Development of technical regulations and standards in the Customs union

Development of technical Development of technical regulations and standards regulations and standards

in the Customs unionin the Customs union

А.G. Leskova Deputy Director

on technical regulation and standardizationBelGISS

Agreement on harmonization basis of

EurAsEC technical regulation

Model agreement on adoption of EurAsEC technical regulation

Agreement on use of the single mark for products circulation in the

EurAsEC market

Agreement on creation of EurAsEC information system in the field of technical regulation, sanitary, veterinary and phytosanitary measures

Establishment and application of common regulatory requirements for products

Establishment of procedure for application of technical regulation measuresin relation to third countries

Establishment of common rules of works implementation on conformity assessment

Agreement on products circulation subject to mandatory conformity

assessment (attestation) on the territory of Customs Union

Agreement on mutual recognition of accreditation of certification (conformity attestation) bodies and

testing laboratories (centers) performing conformity attestation

Systematic policy in the field of technical regulation within EurAsEC and Customs Union

Agreement on common principles and rules of technical regulation in the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation

Systematic policy agreement in the field of technical regulation, sanitary and phytosanitary measures of EurAsEc

2

Adopted:

Uniform list of products, for which mandatory requirements within the Customs Union are established

Development schedule of the first priority Customs Union technical regulations

Regulation on the order of development, adoption, amendment and abolishment of the Customs Union technical regulation Regulations on the procedure of forming the lists of international and regional (intergovernmental) standards, in case of their absence – of national (governmental) standards, that ensure compliance with the requirements of the Customs Union technical regulation, and necessary to perform conformity assessment (attestation) Typical schemes of the conformity assessment (attestation) Uniform forms of documents for conformity assessment (attestation) (declaration of conformity to technical regulations of the Customs Union, certificate of conformity to technical regulations of the Customs Union) Graphic representation of the single mark Regulations on the single mark for products circulation in the market of the Customs Union member-states and its usage

Action plan on implementation of the Agreement on common principles and rules of technical regulation in the Republic of Belarus,

the Republic of Kazakhstan and the Russian Federation

3

2010 г.

2011 г.

2011 г.

In process: Agreement on harmonization of the Customs union member-states legislation related to the establishment of liability for the requirements violation of the Customs Union legislation in the sphere of technical regulation, sanitary and phytosanitary measures Agreement between CIS and EurAsEC on regional (intergovernmental) CIS standards (GОSТ) Regulations on the rules for standardization work in the Customs Union Regulations on the procedure for products conformity attestation against the requirements of the Customs Union technical regulation Action plan for ensure uniformity of measurements on the customs territory of the Customs Union Regulations on the order of entry into the customs territory of the Customs Union for products, for which mandatory requirements within the Customs Union are established Agreement on adoption of emergency measures to prevent the release into circulation of dangerous products within the Customs Union The concept of an information system in the field of the Customs Union technical regulation as part of Integrated information system for external and mutual trade of the Customs Union

Action plan on implementation of the Agreement on common principles and rules of technical regulation in the Republic of Belarus,

the Republic of Kazakhstan and the Russian Federation

4

Products or processes related to the requirements for products, representing the greatest danger

for human life and health, environment, property, economical security of the Customs Union member-states

61 objects of technical regulationon basis of

EC New Approach Directives

low voltage equipment lifts machinery and equipment construction products toys personal protective equipment medical devices appliances burning gaseous fuels equipment operating under

excessive pressure

on basis of ЕС Old Approach

Directivesothers

motor roads furniture synthetic detergents alcoholic products grains coal and derived products

agricultural techniques foods chemical products perfumes and cosmetics

UNIFORM LIST of PRODUCTS, for which mandatory requirements within the Customs Union are

established

5

DEVELOPMENT of the CUSTOMS UNION TECHNICAL REGULATIONS

RF – 26

RB – 8

RК – 13

Development schedule of the first prioritytechnical regulations of the Customs Union

47 ТР ТС

35 ТR EurAsEC5 member-states

adopted through international agreement

Development schedule of the first priority technical regulations of theEurasian Economic Community

2011

RF - 25

RB - 5

RК - 3

КR - 2

47 ТR СU2011

6

Adopted technical regulations of the Customs UnionAdopted technical regulations of the Customs Union – – 6 Т6 ТRR CUCU On safety of low voltage equipment On safety of railway rolling stock On safety of high-speed railway transport Оn safety of railway infrastructure On safety of fireworks On safety of packages

Draft technical regulations of the Customs Union with high degree of Draft technical regulations of the Customs Union with high degree of readinessreadiness – – 6 Т6 ТRR С СUU On safety of toys On safety of products intended for children and adolescents On safety of machinery and equipment On requirements for automobile and aviation gasoline, diesel and marine fuels, jet fuels and heating oils On safety of perfumes and cosmetics On safety of grains

DEVELOPMENT of the CUSTOMS UNION TECHNICAL REGULATIONS

DraftDraft Т ТRR С СUU under domestic endorsementunder domestic endorsement – – 6 Т6 ТRR С СUU

DraftDraft ТТRR С СUU under public considerationunder public consideration – – 6 Т6 ТRR С СUU7

Graphic representation of the single mark for products circulation

in the market of the Customs Union member-states

8

Ascertains that products bearing this mark have undergone all conformity assessment (attestation) procedures specified in technical regulations

of the Customs Union and meet the requirements of all applicable to these products technical regulations of the Customs Union

It stands forIt stands for Eurasian Conformity Eurasian Conformity

Common intergovernmental

standards

GOST ENGOST ISOGOST IEC GOST ISO/IEC

Concentration of safety requirements for products in technical regulation

Customs UnionCustoms Union

Concentration of all safety requirements for products

In one document

technical regulation

Elimination of duplication and contradictions between documents of

different authorities

Safety requirements for products and services have been established in bylaws

Current technical normative documentsCurrent technical normative documents of the Customs of the Customs Union member-statesUnion member-states

Intergovernmental and national (governmental) standards

GOST STB, GOST R, ST RК

Constructionregulations

Fire safetyrules and regulations

Safety of electrical installation

ПУЭ ПТБ ПТЭ

Promnadzor regulations

GRFC rules

Sanitary rules and regulations

SanPiN ГН РДУ

МУМР МВИ

9Difficulties for manufacturers

and importers

Gosstandart Ministry of ConstructionMinistry of Emerg. Ministry of Health Ministry of Agriculture

of department-level nature

10 Concentration of all requirements for toys in one document – technical regulation

Foreword Scope Definitions Rules for the market access Safety requirements Compliance with safety requirements Conformity attestation Marking with the single mark for products circulation in the market of the Customs Union

member-states Disclaimer Annex 1 List of articles, considered as toys and which are not covered by the technical

regulation Annex 2 Hygienic safety requirements for toys Annex 3 Information requirements on hazards and measures taken in using toys,

representing the greatest danger

Content

TECHNICAL REGULATION of the CUSTOMS UNION«ON SAFETY OF TOYS»

Directive 88/378/ЕЕС: requirements for materials physical and mechanical properties flammability chemical properties electrical properties radioactivity

Directive 2009/48/ЕС: requirements to toys contained in food requirements to toys with light-emitting diodes precaution indications


Common sanitary requirements

Safety requirements, differentdifferent from Directives 88/378/ЕЕС and 2009/48/ЕС

Safety requirements of technical regulation are harmonized withare harmonized with:

Particular hygienic safety requirements for toys:

sensory characteristics smell, flavor

physical factors sound level, level of electric field intensity, intensity level of the integrated flux of infrared radiation, level of local vibration…

sanitary and chemical characteristics migration into model media of hazardous chemical substances, list of them is determined depending on the chemical composition of material and standards of harmful chemicals emission from toys

toxicological and hygienic indicators irritant action on mucous coats, toxicity index

microbiological indicators

11

As distinct from Directive 2009/48/ЕС the technical regulation doesn’t contain particular articles on the following:

obligations of economic operators

TECHNICAL REGULATION of the CUSTOMS UNION «ON SAFETY OF TOYS»

objection relative to harmonized standards

requirements to notification procedure and notified bodies

exchange of information about dangerous products

sanctions for violation of technical regulation requirements

EUEU ССUU

Decision 768/2008Directive 2001/95Directive 2009/48

Agreement on common safety of products (under planning) ТR СU (partially)

Not specifiedDecision 768/2008Directive 2009/48

Regulation 765/2008Regulation 768/2008

Directive 2001/95Directive 2009/48

Decision 768/2008Directive 2009/48

Directive 2009/48

Provision on procedure of certification bodies and test laboratories inclusion into Unified Register

Agreement on common principles and rules of technical regulation

Agreement on EurAsEc systematic policy in the field of technical regulation, sanitary and phytosanitary measures

Agreement on establishment of EurAsEc information system in the field of technical regulation, sanitary and phytosanitary measures

Agreement on harmonization of the Customs Union member-states legislation related to the establishment of liability12

Agreement on common safety of products (under planning)Agreement on implementing urgent measures against dangerous products

(under planning)


Interrelated standardsIntergovernmental standards,

national (governmental) standards of the Customs Union member-states,

as a result of their voluntary application the fulfillment of the technical regulation

requirements is ensured

Intergovernmental standards, national (governmental) standards of the

Customs Union member-states, which cover rules and methods of investigations (tests) and measurements, necessary for application and

implementation of the technical regulation requirements and performance of the

conformity assessment (attestation) of products

Harmonized standards

Directive 88/3785 standards

Directive 2009/483 standards

9 standards

19 standards123 procedures

13

EUEU ССUU

List of harmonized standards

Official Journal of the EU

Distinction – 2 lists of standards

ChallengeChallenge: Absence of documents unified for all member-states of the Customs Union for determination of the toys safety indicators

At present hygienic requirements are checked against department-level documents, which are different in member-states of the Customs Union

Procedures for studies (tests) performance are established in

department-level documents

Development Development of intergovernmental standards of intergovernmental standards

on basis of department-level on basis of department-level documentsdocuments

123 methods


Identification оf similar or comparable procedures for studies (tests) performance

Procedures for studies (tests) performance, admitted for use in

transition period for application and implementation of technical regulation

requirements

14


More strict procedures of the conformity attestation

Absence of legislation: on common safety of products on liability of manufacturers on market surveillance

ReasonsReasons::

Difference with Directive 88/378

ObjectiveObjective:: Protection of market

15


Directives 88/378, 2009/48

Application of harmonized

standards

Internal production control

Non-application of harmonized

standards

Expertise of ЕС-type and conformity with

ЕС-type

Declaration of conformity

16

Module АModule В+С

Certification by certification body, included into Unified

Register (by third party)

serial products batch

TestsTests

Conformity certificate of unified format

Inspection control

Analysis of production

status

Certification of quality

management system

CUCUTR CU

Non-application of standardsNon-application of standardsincluding

EUEU

TECHNICAL REGULATION of the CUSTOMS UNION «ON SAFETY OF LOW VOLTAGE EQUIPMENT»

Safety requirements are harmonized with Directive 2006/95/ЕС

ChallengesChallenges

Different ways of establishing indicators and methods of their control in standards and SanPiN

Absence of necessary intergovernmental standards

Inclusion of sanitary requirements to low voltage equipment, defined in SanPiN, into List of standards, during the transition period

SanPiNSanPiNDevelopment ofDevelopment of

intergovernmental standardsintergovernmental standards

17

Hygienic safety indicators

Not related toNot related to Т ТRR Related to TRRelated to TRSafety requirements to physical factors at work sites, technological environment, operation area – SаnPiN

Directives ЕС 89/391/ЕЕС, 2004/40/ЕС, 1999/519/ЕС

Safety requirements against non-electrical dangers

Conduction of sanitary supervision during operation

Technically achievable indicators for products

More strict procedures of the conformity attestation

Absence of legislation:

• on common safety of products• on liability of manufacturers• on market surveillance

ReasonsReasons::

TECHNICAL REGULATION of the CUSTOMS UNION«ON SAFETY OF LOW VOLTAGE EQUIPMENT»

18

ObjectiveObjective:: Protection of market


Directive 2006/95 TR CU

Certification

Declaration Low voltage equipment that is not included in the List

Low voltage equipment included in the List In non-application of standards

19

Internal production

control Module А

Declaration of conformity

CUCU

Declaration of conformity on unified form

Conformity certificate on unified form

EUEU

Serial products Batch

TestsTests

Conformity certificate on unified form

Inspection control

Analysis of production


Certification

20

On basis of proper evidence

With participation of third party

Tests

Declaration

Tests

Production control

BatchSerial products

Declaration of conformity on unified form

TestsProduction control

Tests

Tests

Batch

Production control

Inspection control

Certification of quality management

system

Serial products

Development and implementation of targeted programs for development of intergovernmental standards

for products for which the Customs Union technical regulations are under development

Draft of the Standardization Work Programme (Plan) under the Customs Union technical regulation

Inclusion of standards into The Plan of EurAsEC intergovernmental standardization

Development of intergovernmental standards, applicable for the purpose of conformity assessment (attestation) to the

Customs Union technical regulation

DEVELOPMENT OF COMMON INTERGOVERNMENTAL STANDARDS,

INTERRELATED with the CUSTOMS UNION TECHNICAL REGULATIONS and

EurAsEC TECHNICAL REGULATIONS

DEVELOPMENT of COMMON STANDARDS, INTERRELATED with the CUSTOMS UNION TECHNICAL REGULATIONS and

the EurAsEC TECHNICAL REGULATIONS

Electrotechnical products

ТR Safety of low voltage equipment

ТR Electromagnetic compatibility of technical

means

Toys ТR Safety of toys

Draft list of standards (370)93% harmonization

Necessary to develop 300 GOST based on ISO, IEC, EN,

40% from them based on ISO, IEC, EN new versions

Draft list of standards (9)90% harmonization

Necessary to develop 8 GOST based on ISO, IEC, EN,

50% from them based on ISO, IEC, EN new versions

In addition to prepare 30 documents on the test methods of

hygienic indicators 22

23

COMMON INTERGOVERNMENTAL STANDARDS

For the purpose of meeting the requirements of the Customs Union technical regulation in the result of voluntary application

For the purpose of using and fulfilling the requirements of the Customs Union technical regulation and performing conformity assessment (attestation) of products

PRINCIPLES openness and publicity of development processes acceptance based on consensus availability of standards, information about the procedure of their development, adoption (approval) and publication application of international and regional standards as basis impermissibility of adoption (approval) of standards conflicting with technical regulations

OBLIGATIONS OF PARTIES to put into force mandatory at national level in every member-state of the Customs Union in a single determined deadline to cancel all national (governmental) standards that are in conflict with intergovernmental standards to notify of the beginning of development of national (governmental) standards and to cease their development when deciding on development of intergovernmental standards for a given object of standardization

PARTICIPATION IN INTERNATIONAL AND REGIONAL STANDARDS-SETTING ORGANIZATIONS

Full member

International Organization for Standardization

International Electrotechnical Commission

European Committee for Standardization

European Committee for Electrotechnical Standardization

Affiliate

63 СEN/ТС

13 СLC/ТС

58 ISO/ТС

11 IEC/ТС

106 ISO/ТС/SС

17 IEC/ТС/SС

2010 Voting on ISO drafts– 357

2010 Voting on IEC drafts– 155

3 CEN/СLC/ТС

24

Republic of Belarus − affiliate of CEN and CENELEC beginning from 01.01.2010

Participation in the work of technical committees as observer

More than 60 СEN ТCs (from 299)

13 СENELEC ТCs (from 65)СLC/TC 20 Electric cablesCLC/TC 44X Safety of machinery. Electrotechnical aspectsCLC/TC 61 Safety of household and similar electrical applianceCLC/TC 62 Electrical equipment in medical practiceCLC/TC 210 Electromagnetic compatibility …

CEN/СLC/JWG 1 Energy auditsCEN/SS C01 Food productsCEN/SS F05 Measuring instrumentsCEN/TС 44 Catering refrigerating appliances and industrial refrigeration equipment CEN/TС 52 Safety of toysCEN/TС 67 Ceramic tilesCEN/TС 392 Cosmetics …

Organization of fund of European standards in e-format

СEN

СENELEC

Fund of CEN standards for 2008–2011

4258 documents

Fund of СENELEC standards for 2007–2011

7470 documents

25CEN/CENELEC Guide 10: Guidelines for the distribution and sales of CEN/CENELEC publicationsCEN/CENELEC Guide 12: The concept of Affiliation with CEN and CENELEC

Thank you for attention!

Documents

Development of technical regulations and standards in the Customs union