development of technical regulations and standards in the customs union А.g. leskova deputy...
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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
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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
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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
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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
Directives
others
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
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DEVELOPMENT of the CUSTOMS UNION TECHNICAL REGULATIONS
RF – 26
RB – 8
RК – 13
Development schedule of the first priority
technical 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 СU
2011
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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
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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
TECHNICAL REGULATION of the CUSTOMS UNION«ON SAFETY OF TOYS»
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
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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 765/2008
Regulation 768/2008Directive 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 liability
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Agreement on common safety of products (under planning)
Agreement on implementing urgent measures against dangerous products (under planning)
TECHNICAL REGULATION of the CUSTOMS UNION«ON SAFETY OF TOYS»
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 88/378
5 standards
Directive 2009/48
3 standards
9 standards
19 standards
123 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
TECHNICAL REGULATION of the CUSTOMS UNION «ON SAFETY OF TOYS»
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
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TECHNICAL REGULATION of the CUSTOMS UNION«ON SAFETY OF TOYS»
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
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TECHNICAL REGULATION of the CUSTOMS UNION «ON SAFETY OF TOYS»
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
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Module А
Module В+С
Certification by certification body, included into Unified
Register (by third party)
serial products batch
Tests
Tests
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
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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»
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ObjectiveObjective:: Protection of market
TECHNICAL REGULATION of the CUSTOMS UNION«ON SAFETY OF LOW VOLTAGE EQUIPMENT»
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
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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
TECHNICAL REGULATION of the CUSTOMS UNION«ON SAFETY OF LOW VOLTAGE EQUIPMENT»
Certification
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On basis of proper evidence
With participation of third party
Tests
Declaration
Tests
Production control
BatchSerial products
Declaration of conformity on unified form
Tests
Production 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
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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 publications
CEN/CENELEC Guide 12: The concept of Affiliation with CEN and CENELEC
Thank you for attention!