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 Establishment of procedure for application of technical regulation measures in relation to third countries 2

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 г. 2010 г. 2011 г. 3

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 regulation as part of Integrated information system for external and mutual trade of the Customs Union 4

61 objects of technical regulation 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 EC New Approach Directives on basis of ЕС Old 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 5

DEVELOPMENT of the CUSTOMS UNION TECHNICAL REGULATIONS Development schedule of the first priority technical regulations of the Customs Union 47 ТR СU RF – 26 47 ТР ТС RB – 8 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 RF - 25 RК - 3 RB - 5 КR - 2 2011 6

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 Draft ТR СU under public consideration – 6 ТR СU 7

It stands for Eurasian Conformity 8 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 Health Ministry of Construction Ministry of Agriculture Current technical normative documents of the Customs Union member-states Intergovernmental and national (governmental) standards GOST STB, GOST R, ST RК Sanitary rules and regulations SanPiN ГН РДУ МУ МР МВИ Customs Union Construction regulations Fire safety rules and regulations Safety of electrical installation ПУЭ ПТБ ПТЭ Promnadzor regulations GRFC rules technical regulation Concentration of all safety requirements for products In one document 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 9

TECHNICAL REGULATION of the CUSTOMS UNION «ON 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 10

TECHNICAL REGULATION of the CUSTOMS UNION «ON SAFETY OF TOYS» Safety requirements of technical regulation are harmonized with: 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 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 11

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: obligations of economic operators EU СU Decision 768/2008 Directive 2001/95 Directive 2009/48 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 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 12 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 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 13 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 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 оf similar or comparable procedures for studies (tests) performance 14

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 15

EU CU TECHNICAL REGULATION of the CUSTOMS UNION «ON SAFETY OF TOYS» 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 standards including serial products batch Internal production control Expertise of ЕС-type and conformity with ЕС-type Tests Module А Tests Analysis of production status Certification of quality management system Module В+С Inspection control Declaration of conformity Conformity certificate of unified format 16

Development of intergovernmental standards 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 Hygienic safety indicators Not related to ТR Related to TR Safety requirements to physical factors at work sites, technological environment, operation area – SаnPiN Directives ЕС 89/391/ЕЕС, 2004/40/ЕС, 1999/519/ЕС 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 17

More strict procedures of the conformity attestation 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 18

Declaration of conformity on unified form TECHNICAL REGULATION of the CUSTOMS UNION «ON SAFETY OF LOW VOLTAGE EQUIPMENT» EU CU Directive 2006/95 TR CU Internal production control Certification Low voltage equipment included in the List In non-application of standards Module А 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» Certification Declaration On basis of proper evidence With participation of third party Serial products Batch 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 20

technical regulations are under development 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 ТR 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 ТR 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 ТR Safety of toys 22

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 23 23

PARTICIPATION IN INTERNATIONAL AND REGIONAL STANDARDS-SETTING ORGANIZATIONS Full member International Organization for Standardization 58 ISO/ТС 2010 Voting on ISO drafts– 357 106 ISO/ТС/SС International Electrotechnical Commission 11 IEC/ТС 2010 Voting on IEC drafts– 155 17 IEC/ТС/SС Affiliate European Committee for Standardization 63 СEN/ТС 3 CEN/СLC/ТС European Committee for Electrotechnical Standardization 13 СLC/ТС 24

Republic of Belarus − affiliate of CEN and CENELEC beginning from 01 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 … Fund of CEN standards for 2008–2011 4258 documents 13 СENELEC ТCs (from 65) СENELEC СLC/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 СENELEC standards for 2007–2011 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 25

Thank you for attention!