Embed Size (px)
DESCRIPTION
The EU Training Programme for Turkish Chamber Executives Free Movement of Goods Product legislation in the EU. Mr Henk de Pauw , Eurochambres expert [email protected] Ankara, 18 June 2009 Istanbul, 19 June 2009. Harmonisation and standardisation for SMEs. Purpose of product regulations - PowerPoint PPT Presentation
Citation preview
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
The EU Training Programmefor Turkish Chamber Executives
Free Movement of GoodsProduct legislation in the EU
Mr Henk de Pauw, Eurochambres expert
Ankara, 18 June 2009
Istanbul, 19 June 2009
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Harmonisation and standardisation for SMEs
• Purpose of product regulations
• Barriers to trade
• Removal of non-tariff barriers to trade: The EU way
• New approach directives: Principles of harmonisation and standardisation
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• Protection of men, animals, plants, other
products, environment in general
• Securing the functionality of a product
• Barrier against competitive products from
abroad
Purpose of product regulations
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• Tariff barriers
– Direct tariff barriers: Duties, quotas, licences, import bans
– Indirect tariff barriers: By local regulations
• Non-tariff barriers
– Technical barriers (TBTs): Technical product regulations
– Administrative barriers: Rules for certification and marking
Barriers to trade
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
40
30
2523
15
10
6,4
4
0
5
10
15
20
25
30
35
40
1947 1949 1951 1956 1962 1967 1979 1993
Annecy 1949Gründung des
Gatt Genf 1947
Torquai 1950/51
Genf 1956
Dilion-Runde 1960 - 62
Kennedy-Runde 1964 - 67
Tokio-Runde 1973 - 79
Uruguay-Runde 1986 - 93
Weighted average of duties in % in industrial countries since 1947 (Source: WTO 1997)
Decline of tariff barriers
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• Rising product complexity
• Ever keener competition
• Increased awareness of quality and safety
• User demands for proof of conformity
Rise of non-tariff barriers
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• Higher costs for manufacturer
• Slower introduction to the market of new
products
• Smaller choice for consumers
• Higher prices for consumers
Effect of non-tariff barriers
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• Mutual recognition Principle
– Cassis de Dijon-principle
• Exception: public policy
• Exception: Public security
• Exeption: public morality
– Case 121/85, Conegate Ltd v Customs and Excise
Commissioners
• Exception: Protection of the health and life of
humans, animals and plants
Removal of non-tariff barriers: The EU way
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Product legislation in the EU
• Non-Harmonised• Ex. Furniture
• (-)Need to find the legislation of all Member States
• Harmonised– Old Approach
• Ex. chemicals, medicinal products, foodstuffs
• SCAD database
• (+) Technical details in directive
• (-) Directives underwent several changes – (ex. http://europa.eu.int/scadplus/leg/en/lvb/l21276.htm
– New Approach• 20 directives
• Roughly 20% of trade
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Principles of the New Approach
New Approach principles:
- Legislative harmonization - only essential requirements to be met- “(c) Toys must be so designed and constructed as to minimize the risk
of physical injury which could be caused by the movement of their parts.“
- Technical specifications are to be found in harmonized standards- EN 71-1 Safety of toys-Part 1: Mechanical and physical properties
- Application of standards, including harmonized standards is voluntary
- Essential requirements are presumed to be met if product is manufactured in compliance with harmonized standards
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Where CE
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Where CE
- EU (not mandatory in UK, Ireland and Sweden)
- EEA (EU+Lichtenstein, Norway and Iceland)
- Switserland
- Turkey
- Croatia
- Soon: Kosovo, Morocco, Albania
- Future: MEDA and ENP countries
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Principles of the Global Approach
Global Approach principles: - Modules for various phases of conformity
assessment procedures- CE-marking- Quality assurance (EN/ISO 9000 series standards)- Conformity Assessment bodies (EN 45000 series
standards)- Setting up accreditation systems- Mutual recognition agreements for testing and
certification in the non-regulatory sectors- Programs to reduce differences in the quality of
testing inspection, certification, accreditation
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Questions
1. Who is responsible?
2. Is my product covered by the directive(s)?
3. Does my product meet the Essential
Requirements?
4. Do I apply Standards?
5. Do I need a Notified Body?
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Actions
1. Draft a Technical Construction File
2. Gather Information
3. Draft a Manual
4. Draft a Declaration of Conformity
5. Apply the CE-mark
6. Adaptations and New Developments
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Who is responsible
Compare with Product Liability1. The manufacturer
• the person who is responsible for designing and manufacturing a product with a view of placing it on the Community market on his own behalf.
– In practice: under his own name2. Authorised Representative
• If manufacturer is not established in the EU, though not mandatory
3. Importer4. Distributor5. Assembler and Installer6. User (Employer)
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• Not always clear
• The manufacturer is any natural or
legal person who is responsible for
designing and manufacturing a
product with a view of placing it on
the Community market under his
own name.
• Whoever is on the label
• Whoever retains the overall control
The Manufacturer
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• The manufacturer may appoint any natural or legal person to act on his behalf as an authorised representative.
• Authorised Representative must be established inside the Community.
The Authorised Representative
• The authorised representative is the contact point in the EU for the Marker Authorities
• The manufacturer remains generally responsible for actions carried out by an authorised representative on his behalf.
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• Is considered as the representative of the manufacturer if there is no Authorised Representative
The importer
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• Installer– Has to follow the guidelines laid out by
the manufacturer
• Repair/Service– Can be held responsible for re-marking
the product, if he implements major changes (increased risk)
Others
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• For a large part under the jurisdiction of the Member States
• Cannot exercise any pre-market inspections
• Must be entitled to obtain access to places of manufacture or storage, to receive information, and to select a sample and take it away for examination and testing
• Requests need to be motivated and specific
Market Surveillance Authorities
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• have the right to stop products coming in the Community from third countries, if they find products that display certain characteristics which would give rise to a serious doubt as to the existence of a serious and immediate risk to health and safety, or
• if they find products which are not accompanied by a document or marked in accordance with applicable rules on product safety.
• especially concerned with toys; as in most other cases in the New Approach products, the customer is not a consumer, but a rather more informed client.
Custom officials
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
• The ultimate decision: no more
grey areas
• No technical expert
• Very few cases
The court
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Which products
- Low voltage equipment
- Simple pressure vessels
- Toys
- Construction products
- Machinery
- Personal protective equipment
- Weighing instruments
- Active implantable medical devices
- Gas appliances
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Which products (cont.)
- Hot water boilers
- Civil explosives
- Medical devices
- Products for potentially explosive atmospheres
- Recreational craft
- Lifts
- Refrigeration appliances
- Pressure equipment
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Which products (cont.)
- Telecommunications terminal Equipment
- Electromagnetic compatibility
- Noise emissions
- Cableway installations
- Marine equipment
- High speed rail systems
- Packaging and packaging waste
and the list will be continued...
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Paperwork under the NA
• Technical Construction File
• Manual
• Declaration of Conformity
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
The Technical Construction File
• Part A & B
• Part A should be at hand at all times
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
The Technical Construction File: part A
• First aid kit
• Name(s) and adress of mft.
• ID of product
• Description (prospectus)
• Manual
• Declaration of conformity
• List of standards & directives
• Content of part B
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
The Technical Construction File: part B
• Start with the Essential Requirement at
top of page
• Identify the hazards
• Proof of remedy:
– Application of standard
– Drawings
– Testresults
– …
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
The Manual
• From start to finish
• Essential for limiting product liability
• Language!
• Ingredients in each directive
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
The Declaration of Conformity
• Need a model: PPE
• Ingredients in each
directive
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Labelling
• The most visible part of CE-marking.
• Name & Adress.
• N° of notified body.
• Others, specified per directive.
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Mutual Recognition Agreements (MRA)
• Mutual recognition agreements between the EU and third countries– conformity assessment can be performed by
bodies of the partner countries, eliminating double testing and certification
– mutual acceptance of conformity assessment results (testing, inspection, certification)
• Partners: Australia, New Zealand, Switzerland, United States, Canada, Israel, Japan, partly not yet concluded
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Sources of information
• www.newapproach.org– CEN site, source for standards, text of directives and
link to standard bodies• http://www.eotc.be/newapproach/cdrom/index.htm
– Introduction to the New Approach• http://europa.eu.int/comm/enterprise/newapproach/
index.htm– DG ENTR site on the NA, source for guides, such as the “Blue
Guide”• http://europa.eu.int/comm/enterprise/sectors_en.htm
– DG ENTR site on different industry sectors, if you want to know more about the product-specific directives.
• http://ec.europa.eu/enterprise/newapproach/nando– DG ENTR database on notified bodies
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Sources of information
• www.icsms.org
– Communication tool for market surveillance authorities on products to be taken off the market
• http://www.emars.eu/– Sharing of experience on market
surveillance
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
Thank you…
Please feel free to contact us
Free Movement of Goods
With the support of the European Commission
Eurochambres • Chamber House • 19 A/D Avenue des Arts • B-1000 Brussels • BelgiumTel: +32 (0)2 282 08 50 • Fax +32 (0)2 230 00 38 • Email: [email protected]
www.eurochambres.eu
