schemes could lead to a fragmentation of accreditation, render peer evaluation impossible to perform and thus not only blur the line between conformity assessment and accreditation, but also ultimately jeopardisetheprincipleofmutualrecognitionofcertificatesandtestreports.

6.5.2. PEER EVALUATION

One of the most important tasks of EA is the organisation of the peer evaluation system of national accreditation bodies, which is the cornerstone of the European accreditation system.

National accreditation bodies undergo peer evaluations of their systems, procedures and structures at a maximum of four year intervals. The aim of the peer evaluation system is to ensure consistency and equivalence of accreditation practices across Europe so that the wider market place, including the national public authorities224, mutually recognise the services delivered by those bodies that have successfully passed the peer evaluation, and therefore accept the accreditation certificates andthe attestations issued by the conformity assessment bodies accredited by them. EA provides an appropriate training system to ensure the coherence of peer evaluation activities and results across Europe. Successful peer evaluation allows a national accreditation body to sign the EA Multilateral Agreement, or to maintain signature status. Under the EA Multilateral Agreement, all signatories are obliged to recognise the equivalence of each other’s accreditation systems and the equal reliability of the attestations issued by the conformity assessment bodies accredited by them.

The peer evaluation system is operated at several levels. First of all national accreditation bodies have to meet the requirements of the harmonised standard EN ISO/IEC 17011 “Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies” and the requirements of the Regulation which are not contained in the international accreditation body standard – these are namely the principles of one national accreditation body acting as public authority, non-commerciality and non-competition.

Accreditationbodiesthenhavetodemonstratethattheyarecapableandcompetenttocarryoutaccreditationinthedifferentfieldsof conformityassessment servicedby them. Theseactivitiesare themselvesdeterminedbyanumberofharmonisedstandards (such as EN ISO/IEC 17025 for testing and calibration laboratories, EN ISO/IEC 17020 for inspection bodies or EN ISO/IEC 17065 for bodies certifying products, services and processes). In addition, peer evaluators have to make sure that the accreditationbodytakesintoaccountanyotherrequirementsinitsassessments,whicharerelevantforthespecificconformityassessmentactivitiestobecarriedoutbythebodieswhichtheyaccredit.Thesemaybethespecificrequirementscontainedinconformity assessment schemes, including European and national schemes, as well as European and international standards where the harmonisation process has not yet been completed.

6.5.3. PRESUMPTION OF CONFORMITY FOR NATIONAL ACCREDITATION BODIES

If a national accreditation body can demonstrate as a result of the peer evaluation process that it meets the requirements of the relevant harmonised standard225, it is presumed to meet the requirements for national accreditation bodies that are outlined in Article 8 of the Regulation.

224 Article 11 (2) of Regulation (EC) No 765/2008225 SO/IEC 17 011

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Moreimportantly-andthisisofspecificimportancefortheregulatorysphere–ifanationalaccreditationbodyhassuccessfullyundergonepeerevaluationforaspecificconformityassessmentactivity,nationalauthoritiesareobligedtoaccepttheaccreditationcertificates issuedbythisbody,aswellasanyattestations (e.g. testor inspectionreports,certificates) issuedbyconformityassessment bodies accredited by this accreditation body.

6.5.4. EA’S ROLE IN SUPPORTING AND HARMONISING ACCREDITATION PRACTICE ACROSS EUROPE

Following on from EA’s role as the organisation that is in charge of the peer evaluation of national accreditation bodies there is a need to arrive at a coherent and equivalent approach to accreditation which then warrants the mutual recognition and acceptance of conformity assessment attestations. This means that EA has to facilitate a common approach to accreditation practice and towards the harmonised standards and the requirements that may be contained in any sector schemes. Therefore, with the involvement of all parties concerned such as stakeholders and national authorities, EA has to develop transparent guidance that its members have to respect when conducting accreditation.

6.6. CROSS-BORDER ACCREDITATION

The possibility of a conformity assessment body to request accreditation with a national accreditation body in another Member State is only allowed in a limited number of cases.

According toArticle7(1)ofRegulation (EC)No765/2008, conformityassessmentbodies,whether third-partyorfirst-party/in-house, are required when requesting accreditation to do so with the national accreditation body of the Member State in which they are established. This general rule allows for exceptions: the possibility of a conformity assessment body to request accreditation with a national accreditation body in another Member State is limited to cases where

• there is no national accreditation body in its own Member State and no other national accreditation body to which recourse is had [Article 7(1)(a)],

• thenationalaccreditationbodydoesnotoffertherequestedaccreditationservice[Article7(1)(b)]• the national accreditation body has not received a positive outcome in the peer evaluation in relation to the conformity

assessment activity for which accreditation is requested i.e. the national accreditation body is not a signatory to the EA Multilateral Agreement for the accreditation of the conformity assessment activity concerned [Article 7(1)(c)].

Article 7(1) of the Regulation is closely linked to and is a logical consequence of the non-competition principle.

The cross-border provision laid down in Article 7 is perceived to be very stringent and unnecessarily burdensome for multi-nationallyactiveconformityassessmentbodieshavingtheirheadofficeinoneMemberStatewithlocalentities/sitesestablishedinotherMemberStatesandworkingunderthesupervisionoftheheadofficeandunderthesamequalitysystemandmanagement,as implying costlyduplicationsofassessments. The riskof sufferinga competitivedisadvantagecompared to third-countryorganisations is feared. In case of a strict legal interpretation of Article 7, due to their structures, multinational conformity assessmentbodiesmaynotbenefitfromtheadvantageofoneaccreditationcertificatesufficientforthewholeterritoryoftheEU, although avoiding multiple accreditations is one of the objectives of the Regulation.

The duplication of unnecessary assessments and burdens on multinational conformity assessment bodies should be avoided while ensuring adequate control of local entities of conformity assessment bodies. There has to be an exchange of information andeffectivecooperationbetweennationalaccreditationbodiesforassessment,re-assessmentandsurveillanceoflocalsitesofmultinational conformity assessment bodies where necessary. Based on mutual recognition of all assessments carried out by EA members, any duplication of assessments of organisational aspects or requirements should be strictly avoided.

If necessary and on reasoned request, relevant information on carrying out accreditation against national legislative requirements of another Member State and/or requirements set out in relevant national sectoral schemes are to be provided by the local national accreditation body to the national authorities of the other Member State. National authorities of the Member States in which the local national accreditation body is established should be kept informed thereof.

The conformity assessment bodies with local sites (regardless of their legal personality), provided that the latter operate under thesameglobalqualitysystemandmanagementandthattheheadofficehasthemeanstosubstantiallyinfluenceandcontroltheir activities, can be considered as being only one organisation with regard to the conformity assessment activity carried out. Such a conformity assessment body is therefore allowed to request accreditation with the national accreditation body of the headofficewhosescopecanalsocovertheactivitiesperformedbythelocalsite,includingthoselocatedinanotherMemberState.

The multi-site accreditation is however only permitted under the Regulation if the accredited conformity assessment body maintainsthefinalresponsibilityfortheactivitiesperformedbylocalsitescoveredbythescopeofthemulti-siteaccreditation.Theaccreditationcertificate issuedby thenationalaccreditationbodywhere theheadoffice isestablishednamesone legal

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entity- theheadoffice-and it is this legalentitywhichholdstheaccreditationandwhich is responsiblefortheaccreditedactivities of the conformity assessment body, including any activity performed by the local site that forms part of the scope of theaccreditation.Wheretheselocalsitescarryoutkeyactivities(aslistedinENISO/IEC17011),thentheaccreditationcertificate(initsannexes)hastoclearlyidentifytheaddressofthesesiteoffices.

Thelocalsiteisentitledtoofferdirectlytothelocalmarketconformityattestationsunderthemultisiteaccreditation,butonlyonbehalfoftheaccreditedconformityassessmentbody.Theseaccreditedcertificatesandreportsarethereforeissuedundertheaccreditation,nameandaddressoftheheadofficewithoutthelogoofthelocalsite.Howeverthisdoesnotimpedementioningontheconformityassessmentcertificateorreportthecontactdetailsofthelocalsiteissuingthecertificateorreportinquestion.

Themulti-site accreditation is meant for use only by companies within the same organisation and where the head officemaintainstheresponsibilityfortheactivitiesperformedandcertificates/reportsissuedbythelocalsites.Theresponsibilityhastobedemonstratedonthebasisofcontractualorequivalentlegalrelationshipsbetweentheheadofficeandthelocalentityandinternal regulations that further specify these relationships in terms of management and responsibilities.

Thesolutionofthemulti-siteaccreditationcanbeappliedtoalltypesoflocalentities(subsidiaries,branches,agencies,officesetc.), regardless of their legal personality and is in principle valid for all types of conformity assessment bodies, including laboratories,inspectionandcertificationbodiesaslongastheycarryoutclearlyidentifiedandrelevantactivitiesforthepurposeof accreditation.

Themulti-site accreditation solution is excludedwhen the abovementioned conditions are not fulfilled, i.e. the conformityassessmentbodycannotbeconsideredasoneorganisationwithregardtoconformityassessmentandtheheadofficedoesnotmaintain the ultimate responsibility for the activities of the local entities. In this case the local sites being separate legal entities should apply for their own accreditation with the local national accreditation body. As a consequence it can be considered that thelocalentitycarriesouttheconformityassessmentservicecompletelyindependentlyoftheheadoffice.

In case of the multi-site accreditation, initial assessment and reassessments must be carried out in close cooperation between therespectivelocalnationalaccreditationbodyandthenationalaccreditationbodyoftheheadofficetakingtheaccreditationdecision, while surveillance must be carried out in cooperation with or by the local national accreditation body. The multinational conformity assessment body must fully cooperate with the national accreditation bodies involved. Local entities cannot reject the participation of the local national accreditation body in the assessment, reassessments and surveillance process. Harmonised rules for co-operation between national accreditation bodies exist in the form of the EA cross frontier policy. Multi-site accreditation has to be managed under the EA cross frontier policy in order to guarantee the involvement of the local national accreditation body.

The multi-site accreditation does not supersede sub-contracting, which remains a viable solution in case a conformity assessment body may wish to sub-contract part of its activities to legal entities located and operating in the same or other Member States, which however do not belong to the same organisation, i.e. are not part of a multinational conformity assessment body. In this case, the subcontractor is not covered by the accreditation of the conformity assessment body. The accredited conformity assessmentbodymaysubcontractspecificpartsofitsconformityassessmentactivitiestoadifferentlegalentityaccordingtothe applicable conformity assessment body standard to which it is accredited and only to the extent allowed in this standard. The conformity assessment body must be able to demonstrate to the national accreditation body that the subcontracted activities are carried out in a competent and reliable manner consistent with the applicable requirements for the activities in question. The accredited conformity assessment attestation must be issued exclusively under the name and responsibility of the accredited conformity assessment body, i.e. the legal entity holding the accreditation. The contractual relationship with the client remains with the accredited conformity assessment body.

6.7. ACCREDITATION IN THE INTERNATIONAL CONTEXT

At international level, cooperation between accreditation bodies takes place within the International Accreditation Forum (IAF) and within the International Laboratory Accreditation Cooperation (ILAC).

6.7.1. COOPERATION BETWEEN ACCREDITATION BODIES

Accreditation as an impartial means of assessing and conveying formal demonstration of the technical competence, impartiality andprofessionalintegrityofconformityassessmentbodiesisaneffectivequalityinfrastructuretoolusedworldwide.

At international level, cooperation between accreditation bodies takes place within two organisations: namely within the International AccreditationForum(IAF)betweenaccreditationbodiesaccreditingcertification(productsandmanagementsystems)bodiesandwithin the International Laboratory Accreditation Cooperation (ILAC) between accreditation bodies accrediting laboratories and inspection bodies. Both organisations provide for multilateral mutual recognition arrangements between its accreditation body members. IAF manages a Multilateral Recognition Arrangement (MLA), while ILAC operates a Mutual Recognition Arrangement (MRA). These multilateral mutual recognition arrangements/agreements of competence at technical level between accreditation

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bodies have the ultimate aim to allow products and services accompanied by accredited conformity attestations to enter foreign marketswithouttheneedforre-testingorre-certificationintheimportcountry.Theobjectiveofsuchrecognitionarrangement/agreements between accreditation bodies is therefore to contribute to reinforce the acceptance of conformity assessment results.

At the regional level, to date226, cooperation organisations between accreditation bodies have been established in:

• Europe: European co-operation for accreditation (EA)• America: Inter America Accreditation Cooperation (IAAC)• Asia–Pacific:AsiaPacificLaboratoryAccreditationCooperation(APLAC)andPacificAccreditationCooperation(PAC)• Africa: Southern African Development Community Accreditation (SADCA)• Africa: African Accreditation Cooperation (AFRAC)• Middle East: Arab Accreditation Cooperation (ARCA)

Except for SADCA which is currently developing its regional mutual recognition arrangement, the above listed cooperation organisations have agreements/arrangements in place within their region which the ILAC/IAF arrangements build upon. By granting special recognition IAF accepts the mutual recognition arrangements established within EA, IAAC and PAC: accreditation bodies being member of IAF and signatories to the EA Multilateral agreement (EA MLA) or the PAC Multilateral Recognition Arrangement (PAC MLA) are automatically accepted into the IAF MLA. ILAC accepts the mutual recognition arrangements and underlyingevaluationproceduresofEA,APLAC,andIAAC.Accreditationbodieswhicharenotaffiliatedtoanyrecognisedregionalcooperation entity may apply directly to ILAC and/or IAF for evaluation and recognition.

The requirements which the Regulation sets for accreditation bodies are in line with the globally accepted requirements laid down in the relevant international standards, although some of them can be perceived as being more rigorous. In particular

‣AccreditationiscarriedoutbyonesinglenationalaccreditationbodyappointedbyitsMemberState(Art4.1)‣Accreditationisperformedasapublicauthorityactivity(Art4.5)‣Nationalaccreditationbodiesoperatesfreefromcommercialmotivations(Art8.1)andonanot-for-profitbasis(Art4.7)‣Nationalaccreditationbodiesdonotcompetewithconformityassessmentbodiesoramongeachother(Art6.1andArt6.2)‣Cross-borderaccreditationArt.7(withintheEUandEEA)

6.7.2. THE IMPACT ON TRADE RELATIONS IN THE FIELD OF CONFORMITY ASSESSMENT BETWEEN THE EU AND THIRD COUNTRIES

The ultimate acceptance of conformity assessment attestations is decided by the public authorities in the regulatory sphere and, from an economic point of view, by industry users and consumers. The voluntary multilateral mutual recognition agreements between accreditation bodies taking place at technical level support, further develop and enhance intergovernmental trade agreements.

Therequirementssetoutaboveaffecttheacceptanceofnon-Europeancertificatesandtestresultsaccreditedbynon-Europeanaccreditation bodies not complying with EU requirements but signatories to the ILAC/IAF MRA/MLA in the following way:

• Conformity assessment delivered in the voluntary sphere It is up to the non-European conformity assessment body operating on the European market to decide if and where to get accredited. In order to boost the acceptance of its conformity assessment attestations by the European market (industry as purchasers of conformity assessment services and ultimately consumers) the non-European conformity assessment body opting for accreditation may choose whether to resort to the service of a third country accreditation body not necessarily conforming to the new European requirements but signatory to the ILAC/IAF MRA/MLA or rather to that of an Accreditation body established in the Union. Non-European Conformity assessment attestations issued under accreditation by non-EuropeanAccreditationbodiesnotfulfillingEuropeanrequirementscancontinuetobeusedontheEuropeanMarketbutonlyin the voluntary sphere.

• Conformity assessment delivered in the mandatory sphereWhere conformity assessment is required in regulations, national authorities of EU Member States may refuse to accept attestations of conformity issued under accreditation by non-European accreditation bodies not complying with the EU requirements even though they may be signatories to the ILAC/IAF MRA/MLA. However this refusal cannot be based on the soleargumentofthenon-fulfilmentoftheEUrequirementsbythethirdcountryaccreditationbody.TheconformancetotheEU requirements by the third country accreditation body is not a condition for acceptance of conformity assessment results, but such non-conformance could reinforce doubt as to the quality and value of the accreditation and therefore as to the qualityandvalueoftheaccreditedcertificatesorreports.

226 For latest information refer to www.ilac.org and www.iaf.nu where listings of current regional members of ILAC and IAF are available

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However, where government-to-government Mutual recognition agreements (MRAs) between the Union and a third country in relation to conformity assessment are in place, national authorities of EU Member States will accept the test reports and certificatesissuedbybodiesthattheforeignpartyhasdesignatedundertheMRAforassessingconformityinthecategoriesofproducts or sectors covered by the MRA. The products accompanied by such conformity attestations can be exported and placed on the other party’s market without undergoing additional conformity assessment procedures. Each importing party agrees, by the terms of the MRA, to recognise the conformity assessment attestations issued by agreed conformity assessment bodies of the exporting party, independently of whether accreditation has been used to back up the designation process of the conformity assessment bodies under the MRA or not, and independently of, in case accreditation is used by the non-European Party, the fulfilmentbythethirdPartyaccreditationbodyoftheEUrequirements.

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7. MARKET SURVEILLANCEUnder Regulation (EC) No 765/2008 national market surveillance authorities have clear obligations to proactively control products placed on the market, to organise themselves and ensure coordination between themselves at the national level and to cooperate at the EU level227. Economic operators have the clear obligation to cooperate with the national market surveillance authorities and to take corrective action where necessary. National market surveillance authorities have the authority to take sanctions which can include the destruction of products.

Regulation (EC) No 765/2008 integrates the provisions of Regulation 339/93 on control of products from third countries. Such controls are now part and parcel of market surveillance activities and Regulation (EC) No 765/2008 obliges national market surveillance and customs authorities to cooperate in order to ensure a seamless system. Such controls must be carried out in a non-discriminatory manner in line with the WTO rules and under the same rules and conditions as set out for internal market surveillance controls.

The European Commission has the responsibility to facilitate the exchange of information between national authorities (in relation to their national market surveillance programmes, their risk assessment methodologies, etc.) in order to ensure that marketsurveillanceiseffectivelyEU-wideandthatMemberStatescanpooltogethertheirmeans.

7.1. WHY DO WE NEED MARKET SURVEILLANCE?

Member States have to take appropriate measures to prevent the placing on the market and use228 of non-compliant products. Marketsurveillanceaimsatensuringthatproductsfulfill theapplicable requirementsprovidingahigh levelofprotectionofpublic interests such as health and safety in general, health and safety in the workplace, protection of consumers, protection of the environment and security while ensuring that the free movement of products is not restricted to any extent greater than that which is allowed under Union harmonisation legislation or any other relevant Union rule. Market surveillance entitles citizens to an equivalent level of protection throughout the single market, regardless of the origin of the product. Further, market surveillance is important for the interest of economic operators, because it helps to eliminate unfair competition.

Market surveillance activities are not directed exclusively towards the protection of health and safety but are additionally undertaken with the aim of enforcing Union legislation which seeks also to safeguard other public interests, for example by meansofregulatingtheaccuracyofmeasurement,electromagneticcompatibility,energyefficiency,consumerandenvironmentprotection, following the principle of “high level of protection” as laid down in Article 114 (3) TFEU.

MemberStatesmustensureeffectivesurveillanceoftheirmarket.Theyarerequiredtoorganiseandcarryoutthemonitoringofthe products placed on the market or imported. Member States have to take appropriate measures to ensure that the provisions of Regulation (EC) No 765/2008, of Directive 2001/95/EC and of the other Union harmonisation legislation, as well as non-harmonised, national legislation, in force are respected in the EU and, in particular, to prevent the placing on the market and use of non-compliant and/or unsafe products.

Market surveillance should enable unsafe products or products which otherwise do not conform to applicable requirements setoutinUnionharmonisationlegislationtobeidentifiedandkeptortakenoffthemarketandunscrupulousorevencriminaloperators punished. It should also act as a powerful deterrent229. For that purpose Member States must:

• correctly implement the provisions of the relevant legislation and allow for sanctions proportional to any infringements;

• survey the products (whatever their origin) introduced on their market in order to ensure that they have been subjected to the necessary procedures, that the marking and documentation requirements have been respected and that they have been designed and manufactured in accordance with the Union harmonisation legislation requirements.

In order to be effective, themarket surveillance effort should be uniform across the Union. This is all themore importantconsidering that each point of the Union’s external border constitutes an access point for a great quantity of products from third countries.Ifmarketsurveillanceis“softer”insomepartsoftheUnionthanothers,weakspotsarecreatedwhichthreatensthepublic interestandcreateunfairtradeconditions.Consequently,theremustbeeffectivemarketsurveillancealongtheentirelength of the Union’s external borders.

227 The General Product Safety Directive also contains requirements on market surveillance. The relationship between Regulation (EC) No 765/2008 and the General Product Safety Directive is described in detail in the Working Paper of 3 March 2010 available at: http://ec.europa.eu/consumers/safety/prod_legis/docs/20100324_guidance_gspd_reg_en.pdf 228 SubjecttospecificUnionharmonisationlegislation229 According to Article 16 of Regulation (EC) No 765/2008 “Market surveillance shall ensure that products covered by Union harmonisation legislation which, when used in accordance with their intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Union harmonisation legislation are withdrawn or their being made available on the market is prohibited or restricted and that the public, the Commission andtheotherMemberStatesareinformedaccordingly.MemberStatesshallensurethateffectivemeasurescanbetakeninrelationtoanyproduct category subject to Union harmonisation legislation”.

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In order to guarantee the necessary objectivity and impartiality, market surveillance must be undertaken by the authorities of the MemberStates.Certainchecks(e.g.tests,inspections)canbedelegatedtootherbodies,buttheofficialauthoritiesmustretainfull responsibility for the decisions taken following these checks. Controls carried out within the framework of market surveillance maybecarriedoutatdifferenttimesduringthelife-cycleofaproduct,followingitsplacingonthemarket,suchasdistribution,puttingintouseorfinaluse.Itcan,therefore,beexertedinvariouslocations,e.g.importersestablishments,wholesaleorretaildistributors, hire companies, users, etc.

7.2. MARKET SURVEILLANCE ACTIVITIES

• Market surveillance occurs at the post-marketing stage of the products.

• Market surveillance activities may be organised differently depending on the nature of the product and may range from control of formal requirements to profound laboratory examinations.

• All economic operators have a role and obligations in market surveillance.

Marketsurveillanceauthoritiesmonitorproductsaftertheyhavebeenplacedonthemarket.Thus,marketsurveillancedoesnotformally take place during the design and production stages, which is before the manufacturer has taken formal responsibility fortheconformityoftheproducts,usuallybyaffixingtheCEmarking.However,nothingpreventsmarketsurveillanceauthoritiesand economic operators to collaborate during the design and production phase. Such collaboration may help taking preventive actions and identifying as early as possible safety and conformity issues. When performing market surveillance, authorities shall check the compliance of the product with the legal requirements applicable at the moment of the placing of the market or, if relevant, putting into service.

Formarketsurveillancetobeefficient,resourcesshouldbeconcentratedwhererisksarelikelytobehigherornon-compliancemorefrequent,orwhereaparticularinterestcanbeidentified.Statisticsandriskassessmentprocedurescanbeusedforthispurpose. To be able to monitor products placed on the market, market surveillance authorities must have the power, competence and resources:

• to regularly visit commercial, industrial and storage premises;• to regularly visit, if appropriate, work places and other premises where products are put into service230;• to organise random and spot checks;• to take samples of products, and to subject them to examination and testing and• to require, upon reasoned request, all necessary information.

Otherexceptionstotheprinciplethatmarketsurveillancecanonlytakeplaceafterthemanufacturerhastakenformalresponsibilityfor the products are trade fairs, exhibitions and demonstrations. Most Union harmonisation legislation allows the showing and display of non- CE marked products at trade fairs, exhibitions and demonstrations, provided that a visible sign clearly indicates that the products may not be marketed or put into service until they have been made to comply, and that adequate measures are taken during demonstrations, where appropriate, to ensure the protection of public interests. Market surveillance authorities must monitor that this obligation is respected.

Thefirstlevelofcontrolisformalchecks,forexampleregardingtheCEmarkinganditsaffixing,theavailabilityoftheEUdeclarationof conformity, the information accompanying the product and the correct choice of conformity assessment procedures. More profound checks may be however necessary to verify the conformity of the product, for example regarding the correct application of the conformity assessment procedure, the compliance with the applicable essential requirements, and the contents of the EU declaration of conformity.

In practice, individual market surveillance activities can focus on certain aspects of the requirements. Besides market surveillance activitiesthathaveastheirexplicitaimtheverificationofproductsplacedonthemarket,otherpublicmechanismsexistthat,although not directly designed for that aim, can nevertheless have as a consequence the uncovering of non-compliance231. Labour inspectorates that check safety at the workplace, for example, can discover that the design or construction of a machine, or personal protective equipment bearing the CE marking, is not in conformity with the applicable requirement232.

Information on the compliance of a product at the moment when it was placed on the market can also be obtained during in-use inspections, or by analysing the factors that caused an accident. Complaints from consumers or other users about the product, or from manufacturers or distributors about unfair competition can also provide information for market surveillance purposes.

230 Thisisimportantforproducts(forexamplemachineryandpressureequipment)thataredirectly,afterbeingmanufactured,installedandputintoservice at the premises of the client.231 According to the Directive on high-speed rail systems, each Member State authorises the putting into service of the structural subsystems in their territory. This is a systematic mechanism to monitor the compliance of subsystems and their inter-operability constituents.232 Member States are obliged, according to the Directive on the introduction of measures to encourage improvements in the safety and health of workers at work (89/391/EEC), to ensure adequate controls and supervision.

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Monitoring of products placed on the market may be divided between several authorities on the national level, for example functionally or geographically. Where the same products are subject to control by more than one authority (for example customs and a sectoral authority, or local authorities), coordination between services within a Member State is necessary.

Voluntaryinitiatives,suchasproductcertificationorapplicationofaqualitymanagementsystem,cannotbeputonthesamefooting as market surveillance activities carried out by an authority. Still, they can contribute to the elimination of risks. However, market surveillance authorities must be impartial regarding all voluntary marks, labels and arrangements, and they may only be taken into consideration, in a transparent and non-discriminatory way, for the risk assessment. Accordingly, products should notbeexcludedfrommarketsurveillanceoperationseveniftheyhavebeensubjecttovoluntarycertificationorothervoluntaryinitiatives.

Unionharmonisationlegislationprovidesfortwodifferenttoolsthatenablemarketsurveillanceauthoritiestoreceiveinformationon the product: the EU declaration of conformity and the technical documentation. These must be made available by the manufacturer, the authorised representative established within the Union or under certain circumstances by the importer233. Other natural or legal persons, such as distributors, retailers, suppliers or subcontractors, cannot be obliged to make these available. However, they can assist the market surveillance authority in obtaining them. Further, the market surveillance authority mayrequestthenotifiedbodytoprovideinformationontheconductofconformityassessmentfortheproductinquestion..

The EU declaration of conformity must be made available for the market surveillance authority without delay upon reasoned234 request.ItshallaccompanytheproductwhererequiredsobyspecificUnionharmonisationlegislation.Itcanbemadeavailablefor surveillance purposes in each of the Member States, for instance, by means of administrative cooperation. A failure to present thedeclarationwhenrequestedbyanationalmarketsurveillanceauthoritymayconstitutesufficientgroundsfordoubtingtheconformity of the product with the essential requirements of the Union harmonisation legislation.

The technical documentation must be made available to the market surveillance authority within a reasonable period of time, in response to a reasoned request. The authority cannot request it systematically. In general, it can be requested only during randomchecksmadeformarketsurveillancepurposes,orwhentherearegroundsforaconcernthataproductdoesnotofferthelevel of protection required in all respects. Initially the market surveillance authority may be provided with only a summary of the technical documentation (the essential technical data), if it has been drawn up, with reasonable time allowed for transmission.

Moredetailed information (forexamplecertificatesanddecisionsfromthenotifiedbody)can,nevertheless,be requested incases of serious doubt about the conformity of the product to the applicable Union harmonisation legislation. The full technical documentation should be requested only where clearly necessary, and not, for example, when only a detail has to be checked. This request has to be evaluated in accordance with the principle of proportionality and, thus, taking into account the need to ensure the health and safety of persons or other public interests foreseen in the applicable Union harmonisation legislation, as well as to protect the economic operators from unnecessary burden. Further, failure to present the documentation in response toareasonedrequestbyanationalmarketsurveillanceauthority,withinanacceptabledelay,mayconstitutesufficientgroundsfor doubting the conformity of the product with the essential requirements of the applicable Union harmonisation legislation235.

Inthecaseofareasonedrequestitissufficientforthemanufacturertoprovidethepartofthetechnicaldocumentationrelatedto the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, the request for translation of technical documentation should be limited to these parts of the documentation. If themarketsurveillanceauthorityconsidersatranslationnecessary,itmustclearlydefinethepartofthedocumentationtobetranslated and allow reasonable time for this to take place. No further conditions may be imposed on the translation, such as a requirement of a translator accredited or recognised by the public authorities.

Nationalauthoritymightacceptalanguagetheyunderstandandwhichisdifferentfromthenationallanguage(s).Thelanguagechosen could be a third language, if accepted by that authority.

It must be possible to make the technical documentation available in the Union. However, it does not need to be kept inside the Union, unless otherwise provided for in the applicable Union harmonisation legislation. The requirement for making it available does not mean that the person who bears this responsibility must be in possession of it, as long as he is capable of stating where it can be found and of presenting it on request from the national authority. The name and address of the person in possession ofthedocumentationdoesnotneedtobeexpresslymentionedontheproductoronitspackaging,unlessotherwisespecified.Further, the technical documentation can be kept and sent to market surveillance authorities in paper or electronic form, which allows it to be made available within a period of time commensurate with the risk in question. Member States must ensure that everyone receiving information about the contents of the technical documentation during market surveillance activities is bound toconfidentialityaccordingtoprincipleslaiddowninthenationallegislation.

233 UnderDecisionNo768/2008/EC,moduleB,NotifiedBodiesarerequiredtoprovide,uponrequestfromMemberStates,EuropeanCommissionorother NotifiedBodiesacopyofthetechnicaldocumentation.234 The reasoned request does not necessarily mean a formal decision by an authority. According to Article 19 (1), paragraph 2 of Regulation (EU) No 765/2008, “market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities”.235 As essential technical data is to be considered, in particular: the name and address of the manufacturer; the list of harmonised standards followed or other solutions adopted to satisfy the essential requirements; a description of the product; the operating instructions, if any; and the overall plan of the product, if any. Examples of detailed technical information are test reports, quality manual information, quality control plans and other plans, descriptions of the products and processes and standards applied.

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7.3. MEMBER STATES RESPONSIBILITIES

• Market surveillance is organised at national level and Member States are the primary actors in that activity. Consequently, they are required to ensure an appropriate set of infrastructures for that purpose and prepare national market surveillance programmes.

• One major task for market surveillance authorities is to keep the public informed against potential risks.

• The Market surveillance process is subject to strict procedures.

• Non-compliant products are subject to corrective measures, bans withdrawals or recalls.

• The level of the sanctions is determined at national level.

7.3.1. NATIONAL INFRASTRUCTURES

Market surveillance is the responsibility of public authorities. This is, in particular, to guarantee the impartiality of market surveillance activities. Each Member State can decide upon the market surveillance infrastructure, for example there is no limitation on the allocation of responsibilities between authorities on a functional or geographical basis as long as surveillance isefficientandcoversthewholeterritory.MemberStatesorganiseandcarryoutmarketsurveillancethroughtheestablishmentof market surveillance authorities. Market surveillance authorities are the authorities of a Member State responsible for carrying out market surveillance on their territory. Surveillance of the market by public authorities is a fundamental element for the good implementation of Union harmonisation legislation.

Member States must ensure that the public is aware of the existence, responsibilities and identity of national market surveillance authorities, and of how those authorities may be contacted. They must also ensure that consumers and other interested parties are given an opportunity to submit complaints to the competent authorities on product safety and on surveillance and control activities and that these complaints are followed up appropriately.

Member States must entrust market surveillance authorities with the powers, resources and knowledge necessary for the proper performance of their tasks. This is to monitor products placed on the market and, in case of products presenting a risk or other form of non-compliance, to take appropriate action to remove the risk and enforce conformity. As regards personnel resources, theauthorityhastohave,orhaveaccessto,asufficientnumberofsuitablyqualifiedandexperiencedstaff,withthenecessaryprofessional integrity. The market surveillance authority should also be independent, and carry out its activities in an impartial and non-discriminatory way. Further, the market surveillance authority should carry out market surveillance respecting the principle of proportionality, for example action must be in accordance with the degree of risk or non-compliance and the impact on the free circulation of products may not be more than is necessary for achieving the objectives of market surveillance.

Market surveillance authorities should not only rely on their own risk assessment and conformity evaluation. They should also take into account the actions taken by the manufacturer in this respect. This includes manufacturer’s documents demonstrating product conformity (e.g. the technical documentation) as well as test reports or other documents obtained by the manufacturer from an external testing facility. The documentation provided by the manufacturer may include third party documents, if these exist.

The market surveillance authority may subcontract technical tasks (such as testing or inspection) to another body, provided that itretainstheresponsibilityforitsdecisions,andprovidedthereisnoconflictofinterestbetweentheotherbody’sconformityassessment activities and its surveillance tasks. In doing so the market surveillance authority should exercise great care to ensure that the impartiality of the advice it receives is beyond reproach. The responsibility for any decision to be taken on the basis of such advice should reside in the market surveillance authority.

7.3.2. NATIONAL MARKET SURVEILLANCE PROGRAMMES (NMSP)

National authorities are obliged by Article 18(5) of the Regulation (EC) No 765/2008 to establish, implement and periodically update and communicate their NMSP. Programmes may be general and/or sectoral. They should ensure that the overall EU market surveillance framework is respected. Member States must also communicate the programmes to other Member States and to theCommissionandmakethemaccessibletothepublicviainternet,withoutinformationthatcouldhampertheeffectivenessof the programme if made public. The purpose of these programmes is to allow the other countries’ authorities, as well as citizens in general, to understand how, when, where and in which areas market surveillance is carried out. National programmes then contain information on the general organisation of market surveillance at national level (e.g. mechanisms of coordination betweendifferentauthorities,resourcesattributedtothem,workingmethods,etc.)andonspecificareasof intervention(e.g.product categories, risk categories, types of users, etc.).

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The Commission helped Member States by proposing a common template to lay out their sector programmes. This now facilitates thecomparabilityofnationalinformationinspecificproductorlegislationareasandmakesitpossibleformarketsurveillanceauthorities to plan cross-border cooperation in areas of common interest.

When establishing national market surveillance programmes, market surveillance authorities should take the needs of customs into account. Programmes should take into consideration the balance between proactive and reactive control activities and any otherfactorswhichmayinfluenceenforcementpriorities.Resourcecapabilitiesmustbeensuredattheborderforthispurpose.

7.3.3. CONTROL OF PRODUCTS FROM THIRD COUNTRIES BY CUSTOMS: NATIONAL ORGANISATION AND COORDINATION

Points of entry to the EU are relevant to stop non-compliant and unsafe products coming in from third countries. Being the place where all products from third countries have to pass by, they are the ideal place to stop unsafe and non-compliant products before they are released for free circulation and subsequently circulate freely within the European Union. Thus, customs have an important role in supporting market surveillance authorities in carrying out product safety and compliance controls at the external borders.

Themosteffectivewaytoavoidtheplacingofnon-conformingorunsafeimportedfromthirdcountriesontheUnionmarketisto carry out adequate checks during the import control process. This requires involvement of customs and cooperation between customs and market surveillance authorities.

The authorities in charge of the control of products entering the Union market, customs or market surveillance authorities dependingonthenationalorganisationalstructure,areverywellplacedtocarryoutinitialchecks,atthefirstpointofentry,onthe safety and compliance of the imported products236. To ensure such controls, the authorities in charge of controls of products at the external borders need an appropriate technical support in order to carry out the checks on the characteristics of the products on an adequate scale. They can perform documentary, physical or laboratory checks. They also need appropriate human andfinancialresources.

Regulation (EC) No 765/2008 on checks for conformity with Union harmonisation legislation in the case of products imported from third countries requires the customs authorities to be closely involved in the market surveillance activities and information systems provided for under EU and national rules. Article 27 (2) of Regulation (EC) No 765/2008 foresees the obligation for co-operationbetweencustomsofficersandmarketsurveillanceofficers.ObligationsforcooperationarealsoincludedinArticle13ofthe Community Customs Code which establishes that controls performed with customs and other authorities are undertaken in close cooperation between each other. In addition, the principles of cooperation between the Member States and the Commission established in Article 24 of the Regulation are extended to authorities in charge of external controls, when relevant ( Article 27(5)).

Cooperation at national level should allow for a common approach taken by customs and market surveillance authorities during the control process. This should not be hampered by the fact that various ministries and authorities may be responsible for the implementation of Regulation (EC) No 765/2008.

Customs authorities have the following responsibilities under Regulation (EC) No 765/2008:

• to suspend the release of products when there is a suspicion that the products presents a serious risk to health, safety, environmentorotherpublicinterestand/ordonotfulfildocumentationandmarkingrequirementsand/ortheCE markinghasbeenaffixedinafalseormisleadingmanner(Article27(3))

• not to authorise the release for free circulation for the reasons mentioned in Article 29• to authorise the release for free circulation for any product in compliance with the relevant Union harmonisation legis-

lation and/or nor presenting risks to any public interest;• Where the release for free circulation has been suspended, customs have to immediately notify the competent na-

tional market surveillance authority which is given three working days to perform a preliminary investigation of the products and to decide:

• if they can be released since they do not present a serious risk to the health and safety or cannot be regarded as being in breach of Union harmonisation legislation

• if they must be detained since further checks are necessary to ascertain their safety and conformity. Customs authorities must notify their decisions to suspend release of a product to the market surveillance authorities, which in turn must be in a position to take appropriate action. Four hypotheses must be distinguished as from the moment of the notification.

236 ThereareSpecificguidelinesforimportcontrolsintheareaofproductsafetyandcomplianceavailableat: http://ec.europa.eu/taxation_customs/resources/documents/common/publications/info_docs/customs/product_safety/guidelines_en.pdf

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1. The products in question present a serious and immediate risk If the market surveillance authority ascertains that the products present a serious risk, it must prohibit their placing on the EU market. The market surveillance authorities have to request the customs authorities to mark the commercial invoice accompanying the product, and any other relevant accompanying document, with the words ‘Dangerous product — re-lease for free circulation not authorised — Regulation (EC) No 765/2008’237. Member State authorities may also decide to destroy the products or otherwise render them inoperable, where they deem it necessary and proportionate. The market surveillance authority must use in those cases the system for rapid exchange of information - RAPEX238. As a consequence, market surveillance authorities in all Member States are informed, and they may in turn inform the national customs authorities about products imported from third countries, which display characteristics giving rise to a serious doubt as to the existence of a serious and immediate risk. This information is of particular importance for customs author-ities where it involves measures banning or withdrawing from the market products imported from third countries.

2. The products in question do not comply with Union harmonisation In this case the market surveillance authorities must take appropriate measures, if necessary prohibiting the placing on the market under the rules in question. In cases where placing on the market is prohibited, they must ask the customs authorities to mark the commercial invoice accompanying the products, and any other relevant accompanying document, with ‘Product not in conformity — release for free circula-tion not authorised — Regulation (EC) No 765/2008’.

3. The products in question do not present a serious and immediate risk and cannot be considered as not conforming to the union harmonization legislation. In this case the products must be released for free circulation, provided that all the other conditions and formalities regarding release for free circulation are met.

4. Thecustomsauthoritieshavenotbeennotifiedofanyactiontakenbythemarketsurveillanceauthorities. If, within three working days of the suspension of release for free circulation, the market surveillance authority has not notifiedcustomsofanyactiontakenbythem,theproducthastobereleasedforfreecirculationprovidedthatalltheotherrequirementsandformalitiespertainingtosuchreleasehavebeenfulfilled.

The entire procedure from the suspension until the release for free circulation or the prohibition of the products by customs should be completed without delay to avoid creating barriers for legitimate trade but does not necessarily have to be completed within three working days. The suspension of release can remain valid for the time required by the market surveillance authority tocarryoutappropriatechecksontheproductsandallowthemtotakethefinaldecision.Marketsurveillanceauthoritiesmustensure that the free movement of products is not restricted to any extent greater than that which is allowed under Union harmonisation legislation or any other relevant EU legislation. To that end market surveillance authorities perform their activities regarding products originating from third countries - including the interaction with the relevant economic operators - with the same urgency and methodologies as for products originating from within the EU.

Inthiscase,themarketsurveillanceauthoritynotifiescustomswithinthesethreeworkingdaysthattheirfinaldecisiononthegoods is pending. The release for free circulation has to remain suspended until the market surveillance authority has made afinaldecision.Thatnotificationempowerscustoms toextend the initial suspensionperiod.Theproductswill remainundercustoms supervision even if they are allowed to be stored at another place approved by customs.

7.3.4. PUBLIC INFORMATION

Considering that the aim of market surveillance is to provide a high level of protection of certain public interests, informing the public is an essential element of market surveillance. Therefore, Member States should ensure openness to the public and to interested parties and should ensure public access to the information available to the authorities on product conformity. In accordance with the principle of transparency, information available to the authorities of the Member States or the Commission relating to risks to health and safety posed by products should in general be available to the public, without prejudice to the restrictions required for monitoring and investigation and prosecution activities.239

The public should be aware of the existence, responsibilities and identity of national market surveillance authorities, and of how those authorities may be contacted. Also national market surveillance programmes have to be made available to the public by way of electronic communication and, where appropriate, by other means.

Among the measures that market surveillance authorities have to take, is the obligation to alert users within their territories withinanadequatetimeframeofhazardstheyhaveidentifiedrelatingtoanyproductsoastoreducetheriskofinjuryorotherdamage when the economic operator responsible fails to do so.

237 If the products are declared for customs-approved treatment or use other than release for free circulation, and provided the market surveillance authorities have no objections, the same wording must be added, under the same conditions, to the documents relating to that treatment or use 238 For RAPEX, See Point 7.5.2.239 See General Product Safety Directive, whereas n. 24 and 35 and Article 16.

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7.3.5. MARKET SURVEILLANCE PROCEDURES (INCLUDING SAFEGUARD MECHANISMS)

Market surveillance is carried out through the implementation of a sequence of procedures whose aim is to ensure that an effectiveandconsistentsystemofmarketsurveillanceisestablishedacrosstheEU.Marketsurveillanceauthoritiesfollowtheseprocedures when dealing with products presenting a risk, according to Article 16(2) of Regulation (EC) No 765/2008 and in line with Articles R31 and R32 in Annex 1 of Decision No 768/2008/EC, and with products presenting a serious risk requiring rapid intervention, according to Articles 20 and 22 of Regulation (EC) No 765/2008.

An initial event suggesting to market surveillance authorities that a product presents a risk to the health or safety of persons or to other aspects of public interests may trigger the need for closer scrutiny of the product. It may be an accident, the reception of complaints,exofficioinitiativesofmarketsurveillanceauthorities(includingcustomauthorities’controlofproductsenteringtheEU)aswellasinformationfromeconomicoperatorsonproductspresentingarisk.Whentherearesufficientreasonstobelievethat a product presents a risk, market surveillance authorities carry out an evaluation of compliance with the requirements of the relevant Union harmonisation legislation. They have to perform appropriate checks (both documentary and physical/laboratory checks, as necessary) on the characteristics of the products, duly taking into account the reports and conformity assessment certificatesprovidedbytheeconomicoperators.

Market surveillance authorities carry out a risk assessment in order to verify if products present a serious risk. According to Article 20(2) of the Regulation an appropriate risk assessment “takes account of the nature of the hazard and the likelihood of its occurrence”.240 In case the risk is deemed to be “serious”, market surveillance authorities must adopt a rapid intervention followingthespecificprovisionsofArticles20and22oftheRegulation.

If a product is liable to compromise the health or safety of persons, market surveillance authorities must request without delay to relevant economic operators to:

a) take corrective action (to bring the product into compliance with the applicable requirements laid down in the Union harmonisation legislation) and/or;

b) withdraw the product and/or;

c) recall the product and/or;

d) stop or restrict supplying the product within a reasonable period.

The economic operators must ensure that the corrective action is taken throughout the EU. The market surveillance authorities mustalsoinformtherelevantnotifiedbody(ifany)onthedecisiontaken.Incaseofseriousriskrequiringarapidintervention,themarket surveillance authority may adopt restrictive measures without waiting for the economic operator to take corrective action to bring the product into compliance. According to Article 21 of the Regulation, the measures adopted by market surveillance authorities have to be proportionate and communicated to the relevant economic operator without delay. The market surveillance authorities must also consult the economic operator prior to the adoption of the measures and, if such consultation is not possible because of the urgency of the measures to be taken, the operator must be given the opportunity to be heard as soon as possible. The market surveillance authorities must withdraw or amend the measures taken if the economic operator demonstrates that hehastakeneffectiveaction.

When non-compliance is not limited to the national territory, market surveillance authorities must inform the Commission and the other Member States about the results of the compliance evaluation and about the actions required of the economic operator or the measures adopted. In case of serious risk, market surveillance authorities notify to the Commission through the RAPEX system of any voluntary or compulsory measure according to the procedure laid down in Article 22 of the Regulation and/or Article 12 of the GPSD. In the case of products that do not present a serious risk, the Commission and the other Member States will be informed by means of the information support system indicated in Article 23 of the Regulation and/or Article 11 of the GPSD. Market surveillance authorities have to verify that adequate corrective measures have been taken. Otherwise, they adopt appropriate provisional measures, informing the Commission and the other Member States with the procedures detailed above.

Inorder tobroaden theeffectivenessof themarketsurveillanceactivity launchedby thenotifyingMemberState, theotherMemberStatesarecalledupontofollowuponthenotificationbyverifyingwhetherthesameproducthasbeenmadeavailableon their territories and by adopting appropriate measures. They should inform the Commission and the other Member States accordingtotheproceduresoftheinitialnotification.

If the Commission and the other Member States do not raise any objection within a certain period, the restrictive measures are deemedjustifiedandmustbeadoptedwithoutdelaybytheMemberStates.Inthecaseofnon-complianceduetoshortcomingsinharmonised standards, the Commission informs the relevant standardisation bodies and brings the matter before the Committee set up under Article 22 of Regulation (EU) No 1025/2012. In light of the Committee’s opinion, the Commission can decide to:

240 SeetheRAPEXGuidelinesforamoreprecisedefinitionof“risk”and“seriousrisk”

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a) maintain the reference to harmonised standards in the OJEU; b) maintain with restrictions the reference to the harmonised standards in the OJEU; c) withdraw the reference to the harmonised standards in the OJEU. The Commission also informs the relevant European standardisation organisation and, if necessary, requests the revision of the harmonised standards concerned.

If objections are raised, the Commission opens a consultation with the Member States and the relevant economic operator in order to evaluate the national measures. In doing so, the Commission should review both the conformity evaluation and the risk assessment carried out by the market surveillance authority, also resorting to the advice of experts. At the end of the process theCommissionwillissueabindingdecision.Ifthemeasureisconsideredjustified,allMemberStateshavetocomplywiththedecision of the Commission. The objective of this procedure is to lead to the adoption of a common approach among market surveillanceauthoritiesacrosstheEUwhenthereisdisagreementonnotifiednationalmeasures.

If,onthecontrary,themeasureisconsideredunjustified,theMemberStateconcernedhastowithdrawthemeasure.

7.3.6. CORRECTIVE MEASURES – BANS – WITHDRAWALS-RECALLS

Competent national authorities must take action to enforce conformity, when they discover that a product is not in compliance with the provisions of the applicable Union harmonisation legislation.

The corrective action depends on the degree of non-compliance and, thus, must be in accordance with the principle of proportionality.However,thedifferencebetweenformalandsubstantialnon-complianceisnotalwaysclear,andmustbedecidedon a case by case basis.

Non-conformity to essential requirements must usually be considered as a substantial non-compliance, because this may, for instance, present a potential or actual risk to the health and safety of persons or to other aspects of public interest. However, non-conformitytoaharmonisedstandardisnot,assuch,sufficientevidenceofnon-conformitytoessentialrequirements,butmay indicate that further investigations may be necessary.

If a product covered by Union harmonisation legislation is not CE marked, it is an indication that the product does not comply with the essential requirements or the conformity assessment procedure has not been applied and, consequently, the product may, for instance, endanger the health and safety of persons. Such situation calls for further investigation. If, following this investigation, the product proves to be complaint with the essential safety requirements, the absence of the CE marking is to be considered as a formal non- compliance.

TheincorrectaffixingoftheCEmarkingasregards,forinstance,thedesign,size,visibility,indelibilityorlegibility,canusuallybeconsidered as a formal non-compliance. Examples of typically formal non-compliance could also be the situations where other conformitymarkingsprovidedforintheUnionharmonisationlegislationareincorrectlyaffixed,orwheretheEUdeclarationofconformity cannot be provided for immediately or it does not accompany the product when this is mandatory, or the requirement toaccompanyotherinformationprovidedforinsectoralUnionharmonisationlegislationiscompliedwithinsufficiently,or,whereapplicable,theidentificationnumberofthenotifiedbodyhasnotbeenaffixedtotheCEmarking.

Enforcement of conformity can be achieved by obliging the manufacturer, the authorised representative, or other responsible persons, to take required measures. Corrective action can also take place if the necessary measures are taken (for example the productismodifiedorwithdrawnfromthemarket),eitherasaresultofconsultationscarriedoutbythemarketsurveillanceauthority or as a result of formal or informal warnings. In all cases the market surveillance authority must establish accompanying measures to ensure that conformity is enforced. PROSAFE “Guidelines for Businesses to manage Product Recalls & Other Corrective Actions” have been designed to assist businesses to ensure, whenever necessary, the appropriate corrective actions and follow-up once a product has been already placed on the EU market or is coming from third countries.

Actionstoprohibitorrestricttheplacingonthemarketmayfirstbetemporarytoallowthemarketsurveillanceauthoritytoobtainsufficientevidenceaboutthedangerorothersubstantialnon-complianceoftheproduct.

In case of formal non-compliance themarket surveillance authority should first oblige themanufacturer, or the authorisedrepresentative, to make the product intended to be placed on the market and, if necessary, the product already on the market, comply with the provisions and to remedy the infringement. If no result can be achieved, the market surveillance authority has to, ultimately, take a further step to restrict or prohibit the placing on the market of the product and, if necessary, to ensure that it is also withdrawn from the market.

Any decision taken by national market surveillance authorities to restrict or prohibit the placing on the market or the putting into service, to withdraw or recall the products from the market must state the exact grounds on which it is based. The party concerned–inparticular,themanufacturer,ortheauthorisedrepresentativeestablishedintheUnion–mustbenotified.Theymust also be informed about remedies available under the national law in force in the Member State in question, and of the time limits to which such remedies are subjected.241

241 See Directives relating to simple pressure vessels, toys, machinery, personal protective equipment, non-automatic weighing instruments, active implantablemedicaldevices,gasappliances,potentiallyexplosiveatmospheres,medicaldevices,recreationalcraft,liftsrefrigerationappliances, pressure equipment, ecodesign requirements for energy-related products and in vitro diagnostic medical devices.

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Unless the matter is urgent (for example the product presents a serious risk to the health and safety of persons), the manufacturer, or the authorised representative established in the Union, should have an opportunity to be consulted in advance, before the competentauthoritytakesactiontorestrictthefreecirculationofproducts.Inpractice,itshouldbeconsideredassufficientwhenthe manufacturer or the authorised representative has been provided with an opportunity to react. 242 However, it should not delay the proceedings, if the manufacturer or the authorised representative remains passive.

The decision to restrict the free movement of a CE marked product in case of substantial non-compliance usually invokes the safeguard clause procedure. This procedure is aimed to enable the Commission to keep an overview of such measures, toconsiderwhetherornottheyarejustifiedandtoensureallMemberStatestakesimilarmeasuresinrelationtothesameproducts.Amanufacturer,theauthorisedrepresentative,orothereconomicoperatormayconsiderhimselftohavesufferedaloss as a result of an inappropriate national measure that restricted the free movement of a product. In such a case he could be entitled to claim damages under the jurisdiction of the State which initiated the procedure and accordingly the Commission, at theendofasafeguardclauseprocedure,wherethenationalmeasureisconsideredasnon-justified.Thismayraisethequestionwhether or not a liability case for incorrect implementation of EU law could take place.

Additional information on compulsory restrictive measures can be found in Section 7.4.

7.3.7. SANCTIONS

Regulation (EC) No 765/2008 requires Member States to ensure the correct implementation of its provisions and to take appropriate action in the event of infringement. The Regulation requires penalties to be proportionate to the seriousness of the offenceandconstituteaneffectivedeterrentagainstabuses.

It is up to the Member States to lay down and implement the mechanism for enforcing the provisions of the Regulation in their territories.AccordingtoArticle41oftheRegulation,“thepenaltiesprovidedforshallbeeffective,proportionate,anddissuasiveand may be increased if the relevant economic operator has previously committed similar infringement”.

Sanctionsareimposedbymeansoffines,whosesumsvaryfromoneMemberStatetotheother.Theymayalsoincludecriminalsanctions for serious infringements.

Themostcommonlegalinstrumentsprovidingforsanctionsaregeneralproductsafetyactsand/orsectorspecificlegislation.However, in some Member States sanctions are provided in CE Marking acts, customs code or acts on conformity assessment system.

7.4. SAFEGUARD MECHANISMS FOR MEMBER STATES

• On one hand, the safeguard clause authorizes Member States to take restrictive measures in relation to products presenting a risk. On the other hand, it ensures that all national market surveillance authorities are informed about dangerous products, and, accordingly, having the necessary restrictions extended to all Member States.

• It is a mechanism allowing all interested parties to be kept informed about restrictive measures on the market.

7.4.1. OBJECTIVE AND PLACE OF SAFEGUARD MECHANISMS IN MARKET SURVEILLANCE PROCESS

The safeguard clause procedure, based on Article 114(10) TFEU and included in most sectoral Union harmonisation legislation, authorises Member States to take restrictive measures in relation to products presenting a risk and obliges them to notify those measures to the Commission and other Member States. The safeguard clause procedure is designed to provide a means to inform all national market surveillance authorities about dangerous products, and, accordingly, to have the necessary restrictions extended to all Member States, so as to ensure an equivalent level of protection throughout the EU. Furthermore, it allows the Commission to take a position on the national measures restricting the free movement of products with a view to ensuring the functioning of the internal market.

ItistobenotedthatthesafeguardprocedureisdistinctfromtheRAPEXprocedurebecauseoftheirdifferentobjectives,differentnotificationcriteriaanddifferentmethodsofapplication243. Nevertheless, in some cases it may be possible to communicate information on national measures only once for the purposes of the two procedures244.

242 An explicit provision to consult has been included in Article 21 of Regulation (EC) No 765/2008, as well as in the Directives relating to medical devices and in vitro diagnostic medical services.243 The safeguard clause procedures under the Union harmonisation legislation apply independently from RAPEX. Accordingly, RAPEX does not necessarily have to come into play before the safeguard clause procedure is applied. However, the safeguard clause procedure has to be applied, in addition to RAPEX, when a Member State takes a decision to permanently prohibit or restrict the free movement of harmonised products on the basis of a danger or other serious risk presented by the product.244 Formoreinformation,seePoint7.4.4.2onNotificationtotheCommission

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Where,havingperformedanevaluation,aMemberStatefindsthataproductisnon-compliantoraproductisincompliancebutpresents a risk to the health or safety of persons or to other aspects of public interest protection, it must require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, to withdraw the product from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

For the safeguard clause to be applicable, the non-conformity has to be established regarding a systematic failure in the design of a whole series of products manufactured, however limited the series. For an isolated error, limited to the territory of the Member State that has discovered the non-compliance, there is no need to invoke the safeguard clause, since there is no need to take action at EU level. In addition, the risk must be due to the product itself and not to its misuse.

Conformity can be enforced if the national authority requests the manufacturer or the authorised representative to take the necessarymeasures,oriftheproductismodifiedorvoluntarilywithdrawnfromthemarket.Unlessaformaldecisionistakenin these cases, to prohibit or restrict the placing on the market of the product or to have it withdrawn from the market, the safeguard clause procedure is not invoked. In case there is no compulsory measure; there is no need to invoke the safeguard clause.

However, if an economic operator does not take adequate corrective action within the period indicated by a market surveillance authority, the market surveillance authorities have to take all appropriate provisional measures to prohibit or restrict the product’s being made available on their national market, to withdraw the product from that market or to recall it.

7.4.2. THE APPLICATION OF SAFEGUARD MECHANISMS STEP BY STEP

7.4.2.1. Compulsory restrictive measure taken

The application of the safeguard clause requires that the competent national authority decides to restrict or forbid the placing on the market and, possibly, the putting into service of the product, or has it withdrawn from the market. The contents of the decisionshouldrelatetoallproductsbelongingtothesamebatchorseries.Itmustalsohavebindinglegaleffect:itisfollowedbysanctions, if not respected, and can be subject to an appeals procedure. Court decisions, which restrict the free movement of CE marked product within the scope of the relevant Union harmonisation legislation, do not invoke the safeguard clause. However, whereadministrativeproceedingsinitiatedbythesurveillanceauthoritymustbe,accordingtothenationallaw,confirmedbyacourt, such court decisions are not excluded from the safeguard clause procedure.

Thefindingsthatjustifythenationalmeasureareestablishedeitherbythemarketsurveillanceauthorityonitsowninitiativeorbased on information received from a third party (such as consumers, competitors, consumer organisations, labour inspectorates). Further,thenationalmeasuremustbebasedonevidence(forexampletestsorexaminations)thatconstitutessufficientproofof errors in the product design or the manufacture to indicate a foreseeable potential or actual danger or other substantial non-compliance, even when the products are correctly constructed, installed, maintained and used in accordance with their intended purpose or in a reasonably foreseeable way. There is a grey zone between correct and incorrect maintenance and use, and it can be considered that, to a certain extent, products should be safe, even if maintained and used for their intended purpose in an incorrect way that can reasonably be expected. In evaluating this, the data supplied by the manufacturer on the labelling, in the instructions, in the user’s manual or in promotion materials are to be taken into consideration.

Thereasonfortakingrestrictivemeasuresmayresult,forinstance,fromdifferencesorfailuresintheapplicationofessentialrequirements, incorrect application of harmonised standards or shortcomings in them. The surveillance authority can add or specify other motives (for example failure to comply with good engineering practice) when invoking the safeguard clause, provided that they are directly linked with these three reasons.

Where non-compliance with harmonised standards that give a presumption of conformity is established, the manufacturer, or the authorised representative, must be requested to provide evidence about compliance with essential requirements. The decision of the competent authority to take corrective action must always be based on an established non-compliance with the essential requirements.

The measures taken by authorities have to be proportionate with the seriousness of the risk and the non-compliance of the productandhavetobenotifiedtotheCommission.

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7.4.2.2. Notification to the Commission

As soon as a competent national authority restricts or forbids the free movement of a product in such way that the safeguard clause is invoked, the Member State must immediately notify245theCommissionindicatingthereasonsandjustificationforthedecision.

The information has to include all available details, in particular:

• name and address of the manufacturer, the authorised representative, and in addition – if necessary – the name and address of the importer or other person responsible for placing the product on the market;

• thedatanecessaryfortheidentificationoftheproductconcerned,theoriginandthesupplychainoftheproduct,

• the nature of the risk involved and the nature and duration of the national measures taken

• a reference to the Union harmonisation legislation, and in particular to the essential requirements, against which the non-compliance has been established;

• a comprehensive assessment and evidence to justify the measure (for example harmonised standards or other tech-nicalspecificationsusedbytheauthority,thetestreportsandidentificationofthetestinglaboratory).Inparticular,themarket surveillance authorities must indicate whether the non-compliance is due to either:

(a) failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection; or(b) shortcomings in the harmonised standards conferring a presumption of conformity.

• a copy of the declaration of conformity;

• the arguments put forward by the relevant economic operator;

• thenameandnumberofanynotifiedbodythatintervenedintheconformityassessmentprocedure,ifapplicable. 7.4.2.3. Management of the safeguard process by the Commission

Where objections are raised against a measure taken by a Member State246, or where the Commission considers a national measure to be contrary to Union harmonisation legislation, the Commission must without delay enter into consultation with the Member States and the relevant economic operator or operators and must evaluate the national measure. On the basis of the resultsofthisevaluation,theCommissiondecideswhetherthenationalmeasureisjustifiedornot.

The Commission addresses its decision to all Member States and immediately communicates it to them and the relevant economic operator or operators.

Ifthenationalmeasureisconsideredjustified,allMemberStatesmusttakethemeasuresnecessarytoensurethatthenon-compliant product is withdrawn from their market, and must inform the Commission accordingly. If the national measure is consideredunjustified,theMemberStateconcernedmustwithdrawthemeasure.

Wherethenationalmeasureisconsideredjustifiedandthenon-complianceoftheproductisattributedtoshortcomingsintheharmonised standards, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012 concerning the formal objection to harmonised standard.

245 Asfarasthetoyssectorisconcerned,inordertosimplifytheworkofthenationalauthoritiesandtofostertheefficiencyofthesafeguardprocedure, theCommissionacceptedthatinformationprovidedinnotificationsexchangedthroughtheGRASRAPEXITsystemunderArticle22ofthe Regulation (EC) No 765/2008 for products posing a serious risk and under Article 23 of the Regulation (EC) No 765/2008 for products posing a non-seriousriskservealsoforthepurposeofthesafeguardclauseprocedure.ThenotifyingMemberStateshallmentioninthenotificationthatthe information was submitted also for that purpose. Once this information is communicated to the Commission, RAPEX and safeguard clause procedure apply independently in line with their respective objectives. 246 Union harmonisation legislation aligned to Decision No 768/2008/EC provides for a safeguard procedure which applies only in the event of disagreement between Member States over measures taken by a Member State. The aim is to ensure that proportionate and appropriate measures were takenwhenanon-compliantproductispresentintheirterritoryandthatsimilarapproachesaretakeninthedifferentMemberStates. Whileinthepastanotificationofariskofaproductwasnotified,Commissionhadtoopenacaseandelaborateanopinion,now,thisburdenhas been removed and a safeguard case is only opened if a Member State or Commission objects to the measure taken by the notifying authority. WheretheMemberStatesandtheCommissionagreeastothejustificationofameasuretakenbyaMemberState,nofurtherinvolvementoftheCom mission is required, except where non-compliance can be attributed to shortcomings of a harmonised standard.

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Member States other than the Member State initiating the procedure must without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of theproductconcerned,and,intheeventofdisagreementwiththenotifiednationalmeasure,oftheirobjections.MemberStatesmust ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay.

Where, within a certain period of time of receipt of the information, no objection has been raised by either a Member State or the CommissioninrespectofaprovisionalmeasuretakenbyaMemberState,thatmeasureshouldbedeemedjustified.

Conversely,shouldtheCommissionseenojustificationforthenationalactionthatinvokedthesafeguardclause,itwillasktheMember State to withdraw its action and take immediate appropriate steps to re-establish the free movement of the products in question on its territory.

WhethertheactiontakenbytheMemberStateisconsideredjustifiedornot,ineithercase,theCommissionkeepstheMemberStates informed of the progress and the results of the procedure.

Once the decision is taken by the Commission, it can be legally challenged by Member States on the basis of Article 263 TFEU. The economic operator directly concerned by the Decision may also challenge it on the basis of article 263 TFEU.

If the initiatingMemberStatedoesnotwithdrawthemeasure incaseofnon-justification, in thiscase, theCommissionwillconsider initiating the infringement procedure provided for by Article 258 TFEU.

7.5. COOPERATION AND EXCHANGE OF INFORMATION BETWEEN THE MEMBER STATES AND THE EUROPEAN COMMISSION

7.5.1. COOPERATION AMONG MEMBER STATES

• The cooperation between national market surveillance authorities is indispensable for the success of the market surveillance policy of the Union as a whole.

• The cooperation of Member States is facilitated by the European Commission.

TheproperapplicationofUnionlawdependsonasmoothadministrativecooperationtoensureuniformandefficientenforce-ment of Union legislation in all Member States. The obligation to cooperate is in line with Article 20 of the Treaty on European Union(TEU)whichstatesthatMemberStatesmusttakeallappropriatemeasurestofulfiltheirobligations247, and with Article 24 of Regulation (EC) No 765/2008. Although technical harmonisation has created a single market, where products move over national borders, market surveillance is carried out on a national basis. Administrative cooperation mechanisms between nation-alsurveillanceauthorities,therefore,needtobedevelopedtoincreasetheefficiencyofsurveillance,tominimisetheeffectofdifferentsurveillancepracticesandtoreducetheoverlappingofnationalsurveillanceoperations.Cooperationbetweenmarketsurveillance authorities can also spread good surveillance practice and techniques across the Union, as it allows national author-ities to compare their methods with those of other authorities, for example in the framework of comparisons and joint surveys or study visits. In addition, cooperation can be useful for exchanging views and solving practical problems.Administrative cooperation calls for mutual trust and transparency between national surveillance authorities. Member States and the Commission need to be informed about the way enforcement of Union harmonisation legislation, in particular market surveillance of products is organised throughout the single market. This includes information about national authorities in charge ofmarket surveillance for thedifferent product sectors, andaboutnationalmarket surveillancemechanisms to clarifyhowmonitoring of products placed on the market takes place and what corrective actions and other activities the surveillance authority is entitled to use.

Transparencyisalsonecessaryregardingthenationalrulesonconfidentiality.Fortheachievementofeffectivemarketsurveillancein the Union, it is important that national surveillance authorities assist each other. On request, a national authority should make information available and provide other assistance. Without prior request, a national authority may consider sending to the other national authorities all relevant information concerning operations that constitute, or are likely to constitute, breaches of Union harmonisation legislation, which may have an impact on the territory of other Member States. In addition, the national authorities should communicate to the Commission any information they consider relevant, spontaneously or in response to a reasoned request from the Commission. The Commission may then communicate this information to the other national authorities when considered necessary.

247 An explicit obligation for administrative cooperation is laid down in the Directives relating to pressure equipment and in vitro diagnostic medical devices: Member States are required to take appropriate measures in order to encourage/ensure that the authorities responsible for implementing the Directive cooperate with each other, and provide each other (and the Commission) with information in order to assist the functioning of the Directive.

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Cooperation and mutual assistance are, in particular, necessary to ensure that action can be taken against all those who are responsible for a non-compliant product being placed on the market. In such cases the authority of the Member State, where the manufacturer, the authorised representative, or other responsible person is established, needs to be contacted. This is to obtain informationfromtheseeconomicoperators,forexampletorequiretheEUdeclarationofconformityorsomespecifieddetailsfrom the technical documentation, or to request information concerning the distribution chain. The Member State under whose jurisdictionthenotifiedbodyoperates(whereapplicable)needstobecontactedaswell.Whenanationalauthorityactsduetoinformation it has received from another national body, it should report back to this authority on the outcome of the action.

Moreover,marketsurveillancewouldbemoreefficient,attheUnionlevel, ifthenationalsurveillanceauthoritiescouldagreeonhowtoallocatetheirresourcesinsuchawaythatamaximumnumberofdifferentproducttypescouldbecoveredineachsector. To avoid duplication of product tests, or other investigations for market surveillance purposes, national authorities should exchange a summary report of these tests. This can be done by using the Information and Communication System for Market Surveillance ICSMS248. National surveillance authorities should also consider whether or not there is a special need to carry out technical analyses or laboratory tests when another surveillance authority has already done so, and the results are available to those authorities or may at their request be placed at their disposal249. It might also be useful to exchange results of periodic inspections on equipment in service, to the extent that they provide information on the compliance of products when they were placed on the market.

Informationexchangedbetweennationalsurveillanceauthoritieshastobecoveredbyprofessionalconfidentiality,accordingtothe principles of the national legal system in question, and it has to enjoy the protection extended to similar information under national law. Where a Member States has rules permitting free access by persons to information held by surveillance authorities, this fact must be revealed at the time of the request to another surveillance authority, or during the exchange of information if no such request occurs. If the sending authority indicates that the information involves matters of professional or commercial confidentiality,thereceivingauthorityshouldensurethatthiscanbeprovidedfor.Otherwisethesendingauthorityisentitledtowithhold the information. Coordination and exchange of information between national surveillance authorities need to be agreed by the parties involved and taking into account the needs of the sector concerned. The following principles could be taken into consideration, where appropriate:

• appointing a national communication point or correspondent for every sector, which would coordinate internally as appropriate;

• agreeing about the types of cases for which the communication of surveillance information would serve a useful purpose;

• developingacommonapproachtoissuessuchastheclassificationofrisksandhazardsandtheircoding;• identifying of the details which should be communicated in each case, including the request for further information;• accepting the obligation to respond to enquiries within a given time scale250;• transmitting information (requests and responses), as simply as possible, by e-mail, or through a telematic system

operated by the Commission or an external body, and by using standard multi-language forms;• taking advantage of up-to-date data recording techniques so that enquiries can be easily undertaken and• treatingtheinformationreceivedincompleteconfidence.

Cooperation between national administrations takes place in working groups set up under the Union harmonisation legislation. Discussions mainly focus on interpretation issues, but questions related to market surveillance and administrative cooperation are also dealt with. Administrative cooperation between national authorities carrying out market surveillance is taking place in the following sectors: measuring instruments and non – automatic weighing instruments (WELMEC), low voltage equipment (LVD ADCO), Eco-Design ADCO Group, electromagnetic compatibility (EMC administrative cooperation), machinery, medical devices (Vigilance Working Group and COEN – Compliance and Enforcement Group), PEMSAC (The Platform of European Market Surveillance Authorities for Cosmetics), Toy-ADCO (The Administrative Cooperation Group of toys), telecommunications terminal equipment (TCAM),recreationalcraft,personalprotectiveequipment,machinery,ATEXequipment.Therearealsogroupsdealingwithmorehorizontal issues such as Prosafe (the product safety forum of Europe), the Expert Group on Internal Market for Products (IMP-MSG),a horizontal committee where, for instance, general questions related to the implementation and enforcement of Union harmonisation legislation, such as horizontal aspects of market surveillance, are discussed. The emergencies committees, set up under the Directive on general product safety, regularly discusses administrative cooperation issues of general interest.

248 For ICSMS, see Point 7.5.3.249 See Judgement of the Court, cases 272/80 and 25/88250 An information request does not infringe the right of a national authority to take whatever measures are needed to ensure compliance with Union harmonisation legislation within its jurisdiction.

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7.5.2. RAPEX

RAPEX is EU’s system for rapid exchange of information on dangers arising from the use of products.

Directive 2001/95/EC on general product safety provides a legal basis (article 12) for an information exchange system for emergency situations. It is a general and horizontal system for the rapid exchange of information on serious risks arising from the use of products (RAPEX)251.

RAPEX covers non-food consumer and professional products. It is applicable to non-harmonised products and products covered by the Union harmonisation legislation alike252.

RAPEX works according to the detailed procedures laid down in the annex to the General Product Safety Directive and in the RAPEX guidelines253.

With the entry into force of Regulation (EC) No 765/2008, the scope of the RAPEX system was extended to risks other than those affectinghealthandsafety(i.e.risksfortheenvironmentandintheworkplace,securityrisks)andalsotoproductsintendedforprofessional (as opposed to consumer) use. Therefore, the system was adapted. Member States should ensure that products whichpresentaseriousriskrequiringrapid intervention, includingaseriousrisktheeffectsofwhicharenot immediate,arerecalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay through RAPEX under Article 22 of Regulation (EC) No 765/2008254.

On 16 December 2009, the Commission adopted Decision 2010/15/EU255 laying down the new guidelines for the management ofthe“RAPEX”system.Sinceguidelineswerewrittenbefore1January2010theyreferexplicitlyonlytonotificationsbasedontheGeneralProductSafetyDirective.NeverthelesstheyarethemainreferencealsofornotificationsbasedonRegulation(EC)No765/2008 (see Article 22(4) therein) – professional products and risks other than health and safety.

The RAPEX procedure is as follows:

• When a product (e.g. a toy, a childcare article or a household appliance) is found to be dangerous, the competent national authority takes appropriate action to eliminate the risk. It can withdraw the product from the market, recall it from con-sumers or issue warnings. The National Contact Point then informs the European Commission (through IT system GRAS-RAPEX256) about the product, the risks it poses and the measures taken by the authority to prevent risks and accidents.

• The European Commission disseminates the information that it receives to the National Contact Points of all other EU countries. It publishes weekly overviews of products posing a serious risk and the measures taken to eliminate the risks on the internet.

• TheNationalContactPointsineachEUcountryensurethattheauthoritiesresponsiblecheckwhetherthenewlynotifiedproduct is present on the market. If so, the authorities take measures to eliminate the risk, either by requiring that the product is withdrawn from the market, by recalling it from consumers or by issuing warnings.

The safeguard clause procedures under the Union harmonisation legislation apply in addition to RAPEX. Accordingly, RAPEX does not necessarily have to come into play before the safeguard clause procedure is applied. However, the safeguard clause procedure has to be applied, in addition to RAPEX, when the Member State takes a decision to permanently prohibit or restrict the free movement of CE marked products on the basis of a danger or other serious risk presented by the product.

251 The IT system is also known under the name GRAS-RAPEX.252 Inthefieldofmedicinalproductsandmedicaldevices,thereisaspecificinformationexchangesystem.253 Adopted as Commission Decision 2010/15/EU of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System‘RAPEX’establishedunderArticle12andofthenotificationprocedureestablishedunderArticle11ofDirective2001/95/EC(theGeneralProduct safety Directive, OJEU L 22, 26.11.2010, p. 1. 254 Regulation (EC) No 765/2008 of the Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, OJ L 218, 13.8.2008255 Decision 2010/15/EU is available at: http://ec.europa.eu/consumers/safety/rapex/docs/rapex_guid_26012010_en.pdf 256 GeneralRapidAlertSystemfortheRAPEXnotifications.GRAS-RAPEXreplacedRAPEX-REIS(RapidExchangeInformationSystemforRAPEXnotifications (in use since 2004) which was replaced by the new application GRAS-RAPEX) application and extended the scope of RAPEX to professional products and to other risks than health and safety.

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7.5.3. ICSMS

• ICSMS (Information and Communication System for Market Surveillance) is an IT tool that provides for a comprehensive communication platform between all the market surveillance authorities.

• ICSMS consists of an internal (accessible only to market surveillance authorities) and a public area. 7.5.3.1. Role

ICSMS offers fast and efficient communicationmeans formarket surveillance authorities to exchange informationwithin ashortspaceoftime.ICSMSallowsinformationonnon-compliantproducts(testresults,productidentificationdata,photographs,economic operator information, risk assessments, accident information, information on measures taken by surveillance authorities etc.)tobequicklyandefficientlysharedbetweenauthorities.

Theaimisnotonlytoavoidcaseswhereanunsafeproducttakenoffthemarketinonecountrytobeonsaleforalongtimeinanother country but mainly to have a market surveillance policy tool that allows to establish a co-operation mechanism among authorities.

While being aware of the fact that the mere reliable exchange of information is crucial for the market surveillance, it must be acknowledged that the added value of ICSMS stems from its capacity to be the platform for the implementation of the European market surveillance policy.

In this respect whenever a national authority wants to exchange information about a product under investigation with other authorities in order to share resources (e.g. for product checks), carry out common actions or consult other authorities, it must input into ICSMS the relevant information. This must be done as early as possible and certainly well before the decision to adopt measures for products found to present a risk. E.g. if a national authority cannot determine the level of the risk presented by a relevant product and carries out investigations, it must use ICSMS in order to communicate with the competent authorities of the other Member States.

ThustheultimateroleofICSMSistohelptheEuropeanUniontofulfiloneofitsmajorpoliticalobjectives;i.e.toensurereliabilityandcoherenceintheimplementationandenforcementoftheEuropeanlegislation)inorderforoperatorsandcitizenstobenefitfrom the original intention of full access to the Internal Market.

In particular ICSMS helps market surveillance authorities to:

• proceed to quick and in-time exchange of information on market surveillance measures; • coordinatetheiractivitiesandinspectionsmoreeffectively,especiallybyfocusingonproductswhichhavenotbeenin-

spected or tested yet;• share resources and have thus more time to concentrate on other products which have yet to be tested;• carry out wide-scale market interventions wherever products of a dubious nature are concerned using the latest informa-

tion and avoid thus duplicate and multiple inspections;• Elaborate best practices; • EnsurethatmarketsurveillanceisefficientandofevenrigourinallMemberStatesandavoidthusdistortiontocompeti-

tion;• Establish an encyclopaedia of EU market surveillance intelligence. 7.5.3.1. Structure

The internal area is destined for market surveillance authorities, customs authorities and the EU. It contains all information available (product description, test results, measures taken etc.). Only ICSMS account holders may access this area

The public area is destined for consumers, users and manufacturers. The information which is visible to the public provides only the data, which reference the product and its non-compliance and not any internal documents (i.e. information exchange between authority and importer/manufacturer).

ICSMS enables specific searches for non-compliant products. Confidentiality aspects are protected by a system of accessauthorisations.

Each market surveillance authority can input data about investigated products, which are not already in the database and add information(e.g.additionaltestsresults,measurestaken)toanalreadyexistingproductinformationfile.

The Commission ensures the proper functioning of ICSMS. The use of ICSMS is free of charge.

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7.5.4. MEDICAL DEVICES: VIGILANCE SYSTEM

A specific vigilance system applies in the case of medical devices.

Risks posed by medical devices have necessitated a comprehensive monitoring system whereby all serious product incidents will be reported257. The medical devices vigilance system applies to all incidents which might lead to, or might have led to, the death of a patient or a user, or to a serious deterioration in their state of health, and which result from:

• any malfunction or deterioration in the characteristics or performance of a device;• any inadequacy in the labelling or the instructions for use; or• any technical or medical reason in relation to the characteristics or performance of a device, and which leads the

manufacturer to systematically recall all devices of the same type.

The manufacturer is responsible for activating the vigilance system and must, accordingly, inform the surveillance authority aboutincidentsthatinvokeit.Afterthenotification,themanufacturerisobligedtomakeinvestigations,sendareporttothesurveillance authority and consider, in collaboration with the authority, what action should be taken.

Themanufacturer’snotificationisfollowedbyanassessmentcarriedoutbythesurveillanceauthority,ifpossibletogetherwiththemanufacturer.Aftertheassessment,theauthoritymustimmediatelyinformtheCommission,andtheotherMemberStates,of the incidents for which relevant measures have been taken or are contemplated. The Commission may then take any steps to coordinate, facilitate and support measures taken by the national surveillance authorities when dealing with the same type of incidents,or,ifnecessary,takemeasuresatUnionlevel(forexampleenvisagingthere-classificationofthedevice).Adatabankcontaining, among other information, data obtained in accordance with the vigilance system will be set up and made accessible tothecompetentauthorities.Thevigilancesystemisdifferentfromthesafeguardclauseprocedure,sinceitrequiresnotificationeven if the manufacturer takes the necessary measures on a voluntary basis. Nevertheless, when applying the vigilance system the surveillance authority is also obliged to adopt a restrictive measure vis-à-vis non-compliant CE marked products, if the conditions for invoking the safeguard clause apply and, accordingly, notify this measure following the safeguard clause procedure. However, the vigilance system does not necessarily have to come into play before the safeguard clause procedure is applied.

257 See Directives relating to active implantable medical devices, medical devices and in vitro diagnostic medical devices.

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8. FREE MOVEMENT OF PRODUCTS WITHIN THE EU258

8.1. FREE MOVEMENT CLAUSE

The objective of eliminating trade barriers among Member States and of strengthening the free movement of products is stated by a free movement clause, inserted in Union harmonisation legislation, which guarantees the free movement of products complying with the legislation. Free movement clauses are provisions inserted in EU legislative acts which expressly prevent the MemberStatesfromtakingmorerestrictivemeasuresonamatter,ifthatmatterfulfilstherequirementsofthelawinquestion.Therefore, Member States cannot impede the making available on the market of a product which complies with all the provisions of sectoral harmonisation legislation.

The conformity to all the obligations incumbent on manufacturers by virtue of Union harmonisation legislation is symbolised by the CE marking. Member States must presume that products bearing the CE marking comply with all the provisions of the applicable legislation providing for its affixing. Accordingly,Member Statesmay not prohibit, restrict or impede themakingavailable on the market in their territory of products bearing the CE marking, unless the provisions relating to CE marking are incorrectly applied.

8.2. LIMITS AND RESTRICTIONS

The Union harmonisation legislation is designed to ensure free movement of products that comply with the high level of protection laid down in the applicable legislation. Therefore, Member States may not prohibit, restrict or impede the making available of such products. However, Member States are allowed to maintain or adopt, in compliance with the Treaty (in particular Articles 34 and 36 TFEU), additional national provisions regarding the use of particular products which are intended for the protection of workersorotherusers,ortheenvironment.Suchnationalprovisionsmayneitherrequiremodificationofaproductmanufacturedinaccordancewiththeprovisionsoftheapplicablelegislation,norinfluencetheconditionsformakingitavailable.

A limitation to the free movement of product might be imposed in the case of non-compliance of a product with the essential or other legal requirements. Besides that, it may be the case that products complying with the requirements of harmonised legislation present, nonetheless, a risk to the health or safety of persons or to other aspects of public interest protection. In this case, Member States must require the relevant economic operator to take corrective actions. It is possible, therefore, to limit the free movement of a product not only in case of non-compliance of the product with the requirements set up by the relevant legislation but also in the case of compliance when the essential or other requirements do not entirely cover all of the risks related to the product.259

258 This Chapter deals only with products subject to Union harmonisation legislation. The free movement is products not subject to Union harmonisation legislation is dealt by the Guide to the application of Treaty provisions governing the free movement of goods, available at: http://ec.europa.eu/enterprise/policies/single-market-goods/files/goods/docs/art34-36/new_guide_en.pdf259 A more detailed description of the procedures to be followed in case of products presenting a risk to the health or safety of persons or to other aspects of public interest protection is provided in chapter 7.

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9. INTERNATIONAL ASPECTS OF THE EU LEGISLATION ON PRODUCTS In its relations with third countries the EU, among other things, endeavours to promote international trade in regulated products.

Conditions for open trade include compatibility of approach, coherence of regulations and standards, transparency of rules, appropriate levels andmeans of regulation, impartiality in certification, compatibility ofmarket surveillancemeasures andsupervision practices, and an appropriate level of technical and administrative infrastructure.

Accordingly, depending on the status of the above conditions, a broad variety of measures can be applied in order to facilitate trade. The expansion of the single market of products is pursued through several international legal instruments that enable the achievement of appropriate levels of cooperation, convergence or harmonisation of legislation and thus facilitate the free movement of goods. These instruments include:

• full integration of the EEA EFTA countries in the internal market by virtue of the EEA agreement260,• alignment of the legislative system and infrastructure of the Candidate countries with those of the EU • similar alignment by Neighbouring countries by conclusion of bilateral Agreements on conformity assessment and accept-

ance of industrial products (ACAAs), • conclusionofbilateral(inter-governmental)MutualRecognitionAgreements(MRAs)forconformityassessment,certificates

andmarking,whichareintendedtoreducethecostsoftestingandcertificationinothermarkets,and finally,relianceonWTOAgreementonTechnicalBarrierstoTrade261.

9.1. AGREEMENTS ON CONFORMITY ASSESSMENT AND ACCEPTANCE (ACAAS)

Agreements on Conformity Assessment and Acceptance are established between the Union and the government of EU Neigh-bouring countries.

The European Union has always been at the forefront of support for international co-operation regarding the areas of technical regulations, standards, conformity assessment and the elimination of technical barriers to trade for products.Within the framework of the European Neighbourhood Policy, the European Commission has made clear its intention to intensify cooperation with the EU’s eastern and southern neighbours in the areas of trade, market access and regulatory structures.

The use of the Union system of standardisation and conformity assessment by third countries is designed to facilitate trade and market access in both directions.

Agreements on Conformity Assessment and acceptance of industrial products are intended to be established between the Union and the government of EU Neighbouring countries (Mediterranean – Algeria, Egypt, Israel, Jordan, Lebanon, Morocco, Palestinian Authority, Tunisia, - and Eastern – Armenia, Azerbaijan, Belarus, Georgia, Moldova, Ukraine).

This mutual recognition of equivalence in technical regulation, standardisation and conformity assessment on which are based these agreements operates on the basis of the EU acquis that has been transposed by the partner country, in the same way as it would apply to products placed on the market of a Member State. It allows industrial products covered by it and attested as compliant according to the procedures in the European Union to be placed on the market of the partner country without having to undergo any further approval procedures, and vice versa.

It requires the prior full alignment of the partner country’s legal framework on EU legislation and standards and the upgrading of their implementing infrastructure on the model of the EU system, in relation to standardisation, accreditation, conformity assessment, metrology and market surveillance.

ACAAs consist of a framework agreement and one or more annexes, setting out the products covered, and the means adopted toextendthebenefitoftrade inthatsector.Theframeworkagreementprovidesfortwomechanisms, (a)therecognitionofequivalence in technical regulation, standardisation and conformity assessment for industrial products subject to equivalent regulation in Union law and the national law of the partner country, and (b) where there is no European technical legislation applicabletorelevantproducts,forthemutualacceptanceofindustrialproductsthatfulfiltherequirementstobelawfullyplacedon the market in one of the Parties. More sectoral annexes can be added successively.

AfirstACAAenteredintoforceinJanuary2013withIsraelonpharmaceuticalproducts.Atthetimeofwriting,otherMediterraneanpartners are finalising the preparatory work for launching negotiations in some New Approach sectors (electrical products,construction materials, toys, gas appliances and pressure equipment).

260 or the EEA Agreement, see Point 2.8.2.261 The issues related to the WTO agreement are beyond the scope of the Guide.

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9.2. MUTUAL RECOGNITION AGREEMENTS (MRAS)

• Mutual recognition agreements are established between the Union and the government of third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment.

• These agreements are based on the mutual acceptance of certificates, marks of conformity and test reports issued by the conformity assessment bodies of either party in conformity with the legislation of the other party.

9.2.1. MAIN CHARACTERISTICS

One of the instruments to promote international trade of regulated products is the conclusion of mutual recognition agreements (MRAs) on the basis of Article 207 and 218 TFEU. MRAs are agreements established between the Union and the third countries for the purpose of mutual recognition of conformity assessment of regulated products.

MRAsaredesignedsothateachpartyacceptsthereports,certificatesandmarksthatareinaccordancewithitsownlegislationdelivered in the partner country. These are drawn up and issued by bodies that the other party has designated under the MRA forassessingconformity in thefield(s) coveredby theMRA.This canbeachieved,becauseMRAs includeall theconformityassessment requirements of the parties necessary to obtain full market access, and the products are evaluated in the country of production against the regulatory requirements of the other party. These are usually referred to as ‘Traditional MRAs’.

MRAs cover the entire territory of the parties in order to guarantee, in particular in States with a federal structure, the full free movementofproductscertifiedtobeinconformity.Asageneralrule,MRAsarelimitedtoproductsthathavetheiroriginontheterritory of either party.

MRAs apply to one ormore categories of products or sectors fallingwithin the regulated field (they are covered byUnionharmonisation legislation in force) and, in certain cases, by non-harmonised national law. In principle MRAs should cover all the industrial products for which the regulations of at least one of the parties require third party conformity assessment.

MRAs comprise a framework agreement and sectoral annexes. The framework agreement lays down the essential principles of a traditional agreement. Sectoral annexes specify, in particular, the scope and coverage, regulatory requirements, the list of designated conformity assessment bodies, the procedures and authorities responsible for designating these bodies and, if applicable, transitional periods. More sectoral annexes can be added successively.

MRAs are not based on the necessity to mutually accept other party’s standards or technical regulations, or to consider the legislation of the two parties as equivalent. However, MRAs can pave the way towards a harmonised system of standardisation andcertificationsoftheparties.Nevertheless,thetwolegislationsare,asarule,deemedtoensureacomparablelevelregardingthe protection of health, safety, environment or other public interests. Moreover, MRAs increase the transparency of the regulatory systems,sincethedifferentsystemsareshowntoothercountriesandtheyhavetodemonstratecoherence.

Onceestablished, theMRAneeds tobemaintained, forexamplebykeeping listsof recognised certificationbodies,and thestandards or rules against which they must certify.

ThebenefitsoftheMRAarisefromremovalofduplicatedinspectionorcertification.Whereaproductintendedfortwomarketsmaystillhavetobeassessedtwice(whentechnicalrequirementsorstandardsaredifferent),theassessmentwouldbecheaperwhen carried out by the same body. The time to market is reduced since contacts between the manufacturer and the conformity assessment body, and a single assessment, speed up the process. Even where the underlying regulations are harmonised, for exampleonaninternationalstandard,theneedforrecognitionofcertificatesremains,andinsuchcasesthebenefitwillbeclear:the product is assessed once against the commonly accepted standard instead of twice.

Currently there are MRAs into force with Australia, New Zealand, the United States, Canada, Japan and Switzerland.

Theaboveagreementsareconcludedinsomespecificsectorswhichmightvaryfromonecountrytoanother.Moredetailsontheagreements can be found at the following address:

http://ec.europa.eu/enterprise/policies/single-market-goods/international-aspects/mutual-recognition-agreement/index_en.htm

ThebodiesdesignatedunderMRAsfigureinadedicatedpartofNANDO.

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9.2.2. EU-SWISS MRA

The MRA concluded with Switzerland which entered into force on 1 June 2002 (OJ L114 of 30/04/2002) is a comprehensive agreement based on the equivalence of the legislation of the EU and Switzerland262. It covers the recognition of conformity assessments irrespective of the origin of the products. This type of MRA agreement is usually referred to as an “Enhanced MRA”. However, the case of Switzerland remains quite unique.

The provisions of the Agreement and the harmonisation of Swiss technical regulations with those of the EU ensure seamless market access for EU products on the Swiss market, and vice versa for Swiss products on EU/EEA market. However, despite the MRA, there is no customs union between the EU and Switzerland. According to the Agreement, the Swiss Accreditation Service (SAS) is a full member of European co-operation for Accreditation (EA) and is signatory of all mutual recognition agreements with the EA. In the area of standardisation, Switzerland is full member of CEN, CENELEC and ETSI and participates actively in the work of the European standardisation. Furthermore,anEUconformityassessmentbody isallowedto issuecertificates intheEUaccordingtoEU legislation, which is deemed equivalent to that of Switzerland. The same applies conversely to the Swiss’ conformity assessment bodies. Thus, certificatesissuedbySwissconformityassessmentbodiesaccreditedbySASforproductcoveredbytheMRAshouldbedeemedequivalent to those issued by conformity assessment bodies established in the EU.

This was only possible because, on the one hand, Switzerland has an existing technical infrastructure (e.g. the public or private institutions dealing with standards, accreditation, conformity assessment, market surveillance and consumer protection) which is equally developed and deemed equivalent to the one existing in the EU. On the other hand, Switzerland has chosen to modify its legislation in the sectors covered by the agreement, in order to align it with the one of the Union. Furthermore, it has committed to maintain its legislation aligned whenever amendments to it are introduced by the Union.

The so called “Enhanced MRA” agreement with Switzerland currently covers twenty product sectors: Machinery, Personal Protective Equipment (PPE), Safety of Toys, Medical Devices, Gas Appliances and Boilers, Pressure Equipment, Telecommunications Terminal Equipment, Equipment and Protective Systems intended for use in potentially explosive atmosphere (ATEX), Electrical Safety and Electromagnetic Compatibility (EMC), Construction Plant and Equipment, Measuring Instruments and Pre-packages, Motor Vehicles, Agricultural and Forestry Tractors, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) Inspection and BatchCertification,Constructionproducts,Lifts,BiocidalProducts,CablewaysinstallationsandExplosivesforciviluse.

A parallel MRA covering exactly the same scope has been concluded between the EEA EFTA States and Switzerland (Annex I to the EFTA Vaduz Convention which entered into force on 1 June 2002), ensuring a homogeneous market access throughout the EU internal market, the EEA and Switzerland.

9.2.3. EEA EFTA STATES: MUTUAL RECOGNITION AGREEMENTS AND AGREEMENTS ON CONFORMITY ASSESSMENT AND ACCEPTANCE

The mandate from the Council to the Commission to negotiate mutual recognition agreements and Agreements on conformity assessment and acceptance of industrial products indicated the objective that the third countries concerned will conclude with the EEA EFTA States parallel agreements equivalent to those to be concluded with the Union, and which will, possibly have the same date for entry into force.

The system of parallel agreements formally grants the third country concerned the same market access throughout the European Economic Area for products covered by the mutual recognition agreements or Agreements on conformity assessment and acceptance of industrial products. As to the practical implementation of these agreements, common sessions of the Joint Committee meetings with the third country concerned will be arranged.

262ThefulltextoftheMRAEU-SwitzerlandandspecificprovisionsmaybefoundonthehomepageoftheCommission: http://ec.europa.eu/enterprise/policies/single-market-goods/international-aspects/mutual-recognition-agreement/switzerland/index_en.htm

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10. ANNEXES

103

10.1. ANNEX 1 - EU LEGISLATION REFERRED TO IN THE GUIDE (NON-EXHAUSTIVE LIST)

Horizontal Union harmonisation Act Number

(amendment)

Reference in the OJEU

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

765/2008 OJ L 218/30 of 13/08/2008

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products

768/2008/EC OJ L 218/82 of 13/08/2008

Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC

764/2008 OJ L 218/21 of 13/08/2008

Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products

85/374/EEC(1999/34/EC)

OJ L 210 of 07/08/1985(L 141/20 of 04/06/1999)

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on General Product Safety

2001/95/EC OJ L 11 of 15/01/2002

Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation

1025/2012 OJ L 316/12 of 14/11/2012

October 2012 on European standardisation

104

Sectoral Union harmonisation Act Number (amendment)

Reference in the OJEU

Council Directive of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits

73/23/EEC 93/68/ЕЕС2006/95/EC

OJ L 77 of 26/03/73 OJ L 220 of 30/08/93 OJ L 374 of 27/12/06(OJ L 181 of 04/07/73)

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys

2009/48/EC OJL 170/1 of 30/06/2009

Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility

89/336/EEC 92/31/EEC93/68/ЕЕС2004/108/EC (98/1З/ЕС)

OJ L 139 of 23/05//89 OJ L 126 of 12/05/92 OJ L 220 of 30/08/93 OJ L 390 of 31/12/04 (OJ L 74 of 12/03/98) (OJ L 144 of 27/05/89)

Directive of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery

98/37/EC 98/79/EC

OJ L 207 of 23/07/98 OJ L 331 of 07/12/98 (OJ L 16 of 21/01/99)

Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment

89/686/EEC 93/68/ЕЕС93/95/ЕЕС96/58/ЕС

OJ L 399 of 30/12/89 OJ L 220 of 30/08/93 OJ L 276 of 09/11/93 OJ L 236 of 18/09/96

Directive 2009/23/EC of the European Parliament and of the Council of 23 April 2009 on non-automatic weighing instruments

90/384/EEC 93/68/ЕЕС2009/23/EC

OJ L 189 of 20/07/90OJ L 220 of 30/08/93 OJ L 122 of 16/05/09 (OJ L 258 of 22/09/90)

Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments

2004/22/EC L 135/1 of 30/04/2004

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 93/42/EEC 98/79/ЕС2000/70/EC 2001/104/EC2007/97/EC

OJ L 169 of 12/07/93 OJ L 331 of 07/12/98 OJ L 313 of 13/12/00 OJ L 6 of 10/01/02 OJ L 247 of 21/09/07 (OJ L 323 of 26/11/97) (OJ L 61 of 10/03/99)

Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

90/385/EEC93/42/ЕЕС93/68/ЕЕС

OJ L 189 of 20/07/90OJ L 169 of 12/07/93 OJ L 220 of 30/08/93 (OJ L 7 of 11/01/94) (OJ L 323 of 26/11/97)

105

Sectoral Union harmonisation Act Number (amendment)

Reference in the OJEU

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

98/79/EC OJ L 331 of 07/12/98(OJ L 22 of 29/01/99)(OJ L 74 of 19/03/99)

Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels

90/396/EEC 93/68/ЕЕС09/142/EC

OJ L 196 of 26/07/90 OJ L 220 of 30/08/93 OJ L 330 of 16/12/09

CouncilDirective92/42/EECof21May1992onefficiencyrequirementsfornewhot-waterboilers firedwithliquidorgaseousfuels

92/42/EEC 93/68/ЕЕС

OJ L 167 of 22/06/92 OJ L 220 of 30/08/93 (OJ L 195 of 14/07/92) (OJ L 268 of 29/10/93)

Council Directive of 5 April 1993 on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil uses

93/15/EEC OJ L 121 of 15/05/93 (OJ L 79 of 07/04/95)

Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 on the placing on the market of pyrotechnic articles

2007/23/EC OJ L 154/1 of 14/06/2007

Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres

94/9/EC OJ L 100 of 19/04/94 (OJ L 257 of 10/10/96)

Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft

94/25/EC 03/44/EC OJ L 164 of 30/06/94OJ L 214 of 26/08/03 (OJ L 127 of 10/06/95) (OJ L 17 of 21/01/97)

European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts

95/16/EC OJ L 213 of 07/09/95

Directive 2000/9/EC of the European Parliament and of the Council of 20 March 2000 relating to cableway installations designed to carry persons

2000/9/EC OJ L 106/21 of 03/05/2000

Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment

97/23/EC OJ L 181 of 09/07/97 (OJ L 265 of 27/09/97)

Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels

2009/105/EC L 264/12 of 8/10/2009

Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment

2010/35/EC OJ L 165/1 of 30/06/2010

Council Directive of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers

75/324/EEC94/1/EC2008/47/EC

OJ L 147 of 09/06/1975OJ L 23/28 of 28/01/1994OJ L 96 of 9/04/2008

106

Sectoral Union harmonisation Act Number (amendment)

Reference in the OJEU

Directive 99/5/EC of the European Parliament and of the Council relating to radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity

99/5/EC OJ L 91 of 07/04/99

Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products

2009/125/EC OJ L 285/10 of 31/10/2009

Directive 97/68/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery

97/68/EC2002/88/EC2004/26/EC2006/105/EC2010/26/EU2011/88/EU2012/46/EU

OJ L 59 of 27/02/1998OJ L 35/28 of 11/02/2003OJ L 146/1 of 30/04/2004OJ L 368 of 20/12/2006OJ L 86/29 of 01/04/2010OJ L 350/1 of 23/11/2011OJ L 353/80 of 21/12/2012

Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors

2000/14/EC2005/88/EC219/2009

OJ L 162 of 03/07/2000OJ L 344 of 27/12/2005OJ L 87 of 31/03/2009

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS)

2011/65/EU OJ L 174 of 1/07/2011

Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE)

2012/19/EU OJ L 197/38 of 24/07/2012

Council Directive 96/98/EC of 20 December 1996 on marine equipment 96/98/EC OJ L 46 of 17/02/1997 (OJ L 246 of 10/09/1997) (OJ L 241 of 29/08/1998)

Council Directive 2008/57/EC of of 17 June 2008 on the interoperability of the rail system within the Community

2008/57/EC2009/131/EC2011/18/EU2013/9/EU

OJ L 191/1 of 18/07/2008 OJ L 273/12 of 17/10/2009 OJ L 57/21 of 02/03/2013OJ L 68/55 of 12/03/2013

European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste

94/62/EC 2004/12/EC 2005/20/EC

OJ L 365 of 31/12/1994 OJ L 47 of 18/02/2004 OJ L 70 of 16/03/2005

Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European Air Traffic Management network

552/20041070/2009

OJ L 96 of 31/03/2004OJ L300 of 14/11/2009

Directive 2010/30/EU of the European Parliament and of the Council of 19 May 2010 on the indication by labelling and standard product information of the consumption of energy and other resources by energy-related products

2010/30/EU OJ L 153/1 of 18/06/2010

107

10.2. ANNEX 2 - ADDITIONAL GUIDANCE DOCUMENTS

• Guidance documents from the Expert Group on Toy Safety: http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/index_en.htm

• Measuring instruments and non-automatic weighing instruments: http://ec.europa.eu/enterprise/sectors/legal-metrology-and-prepack/documents/guidance-documents/index_en.htm

• Chemicals: http://echa.europa.eu/support/guidance

• Low Voltage Directive - Guidelines on application and recommendations: http://ec.europa.eu/enterprise/sectors/electrical/documents/lvd/guidance/index_en.htm

• Electromagnetic Compatibility (EMC) – Guidance: http://ec.europa.eu/enterprise/sectors/electrical/documents/emc/guidance/index_en.htm

• Radio and telecommunications terminal equipment (R&TTE) Guidance: http://ec.europa.eu/enterprise/sectors/rtte/documents/guidance/index_en.htm

• Medical Devices – Interpretative documents: http://ec.europa.eu/health/medical-devices/documents/interpretative-documents/index_en.htm

• Frequently Asked Questions on the Construction Products Regulation (CPR): http://ec.europa.eu/enterprise/sectors/construction/faq/index_en.htm

• Automotive industry - Frequently asked questions: http://ec.europa.eu/enterprise/sectors/automotive/faq/index_en.htm

• RoHS 2 - Frequently asked questions: http://ec.europa.eu/environment/waste/rohs_eee/events_rohs3_en.htm

• Pressure Equipment Directive (PED): guidelines: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/guidelines/index_en.htm

• Machinery - Guidance Documents: http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/machinery/index_en.htm

• Directive on cableways - Guide to application: http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/cableways/index_en.htm

• Directiveonlifts-Guidetoapplication: http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/lifts/index_en.htm

• Directive on Personal Protective Equipment - Guide to application: http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/personal-protective-equipment/index_en.htm

• Directive on the noise emission in the environment by equipment for use outdoors - Guide to application, publications and studies: http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/noise-emissions/index_en.htm

• Guidelines on the application of Directive 94/9/EC of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially Explosive Atmospheres (Fourth edition September 2012 ): http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/atex/application/index_en.htm

• Healthcare industries - Frequently asked questions: http://ec.europa.eu/enterprise/sectors/healthcare/faq/index_en.htm

• Guide to the practical application of the General Product Safety Directive: http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm

• RAPEX Guidelines: http://ec.europa.eu/consumers/safety/rapex/index_en.htm

• European standards – General framework: http://ec.europa.eu/enterprise/policies/european-standards/standardisation-policy/general-framework/index_en.htm

108

10.3. ANNEX 3 - USEFUL WEB ADDRESSES

• Single Market for Goods http://ec.europa.eu/enterprise/policies/single-market-goods/index_en.htm

• Internal Market for products http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/index_en.htm

• European standards http://ec.europa.eu/enterprise/policies/european-standards/index_en.htm

• Standardisation in the European internal market - how to access European standards and standards activities on the web: http://www.NewApproach.org

• Rapid Alert System for non-food products posing a serious risk (RAPEX) http://ec.europa.eu/consumers/safety/rapex/index_en.htm

109

10.4. ANNEX 4 - CONFORMITY ASSESSMENT PROCEDURES (MODULES FROM DECISION NO 768/2008/EC)

Modules Manufacturer Manufacturer or Authorised representative Conformity assessment body

A (Internal production control)

• Design + Production• The manufacturer carries out himself

all checks in order to ensure the con-formity of the products to the legisla-tive requirements (no EC-type).

• draws up the technical documentation• ensures compliance of the manu-

factured products to the legislative requirements

• affixestheCEMarking• draws up a written declaration of

conformity and keeps it together with the technical documentation and other relevant information at the disposal of the national authorities

No involvement of conformity assessment body. The manufacturer carries out himself allchecksanotifiedbodywoulddo

A1 (Internal production control plus supervised product testing)

• Design + Production• A+testsonspecificaspectsofthe

product

• draws up the technical documentation • ensures compliance of the manu-

factured products to the legislative requirements

• carries out tests or has tests carried out on his behalf on one or more specificaspectsoftheproduct.Inthisrespect and at his choice tests are carried out either by an accredited in-house body or under the responsi-bilityofanotifiedbodychosenbythemanufacturer

• where the tests are carried out under theresponsibilityofanotifiedbody,heshall, under the responsibility of the notifiedbody,affixthenotifiedbody’sidentificationnumberduringthemanu-facturing process

• affixestheCEMarking• draws up a written declaration of con-

formity and keeps it together with the technical documentation, the decision ofthe(notifiedorin-houseaccredited)body and other relevant information at the disposal of the national authorities

Either notified body or in-house accreditedbody(manufacturer’schoice)*:

A) In-house accredited body• carries out tests on one or more specif-

ic aspects of the product • keeps record of its decisions and other

relevant information• informs authorities and the other

bodies about the examinations it has performed

B)NotifiedBody• supervises and assumes responsibility

for tests carried out by the manufac-turer or on his behalf on one or more specificaspectsoftheproduct

• keeps record of its decisions and other relevant information

• informs authorities and the other bodies about the examinations it has performed

*Thelegislatormayrestrictmanufacturer’schoice

110

Modules Manufacturer Manufacturer or Authorised representative Conformity assessment body

A2 (Internal production control plus supervised product checks at random intervals)

• Design + Production• A + product checks at random intervals

• draws up the technical documentation • ensures compliance of the manu-

factured products to the legislative requirements

• lodges an application for product checks with a single body of his choice

• where the tests are carried out by a no-tifiedbody,heshall,undertherespon-sibilityofthenotifiedbody,affixthenotifiedbody'sidentificationnumberduring the manufacturing process

• affixestheCEMarking• draws up a written declaration of con-

formity and keeps it together with the technical documentation, the decision ofthe(notifiedorin-houseaccredited)body and other relevant information at the disposal of the national authorities

Either notified body or in-house accreditedbody(manufacturer’s choice )*:

• carries out product checks at random intervals determined by the body

• keeps record of its decisions and other relevant information

• informs authorities and the other bodies about the examinations it has performed

B (EC-type examination)

• Design

• draws up the technical documentation• ensures the conformity of the speci-

men(s) to the legislative requirements• Remark: As module B covers only the

design phase, the manufacturer does notdraftanydeclarationofconformityandmaynotaffixthenotifiedbody’sidentificationnumbertotheproduct

• lodges an application for EC-type ex-aminationwithasinglenotified

• body of his choicekeeps the technical documentation and the EC-type exam-inationcertificateandotherrelevantinformation at the disposal of the national authorities

• informsthenotifiedbodyofallmodifi-cations to the approved type

NotifiedBody• examines the technical documentation

and supporting evidence. • verifiesthatthespecimen(s)havebeen

manufactured in conformity to the legislative requirements.

In this respect, the legislator lays down which of the following ways must be used:

a. examination of a specimen, (production type);

b. examination of the technical documen-tation plus examination of specimen, (combination of production type and design type);

c. examination of the technical docu-mentation, without examination of a specimen (design type).

• carries out appropriate examinations and tests

• draws up an evaluation report that may be released only upon agreement with the manufacturer

• issues an EC-type examination certificate

• informs its notifying authorities and the other bodies about the EC-type examinations it has performed

• keeps record of its decisions and other relevant information*Thelegislatormayrestrictmanufacturer’schoice

111

Modules Manufacturer Manufacturer or Authorised representative Conformity assessment body

C (Conformity to EC-type based on internal production control)

• Production (follows B)• The manufacturer carries out himself

all checks to ensure the conformity of the products to the EC-type.

• ensures compliance of the manufac-tured products to the approved (under module B) EC-type and the legislative requirements

• affixestheCEMarking• draws up a written declaration of

conformity and keeps it together with the technical documentation of the ap-proved type (established under module B) and other relevant information at the disposal of the national authorities

• No involvement of Conformity assess-ment body. The manufacturer carries outhimselfallchecksanotifiedbodywould do

C1 (Conformity to EC-type based on internal production control plus supervised product testing)

• Production (follows B)• C+testsonspecificaspectsofthe

product

• ensures compliance of the manufac-tured products to the approved (under module B) EC-type and the legislative requirements

• carries out tests or has tests carried out on his behalf on one or more specificaspectsoftheproduct.Inthisrespect and at his choice tests are carried out either by an accredited in-house body or under the responsi-bilityofanotifiedbodychosenbythemanufacturer

• where the tests are carried out under theresponsibilityofanotifiedbody,heshall, under the responsibility of the notifiedbody,affixthenotifiedbody’sidentificationnumberduringthemanu-facturing process

• affixestheCEMarking• draws up a written declaration of

conformity and keeps it together with the technical documentation of the approved type (established under moduleB),thedecisionofthe(notifiedor in-house accredited) body and other relevant information at the disposal of the national authorities

Eithernotifiedbodyorin-houseaccreditedbody(manufacturer’schoice)*:

A) In-house accredited body• carries out tests on one or more specif-

ic aspects of the product • Remark: the in-house accredited body

takes into account the technical docu-mentation but does not examine it, as it has been already examined under module B

• keeps record of its decisions and other relevant information

• informs authorities and the other bodies about the examinations it has performed

B)NotifiedBody• supervises and assumes responsibility

for tests carried out by the manufac-turer or on his behalf on one or more specificaspectsoftheproduct

• Remark:thenotifiedbodytakesintoaccount the technical documentation but does not examine it, as it has been already examined under module B.

• keeps record of its decisions and other relevant information

• informs authorities and the other bodies about the examinations it has performed*Thelegislatormayrestrictmanufacturer’schoice

112

Modules Manufacturer Manufacturer or Authorised representative Conformity assessment body

C2 (Conformity to EC-type based on internal production control plus supervised product checks at random intervals)

• Production (follows B)• C + product checks at random intervals

• ensures compliance of the manufac-tured products to approved (under module B) EC-type and the legislative requirements

• lodges an application for product checks with a single body of his choice

• where the tests are carried out by a no-tifiedbody,heshall,undertherespon-sibilityofthenotifiedbody,affixthenotifiedbody’sidentificationnumberduring the manufacturing process

• affixestheCEMarking• draws up a written declaration of

conformity and keeps it together with the technical documentation of the approved type (established under moduleB),thedecisionofthe(notifiedor in-house accredited) body and other relevant information at the disposal of the national authorities

Eithernotifiedbodyorin-houseaccreditedbody(manufacturer’schoice)*:

• carries out product checks at random intervals determined by the body

• Remark: the in-house accredited body ornotifiedbodytakesintoaccountthe technical documentation but does not examine it, as it has been already examined under module B

• keeps record of its decisions and other relevant information

• informs authorities and the other bodies about the examinations it has performed

D (Conformity to EC-type based on quality assurance of the production process)

• Production (follows B) • Quality assurance for manufacturing

andinspectionoffinalproduct

• operates an approved quality system forproduction,finalproductinspectionand testing of the products in order to ensure compliance of the manufac-tured products to the approved (under module B) EC-type and the legislative requirements

The quality system must include the following elements and has to be documented: quality objectives, organisa-tional structure, manufacturing and quality control techniques, tests (carried out before, duringandaftermanufacturing),qualityrecords, monitoring methods

• fulfilstheobligationsarisingoutofthequality system

• ensures compliance of the manufac-tured products to approved (under module B) EC-type and the legislative requirements

lodges an application for the assessment ofthequalitysystemwithasinglenotifiedbody of his choice

• keepsthenotifiedbodyinformedofany change to the quality system

• draws up a written declaration of conformity and keeps it together with the technical documentation of the approved type (established under module B), the quality system approval and other relevant information at the disposal of the national authorities

• affixestheCEMarking• affixes,undertheresponsibilityofthe

notifiedbody,thelatter’sidentificationnumber

NotifiedBody

• performs periodic audits in order to assess and survey the quality system

Audits include: review of the technical doc-umentation, control of the quality system, inspections, product tests

• notifiesitsdecisionaboutthequalityassurance system to the manufacturer (thenotificationshallcontainthecon-clusions of the audit and the reasoned assessment decision)

• keeps record of its decisions and other relevant information

• informs its notifying authorities and the other bodies about the quality system examinations it has performed

*Thelegislatormayrestrictmanufacturer’schoice

113

Modules Manufacturer Manufacturer or Authorised representative Conformity assessment body

E (Conformity to EC-type based on product quality assurance)

• Production (follows B)• Final product (=production without the

manufacturing part) quality assurance • Like D without the part of the quality

system that focuses on the manufac-turing process

• operates an approved quality system forfinalproductinspectionandtestingin order to ensure compliance of the manufactured products to the ap-proved (under module B) EC-type and the legislative requirements

The quality system must include the follow-ing elements and has to be documented: quality objectives, organisational structure, tests(carriedoutafterthemanufacturing),quality records, monitoring methods

• Remark: tests carried out before/ during manufacturing, and manufacturing techniques, are not part of the qual-ity system under module E (as it is the case for modules D, D1), because moduleEtargetsthefinalproductquality and not the quality of the whole production process (as it is the case for modules D, D1)

• fulfilstheobligationsarisingoutofthequality system

• ensures compliance of the manufac-tured products to approved (under module B) EC-type and the legislative requirements

• lodges an application for the assess-ment of the quality system with a singlenotifiedbodyofhischoice

• keepsthenotifiedbodyinformedofany change to the quality system

• draws up a written declaration of conformity and keeps it together with the technical documentation of the approved type (established under module B), the quality system approval and other relevant information at the disposal of the national authorities

• affixestheCEMarking• affixes,undertheresponsibilityofthe

notifiedbody,thelatter’sidentificationnumber

NotifiedBody

performs periodic audits in order to assess and survey the quality system

Audits include: control of the quality system, inspections, product tests Remark:thenotifiedbodytakesintoaccount the technical documentation but does not examine it, as it has been already examined under module B

• notifiesitsdecisionaboutthequalityassurance system to the manufacturer (thenotificationshallcontainthecon-clusions of the audit and the reasoned assessment decision)

• keeps record of its decisions and other relevant information

• informs its notifying authorities and the other bodies about the quality system examinations it has performed

114

Modules Manufacturer Manufacturer or Authorised representative Conformity assessment body

E1(Qualityassuranceoffinalproductinspection and testing)

• Design + Production• Final product (=production without the

manufacturing part) quality assurance • Like D1 without the part of the quality

system that focuses on the manufac-turing process

• Used like E without module B (No EC-type)

• draws up the technical documentation • operates an approved quality system

forfinalproductinspectionandtestingin order to ensure compliance of the manufactured products to the legisla-tive requirements

The quality system must include the following elements and has to be documented: quality objectives, organisa-tionalstructure,tests(carriedoutafterthemanufacturing), quality records, monitoring methods

• Remark: tests carried out before/ during manufacturing, and manufacturing techniques, are not part of the qual-ity system under module E1 (as it is the case for modules D, D1), because module E1 (like module E) targets the finalproductqualityandnotthequalityof the whole production process (as it is the case for modules D, D1)

• fulfilstheobligationsarisingoutofthequality system.

• ensures compliance of the manu-factured products to the legislative requirements

• lodges an application for the assess-ment of the quality system with a singlenotifiedbodyofhischoice

• keepsthenotifiedbodyinformedofany change to the quality system

• draws up a written declaration of con-formity and keeps it together with the technical documentation, the quality system approval and other relevant information at the disposal of the na-tional authorities

• affixestheCEMarking• affixes,undertheresponsibilityofthe

notifiedbody,thelatter’sidentificationnumber

NotifiedBody

• performs periodic audits in order to assess and survey the quality system

Audits include: review of the technical doc-umentation, control of the quality system, inspections, product tests

• notifiesitsdecisionaboutthequalityassurance system to the manufacturer (thenotificationshallcontainthecon-clusions of the audit and the reasoned assessment decision)

• keeps record of its decisions and other relevant information

• informs its notifying authorities and the other bodies about the quality system examinations it has performed

115

Modules Manufacturer Manufacturer or Authorised representative Conformity assessment body

F (Conformity to EC-type based on product verification)

• Production (follows B)• Product examination (testing of every

product or statistical checks) in order to ensure conformity to EC-type

• LikeC2butthenotifiedbodycarriesout more detailed product checks.

• ensures compliance of the manufac-tured products to approved (under module B) EC-type and the legislative requirements

• incasewherestatisticalverificationisperformed, takes all measures neces-sary so that the manufacturing process and its monitoring ensure the homo-geneity of each lot produced, and shall presenthisproductsforverificationinthe form of homogeneous lots

• lodges an application for product checkswithasinglenotifiedbodyofhis choice

• affixestheCEMarking• draws up a written declaration of

conformity and keeps it together with the technical documentation of the approved type (established under moduleB),thecertificateofconformityand other relevant information at the disposal of the national authorities

• Uponpermissionofthenotifiedbodyaffixesitsidentificationnumber

NotifiedBody

• carries out appropriate examinations and tests (testing of every product or statistical checks)

• Inthescenarioofstatisticalverifica-tionandifalotisrejected,thenotifiedbody shall take appropriate measures to prevent that lot’s being placed on the market. In the event of the fre-quentrejectionoflotsthenotifiedbodymaysuspendthestatisticalverificationand take appropriate measures

• Remark:thenotifiedbodytakesintoaccount the technical documentation but does not examine it, as it has been already examined under module B

• issuesacertificateofconformity• affixesitsidentificationnumberordel-

egatestothemanufacturertheaffixingofitsidentificationnumber

• keeps record of its decisions and other relevant information

• informs its notifying authorities and the other bodies about the examinations it has performed

116

Modules Manufacturer Manufacturer or Authorised representative Conformity assessment body

F1(Conformitybasedonproductverifica-tion)

• Design + Production• Product examination (testing of every

product or statistical checks) in order to ensure conformity to legislative requirements)

• Used like F without module B (no EC-type)

• draws up the technical documentation • ensures compliance of the manufac-

tured products to approved (under module B) EC-type and the legislative requirements

• incasewherestatisticalverificationisperformed, takes all measures neces-sary so that the manufacturing process and its monitoring ensure the homo-geneity of each lot produced, and shall presenthisproductsforverificationinthe form of homogeneous lots

• lodges an application for product checkswithasinglenotifiedbodyofhis choice

• affixestheCEMarking• draws up a written declaration of con-

formity and keeps it together with the technicaldocumentation,thecertificateof conformity and other relevant infor-mation at the disposal of the national authorities

• Uponpermissionofthenotifiedbodyaffixesitsidentificationnumber

NotifiedBody

• carries out appropriate examinations and tests (testing of every product or statistical checks)

• Inthescenarioofstatisticalverifica-tionandifalotisrejected,thenotifiedbody shall take appropriate measures to prevent that lot’s being placed on the market. In the event of the fre-quentrejectionoflotsthenotifiedbodymaysuspendthestatisticalverificationand take appropriate measures.

• issuesacertificateofconformity• affixesitsidentificationnumberordel-

egatestothemanufacturertheaffixingofitsidentificationnumber

• keeps record of its decisions and other relevant information

• informs its notifying authorities and the other bodies about the examinations it has performed

G(Conformitybasedonunitverification)

• Design + Production• Verificationofeveryindividualproduct

in order to ensure conformity to legis-lative requirements (no EC-type)

• draws up the technical documentation• ensures compliance of the manu-

factured products to the legislative requirements

• lodges an application for product checkswithasinglenotifiedbodyofhis choice

• affixestheCEmarking• affixes,undertheresponsibilityofthe

notifiedbodythelatter’sidentificationnumber

• draws up a written declaration of con-formity and keeps it together with the technicaldocumentation,thecertificateof conformity and other relevant infor-mation at the disposal of the national authorities

NotifiedBody

• carries out appropriate examinations • issuesacertificateofconformity• keeps record of its decisions and other

relevant information• informs its notifying authorities and the

other bodies about the examinations it has performed

117

Modules Manufacturer Manufacturer or Authorised representative Conformity assessment body

H (Conformity based on full quality assur-ance)

• Design + Production• Full quality assurance • No EC-type

• draws up the technical documentation • operates an approved quality system

forproduction,finalproductinspectionand testing of the products.

• The quality system must include the following elements and has to be documented: quality objectives, organ-isational structure, manufacturing and qualitycontroltechniques,verificationtechniques for product design, tests (carriedoutbefore,duringandaftermanufacturing), quality records, moni-toring methods

• fulfilstheobligationsarisingoutofthequality system

• ensures compliance of the manu-factured products to the legislative requirements

• lodges an application for the assess-ment of the quality system with a singlenotifiedbodyofhischoice

• keepsthenotifiedbodyinformedofany change to the quality system.

• draws up a written declaration of con-formity and keeps it together with the technical documentation, the quality system approval and other relevant information at the disposal of the na-tional authorities

• affixestheCEMarking• affixes,undertheresponsibilityofthe

notifiedbody,thelatter’sidentificationnumber

NotifiedBody

• performs periodic audits in order to assess and survey the quality system

• Audits include: review of the technical documentation, control of the quality system, inspections, product tests

• notifiesitsdecisionaboutthequalityassurance system to the manufacturer (thenotificationshallcontainthecon-clusions of the audit and the reasoned assessment decision)

• keeps record of its decisions and other relevant information

• informs its notifying authorities and the other bodies about the quality system examinations it has performed

H1 (Conformity based on full quality assur-ance plus design examination)

• Design + Production• Full quality assurance plus design ex-

amination in order to ensure conform-ity to legislative requirements

• No EC-type but EC-design examination certificate

• Like module H plus issuing of a EC designexaminationcertificate

• draws up the technical documentation • operates an approved quality system

forproduction,finalproductinspectionand testing of the products.

• The quality system must include the following elements and has to be documented: quality objectives, organ-isational structure, manufacturing and qualitycontroltechniques,verificationtechniques for product design, tests (carriedoutbefore,duringandaftermanufacturing), quality records, moni-toring methods

• fulfilstheobligationsarisingoutofthequality system

• ensures compliance of the manufac-tured products to the approved EC-de-sign and the legislative requirements

• lodges an application for EC design ex-aminationwiththesamenotifiedbodythat will assess the quality system

• lodges an application for assessment ofhisqualitysystemwiththenotifiedbody of his choice

• keepsthenotifiedbodyinformedofanymodificationtotheapprovedde-sign and of any change to the quality system.

• draws up a written declaration of con-formity and keeps it together with the technical documentation, the EC design examinationcertificate,thequalitysystem approval and other relevant information at the disposal of the na-tional authorities

• affixestheCEMarking• affixes,undertheresponsibilityofthe

notifiedbody,thelatter’sidentificationnumber

NotifiedBody

• examines the product design • issues an EC design examination cer-

tificate• performs periodic audits in order to

assess and survey the quality system • Audits include: review of the technical

documentation, control of the quality system, inspections, product tests

• notifiesitsdecisionaboutthequalityassurance system to the manufacturer (thenotificationshallcontainthecon-clusions of the audit and the reasoned assessment decision)

• keeps record of its decisions and other relevant information

• informs its notifying authorities and the other bodies about the quality system and EC-design examinations it has performed

118

Quality requirements re-ferred to under modules of Decision 768/2008

Module D Module D1 Module E Module E1 Module H Module H1

the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

ENISO9001:2008,§5.1,§5.3,§5.4,§5.5,§5.6(without§5.6.2.b–cus-tomer feed-back)

ENISO9001:2008,§5.1,§5.3,§5.4,§5.5,§5.6(without§5.6.2.b–cus-tomer feed-back)

EN ISO 9001:2008, §5.1,§5.3,§5.4(withoutreferenceto§7.1),§5.5,§5.6(without§5.6.2.b–customer feed-back)

EN ISO 9001:2008, §5.1,§5.3,§5.4(withoutreferenceto§7.1),§5.5,§5.6(without§5.6.2.b–customer feed-back)

ENISO9001:2008,§5.1,§5.3,§5.4,§5.5,§5.6(without§5.6.2.b–cus-tomer feed-back)

ENISO9001:2008,§5.1,§5.3,§5.4,§5.5,§5.6(without§5.6.2.b–cus-tomer feed-back)

• the technical design Not relevant - Module D does not cover the design phase

Not relevant – under module D1, design issues are covered by means of technical documentation

Not relevant - Module E does not cover the design phase

Not relevant – under module E1, design issues are covered by means of technical documentation

EN ISO 9001:2008, §7.3.1,§7.3.2,§7.3.3

EN ISO 9001:2008, §7.3.1,§7.3.2,§7.3.3

• the design control and designverificationtechniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered

Not relevant - Module D does not cover the design phase

Not relevant – under module D1, design issues are covered by means of technical documentation

Not relevant - Module E does not cover the design phase

Not relevant – under module E1, design issues are covered by means of technical documentation

ENISO9001:2008,§7.3.4-§7.3.7

ENISO9001:2008,§7.3.4-§7.3.7

• the corresponding manu-facturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

EN ISO 9001:2008, §7.5.1,§7.5.2,§7.5.3

EN ISO 9001:2008, §7.5.1,§7.5.2,§7.5.3

Not relevant - module E does not cover the manu-facturing part

Not relevant - module E1 does not cover the manufacturing part

EN ISO 9001:2008, §7.5.1,§7.5.2,§7.5.3

EN ISO 9001:2008, §7.5.1,§7.5.2,§7.5.3

• the examinations and tests that will be carried out and

• the means of monitoring theeffectiveoperationofthe quality system.

ENISO9001:2008,§7.6,§8.2.2,§8.2.3,§8.2.4(onlyfirstparagraph),§8.3,§8.4(without§8.4.a-customersatisfaction),§8.5

ENISO9001:2008,§7.6,§8.2.2,§8.2.3,§8.2.4(onlyfirstparagraph),§8.3,§8.4(without§8.4.a-customersatisfaction),§8.5

ENISO9001:2008,§7.6,§8.2.2,§8.2.3,§8.2.4(onlyfirstparagraph),§8.3,§8.4(without§8.4.a-customersatisfaction),§8.5

ENISO9001:2008,§7.6,§8.2.2,§8.2.3,§8.2.4(onlyfirstparagraph),§8.3,§8.4(without§8.4.a-customersatisfaction),§8.5

ENISO9001:2008,§7.6,§8.2.2,§8.2.3,§8.2.4(onlyfirstparagraph),§8.3,§8.4(without§8.4.a-customersatisfaction),§8.5

ENISO9001:2008,§7.6,§8.2.2,§8.2.3,§8.2.4(onlyfirstparagraph),§8.3,§8.4(without§8.4.a-customersatisfaction),§8.5

• the quality records, such as inspection reports and test data, calibra-tiondata,qualificationreports on the personnel concerned, etc.

ENISO9001:2008,§4 ENISO9001:2008,§4 ENISO9001:2008,§4 ENISO9001:2008,§4 ENISO9001:2008,§4 ENISO9001:2008,§4

10.5. ANNEX 5 - 10.5. RELATION BETWEEN ISO 9000 AND MODULES REQUIRING A QUALITY ASSURANCE SYSTEM

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10.6. ANNEX 6 - USING HARMONISED STANDARDS TO ASSESS THE COMPETENCE OF CONFORMITY ASSESSMENT BODIES

Please note that the annex below is indicative guidance only. It does not lay down procedures for assessing the competence of Conformity Assessment Bodies.

1. REQUIREMENTS ON CONFORMITY ASSESSMENT BODIES

A conformity assessment body wishing to be notified under an Union harmonisation act for one or several conformity assess-ment modules of Decision No 768/2008/EC has to be assessed in order to determine if it is technically competent to carry out the tasks required by the module(s) in question.

Equally important is the continuous surveillance of the competence of the notified body. This must be done at regular intervals and follow the practice established by the accreditation organisations.

The assessment process must determine if the conformity assessment body has adequately trained technical staff with knowl-edge and experience of the relevant technology, suitable facilities and equipment, policies and procedures to ensure integrity and impartiality, correct understanding of the directive etc.

Conformity assessment includes activities such as testing (carried out by laboratories), inspection, certification etc. Inspection and product certification can be considered similar and there is some overlapping in the definitions. They both go beyond simple testing by including tasks related to the ability to assess test results and decide on conformity. They pursue the same goal (i.e. the assessment of the conformity of a product) in slightly different ways.

Generally, inspection involves direct determination of the conformance with specifications of unique or small series products. Product certification primarily involves determination of the conformance of products manufactured in long series.

In practice, inspection may also involve professional judgement on the basis of general requirements, while product certification is done against standards or other technical specifications.

Thus different criteria apply to conformity assessment bodies depending on whether the latter are laboratories, inspection bodies or certification bodies.

2. SET OF CORE STANDARDS SETTING OUT COMPETENCE CRITERIA FOR CONFORMITY ASSESSMENT BODIES

The general criteria, independent of the sector in question, that notified bodies must fulfil in order to be positively assessed are set out in harmonised standards published in the Official Journal of the EU following mandate M417. Sectoral legislation may, if necessary, lay down additional specific criteria related to the knowledge of the sector a body must have.

EN ISO/IEC 17025, EN ISO/IEC 17020, EN ISO/IEC 17021, EN ISO/IEC 17065 are the core standards for assessing the competence of conformity assessment bodies. EN ISO/IEC 17020, EN ISO/IEC 17065 focus on criteria for performing conformity assessment, while EN ISO/IEC 17025 tackles in more detail the testing aspect.

- EN ISO/IEC 17025 (applies to laboratories - replaces EN 45001 and ISO Guide 25) sets out the general requirements a laboratory (first-, second- and third-party and regardless of the number of personnel or the extent of the scope of activities) must meet if it is to be recognised as competent to carry out testing and/or calibration including sampling (sampling was not tackled by ISO 45001).

These activities involve determining one or several characteristics of a product according to a defined method (can be standard, non-standard methods, laboratory-developed). Compliance of the operation of laboratories with regulatory and safety require-ments is not covered by this standard.

When a laboratory does not undertake one or more of the activities covered by this International Standard, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.

- EN ISO/IEC 17020 (applies to inspection bodies - replaces EN 45004). This standard specifies general criteria for the competence of impartial bodies performing inspection irrespective of the sector involved.

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Inspection involves examination of a product design, product, service, process or plant and determination of their conformity with specific requirements or, on the basis of professional judgement, general requirements. It also specifies independence criteria. This standard does not cover testing laboratories, certification bodies or the supplier’s declaration of conformity.

- EN ISO/IEC 17065 (applies to certification bodies – replaces EN 45011) specifies the general requirements that a third party operating a product certification system shall meet if it is to be recognised as competent and reliable.

Product certification entails giving assurance that a product conforms to specified requirements such as regulations, standards or other technical specifications. A product certification system can include e.g. type testing or examination, testing or inspection of every product or of a particular product, batch testing or inspection, design appraisal, which could be coupled with production surveillance or assessment and surveillance of the manufacturer’s quality system. This standard does not cover testing labora-tories, inspection bodies or the supplier’s declaration of conformity.

- ISO/IEC 17021 (replacing EN 45012) contains principles and requirements for the competence and impartiality of bod-ies performing audit and certification of management systems of all types (e.g. quality management systems or environmental management systems).

Bodies operating according to this standard are not obliged to offer all types of management system certification. Quality sys-tem certification involves the assessment, determination of conformity against a quality system standard and within a certain scope of activity and surveillance of the manufacturer’s quality system.

3. APPROPRIATE STANDARDS RELATED TO THE COMPETENCE OF CONFORMITY ASSESS-MENT BODIES FOR EVERY MODULE

The sections below describe which of the above standards are the most appropriate for the tasks in the modules as laid down in the Decision No 768/2008/EC.

3.1 Modules A1, A2, C1, C2Under these modules the body must have the technical knowledge, experience and ability in carrying out tests. Even if the test equipment is situated with the manufacturer, requirements on the equipment’s suitability, functioning, maintenance (e.g. calibra-tion programmes) and measurement traceability must be ensured and should be considered as the responsibility of the notified body. Furthermore, if the manufacturer has not applied the relevant harmonised standards, equivalent tests must be carried out, or failing this, appropriate methods must be developed. In either case, the notified body must validate the tests used.

For A2, C2 the body must in addition be able to deal with statistical methods, sampling plan, random methods, operational char-acteristics, that are included in the product checking and specified by the applicable Union harmonisation legislation.

In this respect and for all these modules, as EN ISO/IEC 17025, EN ISO/IEC 17020 or EN 45011 (depending if the body in ques-tion is a laboratory, inspection body, product certification body) lay down the competence and deontology criteria for performing product examination, their requirements can be considered as the most appropriate for the assessment of the bodies seeking notification for carrying out the tasks in this module.

However, if the assessment is based on EN ISO/IEC 17025 and as this standard lays down criteria only for testing/calibration without tackling the evaluation of test results by the notified body, the latter must demonstrate separately its capability of and procedures for judging and deciding, based on the results of the tests, if the essential or other legal requirements are fulfilled and/or the harmonised standards have been applied.

On the other hand if EN ISO/IEC 17020 or EN ISO/IEC 17065 are used and as these standards do not tackle criteria for testing/calibration, the requirements on testing activities as set out in EN ISO/IEC 17025 must be taken into account. In all cases the notified body must have the capability of assessing a product regardless of whether the manufacturer has applied relevant harmonised standards or not.

3.2 Module BThe notified body must determine if the product design complies with the relevant legislative requirements.

In this respect stand-alone EN ISO/IEC 17025 must be regarded as not being appropriate for the purpose of module B. The reason is that this standard tackles only pure testing issues and does not cover the important functions of module B con-cerning evaluation of product design, which due to its complexity (it goes well beyond the mere examination of technical documentation as in modules D1, E1, F1) requires from the notified body additional competencies (similar to modules G, H1)

The requirements in both EN ISO/IEC 17020 and EN ISO/IEC 17065 can be considered as appropriate for the assessment of bod-ies seeking notification for carrying out the tasks in module B, because these standards lay down the competence and deontology criteria for performing product examination and conformity assessment. However, as these standards do not tackle criteria for

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testing/calibration, the relevant requirements in EN ISO/IEC 17025 must always be taken into account for the testing required. 3.3 Modules D, D1, E, E1, HThe notified body assesses and decides if the manufacturer’s quality system ensures that the products are in conformity with or ensure compliance with the legislative instrument that apply to them (in case of modules D1, E1, H) or with the approved EC-type (in case of modules D, E).

Thus, the requirements in EN ISO/IEC 17021 can be considered as the most appropriate for the assessment of the bodies seek-ing notification for carrying out the tasks in this module. It must be underlined that the operation of the manufacturer’s quality system must ensure the conformity of the final products with the requirements of the applicable Union harmonisation legislation. Therefore, the notified body must have, in addition, adequate capability of assessing the manufacturer’s ability to identify rele-vant product requirements and carry out the necessary inspections and tests.

3.4 Modules F, F1The notified body carries out the appropriate examinations and tests either by examination and testing of every product or by examination and testing of products on a statistical basis. Under module F1, the notified body must in addition examine the technical documentation.

In this respect and for all these modules, as EN ISO/IEC 17025, EN ISO/IEC 17020 or EN ISO/IEC 17065 (depending on whether the body in question is a laboratory, inspection body, product certification body) lay down the competence and deontology criteria for performing product examination, their requirements can be considered as the most appropriate for the assessment of the bodies seeking notification for these modules.

It must be noted that although EN ISO/IEC 17025 does not tackle the examination of product design and although module F1 also covers the design phase, this standard, even stand-alone, remains appropriate for this module: the reason is that design examination under F1 is relatively simple, and is performed only by means of examination of technical documentation and not by means of examination of any specimen or any critical parts of the design that would require additional competences from the notified body as is the case with modules B (or G -see below).

However, if the assessment is based on EN ISO/IEC 17025, and as this standard lays down criteria only for testing/calibration without tackling the evaluation of test results by the notified body, the latter must demonstrate separately its capacity and procedures for judging and deciding, based on the results of the tests, if the essential requirements are fulfilled and/or the har-monised standards have been applied.

On the other hand if EN ISO/IEC 17020 or EN ISO/IEC 17065 are used, and as these standards do not tackle criteria for testing/calibration, the requirements on testing activities as set out in EN ISO/IEC 17025 must be taken into account. In all cases the notified body must have the capability of assessing a product regardless of whether the manufacturer has applied relevant harmonised standards or not.

3.5 Module GThe notified body examines the complete individual product in both design and production phase.

In this respect stand-alone EN ISO/IEC 17025 must be regarded as not being appropriate for the purpose of module G. The rea-son being that this standard tackles only pure testing issues and does not cover the important functions of module G concerning evaluation of product design, which due to its complexity (it goes well beyond the mere examination of technical documentation as in modules D1, E1, F1) requires from the notified body additional competencies (similar to modules B, H1).

The requirements in both EN ISO/IEC, 17020 or EN ISO/IEC 17065 can be considered as appropriate for the assessment of bodies seeking notification for carrying out the tasks in module G, because these standards lay down the competence and deontology criteria for performing product examination and conformity assessment. However, as these standards do not tackle criteria for testing/calibration, the relevant requirements in EN ISO/IEC 17025 must be always taken into account for the testing required.

3.6 Module H1The notified body assesses and decides if the manufacturer’s quality system ensures that the products are in conformity with the legislative instrument(s) applying to them. Furthermore it examines the manufacturer’s technical design specifications, including the necessary supporting evidence and the result of tests carried out by the manufacturer.

Thus, the requirements in EN ISO/IEC 17021 can be considered as the most appropriate for the assessment of the bodies seeking notification for this module. It must be underlined that the operation of the manufacturer’s quality system must ensure the con-formity of the final products with the requirements of the applicable Union harmonisation legislation. Therefore, the notified body must have, in addition, adequate capability of assessing the manufacturer’s ability to identify relevant product requirements and carry out the necessary inspections and tests.

In addition, as the notified body also examines the product design in order to certify it by issuing a EC-design examination cer-tificate, the requirements in both EN ISO/IEC 17020 or EN ISO/IEC 17065 can be considered as appropriate for the assessment

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of bodies seeking notification under module H1, because these standards lay down the competence and deontology criteria for performing product examination and conformity assessment. However, as these standards do not tackle criteria for testing/cali-bration, the relevant requirements in EN ISO/IEC 17025 must be always taken into account for the testing required.

In this respect it must be noted that stand-alone EN ISO/IEC 17025 must be regarded as not being appropriate for the purpose of module H1. The reason is that this standard tackles only pure testing issues and does not cover the important functions of mod-ule H concerning evaluation of product design, which due to its complexity (it goes well beyond the mere examination of technical documentation as in modules D1, E1, F1) requires from the notified body additional competencies (similar to modules B, G).

Thus for module H1 the notified body should be assessed according to the requirements in EN ISO/IEC 17021 (together with product related knowledge) in combination with EN ISO/IEC 17020 or EN ISO/IEC 17065.

4. SummaryThe table that follows reflects the desired approach to the choice of standards for the different modules. EA is in parallel prepar-ing a similar table that may at present differ in certain aspects due to divergent practices in Member States. EA’s table will be brought in line with the table below in the medium term:

• For those Directives where an Alignment to Decision No 768/2008/EC is currently under way, the table below will replace EA’s current table when conformity assessment bodies have to be notified for the new aligned legislation.

• For legislation, where the Alignment has already taken place or is not currently under way, the table below should be applied at the latest five years after 1 May 2016.

Module EN Standard(s) applicable

A1, A2 EN ISO/IEC 17025 (+ability to decide on conformity), orEN ISO/IEC 17020 (EN ISO/IEC 17025 to be taken into account for testing required), orEN ISO/IEC 17065 (EN ISO/IEC 17025 to be taken into account for testing required)

B EN ISO/IEC 17020 (EN ISO/IEC 17025 to be taken into account for testing required), orEN ISO/IEC 17065 (EN 17025 to be taken into account for testing required)

C1, C2 C1, C2EN ISO/IEC 17025 (+ability to decide on conformity), orEN ISO/IEC 17020 (EN ISO/IEC 17025 to be taken into account for testing required), orEN ISO/IEC 17065 (EN ISO/IEC 17025 to be taken into account for testing required)

D, D1 EN ISO/IEC 17021 (+product related knowledge)

E, E1 EN ISO/IEC 17021(+product related knowledge)

F, F1 EN ISO/IEC 17025 (+ability to decide on conformity), orEN ISO/IEC 17020 (EN 17025 to be taken into account for testing required), orEN ISO/IEC 17065 (EN 17025 to be taken into account for testing required)

G EN ISO/IEC 17020 (EN 17025 to be taken into account for testing required), orEN ISO/IEC 17065 (EN 17025 to be taken into account for testing required)

H EN ISO/IEC 17021 (+product related knowledge)

H1 EN ISO/IEC 17021 (+product related knowledge) + EN ISO/IEC 17020 (EN ISO/IEC 17025 to be taken into account for testing required),orEN ISO/IEC 17021 (+product related knowledge) + EN ISO/IEC 17065 (EN ISO/IEC 17025 to be taken into account for testing required)

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10.7. ANNEX 7 - FREQUENTLY ASKED QUESTIONS ON CE MARKING

What does the CE marking on a product indicate?By affixing the CE marking to a product, the manufacturer declares on his sole responsibility that the product is in conformity with the essential requirements of the applicable Union harmonisation legislation providing for its affixing and that the relevant conformity assessment procedures have been fulfilled. Products bearing the CE marking are presumed to be in compliance with the applicable Union harmonisation legislation and hence benefit from free circulation in the European Market.

Is a product affixed with the CE marking always produced in the EU?No. The CE marking only signals that all essential requirements have been fulfilled when the product was manufactured. The CE marking is not a mark of origin, as it does not indicate that the product was manufactured in the European Union. Consequently, a product affixed with the CE marking may have been produced anywhere in the world.

Are all CE marked products tested and approved by authorities?No. In fact, the assessment of the conformity of the products with the legislative requirements applying to them is the sole responsibility of the manufacturer. The manufacturer affixes the CE marking and drafts the EU Declaration of Conformity. Only products which are regarded as presenting a high risk to the public interest, e.g. pressure vessels, lifts and certain machine tools, require conformity assessment by a third party, i.e. a notified body.

Can I, as a manufacturer, affix my products with the CE marking myself?Yes,theCEmarkingisalwaysaffixedbythemanufacturerhimselforhisauthorisedrepresentativeafterthenecessaryconform-ity assessment procedure has been performed. This means that, before being affixed with the CE marking and being placed on the market, the product must be subject to the conformity assessment procedure provided for in one or more of the applicable Union harmonisation acts. The latter establish whether the conformity assessment may be performed by the manufacturer him-self or if the intervention of a third party (the notified body) is required.

Where should the CE marking be affixed?The marking shall be affixed either to the product or to the product’s data plate. When that is not possible due to the nature of the product, the CE marking shall be affixed to the packaging and/or to any accompanying documents.

What is a manufacturer’s Declaration of Conformity?The EU Declaration of Conformity (EU DoC) is a document in which the manufacturer, or his authorised representative within the European Economic Area (EEA), indicates that the product meets all the necessary requirements of the Union harmonisation legislation applicable to the specific product. The EU DoC shall also contain the name and address of the manufacturer along with information about the product, such as the brand and serial number. The EU DoC must be signed by an individual working for the manufacturer or his authorised representative, and the employee’s function shall also be indicated.Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EE Declaration of Conformity.

Is CE marking mandatory, and if so; for what products?Yes,CEmarkingismandatory.However,onlytheproductsthatarecoveredbythescopeofoneormoreoftheUnionharmonisa-tion acts providing for CE marking shall be affixed with it in order to be placed on the Union market. Examples of products that fall under Union harmonisation acts providing for CE marking are toys, electrical products, machinery, personal protective equipment and lifts. Products that are not covered by CE marking legislation shall not bear the CE marking.Information the products that are CE marked and the Union harmonisation legislation providing for CE Marking under http://ec.europa.eu/CEmarking/ and http://ec.europa.eu/enterprise/policies/single-market-goods/regulated-sectors/index_en.htm

What is the difference between the CE marking and other markings, and can other markings be affixed on the product if there is a CE marking?The CE marking is the only marking that indicates conformity to all the essential requirements of the Union harmonisation legis-lation that provide for its affixing. A product may bear additional markings provided that they do not have the same significance as the CE marking, that they are not liable to cause confusion with the CE marking and that they do not impair the legibility and visibility of the CE marking. In this respect, other markings may be used only if they contribute to the improvement of consumer protection and are not covered by harmonisation legislation of the European Union.

Who supervises the correct use of the CE marking?In order to guarantee the impartiality of market surveillance operations, the supervision of the CE marking is the responsibility of public authorities in the Member States in cooperation with the European Commission.

What are the sanctions for counterfeiting the CE marking?The procedures, measures and sanctions that apply to counterfeiting of the CE marking are laid down in Member State’s national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation before being obliged to

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take the product off the market.What implications may the affixing of the CE marking have for the manufacturer/importer/distributor?While manufacturers are responsible for ensuring product compliance and affixing the CE marking, importers and distributors also play an important role in making sure that only products complying with legislation and bearing the CE marking are placed on the market. Not only does this help to reinforce the EU’s health, safety and environmental protection requirements, it also supports fair competition with all players being held accountable to the same rules.

When products are produced in third countries and the manufacturer is not represented in the EEA, importers must make sure that the products placed by them on the market comply with the applicable requirements and do not present a risk to the Eu-ropean public. The importer must verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request.

Thus, importers must have an overall knowledge of the respective Union harmonisation acts and are obliged to support national authorities should problems arise. Importers should have a written assurance from the manufacturer that they will have access to the necessary documentation – such as the EU Declaration of Conformity and the technical documentation – and be able to provide it to national authorities, if requested. Importers should also make sure that contact with the manufacturer can always be established.

Further along in the supply chain, distributors play an important role in ensuring that only compliant products are on the market and must act with due care to ensure that their handling of the product does not adversely affect its compliance. The distributor must also have a basic knowledge of the legal requirements – including which products must bear the CE marking and the ac-companying documentation – and should be able to identify products that are clearly not in compliance.

Distributors must be able to demonstrate to national authorities that they have acted with due care and have affirmation from the manufacturer or the importer that the necessary measures have been taken. Furthermore, a distributor must be able to assist the national authority in its efforts to receive the required documentation.

If the importer or distributor markets the products under his own name, he then takes over the manufacturer’s responsibilities. In this case, he must have sufficient information on the design and production of the product, as he will be assuming the legal responsibility when affixing the CE marking.

Where can I find more information?Information about CE marking, the products that are CE marked, the Union harmonisation legislation providing for CE Marking and the steps to follow under http://ec.europa.eu/CEmarking/ and http://ec.europa.eu/enterprise/policies/single-market-goods/regulated-sectors/index_en.htm

Economic operators may contact the Enterprise Europe Network under http://www.enterprise-europe-network.ec.europa.eu/

The ‘Blue Guide’ on the implementation of EU product rules 2014

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EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Standardisation

Brussels, 6th April 2005 D(2005) C2/MJE/IG –D (2005) 7049

Guidelines for the publication of references of standards

in the Official Journal of the European Union

Introduction

The objective of this document is to assist the Commission services (EC sectorial units and unit ENTR-Standardisation) with guidelines on the way to handle the publication of the references of harmonised standards in the Official Journal.

Part I of these guidelines "Practical steps" explains the different procedures to be followed regarding the publication of the references of harmonised standards in the Official Journal. The explanations on what needs to be done by whom, and which concrete actions are to be taken, are presented in a questions and answers format.

Part II “Clarifications on the harmonised layout", provides explanations regarding a uniform harmonised template, to be used by the European Standards organisations (ESO) and the Commission services. The harmonised template itself is attached in the Annex.

The titles of the harmonised standards in Icelandic and Norwegian are to be published the same way in the EEA Supplement of the OJ as it is for the publication within the EU.

The harmonised template is made available by the EC/ENTR-Standardisation unit on its Intranet pages in all official EU languages.

Content :

Part I Practical steps p. 2-11 Part II Clarifications on the harmonised layout p. 12-15 Part III Useful links p. 16 Annex 1 Harmonised model p. 17-18 Annex 2 Contact details of EC units, EFTA and ESOs p. 19-25

U:\PRS\Michel Jeanson\References of EN in OJEU\Process and guidelines\2005-04-06 - Guidance document.pdf Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel - Belgium. Telephone: (32-2) 299 11 11. Office: SC15 2/168. Telephone: direct line (32-2) 2968994 Fax (32-2)2991675 E-mail: Ingrid.Gillisjans@cec.eu.int

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Part 1 Practical steps

1. How is the process of publication of the references of harmonised standards initiated?

The ESO send the references of adopted harmonised standards, in electronic format, to the Commission (ENTR-Standardisation Unit and EC sectorial units) with a copy to the EFTA secretariat. The list of e-mail addresses to be used is given in annex 2.

2. What is the content of the mailing?

The mailing consists of a formal letter from the ESO to the Commission and a list, for each directive and in all EU languages, of the references of harmonised standards to be published in the OJ.

In addition, it is desirable that the mailing includes more detailed information (sorted by directive) about new references (i.e. references of harmonised standards which are presented for the first time). This information enables the EC sectorial units to identify references of all new standards. The data for each new standard consists of their respective identification number with the year of availability, the title of the standard, the date of availability and number of the mandate under which the work is done. Moreover, in the case of the presentation of a consolidated list (see 8.2), it is also suitable that the ESO communicates the ‘out of date’ standards (those deleted from the consolidated list). This list of ‘out of date’ standards, standards for which the date of cessation of presumption of conformity has passed, should be given in a separate section of mailing of the ESO.

3. Which checks does the EC sectorial unit have to make?

The sectorial unit has to make checks for each standard, the references of which are presented by the ESO for publication in the Official Journal on the following two levels: a) on the presentation of the data:

- has the list been provided in all official EU languages? - has the format and the uniform layout been kept ? (see part 2 and annex 1)

b) on the conformity of the content:

- is the standard covered by the relevant directive? - is the standard subject to the relevant mandate? - does the standard include an indication of the relationship between the clauses of the

standard and the essential requirements?

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(see “Role, elaboration and follow-up of mandates” documents which are available in the “Vademecum on European Standardisation” on the European Commission Enterprise DG Standardisation website at : http://europa.eu.int/comm/enterprise/standards_policy/vademecum/index.htm)

As a general rule, the Commission should not review the technical adequacy of the content of a standard. The ESO are responsible for the content and are expected to deliver correct data. Their procedures should ensure that the translated titles, as presented, refer to the correct identification number of the standard.

On the other hand, the sectorial units have to be aware that the publication of references of harmonised standards in the Official Journal has a legal effect and thus errors have to be avoided.

The full text of European standards is available as follows: – CEN standards: The EC sectorial units can obtain on line access rights to the “CEN

Standard Database” where full texts of standards are available for internal use in the Commission. Request for a password are to be sent to ENTR-Standardisation Unit (entr-standardisation@cec.eu.int );

– CENELEC standards (including IEC standards): CENELEC has provided entry rights to ENTR-Standardisation Unit to use the CENELEC on line access to its library. The EC sectorial units can obtain the text of a CENELEC standard (or, if needed, a password to access the CENELEC library) by sending their request to ENTR-Standardisation (entr-standardisation@cec.eu.int) ;

– ETSI standards: ETSI makes the text of ETSI standards publicly available. The ETSI standards are downloadable free of charge via their web site at http://www.etsi.org .

It has to be underlined that the full text of the CEN and CENELEC standards may only be used for internal Commission and internal EFTA purposes and may not be distributed. More information for Commission staff on “how to obtain the access rights” is available on the ENTR Standardisation unit’s website on the Intranet.

4. What must the EC sectorial unit do if one of the above-mentioned criteria is not followed for one or more standards of a given list?

If one of the criteria is not followed, the sectorial unit should NEITHER publish NOR modify the document but return it without delay by a formal letter to the ESO for revision. A decision has to be made by the sectorial unit to send back the whole list or to continue with the publication of the “valid” standard(s). ENTR-Standardisation should always be informed. Thereafter, the European Standards Organisation concerned will retransmit the revised version (either the standard or the list) to the Commission (both to ENTR Standardisation Unit and the sectorial units) for publication.

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Delays in publication should be avoided as far as possible. The presumption of conformity is delayed until the references of a standard are published in the Official Journal. When the EC sectorial unit requests the respective European Standards Organisation to correct the titles or any other data, a precise deadline should be indicated in order to prevent postponements in the publication. In a case where, to the knowledge of the Commission services, the content of a standard may pose a problem, the best means to avoid unnecessary delays in publication, is to look at the standard at the stage of enquiry and/or prior to its final adoption. The problem should be addressed as a proactive measure.

5. What does the EC sectorial unit do, if it becomes aware that a standard would be challenged?

In principle, publication can only be postponed if there is a formal objection against a standard presented in accordance with the pertinent procedure laid down in the directive concerned.

Where, exceptionally, the Commission has substantiated indications, in particular from a Member State, that a standard in question may present a problem in compliance with the Directive, it is recommended to seek clearance before going for publication. ∗

The follow up in such case could be: – discussion with the plaintiff or the challenging Member State; – discussion with the working party/expert group/committee of the Directive; – discussion with the responsible European Standardisation Organisation; – discussion with the 98/34/EC Committee.

This informal search for clearance could clarify whether there would be really a need to proceed with a formal objection procedure.

The outcome of this investigation could result in one of the three alternatives: 1. the standard is adequate and the procedure for publication can continue; 2. the relevant European Standardisation Organisation is prepared to reconsider the

standard; 3. the Commission or a Member State decides to proceed with a formal objection

procedure (see below).

For more guidance on the administrative procedure “Formal objection to a standard”, please refer to document n° 49/99rev2 of the Committee of Standards and Technical Regulations. This document is available in the Vademecum on European Standardisation on the European Commission Enterprise DG Standardisation Policy website at http://europa.eu.int/comm/enterprise/standards_policy/vademecum/index.htm

∗ It would help if the ESO prepares an informative summary table about the steps concerning standards under revision or development. EC sectorial units could then become more pro-active and they could intervene earlier.

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The sectorial unit should inform the relevant European Standards Organisation (with informative copy to ENTR Standardisation Unit) about the problems encountered. This should be done by an official letter at an early stage.

Every formal objection against a standard will be subject of decision (acceptance or rejection) on the part of the Commission. Any Commission decision regarding the acceptance of a formal objection to a standard will be published in the Official Journal L series. Therefore in the case of publication of a consolidated list of references of harmonised standards in the Official Journal (C series), all Commission decisions, related to complete withdrawal or partial publication, should be taken into account. The EC services have to be vigilant.

6. What has to be done if a “mistake” is published in the Official Journal?

In the case of apparent inaccuracies and errors with regard to the published information in the Official Journal, the Commission (EC sectorial unit) has to initiate a corrigendum. Such errors may concern e.g. translation errors, references of standards which have been published by mistake, omission. If the source of such an error is within the European Standards Organisation, the EC sectorial unit should return to the relevant ESO (with an informative copy to ENTR Standardisation Unit) and ask for correction as soon as possible.

If the error is limited to a given language, it is recommended to publish this corrigendum in that particular language version.

Please note that such a “corrigendum” procedure cannot be used if a standard presents a problem in its content. In this case the formal objection procedure against a standard should apply (see clause 5 above).

7. Who requests the publication in the OJ?

The EC sectorial unit transmits the list of references of harmonised standards for each Directive (in all official EU languages) to the Secretariat General ( SG-Publications-au-JO@cec.eu.int ) via electronic mail only, with copy to ENTR Standardisation Unit ( entr-standardisation@cec.eu.int ).

Publication is considered as an administrative matter which is initiated by the responsible EC services.

The references are published by the Publications Office in the C series of the Official Journal under the item Commission communication (normally about one week after transmission by the sectorial units to SG).

As soon as the references of harmonised standards are published in the OJ, the updates are made available by ENTR-Standardisation Unit on the "New Approach-Harmonised

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Standards" website at http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/index_en.html .

8. What has to be understood by “List of new harmonised standards” and “Consolidated list of harmonised standards”?

8.1 List of new harmonised standards

It may be possible that, from time to time, a sectorial unit receives a list containing only “new” harmonised standards. These “new” harmonised standards could be either really brand new standards or could be revisions, replacing existing harmonised standards, or amendments to existing standards, the references of which have already been published. The references of each of these new harmonised standards will appear for the first time in the OJ. For this reason this publication is called “First” or “Initial” publication of the references of a harmonised standard.

To obtain an overview of all valid harmonised standards, two cases have to be considered:

a. There has never been a publication of a consolidated list (see 8.2): the set of all published lists of new harmonised standards gives a complete overview of all harmonised standards, valid at that moment for a given directive.

b. There has previously been a publication of a consolidated list: the last consolidated list, together with all lists of new harmonised standards published since the publication of that consolidated list, gives the complete overview of all harmonised standards valid at that moment for a given directive.

In order to enable the manufacturers to have this complete overview, each list of new harmonised standards should indicate at its end the references of the OJ, in which all such previous lists were published. It has to be underlined that each sectorial unit should keep a complete overview of all their publications of the lists they made.

8.2 Consolidated list of harmonised standards

In order to improve visibility and to facilitate the tasks for manufacturers and other interested parties, it is recommended to publish a consolidated list of harmonised valid standards at least once per year. A consolidated list is a list of all harmonised standards that give presumption of conformity at a certain moment (normally on the date of publication of this list in the OJ) in a given sector. It is up to the ESOs to provide such a consolidated list.

No ‘out of date’ harmonised standards may appear anymore in a consolidated list. A consolidated list replaces the whole set of previous valid lists (previous consolidated list and all lists of new harmonised standards published since the publication of the last consolidated list).

It has to be noted that a harmonised standard can in principle only be considered out of date:

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- when it has been revised and under condition that its date of cessation of presumption has passed or

- when a Commission Decision (following a formal objection) has withdrawn its references from the OJ.

It has to be indicated at the end of a consolidated list that it replaces all previous lists. (It would be useful if the sectorial units keep a complete overview of these previous lists in their field of competence.)

It is preferable, from the point of view of the Commission, that the ESO provide only consolidated lists. The ESO should co-ordinate when they send lists of standards giving presumption of conformity to a same directive. These lists should arrive simultaneously at the Commission, in order to provide a simultaneous publication in the OJ.

9. What information is to be provided by the ESO ?

Information to be provided by the ESO is the information, necessary to identify a standard in a unique way and to inform the users on the applicability of the presumption of conformity.

The information which is required is as follows: (see part 2)

[1] ESO: (see column 1 of model) the acronym of the European Standardisation Organisation: CEN, CENELEC, ETSI.

[2] Reference and title of the harmonised standard (and reference document): (see column 2 of model) reference: identification number of the standard including its year of availability, presented according to the rules of the ESO; title of the harmonised standard: title of the standard ( in all official EU languages); reference document: the reference document (e.g. ISO standard, IEC standard), if applicable, based upon which the harmonised standard has been established

The reference of Amendments (or corrigenda) shall be put in the same cell as the reference of the standard that they amend (or correct).

It is up to the ESO to send references of Corrigenda to standards to the EC for publication in the OJ. CEN will systematically send these references to corrigenda, whilst CENELEC will do it on a case by case basis.

In case of a consolidated list of references of harmonised standards or if there are revised or amended standards, the following supplementary information can be presented: (additional columns 3 to 4 of model on p.13 can be completed):

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[3] Reference of the superseded standard: (see column 3 of model) if the standard, for which publication of the references has been requested, replaces an existing harmonised standard: the reference of the old harmonised standard.

[4] Date of cessation of presumption of conformity of superseded standard Note 1: (see column 4 of model) If a harmonised standard, for which the publication of the references in the OJ has been requested by the ESO, replaces an existing harmonised standard, the date when the presumption of conformity of this existing standard finishes is called the “date of cessation of conformity of superseded standard”.

The ESO indicate in column 4 the date of cessation of presumption of conformity. As a general rule, this date of cessation is identical to the date of withdrawal as determined by the ESO, i.e generally equal to the date of availability of the standard (dav) + 6 months for CEN standards and up to the date of ratification (dor) + 36 months for CENELEC standards. However, in exceptional cases, the date of cessation may need to be sooner or later than the date of withdrawal as proposed by the ESO. In such cases, the determination of the date of cessation belongs to the responsibility of the Commission services. In exceptional cases, the ESO, on request of a Technical Committee may propose a date of cessation of presumption of conformity which goes beyond usual limits. These exceptional delays should however not exceed, as a general rule, a period of 36 months after the date of availability.

Special case: For LVDa standards containing a "certification clause" - in the mean time abandoned - there is a transitional arrangement where the date of cessation is equal to the end date of this "certification clause".b

Attention has to be paid to the coherence between the date of cessation of presumption of conformity of the superseded standard and the date of the publication in the OJ. The manufacturers must not be confronted with a retroactive withdrawal of the presumption of conformity of a harmonised standard. That means that the date of cessation of presumption of conformity cannot be, as a general rule, a date prior to the date of publication of the OJ, but can only be the same date or a later date. If the date of cessation of presumption of conformity proposed by the ESO is prior to the date of publication in the OJ, the sectorial unit shall replace it with the wording “The date of this publication” in the column “date of cessation of presumption of conformity”. The

a LVD = Low Voltage Directive

b For LVD standards, there is the common understanding that the dow may exceptionally exceed dor + 36 months for those standards/amendments not altering the safety level.

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translation of the expression “The date of this publication” in all EU languages is available from ENTR-Standardisation on request.

In the case of a publication of a consolidated list, the question arises whether all data about a superseded harmonised standard (its references and its date of cessation of presumption of conformity) must be published again. As a general rule, the data of a superseded harmonised standard will only be deleted from the list when the date of publication in the OJ of this consolidated list is after the date of cessation of presumption of conformity of this harmonised standard.

[ ] Date of first publication in the Official Journal:

The date of first publication in the Official Journal marks the beginning of the presumption of conformity for the standard in question.

If a specific sector decides that there is a strong need to provide the information regarding the date of first publication in the Official Journal, this EC sectorial unit may provide for this. An additional column can be added by the EC sectorial unit, entitled “Date of first publication” (The translation into all Community languages of the expression “Date of first publication” is available from ENTR-Standardisation Unit).

The concerned EC sectorial unit should complete this column with:

– either the number (C #) and the date (D.M.YYYY) of the Official Journal, in which the references of the harmonised standard were published for the first time (for already published references of a harmonised standard);

– or with the indication “This is the first publication” if it concerns new references of a standard which are published for the first time (for new initial references).

The EC sectorial unit should verify and make sure that the required (human) resources are available within the unit to complete and to update systematically and continuously the column “Date of 1st publication in the Official Journal”.

The ESO do not provide the data concerning the “Date of 1st publication in the Official Journal” to the Commission.

In order to establish traceability for the users of the standards regarding the history of presumption of conformity, it should be possible for them to consult the previous publications in the Official Journal. For this reason each new publication in the Official Journal should indicate the references of the previous publication(s) made in the Official Journal.

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10. How are the references presented by the ESOs?

The ESO transmit the lists of references of harmonised standards in electronic format to the Commission, both to ENTR-Standardisation Unit and to the sectorial units.

The ESO present the lists as follows:

CEN and CENELEC:

– each list is given in Word format per EU language per Directive;

– these lists are transmitted for the same Directive in a compressed folder, Zip format;

The content of the lists are validated by CEN Project Managers and, if needed, by the CEN Consultants, before they are sent to EC. For CENELEC the content of the lists are also validated, where appropriate, by the Consultants before they are sent to the EC.

ETSI:

– each list is presented per EU language per Directive;

– the list is transmitted for the same Directive in a database format;

In addition to data provided according to clause 9 above, ETSI provides in each list an additional column which refers to the relevant requirements of the directive 1999/5/EC, in order to take into account the specificity of the R&TTE Directive.

It is possible that the ESO present references of single harmonised standards for initial publications.

11. What are the roles and the responsibilities (summarized) of the different actors?

ESO:

- are responsible for the content of the harmonised standards; - are responsible for the information provided for each harmonised standard; - are responsible for the quality checking of the translated titles; - are responsible for offering all references of harmonised standards to the

Commission; - transmit the references of the adopted European standards to the Commission.

Commission services:

- EC sectorial units: are responsible for the process of publication (of the references of harmonised standards offered by the ESO) in the OJ;

- ENTR-Standardisation Unit co-ordinates the work and updates the web site “New Approach – Harmonised Standards”; provides an updated list of titles of directives in all languages to the ESO; owns the model in all EU languages

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- Secretariat General: transmits the requests of the EC sectorial units to the Publications Office for publication in the Official Journal.

EFTA secretariat:

– proceeds with the publication in the EEA supplement of the OJ.

12. What is the harmonised layout for publication of references in the Official Journal?

The title of the list of references includes the following sentence “Commission Communication in the framework of the implementation of the”, and is completed by the ESO with the full official title of the concerned directive (no mention of potential amendments to the directive). A list of the titles of all concerned directives is kept updated and sent to the ESO by the EC (ENTR-Standardisation Unit). EFTA Secretariat provides the titles of directives in Icelandic and Norwegian to ESO.

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Part II Clarifications on the harmonised layout

The uniform harmonised template is to be used for the publication of consolidated lists of references of harmonised standards in the Official Journal (a special template is used for the Construction Products Directive).

The uniform harmonised layout is accompanied by a set of specific and additional notes and footnotes to be used for the publications in the Official Journal. It is the decision of the ESO whether to use these notes or not. Notes 2.1, 2.2 and 2.3 will appear in all lists provided by CENELEC. They will not appear in lists provided by CEN, unless CEN decides otherwise. Lists published in the OJ referring to a directive for which both CEN and CENELEC standards provide presumption of conformity, will include notes 2.1, 2.2 and 2.3.

The term “scope” as used in notes 2.1, 2.2 and 2.3 is to be read in the sense of “products covered by the scope of the standard”.

An electronic version of the model is provided by the Commission to the ESOs, as well as a translation, in all Community languages, of the expression “Commission Communication in the framework of the implementation of the”

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Model with clarifications

[The clarifications are edited in Arial font. The numbers of the columns [1] to [4] should not be copied.]

Commission communication in the framework of the implementation of the [full title of the directive]

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

[1]

ESO (1)

[2]

Reference and title of the harmonised standard (and reference document)

[3]

Reference of superseded

standard

[4] Date of cessation of presumption of

conformity of superseded

standard Note 1

CEN EN 71-1:1998

Safety of toys – Part 1: Mechanical and physical properties

EN 71-1:1988 31.01.2001

CENELEC EN 60079-7:2003

Electrical apparatus for explosive gas atmospheres - Part 7: Increased safety "e" (IEC 60079-7:2001)

EN 50019:2000 Note 2.1

01.07.2006

[the above data are incorporated in the table to show 2 examples]

(1) ESO: European Standardisation Organisations: – CEN: rue de Stassart 36, B-1050 Brussels, Tel.(32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be) – CENELEC: rue de Stassart 35, B-1050 Brussels, Tel.(32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org) – ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.(33) 492 94 42 00 ; fax (33) 493 65 47 16, (http://www.etsi.org)

Note 1 Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

Note 2.1 The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

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Note 2.2 The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

Note 2.3 The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

Note 3 In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

[The wording “Note 1” will always appear in the title heading of the 4th column of the template.

The table will always be followed by the above text of note 1].

[Note 2.1, 2.2, 2.3 and 3

The wording “Note 2.1”, “Note 2.1”, … , are put on the level of a standard in column 3 of template.

“Scope” as mentioned in notes 2.1, 2.2 and 2.3 has to be understood as “products covered by the scope”

The table will only be followed by the text of Note 2.1, Note 2.2, Note 2.3 or Note 3 if applicable. (For example, they will always appear in lists provided by CENELEC, and only on a case-by-case basis in lists provided by CEN)

The last column (Date of cessation of presumption of conformity of superseded standard) remains empty when the standard is a new one and/or does not supersede another harmonised standard. In such case CENELEC puts "-".The words "Not applicable" appear in column 4.]

[The notes could be followed by a concrete relevant example under the relevant directive]

Example: For EN 50014:1997, the following applies : CENELEC EN 50014:1997

Electrical apparatus for potentially explosive atmospheres – General requirements (The referenced standard is EN 50014:1997)

Amendment A1:1999 to EN 50014:1997 (The referenced standard is EN 50014:1997 +A1:1999 to EN 50014:1997)

Amendment A2:1999 to EN 50014:1997 (The referenced standard is EN 50014:1997 +A1:1999 to EN 50014:1997 +A2:1999 to EN 50014:1997)

None (There is no superseded standard)

Note 3 (The superseded standard is EN 50014:1997)

Note 3 (The superseded standard is EN 50014:1997 +A1:1999 to EN 50014:1997)

_

_

_

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NOTE:

– Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/ECa of the European Parliament and Council amended by the Directive 98/48/ECb.

– Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages.

– This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list.

– More information about harmonised standards on the Internet at http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/

[The table (list of references of harmonised standards) will always be followed at the end by the text of three of the above paragraphs (1st , 2nd and 4th §) under "NOTE".

The table will be followed by the 3rd paragraph “This list replaces …” if the publication concerns a consolidated list of references of harmonised standards. This statement should not occur if the publication concerns ‘new’ standards (brand new standards or revised standards, replacing existing harmonised standards, which references have never been published before)

In the case of an initial publication as described in 8.1, the references of all previous publications made in the Official Journal have to be listed in a footnote. Please note that only the publication of the last consolidated list, if any, and all publications made since the last consolidated list have to be mentioned.]

a OJ L 204, 21.7.1998, p.37.

b OJ L 217, 5.8.1998, p. 18.

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Part III Useful links

A “Standardisation related websites” page is available on the European Commission Enterprise & Industry DG Standardisation website on the Internet at http://europa.eu.int/comm/enterprise/standards_policy/links/index.htm Standardisation General information on Standardisation Policy on EUROPA http://europa.eu.int/comm/enterprise/standards_policy/index_en.htm New Approach Standardisation Information on standards and standards activities http://www.newapproach.org New Approach - Harmonised Standards References of harmonised standards on EUROPA http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/index_en.html CEN European Committee for Standardization http://www.cenorm.be/ CENELEC European Committee for Electro-technical Standardization http://www.cenelec.org/ ETSI The European Telecommunications Standards Institute http://www.etsi.org/ EFTA The European Free Trade Association http://www.efta.int

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Annex 1

Commission communication in the framework of the implementation of the [full title of the directive to be completed]

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

ESO (1)

Reference and title of the harmonised standard (and reference document)

Reference of superseded

standard

Date of cessation of presumption of

conformity of superseded

standard Note 1

(1) ESO: European Standardisation Organisation: – CEN: rue de Stassart 36, B-1050 Brussels, Tel.(32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be) – CENELEC: rue de Stassart 35, B-1050 Brussels, Tel.(32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org) – ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.(33) 492 94 42 00 ; fax (33) 493 65 47 16, (http://www.etsi.org)

Note 1 Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

Note 2.1 The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

Note 2.2 The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

Note 2.3 The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

Note 3 In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3)

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therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

NOTE:

– Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/ECa of the European Parliament and Council amended by the Directive 98/48/ECb.

– Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages.

– This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. [this note has only to be included in the case of a consolidated list]

– More information about harmonised standards on the Internet at http://europa.eu.int/comm/enterprise/newapproach/standardization/harm

a OJ L 204, 21.7.1998, p.37.

b OJ L 217, 5.8.1998, p. 18.

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Annex 2

Contact details of EC sectorial units dealing with publications of references of harmonised standards in OJ (under the New Approach or New Approach like directives)

DG-Unit

Head of Unit

Contact person

Directive number and area

E-mail address

ENTR.C2

M. Anselmann

M. Jeanson I. Gillisjans

Standardisation unit (co-ordinator)

Entr-Standardisation@cec.eu.int ingrid.gillisjans@cec.eu.int michel.jeanson@cec.eu.int

ENTR.I4

L. Girao

I. Guerra

88/378/EEC - 93/68/EEC Toys

Entr-textiles-fashion@cec.eu.int

ENTR.G2

V. Leoz Argüelles

M. Schmahl

93/15/EEC Explosives for civil uses

Entr-Chemicals@cec.eu.int

J. Renders

94/25/EC – 2003/44/EC Recreational craft

recreational-craft@cec.eu.int

B. Martinez

Arriola

2000/9/EC Cableway installations for persons

entr-cableways-directive@cec.eu.int

ENTR.H1

G. Cozigou

V. Martins

96/48/EC - 2004/50/EC High-speed rail system

entr-aerosp-def-rail-mar@cec.eu.int

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I. Fraser

95/16/EC Lifts

lifts@cec.eu.int

M. Eifel

98/37/EC - 98/79/EC Machinery

machinery@cec.eu.int

D. Eardley

89/686/EEC - 93/68/EEC - 93/95/EEC - 96/58/EC PPE Personal Protective Equipment

ppe@cec.eu.int

C. Mattiuzzo

94/9/EC ATEX

atex@cec.eu.int

T. Brefort

89/336/EC - 92/31/EEC - 93/68/EEC 2004/108/EC EMC - Electromagnetic Compatibility

emc@cec.eu.int

G. Hilpert

73/23/EEC - 93/68/EEC Low Voltage

lvd@cec.eu.int

ENTR.H5

L. Montoya

M. Bogers

1999/5/EC R & TTE

ENTR-RTTE@cec.eu.int

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D. Eardley

Noise 2000/14//EC

Entr-dir-noise@cec.eu.int

M.

Papadayonnakis

2002/96/EC Waste electrical and electronic equipment (WEEE)

entr-mechan-elctr-equipm@cec.eu.int

K. Steininger

87/404/EEC - 90/488/EEC - 93/68/EEC Simple Pressure Vessels

Entr-Vessels-Metrology@cec.eu.int

V. Katajisto

90/396/EEC - 93/68/EEC Appliances burning gaseous fuels

Entr-Vessels-Metrology@cec.eu.int

K. Steininger

97/23/EC Pressure Equipment

ped-info@cec.eu.int

D. Hanekuyk

90/384/EEC - 93/68/EEC Non-automatic weighing instruments

entr-vessels-metrology@cec.eu.int

ENTR.H6

C. Brekelmans

D. Hanekuyk

2004/22/EC Measuring instruments

entr-vessels-metrology@cec.eu.int

ENTR.F3

A. Carvalho

A. Lacerda

S. Frank

90/385/EEC - 93/42/EEC - 93/68/EEC Active implantable medical devices

Entr-medical-devices@cec.eu.int

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A. Lacerda

S. Frank

93/42/EEC - 98/79/EC - 2000/70/EC Medical devices

Entr-medical-devices@cec.eu.int

A. Lacerda

S. Frank

98/79/EC In vitro diagnostic medical devices

Entr-medical-devices@cec.eu.int

ENTR.G3

R. Klein

I. Gomez Lopez

G. Bedotti

89/106/EEC - 93/68/EEC Construction products

construction@cec.eu.int

ENTR.G2

V. Leoz Argüelles

D. Hadrich

Market restrictions for dangerous substances 76/769/EEC – 94/27/EC azocolourants 2002/61/EC nonylphenol, - ethoxylate and cement 2003/53/EC

Entr-chemicals@cec.eu.int

ENV.C4

P. Vis

M. Ferreiro

Garcia

Waste incineration 2000/76/EC

peter.vis@cec.eu.int

ENV.C1

P. Gammeltoft

G. Paque

86/594/EEC Airborne noise by household appliances

peter.gammeltoft@cec.eu.int

U:\PRS\Michel Jeanson\References of EN in OJEU\Process and guidelines\2005-04-06 - Guidance document.pdf

23

ENV.G4

M. Klingbeil

O. Linher

94/62/EC Packaging and packaging waste

marianne.klingbeil@cec.eu.int

MARKT.

E4

J. Reinbothe

D. Scheerens

H. De la Motte

97/67/EC 2002/39/EC Postal services

markt-e4@cec.eu.int

SANCO B3

B. Delogu

E. Hansson M. Cintra

2001/95/EC General Product Safety

sanco-unit-b3@cec.eu.int

TREN.E2

J-A. Vinois

H. Kunst

R. Ferravante

2001/16/EC 2004/50/EC Interoperability of the trans-European conventional rail system

jean-arnold.vinois@cec.eu.int

TREN.D1

L. Werring

A. Brisaer M. Kestner

92/42/EEC - 93/68/EEC Efficiency requirements for new hot-water boilers 2000/55/EC Energy efficiency requirements for ballast for fluorescent lighting

luc.werring@cec.eu.int

U:\PRS\Michel Jeanson\References of EN in OJEU\Process and guidelines\2005-04-06 - Guidance document.pdf

24

TREN.D1

L. Werring

A. Brisaer M. Kestner

Other directives referring to standards 96/57/EC Energy efficiency requirements for household refrigerators, freezers Commission directives implementing Council Directive 92/75/EC with regard to energy labelling of: 95/12/EC household washing machines 98/11/EC electric lamps 97/17/EC dishwashers

luc.werring@cec.eu.int

96/60/EC washer-driers 95/13/EC tumble driers 94/2/EC household electric refrigerators, freezers and their combinations 2002/31/EC household air-conditioners 2002/40/EC household electric ovens

Acronym Directorate-General ENTR Enterprise & Industry ENV Environment MARKT Internal Market SANCO Health and Consumer Protection TREN Energy and Transport

U:\PRS\Michel Jeanson\References of EN in OJEU\Process and guidelines\2005-04-06 - Guidance document.pdf

25

Contact details of co-operating partner EFTA and the 3 European Standards Organisations

Organisation

Head of Unit

Contact person

E-mail address

EFTA

Goods

Geir Bekkevold

Johannes Thorsteinsson

mail.bxl@efta.int jt@efta.int

CEN

Standards Management Stephen Russell

Isabel Quintana-Soria

production@cenorm.beisabel.quintana-soria@cenorm.be

CENELEC

Directorate Technical Jean-Paul Vetsuypens

Ingrid Soetaert

technical@cenelec.org isoetaert@cenelec.org

ETSI

EC/EFTA Mandates Management Gavin Craik

Claudine Bopp

gavin.craik@etsi.org

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL New Approach Industries, Tourism and CSR Standardisation

Vademecum on European Standardisation

Part II

European standardisation in support of European policies

Chapter 6

Procedure for formal objections against harmonised standards

15 October 2009 Status of the document: Final Author: DG ENTR I/3 For further information: entr-standardisation@cec.eu.int

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL New Approach Industries, Tourism and CSR Standardisation

Formal objection to a harmonised standard Guidelines for the administrative procedure

1. Formal objections – general aspects 1.1. Definition The New Approach directives contain a clause according to which a harmonised standard can be challenged through a formal objection. The Decision No 768/2008/EC on a common framework for the marketing of products1 provides in Annex I, Chapter R3, Article R9 for a “standard” text of such a clause:

Formal objection against harmonised standards

1. When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements which it covers and which are set out in … [reference to the relevant part of the legislation], the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, hereinafter the "Committee", giving its arguments. The Committee shall deliver its opinion without delay.

2. In the light of the Committee’s opinion, the Commission shall decide to publish, not to

publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.

3. The Commission shall inform the European standardisation body concerned and, if

necessary, request the revision of the harmonised standards concerned. The institute of a formal objection makes it possible for Member States or the Commission to object in cases in which a harmonised standard does not entirely satisfy the requirements in Community harmonisation legislation. However, a harmonised standard does not necessarilly need to meet all essential requirements included in the directive concerned. A harmonised standard can only be challenged if it is considered to have a shortcoming as regards an essential requirement it claims to cover. The relationship between the content of a harmonised standard 1 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC, OJ L 218/82, 13.08.2008, p. 82

2

and the essential requirements covered is indicated preferably in the harmonised standard itself (e.g. as annex thereof). 1.2. Legal consequences The introduction of a formal objection gives rise to the obligation of the Commission to decide on the formal objection, taking into account the opinion of the Standing Committee2. The Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union. While of itself the acceptance of a formal objection has no legal consequences for the existence of the said harmonised standard, it does for the legal effects related to the application of this harmonised standard. These legal effects consist of the presumption of conformity to essential requirements of products manufactured on the basis of this harmonised standard and the choice of the conformity assessment procedures. It must be stressed that it is part of the New Approach concept that standardisation remains a voluntary process based on consensus achieved in the framework of independent bodies. In principle, the public authorities accept the results of this process, provided that certain conditions are fulfilled, such as compliance with the mandate (the mechanism by which the Commission requests the European standardisation bodies3 to carry out some standardisation work in support of European policies and legislation) and respect for the principles embodied in the general guidelines agreed upon by the Commission and the European standardisation bodies. What is more, additional procedures have been introduced, such as the posibility of checking by independent consultants within the context of standardisation. Similarly, to monitor the correct execution of the mandate, the public authorities may be encouraged to participate in the standardisation process through their national standards bodies, and in the case of ETSI in a different appropriate format) with a view to avoid raising a formal objection later on in the process. The formal objection procedure does not constitute a procedure of appeal available to the Member States or the Commission, when the latter note that their observations were not taken into account during the standardisation process. As part of the New Approach concept, however, the public authorities maintain their responsibility concerning the safeguarding of the interests which the essential requirements are aimed at protecting. The procedure described in this document covers, therefore, the formal objection to a harmonised standard on account of the fact that it presents shortcomings in relation to the essential requirements of a directive, of a kind to harm the interests, which the essential requirements are designed to protect. To prevent later formal objections, the opinions on safety matters forwarded by national authorities participating in the standardisation work should be considered seriously.

2 The Standing Committee set up by Article 5 of Directive 98/34/EC (OJ L 204, 21.7.1998, p. 37–48), also known as the ’98/34 Committee‘ or the ’Committee on Standards and Technical Regulations‘ 3 see Annex I of the Directive 98/34/EC (OJ L 204, 21.7.1998, p. 37–48)

3

Confirming the existence of such a shortcoming is no longer the act of a single Member State, but is based on the opinion of the Standing Committee composed of all the Member States. The consequences of this opinion have to apply at Community level according to the procedures laid down. In the light of the opinion delivered by the Standing Committee and also on the basis of all available information, the Commission will decide on the measures to be taken. This decision will be communicated to the Member States and the Commission will inform the parties concerned in an appropriate publication. A formal objection falls outside the framework of standardisation and is not subject to the provisions or procedures established by the standardisation bodies. It cannot be invoked with respect to a document that has not yet received the status of a harmonised standard. 1.3. Relationship to the safeguard clause The question arises of the relationship between the formal objection procedure and the procedure for a safeguard clause against a product, on the grounds of a shortcoming in a harmonised standard. A formal objection does not necessarily have to be preceded by an introduction of a safeguard clause, however such a situation is not excluded. In this context reference must be made to the texts of the New Approach directives. The Commission shall bring the matter before the Standing Committee and shall initiate the procedure for a formal objection to the harmonised standard in the following two cases: - when the Commission considers that, on the grounds of a shortcoming in the harmonised

standard, the safeguard measure against a product is justified, - when the Commission notes that such a measure is not justified, but that the Member

State in question intends to maintain its position. It is obvious that in these two cases the formal objection is considered to have been introduced by the Member State in question. Thus the introduction of a safeguard clause against a product, on the grounds of a shortcoming in a harmonised standard, does not require the separate introduction of a formal objection to this harmonised standard, but nor does it exclude it. 2. Formal objections – procedural steps 2.1. Introduction of a formal objection a. Introduction by a Member State As this is a formal procedure, which may entail legal consequences for economic operators, it is necessary for Member States that they introduce a formal objection by a formal step. In order to ensure a maximum of transparency at the level of procedures, it is suggested that this formal objection be introduced to the Secretariat-General of the Commission, through the intermediary of their Permanent Representation to the European Union.

4

At the same time the Member State shall also send a copy to the Commission service responsible for managing the directive concerned and to the European standardisation bodies concerned. In order to prevent unnecessary formal objections, the Member State shall consult the European standardisation bodies concerned before introducing a formal objection, A Member State may forward any documents concerning a formal objection to a harmonised standard in one of the official languages of the EU. The Commission services will ensure that these documents are made available in at least one of the working languages used by the Standing Committee. However nothing impedes a Member State from bringing a formal objection before the Standing Committee, in conformity with the internal rules of this Standing Committee. Withdrawal of a formal objection must be notified using the same channels as those used for introducing a formal objection. b. Introduction by the Commission A formal objection by the Commission shall be brought before the Standing Committee in at least one of the three (EN/DE/FR) working languages used by the Standing Committee, and, if provided for, the sectoral committee, giving reasons for doing so. 2.2. Earliest date possible for introducing a formal objection 2.2.1. Before introducing a formal objection to a harmonised standard, it is advisable to check

whether the following two conditions have been fulfilled: (a) the standard, qualified as a harmonised standard, has been ratified by CEN or

CENELEC, or adopted by ETSI. In fact the text of a standard is only definitive when it is ratified4 or adopted.

(b) a request has been made to the Commission by a European standardisation body to

publish the references of this harmonised standard in the Official Journal of the European Union (OJ), in the C series. Indeed, it is always possible that the European standardisation body concerned is of the opinion, after its final examination, that the harmonised standard in question does not correspond to the terms of the mandate and/or meet the essential requirements of the directive concerned and, as a result, it will not ask for the publication of its references.

2.2.2. The question has been raised as to whether, on the basis of existing directives, the

references of a harmonised standard must have been published in the Official Journal before a formal objection can be introduced. The reason for this question is given by the

4 Even if some Member States are not able to be familiar with the text of a standard before it has been forwarded to the national standardisation bodies, with the request to include the standard in their national collection, there is nothing to stop those who are aware of the ratified/adopted, harmonised standard from already formulating a formal objection.

5

fact that the standard article used in the New Approach directives establishes a formal objection procedure which may lead to the “withdrawal” of the reference of a harmonised standard; however it is unclear as to whether this procedure also applies to harmonised standards which have not yet been published in the Official Journal, since the legal text only refers to a withdrawal but not to the non-publication.

In agreement with the Member States, a practice has evolved whereby, for reason of economy of procedure and in the absence of other procedural provisions, a formal objection can indeed be introduced before the harmonised standard has been published. However, the two conditions indicated in 2.2.1 must be met, i.e. the harmonised standard must have been ratified/adopted and the publication of its references as a harmonised standard must have been requested. Of course, the same procedural guarantees must be respected as those, which are applicable, when the harmonised standard's references have already been published in the Official Journal. It has to be noted that the possibility of introducing a formal objection before publication may not be considered as a new legal framework but as the consequence of an interpretation of the existing legal rules.

To provide for legal certainty with respect to the question whether a formal objection can be introduced before the references of a harmonised standard have been published in the Official Journal, the Decision No 768/2008/EC on a common framework for the marketing of products explicitely provides in Article Annex I, Chapter R3, Article R9, para. 2 that the Commission shall have the posibility to decide „ … not to publish … the references to the harmonised standard concerned in the Official Journal of the European Union …“.

2.3. Information to be forwarded when introducing a formal objection In order for the Commission services and the other Member States to be able to examine properly a formal objection to a harmonised standard, the file on such an objection must contain at least the following: – a reference to the directive concerned and an explicit reference to the safeguard clause of

this directive; – the references of the harmonised standard (number, year and title); – precise details as to the part of the harmonised standard which is contested and as to the

related essential requirements; – an indication of the type(s) of products concerned, where necessary; – detailed arguments justifying why the harmonised standard is being contested in relation

to the directive’s provisions; Other information, such as statistics on accidents and suggested measures to be taken, may be useful.

6

A Member State may, if necessary, suggest a time limit by which the opinion of the Standing Committee should be delivered, having regard for the respective consultation procedures of this Standing Committee and of the sectoral committee/group of expert concerned. In the case of a formal objection coming from the Commission’s services, a similar file must be constituted. 2.4. Dealing with fomal objection files The texts of the directives require that the Standing Committee and a fortiori the Commission take urgent action. This urgency is justified, either because complying with the harmonised standard may create situations leading to risks connected with the failure to respect essential requirements, or to avoid legal uncertainty which would affect economic operators, notified bodies and the authorities responsible for market surveillance. 2.5. The Standing Committee As laid down in the New Approach directives, it is up to the Standing Committee of Directive 98/34/EC to give an opinion on any formal objection to a harmonised standard. The Standing Committee shall deliver an opinion without delay. The Commission services handling contacts with the Standing Committee Secretariat on standardisation issues will forward the file and useful information to this Standing Committee. As soon as a formal objection has been received, the respective sectoral service of the Commission will forward the file for evaluation to the committee/group of experts for the directive concerned. A formal objection will therefore automatically be dealt with first by this sectoral committee or group of experts before the opinion of the Standing Committee is sought. This will help save time by precluding situations such as this Standing Committee simply sending back the file to the sectoral group concerned at its first meeting on the subject. The service responsible for the Secretariat of the Standing Committee for standardisation questions will submit the proposal of measures to be taken to the Standing Committee for its opinion. This proposal will be drawn up by the responsible sectoral service of the Commission on the basis of all available information, such as the assessment of the committee/group of experts for the directive concerned and the opinions of other Commission services involved. 2.6. Sectoral committee/group of experts The sectoral service responsible for the directive in question will examine the file coming from a Member State in order to verify the justification for a formal objection. It will make direct contact with the ministries concerned and will consult all the interested parties. This service will ask the European standardisation body concerned to communicate any opinion that the consultant might have expressed, and what follow-up measures were taken. This sectoral service will be responsible for consulting the committee/group of experts of the directive concerned. A clear assessment of the formal objection, that has been introduced, will

7

have to be obtained from this latter sectoral group. Its assessment will be communicated to the Standing Committee as soon as possible. 2.7. Decisions and publications 2.7.1. Decisions Every formal objection introduced with regard to a harmonised standard will be the subject of a decision (acceptance or rejection) on the part of the Commission once the consultation procedures have been completed. A decision will also be taken if the formal objection has become irrelevant meanwhile. An example would be if the harmonised standard had already been reviewed and was now regarded as satisfactory. 2.7.2. Addressees of a decision The Commission decision will be addressed to the Member States. 2.7.3. Publication Any Commission decision regarding the acceptance of a formal objection to a harmonised standard will be published in the Official Journal. It is only in this way that all the parties concerned will be able to be aware of the legal situation that follows, depending on the case, from non-publication or restrictive publication in the OJ of references to the harmonised standard in question. Should the decision be taken to withdraw a publication that has already appeared or to decide not to publish the references of the harmonised standard, the publication of this decision in the Official Journal will be the only way of informing all the interested parties. Commission decisions which reject formal objections to harmonised standards will not be published in the Official Journal. 2.7.4. Partial decisions It must be acknowledged that a formal objection and the related Commission decision do not always concern the whole of the harmonised standard but only some of its parts or clauses. 2.7.4.1. Case where the references of a harmonised standard have not yet been published in the OJ In order for those parts of the harmonised standard that are not contested to be used as soon as possible, the Commission will carry out a so-called “partial publication”. This will comprise a Commission Decision specifying the precise part of the harmonised standard that will not give presumption of conformity, and indicating the reasons why.

8

2.7.4.2 Case where the references of the harmonised standard have already been published in the OJ In order to allow the manufacturers to continue to confer presumption of conformity for the uncontested parts of the harmonised standard, the Commission will carry out a "partial withdrawal". This will comprise a Commission decision specifying the part of the harmonised standard, that will no longer give presumption of conformity, and indicating the reasons why. A partial withdrawal of the publication of the references is in practice a partial publication completely replacing a previous publication. 2.7.5 Publication options for references and decisions The annexed table shows the various possibilities as regards both, the publication of the harmonised standard’s references in the OJ and the publication of the decision concerned. 3. Formal objections – other aspects 3.1. Request to review the harmonised standard Whenever the Commission has agreed with a formal objection to a harmonised standard, it will forward a precise mandate to the European standardisation body concerned to review the harmonised standard in question. This mandate will be the subject of an opinion delivered by the Standing Committee, if possible at the same time as its opinion on the formal objection concerned. The mandate may take the form of a simple letter or be a precise and detailed request according to the nature of the case and the standardisation work already in progress to remedy the problem that has been caused. The Commission will adopt the necessary measures to ensure the close follow-up of this mandate. The Standing Committee will be kept informed on a regular basis of progress with the respective standardisation work. A mandate of this kind could, moreover, also be conferred when a formal objection has been rejected, but the Commission and the Standing Committee are of the opinion that it is nevertheless necessary to (partially) review the harmonised standard. 3.2. Suspension of a formal objection In the past, some Member States have proposed suspending a formal objection procedure that had already been introduced in certain cases because the standardisation revision work was making good progress. A suspension of a formal objection creates a situation of legal vagueness. A formal objection refers to a serious situation for either safety or health, and sometimes both, and hence requires urgent action. The deadlines for action and the processing of the file are no longer under the control of the public authorities but depend on the progress of standardisation work and its results, which are not guaranteed in advance. Although it has to be recognised that close cooperation between the public authorities and the European standardisation body is useful and even necessary, such situations of legal vagueness should be avoided.

9

Thus there are only two possible scenarios: – the Member State maintains its formal objection and the Commission services are obliged

as a result to pursue the procedures described in this document in order to halt a situation of legal uncertainty;

– the Member State withdraws its formal objection in the light of a precise mandate to the

European standardisation body concerned to solve the problems raised by its formal objection.

3.3. Other communication than formal objections from the public authorities regarding a problem with a harmonised standard The formal objection procedure does not undermine the rights of Member States to communicate to the Commission, or directly to the Standing Committee, any problem related to the application of the essential requirements in a harmonised standard, even before it has been ratified/adopted. In some cases the problem could be serious enough for a formal objection to be introduced at a later stage. Such communications could therefore avoid a formal objection at a later stage. These communications do not have the legal consequences of a formal objection. If the harmonised standard has not been ratified yet, the Member States are invited to approach their national standards bodies – members of the European standardisation bodies - as a first step if any problem related to the application of the essential requirements in a harmonised standard arises. 3.4. The continuous checking of the standardisation process The procedure for a formal objection and notification of the intention to introduce such an objection, do not preclude the Standing Committee from examining, in the framework of its work, the progress of standardisation activities, including the conformity of draft standards with the requirements of the directives and the mandates, and from informing the standards bodies of its conclusions. This type of dialogue may be useful because potential problems may be solved before the standard is ratified. The possibility for such an examination, which may occur at any moment during the process of the development of the standard, has no formal character. Communication of a position does not have legal consequences. 3.5. Informing the Standing Committee The Standing Committee shall be informed by the Commission regularly and systematically of the way the procedure described above is progressing and its results for each formal objection file. For this purpose, a reference document was established by the Commission which is presented in each meeting of the Standing Committee. The Standing Committee shall also be informed by the Commission of every communication expressing an intention to introduce a formal objection. Annex: Table indicating different cases of „Decisions and Publications“

10

Annex: Table indicating the different cases of „Decisions and Publications“

Case Commission decision

Conclusion following consultations

No

Formal objection

Is the harmonised

standard deficient?

Have the harmonised standard’s references already been

published?

Publication of the decision in

the OJ

1

Yes

Complete withdrawal from

publication of the harmonised

standard’s references

2

Totally

No

The harmonised standard’s

references will not be published

3

Yes

Partial withdrawal from

publication of the harmonised

standard’s references

4

The objection to the harmonised

standard is accepted

Partially

No

Partial publication of

the harmonised standard’s references

Yes

5

- Yes

Publication of the harmonised

standard’s references is not

withdrawn

6

The objection to the harmonised

standard is rejected -

No Publication of

the harmonised standard’s references

No

NB: 1. Partial publication means the publication of the harmonised standard’s references with an indication as to the parts which do not confer presumption of conformity

2. A partial withdrawal consists, in a single action, of the complete withdrawal of the previouspublication and of a new partial publication

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Standardisation

Vademecum on European Standardisation

Part III

Co-financing by EU/EFTA of European Standardisation

Chapter 1

Descriptive document on financing methods and referencing to the foreseen Framework Partnership Agreement

15 November 2003

Status of the document: Presentation to the Member States (SOGS-Group) on

18 November 2003

Author: Enterprise DG Standardisation Unit

For further information: entr-standardisation@cec.eu.int

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Conformity and standardisation, new approach, industries under new approach

Information on the procedures for funding European standardisation

Introduction

The main purpose of DG Enterprise's financial support measures for European standardisation is to create European standards in support of Community policies relating, in particular, to implementation of the technical harmonisation Directives and improvement of the competitiveness of European industry.

To achieve this key objective, the Commission provides financial support to the Central Secretariats of European standardisation bodies with a view to improving the quality of harmonised standards and promoting European standardisation at international level.

This support is provided primarily through a multiannual framework contract which sets out the general conditions of funding and the specific agreements adapted to the various subsidised activities.

I. The five pillars of funding standardisation activities

Financial support for European standardisation is organised on the basis of five pillars (see the annex for the funding breakdowns for 2001/2002/2003). For each pillar, specific agreements are signed by the Commission and the European standardisation bodies, as the need arises, on the basis of a programme drawn up at the beginning of the year in agreement with the relevant Commission departments (there are currently 89 standardisation contact points spread among 49 units and 12 Directorates-General). The programming is revised in September in order to reallocate unused budgetary funds in the light of new priorities.

a) Annual performance contracts signed between the Commission and CEN-CENELEC-ETSI. These are designed to help improve the effectiveness, quality and visibility of the European standardisation system. Each year, these three bodies send the Commission reasoned requests for subsidies, in line with their work programme and in support of Community policies. On the basis of these requests, a list of selected projects is drawn up, together with performance indicators which make it possible to measure the level and quality of implementation in an interim and final report.

These actions are designed, inter alia, to make the parties concerned more aware of, and involve them more fully in, standardisation work, to optimise the use of European standards according to market requirements, to more effectively manage the procedures laid down in Directive 98/34/EC and translations of harmonised standards, encourage on-line working and benchmarking within the ESOs, to prepare for enlargement and to strengthen the ESOs' institutional ties at international level.

b) "consultants" contracts are intended for the co-funding of experts. They are designed to ensure that harmonised standards drawn up in support of Community legislation meet the essential requirements of the Directives and mandates.

This activity was necessary in order to avoid safeguard clauses being triggered when the standards are applied (following their publication in the Official Journal). This is why the Commission supports the ESOs in this action.

c) Translations of harmonised standards (used in support of European legislation) in languages other than FR/EN/DE are likely to accelerate the use of these standards by industry, particularly SMEs. At the beginning of the year, the ESOs draw up a list of standards which were adopted the previous year and for which EU cofunding is required for translations. As a result of the forthcoming enlargement and the near-doubling of the number of official languages, the funds which the Commission will allocate to this work will double in 2004 compared with 2003. In order to prevent costs from getting out of control, however, and to allow the funding of the other pillars, the Commission's overall contribution will remain unchanged, based on a maximum cost per page.

d) The cofunding of European standardisation activities is the central element in the standardisation budget in support of Community policies. This work is done mostly in support of legislative projects, but also of other projects which have been identified by the European institutions as priorities. Mandate work is given priority, except in the case of e-Europe, which is based on the Lisbon Strategy. On this basis, ESOs are invited to submit estimates, with timeframes which are compatible with market needs. After the specific funding agreements have been approved by the Commission and the ESOs, follow-up meetings are organised regularly with the ESO to ensure that the work runs smoothly.

e) The external promotion of the European standardisation system is a major element in the context of promoting exports from the internal market. This action also lends itself to greater consistency in our approach at international level. The Commission is interested in contributing to such projects to the extent that industry is interested and is willing to contribute to funding.

In 2003, for example, actions were supported at the request of CENELEC for the promotion of the European standardisation system at both bilateral and multilateral levels in China, Brazil, the Mediterranean countries and Mercosur.

II. Funding procedures

The financial Regulation applicable to the Commission's general budget provides for two types of funding: subsidies and service contracts.

By its very nature, financial support for standardisation clearly entails subsidies, at least where the five pillars described above are concerned.

This involves both direct financial contributions to achieve objectives in support of the Union's policies and support to the ESOs' Central Secretariats.

Other, detailed rules apply to service contracts:

- they can be concluded only on the basis of a call for tenders. This is incompatible with the exclusive recognition of the three ESOs under European legislation, which gives them a de facto monopoly for devising standards.

- their terms of reference are written by Commission departments, which is incompatible with standardisation activities.

- they are 100%-funded, but the results of the work are owned by the Commission. This is incompatible with industrial property law on standards.

By contrast, subsidy contracts are well suited to standardisation activities, especially as the Outline Partnership Agreements negotiated recently by the ESOs and the Commission envisage ad hoc procedures for implementing these subsidies:

- the subsidies are not the subject of calls for proposals; they are made available at the request of the ESOs, and are accompanied by estimates;

- the principle of cofunding applies, but with the possibility of derogation for a specific subsidy for certain tasks (laboratory work, etc.);

- the principle of non-retroactive project funding applies, but with some degree of flexibility, which makes it possible to accept funding prior to signature of the contracts (especially for standardisation and translation work);

- the funding of audits required under the financial Regulation is mostly dealt with in the annual performance contracts;

- contributions in kind are becoming the general rule for standardisation, because of the important role played by experts funded by industry;

- the rules on subcontracting were made more flexible for the allocation of work among the ESOs, in line with their internal rules;

- model documents have been drawn up to allow harmonised presentation of estimates, payments and actual costs, in order to facilitate management of those items.

III. Future developments: strengthening the legal basis for funding European standardisation

Following adoption of the new financial Regulation, the legal basis for funding European standardisation needs to be strengthened in order to ensure the long-term viability of this mechanism of the European standardisation system.

The ever closer involvement of European standardisation in support of Community policies is requiring the mobilisation of EU funds. This cannot be done solely on the basis of existing legislation, i.e. Directive 98/34/EC, Decision 87/95 in the ICT field and the sectoral Directives on technical harmonisation.

A text laying down a specific legal basis is becoming increasingly urgent.

The possibilities for simplifying the current funding system could be explored under the financial Regulation. For example, procedures for funding the ESOs' Central Secretariats and those relating to standardisation work could be re-examined.

A Working Party bringing together representatives of the EC, EFTA and the ESOs was recently created for that purpose.

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Standardisation

Vademecum on European Standardisation

Part IV

European Standardisation in the International Context

Chapter 1

Strategy for the international promotion of standards

15 November 2003

Status of the document: Internal EC Working Document

Author: Enterprise DG Standardisation Unit

For further information: entr-standardisation@cec.eu.int

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL

STRATEGY FOR THE INTERNATIONAL PROMOTION OF STANDARDS

The Commission’s strategy on standardisation in the global context is a coherent and established one. Due to our role in standardisation -a market-led system- the Commission pursues a partnership approach and acts by way of dialogue with all European players rather than playing an aggressive and visible role as done by the US administration.

Our approach was laid down two years ago by the publication of the European policy principles on international standardisation (document SEC (2001) 1296). These policy principles are essentially:

I. Europe has an interest in international standardisation because of its potential to eliminate technical barriers to trade and to increase market access for all. International standardisation also offers the possibility to promote and disseminate technologies.

II. The standards making process should respect some basic requirements: openness, transparency, consensus and a balanced participation of stakeholders. If regulatory authorities decide to make recourse to international standards it is important that they can make use of standards from standards bodies which can be held accountable for establishing consensus between all national positions and interested parties.

III. International, European and National Standardisation complement each other: it can be of particular value to consult between stakeholders nationally and represent national positions independently in the international context. For that purpose, it is important that the national standardisation systems allow under fair conditions for effective participation by all interested parties, and that national positions are coherent with European policies and legislation, if existing.

IV. To have one applied standard and one accepted test for each product, process or service is a trade-facilitating objective. International standards have a maximum effect in trade facilitation when they are part of a single and coherent set of standards. If international standards are used in relation to technical regulations as promoted by the WTO TBT Agreement, international standards bodies need to have a clearly defined constituency. The WTO principles taken as a whole ensure that international standardising bodies

3

are open to participation by national standards bodies and produce international standards that do not conflict with each other.

V. The use of standards in regulation requires a clear definition of each party’s roles and competencies. Voluntary standards can nevertheless reduce the need for regulation, respectively government intervention.

VI. Measures to improve efficiency of international standards bodies should further be deployed. Striving for more efficiency should not conflict with accountability.

VII. It may be beneficial to channel standards, specifications and other deliverables that have reached a certain consensus outside international standards bodies into the international standardisation process. Fairly balanced co-operative arrangements with international standards bodies offer a systematic framework to take over international standards and/or to contribute to the international standards making process. The Vienna and Dresden Agreements between ISO and CEN, respectively the IEC and CENELEC are useful examples how to enable for input, to avoid double work or to speed up standardisation work. In this regard, it is important to ensure that the maintenance of the international standard is considered first with the international standards body who may decide whether or not to delegate the maintenance responsibility to the originating body.

VIII. The Community generally supports, in line with its political objectives, the development of a (preferably regional) infrastructure for standardisation. This would facilitate greatly the establishment of international standards since it would permit a reduction of “players”. The EC also promotes the creation of legal and economic conditions which facilitate trade and which are receptive to the use of voluntary consensus standards.

IX. European actors should communicate with each other to ensure mutual understanding and positions in respect of legal requirements or in support of policies of the EC. While representing their own constituencies in specific discussions European actors are invited to follow the principles set out in this paper which, taken together, define the European policy in relation to international standardisation.

The tools for the promotion of European standards and the European standardisation system are:

(1) Business Dialogues

Standardisation, Technical Regulations and Conformity Assessment are a regular topic of talks between businesses. This is the case in the Transatlantic Business Dialogue (TABD), in the Mercosur-European Business Forum (MEBF) and in the EU-Russia Industrialists’ Round Table (EU-Russia IRT). Business talks with Japan also dedicate attention to the subject and a dialogue with China has also started to tackle this field.

4

(2) Co-operation and Partnership Agreements of the European Standards Organisations

CEN and CENELEC have framework arrangements with ISO and IEC. In the telecommunications field, a co-operation agreement has been concluded between ETSI and the ITU. These agreements help to avoid duplication of work at the regional and international level and ensure the operation of a coherent international system.

To help other regions with their integration process, CEN and CENELEC concluded MoUs with AMN, the Mercosur Association for Standardisation. CEN has also signed an agreement with EASC, the Euro Asian Council on Standardisation, which is a co-operation among the standards organisations of the CIS. CEN has advanced co-operation contacts with AIDMO (the Arab Industrial Development and Mining organisation, the co-ordinating body for standardisation in the Arab countries). ETSI is collaborating with Asian partners in particular Japan, China and Korea as well as with American partners in the 3rd Generation Partnership Project (3GPP). In Latin America a co-operation agreement was concluded with the Inter-American telecommunications conference, CITEL. The @LIS project supported by the Commission for the co-operation with Mercosur countries regarding interoperability in the telecom sector advances well. ETSI entertains an institutional co-operation with the League of Arab States and the ITU Regional Office for Arab States.

(3) Promotion of standards-receptive regulatory models

The United Nations Economic Commission for Europe (UN/ECE), in particular its Working Party on Technical Harmonisation and Standardisation Policies1, published an international model for technical harmonisation via the use of international standards. This concept is similar to the EC New Approach and encourages governmental co-operation on essential legal requirements. Governments would also identify the relevant international standards and conformity assessment requirements needed to meet the common regulatory objectives. The CIS countries, including the Russian Federation want to use this model for technical harmonisation in their inter-state context. Representatives from global telecommunications companies have suggested to regulators from the UNECE countries to apply this recommendation for certain ICT products. Further, the Russian Federation stated recently in the context of their WTO accession their intention to align their legislation to areas covered by about 20 New Approach Directives with it of the European Union.

(4) Promotion of “PECA type”2 agreements

The alignment of legislation and infrastructure so that the same standards and legal requirements are applicable to the EU and third countries should not be limited to candidate countries. As European standards are an important part of possible PECA type agreements, the countries wanting to align their legislation should be able to

1 See website http://www.unece.org/trade/tips/stdpol/

2 These agreements are now called ACAAs (Agreements on Conformity Assessment and Acceptance of Industrial Products). For further information, please see internal note 815387 of 25 June 2006.

5

participate in the work of the European standards organisations. CEN and CENELEC have created the possibility for ‘partner’ standardisation bodies to take part in their work, albeit without voting rights. ETSI membership is open to organisations from non-European countries, but they have no voting rights on European standards.

(5) Technical Assistance

Technical assistance plays a pre-eminent role in the pursuit of the Commission's objectives. Emphasis is placed on better co-ordination within the Commission and also with the member states on the donor side in order to avoid projects, which create overlap or gaps. Efforts were made to ensure that the amounts spent do reflect Community priorities, and that the timing of projects is matched against the availability of European experts.

Geographically, Europe’s targets can be presented by means of concentric circles.

– The candidate countries form part of an inner circle since they are taking over the acquis and their standards organisations have already or will become full members of the European standardisation family. This target is therefore considered achieved.

– The next circle concerns the Mediterranean basin. The Mediterranean countries are interested in using European standards for reasons of trade with the EU. However, their standards institutes will not join the European system, but may be interested in becoming partner standardisation bodies of CEN and CENELEC. Neighbouring countries like Russia and the Ukraine build another circle for activities in relation to standards. Here, much will depend on the implementation of the economic partnership with the Russian Federation.

– Outside Europe’s geographic boundaries, attention is dedicated towards countries heading for regional integration. Brazil, Argentina, Paraguay and Uruguay building up the Mercosur are attractive targets for the promotion of European standardisation. Finally, there is a group of countries like China, India and the some Asian-Pacific countries including Japan and Australia which offer interesting trade opportunities.

The coherent use of international standards is a goal Europe must share with these countries. Depending on the level of development of the individual trade partner from these regions, different activities are pursued.

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Standardisation

Vademecum on European Standardisation

Part IV

European standardisation in the International Context

Chapter 2

TBT code and standards

15 November 2003

Status of the document: Internal EC Working Document Author: Enterprise DG Standardisation Unit

For further information : entr-standardisation@cec.eu.int

Standards and the WTO Agreement on Technical Barriers to Trade (TBT) Technical regulations and industrial standards may vary from country to country. Having too many different standards makes life difficult for producers and exporters. If regulations and standards are set arbitrarily, they can complicate foreign market access or they can even be used as instruments of trade protectionism. The WTO Agreement1 on Technical Barriers to Trade aims at ensuring that regulations, standards, testing and certification procedures do not create unnecessary barriers to trade. Under the Agreement WTO members are bound to use international standards as a basis for their technical regulations, provided that such regulations are necessary and not more trade-restrictive than necessary to fulfil a legitimate objective. WTO members may abstain from using international standards when such standards would be ineffective or inappropriate for the fulfilment of the legitimate objectives pursued. As the Agreement lacks a definition of an international standard there has been a lengthy debate between WTO members on the criteria for international standards. The input2 prepared by the standardisation policy unit found acceptance and support from member states in the Article 133 Committee. The Commission, speaking on behalf of the member states in Geneva, was therefore amongst the most active contributors to this debate which resulted in a set of agreed principles for international standards development3 in relation with the WTO TBT Agreement. These principles have been adopted on 10 November 2000. Although these principles do not have a legal value as such, they can be considered as guidelines for regulators to choose the appropriate international standards as a basis for technical regulations. Once a year, DG Enterprise organises together with DG Trade a seminar to explain the core provisions of the TBT agreement and their implications including relevant WTO dispute settlement results, notably for colleagues from the Commission and from authorities in the member states and candidate countries. If you are involved in legal drafting, you should know about the TBT Agreement and its relation to international standards. Also, you should appraise yourself about the different techniques on how to make reference in European legislation.

1 Link up to the Agreement 2 G/Tbt/W/87, 87rev 1, G/TBT/W/141 3 G/TBT/9 of 10 November 2000 ANNEX 4

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 26.7.2001SEC(2001) 1296

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Introduction ................................................................................................................................ 3

I. Standards matter .............................................................................................................. 4

II. Trade, Integration and Convergence: Priority for International Standards ..................... 5

III. International, European and National Standardisation complement each other.............. 6

IV. The WTO accepted Principles for International Standardisation.................................... 6

V. Standards can offer a Potential for Deregulation............................................................. 8

VI. Striving for more Efficiency and Accountability in International standardisation ......... 9

VII. Create Awareness and Enable Third Countries to Join Forces ..................................... 11

VIII. An open invitation ......................................................................................................... 11

3

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The Commission was asked by the Council to develop Guidelines for a EuropeanStandardisation Policy in the International Context by June 2001 (1).

The standards making process is considered a voluntary activity carried out by and for theinterested parties themselves. Albeit not playing an active role in the production of standardsitself, the Commission deals with standardisation in relation with many Community policies,in particular with the Single market and Community external trade. The role standards canplay for market access and free movement of goods, and their potential for deregulation andfor ensuring a high level of protection has been discerned by the Community more than15 years ago when the New Approach to technical harmonisation and standardisation wasintroduced (2).

Trade in goods must also comply with the WTO Agreement on Technical Barriers to Tradewhich deals to a significant extent with international standards. Hence, the Commissionretains a European policy on international standards, and more specifically on their use inregulation. Important elements of this policy have been set out in the 1996 Communicationfrom the Commission on the Community External Trade Policy in the fields of Standards andConformity Assessment (3). However, the use of standards in more and more fields makes itdesirable to offer further clarification and guidance on this topic.

This paper sets out in a single document a number of established policy principles oninternational standardisation and on the use of international standards in Community policies,in the light of the advantages offered by international standards, notably their potential tofacilitate trade in goods (4). The paper also recognises the limitations of standardisation.Standards cannot replace governmental responsibility to safeguard a high level of protectionconcerning health, safety and the environment as stipulated by the Treaty establishing theEuropean Community. On top of that, the international standardisation process is lengthy,does sometimes not achieve a sufficiently balanced consensus among the stakeholders anddoes not always meet the level of protection deemed appropriate by the Community.Nonetheless, voluntary standards can reduce the need for regulation and governmentintervention.

The Commission will continue to make use of standardisation in the execution of existingpolicies and will give due consideration to them when developing new policy initiatives (5).This paper may serve as a point of reference to Member States and the parties involved in ordealing with international standardisation, notably the parties engaged in the European andnational standards bodies. It can be of use to interested parties in the EC and EFTA memberstates and in the candidate countries for accession to the EC. And it may serve as a referencedocument for contacts with third countries and in relation with technical assistance projectssupported by the Community.

(1) OJ C 141 of 19.5.2000, Council resolution on the role of standardisation in Europe.(2) OJ C 136 of 4.6.1985.(3) COM(1996) 564 final of 13.11.1996.(4) This document is not dealing with sanitary and phytosanitary measures.(5) Cf. COM(1995) 412 final of 30.10.1995.

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1. Standards significantly matter to enterprises, consumers and governments. Forbusinesses standards help to create a common trading language. They ensure thatparts produced across borders are compatible and that networks are interoperable,they reduce costs for manufacturing and warehousing. For consumers, standardsreduce the costs they generally face when deciding for options, such as time andefforts they devote to their search. Standards generally reduce the costs ofuncertainty, in particular when relating to functional properties as they facilitatecomparisons. For governments, standards offer an opportunity for deregulation andimproved governance as they help to reduce the level of regulatory detail to theessential requirements needed to attain legitimate objectives such as the protection ofhealth, safety and the environment. Standards help to reduce the risk of being lockedinto a specific technology and promote the dissemination of know-how.

2. Increased trade is linked with economic development and, in many ways, leads tomore convergence between trading partners. Had it not been for its capacity tofacilitate exchange and access to markets, to improve the quality and safety ofproducts and services, and to disseminate knowledge, technology and businesspractices, standardisation would not have become a crucial element in Europeaneconomic integration and world trade. Beyond the role standards play for thefunctioning of the internal market and for contributing to the protection of publicinterest, they are also an important element in the Community’s enlargement processand in external trade agreements.

3. Standardisation is a voluntary process and for no matter which subject, this processhas to be open and transparent, and result in a consensus amongst stakeholders.International standardisation is carried out by a number of societal stakeholders whoreconcile their positions nationally and internationally. (XURSH� KDV� DQ� LQWHUHVW� LQLQWHUQDWLRQDO� VWDQGDUGLVDWLRQ� EHFDXVH� RI� LWV� SRWHQWLDO� WR� HOLPLQDWH� WHFKQLFDOEDUULHUV� WR� WUDGH� DQG� WR� LQFUHDVH� PDUNHW� DFFHVV� IRU� DOO�� ,QWHUQDWLRQDOVWDQGDUGLVDWLRQ� DOVR� RIIHUV� WKH� SRVVLELOLW\� WR� SURPRWH� DQG� GLVVHPLQDWHWHFKQRORJLHV�RQ�D�SDU�EDVLV�ZLWK�RWKHUV�

4. But to reap the full benefits of international standardisation, it is important to takesome basic requirements into account and to balance the interests not only ofindustry, but also consumer concerns, health and safety considerations, environmentaspects and concerns of small and medium sized enterprises (SMEs). It may also bebeneficial to consider the interface of standards and regulations, respectively thescope for standardisation and regulatory activity and the procedures chosen todemonstrate conformity with legal requirements and/or standards.

5. ,Q�(XURSH��WKHUH�DUH��IRU�PRVW�DUHDV�RI�WKH�HFRQRP\��ZHOO�HVWDEOLVKHG�SULQFLSOHVIRU� WKH� VWDQGDUGV� GHYHORSLQJ� SURFHVV� DQG� IRU� WKH� ERGLHV� DFFRXQWDEOH� IRU� WKLVSURFHVV�� 7KH� SULQFLSOH� RI� RSHQQHVV� DLPV� DW� HQVXULQJ� WKDW� D� EURDG� UDQJH� RIVRFLHWDO� LQWHUHVWV�� LQFOXGLQJ� FRQVXPHU� DQG� HQYLURQPHQWDO� LQWHUHVWV�� DUHUHSUHVHQWHG� LQ� WKH� VWDQGDUGLVDWLRQ� SURFHVV� In addition, these principles ensure,among other aspects, that all interested parties can participate in the work and thatstandards neither impede competition, nor hinder progress and technologicalinnovation. European stakeholders also strive for coherent standards, preferably onestandard, based on the international one.

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6. Today, standards, also when used in relation to legislation, are a cornerstone of thefunctioning of the European Single Market. They are one of the basic elements in asystem including, amongst others, conformity assessment procedures and marketsurveillance. The interoperability, accuracy, and acceptance of measurements arealso fundamental for meaningful standards, in particular where these have influenceon the transparency of economical transactions, health and safety. The Europeansystem has contributed to economic integration and has helped to attain other policyobjectives set out in the Treaty.

7. Whilst the character of the European Single Market and its political will to build itmay be unique, it may be beneficial for third countries to understand and work withEuropean principles. Especially, countries engaged in efforts to set up or review astandardisation system and its possible links with regulation may take an interest inEuropean principles, as well as regions which want to further integrate.

8. In the international context, it should be noted that the way regulatory authorities usestandards in technical regulation has also become an important element with regardto trade facilitation. The WTO Agreement on Technical Barriers to Trade (WTOTBT Agreement) obliges WTO members to use existing international standards as abasis for their technical regulations, except when such international standards wouldbe an ineffective or inappropriate means for the fulfilment of the legitimateobjectives pursued. In some industrial sectors (and often for historic reasons),recommendations or other deliverables from intergovernmental organisations arealso considered as international standards. Such bodies are generally referred to asstandardising bodies and their work tends to be used as a basis for harmonisation oflegislation.

9. European stakeholders are interested in collaborating with their trading partners tofacilitate market access and economic integration through the use of internationalstandards and the creation of standards-receptive economic and legal conditions.Generally, regional or national standards should be aligned to the greatest possibleextent to international standards, but the value of national and regional standards asstepping-stones to international standardisation should also be recognised. It is alsoconsidered helpful to have explanations from authorities for deviations frominternational standards as foreseen under the WTO TBT Agreement. 7R� DYRLGFRQIXVLRQ� DQG� XQFHUWDLQW\� DPRQJVW� WUDGLQJ� SDUWQHUV� DQG� WR� LQFUHDVHWUDQVSDUHQF\�� LW� LV� QHFHVVDU\� WR� ZLWKGUDZ� FRQIOLFWLQJ� QDWLRQDO� VWDQGDUGV� IURPWKH� FROOHFWLRQV� RI� WKH� QDWLRQDO� VWDQGDUGV� ERGLHV� DV� VRRQ� DV� UHJLRQDO� RULQWHUQDWLRQDO� VWDQGDUGV� DUH� DYDLODEOH�� SURYLGHG� OHJLWLPDWH� UHJXODWRU\UHTXLUHPHQWV�SHUPLW�

10. There is, however, widespread concern among the public on the appropriateness, useand limitations of international standards for political and ethical reasons or due tocultural diversity. Therefore it should be noted that, under the WTO TBT Agreement,each WTO member has the sovereign right to define the level of protection it deemsappropriate to meet legitimate objectives, subject to the requirement that they are notapplied in an arbitrary or discriminatory manner. Whilst international standards maybe seen as beneficial in some instances, they may be perceived as little advantageousor even as threats in others. Different national standards or not having a recognised

6

standard at all could also reflect differences in risk perception, individual tastes ordistinctive markets. ,I� UHJXODWRU\� DXWKRULWLHV� GHFLGH� WR� PDNH� UHFRXUVH� WRLQWHUQDWLRQDO� VWDQGDUGV�� LW� LV� LPSRUWDQW� WKDW� WKH\� FDQ� PDNH� XVH� RI� VWDQGDUGVIURP�VWDQGDUGV�ERGLHV�ZKLFK�FDQ�EH�KHOG�DFFRXQWDEOH�IRU�HVWDEOLVKLQJ�FRQVHQVXVEHWZHHQ�DOO�QDWLRQDO�SRVLWLRQV�DQG�LQWHUHVWHG�SDUWLHV�

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11. ,QWHUQDWLRQDOO\� WUDGHG� JRRGV� QHHG� LQWHUQDWLRQDO� VWDQGDUGV� ZKHQHYHU� SRVVLEOH�However, under certain circumstances, international standards may be ineffective orinappropriate, for instance, because of an insufficient level of protection or regionalor local differences. National standardisation is therefore considered to complementthe international standardisation process while European standardisation providescoherence for free circulation on the European market or to meet Europeanharmonisation and other public interests. National standardisation takes account ofnational and local particularities including geographic, cultural and linguisticcharacteristics; it strengthens the capacity of the European and internationalstandardisation process to reach out to local interests, and it helps to ensure a wideparticipation of stakeholders. ,W� FDQ� EH� RI� SDUWLFXODU� YDOXH� WR� FRQVXOW� EHWZHHQVWDNHKROGHUV� QDWLRQDOO\� DQG� UHSUHVHQW� QDWLRQDO� SRVLWLRQV� LQGHSHQGHQWO\� LQ� WKHLQWHUQDWLRQDO� FRQWH[W�� )RU� WKDW� SXUSRVH�� LW� LV� LPSRUWDQW� WKDW� WKH� QDWLRQDOVWDQGDUGLVDWLRQ� V\VWHPV� DOORZ� IRU� HIIHFWLYH� SDUWLFLSDWLRQ� E\� DOO� LQWHUHVWHGSDUWLHV�� DQG� WKDW� QDWLRQDO� SRVLWLRQV� DUH� FRKHUHQW� ZLWK� (XURSHDQ� SROLFLHV� DQGOHJLVODWLRQ��LI�H[LVWLQJ�

12. In view of the amount of financial, technical and human resources required foreffective participation in international standardisation, stakeholders, in particularrepresentatives of environment, consumer and employees’ interest and SMEs areinterested in an efficient allocation of their resources. This is also the case forcountries with a lack of technical expertise and financial resources to participate ininternational standardisation. To this end, stakeholders may wish to considerallocating resources for representation in international work in a targeted manner sothat domestic priorities or societal concerns are reflected properly. An exchange ofinformation and co-operation with other participants in international standardisation -active or observing - may facilitate priority setting and allocation of resources. If therelevant standards were to be used in relation with public policy or legislation, publicauthorities should consider support to ensure that all societal interests are representedat all levels of the international standardisation process.

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13. 7R�KDYH�RQH�DSSOLHG�VWDQGDUG�DQG�RQH�DFFHSWHG�WHVW�IRU�HDFK�SURGXFW��SURFHVV�RUVHUYLFH� LV� D� WUDGH�IDFLOLWDWLQJ�REMHFWLYH� This principle is commonly promoted byenterprises operating at a global scale, but it offers also benefits for small andmedium sized enterprises. It seeks to reduce the costs a manufacturer of a producthas to face for goods being re-designed and re-tested when entering foreign markets.Such a principle is beneficial for consumers provided that the one applied standardtakes their interests into account and/or meets legal requirements concerninglegitimate regulatory objectives such as the protection of human health and the

7

environment. Consequently, such standards ought to respect some basicrequirements.

14. ,QWHUQDWLRQDO�VWDQGDUGV�KDYH�D�PD[LPXP�HIIHFW� LQ�WUDGH�IDFLOLWDWLRQ�ZKHQ�WKH\DUH�SDUW�RI�D�VLQJOH�DQG�FRKHUHQW�VHW�RI�VWDQGDUGV��,I�LQWHUQDWLRQDO�VWDQGDUGV�DUHXVHG� LQ� UHODWLRQ� WR� WHFKQLFDO� UHJXODWLRQV� DV� SURPRWHG� E\� WKH� :72� 7%7$JUHHPHQW�� LQWHUQDWLRQDO� VWDQGDUGV� ERGLHV� QHHG� WR� KDYH� D� FOHDUO\� GHILQHGFRQVWLWXHQF\� If standards bodies were to produce simultaneously international andregional or national standards, some partiality, incoherence and conflict in the set ofinternational standards could arise. Such a situation would be confusing forbusinesses, users and public authorities, and the latter would risk creating regulatorybarriers if using conflicting international standards as a basis for technical regulation.

15. To this end, WTO members adopted a set of principles to clarify and strengthen theconcept of international standards under the TBT Agreement (6). The WTO acceptedprinciples are:

7UDQVSDUHQF\�All essential information regarding work planning, work under progress and finalresults should be made easily accessible to all interested parties and throughout allstages of standards development. Appropriate time and opportunities for writtencomments should be provided.

2SHQQHVV�Any interested national member should be provided with meaningful opportunities toparticipate in standards development.

,PSDUWLDOLW\�DQG�FRQVHQVXV�The standards development process should be conducted in a non-discriminatoryway and should not give privilege to, or favour the interests of, a particular supplieror country. Conflicting arguments must be reconciled to satisfy all national members.

(IIHFWLYHQHVV�DQG�UHOHYDQFH�The international standards development process should take account of marketneeds, scientific and technological development. It should also consider regulatoryneeds and pay due respect to consumer concerns, and concerns relating to the healthand safety of workers and the protection of the environment.

&RKHUHQFH�The standards development process should result in a coherent set of internationalstandards that do not conflict with each other. International standards bodies shouldco-operate and co-ordinate with each other to avoid conflicting internationalstandards.

'HYHORSPHQW�GLPHQVLRQ�International standardisation should take the constraints on developing countries toeffectively participate in standards development into consideration. Provisions forcapacity building and technical assistance within international standards bodiesshould also be considered.

(6) WTO/G/TBT/9 of 10 November 2000, and Annex 4 thereof.

8

16. The principles adopted in relation with the WTO TBT are in line with Europe’sthinking on international standards, and they are consistent with the basic principlesrespected by the European standards bodies and their national members. However,from a European perspective, not only the standards development process, but alsothe constitution of the bodies developing international standards plays an importantrole if public authorities were to use international standards as a basis for regulation.7KH�:72�SULQFLSOHV� WDNHQ�DV�D�ZKROH� HQVXUH� WKDW� LQWHUQDWLRQDO� VWDQGDUGLVLQJERGLHV� DUH� RSHQ� WR� SDUWLFLSDWLRQ� E\� QDWLRQDO� VWDQGDUGV� ERGLHV� DQG� SURGXFHLQWHUQDWLRQDO� VWDQGDUGV� WKDW�GR�QRW�FRQIOLFW�ZLWK�HDFK�RWKHU� Another importantelement is the participation of all stakeholders including environmental andconsumer interests in international standardisation.

17. Whilst there is an emphasis on contributing to global convergence by elaborating andusing coherent international standards, this is sometimes difficult in fast movingtechnology sectors. In such sectors, there are a number of initiatives outside thescope of international standards bodies which are intended to contribute to globalconvergence in an early phase of standards development, however, and pending apossible further elaboration and adoption in international standards bodies. This isnotably the case in the telecom and information technologies field. To contemplatesuch situations, the European Telecommunications Standards Institute (ETSI), forinstance, has set up liaison committees with other regional associations to ensurecommon understanding on specific developments concerning telecomstandardisation. In addition, extended use of the mechanism in ETSI known as the“Partnership Project” has been applied to develop specifications at the earliestmoment in new emerging technological areas requiring stabilisation at global level.6RPH�VHFWRUV��LQ�SDUWLFXODU IDVW�PRYLQJ�WHFKQRORJ\�VHFWRUV��PD\�EHQHILW�IURP�DQHDUO\�SKDVH�VWDQGDUGV�GHYHORSPHQW�RXWVLGH� LQWHUQDWLRQDO�VWDQGDUGV�ERGLHV�DQGLW� LV� LPSRUWDQW� WKDW�� LI� UHTXLUHG�� VXFK� ZRUN� FRXOG� EH� FKDQQHOOHG� LQWRLQWHUQDWLRQDO� VWDQGDUGV� ERGLHV� However, further reflection on the standardsmaking process is needed in view of the fast pace of technology evolution in somesectors.

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18. When legislation is needed to protect legitimate public objectives, regulatoryauthorities may have an interest to concentrate on the setting of public policyobjectives and to keep the necessary mandatory regulation slim, stable andtechnology neutral, allowing for innovation. This may be achieved by leavingdetailed technical work leading to compliance with legal requirements to privatesector standards bodies. 7KH�YROXQWDU\�XVH�RI�VWDQGDUGV�LQ�UHJXODWLRQ�UHTXLUHV�DFOHDU�GHILQLWLRQ�RI�HDFK�SDUW\¶V�UROHV�DQG�FRPSHWHQFLHV� Where objectives are setout by legislation, standards can offer solutions for compliance with essential legalrequirements. The voluntary standardisation process, however, cannot duplicate orreplace governmental responsibility for the protection of fundamental public interestsuch as the protection of human health and safety and the environment. 9ROXQWDU\VWDQGDUGV� FDQ� UHGXFH� WKH� QHHG� IRU� UHJXODWLRQ�� UHVSHFWLYHO\� JRYHUQPHQWLQWHUYHQWLRQ� This is notably the case in the telecom and information technologiessectors where open standards aiming at achieving interoperability can play animportant role to ensure that the benefits of competition can be maximised forconsumers, reducing the risk that they become locked into a specific technology.

9

19. The strive for deregulation and trade facilitation at global level has triggeredconceptual thinking and discussion in a number of international andintergovernmental fora in order to achieve a common understanding on goodregulatory practice and to closer align regulations and standards. The variety ofmeans considered range from agreement on equivalency of standards, alignment oninternational standards to international harmonisation of regulations. Theidentification of common regulatory objectives is often the starting point for aregulatory dialogue which can help to approximate legal requirements, iffundamental cultural and societal concerns permit and if the level of protectiondefined by each country is comparable.

20. The use of international standards as a basis for technical regulations offers apresumption of conformity with international trade rules, notably with WTO rules.However, countries have the right to go beyond the level of protection defined byinternational standards in order to achieve the desired level of protection at thedomestic level, provided the respective measures are not arbitrary and do notdiscriminate. An important element in these efforts is to provide information onexisting regulations and standards in order to explore commonalties. Europeaninitiatives are also directed to build common understanding of best regulatorypractice with trading partners. 7KH�(XURSHDQ�VLGH�FDQ�VKDUH�ZLWK�WKLUG�FRXQWULHVDQG� RWKHU� UHJLRQV� PRUH� WKDQ� ���\HDUV� H[SHULHQFH� RQ� LWV� 1HZ� $SSURDFK� WRWHFKQLFDO�KDUPRQLVDWLRQ�DQG�VWDQGDUGLVDWLRQ�ZKLFK�ZDV�D�VLJQLILFDQW�VWHS�LQ�WKHLPSOHPHQWDWLRQ�RI�WKH�6LQJOH�0DUNHW�LQ�(XURSH�

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21. The use of deliverables from single standards developing organisations or otherspecifications promoted by private consortia meets the requirements of industry insome sectors, allowing direct representation by industry. This approach is ofrelevance in areas with fast moving technology or in cases with no environment,health and safety aspects or other public interest in standardisation. Therefore, it co-exists along the more formal approach where standards from international standardsbodies offer consensus via national member bodies. It is important to ensure thatnational positions balance the interests of all concerned parties, including economic,social, health and safety concerns, environmental aspects and, if needed, respond toregulatory concerns through participation of regulators in all phases of standardsdevelopment.

22. To obtain efficiency in international standards development and effective responsesto sectoral needs, a large spectrum of standards developing organisations should beavoided. Furthermore, attaining these objectives does not reduce the need for acoherent set of international standards reflecting the consensus of all nationalmembers. :LWKLQ� LQWHUQDWLRQDO� VWDQGDUGV� ERGLHV�� PHDVXUHV� WR� LPSURYH� WKHLUHIILFLHQF\� VKRXOG� IXUWKHU� EH� GHSOR\HG.� +RZHYHU�� VWULYLQJ� IRU� PRUH� HIILFLHQF\VKRXOG� QRW� FRQIOLFW� ZLWK� DFFRXQWDELOLW\� ZKLFK� LV� FRQVLGHUHG� LPSRUWDQW� LIVWDQGDUGV�ZHUH�XVHG�DV�D�EDVLV� IRU� OHJLVODWLRQ� While the standardisation processshould be stepped up to become more efficient, it must not fail to be open forparticipation by all interested parties and to strike a balance of national interests,considering the constraints of developing countries.

10

23. Sectoral characteristics are mirrored at the international level by the fact that, inaddition to the International Organisation for Standardisation (ISO) and theInternational Electrotechnical Commission (IEC), other specialised standardisationbodies exist. Most of them are intergovernmental organisations. The InternationalTelecommunication Union (ITU) elaborates recommendations that, in some cases,have binding status and/or regulatory implications, notably in the ITU-R sector, butalso to a lesser extent in the ITU-T sector.

24. When converging technologies blur the boundaries between sectors, bodies withsimilar rules are well positioned to respond by setting up joint groups, for instance.Generally, there are groups for sectoral focus in standardisation bodies such astechnical committees or workshops, and they bring the relevant stakeholderstogether. These groups operate on a common platform and share procedures andprinciples for consensus. This ensures consistency and coherence and allows easily acombination of efforts in cross-sectoral matters without having to set up additionalorganisational structures. ,W�PD\�EH�EHQHILFLDO�WR�FKDQQHO�VWDQGDUGV��VSHFLILFDWLRQVDQG�RWKHU�GHOLYHUDEOHV� LQWR�WKH� LQWHUQDWLRQDO�VWDQGDUGLVDWLRQ�SURFHVV� WKDW�KDYHUHDFKHG� D� FHUWDLQ� FRQVHQVXV� RXWVLGH� LQWHUQDWLRQDO� VWDQGDUGV� ERGLHV� In suchcases, it is essential to define criteria for a coherent integration into the existing set ofinternational standards and for an impartial maintenance of such standards. In othercases, research aimed at solving technical problems that impede the drafting andimplementation of international standards may be needed. Such research shouldaddress the most pressing problems on a consistent world-wide basis, and avoidduplication.

25. Co-operative agreements do already exist between international and regional ornational standards organisations. The Vienna and Dresden Agreements between ISOand CEN, respectively the IEC and the European Committee for ElectrotechnicalStandardisation (CENELEC) are useful examples how to enable for input, to avoiddouble work or to speed up standardisation work. These agreements provide, ifwished, for development in one body and approval, by parallel voting, in both. Thesearrangements provide at the international scale for early information and thepossibility to provide comments. Another example for a co-operative agreement isthe one between the ITU and ETSI. With regard to the co-operation betweeninternational and regional or national standards bodies, it is important that themaintenance of the international standard is considered first with the internationalstandards body who may decide whether or not to delegate the maintenanceresponsibility to the originating body.

26. &R�RSHUDWLYH� DUUDQJHPHQWV� ZLWK� LQWHUQDWLRQDO� VWDQGDUGV� ERGLHV� RIIHU� DV\VWHPDWLF�IUDPHZRUN�WR�WDNH�RYHU�LQWHUQDWLRQDO�VWDQGDUGV�DQG�RU�WR�FRQWULEXWHWR� WKH� LQWHUQDWLRQDO� VWDQGDUGV� PDNLQJ� SURFHVV� In some specific cases whereinternational standards are not considered appropriate, for instance, when they do notmeet regulatory requirements for European legitimate objectives, or in those areaswhere international standards do not yet exist, the European standards communitymay deviate from international work. In such instances, the co-operative agreementsneed to provide a framework to indicate and justify such deviations in a transparentway. Other regional or national standards bodies may also find it beneficial for theirconstituency to set up transparent agreements for co-operation with the respectiveinternational standards body.

11

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27. The EC and its Member States provide considerable technical assistance to thirdcountries to help them aligning their technical regulations, standards and conformityassessment structures and procedures as well as the quality of their products andservices to European and international requirements. The type of assistance providedis decided on a case-by-case basis, taking into account the situation and thedevelopment level of the recipient country. The decision about priority areas forassistance in the various countries is generally made jointly by the donor and therecipient.

28. 7KH� &RPPXQLW\� JHQHUDOO\� VXSSRUWV�� LQ� OLQH� ZLWK� LWV� SROLWLFDO� REMHFWLYHV�� WKHGHYHORSPHQW�RI�D� �SUHIHUDEO\�UHJLRQDO�� LQIUDVWUXFWXUH� IRU� VWDQGDUGLVDWLRQ��7KH(&�DOVR�SURPRWHV�WKH�FUHDWLRQ�RI�OHJDO�DQG�HFRQRPLF�FRQGLWLRQV�ZKLFK�IDFLOLWDWHWUDGH� DQG� ZKLFK� DUH� UHFHSWLYH� WR� WKH� XVH� RI� YROXQWDU\� FRQVHQVXV� VWDQGDUGV�Typical assistance areas are: if needed, regional integration, the harmonisation oflegislation and technical regulations, standardisation and conformity assessmentinfrastructures, effective participation in regional or international standards bodies,and questions concerning marking issues and market surveillance systems. The ECsupports also research projects that contribute to standardisation and harmonisationof technical regulations.

29. A more efficient implementation of the WTO TBT agreement is another goalpursued in the EC’s technical assistance activities. 6SHFLDO�DWWHQWLRQ�LV�DOVR�GLUHFWHGWR�WUDGLQJ�SDUWQHUV�KDYLQJ�DQ�LQWHUHVW�LQ�XVLQJ�(XURSHDQ�VWDQGDUGV�GLUHFWO\���EHLW� LQ� WKH� DEVHQFH� RI� DSSURSULDWH� LQWHUQDWLRQDO� VWDQGDUGV� RU� IRU� RWKHU� UHDVRQVVXFK�DV�UHJLRQDO�LQWHJUDWLRQ�RU�FORVH�OLDLVRQ�ZLWK�(XURSH�

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30. Increasing the effectiveness of international standardisation, building on thesynergies that can be created by standards-receptive economic and legal conditionsas well as the support of third countries in international standardisation requirecommunication and co-ordination between all relevant stakeholders to avoid overlapand duplication. Hence, (XURSHDQ�DFWRUV�VKRXOG�FRPPXQLFDWH�ZLWK�HDFK�RWKHU�WRHQVXUH�PXWXDO�XQGHUVWDQGLQJ�DQG�SRVLWLRQV�LQ�UHVSHFW�RI� OHJDO�UHTXLUHPHQWV�RULQ�VXSSRUW�RI�SROLFLHV�RI�WKH�(&.�:KLOH�UHSUHVHQWLQJ�WKHLU�RZQ�FRQVWLWXHQFLHV�LQVSHFLILF�GLVFXVVLRQV��(XURSHDQ�DFWRUV�DUH�LQYLWHG�WR�IROORZ�WKH�SULQFLSOHV�VHW�RXWLQ� WKLV�SDSHU�ZKLFK�� WDNHQ� WRJHWKHU�� GHILQH� WKH�(XURSHDQ�SROLF\� LQ� UHODWLRQ� WRLQWHUQDWLRQDO�VWDQGDUGLVDWLRQ�

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Standardisation

Vademecum on European Standardisation

Part IV

European standardisation in the International Context

Chapter 4.1

The external dimension of the Internal Market - Overview

15 November 2003

Status of the document: EC Working Document of July 2003

Author: Enterprise DG Unit G1

For further information: entr-regul-coord-MRA@cec.eu.int

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Legislative coordination and simplification; mutual recognition

Brussels, 31 July 2003

The External Dimension of the Internal Market When exporting goods to foreign countries, industry and suppliers need to comply with technical regulations, conformity assessment procedures and certification requirements. These regulations normally serve legitimate ends (protection of health, consumers, environment, safety and so on). However, sometimes they might be more trade-restrictive than necessary to achieve such ends. This is why any regulatory measures concerning products should be proportionate to the objective pursued. This is the main principle that ensures both EC internal and international trade in goods. The Commission has identified the following variety of measures that could facilitate international trade in products between the EU and third countries. All these measures have three main objectives: preventing and reducing the effect of regulatory technical barriers, supporting varying degrees of regulatory convergence and promoting the EU regulatory approach, notably the internal market philosophy.

Mutual Recognition Agreements. Mutual Recognition Agreements (MRAs) are treaties established between the European Community and governments of third countries that have a comparable level of technical development and a compatible approach concerning conformity assessment. These agreements are based on the mutual acceptance of certificates, marks of conformity and test reports concerning industrial products issued by the conformity assessment bodies (CABs) of one of the parties of the agreement in conformity with the legislation of the other party. Their objective is to facilitate international trade by reducing approval costs of industrial products and simplifying their placing on the market. MRAs are also a tool for regulatory convergence. As far as the EU is concerned, their legal basis stems from Article 133 (Common Commercial Policy) of the EC Treaty and they normally include a framework agreement, along with annexes that (normally) cover several sectors.

So far the EC has signed 7 MRAs, with Japan, Switzerland, the USA, Israel, Australia, New Zealand and Canada.

MRAs should also bring additional benefits, such as the elimination or reduction of duplicate testing, improved regulatory transparency, increased co-operation between the regulators of both parties and a reduction of the risk that conformity assessment will be used to protect domestic markets.

These benefits are particularly relevant for small and medium-sized enterprises (SMEs) which may lack the resources to access the regulatory system of a distant third country. MRAs can enable them to test and certify their products locally.

3

However, a few Member States, some industry representatives and stake-holders have criticised some MRAs because, in some sectors, they have not yet produced the expected increase in trade.

Other trade facilitating instruments. This experience has led to the view that other measures can be applied to facilitate trade. Indeed, conditions for open trade include compatibility of approach, coherence of regulations and standards, transparency of rules, appropriate levels and means of regulation, impartiality in certification, compatibility of market surveillance measures and an appropriate level of technical administrative infrastructure.

The Commission has identified a “tool box” of instruments to bring these conditions closer in a working paper produced on 28 September 2001. These measures include regulatory co-operation, harmonisation, recognition of equivalence, partial or voluntary reduced or less formal types of mutual recognition, international standardisation and technical assistance. The selection of the right instrument depends on the characteristics of the markets, the regulatory environment in the third country concerned, and the willingness on the part of industries, regulators and other stakeholders to achieve the agreed objectives1.

Regulatory coo-operation means reciprocal understanding of regulation, transparency (e.g. WTO TBT agreement, ASEM best regulatory practice, EC-Mexico FTA, MERCOSUR, TEP regulatory guidelines, UNECE recommendations on standardisation) seminars, training sessions, joint visits, surveys and information gathering.

International standardisation implies using international standards as a basis for technical regulation (e.g. UNECE WP 29 for motor vehicles).

Recognition of equivalency leads to free trade of products assessed against different regulations that have the same objectives (e.g. EU-US marine safety equipment agreement).

Partial or voluntary reduced or less formal types of mutual recognition includes agreements in some specific sectors such as Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP), co-operation in the field of accreditation, subcontracting, voluntary co-operation of laboratories and certification bodies, co-operation in the development of standards.

Technical Assistance means, for example, raising awareness of the WTO-TBT agreement, preparing recipients for membership and building up the related infrastructure.

Harmonisation denotes drawing-up common rules. The international promotion of the so-called EC New and Global Approach (NGA) to technical regulation plays a huge role in trade facilitation. The advantages of this “regulatory system” are still not well enough known outside the EC. Indeed, it would be the ideal regulatory approach for large decentralised countries, federal countries or members of economic areas (e.g. MERCOSUR) whose regions or states have their own technical specifications. Essential requirements could be made compulsory for the entire territory and regional standards

1 See document SEC (2001) of September 28, 2001 “Implementing Policy for External Trade in the Fields of Standards and Conformity Assessment: a Tool Box of Instruments”.

4

made voluntary. Furthermore, it would facilitate trade with third countries, as the New Approach is based on the notion of “essential requirements”, which are more easily negotiable than detailed technical specifications. This is why recent bilateral agreements signed with some candidate countries for EU membership are almost completely founded on the New and Global Approach.

These bilateral agreements, known as PECAs (Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products), can be considered as the major instrument of the pre-accession strategy in the field of the free movement of goods. They are a specific type of mutual recognition agreement, based on the approximation of the legislation of the candidate country for EU accession with that of the EC and the development of the appropriate implementation infrastructure in the areas of standardisation, conformity assessment and market surveillance. PECAs create an enlarged internal market for products in certain industrial sectors prior to accession and represent a recognition of progress made in preparation for full participation in the EC internal market. As such, they are of great political and economic significance to the countries concerned. PECAs are also important to the EU in extending the benefits of the internal market using a sectoral approach, on the basis of the sectors identified by the candidate countries.

The Community has made a success of PECA negotiation and implementation, effectively ‘exporting’ the New Approach to third countries. To date, PECAs have been signed with six acceding countries (the Czech Republic, Hungary, Latvia, Lithuania, Slovenia and the Slovak Republic) and have entered into force. New sectors should be added as negotiations proceed. A PECA has been signed with Estonia and awaits the completion of the ratification procedures. A PECA-type agreement has been initialled with Malta. Formal negotiations on PECAs are ongoing with Poland and have been requested by Bulgaria and Romania.

Based on the experience gained from PECA negotiation, DG Enterprise believes that the EC should explore the possibility of extending the application of the model to other third countries. However, it is necessary to adapt the PECA model to a new context, bearing in mind that countries concerned are not, at this time, candidates for EU membership. The Commission is developing the concept of a ‘ring of friends’ with a view to promoting stability and prosperity in neighbouring countries following the next enlargement in 20042. This process should address the issue of the expansion of the internal market to these countries and the adoption of common regulatory structures wherever possible. Particular attention should be paid to the advantages for third countries of adopting established common principles, within the context of existing WTO objectives. There is also a political advantage in binding the markets of third countries more closely to that of the EU.

Preliminary contacts with Mediterranean and western Balkan countries demonstrate a keen interest in cooperating with the EC in the furtherance of these key economic and political objectives. The next steps will be to engage in extensive preliminary dialogue with the countries concerned and to carry out detailed analysis of the framework conditions necessary to embark on a successful round of negotiations. Given that the

2 COM (2003) 83 final, Communication from the Commission to the European Parliament and the Council, Annual Policy Strategy for 2004, pp. 7-8.

5

degree of political leverage that can be exerted by the EC is less than that used with candidate countries, the conclusion of final agreements is likely to be a medium- to long-term process.

Giuseppe Casella Thomas McClenaghan DG ENTR/G/1 Tel. 56396 “ 95136

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 28.9.2001SEC(2001) 1570

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Summary..................................................................................................................................... 3

Introduction ................................................................................................................................ 4

Scope . ..................................................................................................................................... 4

Background: policy objectives and current activities of the Community................................... 4

The mechanisms of technical regulation and their relationship with trade ................................ 5

Conditions for open trade ........................................................................................................... 6

Working towards the ideal: a diversity of measures................................................................... 8

Regulatory co-operation ............................................................................................................. 9

Harmonisation .......................................................................................................................... 11

Recognition of equivalence ...................................................................................................... 12

Mutual Recognition Agreements.............................................................................................. 13

Partial, voluntary, reduced or less formal types of mutual recognition.................................... 15

International standardisation..................................................................................................... 18

Technical assistance ................................................................................................................. 19

Implementing systems .............................................................................................................. 22

Conclusion: selecting the right instrument ............................................................................... 22

3

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All governments make regulations. When such regulations relate to things that are traded,there will be an effect on trade with other countries, since foreign suppliers will need tocomply with the importing country’s rules. Consequently, there have been substantial effortsto reduce the impact on trade of national or regional regulation. Regulations may servelegitimate ends, but at the same time efforts are necessary to ensure that regulation should notbe more trade-restrictive than necessary to achieve such ends. The application of the principleof proportionality ought to ensure the necessity and effectiveness of the measures undertakenin comparison to the objective pursued.

The experience of the Commission in trade facilitation has led to the view that a broad varietyof measures can be applied to accomplish it. Conditions for open trade include compatibilityof approach, coherence of regulations and standards, transparency of rules, appropriate levelsand means of regulation, impartiality in certification, compatibility of market surveillancemeasures and supervision practices, and an appropriate level of technical and administrativeinfrastructure.

Different measures are available to the Community and its trading partners to bring theseideal conditions closer. Measures such as regulatory co-operation (to make regulatory andmarket surveillance systems more compatible); harmonisation (to create single technicalrules); mutual recognition agreements (to eliminate costs arising from unnecessaryduplication of certification requirements); support for the development of internationalstandards (to create compatibility and interoperability of products and, eventually, to providea common technical basis for rules); and the development of codes of conduct and technicalassistance (to provide support for the setting-up of a quality infrastructure in third countries),are all actions that can be used effectively to facilitate trade.

The Community should work towards achieving an optimal mix among these measures. Thispaper examines them in some depth, together with examples where appropriate, in order tofacilitate future choices.

4

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There has in recent years been a renewed interest in international co-operation in the areas ofstandards, conformity assessment, and the elimination of technical barriers to trade (TBT).

The purpose of this paper is to examine questions concerning technical rules and requirementsfor products, and their effect on trade. The effectiveness of measures for rendering rules lesstrade-restrictive, while pursuing legitimate regulatory objectives such as the protection ofhealth and safety, consumer protection and information, and protection of the environment,will also be considered. The analysis is intended to facilitate the identification anddevelopment of priorities for action in the field, in such a way as to be as effective and cost-efficient as possible.

With the increasing recognition of the impact of technical rules on trade in goods, a numberof mechanisms to lessen this impact have been identified. They could be further exploited inorder to offer a variable response, adapted to the needs and opportunities that presentthemselves in each specific situation. The choice of instrument will depend on thecharacteristics of the markets, the regulatory environment and technical infrastructure in thecountries or regions concerned, the nature of the products, and the willingness on the part ofindustries and regulators to make use of such different instruments.

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What follows is intended to deal with issues of external trade in industrial products. However,the issues raised here may have implications for trade in other areas – for example, services,and agricultural products – since the issues are often similar, even though existing regulatorymodalities are generally different.

In other words, the concepts developed here may be useful in other areas, on theunderstanding that their application, if any, to those areas would depend on the specificregulatory framework in each case.

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The Community's trade objectives can easily be summarised: first, to reduce technical barriersin external markets and to prevent the emergence of new ones; and second, to encourage ourtrading partners to adopt standards and regulatory approaches based on, or compatible withinternational and European practice. Achievement of both objectives will mutually facilitatetrade and market access.

The general principles of EC external trade policy in this area are set out in the 1996&RPPXQLFDWLRQ�IURP�WKH�&RPPLVVLRQ�RQ�WKH�&RPPXQLW\�([WHUQDO�7UDGH�3ROLF\�LQ�WKH�ILHOGVRI�6WDQGDUGV�DQG�&RQIRUPLW\�$VVHVVPHQW 1 The Communication rests on two assumptions:

(a) that the impact on trade of product standards and means of determining conformitywith them appears to be increasing, thereby giving rise to technical barriers to trade,and demanding greater attention and action than in the past; and

1 COM(1996) 564 final of 13.11.1996.

5

(b) that the completion of the single market has placed the Community in a position topursue a more outward-looking trade policy in this field.

At the same time, other developments in the Community’s legal framework have propelledthe EU towards improving the effectiveness of regulatory authorities in protecting an ever-increasing number of public policy interests such as health and safety, the environment, andconsumers’ interests. In this respect, it is worth mentioning the application of the principle ofproportionality and the recent Commission Communication on the precautionary principle 2,where the Commission considers that the principle has a scope to cover measures forprotection of human, animal and plant health in addition to environmental aspects.

The internal market itself has developed from a largely trade facilitation mechanism to onethat marries trade facilitation with a high level of protection of public interests, as defined inthe EC Treaty. The policy towards standards and conformity assessment in external trade setout in the Communication was endorsed by the Council 3, which has also reaffirmed otheraspects of this policy, for example, the importance of coherence in international standards,and the creation of standards-receptive regulatory models 4.

The trade objectives have so far been pursued through a four-fold strategy, comprising:

(a) Reliance on the WTO, notably the Agreement on Technical Barriers to Trade;

(b) Conclusion of bilateral (inter-governmental) agreements� to reduce barriers and thecost of trade, which have so far consisted in the conclusion of Mutual RecognitionAgreements (MRAs) for conformity assessment, certificates and marking, which areintended to reduce the costs of testing and certification in other markets, notablythose of major trading partners;

(c) Technical assistance to ensure that other countries’ regulatory regimes aretransparent and trade-friendly, and that an appropriate infrastructure in the areas oftesting and certification is being put into place;

(d) Regulatory co-operation, aiming at harmonising regulations with trading partners,achieving a common understanding of “best regulatory practice” (BRP), andpromoting recourse to it, including increased transparency in regulations andstandards, international standardisation, and the harmonisation of regulationsamongst trading partners.

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The main elements that govern the placing on the market of goods can be identified for thepurposes of this paper, as:

(a) Technical regulations (laws) applying to the characteristics of products;

(b) Standards (drawn up by consensus), whether for voluntary application orincorporated into the legal framework in some way or other;

2 COM(2000) 1 final of 2.2.2000.3 Council conclusions of 26 June 1997, OJ C 8 of 11.1.2001, p.1-3.4 Council resolution of 28 October 1999, OJ C 141 of 19.5.2000, p. 1-4.

6

(c) Certification requirements, determining how compliance with regulations is to bedetermined, including marking and similar procedures;

(d) Testing procedures for the actual determination of compliance, and related aspects,such as good laboratory practice, laboratory accreditation, and metrology;

(e) Market surveillance (including, where appropriate, product liability aspects).

Governments prescribe technical rules that apply to products; for a variety of reasons, suchrules may relate to the characteristics of the products, and may also make provision for thecertification that the product in fact complies with those technical rules. Of course, rules areadopted for legitimate purposes: the protection of safety and health, the environment, and soon; but they can also be misused as means of erecting protective barriers around the domesticmarket. For this reason the WTO TBT Agreement calls for technical rules and certificationprocedures not to be more trade-restrictive than is necessary for the objective being pursued,to be transparent and non-discriminatory, and for the use, where appropriate, of internationalstandards. There remains, however, a need for further progress in its practical implementation.

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A fully-developed common market between two or more territories will have thecharacteristics that any product lawfully placed on the market in one territory will be equallyfreely marketed in the other, and conversely, that products that may not be lawfully placed onthe market in one territory may not be so placed in the other. The obvious example isprovided by the EU internal market. The recommendations of the TBT Agreement go someway towards achieving the situation described above. It must be borne in mind, however, thatthe concepts contained in the TBT Agreement cannot approach the situation of a commonmarket, in the absence of a strong institutional framework to support it, that is, of legislativeand administrative bodies such as the Council, the Parliament and the Commission, andjudicial control such as that exercised by the European Court of Justice.

With this in mind, the most desirable situation, compatible with the provisions of the TBTAgreement, would imply the following.

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Approaches to product regulation should be compatible, if not identical, at least withindefined product sectors. Where sophisticated systems of product regulation have emerged,there may be imbalances with less sophisticated systems (for example, with developingcountries).

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Technical requirements (regulations) for specific products should be the same, or recognisedas equivalent for the purpose of fulfilling the same regulatory objectives.

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Standards, where they have either a regulatory impact or a major market impact, should be thesame, or technically equivalent, or at least be recognised as fulfilling the same technicalobjectives not conflicting with each other.

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This should perhaps be explained: standards, VWULFWX� VHQVX, are voluntary-compliancedocuments, drawn up in principle by a consensus of those who will use them, to reachtechnical objectives such as reducing unnecessary variety and providing known means ofspecification and levels of performance. Sometimes, as with the EU’s New Approach andpublic procurement legislation, reference is made to them in laws; in many other cases,although entirely voluntary, standards in effect have some prescriptive force because theyprovide a fundamental reference for market participants.

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Both standards and technical regulations should be transparent and available to those who willuse them, be based on recognised international work wherever appropriate, and not be such asto favour the products of one party over those of another.

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Technical regulations, and standards with regulatory or quasi-regulatory force, should be onlyas stringent as is necessary for the achievement of legitimate public policy aims (such as thoseset out in Art. 95 (3) of the EC Treaty for a high level of protection of health, safety,environmental protection and consumer protection), taking account of new scientificdevelopments. The TBT Agreement provides that regulations and standards shall not be moretrade-restrictive than necessary to fill a legitimate objective.

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Certificates, where required, must be available by procedures that are the same whatever thenature and nationality of the entity seeking them.

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Certificates, where required, must be recognised by all authorities impartially as giving accessto the market. As a consequence of this, there must be transparency as to the nature of thebodies issuing the certificates and guarantees as to the quality of certificates. Whereappropriate (for example, when certificates are granted by independent certification andassessment bodies rather than directly by public authorities), there will be a requirement foragreement on accreditation or other assessment of certification bodies, and on relevantmetrology requirements.

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Market surveillance procedures - both before and after sale - must work in practice. That is,they should be effective, compatible and impartial, and not favour the products of one entityover those of another.

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A country must have the capacity and infrastructure necessary to make the relevant systemswork, including the capacity for regulation. The necessary certification bodies, standardsbodies, laboratories and other facilities must exist and be sufficiently effective.

Imbalances between developed and developing economies may result in barriers to trade, forexample where producers in developing economies cannot meet other countries’ moresophisticated product regulations, or where developing countries’ governments must rely on

8

H[�DQWH�rules for market access because they do not possess sufficient resources for effectiveH[�SRVW market surveillance. It will be difficult for developing countries to participate in thiskind of co-operative trade facilitation measure until they have reached an adequate level ofregulatory sophistication. The roles of technical assistance and capacity-building initiativesare important in this area.

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The 1996 Commission Communication on &RPPXQLW\� H[WHUQDO� WUDGH� SROLF\� LQ� WKH� ILHOG� RIVWDQGDUGV� DQG� FRQIRUPLW\� DVVHVVPHQW, already mentioned above, formulates two “basicobjectives”, as follows.

“First, to reduce or prevent the emergence of new standards and conformity assessmentbarriers for industrial products in other markets. Secondly, to promote where possible, theadoption overseas of standards and regulatory approaches based on, or compatible with,international and European practices, in order to improve the market access andcompetitiveness of European products.”

Sometimes the adoption of Community practice is complete. For example, the countries of theEuropean Economic Area (EEA) have adopted all the DFTXLV�FRPPXQDXWDLUH as it relates tothe trade in goods. Countries that are candidates for accession to the EU have also committedthemselves to adopting all the elements of the European system (since their intention is tobecome Member States, this will be necessary at the time of their accession in any case).

For other countries though, it may not be commercially profitable, or politically desirable orpractical, to achieve such complete alignment in all the areas of the DFTXLV. Other instrumentsare being explored by the Community and by other countries, such as mutual recognitionagreements (MRAs). However, it has become increasingly clear that MRAs represent onlyone of a series of instruments, and that all trade facilitation instruments have implications fortheir practical implementation that need careful consideration.

Some tools for addressing each of the issues indicated above can be identified: for Nos.1, 5and 8, regulatory co-operation; for No.2, harmonisation of regulation, international regulation,and recognition of equivalence; for Nos. 3 and 4, harmonisation of standards, internationalstandardisation and recognition of equivalence; for Nos. 6 and 7, mutual recognitionagreements, and for Nos. 8 and 9, technical assistance programmes (See Table 1 for asummary).

These elements are not, of course, entirely separate, and for that reason the correlations set outin Table 1 should be regarded as merely indicative. For example, harmonisation andregulatory co-operation are closely linked, and international standardisation has strong linksboth with regulation and with certification. The choice of measures will need to takecoherence into account, together with other factors such as the level of trade between theparties and the technical infrastructure in those countries. It should also be remarked that allthese instruments can be applied bilaterally, regionally or multilaterally.

9

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1. Compatibility of approach Regulatory co-operation

2. Coherence of regulation Harmonisation of regulationInternational regulationRecognition of equivalence

3. Coherence of standards Harmonisation of standardsInternational standardisationRecognition of equivalence

4. Transparency and impartiality of regulations andstandards

HarmonisationInternational regulation and standardisationRecognition of equivalence

5. Appropriate level of regulation Regulatory co-operation

6. Transparency and impartiality in obtainingcertification

Mutual recognition agreementsTechnical assistance

7. Recognition of certificates Mutual recognition agreements

8. Compatibility of market surveillance Regulatory co-operationTechnical assistance

9. Development of infrastructure Technical assistance

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As has already been indicated, regulations, standards and conformity assessment proceduresserve legitimate objectives, such as protection of safety and health, the environment, thepromotion of quality, the control of unnecessary diversity in products, and the protection ofconsumers from deceptive marketing. On the other hand, they have a very substantialpotential to impede trade. One purpose of regulatory co-operation is to reconcile these aims.Thus the objective quoted above, “to reduce or prevent the emergence of new standards”,should be understood as being applicable where such standards constitute unnecessary 6

obstacles to trade.

5 In line with the Commission Communication, this encompasses both multilateral initiatives for

harmonising regulatory requirements and mandatory standards and for developing best practice inconformity assessment, and bilateral co-operation with the EU’s trading partners in developingtechnical regulations, harmonising standards and regulatory reform.

6 It is assumed that the trade impact of regulation that is necessary to achieve the objectives of theregulation is proportional, and is compatible with the TBT Agreement (Art.2.2: “...technical regulationsshall not be more trade-restrictive than is necessary to fulfil a legitimate objective, taking account of therisks non-fulfilment would create.”).

10

The co-operative mechanisms that emerge will inevitably differ in the light of the nature ofthe products, historical factors (the previously existing structure of regulation), thecompatibility of regulatory systems, and the extent of the will to open trade.

Regulatory co-operation is typically an informal process during which regulators consult witheach other during various stages of the regulatory process. Such co-operation can be based onbilateral, regional or multilateral arrangements, and is often encouraged by industry willing tosee governments agree on common solutions.

The major instrument already achieved in this area is, of course, the WTO TBT Agreement.In prescribing notification of proposals for technical regulations and standards programmes,and calling upon its signatories and their standards bodies to base technical rules, standardsand certification requirements on international standards wherever possible, the TBTAgreement represents a major step forward. However, the breadth of its scope, and thenumber of its signatories, means that for practical reasons there must be a certain amount of“lowest common denominator” in its regulatory approach. It should also be observed thatthere is considerable scope to improve its implementation. Some progress has been made intwo “triennial reviews” of the TBT agreement; however, other issues remain unresolved.

Bilateral, regional and inter-regional initiatives in this area also offer potential for advance.For example, principles on best regulatory practice agreed in the context of ASEM set outsome useful guidance for consultation; an exchange of information is foreseen under the FTAbetween the EC and Mexico; and certain forms of co-operation are envisaged between theCommunity and the countries of Mercosur. Such initiatives could be regarded as a first step tothe achievement of regulatory co-operation.

Particular mention should be made of EHVW�UHJXODWRU\�SUDFWLFH��efforts to establish a commonunderstanding of the basic principles of good ways to regulate, such as exchanginginformation on trade issues, transparency in programmes, clarity of rules, fitting theregulatory approach to the objective of the regulation, and the like.

Another important element of regulatory development is transparency. The EuropeanCommission places great importance on the issue: bringing the legislator closer to its citizensand getting them fully involved in the process is a key priority. While the principles oftransparency (such as public consultation and public access to official documents) aregenerally shared, the ways these principles are implemented differ widely. When regulators indifferent countries co-operate, it is therefore important that they are aware of each other’ssystems of addressing transparency aspects and their impact on the regulatory process.

Two further points should be made. First, agreements on paper need to be backed up byconcrete implementation. Second, the EU itself should continue to be flexible in its regulatorysystem for trade in goods where mutual advantage can be gained by opening trade.

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The experience of the EU in the area of free movement of goods within the internal markethas shown that many obstacles stem from lack of understanding of legal and marketrequirements. Removing such obstacles would be facilitated by the development anddistribution of information on certification, accreditation and standardisation procedures. It istherefore useful to organise exchanges of information and institutional experience and specificrequirements for sectors or product categories. Seminars, training sessions, joint visits, audits,surveys and information gathering can also contribute to the objective.

11

This can lead to an indirect “bench-marking” process whereby regulatory authorities are madefamiliar with other authorities’ experience, and amend their regulatory practice as a result.The identification of good regulatory practices can also lead to regulatory transparency andenhanced market access. The EU is pursuing this line in bilateral fora such as theTransatlantic Economic Partnership (TEP) with the USA and in multilateral fora such asASEM.

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At the outset, it is perhaps necessary to underline the difference between harmonisation andinternational standardisation, though obviously they have strong similarities. In general,KDUPRQLVDWLRQ�may be regarded as the drawing up of common or identical rules by a group ofauthorities, with the intention that the mandatory rules governing a product or service shall bethe same among them. ,QWHUQDWLRQDO�VWDQGDUGLVDWLRQ (in its broadest sense, i.e. including thedrawing up of technical specifications by public authorities) has as its aim the elaboration of acommon set of requirements at international level, with the involvement of those who have alegitimate interest in them: governments, economic entities such as industry, and users,without the intention that mandatory rules and technical practice should always be the same.

This distinction is necessary, for it must be recognised that international standards are notuniversally used, despite the call for their use in the TBT agreement as a basis for national andregional regulation and standardisation where appropriate. The coherence of regulations andof standards can be achieved through harmonisation, which has already proved its usefulnessin the context of the EU internal market. Harmonisation, both of rules and of standards, hasthe advantage that it is clear that the rules are the same, and a supplier placing a product onthe market can therefore be confident that the same rules are applicable whatever thejurisdiction.

Some international regulatory harmonisation is already in place. Organisations such as theCodex Alimentarius Commission, ICAO, IMO, and the like are already active in internationalrule-making on an inter-governmental basis.

Harmonisation, however, is a “maximal” option, that is not always practical or even desirable,for example because of its potentially high cost. Harmonisation of rules requires regulatoryadaptation, either through bringing one party’s rules into alignment with another’s (as is thecase with the applicant countries) or through the development of entirely new rules. Suchprocedures are costly, both in administrative terms and for suppliers of products that mustconform. In addition, attempts at harmonisation can run into political problems; for example,different regulatory systems may not be compatible, and administrations may not wish tobring their regulatory systems into line with what may be perceived as alien requirements, ormay encounter difficulties in persuading their legislatures of the expediency of doing so.

Finally, harmonisation does not imply mutual recognition of certificates. It is one thing to setout rules that are identically the same, or technically compatible; it is another to accept thatproducts conform with the rules. Even when the rules of two countries are the same, theacceptance of certificates of conformity with them by one country is based on that country’strust in the conformity assessment procedures of the other. In effect, therefore, to achieve fullcompatibility in regulated areas, harmonisation of regulations and standards will need to bematched with mutual recognition of certificates of conformity, and market surveillancemechanisms on the parties’ territories must allow for the placing on the market of goods thatconform to the commonly agreed rules.

12

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Even where regulations or standards differ, progress towards mutual opening of markets maybe possible if they are recognised as equivalent. Where the regulation in each territory has thesame regulatory objective as that in the other, and the two sets of regulations both actuallyfulfil this objective, the authorities can agree to regard them as equivalent. Then, they canagree that products conforming to the other party’s regulations (where necessary, includingrelevant conformity assessment and certification procedures) can be placed on the market inthe territory of either party as though it conformed to the rules in force there.

While potentially a powerful tool, and one recommended by the WTO TBT Agreement, thismechanism can be technically complex in practice, which perhaps explains why it is littleused. First, the REMHFWLYHV of a regulation have to be set out (this is done for EU legislation),then they have to be agreed as being equivalent, and finally agreement has to be reached ontheir mutual acceptability. This is a complex process, not least because it has to be done indetail, sector by sector; in addition, any substantial revision or updating (for example, to takeaccount of technical progress) is likely to make a new determination and recognition ofequivalence necessary. For these reasons, this relatively simple principle cannot be consideredof general applicability. Where it can be applied, however, it is a valuable instrument of tradefacilitation while fully respecting the regulatory autonomy of the parties.

Where harmonisation is considered feasible, it is generally considered as a better tool thanequivalence. Nevertheless, harmonisation risks being a longer process than recognition ofequivalence. Moreover, there may be non-technical reasons why harmonisation is not anoption, where equivalence would help achieve a very similar result in terms of tradefacilitation. On the other hand, where technical regulations differ radically, in particular interms of the objectives they seek to achieve, it is likely that a determination of equivalencewill not be possible and that harmonisation will prove unfeasible.

With recognition of equivalence (which can be mutual or unilateral), a country accepts thatimported products that meet the applicable technical requirements of the exporting countryare placed on its market as if they met its own applicable technical requirements. Recognitionof equivalence of standards may be envisaged in situations where no relevant internationalstandards exist or their completion is not imminent. As an interim measure until suitableinternational standards are developed, standards originating from other trading partners couldbe accepted as equivalent even though these standards are different from the domestic ones.

Recognition of equivalence does not imply, SHU�VH, recognition of conformity assessment. Itdoes make sense, however, to combine the two, both in terms of trade facilitation and in termsof regulatory efficiency. Together with recognition of conformity assessment, recognition ofequivalence of technical regulations ensures that a product needs to comply with only one setof technical requirements and is tested and assessed only once, by the public or privateconformity assessment bodies that are most familiar with the requirements against which theproduct is being assessed.

In order to achieve this result, however, two sets of conditions must be fulfilled.

First, the technical regulations must be equivalent in their regulatory objectives. This can bedetermined either if the objectives are set out explicitly, or if they can be determined in detailfrom the regulations themselves. The objectives should be very similar, if not identical, andthe requirements of each set of regulations should be capable of meeting the regulatoryobjectives of the other. These conditions are more likely to be met, in practice, when the two

13

sets of technical regulations are based on very similar standards or the same standard (forinstance, international standards).

Second, the two parties must have confidence in the conformity assessment infrastructure ofthe other party, in terms of technical competence, honesty, impartiality, independence, etc., ofthe conformity assessment bodies of the other party.7.

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The EU “New Approach” legislation does not set mandatory standards, but recognises themas a means towards achieving regulatory objectives: the standards are not mandatory, butgive “presumption of conformity” with the (obligatory) requirements of the relevantDirective.

In an Agreement on Marine Equipment between the EU and the US, being negotiated in thecontext of the EU-US Transatlantic Economic Partnership (TEP), the potential recognition ofequivalence of regulations would be based on the Conventions of the International MaritimeOrganisation (IMO), which form the technical basis for the regulations both of the EU andthe US in this sector.

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Mutual Recognition Agreements are agreements on the mutual recognition of conformityassessment of regulated products. Through an MRA, each importing party is given theauthority to test and certify products against the regulatory requirements of the other party, inits own territory and prior to export. In cases where countries require mandatory third-partycertification of specific products, each importing party agrees, by the terms of the MRA, torecognise the tests, certificates and approvals issued by agreed conformity assessment bodiesof the exporting party, and the products can be exported and placed on the other party’smarket without undergoing additional procedures. The mandate received in 1992 by theEuropean Commission on MRA and the following 1994 and 1998 negotiating directivesauthorised negotiations on a bilateral basis. This has made possible the MRAs currently inplace, and (with a supplementary mandate) the Transatlantic Economic Partnership (TEP)actions with the United States. The mandate from the Council to the Commission to negotiatemutual recognition agreements indicated the objective that the third countries concerned willconclude with the EEA EFTA States parallel agreements equivalent to those to be concludedwith the Community. The system of parallel agreements protocols formally grants the thirdcountry concerned the same market access throughout the European Economic Area forproducts covered by the mutual recognition agreements.

MRAs do not require or presuppose harmonisation of each party’s technical requirements, orrecognition of their equivalence. Each party is free to set its own regulations or standards,though the partners to an MRA must obviously have concepts for product testing and

7 It is worth pointing out the difference between recognition of conformity assessment in the contexts of

equivalence and of MRAs. In both cases, the parties must have confidence that the conformityassessment bodies of the other party (public or private) present certain characteristics: adequatequalifications and training of their personnel, impartiality, independence from vested interests, technicalcompetence to carry out tests, etc. Under an MRA, the conformity assessment bodies of the exportingparty must also understand the requirements of the importing country and be competent to assessproducts for conformity with such requirements. Under equivalence the conformity assessment bodiesof an exporting country assess the conformity of a product with the requirements of that country; thus,they do not need technical competence additional to what they need in the domestic context.

14

approval that are broadly compatible, and each party must have comparable - or at leastmutually acceptable - systems of certification and underlying technical infrastructures. Onceestablished, the MRA will need to be maintained, for example by keeping lists of recognisedcertification bodies, and the standards or rules against which they must certify.

The benefits arise from removal of duplicated inspection or certification. Where a productintended for two markets may have to be assessed twice (when technical requirements orstandards are different), the assessment would be cheaper when carried out by the same body.The time to market is reduced since contacts between the manufacturer and the conformityassessment body, and a single assessment, speed up the process. Even where the underlyingregulations are harmonised, for example on an international standard, the need for recognitionof certificates remains, and in such cases the benefit will be clear: the product is assessed onceagainst the commonly accepted standard instead of twice.

Other benefits include increased transparency (all procedures have to be clearly laid down);furthermore, contacts between regulators may lead to some harmonisation, and transparencyin procedures ensures greater predictability, which makes it easier for companies better toplan their market strategies.

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Internationally in recent years multi-lateral agreements or arrangements have begun to beconcluded, either at government level or by regional organisations. The underlying rationaleis to extend to a larger number of trade partners the benefits of easier market access.However, because of the involvement of a large number of parties, these arrangements oftenlead to increased complexity (owing to the wider range of differences in each system).

The contents of this type of MRA are often different in nature, involving either a limitednumber of sectors or partial recognition leading to a lower level of trade facilitation. This isthe case for most of the existing multilateral arrangements on mutual recognition, where thescope is generally limited to acceptance of test reports performed by a laboratory in theterritory of one party by the other parties, based normally on the use of commonly agreed orinternational standards.

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The Asia-Pacific Economic Co-operation (APEC) MRA represents the best known exampleoutside the EU of a multilateral agreement. APEC 8 has given its support, through the OsakaAction Agenda, to the development of multilateral and bilateral mutual recognitionarrangements in the APEC region. There are four sectors.

(a) The $3(&�0XWXDO�5HFRJQLWLRQ�$UUDQJHPHQW�RQ�&RQIRUPLW\�$VVHVVPHQW�RI�)RRGV�DQG)RRG� 3URGXFWV (APEC Food MRA) consists of a framework arrangement (the“Umbrella Arrangement”) and separate implementation arrangements (SectoralArrangements). The Sectoral Arrangements involve the acceptance by an importingparty that foodstuffs conform with that party’s requirements.

(b) The $3(&�PRGHO�0XWXDO�5HFRJQLWLRQ�$UUDQJHPHQW�RQ�$XWRPRWLYH�3URGXFWV is not anarrangement in its own right, but a template or SUR�IRUPD to be used by member

8 APEC, established in 1989 in response to growing interdependence among Asia-Pacific economies,

began as an informal dialogue, but has since become the primary regional vehicle for promoting opentrade between its 21 member economies.

15

economies in entering into bilateral arrangements. Each party guarantees that productsexported under the arrangement comply with the list of harmonised standardsspecified in the arrangement. The harmonised standards will be based on theequivalent UN/ECE standards.

(c) The $3(&� 0XWXDO� 5HFRJQLWLRQ� $UUDQJHPHQW� RQ� &RQIRUPLW\� $VVHVVPHQW� RI7HOHFRPPXQLFDWLRQ� (TXLSPHQW� (APEC Tel MRA) comprises a frameworkarrangement and two conformity arrangements (one relating to test reports and theother relating to certificates). Member economies are free to participate in whicheverof the conformity arrangements best suit their regulatory régime.

(d) The $3(&�0XWXDO�5HFRJQLWLRQ�$UUDQJHPHQW�RQ�&RQIRUPLW\�$VVHVVPHQW�RI�(OHFWULFDODQG�(OHFWURQLF�(TXLSPHQW�(APEC Electrical MRA�, like the Tel MRA, deals with therecognition of test reports and certificates; however, the provisions are containedwithin a single document.

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The costs and benefits of MRAs have to be regarded in the light of political and commercialcompetition aspects. The Commission’s experience is that MRAs are only worth negotiatingin the following circumstances:

(a) where certification systems are not too different in principle and in practice; and

(b) where there are substantial, functioning regulatory, standards and certificationinfrastructure and market surveillance infrastructures and capacities, that arecomparable and compatible with those of the EU; and

(c) where trade between the parties is sufficient to justify the cost involved in settingthem up; and

(d) where the trade that is being liberalised offers some opportunities to open markets toEU industry as well as to that of the third country, since political support fromindustry is evidently necessary if trade liberalisation measures are to gain support.

MRAs do not remove some serious technical barriers to trade. In some sectors, certificationactivities are subject to restrictive government control. There may be technical regulationsthat for political or other reasons are not susceptible to modification. There may be marketsectors in which, although products are in theory not subject to mandatory certification, it isinevitable in practice, for example for market reasons (customers may demand certifiedproducts even though uncertified products may be lawfully placed on the market).

MRAs cannot resolve such issues. They are a trade facilitation tool, for use when the potentialpartners have paved the way by bringing their systems close enough to make MRAsworkable, while either not addressing questions of harmonisation, or accepting thatharmonisation is too remote an objective to be practicable within any reasonable time-frame.

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Mutual recognition agreements require confidence on the part of each party, that the systemsfor certifying products in the other are effective and can be relied upon to deliver anappropriate level of protection. This confidence may take some time to establish, since theauthorities of each party are effectively placing part of the task of enforcement of technical

16

rules in the hands of bodies over whom they have no direct control (though they may be saidto have a degree of indirect control through their relations with the authorities of the otherparty), and resistance to this is understandable where a product may present a potentialhazard.

In effect, the parties to an MRA have agreed to share some degree of control over their homemarkets in the relevant product area in exchange for the other party doing the same. At earlystages in the operation of such an agreement, they may be unwilling to surrender a part oftheir discretion to regulate their own markets.

In addition, if one party lacks the necessary technical infrastructure for an MRA, this may notbe the most appropriate instrument, for it requires comparable levels of technicalinfrastructure. A country with a more developed infrastructure may be able to deliver therequisite certificates to another country, but if the latter has a less developed certificationinfrastructure, its conformity assessment bodies may well not have the capacity to delivercertificates that can be relied upon by the other party. On the other hand, the less developedpartner may have strict rules regarding control at import that substitute for the lack of aneffective market surveillance mechanism.

Mutual recognition can be broken down into a number of elements, which the classical MRAincludes as a package. However, if it is regarded as premature to conclude an MRA, or if thepolitical willingness or technical resources for doing so are wanting, it may be possible toidentify certain elements that can be applied separately, on a stand-alone basis or as part of agroup of measures that fall short of a complete MRA. An “MRA by steps” might consist of anumbrella agreement with phased supplementary agreements to achieve regulatory co-operation, mutual recognition, or other objectives. Political willingness to reach an MRAmight be helped by a “package” approach in which each side can gain a part of its wants inexchange for concessions from the other.

For example, in the pharmaceutical sector, good manufacturing practice (GMP) or goodlaboratory practice (GLP) may be treated as part of an MRA; but they could be the subject ofa stand-alone agreement (one on GLP has been reached with Israel). The traceability ofmeasurement standards offers another area for co-operation. If the measurement standardsused by laboratories on the territory of one party are regarded as acceptable by the other, itwill facilitate the acceptance of test results.

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One area particularly susceptible to development is accreditation: one of the more commonmeans by which a body is recognised as competent in certification, testing and associatedfunctions. In general, certification bodies are accredited to grant certificates of conformity byan accreditation body in their own country or region. The certification may be based ontesting by accredited test laboratories, similarly accredited to carry out tests for their owncountry or region.

The increasing development of contacts and agreements between accreditors is a reality andthis can certainly play a relevant role as a support to trade facilitation activities in the area ofconformity assessment.

However, there is no D�SULRUL�reason why accreditation should be so limited; and, in theory, asystem or arrangement could be set in place by which laboratories on the territory of one partywere accredited by the accreditation body of the other party to grant certificates of conformity

17

with the other party’s technical rules. This would make it possible to extend the area in whichcertificates of conformity are accepted, and in general would facilitate trade by makingcertification administratively easier to obtain. But such an arrangement would need to becarefully designed, and would in any case require a similar degree of trust between parties.This is perhaps a matter to be explored further in the light of experience with the existingMRAs.

Voluntary agreements between accreditors, certifiers, and test laboratories are alreadyincreasingly being set up. They take account of common experiences, and create networks forinterchange of information, technical work and practices. Such activities are applied on avoluntary basis by non-governmental parties, though governments can play a role insupporting and facilitating agreements. Support can be provided directly, by promoting orfinancing exchange of information and organisation of events, or indirectly, by establishing orrecognising a role for the existing schemes in bilateral or multilateral agreements.

In addition, there is already a whole range of sub-contracting agreements in existence betweentesting laboratories and certification bodies. In such cases, while the leading organisationkeeps the responsibility for whole or part of the conformity assessment, the partner laboratorycarries out most of the product testing. This type of agreement is also very common atinternational level, between organisations located in different countries.

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At the regional European level, EA (European Accreditation) members can apply for peer-group evaluation of their activities. Successful members may sign the appropriatemultilateral agreement (MLA) for accreditation as certification body, laboratory orinspection body under which they recognise and promote the equivalence of each other’ssystems and of certificates and reports issued by bodies accredited under these systems. EApromotes the recognition and acceptance in all the MLA countries of certificates and reportsissued by organisations accredited by national accreditation bodies who have signed theMLA. The EA MLA aims at achieving a uniform level of competence of the accreditedbodies involved and to diminish or eliminate the need for multiple assessments.

The developing system of multilateral mutual recognition agreements between laboratoryaccreditation bodies within ILAC (International Laboratory Accreditation Co-operation)based on peer reviews enables accredited laboratories world-wide to achieve a form ofinternational recognition, and allows their test data accompanying exported goods to be morereadily accepted on overseas markets.

Similarly, the IAF (International Accreditation Forum) is establishing multilateral mutualrecognition agreements globally based on the equivalence of conformity assessment bodyaccreditation programmes operated by accreditation body members, verified through peerreview among those accreditation body members. The primary function of both ILAC andthe IAF is to develop voluntary world-wide recognition by setting programmes withcommon criteria for accreditation and conformity assessment, which contribute in theelimination of non-tariff barriers to trade. This effectively reduces costs for both themanufacturer and the importers, as it reduces or eliminates the need for products to be re-tested in another country.

9 EA (European Accreditation) is an organisation of national accreditation organizations in Europe. ILAC

(International Laboratory Accreditation Co-operation) unites laboratory accreditors at world level; IAF(International Accreditation Forum) is its analogue for certification bodies.

18

The IECEE-CB Scheme is a multilateral agreement among participating certificationorganisations in many countries. Countries that are members of the InternationalElectrotechnical Commission IEC, may join the Scheme and can designate NationalCertification Bodies CB. The scheme uses Certification Bodies Test Certificates to attest thatproduct samples are in compliance with the requirements of relevant IEC standards and withthe declared national deviations existing in various member countries. The Scheme istherefore based on the use of international IEC standards, and the transparent exchange ofinformation of any deviation from those standards that can be nationally applied. Amanufacturer utilising a CB test report issued by one of the member certificationorganisations can obtain easy national product certification in all other countries of thescheme.

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Co-operation on the development of standards is also of value, for though in general standardstend to enshrine existing technical practice, it will be economically beneficial for technicalpractices to converge.

While measures of this kind fall short of actual harmonisation, nonetheless they serve to buildup confidence and develop an environment that is, over the medium to long term, conduciveto the convergence of technical rules. Once confidence has been built up, more elements ofmutual recognition and convergence can be introduced, if necessary sector by sector.

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In addition to the harmonisation of regulatory requirements, international standardisation hasbecome important as a means of establishing technical requirements at the international level,in principle for voluntary application. The classical international standards bodies IEC andISO have been established for many years, and have established a position at the world level.Particularly in the case of the IEC, it may be said that internationalisation of the technicalpractice in the area it covers (the electrotechnical sector) has been a substantial success, atleast in some areas (for example, the standards according to which electrical equipment isbuilt are much the same across the world).

As mentioned above, the WTO TBT agreement gives a certain priority to internationalstandards – where they exist - as a basis for technical regulation (by governments) and fornational and regional standardisation (by recognised standards bodies at the national andregional levels). But this is by no means an absolute requirement, and can be deviated fromwhere appropriate where the WTO Member has a legitimate reason for doing so. Suchreasons, however, must relate to the legitimate objective of the regulation or standard. Ofcourse, if international standards are lacking, WTO Members are free to standardise orregulate as they see fit.

International standardisation has some advantages: a single solution agreed across the globaleconomy will open trade to the extent that it unifies technical practice, provides a globallyaccepted reference, and promotes the economic benefit that derives from the elimination ofdivergent though technically equally valid solutions while leaving room for competition ofdiverging products.

Nonetheless, there continue to be problems with the international standards system as it hasevolved. One is the proliferation of bodies: the OECD and the WTO have both identified alarge number of organisations that draw up technical specifications for international use, for

19

example, IEC, ISO, ITU, OECD, UN-ECE and OIE all made presentations at a WTO meetingon the subject. New bodies continue to emerge, such as GHTF, W3C and IETF 10. In somecases, the members of these bodies are governments; in others, standards bodies; in others,industry federations or even individual commercial enterprises. Although the position in thisrespect remains not entirely clear, some basic principles for the development of internationalstandards have emerged from the WTO Triennial Review of the TBT Agreement and it is tobe hoped that they can now be developed further.

Furthermore, there is some difficulty in establishing timely responses to regulatory needs. Theinternational standardisation process can be painfully slow (typically four or five years fromproposal to publication); and priorities do not always appear to be set by the needs ofinternational trade. As a result, even the EU, which is the leading participant in internationalstandardisation, and has a strong commitment to it, has made relatively limited use ofinternational standards as the basis for technical legislation and the opening of trade.

In addition, there is still no established mechanism by which governments can call upon theinternational standards bodies (as distinct from inter-governmental bodies) to draw upinternational standards that can then be used in support of a common regulatory structure.Work towards devising a mechanism to do this is under way in the context of the UNEconomic Commission for Europe. However, it is at a preliminary stage, and support at theworld level is yet to be sought.

In short, it may be said that international standardisation offers a potential route towardscommonality in the regulatory environment. This is to an extent demonstrated by theexperience of the EU in using regional standardisation as a tool for the development of itsown internal market. At present, however, the effectiveness of international standardisation issomewhat limited, though active efforts are being made to pursue it within internationalstandards bodies, and to improve alignment of national standards on international ones in anumber of fora. In general, Europe is strong in international standardisation, and this tooloffers Europe an opportunity to promote its system. To this end, the Council has requested theCommission to develop guidelines for a European standardisation policy in the internationalcontext. 11

7(&+1,&$/�$66,67$1&(

7KH�DLPV�RI�WHFKQLFDO�DVVLVWDQFH

Technical assistance offered by the EU in the context of programmes whose main objective isto pursue targets based on broad EU objectives, the partner country’s policy agenda, analysisof the partner country's situation, and the activities of the major partners. Particularly in thecase of developing countries, the system of trade preferences is not the only element to favourthe development of exports. Technical assistance to develop the supply side is necessary;

10 OECD: Organisation for Economic Co-operation and Development. ITU: International

Telecommunications Union. UN-ECE: United Nations Economic Commission for Europe. OIE: OfficeInternational des Epizooties. GHTF: Global Harmonization Task Force. W3C: World Wide WebConsortium. IETF: Internet Engineering Task Force. All these organizations – and many others – makespecifications, standards or technical regulations (the difference is not always entirely clear) at theglobal level.

11 Council Resolution of 28 October 1999, OJ C141 of 19.5.2000, p. 1-4.

20

technical assistance in the field of standards and conformity assessment can contribute toensuring that requirements for products are met.

In this context, the type of assistance will depend upon the situation and the level ofdevelopment level of the recipient country. In addition, the results of that assistance should besustainable with the recipient’s own resources.

Technical assistance actions can aim at reducing TBTs; and raising awareness of TBTs andthe need to reduce them; helping recipients to fulfil EU requirements; at preventing the exportof unsafe products; at the preparation of agreements to reduce TBTs; at preparing recipientsfor membership of the WTO; at helping recipients to implement the TBT agreementeffectively; at preparing recipients for MRAs or free trade agreements; at gaining support forthe EU approach; at building up necessary institutions and other facilities; and at theencouraging economic and social development of the recipient country. This list is notexhaustive: there may be other reasons for technical assistance.

Such programmes can help developing countries to develop a regulatory, standards andconformity infrastructure; to encourage the adoption by developing countries of internationaland European standards, to improve their infrastructure and set up accreditation andstandardizing systems, and to train officials in developing technical regulations and standards.It is in the interest of both the Community and the third country in question to be helped toproduce better quality or safer products, so that developing countries’ products can be tradedwith developed countries in full compliance with relevant requirements for the protection ofhealth, safety, etc. The Community also has an interest in promoting consumer demand inthird countries for high-value Community products.

Some partner countries have now reached a stage of economic and industrial developmentwhere basic infrastructures - such as a functional standards body, a range of basic industrialstandards, and testing laboratories - are in place. Assistance may therefore be directed towardsareas such as improving the regulatory regime for specific sectors, refining the infrastructurenecessary for mutual recognition agreements to be concluded, and promoting European andinternational regulatory approaches, including approaches to conformity assessment. Wheretechnical conditions are met, mutual recognition can be one of the objectives. TheCommunity's own single market experience may provide a relevant model for many areas ofthe world considering regional systems.

7\SHV�RI�WHFKQLFDO�DVVLVWDQFH

Independently of what assistance is provided, the recipient has to have the capability andmotivation to take advantage of and apply the results of the assistance. Two most effectivemethods are “learning by doing”, and exchanging experiences in practical work. When therecipients’ needs and priorities are not clear, assistance for assessment of the situation mightbe a good starting point. Support for investment requires that necessary structures andresources are in place.

Assistance might take the form of assessment of the situation in the country, enablingdeveloping countries to assess their needs and priorities; information seminars andworkshops; awareness conferences and campaigns; training courses, including trainingtrainers; “hands-on” training in European public and private organisations; participation in thework of international organisations; regional co-operation activities; expert advice;institution-building (creating and reinforcing relevant organisations); and investment.

21

Where the aim of the assistance is to reduce technical barriers to trade, EU policy is to spreadthe European approach to reconciling regulatory and trade objectives. Accordingly, assistancemay focus on the New and Global Approaches; harmonisation of legislation and regulations;standardisation, accreditation, inspection, testing and certification (and conformity assessmentin general); marking, metrology and market surveillance. Target groups include publicauthorities (including customs services), standardisation accreditation and conformityassessment bodies, economic operators, including manufacturers and trade organisations,testing laboratories and consumer groups.

'HOLYHULQJ�WHFKQLFDO�DVVLVWDQFH

EC technical assistance is usually provided as grants, though there may be a requirement forthe recipient to pay a share of the investment (typically 25 %). EU financing of the assistancemay be through multi-annual programmes with projects and sub-projects, or as singleprojects. Agreements for assistance can be made at different levels, for example, governmentto government, region to government, region to region, private organisation to privateorganisation, or within multinational private organisations.

In deciding on technical assistance, it is necessary to take into account such factors as: co-ordination with other assistance projects, completed, existing or planned; the possibility ofpooling resources for funding; the possibilities of regional co-operation, and other bilateraland international assistance; the state of existing institutions and other facilities; whether therecipient is member of WTO TBT, and where appropriate, its fulfilment of its obligationsunder the TBT Agreement and other TBT problems; the long term (about five-year)infrastructure strategy, the priorities and realism of present development plans and proposedprojects, including financing and human resources; the sustainability of the results ofproposed assisted activities; the management of such activities, and political considerations.

&DVH�VWXGLHV��VRPH�(8�WHFKQLFDO�DVVLVWDQFH�SURMHFWV

(a) A project on 6WDQGDUGV� DQG� &RQIRUPLW\� $VVHVVPHQW� IRU� D� QRQ�FDQGLGDWH� (DVWHUQ(XURSHDQ� FRXQWU\ is intended to facilitate the transition to a market economy, andintegration of the country and its companies into the global economy. Assistance willbe provided to help bring about a significant reduction in the number of productssubject to compulsory pre-market third party certification; where appropriate, tointroduce manufacturer’s declarations of conformity; to help draft horizontallegislation, in particular on conformity assessment and product safety; to help inconsolidating the distinction between compulsory technical regulations and voluntarystandards; to help in any matter related to compliance with the WTO TBT agreement(in particular, the operation of the Enquiry Point); to cover organisational matterswithin the standardisation body, and between it and other organisations involved inactivities in the field; and to acquaint officials with the implications of the movetowards EU and international systems of standardisation and conformity assessment.

(b) $� SURMHFW� RQ� 6WDQGDUGV� DQG� 4XDOLW\� LQ� DQ� $VLDQ� OHDVW� GHYHORSHG� FRXQWU\ has theobjective of contributing to efforts in the country’s transition to a market economy.The specific purpose is to improve quality at institutional and enterprise level.Assistance is provided to strengthen the quality structure of industry; encourage andfacilitate the understanding and use of standards and technical regulation by industry,particularly in the context of exports; provide industry and regional centres with wellbased and reliable metrology and calibration services; provide companies withinternationally recognised and accepted testing and product certification services;improve the quality of products through introduction of a quality management system

22

based on international standards and certification; and establish a nationalaccreditation scheme for laboratories and certification bodies.

(c) A South American regional programme provides technical support to countries in theregion for activities and co-operation in the quality infrastructure field. It includesfinancing participation of technical experts in international meetings and knowledgetransfer from Europe. “Sub-projects” cover training of quality auditors and qualitytrainers; assistance to SMEs to obtain quality certification according to ISO 9000;assistance to set up national information and notification systems in the participatingcountries; support to the participating countries for developing regionalstandardisation activities and applying the European INES system; assistance todevelop certification and accreditation systems according to international models;creation of consistent legal and industrial metrology and reinforcing capabilities inthese fields in the participating countries; and reinforcing regional information centresfor SMEs in the field of standardisation and quality.

These three examples contain a variety of components; however, all contain the characteristicelements of support for information and training, development of legislation and regulationsand implementation by setting up and improving procedures and developing organisations.

When the development of the basic quality infrastructure has progressed, technical assistancefor specific issues such as participation in international work, solving trade problems andsupport for investment become more widespread. It should be recognised that despite theexistence of typical patterns, the situation of each potential recipient is unique.

,03/(0(17,1*�6<67(06

It is not sufficient to make agreements; there must be reasonable confidence that they will beadhered to. Experience has demonstrated that if the capacity, or the political will, toimplement an agreement is missing, then the agreement itself will remain merely words; and awell-intentioned agreement that goes beyond the ability or willingness of any party toimplement it will do more harm than good, since the entire concept will become discredited.

Consequently, any agreement to facilitate trade should be accompanied by genuine readiness,capacity and willingness to implement it. This implies, among other things, that the relevantbodies (for example, legislative or governmental entities) in both parties to a negotiationought to be involved in it, and there should be a reasonable expectation that they can and willimplement the results. Ultimately, agreements of this type depend upon the commitment ofthe parties to carry them out, and it is better to determine what can realistically be delivered,rather than to agree an ambitious programme, only to find that what can be agreed on papercannot be implemented on the ground.

&21&/86,21��6(/(&7,1*�7+(�5,*+7�,167580(17

Analysis of trade facilitation measures in the area of technical regulation, conformityassessment and certification shows that a range of instruments is available. Selection of theright instrument will depend on the characteristics of the markets, the regulatory environmentin the third country or region concerned, and the willingness on the part industries, regulatorsand other parties to achieve the agreed objectives.

In any case, the sectors in question should offer clear opportunities to facilitate access by EUindustry to foreign markets; at the same time it should guarantee the functioning of the EU

23

internal market without undermining its principles. Trade facilitation measures can also beused to promote the regulatory approaches experienced in the EU, which have proved theiradvantage in the establishment of the single market. Different sectors will often have differentneeds. For example, if there is an established corpus of international rules already in place(the example of marine equipment has already been quoted), then harmonisation and / orequivalence can be based on such rules.

3DUWLFXODU�FKDUDFWHULVWLFV�RI�WKH�SDUWQHUV�WR�DQ�DJUHHPHQW

Asymmetries in requirements between the partners may be an obstacle in particular sectors.They may arise from differences in regulatory practice, for example, H[� DQWH certification,active market surveillance by governmental agencies, or H[�SRVW�product liability based on theaggrieved customer’s right to sue the supplier. They may also arise from fundamentaldifferences in technological practice. Such problems may not easily be reconcilable byrecognition of certificates or common standards, particularly if one party maintains a moreliberal régime than another. One avenue to explore in this direction is the possibility of PXOWL�VHFWRUDO� DJUHHPHQWV, possibly involving different instruments. But this will require asubstantial degree of administrative sophistication, and will clearly be more difficult toaccomplish than a simple mutual agreement in a single sector.

If several trading partners have economies that are well integrated with one or more otherlocal partners, then a further problem may arise in making an agreement with one, withoutmaking agreements with all of them. If trade between the EU and a particular country isfacilitated, for example through an MRA, and if the partner country is a regional tradingcentre, full of goods being exported or imported elsewhere, then goods in the partner countryoriginating from its local partners will enter the European market on the back of the MRA,though the local partners have made no similar agreement with the EU, and therefore EUexports to these countries will not enjoy the same advantages. “Rules of origin” or similarprovisions are likely to be ineffective, because the EU will have no means, and the partnercountry no incentive, to enforce them. The decision to conclude an agreement with suchcountries must bear this risk in mind; either the possibility of facilitating trade on anasymmetrical basis “through the back door” will have to be tolerated, or agreements with suchtrading centres may have to depend on the ability to make agreements with all of the localpartners.

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The EU is already actively engaged in a substantial number of activities, in all of these areas,some of which have been described in detail above. As well as the MRAs in place or planned,there are other activities, such as the ASEM dialogue on standards (as part of ASEM’s TradeFacilitation Action Plan) and the Transatlantic Economic Partnership. Through agreementswith the European standards bodies, the EU is a major supporter of internationalstandardisation, and is active in the WTO Technical Barriers to Trade (TBT) Committee.

Future trade facilitation activities should continue to make use of all the various tools that areavailable. A V\VWHPDWLF� DSSURDFK to identifying the tool to use might be based upon anassessment of the potential for increased trade; the nature of the barriers (different standards,certification procedures, market surveillance capacity, etc.); the political will among theparties to reach a solution (for example, if a government agency in a particular country isknown to be systematically uncooperative, it may not be worth the effort if the agency’s co-operation is needed in another sector); the desire among economic operators for an agreement;and the relative regulatory capacities of the parties.

24

At the same time, factors other than trade will need to be taken properly into account. Forexample, where regulation has a legitimate aim such as safety, any moves intended for tradefacilitation must leave the necessary level of protection in place. Furthermore, the parties toan agreement may find it politically necessary to maintain a degree of regulatory autonomy.

1

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Standardisation

Vademecum on European Standardisation

Part V

Technical assistance and Standardisation

Chapter 2

European Community TBT related technical assistance to developing Countries – EC submission to the TBT committee

15 November 2003

Status of the document: EC Working Document of September 2003 Author: Enterprise DG Unit G1

For further information: entr-regul-coord-MRA@cec.eu.int

2

EC submission to the TBT Committee EUROPEAN COMMUNITY TBT RELATED TECHNICAL ASSISTANCE TO DEVELOPING COUNTRIES 1. Introduction Following a number of requests from developing countries, and with a view to further enhancing transparency, this document provides information about the programming of TBT related assistance within the European Commission and possibilities for obtaining such assistance. It also aims to help developing countries understand the EC system. The link between trade and development has been designated as one of the priority areas for the European Community's (EC’s) development co-operation. The trade dimension is taken into account in all the relevant levels of decision making on how to allocate funds for assistance - thus providing a possibility of developing countries to benefit from EC development aid for TBT purposes. As part of its efforts to respond to technical assistance needs in the TBT field, the EC is funding a number of projects around the world. An updated list of European Commission and EU Member States’ technical assistance activities in the TBT field is attached. 2. Technical assistance programming within the European Commission The majority of EC development co-operation programmes are carried out in accordance with various agreements between the EC and developing countries. The development co-operation cycle starts with the programming phase that leads to the development and adoption of multiannual (typically five year) Country and/or Regional Strategy Papers (CSPs and/or RSPs). CSPs provide a framework for co-operation programmes based on a number of factors, including the partner country government policy agenda, an analysis of the partner country’s situation and the activities of other major partners. RSPs provide a similar framework for regions. The strategy papers point to where EC assistance should be directed, including a description of the priorities pursued and the focal sectors. The papers also highlight how EC activities integrate with the activities of other donors and contain an outline of the specific EC contribution to the agreed co-operation goals. There are presently 120 CSPs and 15 RSPs. Information about the CSPs and RSPs can be found on the Internet sites: http://europa.eu.int/comm/development/body/csp_rsp/csp_en.cfm and http://europa.eu.int/comm/external_relations/sp/index.htm. National and Regional Indicative Programmes are management tools that are included in the CSPs and RSPs. They define in more detail the selected areas/sectors of co-operation to be financed and appropriate measures and action for attaining the

3

set objectives. Where appropriate, these programmes include an indicative resource allocation. The next steps are programme/project identification, preparation and appraisal. This includes discussions with the partner country to determine the intervention network, one or more identification missions, and the drafting and finalisation of both a project identification sheet and a financing proposal. The partner country is closely involved throughout this process. The following phase is the implementation of the programmes/projects. The implementation and its follow up are generally managed by the responsible European Commission Delegation in the partner county in co-operation with the European Aid Co-operation Office of the European Commission in Brussels. The beneficiary government or regional organisation in close co-operation with the delegation draws up terms of reference, carries out tendering and contracting of the projects/sub-projects and proposes revisions or modifications in the programme/project when required. The final step is evaluation, which feeds back into the overall programming. Strategy papers and indicative programmes are regularly reviewed and can be adjusted in view of needs and performance. The review process is the occasion to assess or reassess the coverage of specific themes such as trade development in general or assistance in the TBT area. 3. Information about EC technical assistance Further information about EC trade related assistance can be found on the Internet sites: http://europa.eu.int/comm/europeaid/index_en.htm http://europa.eu.int/comm/trade/issues/global/development/trta/index_en.htm It is also possible to ask for information from the European Commission Delegations in partner countries. A list of the EC Delegations is available on the Internet site: http://europa.eu.int/comm/external_relations/index.htm. In countries to which no Delegation is accredited, the headquarters of the European Commission in Brussels should be contacted. A list of EC Member State agencies working in the development field is available at the Internet site: http://europa.eu.int/comm/development/body/organisation/dev_links_en.cfm. The EC also provides various types of assistance to countries that have applied to become members of the European Union. The assistance is based on the priorities identified in Accession Partnership Agreements with these countries. Information about these EC programmes/projects can be found on the Internet site: http://europa.eu.int/comm/enlargement/fiche_projet/.

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single Market : regulatory environment, standardisation and New Approach Standardisation

Vademecum on European Standardisation

Part V

Technical Assistance and Standardisation

Chapter 3

Technical Assistance and capacity building in the field of

Technical Barriers to Trade

15 November 2003

Status of the document: EC Working Document of 2001

Author: Enterprise DG Unit G1

For further information: entr-regul-coord-MRA@cec.eu.int

EC submission to the TBT Committee

Technical assistance and capacity building in the field of Technical Barriers to Trade

1. Introduction. This note aims to identify realistic and practical options for possible actions in the TBT technical assistance field, and to contribute to the development of a technical co-operation programme, as agreed in the 2nd Triennial Review of the TBT agreement. In developing its ideas, the EC has drawn on its extensive experience as a donor of technical assistance in the TBT field. It should be emphasised that any technical assistance programme must be demand driven and tailored to fit each recipient’s specific needs. 2. Background. Technical assistance has been the subject of considerable debate in the TBT Committee. The Committee organised in July 2000 a workshop on Technical Assistance and Special and Differential Treatment. This provided an opportunity for recipients of technical assistance to inform the Committee of their needs and for donors to inform the Committee about national and regional technical assistance programmes. The Second Triennial Review of the TBT agreement was concluded in November 2000. One of the major results was that the Review recognised the importance of enhancing the effectiveness of technical assistance and co-operation and agreed that the Committee should develop a demand driven technical co-operation programme on the basis of the following elements:

• Design of a survey with the assistance of relevant international, regional and bilateral organisations to assist developing countries in technical assistance needs identification;

• Identification and prioritisation by developing and least developed country members of their specific technical assistance needs in the TBT field;

• Consideration of existing technical assistance activities by multilateral, regional and bilateral organisations with a view to the effective and efficient development of technical assistance programmes;

• Enhancement of co-operation between technical assistance donors and • Reassessment of needs in light of agreed priorities, identification of technical assistance

partners and financial considerations.

This paper focuses on the second and third elements of the above programme. The EC intends to follow-up this paper in due course through the submission to the TBT Committee of a list of existing and planned EC technical assistance and capacity building programmes.

3

3. TBT Technical Assistance - Identification of Needs. A key requirement for the success of any technical assistance project is to be demand driven. Therefore it is essential to identify requirements of both private and public sectors and define priorities in order to take account of the specific needs and characteristics of each developing country. The needs for technical assistance in developing countries vary considerably depending upon their own priorities. A technical assistance project can only be of use to the recipient if it addresses the right needs. Donor countries should be flexible in helping recipient countries meet their prioritised needs. The EU does finance a large number of technical assistance projects in the TBT field and will continuously assess the effectiveness of this support based on prioritised needs. Practical Options: • The first element when planning technical assistance projects is therefore to identify and

prioritise the needs for assistance if they are not already known.

• Assistance could be provided for a needs survey if necessary. The survey may describe as background the country’s situation regarding the TBT Agreement and it’s implementation and present quality infrastructure. It may specify general development needs and specific needs e.g. regarding technical regulations, standardisation, accreditation, conformity assessment, metrology and market surveillance.

• Input from a range of concerned actors, including public authorities, standardisation and accreditation bodies, testing laboratories, manufacturers, trade and consumer organisations, may enhance the effectiveness of this first phase.

4. TBT Technical Assistance – Options for Addressing Needs.

4.1. Increasing Knowledge The type of knowledge required to achieve maximum benefit varies from country to country. Knowledge and awareness is needed among all actors in the quality infrastructure field including government departments and agencies, testing laboratories, conformity assessment bodies and industry. Practical Options:

• Information seminars and workshops could be provided to increase knowledge and raise awareness.

• More specific training for government departments, industry and other concerned parties of the importance of technical regulations, standards, conformity assessment, metrology and quality in global trade, as well as of the rights and obligations under the TBT Agreement.

• Hands-on training through participating in practical work and solving practical problems in developed or other developing country organisations could be provided.

4

• Training trainers, i.e. by improving the skills of trainers, policy-makers, accreditation professionals, technical assessors, laboratory personnel, industry personnel and other concerned parties. This could draw on existing know-how in both developed and developing countries, possibly through some form of twinning arrangement or mentorship scheme.

4.2. Infrastructure Related Measures. A suitably functioning quality infrastructure would enable countries to make best use of the provisions of the TBT agreement and maximise their trading potential. Issues of importance in this respect include having the necessary legislation in place, and a general strategy for developing the infrastructure and necessary bodies for e.g. standardisation, accreditation conformity assessment, metrology and market surveillance. Practical Options: • Assistance could be provided to countries to help them be able to comply with specific

technical regulations and standards in their export markets. These actions could target vital bottlenecks faced by exporters.

• Support could be provided to countries to develop a general strategy for the quality infrastructure field.

• Assistance and financial support could be provided for development of specific bodies e.g. for standardisation, accreditation, conformity assessment, metrology and market surveillance.

• Help establish national information-gathering and dissemination mechanisms related to technical barriers to trade, notably TBT enquiry points, in order to fulfil the obligations of and benefit from the TBT notification provisions.

• Support in the provision of effective means of communication and information processing, for example: - furthering the use of e-commerce applications to allow developing countries to receive technical notifications by electronic means, thereby encouraging participation; - to establish practical means to aid developing countries to procure necessary e-commerce hardware and networks.

4.3. Support for Participation in International Activities. Developing country participation in international fora such as the TBT Committee itself, International Standardisation Bodies and also accreditation organisations is limited. Reasons include a lack of technical capacity and financial and human resource constraints Participation through regional representation should be considered as an alternative to direct participation.

5

Practical Options: • Countries or regions could be supported to participate (at the appropriate level) in

international standardisation and accreditation activities, notably in areas that are important to their economic development and trade. Assistance could also be provided to help developing countries participate in other international activities in the TBT field.

4.4. Regional Arrangements. The rapid growth of regional arrangements and groupings in recent years ought to be better reflected in the aims of technical assistance, which is still mostly delivered bilaterally or geared to national, rather than regional solutions. There is an interest in encouraging standardisation, and the development of technical regulations and conformity assessment on a regional basis. Other fields where regional co-operation is of advantage are in accreditation, metrology and market surveillance. Useful regional co-operation activities are as follows: Practical Options: • Joint seminars and workshops – Joint multi-country seminars and workshops lead to

useful contacts between countries and to the establishment of informal networks and also have an economy of scale.

• Multi-country groups – Working in multi-country groups may help solve problems and lead to the establishment and development of networks

• Joint use of expertise and facilities in a region – Co-operation between countries in a region through joint use of the available scarce expertise and facilities in the region helps utilise the resources efficiently and effectively.

• Proficiency tests – Multi-country proficiency tests may be effective benchmarking exercises for determining the competence of laboratories. They may also help promote higher standards of performance.

• Joint assessments of countries’ progress – Assessments of progress of a group of countries in different fields/sectors have proven to be another useful benchmarking exercise. These assessments should be based on the same criteria in every country.

• Consistent use of outside experts – Establishing and maintaining a joint database of outside experts that can be used for short-term technical assistance to several countries leads to an economy of scale. It also leads to better and faster assistance because the experts can use the knowledge and experience they have obtained from previous assignments to similar countries.

• Direct and indirect representation in international bodies – Another successfully used form of co-operation between countries in a region is joint representation in international bodies. This has the potential to save time and expenses and gives still a possibility for all the countries in the region to indirectly express their opinions.

REGULATION (EU) No 1025/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 25 October 2012

on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision

87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee ( 1 ),

Acting in accordance with the ordinary legislative procedure ( 2 ),

Whereas:

(1) The primary objective of standardisation is the definition of voluntary technical or quality specifications with which current or future products, production processes or services may comply. Standardisation can cover various issues, such as standardisation of different grades or sizes of a particular product or technical spec­ifications in product or services markets where compati­bility and interoperability with other products or systems are essential.

(2) European standardisation is organised by and for the stakeholders concerned based on national representation (the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standard­isation (Cenelec)) and direct participation (the European Telecommunications Standards Institute (ETSI)), and is founded on the principles recognised by the World Trade Organisation (WTO) in the field of standardisation, namely coherence, transparency, openness, consensus, voluntary application, independence from special interests and efficiency (‘the founding principles’). In accordance with the founding principles, it is important that all relevant interested parties, including public auth­orities and small and medium-sized enterprises (SMEs), are appropriately involved in the national and European

standardisation process. National standardisation bodies should also encourage and facilitate the participation of stakeholders.

(3) European standardisation also helps to boost the competitiveness of enterprises by facilitating in particular the free movement of goods and services, network inter­operability, means of communication, technological development and innovation. European standardisation reinforces the global competitiveness of European industry especially when established in coordination with the international standardisation bodies, namely the International Organisation for Standardisation (ISO), the International Electrotechnical Commission (IEC) and the International Telecommunication Union (ITU). Standards produce significant positive economic effects, for example by promoting economic interpenetration on the internal market and encouraging the development of new and improved products or markets and improved supply conditions. Standards thus normally increase competition and lower output and sales costs, benefiting economies as a whole and consumers in particular. Standards may maintain and enhance quality, provide information and ensure interoperability and compati­bility, thereby increasing safety and value for consumers.

(4) European standards are adopted by the European stan­dardisation organisations, namely CEN, Cenelec and ETSI.

(5) European standards play a very important role within the internal market, for instance through the use of harmonised standards in the presumption of conformity of products to be made available on the market with the essential requirements relating to those products laid down in the relevant Union harmonisation legislation. Those requirements should be precisely defined in order to avoid misinterpretation on the part of the European standardisation organisations.

(6) Standardisation plays an increasingly important role in international trade and the opening-up of markets. The Union should seek to promote cooperation between European standardisation organisations and international standardisation bodies. The Union should also promote bilateral approaches with third countries to coordinate standardisation efforts and promote European standards, for instance when negotiating agreements or by seconding standardisation experts to third countries. Furthermore the Union should encourage contact

EN L 316/12 Official Journal of the European Union 14.11.2012

( 1 ) OJ C 376, 22.12.2011, p. 69. ( 2 ) Position of the European Parliament of 11 September 2012 (not yet

published in the Official Journal) and decision of the Council of 4 October 2012.

between European standardisation organisations and private forums and consortia, while maintaining the primacy of European standardisation.

(7) European standardisation is governed by a specific legal framework consisting of three different legal acts, namely Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services ( 1 ), Decision No 1673/2006/EC of the European Parliament and of the Council of 24 October 2006 on the financing of European standardisation ( 2 ) and Council Decision 87/95/EEC of 22 December 1986 on standardisation in the field of information tech­nology and telecommunications ( 3 ). However, the current legal framework is no longer up to date with devel­opments in European standardisation over recent decades. Therefore, the current legal framework should be simplified and adapted in order to cover new aspects of standardisation to reflect those latest developments and future challenges in European standardisation. That relates in particular to the increased development of standards for services and the evolution of standard­isation deliverables other than formal standards.

(8) The European Parliament’s Resolution of 21 October 2010 on the future of European standardisation ( 4 ), as well as the report of the Expert Panel for the Review of the European Standardization System (Express) of February 2010 entitled ‘Standardization for a competitive and innovative Europe: a vision for 2020’, have set out an important number of strategic recommendations regarding the review of the European standardisation system.

(9) In order to ensure the effectiveness of standards and standardisation as policy tools for the Union, it is necessary to have an effective and efficient standard­isation system which provides a flexible and transparent platform for consensus building between all participants and which is financially viable.

(10) Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market ( 5 ) establishes general provisions facili­tating the exercise of the freedom of establishment for service providers and the free movement of services, while maintaining a high quality of services. It obliges the Member States to encourage, in cooperation with the Commission, the development of voluntary European standards with the aim of facilitating compatibility between services supplied by providers in different

Member States, the provision of information to the recipient and the quality of service provision. However, Directive 98/34/EC only applies to standards for products while standards for services are not expressly covered by it. Furthermore, the delineation between services and goods is becoming less relevant in the reality of the internal market. In practice, it is not always possible to clearly distinguish standards for products from standards for services. Many standards for products have a service component while standards for services often also partly relate to products. Thus, it is necessary to adapt the current legal framework to these new circumstances by extending its scope to standards for services.

(11) Like other standards, standards for services are voluntary and should be market-driven, whereby the needs of the economic operators and stakeholders directly or indi­rectly affected by such standards prevail, and should take into account the public interest and be based on the founding principles, including consensus. They should primarily focus on services linked to products and processes.

(12) The legal framework allowing the Commission to request one or several European standardisation organisations to draft a European standard or European standardisation deliverable for services should be applied while fully respecting the distribution of competences between the Union and the Member States as laid down in the Treaties. This concerns in particular Articles 14, 151, 152, 153, 165, 166 and 168 of the Treaty on the Func­tioning of the European Union (TFEU) and Protocol (No 26) on Services of General Interest annexed to the Treaty on European Union (TEU) and to the TFEU in accordance with which it remains the exclusive competence of the Member States to define the fundamental principles of their social security, vocational training and health systems and to shape the framework conditions for the management, financing, organisation and delivery of the services supplied within those systems, including - without prejudice to Article 168(4) TFEU and to Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications ( 6 ) - the definition of requirements, quality and safety standards applicable to them. The Commission should not, by means of such a request, affect the right to negotiate, conclude and enforce collective agreements and to take industrial action in accordance with national law and practices which respect Union law.

(13) The European standardisation organisations are subject to competition law to the extent that they can be considered to be an undertaking or an association of undertakings within the meaning of Articles 101 and 102 TFEU.

EN 14.11.2012 Official Journal of the European Union L 316/13

( 1 ) OJ L 204, 21.7.1998, p. 37. ( 2 ) OJ L 315, 15.11.2006, p. 9. ( 3 ) OJ L 36, 7.2.1987, p. 31. ( 4 ) OJ C 70 E, 8.3.2012, p. 56. ( 5 ) OJ L 376, 27.12.2006, p. 36. ( 6 ) OJ L 255, 30.9.2005, p. 22.

(14) Within the Union, national standards are adopted by national standardisation bodies which could lead to conflicting standards and technical impediments in the internal market. Therefore, it is necessary for the internal market and for the effectiveness of standard­isation within the Union to confirm the existing regular exchange of information between the national standard­isation bodies, the European standardisation organi­sations and the Commission, about their current and future standardisation activities as well as the standstill principle applicable to the national standardisation bodies within the framework of the European standardisation organisations which provides for the withdrawal of national standards after the publication of a new European standard. The national standardisation bodies and European standardisation organisations should also observe the provisions on exchange of information in Annex 3 to the Agreement on Technical Barriers to Trade ( 1 ).

(15) The Member States’ obligation to notify the Commission of their national standardisation bodies should not require the adoption of a specific national legislation for the purposes of recognition of those bodies.

(16) The regular exchange of information between the national standardisation bodies, the European standard­isation organisations and the Commission should not prevent national standardisation bodies from complying with other obligations and commitments, and in particular with Annex 3 to the Agreement on Technical Barriers to Trade.

(17) The representation of societal interests and societal stake­holders in European standardisation activities refers to the activities of organisations and parties representing interests of greater societal relevance, for instance envi­ronmental, consumer interests or employee interests. However, the representation of social interests and social stakeholders in European standardisation activities refers particularly to the activities of organisations and parties representing employees and workers’ basic rights, for instance trade unions.

(18) In order to speed up the decision-making process, national standardisation bodies and European standard­isation organisations should facilitate accessible information on their activities through the promotion of the use of information and communication tech­nologies (ICT) in their respective standardisation systems, for example by providing to all relevant stake­holders an easy-to-use online consultation mechanism for the submission of comments on draft standards and by organising virtual meetings, including by means of web conferencing or video conferencing, of technical committees.

(19) Standards can contribute to helping Union policy address the major societal challenges such as climate change, sustainable resource use, innovation, ageing population, integration of people with disabilities, consumer protection, workers’ safety and working conditions. By driving the development of European or international standards for goods and technologies in the expanding markets in those areas, the Union could create a competitive advantage for its enterprises and facilitate trade, in particular for SMEs, which account for a large part of European enterprises.

(20) Standards are important tools for the competitiveness of undertakings and especially SMEs, whose participation in the standardisation process is important for technological progress in the Union. Therefore it is necessary that the standardisation framework encourage SMEs to actively participate in and provide their innovative technology solutions to standardisation efforts. This includes improving their participation at national level where they can be more effective due to lower costs and lack of linguistic barriers. Consequently this Regulation should improve representation and participation of SMEs in both national and European technical committees and should facilitate their effective access to and awareness of standards.

(21) European standards are of vital interest for the competi­tiveness of SMEs which, however, are in some cases under-represented in European standardisation activities. Thus, this Regulation should encourage and facilitate appropriate representation and participation of SMEs in the European standardisation process by an entity that is effectively in contact with, and duly representative of, SMEs and organisations representing SMEs at national level.

(22) Standards can have a broad impact on society, in particular on the safety and well-being of citizens, the efficiency of networks, the environment, workers’ safety and working conditions, accessibility and other public policy fields. Therefore, it is necessary to ensure that the role and the input of societal stakeholders in the development of standards are strengthened, through the reinforced support of organisations representing consumers and environmental and social interests.

(23) The obligation of the European standardisation organi­sations to encourage and facilitate representation and effective participation of all relevant stakeholders does not entail any voting rights for these stakeholders unless such voting rights are prescribed by the internal rules of procedure of the European standardisation organisations.

EN L 316/14 Official Journal of the European Union 14.11.2012

( 1 ) Approved by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994) (OJ L 336, 23.12.1994, p. 1).

(24) The European standardisation system should also fully take into account the United Nations Convention on the Rights of Persons with Disabilities ( 1 ). It is therefore important that organisations representing the interests of consumers sufficiently represent and include the interests of people with disabilities. In addition, the participation of people with disabilities in the standardisation process should be facilitated by all available means.

(25) Due to the importance of standardisation as a tool to support Union legislation and policies and in order to avoid ex-post objections to and modifications of harmonised standards, it is important that public auth­orities participate in standardisation at all stages of the development of those standards where they may be involved and especially in the areas covered by Union harmonisation legislation for products.

(26) Standards should take into account environmental impacts throughout the life cycle of products and services. Important and publicly available tools for evaluating such impacts throughout the life cycle have been developed by the Commission’s Joint Research Centre (JRC). Thus, this Regulation should ensure that the JRC can play an active role in the European standard­isation system.

(27) The viability of the cooperation between the Commission and the European standardisation system depends on careful planning of future requests for the development of standards. This planning could be improved, in particular through the input of interested parties, including national market surveillance authorities, by introducing mechanisms for collecting opinions and facilitating the exchange of information among all interested parties. Since Directive 98/34/EC already provides for the possibility to request the European stan­dardisation organisations to develop European standards, it is appropriate to put in place a better and more trans­parent planning in an annual work programme which should contain an overview of all requests for standards which the Commission intends to submit to European standardisation organisations. It is necessary to ensure a high level of cooperation between the European standardisation organisations and the European stake­holder organisations receiving Union financing in accordance with this Regulation and the Commission in the establishment of its annual Union work programme for standardisation and in the preparation of requests for standards in order to analyse the market relevance of the proposed subject matter and the policy objectives set by the legislator, and to allow

the European standardisation organisations to respond more quickly to the requested standardisation activities.

(28) Before bringing a matter regarding requests for European standards or European standardisation deliverables, or objections to a harmonised standard before the committee set up by this Regulation, the Commission should consult experts of the Member States, for instance through the involvement of committees set up by the corresponding Union legislation or by other forms of consultation of sectoral experts, where such committees do not exist.

(29) Several directives harmonising the conditions for the marketing of products specify that the Commission may request the adoption, by the European standard­isation organisations, of harmonised standards on the basis of which conformity with the applicable essential requirements is presumed. However, many of those directives contain a wide variety of provisions on objections to these standards when the latter do not, or do not entirely, cover all applicable requirements. Diverging provisions which lead to uncertainty for economic operators and European standardisation organisations are in particular contained in Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment ( 2 ), Council Directive 93/15/EEC of 5 April 1993 on the harmon­isation of the provisions relating to the placing on the market and supervision of explosives for civil uses ( 3 ), Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres ( 4 ), Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft ( 5 ), European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts ( 6 ), Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment ( 7 ), Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments ( 8 ), Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 on the placing on the market of pyrotechnic articles ( 9 ), Directive 2009/23/EC of the European Parliament and of the Council of

EN 14.11.2012 Official Journal of the European Union L 316/15

( 1 ) Approved by Council Decision 2010/48/EC of 26 November 2009 concerning the conclusion, by the European Community, of the United Nations Convention on the Rights of Persons with Disabilities (OJ L 23, 27.1.2010, p. 35).

( 2 ) OJ L 399, 30.12.1989, p. 18. ( 3 ) OJ L 121, 15.5.1993, p. 20. ( 4 ) OJ L 100, 19.4.1994, p. 1. ( 5 ) OJ L 164, 30.6.1994, p. 15. ( 6 ) OJ L 213, 7.9.1995, p. 1. ( 7 ) OJ L 181, 9.7.1997, p. 1. ( 8 ) OJ L 135, 30.4.2004, p. 1. ( 9 ) OJ L 154, 14.6.2007, p. 1.

23 April 2009 on non-automatic weighing instru­ments ( 1 ) and Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels ( 2 ). Therefore, it is necessary to include in this Regulation the uniform procedure provided for in Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products ( 3 ), delete the relevant provisions in those Directives and extend to the European Parliament the right to object to a harmonised standard in accordance with this Regulation.

(30) Public authorities should make best use of the full range of relevant technical specifications when procuring hardware, software and information technology services, for example by selecting technical specifications which can be implemented by all interested suppliers, allowing for more competition and reduced risk of lock-in. Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coor­dinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors ( 4 ), Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts ( 5 ), Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security ( 6 ) and Commission Regu­lation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities ( 7 ) specify that technical specifications in public procurement should be formulated by reference to national standards transposing European standards, European technical approvals, common technical specifications, international standards, other technical reference systems established by the European standardisation organisations or - when these do not exist - to national standards, national technical approvals or national technical specifications relating to the design, calculation and execution of the works and use of the products, or equivalent. ICT technical specifi­cations, however, are often developed by other standard developing organisations and do not fall in any of the categories of standards and approvals laid down in Directives 2004/17/EC, 2004/18/EC or 2009/81/EC or Regulation (EC, Euratom) No 2342/2002. Therefore, it is necessary to provide for the possibility that technical specifications for public procurement could refer to ICT technical specifications, in order to respond to the fast

evolution in the field of ICT, facilitate the provision of cross-border services, encourage competition and promote interoperability and innovation.

(31) Technical specifications not adopted by European stan­dardisation organisations do not hold an equivalent status to European standards. Some ICT technical spec­ifications are not developed in accordance with the founding principles. Therefore, this Regulation should lay down a procedure for the identification of ICT technical specifications that could be referenced in public procurement, involving a broad consultation of a large spectrum of stakeholders, including the European standardisation organisations, enterprises and public authorities. This Regulation should also lay down requirements, in the form of a list of criteria, for such technical specifications and their associated devel­opment processes. The requirements for the identification of ICT technical specifications should ensure that public policy objectives and societal needs are respected, and should be based on the founding principles.

(32) In order to further innovation and competition, the identification of a particular technical specification should not disqualify a competing technical specification from being identified in accordance with the provisions of this Regulation. Any identification should be subject to the criteria being fulfilled and to the technical specifi­cation having achieved a significant level of market acceptance.

(33) The identified ICT technical specifications could contribute to the implementation of Decision No 922/2009/EC of the European Parliament and of the Council of 16 September 2009 on interoperability solutions for European public administrations (ISA) ( 8 ) which establishes, for the period 2010-2015, a programme on interoperability solutions for European public administrations and institutions and bodies of the Union, providing common and shared solutions facilitating interoperability.

(34) Situations may arise in the field of ICT where it is appro­priate to encourage the use of, or require compliance, with relevant standards at Union level in order to ensure interoperability in the single market and to improve freedom of choice for users. In other circum­stances, it may also happen that specified European standards no longer meet consumers’ needs or are hampering technological development. For these reasons, Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communi­cations networks and services ( 9 ) enables the

EN L 316/16 Official Journal of the European Union 14.11.2012

( 1 ) OJ L 122, 16.5.2009, p. 6. ( 2 ) OJ L 264, 8.10.2009, p. 12. ( 3 ) OJ L 218, 13.8.2008, p. 82. ( 4 ) OJ L 134, 30.4.2004, p. 1. ( 5 ) OJ L 134, 30.4.2004, p. 114. ( 6 ) OJ L 216, 20.8.2009, p. 76. ( 7 ) OJ L 357, 31.12.2002, p. 1.

( 8 ) OJ L 260, 3.10.2009, p. 20. ( 9 ) OJ L 108, 24.4.2002, p. 33.

Commission, where necessary, to request European stan­dardisation organisations to draw up standards, to establish and publish in the Official Journal of the European Union a list of standards or specifications with the view to encourage their use, or to make their imple­mentation compulsory, or to remove standards or spec­ifications from that list.

(35) This Regulation should not prevent European standard­isation organisations from continuing to develop standards in the field of ICT and to increase their cooperation with other standard developing bodies, especially in the field of ICT, in order to ensure coherence and avoid fragmentation or duplication during implementation of standards and specifications.

(36) The procedure for identification of ICT technical specifi­cations provided for in this Regulation should not undermine the coherence of the European standard­isation system. Therefore, this Regulation should also lay down the conditions under which it can be considered that a technical specification does not conflict with other European standards.

(37) Before identifying ICT technical specifications which may be eligible for referencing in public procurement, the Multi Stakeholder Platform established by the Commission Decision of 28 November 2011 ( 1 ) should be used as a forum for consultation of European and national stakeholders, European standardisation organi­sations and Member States in order to ensure legitimacy of the process.

(38) Decision No 1673/2006/EC establishes the rules concerning the contribution of the Union to the financing of European standardisation in order to ensure that European standards and other European stan­dardisation deliverables are developed and revised in support of the objectives, legislation and policies of the Union. It is appropriate, for the purpose of administrative and budgetary simplification, to incorporate the provisions of that Decision into this Regulation and to use wherever possible the least burdensome procedures.

(39) In view of the very broad field of involvement of European standardisation in support of Union legislation and policies and the different types of standardisation activity, it is necessary to provide for different financing arrangements. This mainly concerns grants without calls for proposals to the European standard­isation organisations and national standardisation bodies in accordance with the second subparagraph of

Article 110(1) of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities ( 2 ) and point (d) of Article 168(1) of Regu­lation (EC, Euratom) No 2342/2002. Furthermore, the same provisions should apply to those bodies which, whilst not recognised as European standardisation organisations in this Regulation, have been mandated in a basic act and have been entrusted with carrying out preliminary work in support of European standard­isation in cooperation with the European standardisation organisations.

(40) Inasmuch as European standardisation organisations provide ongoing support for Union activities, they should have effective and efficient central secretariats. The Commission should therefore be allowed to provide grants to those organisations that are pursuing an objective of general European interest without applying, in the case of operating grants, the principle of annual reduction provided for in Article 113(2) of Regulation (EC, Euratom) No 1605/2002.

(41) Decision No 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Competitiveness and Innovation Framework Programme (2007 to 2013) ( 3 ), Decision No 1926/2006/EC of the European Parliament and of the Council of 18 December 2006 establishing a programme of Community action in the field of consumer policy (2007-2013) ( 4 ) and Regu­lation (EC) No 614/2007 of the European Parliament and of the Council of 23 May 2007 concerning the Financial Instrument for the Environment (LIFE+) ( 5 ) already provide for the possibility of financial support of European organisations representing SMEs, consumers and environmental interests in standardisation, while specific grants are paid to European organisations repre­senting social interests in standardisation. The financing under Decision No 1639/2006/EC, Decision No 1926/2006/EC and Regulation (EC) No 614/2007 will end on 31 December 2013. It is essential for the devel­opment of European standardisation to continue fostering and encouraging the active participation of European organisations representing SMEs, consumers and environmental and social interests. Such organi­sations pursue an aim of general European interest and constitute, by virtue of the specific mandate that national non-profit organisations have given them, a European network representing non-profit organisations active in the Member States and promoting principles and policies consistent with the objectives of the Treaties. Because of the context in which they operate and their statutory objectives, European organisations representing SMEs, consumers and environmental and social interests in European standardisation have a permanent role which is essential for Union objectives and policies. Therefore, the Commission should be in a position to continue providing grants to those organisations without

EN 14.11.2012 Official Journal of the European Union L 316/17

( 1 ) OJ C 349, 30.11.2011, p. 4.

( 2 ) OJ L 248, 16.9.2002, p. 1. ( 3 ) OJ L 310, 9.11.2006, p. 15. ( 4 ) OJ L 404, 30.12.2006, p. 39. ( 5 ) OJ L 149, 9.6.2007, p. 1.

applying, in the case of operating grants, the principle of annual reduction provided for in Article 113(2) of Regu­lation (EC, Euratom) No 1605/2002.

(42) The financing of standardisation activities should also be capable of covering preliminary or ancillary activities in connection with the establishment of European standards or European standardisation deliverables for products and for services. This is necessary primarily for work involving research, the preparation of preliminary documents for legislation, inter-laboratory tests and the validation or evaluation of standards. The promotion of standardisation at European and international level should also continue through programmes relating to the technical assistance to, and cooperation with, third countries. With a view to improving market access and boosting the competitiveness of enterprises in the Union, it should be possible to give grants to other bodies through calls for proposals or, where necessary, by awarding contracts.

(43) Union financing should seek to establish European standards or European standardisation deliverables for products and for services, to facilitate their use by enter­prises through the enhanced support for their translation into the various official Union languages, in order to allow SMEs to fully benefit from the understanding and application of the European standards, to strengthen the cohesion of the European standardisation system and to ensure fair and transparent access to European standards for all market players throughout the Union. This is especially important in cases where the use of standards enables compliance with relevant Union legis­lation.

(44) In order to ensure the effective application of this Regu­lation, there should be the possibility of using the requisite expertise, particularly with regard to auditing and financial management, as well as administrative support resources capable of facilitating implementation, and of evaluating on a regular basis the relevance of the activities receiving Union financing in order to ensure their usefulness and impact.

(45) Appropriate measures should also be taken to avoid fraud and irregularities and to recover funds unduly paid in accordance with Council Regulations (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial inter­ests ( 1 ) and (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities ( 2 ) and Regulation (EC)

No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) ( 3 ).

(46) In order to update the list of European standardisation organisations and to adapt the criteria for organisations representing SMEs and societal stakeholders to further developments as regards their non-profit making nature and representativity, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amendments to the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(47) The committee set up by this Regulation should assist the Commission in all matters related to the implemen­tation of this Regulation, having due regard for the views of sectoral experts.

(48) In order to ensure uniform conditions for the implemen­tation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers ( 4 ).

(49) The advisory procedure should be used for the adoption of implementing acts with respect to the objections to harmonised standards and where the references to the harmonised standard concerned have not yet been published in the Official Journal of the European Union, given that the relevant standard has not yet led to the presumption of conformity with the essential requirements set out in the applicable Union harmon­isation legislation.

(50) The examination procedure should be used for each stan­dardisation request submitted to European standard­isation organisations and the adoption of implementing acts with respect to the objections to harmonised standards and where the references to the harmonised standard concerned have already been published in the Official Journal of the European Union, given that such decision could have consequences on the presumption of conformity with the applicable essential requirements.

EN L 316/18 Official Journal of the European Union 14.11.2012

( 1 ) OJ L 312, 23.12.1995, p. 1. ( 2 ) OJ L 292, 15.11.1996, p. 2.

( 3 ) OJ L 136, 31.5.1999, p. 1. ( 4 ) OJ L 55, 28.2.2011, p. 13.

(51) In order to achieve the main objectives of this Regulation and to facilitate speedy decision-making procedures as well as reducing the overall development time for stan­dards, use should be made as far as possible of the procedural measures provided for in Regulation (EU) No 182/2011, which enables the chair of the relevant committee to lay down a time limit within which the committee should deliver its opinion, according to the urgency of the matter. Moreover, where justified, it should be possible for the opinion of the committee to be obtained by written procedure, and silence on the part of the committee member should be regarded as tacit agreement.

(52) Since the objectives of this Regulation, namely to ensure the effectiveness and efficiency of standards and stan­dardisation as policy tools for the Union through cooperation between European standardisation organi­sations, national standardisation bodies, Member States and the Commission, the establishment of European standards and European standardisation deliverables for products and for services in support of Union legislation and policies, the identification of ICT technical specifi­cations eligible for referencing, the financing of European standardisation and stakeholder participation in European standardisation cannot be sufficiently achieved by the Member States and can, therefore, by reason of their effect, be better achieved at the Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(53) Directives 89/686/EEC, 93/15/EEC, 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC should therefore be amended accordingly.

(54) Decision No 1673/2006/EC and Decision 87/95/EEC should be repealed,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Regulation establishes rules with regard to the cooperation between European standardisation organisations, national stan­dardisation bodies, Member States and the Commission, the establishment of European standards and European standard­isation deliverables for products and for services in support of Union legislation and policies, the identification of ICT technical specifications eligible for referencing, the financing of European standardisation and stakeholder participation in European stan­dardisation.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘standard’ means a technical specification, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following:

(a) ‘international standard’ means a standard adopted by an international standardisation body;

(b) ‘European standard’ means a standard adopted by a European standardisation organisation;

(c) ‘harmonised standard’ means a European standard adopted on the basis of a request made by the Commission for the application of Union harmon­isation legislation;

(d) ‘national standard’ means a standard adopted by a national standardisation body;

(2) ‘European standardisation deliverable’ means any other technical specification than a European standard, adopted by a European standardisation organisation for repeated or continuous application and with which compliance is not compulsory;

(3) ‘draft standard’ means a document containing the text of the technical specifications concerning a given subject, which is being considered for adoption in accordance with the relevant standards procedure, as that document stands after the preparatory work and as circulated for public comment or scrutiny;

(4) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following:

(a) the characteristics required of a product including levels of quality, performance, interoperability, envi­ronmental protection, health, safety or dimensions, and including the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;

(b) production methods and processes used in respect of agricultural products as defined in Article 38(1) TFEU, products intended for human and animal consumption, and medicinal products, as well as production methods and processes relating to other products, where these have an effect on their char­acteristics;

EN 14.11.2012 Official Journal of the European Union L 316/19

(c) the characteristics required of a service including levels of quality, performance, interoperability, environmental protection, health or safety, and including the requirements applicable to the provider as regards the information to be made available to the recipient, as specified in Article 22(1) to (3) of Directive 2006/123/EC;

(d) the methods and the criteria for assessing the performance of construction products, as defined in point 1 of Article 2 of Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction prod­ucts ( 1 ), in relation to their essential characteristics;

(5) ‘ICT technical specification’ means a technical specification in the field of information and communication technol­ogies;

(6) ‘product’ means any industrially manufactured product and any agricultural product, including fish products;

(7) ‘service’ means any self-employed economic activity normally provided for remuneration, as defined in Article 57 TFEU;

(8) ‘European standardisation organisation’ means an organi­sation listed in Annex I;

(9) ‘international standardisation body’ means the Inter­national Organisation for Standardisation (ISO), the Inter­national Electrotechnical Commission (IEC) and the Inter­national Telecommunication Union (ITU);

(10) ‘national standardisation body’ means a body notified to the Commission by a Member State in accordance with Article 27 of this Regulation.

CHAPTER II

TRANSPARENCY AND STAKEHOLDER PARTICIPATION

Article 3

Transparency of work programmes of standardisation bodies

1. At least once a year, each European standardisation organisation and national standardisation body shall establish its work programme. That work programme shall contain information on the standards and European standardisation deliverables which a European standardisation organisation or national standardisation body intends to prepare or amend, which it is preparing or amending and which it has adopted in the period of the preceding work programme, unless these are identical or equivalent transpositions of international or European standards.

2. The work programme shall indicate, in respect of each standard and European standardisation deliverable:

(a) the subject matter;

(b) the stage attained in the development of the standards and European standardisation deliverables;

(c) the references of any international standards taken as a basis.

3. Each European standardisation organisation and national standardisation body shall make its work programme available on its website or any other publicly available website, as well as make a notice of the existence of the work programme available in a national or, where appropriate, European publication of standardisation activities.

4. No later than at the time of publication of its work programme, each European standardisation organisation and national standardisation body shall notify the existence thereof to the other European standardisation organisations and national standardisation bodies and to the Commission. The Commission shall make that information available to the Member States via the committee referred to in Article 22.

5. National standardisation bodies may not object to a subject for standardisation in their work programme being considered at European level in accordance with the rules laid down by the European standardisation organisations and may not undertake any action which could prejudice a decision in this regard.

6. During the preparation of a harmonised standard or after its approval, national standardisation bodies shall not take any action which could prejudice the harmonisation intended and, in particular, shall not publish in the field in question a new or revised national standard which is not completely in line with an existing harmonised standard. After publication of a new harmonised standard, all conflicting national standards shall be withdrawn within a reasonable deadline.

Article 4

Transparency of standards

1. Each European standardisation organisation and national standardisation body shall send at least in electronic form any draft national standard, European standard or European stan­dardisation deliverable to other European standardisation organisations, national standardisation bodies or the Commission, upon their request.

2. Each European standardisation organisation and national standardisation body shall within three months reply to, and take due account of, any comments received from any other

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( 1 ) OJ L 88, 4.4.2011, p. 5.

European standardisation organisation, national standardisation body or the Commission with respect to any draft referred to in paragraph 1.

3. When a national standardisation body receives comments indicating that the draft standard would have a negative impact on the internal market, it shall consult the European standard­isation organisations and the Commission before adopting it.

4. National standardisation bodies shall:

(a) ensure access to draft national standards in such a way that all relevant parties in particular those established in other Member States have the opportunity to submit comments;

(b) allow other national standardisation bodies to be involved passively or actively, by sending an observer, in the planned activities.

Article 5

Stakeholder participation in European standardisation

1. European standardisation organisations shall encourage and facilitate an appropriate representation and effective partici­pation of all relevant stakeholders, including SMEs, consumer organisations and environmental and social stakeholders in their standardisation activities. They shall in particular encourage and facilitate such representation and participation through the European stakeholder organisations receiving Union financing in accordance with this Regulation at the policy development level and at the following stages of the development of European standards or European standardisation deliverables:

(a) the proposal and acceptance of new work items;

(b) the technical discussion on proposals;

(c) the submission of comments on drafts;

(d) the revision of existing European standards or European standardisation deliverables;

(e) the dissemination of information of, and awareness-building about, adopted European standards or European standard­isation deliverables.

2. In addition to the collaboration with market surveillance authorities in the Member States, research facilities of the Commission and the European stakeholder organisations receiving Union financing in accordance with this Regulation, European standardisation organisations shall encourage and facilitate appropriate representation, at technical level, of under­takings, research centres, universities and other legal entities, in standardisation activities concerning an emerging area with significant policy or technical innovation implications, if the

legal entities concerned participated in a project that is related to that area and that is funded by the Union under a multi­annual framework programme for activities in the area of research, innovation and technological development, adopted pursuant to Article 182 TFEU.

Article 6

Access of SMEs to standards

1. National standardisation bodies shall encourage and facilitate the access of SMEs to standards and standards devel­opment processes in order to reach a higher level of partici­pation in the standardisation system, for instance by:

(a) identifying, in their annual work programmes, the standard­isation projects, which are of particular interests to SMEs;

(b) giving access to standardisation activities without obliging SMEs to become a member of a national standardisation body;

(c) providing free access or special rates to participate in stan­dardisation activities;

(d) providing free access to draft standards;

(e) making available free of charge on their website abstracts of standards;

(f) applying special rates for the provision of standards or providing bundles of standards at a reduced price.

2. National standardisation bodies shall exchange best practices aiming to enhance the participation of SMEs in stan­dardisation activities and to increase and facilitate the use of standards by SMEs.

3. National standardisation bodies shall send annual reports to the European standardisation organisations with regards to their activities in paragraphs 1 and 2 and all other measures to improve conditions for SMEs to use standards and to participate in the standards development process. The national standard­isation bodies shall publish those reports on their websites.

Article 7

Participation of public authorities in European standardisation

Member States shall, where appropriate, encourage participation of public authorities, including market surveillance authorities, in national standardisation activities aimed at the development or revision of standards requested by the Commission in accordance with Article 10.

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CHAPTER III

EUROPEAN STANDARDS AND EUROPEAN STANDARDISATION DELIVERABLES IN SUPPORT OF UNION

LEGISLATION AND POLICIES

Article 8

The annual Union work programme for European standardisation

1. The Commission shall adopt an annual Union work programme for European standardisation which shall identify strategic priorities for European standardisation, taking into account Union long-term strategies for growth. It shall indicate the European standards and European standardisation deliverables that the Commission intends to request from the European standardisation organisations in accordance with Article 10.

2. The annual Union work programme for European stan­dardisation shall define the specific objectives and policies for the European standards and European standardisation deliverables that the Commission intends to request from the European standardisation organisations in accordance with Article 10. In cases of urgency the Commission can issue requests without prior indication.

3. The annual Union work programme for European stan­dardisation shall also include objectives for the international dimension of European standardisation, in support of Union legislation and policies.

4. The annual Union work programme for European stan­dardisation shall be adopted after having conducted a broad consultation of relevant stakeholders, including European stan­dardisation organisations and European stakeholder organi­sations receiving Union financing in accordance with this Regu­lation, and Member States via the committee referred to in Article 22 of this Regulation.

5. After its adoption, the Commission shall make the annual Union work programme for European standardisation available on its website.

Article 9

Cooperation with research facilities

The Commission’s research facilities shall contribute to the preparation of the annual Union work programme for European standardisation referred to in Article 8 and provide European standardisation organisations with scientific input, in their areas of expertise, to ensure that European standards take into account economic competitiveness and societal needs such as environmental sustainability and safety and security concerns.

Article 10

Standardisation requests to European standardisation organisations

1. The Commission may within the limitations of the competences laid down in the Treaties, request one or several European standardisation organisations to draft a European standard or European standardisation deliverable within a set

deadline. European standards and European standardisation deliverables shall be market-driven, take into account the public interest as well as the policy objectives clearly stated in the Commission’s request and based on consensus. The Commission shall determine the requirements as to the content to be met by the requested document and a deadline for its adoption.

2. The decisions referred to in paragraph 1 shall be adopted in accordance with the procedure laid down in Article 22(3) after consultation of the European standardisation organisations and the European stakeholder organisations receiving Union financing in accordance with this Regulation as well as the committee set up by the corresponding Union legislation, when such a committee exists, or after other forms of consul­tation of sectoral experts.

3. The relevant European standardisation organisation shall indicate, within one month following its receipt, if it accepts the request referred to in paragraph 1.

4. Where a request for funding is made, the Commission shall inform the relevant European standardisation organi­sations, within two months following the receipt of the acceptance referred to in paragraph 3, about the award of a grant for drafting a European standard or a European standard­isation deliverable.

5. The European standardisation organisations shall inform the Commission about the activities undertaken for the devel­opment of the documents referred to in paragraph 1. The Commission together with the European standardisation organi­sations shall assess the compliance of the documents drafted by the European standardisation organisations with its initial request.

6. Where a harmonised standard satisfies the requirements which it aims to cover and which are set out in the corresponding Union harmonisation legislation, the Commission shall publish a reference of such harmonised standard without delay in the Official Journal of the European Union or by other means in accordance with the conditions laid down in the corresponding act of Union harmonisation legislation.

Article 11

Formal objections to harmonised standards

1. When a Member State or the European Parliament considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union harmonisation legislation, it shall inform the Commission thereof with a detailed explanation and the Commission shall, after consulting the committee set up by the corresponding Union harmonisation legislation, if it exists, or after other forms of consultation of sectoral experts, decide:

(a) to publish, not to publish or to publish with restriction the references to the harmonised standard concerned in the Official Journal of the European Union;

EN L 316/22 Official Journal of the European Union 14.11.2012

(b) to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in or from the Official Journal of the European Union.

2. The Commission shall publish information on its website on the harmonised standards that have been subject to the decision referred to in paragraph 1.

3. The Commission shall inform the European standard­isation organisation concerned of the decision referred to in paragraph 1 and, if necessary, request the revision of the harmonised standards concerned.

4. The decision referred to in point (a) of paragraph 1 of this Article shall be adopted in accordance with the advisory procedure referred to in Article 22(2).

5. The decision referred to in point (b) of paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 22(3).

Article 12

Notification of stakeholder organisations

The Commission shall establish a notification system for all stakeholders, including European standardisation organisations and European stakeholder organisations receiving Union financing in accordance with this Regulation in order to ensure proper consultation and market relevance prior to:

(a) adopting the annual Union work programme for European standardisation referred to in Article 8(1);

(b) adopting standardisation requests referred to in Article 10;

(c) taking a decision on formal objections to harmonised stan­dards, as referred to in Article 11(1);

(d) taking a decision on identifications of ICT technical specifi­cations referred to in Article 13;

(e) adopting delegated acts referred to in Article 20.

CHAPTER IV

ICT TECHNICAL SPECIFICATIONS

Article 13

Identification of ICT technical specifications eligible for referencing

1. Either on proposal from a Member State or on its own initiative the Commission may decide to identify ICT technical specifications that are not national, European or international standards, but meet the requirements set out in Annex II, which may be referenced, primarily to enable interoperability, in public procurement.

2. Either on proposal from a Member State or on its own initiative, when an ICT technical specification identified in accordance with paragraph 1 is modified, withdrawn or no

longer meets the requirements set out in Annex II, the Commission may decide to identify the modified ICT technical specification or to withdraw the identification.

3. The decisions provided for in paragraphs 1 and 2 shall be adopted after consultation of the European multi-stakeholder platform on ICT standardisation, which includes European stan­dardisation organisations, Member States and relevant stake­holders, and after consultation of the committee set up by the corresponding Union legislation, if it exists, or after other forms of consultation of sectoral experts, if such a committee does not exist.

Article 14

Use of ICT technical specifications in public procurement

The ICT technical specifications referred to in Article 13 of this Regulation shall constitute common technical specifications referred to in Directives 2004/17/EC, 2004/18/EC and 2009/81/EC, and Regulation (EC, Euratom) No 2342/2002.

CHAPTER V

FINANCING OF EUROPEAN STANDARDISATION

Article 15

Financing of standardisation organisations by the Union

1. The financing by the Union may be granted to the European standardisation organisations for the following stan­dardisation activities:

(a) the development and revision of European standards or European standardisation deliverables which is necessary and suitable for the support of Union legislation and policies;

(b) the verification of the quality, and conformity to the corresponding Union legislation and policies, of European standards or European standardisation deliverables;

(c) the performance of preliminary or ancillary work in connection with European standardisation, including studies, cooperation activities, including international cooperation, seminars, evaluations, comparative analyses, research work, laboratory work, inter-laboratory tests, conformity evaluation work and measures to ensure that the periods for the development and the revision of European standards or European standardisation deliverables are shortened without prejudice to the founding principles, especially the principles of openness, quality, transparency and consensus among all stakeholders;

(d) the activities of the central secretariats of the European standardisation organisations, including policy development, the coordination of standardisation activities, the processing of technical work and the provision of information to interested parties;

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(e) the translation of European standards or European standard­isation deliverables used in support of Union legislation and policies into the official Union languages other than the working languages of the European standardisation organi­sations or, in duly justified cases into languages other than the official Union languages;

(f) the drawing up of information to explain, interpret and simplify European standards or European standardisation deliverables, including the drawing up of user guides, abstracts of standards, best practice information and awareness-building actions, strategies and training programmes;

(g) activities seeking to carry out programmes of technical assistance, cooperation with third countries and the promotion and enhancement of the European standard­isation system and of European standards and European standardisation deliverables among interested parties in the Union and at international level.

2. The financing by the Union may also be granted to:

(a) national standardisation bodies for the standardisation activities referred to in paragraph 1, which they jointly undertake with the European standardisation organisations;

(b) other bodies which have been entrusted with contributing to the activities referred to in point (a) of paragraph 1, or carrying out the activities referred to in points (c) and (g) of paragraph 1, in cooperation with the European standard­isation organisations.

Article 16

Financing of other European organisations by the Union

The financing by the Union may be granted to the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation for the following activities:

(a) the functioning of these organisations and of their activities relating to European and international standardisation, including the processing of technical work and the provision of information to members and other interested parties;

(b) the provision of legal and technical expertise, including studies, in relation to assessment of the need for, and the development of, European standards and European stan­dardisation deliverables and training of experts;

(c) the participation in the technical work with respect to the development and revision of European standards and

European standardisation deliverables which is necessary and suitable for the support of Union legislation and policies;

(d) the promotion of European standards and European stan­dardisation deliverables, and the information on, and use of, standards among interested parties, including SMEs and consumers.

Article 17

Financing arrangements

1. Financing by the Union shall be provided in the form of:

(a) grants without a call for proposals, or contracts after public procurement procedures, to:

(i) European standardisation organisations and national standardisation bodies to carry out the activities referred to in Article 15(1);

(ii) bodies identified by a basic act, within the meaning of Article 49 of Regulation (EC, Euratom) No 1605/2002, to carry out, in collaboration with the European stan­dardisation organisations the activities referred to in point (c) of Article 15(1) of this Regulation;

(b) grants after a call for proposals, or contracts after public procurement procedures, to other bodies referred to in point (b) of Article 15(2):

(i) for contributing to the development and revision of European standards or European standardisation deliverables referred to in point (a) of Article 15(1);

(ii) for carrying out the preliminary or ancillary work referred to in point (c) of Article 15(1);

(iii) for carrying out the activities referred to in point (g) of Article 15(1);

(c) grants after a call for proposals to the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation to carry out the activities referred to in Article 16.

2. The activities of the bodies referred to in paragraph 1 may be financed by:

(a) grants for actions;

(b) operating grants for the European standardisation organi­sations and the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation in accordance with the rules set out in Regulation (EC, Euratom) No 1605/2002. In the event of renewal, operating grants shall not be automatically decreased.

EN L 316/24 Official Journal of the European Union 14.11.2012

3. The Commission shall decide on the financing arrangements referred to in paragraphs 1 and 2, on the amounts of the grants and, where necessary, on the maximum percentage of financing by type of activity.

4. Except in duly justified cases, grants awarded for the stan­dardisation activities referred to in points (a) and (b) of Article 15(1) shall take the form of lump sums and for the standardisation activities referred to in point (a) of Article 15(1) shall be paid upon fulfilment of the following conditions:

(a) European standards or European standardisation deliverables requested by the Commission in accordance with Article 10 are adopted or revised within a period not exceeding the period specified in the request referred to in that Article;

(b) SMEs, consumer organisations and environmental and social stakeholders are appropriately represented and can participate in European standardisation activities, as referred to in Article 5(1).

5. The common cooperation objectives and the adminis­trative and financial conditions relating to the grants awarded to European standardisation organisations and the European stakeholder organisations meeting the criteria set out in Annex III to this Regulation shall be defined in the framework partnership agreements between the Commission and those standardisation and stakeholder organisations, in accordance with Regulations (EC, Euratom) No 1605/2002 and (EC, Euratom) No 2342/2002. The Commission shall inform the European Parliament and the Council of the conclusion of those agreements.

Article 18

Management

The appropriations determined by the budgetary authority for the financing of standardisation activities may also cover the administrative expenses relating to the preparation, monitoring, inspection, auditing and evaluation which are directly necessary for the purposes of implementing Articles 15, 16 and 17, including studies, meetings, information and publication activ­ities, expenses relating to informatics networks for the exchange of information and any other expenditure on administrative and technical assistance which the Commission may use for stan­dardisation activities.

Article 19

Protection of the financial interests of the Union

1. The Commission shall ensure that, when the activities financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and other illegal activities, by effective checks and by the recovery of amounts unduly paid and, if irregularities are detected, by effective,

proportionate and dissuasive penalties, in accordance with Regulations (EC, Euratom) No 2988/95, (Euratom, EC) No 2185/96 and (EC) No 1073/1999.

2. For the Union activities financed pursuant to this Regu­lation, the notion of irregularity defined in Article 1(2) of Regu­lation (EC, Euratom) No 2988/95 shall mean any infringement of a provision of Union law or any breach of a contractual obligation resulting from an act or omission by an economic operator which has, or would have, the effect of prejudicing the general budget of the Union or budgets managed by it by an unjustified item of expenditure.

3. Any agreements and contracts resulting from this Regu­lation shall provide for monitoring and financial control by the Commission or any representative which it authorises and for audits by the European Court of Auditors, which if necessary may be conducted on the spot.

CHAPTER VI

DELEGATED ACTS, COMMITTEE AND REPORTING

Article 20

Delegated acts

The Commission shall be empowered to adopt delegated acts in accordance with Article 21 concerning amendments to the Annexes, in order to:

(a) update the list of European standardisation organisations set out in Annex I to take into account changes in their name or structure;

(b) adapt the criteria for European stakeholder organisations set out in Annex III to this Regulation to further developments as regards their non-profit making nature and representa­tivity. Such adaptations shall not have the effect of creating any new criteria or abolishing any existing criteria or category of organisation.

Article 21

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 20 shall be conferred on the Commission for a period of five years from 1 January 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

EN 14.11.2012 Official Journal of the European Union L 316/25

3. The delegation of power referred to in Article 20 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5. A delegated act adopted pursuant to Article 20 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 22

Committee procedure

1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regu­lation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

4. Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so request.

Article 23

Committee cooperation with standardisation organisations and stakeholders

The committee referred to in Article 22(1) shall work in cooperation with the European standardisation organisations and the European stakeholder organisations receiving Union financing in accordance with this Regulation.

Article 24

Reports

1. The European standardisation organisations shall send an annual report on the implementation of this Regulation to the Commission. It shall contain detailed information on the following:

(a) the application of Articles 4, 5, 10, 15 and 17;

(b) the representation of SMEs, consumer organisations and environmental and social stakeholders in national standard­isation bodies;

(c) the representation of SMEs on the basis of the annual reports referred to in Article 6(3);

(d) the use of ICT in the standardisation system;

(e) cooperation between the national standardisation bodies and European standardisation organisations.

2. The European stakeholder organisations that received Union financing in accordance with this Regulation shall send an annual report on their activities to the Commission. This report shall contain in particular detailed information about the membership of these organisations and the activities referred to in Article 16.

3. By 31 December 2015 and every five years thereafter, the Commission shall present a report to the European Parliament and to the Council on the implementation of this Regulation. This report shall contain an analysis of the annual reports referred to in paragraphs 1 and 2, an evaluation of the relevance of the standardisation activities receiving Union financing in the light of the requirements of Union legislation and policies as well as an assessment of potential new measures to simplify the financing of European standardisation and to reduce the administrative burden for the European standard­isation organisations.

Article 25

Review

By 2 January 2015, the Commission shall evaluate the impact of the procedure established by Article 10 of this Regulation on the timeframe for issuing standardisation requests. The Commission shall present its conclusions in a report to the European Parliament and to the Council. Where appropriate, that report shall be accompanied by a legislative proposal to amend this Regulation.

CHAPTER VII

FINAL PROVISIONS

Article 26

Amendments

1. The following provisions are deleted:

(a) Article 6(1) of Directive 89/686/EEC;

(b) Article 5 of Directive 93/15/EEC;

(c) Article 6(1) of Directive 94/9/EC;

(d) Article 6(1) of Directive 94/25/EC;

(e) Article 6(1) of Directive 95/16/EC;

(f) Article 6 of Directive 97/23/EC;

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(g) Article 14 of Directive 2004/22/EC;

(h) Article 8(4) of Directive 2007/23/EC;

(i) Article 7 of Directive 2009/23/EC;

(j) Article 6 of Directive 2009/105/EC.

References to those deleted provisions shall be construed as references to Article 11 of this Regulation.

2. Directive 98/34/EC is hereby amended as follows:

(a) in Article 1, paragraphs 6 to 10 are deleted;

(b) Articles 2, 3 and 4 are deleted;

(c) in Article 6(1), the words ‘with the representatives of the standards institutions referred to in Annexes I and II’ are deleted;

(d) in Article 6(3), the first indent is deleted;

(e) in Article 6(4), points (a), (b) and (e) are deleted;

(f) Article 7 is replaced by the following:

‘Article 7

Member States shall communicate to the Commission, in accordance with Article 8(1), all requests made to standards institutions to draw up technical specifications or a standard for specific products for the purpose of enacting a technical regulation for such products as draft technical regulations, and shall state the grounds for their enactment.’;

(g) in Article 11, the second sentence is replaced by the following sentence:

‘The Commission shall publish annual statistics on the notifications received in the Official Journal of the European Union.’;

(h) Annexes I and II are deleted.

References to those deleted provisions shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex IV to this Regu­lation.

Article 27

National standardisation bodies

Member States shall inform the Commission of their standard­isation bodies.

The Commission shall publish a list of national standardisation bodies and any updates to that list in the Official Journal of the European Union.

Article 28

Transitional provisions

In Union acts that provide for a presumption of conformity with essential requirements through the application of harmonised standards adopted in accordance with Directive 98/34/EC, references to Directive 98/34/EC shall be construed as references to this Regulation, except references to the committee set up by Article 5 of Directive 98/34/EC regarding technical regulations.

Where a Union act provides for a procedure for objection to harmonised standards, Article 11 of this Regulation shall not apply to that act.

Article 29

Repeal

Decision No 1673/2006/EC and Decision 87/95/EEC are hereby repealed.

References to the repealed Decisions shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex IV to this Regu­lation.

Article 30

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 25 October 2012.

For the European Parliament The President M. SCHULZ

For the Council The President

A. D. MAVROYIANNIS

EN 14.11.2012 Official Journal of the European Union L 316/27

ANNEX I

EUROPEAN STANDARDISATION ORGANISATIONS

1. CEN — European Committee for Standardisation

2. Cenelec — European Committee for Electrotechnical Standardisation

3. ETSI — European Telecommunications Standards Institute

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ANNEX II

REQUIREMENTS FOR THE IDENTIFICATION OF ICT TECHNICAL SPECIFICATIONS

1. The technical specifications have market acceptance and their implementations do not hamper interoperability with the implementations of existing European or international standards. Market acceptance can be demonstrated by operational examples of compliant implementations from different vendors.

2. The technical specifications are coherent as they do not conflict with European standards, that is to say they cover domains where the adoption of new European standards is not foreseen within a reasonable period, where existing standards have not gained market uptake or where these standards have become obsolete, and where the transposition of the technical specifications into European standardisation deliverables is not foreseen within a reasonable period.

3. The technical specifications were developed by a non-profit making organisation which is a professional society, industry or trade association or any other membership organisation that within its area of expertise develops ICT technical specifications and which is not a European standardisation organisation, national or international standard­isation body, through processes which fulfil the following criteria:

(a) openness:

the technical specifications were developed on the basis of open decision-making accessible to all interested parties in the market or markets affected by those technical specifications;

(b) consensus:

the decision-making process was collaborative and consensus based and did not favour any particular stakeholder. Consensus means a general agreement, characterised by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments. Consensus does not imply unanimity;

(c) transparency:

(i) all information concerning technical discussions and decision making was archived and identified;

(ii) information on new standardisation activities was publicly and widely announced through suitable and accessible means;

(iii) participation of all relevant categories of interested parties was sought with a view to achieving balance;

(iv) consideration and response were given to comments by interested parties.

4. The technical specifications meet the following requirements:

(a) maintenance: ongoing support and maintenance of published specifications are guaranteed over a long period;

(b) availability: specifications are publicly available for implementation and use on reasonable terms (including for a reasonable fee or free of charge);

(c) intellectual property rights essential to the implementation of specifications are licensed to applicants on a (fair) reasonable and non-discriminatory basis ((F)RAND), which includes, at the discretion of the intellectual property right-holder, licensing essential intellectual property without compensation;

(d) relevance:

(i) the specifications are effective and relevant;

(ii) specifications need to respond to market needs and regulatory requirements;

(e) neutrality and stability:

(i) specifications whenever possible are performance oriented rather than based on design or descriptive char­acteristics;

(ii) specifications do not distort the market or limit the possibilities for implementers to develop competition and innovation based upon them;

(iii) specifications are based on advanced scientific and technological developments;

EN 14.11.2012 Official Journal of the European Union L 316/29

(f) quality:

(i) the quality and level of detail are sufficient to permit the development of a variety of competing implemen­tations of interoperable products and services;

(ii) standardised interfaces are not hidden or controlled by anyone other than the organisations that adopted the technical specifications.

EN L 316/30 Official Journal of the European Union 14.11.2012

ANNEX III

EUROPEAN STAKEHOLDER ORGANISATIONS ELIGIBLE FOR UNION FINANCING

1. A European organisation representing SMEs in European standardisation activities which:

(a) is non-governmental and non-profit-making;

(b) has as its statutory objectives and activities to represent the interests of SMEs in the standardisation process at European level, to raise their awareness for standardisation and to motivate them to become involved in the standardisation process;

(c) has been mandated by non-profit organisations representing SMEs in at least two thirds of the Member States, to represent the interests of SMEs in the standardisation process at European level.

2. A European organisation representing consumers in European standardisation activities which:

(a) is non-governmental, non-profit-making, and independent of industry, commercial and business or other conflicting interests;

(b) has as its statutory objectives and activities to represent consumer interests in the standardisation process at European level;

(c) has been mandated by national non-profit consumer organisations in at least two thirds of the Member States, to represent the interests of consumers in the standardisation process at European level.

3. A European organisation representing environmental interests in European standardisation activities which:

(a) is non-governmental, non-profit-making, and independent of industry, commercial and business or other conflicting interests;

(b) has as its statutory objectives and activities to represent environmental interests in the standardisation process at European level;

(c) has been mandated by national non-profit environmental organisations in at least two thirds of the Member States, to represent environmental interests in the standardisation process at European level.

4. A European organisation representing social interests in European standardisation activities which:

(a) is non-governmental, non-profit-making, and independent of industry, commercial and business or other conflicting interests;

(b) has as its statutory objectives and activities to represent social interests in the standardisation process at European level;

(c) has been mandated by national non-profit social organisations in at least two thirds of the Member States, to represent social interests in the standardisation process at European level.

EN 14.11.2012 Official Journal of the European Union L 316/31

ANNEX IV

CORRELATION TABLE

Directive 98/34/EC This Regulation

Article 1, first paragraph, point (6) Article 2(1)

Article 1, first paragraph, point (7) —

Article 1, first paragraph, point (8) Article 2(3)

Article 1, first paragraph, point (9) Article 2(8)

Article 1, first paragraph, point (10) Article 2(10)

Article 2(1) Article 3(1)

Article 2(2) Article 3(2)

Article 2(3) Article 3(3) and (4)

Article 2(4) Article 27

Article 2(5) Article 20(a)

Article 3 Article 4(1)

Article 4(1) Article 3(3) and (5) and Article 4(4)

Article 4(2) —

Article 6(3), first indent —

Article 6(4)(a) Article 20(a)

Article 6(4)(b) —

Article 6(4)(e) Article 10(2)

Annex I Annex I

Annex II Article 27

Decision No 1673/2006/EC This Regulation

Article 1 Article 1

Articles 2 and 3 Article 15

Article 4 —

Article 5 Article 17

Article 6(1) Article 18

Article 6(2) Article 24(3)

Article 7 Article 19

Decision 87/95/EEC This Regulation

Article 1 Article 2

Article 2 Article 3

Article 3 Article 13

EN L 316/32 Official Journal of the European Union 14.11.2012

Decision 87/95/EEC This Regulation

Article 4 Article 8

Article 5 Article 14

Article 6 —

Article 7 —

Article 8 Article 24(3)

Article 9 —

EN 14.11.2012 Official Journal of the European Union L 316/33

GENERAL GUIDELINES FOR THE COOPERATION BETWEEN CEN, CENELEC AND ETSI ANDTHE EUROPEAN COMMISSION AND THE EUROPEAN FREE TRADE ASSOCIATION

28 March 2003

(2003/C 91/04)

1. GENERAL

CEN, Cenelec, and ETSI on one side and the EuropeanCommission and the European Free Trade Association (EFTA)on the other side, confirm that standardisation is a voluntary,consensus-driven activity, carried out by and for the interestedparties themselves, based on openness and transparency, withinindependent and recognised standards organisations, leading tothe adoption of standards, compliance with which isvoluntary (1). They take note that because of the public recog-nition (2) of the organisations that issue them, and bycompliance with specific procedures, including a publicenquiry and a vote, standards (ENs) thus adopted are distinctfrom other technical specifications established on a voluntarybasis.

CEN, Cenelec, ETSI, the European Commission and EFTAacknowledge that standards should be fit for purpose, have ahigh degree of acceptability as a result of the full involvementof all relevant parties in the standardisation process, becoherent with each other and allow for technological inno-vation and competition; that therefore they should be basedon sound scientific research, be updated regularly, and beperformance-based, where possible (3).

Although standardisation is a voluntary and independentactivity, CEN, Cenelec, ETSI, the European Commission andEFTA recognise that it has an effect on a number of areas ofpublic concern, such as the competitiveness of industry, thefunctioning of the single market and the environment. Onvarious occasions the EU institutions and EFTA haverecognised that standardisation can play a role in publicpolicy and support legislation.

This understanding was first established in 1984, and laiddown in the General Guidelines for Cooperation between theEuropean Commission and CEN and Cenelec, agreed on 13November 1984, and published as CEN/Cenelec MemorandumNo 4, Part 1. Since then, however, the situation has evolvedand they agree that these Guidelines should be updated inorder to take account of this evolution.

Equivalent agreed guidelines were signed between EFTA andCEN and Cenelec on 30 April 1985 (published as CEN/CenelecMemorandum No 4, Part 2). A revised version of these was

adopted by the EFTA Council on 30 October 1992, takingespecially into account the extended status attributed tostandards in the EFTA States by the Agreement on theEuropean Economic Area (EEA).

2. THE EVOLUTION OF EUROPEAN STANDARDISATION

CEN, Cenelec, ETSI, the European Commission and EFTAconsider that the new Guidelines should take into considerationthe following elements, presenting notable changes withrespect to the situation which existed in 1984 and 1985respectively:

— Whilst in 1984 there were only two European StandardsOrganisations, with the recognition under Directive98/34/EEC of the European TelecommunicationsStandards Institute, ETSI, there are now three EuropeanStandards Organisations, i.e., CEN, Cenelec and ETSI.

— With the EEA Agreement, the EFTA States party to theAgreement committed themselves to participating in theSingle Market, with the same rights and obligations asthe EU Member States. The Agreement created the samelegal basis for the use of standards in the EFTA EEA Statesas exists in the EU.

— Standardisation activities in Europe have movedsubstantially from the national level to the European andinternational level. The role of the national standardsorganisations has, in consequence, taken a new dimensionin the context of European and international standard-isation. The national standards bodies will, however,continue to play an important role in international andEuropean standardisation. They contribute on a nationallevel to consensus, in many cases provide support to thetechnical work, are a permanent link between marketplayers, in particular SMEs, consumers and environmen-talists, and provide access to, and advice on, both inter-national and European standards. The official adoptionthrough public enquiry and formal vote on Europeanstandards (ENs) is carried out by the national standardsbodies.

— Economic and social interest groups and relevant organi-sations, namely NGOs have shown an increased interest inEuropean standardisation, and, organised at the Europeanlevel, they now have increased possibilities of access to theEuropean standards-making process and various structureswithin CEN, Cenelec and ETSI. However, this does notdiminish the need for their involvement at national level.

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(1) Council Resolution of 28 October 1999 on the role of standard-isation in Europe, point 11 (OJ C 141, 19.5.2000).

(2) Council Directive 98/34/EC laying down a procedure for theprovision of information in the field of technical standards andregulations (OJ L 204, 21.7.1998).

(3) Council Resolution of 28 October 1999 on the role of standard-isation in Europe, point 12 (OJ C 141, 19.5.2000).

— High levels of environmental and consumer protection havebecome fundamental objectives under the EC Treaty.Subsequently, environmental and consumer considerationsneed to be systematically integrated into other policy areasand sectors of society. This development also concernsEuropean standardisation.

— European standardisation is acknowledged as playing a keyrole for the economic and political integration of thecandidate countries into the European Union; andconversely, these countries are increasingly participatingin the work of the European Standards Organisations.

— With the globalisation of the economy, internationalstandards have become a major factor for Europe. Theimportance to be attributed to international standards hasbeen confirmed by the WTO, notably the Agreement onTechnical Barriers to Trade and the WTO decision on prin-ciples for the development of international standards usedunder the Agreement (1), as well as by the Commission'sservices in the staff working paper SEC(2001) 1296 onEuropean policy principles on International Standardisationof 26 July 2001.

— The needs of the market for technical specifications havebeen subject to change and they differ by sector. Inaddition, industrial sectors are becoming more interrelated,and the traditional boundaries between them are becomingless distinct, thus reinforcing the need for a strong coop-eration between the European Standards Organisations andthe way in which standards are made.

— The use of standards in public policy has evolved. Apartfrom the continuing need to complete the internal market,encouraging competitiveness and information technology,there are new areas in which policy makes increasing useof standards, such as safety in the work place, consumersand the environment, transfer of research results to themarket, and the establishment of trans-European networks.

— The rapid development of technologies and processes in theInformation and Communication Technology (ICT) has ledto a need for the equally rapid elaboration of new types ofpublications. Taking account of these developments, theEuropean Standard Organisations have developed newdeliverables which do not have the status of formalstandards (ENs).

— With regard to the possible restrictions to competitioncaused by horizontal cooperation agreements betweencompanies operating on the same market level(s), the

Commission published a notice on the applicability ofArticle 81 of the EC Treaty (2). In this notice, standard-isation agreements are considered to be a type of horizontalcooperation agreement, either concluded between privateundertakings or determined under the aegis of publicbodies or bodies entrusted with the operation of servicesof general economic interest, such as the standards organi-sations recognised under Directive 98/34/EC. The noticealso states that, in principle, standardisation agreementsdo not restrict competition if the standards are adoptedby the recognised standard organisations, based onnon-discriminatory, open and transparent procedures.

— Standardisation has acquired a high political profile. Thisreflects the unique position of standards in contrast toother forms of specification and creates a correspondinglyenhanced obligation to observe the principles of trans-parency, openness, consensus, independence, efficiencyand coherence.

For these reasons, CEN, Cenelec, ETSI, the EuropeanCommission and EFTA wish to confirm their mutual under-standing on a number of policy objectives and the role ofstandards in that context, on the principles of their relationshipand cooperation, and on their present intentions for theattainment of these objectives.

3. COMMON POLICY OBJECTIVES

CEN, Cenelec, ETSI, the European Commission and EFTA havea common understanding that standardisation plays animportant role for the European market, for the competi-tiveness of enterprises and that it constitutes an importantinstrument in support of European policy reflecting thepublic interest. European Standardisation policy objectivesare, therefore, as follows:

— To play a role in the completion of the internal market,facilitating the free movement of goods and services andensure sustainable development, having a high level ofsafety and quality and taking into account all economic,social and environmental aspects. Under the NewApproach, harmonised European standards providetechnical solutions for presumption of conformity withlegal requirements; they constitute a common and trans-parent reference for public procurement; they contributeto the elimination of technical trade barriers; theyencourage environmentally sound development ofproducts; and they provide a source of common referencefor trade and national and European legislation, thuspromoting European technical integration.

— To help attain the goal of high environmental protection.

ENC 91/8 Official Journal of the European Union 16.4.2003

(1) Annex 4 of G/TBT/9, 10.11.2000. (2) OJ C 3, 6.1.2001, pp. 2 to 30.

— To constitute a tool for the advancement of Europeancompetitiveness and to allow for technological innovation.European standards provide a common, yet flexible,technical environment across the single market andconstitute accepted references for quality, certification,and regulatory compliance; they encourage technical coop-eration and the exchange of expertise and provide entre-preneurs with an opportunity to exploit economies of scale.

— To provide a graduated range of types of deliverables thatrespond to different market needs.

— To provide a flexible and transparent mechanism forconsensus building on identified issues in Europe. Thebasis of consensus necessary to meet the needs of theparties concerned (including the public authorities) variesaccording to the industrial sector, the relationship to theregulatory environment and factors such as safety and thepotential for harm to the environment.

— Through participation by their respective members in theinternational work, to promote Europe's interests in theglobal economy and create conditions for access to worldmarkets; standards provide a means of reference fortechnical cooperation, assistance and Mutual RecognitionAgreements (MRAs) with third countries. It is of utmostinterest that international standards be uniformly adoptedand applied when legitimate objectives can be ensured, i.e.the protection of human health and safety, animals or plantlife and/or the environment.

— To provide candidate countries and neighbouring countrieswith a major tool for the facilitation of adaptation of theireconomies to the Community market and to promotesustainable development, economic and technological inte-gration or cooperation.

— To provide a mechanism for economic and social partnersin Europe and other relevant interest groups, namelyNGOs, that might not otherwise be involved but whohave a legitimate interest in the outcome, to be involvedin the process of standardisation. This constitutes a meansfor them to play an active role in relation to public interestssuch as protection of the environment, workers, andconsumers. It allows them to contribute to sustainabledevelopment and to safeguard the public interest in areaswhere co-regulation or self-regulation is consideredpreferable to outright regulation.

4. PRINCIPLES OF RELATIONSHIP AND COOPERATION

In order to attain these objectives, CEN, Cenelec, ETSI, theEuropean Commission and EFTA have a common under-standing that:

— Relations between the European Standards Organisationsand the public authorities at a European level should bebased on their acknowledgement of the common objectivesset out in detail in section 3 above, bearing in mind theirdistinct responsibilities and competencies. They emphasisethat a permanent, open and transparent dialogue betweenthem is a fundamental basis for cooperation.

— The national member bodies of CEN and Cenelec and themembers of ETSI have a vital role in the cooperationbetween the European Standards Organisations, theEuropean Commission and EFTA. Cooperation betweenall the relevant bodies and common understanding of theobjectives set out in section 3 above is essential for theseguidelines to be successful.

— The institutional rules of the European Standards Organi-sations should ensure that European standardisation, inparticular where it supports European policies andCommunity regulation, remains fully accountable to allthe interested parties in Europe, that is, that the stan-dardisers take into account the broadest possible range ofviews in drawing up standards and other documents andthat the procedures (during development, inquiry andvoting) are open and transparent.

— The European standardisation system has a broad respon-sibility to all interests, including industry, workers,consumers, environmental interests, public authorities, andin consequence must not act on the basis of vestedinterests.

— Coherence, at all levels and between the three EuropeanStandards Organisations, should be ensured in theplanning, execution and implementation of standardisationprogrammes and activities carried out by the EuropeanStandards Organisations, where applicable through theapproval and implementation activities at national level.

— It is essential that the European standardisation systemshould respond readily and appropriately to differingmarket needs in different sectors, with due respect for thefundamental principles of European standardisation set outin section 3 above. In particular, different market needsmay call for different types of deliverables. However, forall types of deliverables the principles of transparency,access, openness, efficiency, coherence and voluntarywork and application should still be followed.

— International standardisation should be reinforced andEurope's interests safeguarded within it; internationalstandards should be uniformly applied except where thiswould be ineffective or inappropriate for the objectivespursued.

— Effort shall be made to support the integration of theeconomies of the candidate countries into the Community.

EN16.4.2003 Official Journal of the European Union C 91/9

— The use of European standards should be furtherencouraged as an instrument of economic and tech-nological integration within and outside the Europeanmarket and as an instrument in order to work with themarket and as a technical basis for legislation, in particularin defining technical specifications for products and servicesand for testing methods.

5. IMPLEMENTATION

Against the background of the previous sections, the EuropeanStandards Organisations expect the European Commission andEFTA to:

— Maintain a transparent legal and political framework forEuropean standardisation as an independent, consensus-oriented and voluntary activity.

— Make use of European standards where they are appropriatein support of European regulations and other policies, andcontinue to pursue a policy of broader use of standards.

— In accordance with the provisions of Directive 98/34/EC,indicate legal and political requirements for standards.

— Refrain from drawing up technical regulations on subjectscovered by mandates assigned to the European StandardsOrganisations, except where considered necessary in thepublic interest. Request, to the extent feasible, theopinion of the European Standards Organisations, andpossibly their members, on matters relating to standard-isation and, where appropriate, technical barriers to tradeat the European and global levels.

— Intend to continue to provide targeted financial support tothe European Standards Organisations, subject to the limitsimposed by available budgetary assets, towards the main-tenance of an appropriate European standardisation infra-structure and towards the improvement of the quality ofefficiency and visibility of the European Standards Organi-sations.

— Invite the advice of the European Standards Organisationson the needs for pre-normative research and development,and stimulate the exploitation of Community and/or EFTAfunded pre-normative research, arising both from the directand indirect research actions, into European standards.

— Encourage those participating in European R & Dprogrammes to feed back their results into the EuropeanStandards Organisations, as appropriate.

— Seek, where appropriate, the advice and active cooperationof the European Standards Organisations in the estab-lishment and implementation of European programmes oftechnical assistance to, and cooperation with, thirdcountries.

— Promote the use of standards by Europe's trading partnersin their policy and regulation.

For their part, the European Commission and EFTA expect theEuropean Standards Organisations CEN, Cenelec and ETSI to:

— Maintain the standardisation infrastructure and proceduresto meet legitimate needs (including safety, health, consumerand environmental protection) in Europe, and activelycooperate to ensure that stakeholders gain the maximumbenefit of the European standardisation infrastructure andits links with other standards organisations.

— Ensure that structures and procedures allow for the highestpossible degree of openness, transparency and representa-tiveness. Procedures should be transparent and ensure inde-pendence from vested interests. Further efforts should bemade to increase the participation of interested circles,especially public authorities, manufacturers, small andmedium-sized enterprises, consumers, workers and environ-mental interest groups, at the national and European levelin the drafting of standards and other deliverables and inensuring their views are adequately taken into account.

— Ensure that all interested parties participating in the devel-opment process have access to documents in order toeffectively participate.

— Take the public interest into account, in particular, safetyand health, the protection of workers, consumers andenvironment.

— Maintain a dialogue with the Commission and EFTA whilecarrying out standardisation work.

— Ensure that the environment is fully considered and whererelevant taken into account in the development of standardsin order to contribute to a high level of environmentalprotection.

— Pro-actively support participation of relevant stakeholdersin standardisation work on national, European, and inter-national level.

— Establish and maintain institutional rules and proceduresthat ensure coherence, speed and quality in the estab-lishment, elaboration and implementation of theprogrammes, standards, other deliverables and activitiescarried out in order to meet the needs of evolvingmarkets. This specifically includes coherent rules forstandstill, notification of activities, uniform transpositionand withdrawal of conflicting national standards (as far asENs are concerned).

ENC 91/10 Official Journal of the European Union 16.4.2003

— Ensure that when common mandates are issued by theCommission and the EFTA side a consistent approach istaken in accepting and executing or in rejecting themandate.

— Ensure that rules in decision-making procedures continueto preserve accountability to European Community, EFTAmembers and the economic and social partners concernedin work undertaken under a mandate from the EuropeanCommission and the EFTA side.

— Carry out their tasks with the highest efficiency and quality,including the use of modern methods and technologies forthe elaboration and distribution of their work.

— Keep their corpus of publications up to date and in linewith technological evolution by means of regular reviewsleading to their confirmation, amendment, revision or with-drawal, as appropriate.

— Together with their members, adapt their structures,procedures, and publications to meet developments in thelegitimate needs of interested parties. Develop appropriatemechanisms to accept documents originating from interestgroups and other parties, and transform them, if appro-priate, into deliverables of the European Standards Organi-sations.

— Ensure that all interested parties have access to standards,by broad provision of information on their availability, andby ensuring that standards, including any intellectualproperty rights (IPRs) they might contain, can be used bymarket operators on fair, reasonable and non-discrimi-natory conditions.

— Undertake and support actions to improve the visibility ofEuropean standardisation.

— Work towards the development and widespread use of asingle mark of conformity with European standards, asappropriate.

— Provide support to the progress of standards organisationsin the countries that have applied for EU or EFTAmembership, to full participation in, and membership ofthe European Standards Organisations. Grant fullmembership once the appropriate and approved conditionshave been met.

— Cooperate actively with international standardisationstructures; observe the terms of the WTO Code of GoodPractice for the Preparation, Adoption and Application ofStandards; promote the international standard organi-sations, promote the use of international standards intheir own work and at the global level when legitimateobjectives can be ensured, i.e. the protection of humanhealth and safety, animals or plant life and/or theenvironment. Use best efforts to support access byinterested circles to standardisation processes at the inter-national level.

— Cooperate with the European Commission and EFTA in thedevelopment and implementation of Community and EFTAprogrammes of technical assistance and cooperation withthird countries, and ensure where possible that relatedpolicies of their member organisations are coherent.

— Maintain and develop a dialogue with the EuropeanCommission and EFTA on all issues of strategic, politicalor technical importance of common interest.

EN16.4.2003 Official Journal of the European Union C 91/11