Development of technical regulations and standards in the Customs union

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?.G. Leskova Deputy Director on technical
regulation and standardizationBelGISS
Development of technical regulations and
standards in the Customs union
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Systematic policy in the field of technical
regulation within EurAsEC and Customs Union
Systematic policy agreement in the field of
technical regulation, sanitary and phytosanitary
measures of EurAsEc

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
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
Agreement on common principles and rules of
technical regulation in the Republic of Belarus,
the Republic of Kazakhstan and the Russian
Federation
Establishment and application of common
regulatory requirements for products
Establishment of common rules of works
implementation on conformity assessment
Establishment of procedure for application of
technical regulation measuresin relation to
third countries
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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

• 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

2011 ?.
2010 ?.
2011 ?.
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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

• 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 (G?S?)
• 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

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UNIFORM LIST of PRODUCTS, for which mandatory
requirements within the Customs Union are
established
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 regulation
on basis of ?? Old Approach Directives
on basis of EC New Approach Directives
others

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

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

• agricultural techniques
• foods
• chemical products
• perfumes and cosmetics

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DEVELOPMENT of the CUSTOMS UNION TECHNICAL
REGULATIONS
Development schedule of the first
priority technical regulations of the Customs
Union
RF 26
47 ?R ?U
RB 8
47 ?? ??
2011
R? 13
Development schedule of the first priority
technical regulations of the Eurasian Economic
Community
RF - 25
R? - 3
35 ?R EurAsEC 5 member-states adopted through
international agreement
RB - 5
?R - 2
2011
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DEVELOPMENT of the CUSTOMS UNION TECHNICAL
REGULATIONS

• Adopted technical regulations of the Customs
  Union 6 ?R CU
• On safety of low voltage equipment
• On safety of railway rolling stock
• On safety of high-speed railway transport
• ?n safety of railway infrastructure
• On safety of fireworks
• On safety of packages

• Draft technical regulations of the Customs Union
  with high degree of readiness 6 ?R ?U
• 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

Draft ?R ?U under domestic endorsement 6 ?R ?U
Draft ?R ?U under public consideration 6 ?R ?U
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Graphic representation of the single mark for
products circulation in the market of the
Customs Union member-states
It stands for Eurasian Conformity
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
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Concentration of safety requirements for
products in technical regulation
Safety requirements for products and services
have been established in bylaws
of department-level nature
Gosstandart
Ministry of Construction
Ministry of Health
Ministry of Emerg.
Ministry of Agriculture
Current technical normative documents of the
Customs Union member-states
Customs Union
Construction regulations
Fire safety rules and regulations
Promnadzor regulations
GRFC rules
technical regulation
In one document
Concentration of all safety requirements for
products
Common intergovernmental standards
Elimination of duplication and contradictions
between documents of different authorities
GOST EN GOST ISO GOST IEC GOST ISO/IEC
Difficulties for manufacturers and importers
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TECHNICAL REGULATION of the CUSTOMS UNIONON
SAFETY OF TOYS
Content

• 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

Concentration of all requirements for toys in
one document technical regulation
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TECHNICAL REGULATION of the CUSTOMS UNIONON
SAFETY OF TOYS
Safety requirements, different from Directives
88/378/??? and 2009/48/??
Safety requirements of technical regulation
are 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

• Directive 88/378/???
• requirements for materials
• physical and mechanical properties
• flammability
• chemical properties
• electrical properties
• radioactivity

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

Common sanitary requirements
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TECHNICAL REGULATION of the CUSTOMS UNION ON
SAFETY OF TOYS

• As distinct from Directive 2009/48/?? the
  technical regulation doesnt contain particular
  articles on the following
• obligations of economic operators

EU
?U
Decision 768/2008 Directive 2001/95 Directive
2009/48
Agreement on common safety of products (under
planning) ?R ?U (partially)

• objection relative to harmonized standards

Decision 768/2008 Directive 2009/48
Not specified

• requirements to notification procedure and
  notified bodies

Provision on procedure of certification bodies
and test laboratories inclusion into Unified
Register
Decision 768/2008 Directive 2009/48

• exchange of information about dangerous products

Agreement on EurAsEc systematic policy in the
field of technical regulation, sanitary and
phytosanitary measures
Regulation 765/2008 Regulation 768/2008 Directive
2001/95 Directive 2009/48
Agreement on common principles and rules of
technical regulation
Agreement on establishment of EurAsEc information
system in the field of technical regulation,
sanitary and phytosanitary measures
Agreement on common safety of products (under
planning)
Agreement on implementing urgent measures against
dangerous products (under planning)

• sanctions for violation of technical regulation
  requirements

Directive 2009/48
Agreement on harmonization of the Customs Union
member-states legislation related to the
establishment of liability
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TECHNICAL REGULATION of the CUSTOMS UNIONON
SAFETY OF TOYS
EU
?U
Harmonized standards
Interrelated standards
Intergovernmental 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
List of harmonized standards
Official Journal of the EU
9 standards
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
Directive 88/378
5 standards
Directive 2009/48
3 standards
19 standards
123 procedures
Distinction 2 lists of standards
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TECHNICAL REGULATION of the CUSTOMS UNION ON
SAFETY OF TOYS
Challenge 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,
admitted for use in transition period for
application and implementation of technical
regulation requirements
Procedures for studies (tests) performance are
established in department-level documents
123 methods
Development of intergovernmental standards on
basis of department-level documents
Identification ?f similar or comparable
procedures for studies (tests) performance
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TECHNICAL REGULATION of the CUSTOMS UNIONON
SAFETY OF TOYS
More strict procedures of the conformity
attestation
Difference with Directive 88/378
Objective
Protection of market
Reasons

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

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TECHNICAL REGULATION of the CUSTOMS UNION ON
SAFETY OF TOYS
CU
EU
Directives 88/378, 2009/48
TR CU
Certification by certification body, included
into Unified Register (by third party)
Application of harmonized standards
Non-application of harmonized standards
Non-application of standardsincluding
serial products
batch
Internal production control
Expertise of ??-type and conformity with ??-type
Tests
Tests
Module ?
Analysis of production status
Certification of quality management system
Module ??
Inspection control
Declaration of conformity
Conformity certificate of unified format
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TECHNICAL REGULATION of the CUSTOMS UNION ON
SAFETY OF LOW VOLTAGE EQUIPMENT
Safety requirements are harmonized with Directive
2006/95/??
Safety requirements against non-electrical dangers
Hygienic safety indicators
Not related to ?R
Related to TR
Safety requirements to physical factors at work
sites, technological environment, operation area
S?nPiN Directives ?? 89/391/???, 2004/40/??,
1999/519/??
Technically achievable indicators for products
Conduction of sanitary supervision during
operation
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
Challenges
Development of intergovernmental standards
SanPiN
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TECHNICAL REGULATION of the CUSTOMS UNIONON
SAFETY OF LOW VOLTAGE EQUIPMENT
More strict procedures of the conformity
attestation
Objective
Protection of market
Reasons

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

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TECHNICAL REGULATION of the CUSTOMS UNIONON
SAFETY OF LOW VOLTAGE EQUIPMENT
CU
EU
Directive 2006/95
TR CU
Certification
Internal production control

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

Module ?
Conformity certificate on unified form
Declaration of conformity
Declaration

• Low voltage equipment that is not included in
  the List

Declaration of conformity on unified form
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TECHNICAL REGULATION of the CUSTOMS UNIONON
SAFETY OF LOW VOLTAGE EQUIPMENT
Declaration
Certification
On basis of proper evidence
With participation of third party
Batch
Serial products
Serial products
Tests
Tests
Serial products
Batch
Batch
Analysis of production
Tests
Tests
Tests
Tests
Production control
Inspection control
Production control
Tests
Production control
Certification of quality management system
Conformity certificate on unified
form
Inspection control
Declaration of conformity on unified form
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DEVELOPMENT OF COMMON INTERGOVERNMENTAL
STANDARDS, INTERRELATED with the CUSTOMS
UNION TECHNICAL REGULATIONS and EurAsEC
TECHNICAL REGULATIONS
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
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DEVELOPMENT of COMMON STANDARDS, INTERRELATED
with the CUSTOMS UNION TECHNICAL REGULATIONS and
the EurAsEC TECHNICAL REGULATIONS
?R Safety of low voltage equipment
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
Electrotechnical products
?R Electromagnetic compatibility of technical
means
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
Toys
?R Safety of toys
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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
OBLIGATIONS OF PARTIES

• 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

• 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

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PARTICIPATION IN INTERNATIONAL AND REGIONAL
STANDARDS-SETTING ORGANIZATIONS
Full member
International Organization for Standardization
58 ISO/??
2010 Voting on ISO drafts 357
106 ISO/??/S?
International Electrotechnical Commission
11 IEC/??
2010 Voting on IEC drafts 155
17 IEC/??/S?
Affiliate
European Committee for Standardization
63 ?EN/??
3 CEN/?LC/??
European Committee for Electrotechnical
Standardization
13 ?LC/??
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Republic of Belarus - affiliate of CEN and
CENELEC beginning from 01.01.2010
Participation in the work of technical committees
as observer
Organization of fund of European standards in
e-format
?EN
More than 60 ?EN ?Cs (from 299)
CEN/?LC/JWG 1 Energy audits CEN/SS C01 Food
products CEN/SS F05 Measuring instruments CEN/T?
44 Catering refrigerating appliances and
industrial refrigeration equipment CEN/T? 52
Safety of toys CEN/T? 67 Ceramic tiles CEN/T?
392 Cosmetics
Fund of CEN standards for 20082011 4258
documents
13 ?ENELEC ?Cs (from 65)
?ENELEC
?LC/TC 20 Electric cables CLC/TC 44X Safety of
machinery. Electrotechnical aspects CLC/TC 61
Safety of household and similar electrical
appliance CLC/TC 62 Electrical equipment in
medical practice CLC/TC 210 Electromagnetic
compatibility
Fund of ?ENELEC standards for 20072011 7470
documents
CEN/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
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Thank you for attention!