Transcript А.G. Leskova Deputy Director on technical regulation and standardization BelGISS Development of technical regulations and standards in the Customs union.

А.G. Leskova
Deputy Director
on technical regulation and standardization
BelGISS
Development of technical
regulations and standards
in the Customs union
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
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Establishment of procedure for application of technical regulation measures
in relation to third countries
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
2011 г.
Adopted:
 Uniform list of products, for which mandatory requirements within the Customs
Union are established
2010 г.
 Development schedule of the first priority Customs Union technical regulations
2011 г.
 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
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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
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
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regulation as part of Integrated information system for external and mutual trade
of the Customs Union
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
ЕС Old Approach
Directives
on basis of
EC New Approach
Directives
 low voltage equipment
 agricultural techniques
 motor roads
 lifts
 foods
 furniture
 machinery and equipment
 chemical products
 synthetic detergents
 construction products
 perfumes and cosmetics
 alcoholic products
 toys
 personal protective equipment
 medical devices
 appliances burning gaseous fuels
 equipment operating under
excessive pressure
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others
 grains
 coal and derived products
DEVELOPMENT
of the CUSTOMS UNION TECHNICAL REGULATIONS
Development schedule of the first priority
technical regulations of the Customs Union
RF – 26
47 ТR СU
RB – 8
47 ТР ТС
2011
RК – 13
Development schedule of the first priority technical regulations of the
Eurasian Economic Community
35 ТR EurAsEC
5 member-states
adopted through international agreement
2011
6
RF - 25
RК - 3
RB - 5
КR - 2
DEVELOPMENT
of the CUSTOMS UNION TECHNICAL REGULATIONS
Adopted technical regulations of the Customs Union – 6 ТR CU
 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
readiness – 6 ТR СU
 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 ТR СU under domestic endorsement – 6 ТR СU
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Draft ТR СU under public consideration – 6 ТR СU
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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
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 Emerg.
Ministry of Construction
Ministry of Health
Ministry of Agriculture
Current technical normative documents of the Customs
Union member-states
Intergovernmental and national
(governmental) standards
Sanitary rules and regulations
SanPiN
GOST
STB, GOST R, ST RК
Construction
regulations
Safety of electrical
installation
ПУЭ
ПТБ
МР
ГН
РДУ
МУ
МВИ
Promnadzor
regulations
GRFC
rules
ПТЭ
Concentration of all safety requirements
for products
Elimination of duplication and
contradictions between documents of
different authorities
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Customs Union
Fire safety
rules and regulations
Difficulties for manufacturers
and importers
In one
document
technical
regulation
Common
intergovernmental
standards
GOST EN
GOST ISO
GOST IEC
GOST ISO/IEC
TECHNICAL REGULATION of the CUSTOMS UNION
«ON SAFETY OF TOYS»
Content
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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
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Concentration of all requirements for toys
in one document – technical regulation
TECHNICAL REGULATION of the CUSTOMS UNION
«ON SAFETY OF TOYS»
Safety requirements
of technical regulation
are harmonized with:
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
Safety requirements, different from
Directives 88/378/ЕЕС and 2009/48/ЕС
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
Common sanitary requirements
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TECHNICAL REGULATION of the CUSTOMS UNION
«ON SAFETY OF TOYS»
As distinct from Directive 2009/48/ЕС the technical regulation
doesn’t contain particular articles on the following:
EU
 obligations of economic operators
Decision 768/2008
Directive 2001/95
Directive 2009/48
СU
Agreement on common safety of products (under planning)
ТR СU (partially)
 objection relative to harmonized standards
Decision 768/2008
Directive 2009/48
Not specified
 requirements to notification procedure and notified bodies
Decision 768/2008
Directive 2009/48
Provision on procedure of certification bodies and test laboratories
inclusion into Unified Register
 exchange of information about dangerous products
Regulation 765/2008
Regulation 768/2008
Directive 2001/95
Directive 2009/48
Agreement on EurAsEc systematic policy in the field of technical regulation,
sanitary and phytosanitary measures
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
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Directive 2009/48
Agreement on harmonization of the Customs Union member-states legislation
related to the establishment of liability
TECHNICAL REGULATION of the CUSTOMS UNION
«ON SAFETY OF TOYS»
EU
СU
Harmonized standards
List of harmonized standards
Official Journal of the EU
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
9 standards
Directive 88/378
5 standards
Directive 2009/48
3 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
19 standards
123 procedures
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Distinction – 2 lists of standards
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 departmentlevel documents, which are different in member-states of the
Customs Union
Procedures for studies (tests)
performance are established in
department-level documents
123 methods
Identification оf similar or
comparable procedures for
studies (tests) performance
14
Procedures for studies (tests)
performance, admitted for use in
transition period for application and
implementation of technical regulation
requirements
Development
of intergovernmental standards
on basis of department-level
documents
TECHNICAL REGULATION of the CUSTOMS UNION
«ON 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»
EU
CU
Directives 88/378, 2009/48
Application of
harmonized
standards
TR CU
Non-application of
harmonized
standards
Certification
by certification body, included into Unified
Register (by third party)
Non-application of standards
including
serial products
Internal production
control
Module А
Expertise of ЕС-type
and conformity with
ЕС-type
Module В+С
Tests
Analysis of
production
status
Certification of
quality
management
system
Inspection control
Declaration of conformity
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batch
Conformity certificate
of unified format
Tests
TECHNICAL REGULATION of the CUSTOMS UNION
«ON SAFETY OF LOW VOLTAGE EQUIPMENT»
Safety requirements are harmonized with Directive 2006/95/ЕС
Safety requirements against non-electrical
dangers
Not related to ТR
Safety requirements to physical factors at work
sites, technological environment, operation area –
SаnPiN
Hygienic safety indicators
Related to TR
Technically achievable
indicators for products
Directives ЕС 89/391/ЕЕС, 2004/40/ЕС,
1999/519/ЕС
Conduction of sanitary supervision during
operation
Different ways of establishing indicators and methods of their control in standards
and SanPiN
Challenges
Absence of necessary intergovernmental standards
Inclusion of sanitary requirements to low voltage equipment, defined in SanPiN,
into List of standards, during the transition period
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SanPiN
Development of
intergovernmental standards
TECHNICAL REGULATION of the CUSTOMS UNION
«ON 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 UNION
«ON SAFETY OF LOW VOLTAGE EQUIPMENT»
EU
CU
Directive 2006/95
Internal
production
control
Module А
TR CU
Certification
 Low voltage equipment included in the List
 In non-application of standards
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
19
TECHNICAL REGULATION of the CUSTOMS UNION
«ON SAFETY OF LOW VOLTAGE EQUIPMENT»
Declaration
Certification
Serial products
Batch
Tests
Tests
Analysis of
production
Inspection
control
On basis of proper
evidence
Serial
products
Tests
Production
control
Batch
Tests
With participation of
third party
Serial
products
Batch
Tests
Tests
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
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
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
Toys
ТR Safety of toys
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
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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
2010
Voting on ISO drafts– 357
International Electrotechnical Commission
2010
Voting on IEC drafts– 155
58 ISO/ТС
106 ISO/ТС/SС
11 IEC/ТС
17 IEC/ТС/SС
Affiliate
European Committee for Standardization
63 СEN/ТС
3 CEN/СLC/ТС
24
European Committee for Electrotechnical
Standardization
13 СLC/ТС
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
More than 60 СEN ТCs (from 299)
СEN
CEN/СLC/JWG 1 Energy audits
CEN/SS C01 Food products
CEN/SS F05 Measuring instruments
CEN/TС 44 Catering refrigerating appliances and
industrial refrigeration equipment
CEN/TС 52 Safety of toys
CEN/TС 67 Ceramic tiles
CEN/TС 392 Cosmetics
…
13 СENELEC ТCs (from 65)
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Fund of CEN standards for 2008–2011
4258 documents
СENELEC
СLC/TC 20 Electric cables
CLC/TC 44X Safety of machinery. Electrotechnical
aspects
Fund of СENELEC standards for 2007–
CLC/TC 61 Safety of household and similar
2011
electrical appliance
CLC/TC 62 Electrical equipment in medical
practice
7470 documents
CLC/TC 210 Electromagnetic compatibility
…
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
Thank you for attention!