Development of technical regulations and standards in the Customs union

1. А.G. Leskova Deputy Director on technical regulation and standardizationBelGISS Development of technical regulations and standards in the Customs union

2. Systematic policy in the field of technical regulationwithin EurAsEC and Customs Union Systematic policy agreement in the field of technical regulation, sanitary and phytosanitary measures of EurAsEc Agreement on harmonization basis of EurAsECtechnical regulation Model agreement on adoption ofEurAsEC technical regulation Agreement on use of the single mark for products circulationin the EurAsEC market Agreement oncreation of EurAsEC information system in the field of technical regulation, sanitary, veterinary andphytosanitarymeasures Agreement on mutual recognition of accreditationof certification (conformity attestation)bodies andtesting laboratories (centers) performing conformity attestation Agreement on products circulation subject to mandatoryconformity assessment (attestation)on the territory of Customs Union Agreement on common principles and rulesof technical regulation in the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation Establishment and application of common regulatory requirementsfor products Establishment of commonrules of works implementation on conformity assessment Establishment of procedurefor application of technical regulation measuresin relation tothird countries 2

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 Adopted: • Uniform list of products,for which mandatory requirements within the Customs Union are established • Development scheduleof the first priority Customs Uniontechnical regulations • Regulation on the order of development,adoption, amendment and abolishment of the Customs Uniontechnical 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 formsof documentsfor conformity assessment (attestation)(declaration of conformity totechnical regulations of the Customs Union,certificate of conformity totechnical regulations of the Customs Union) • Graphic representation of the single mark • Regulations on the single markfor products circulation in the market of the Customs Union member-states and its usage 2011 г. 2010 г. 2011 г. 3

4. 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 harmonizationof the Customs union member-states legislation related to the establishment of liabilityfor 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 ontherules for standardization work in the Customs Union • Regulations onthe procedure for products conformity attestation against the requirements of the Customs Union technical regulation • Action plan forensure uniformity of measurementson the customs territory of the Customs Union • Regulations onthe 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 systemin the field of the Customs Union technical regulation as part of Integrated information system for external and mutual trade of the Customs Union 4

5. 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 dangerfor 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 others • low voltage equipment • lifts • machinery and equipment • construction products • toys • personal protective equipment • medical devices • appliances burning gaseous fuels • equipment operating underexcessive pressure • motor roads • furniture • synthetic detergents • alcoholic products • grains • coal and derived products • agricultural techniques • foods • chemical products • perfumes and cosmetics 5

6. DEVELOPMENT of the CUSTOMS UNION TECHNICAL REGULATIONS Development schedule of the first priority technical regulations of theCustoms 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 RF - 25 RК - 3 35 ТREurAsEC 5 member-states adopted through international agreement RB - 5 КR - 2 2011 6

7. DEVELOPMENT of the CUSTOMS UNION TECHNICAL REGULATIONS • Adopted technical regulations of the Customs Union – 6 ТRCU • 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 СUunder domestic endorsement – 6 ТR СU DraftТR СUunder public consideration – 6 ТR СU 7

8. 8 Graphic representation of the single markfor 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)proceduresspecified in technical regulations of the Customs Union and meet the requirements of all applicable to these products technical regulations of the Customs Union

9. Intergovernmental and national (governmental) standards Sanitary rules and regulations GOST STB, GOST R, STRК SanPiN ГН РДУ МР МУ МВИ Safety of electrical installation ПУЭ ПТБ ПТЭ Concentration of safety requirements for products in technical regulation Safety requirements for products and services have been established in bylaws of department-level nature Ministry of Construction Gosstandart Ministry of Health Ministry of Emerg. Ministry of Agriculture Current technical normative documentsof 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 GOSTEN GOSTISO GOSTIEC GOSTISO/IEC Difficulties for manufacturers and importers 9

10. 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  Informationrequirements on hazards and measures taken in using toys, representing the greatest danger Concentration of all requirements for toys in one document – technical regulation 10

11. TECHNICAL REGULATION of the CUSTOMS UNION«ON SAFETY OF TOYS» Safety requirementsof technical regulation are harmonized with: Safety requirements, different fromDirectives 88/378/ЕЕСand2009/48/ЕС • Particular hygienic safety requirements fortoys: • 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

12. TECHNICAL REGULATION of the CUSTOMS UNION «ON SAFETY OF TOYS» • As distinct from Directive 2009/48/ЕСthe 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 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 Regulation768/2008 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 regulationrequirements Directive 2009/48 12 Agreement on harmonizationof the Customs Union member-states legislation related to the establishment of liability

13. 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 voluntaryapplication 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 13

14. 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-leveldocuments, which are different in member-states of the Customs Union Procedures for studies (tests) performance, admitted for use in transition periodfor application and implementation oftechnical regulationrequirements Procedures for studies (tests) performance are established in department-level documents 123 methods Development of intergovernmental standards on basis of department-level documents Identificationоf similar or comparable procedures forstudies (tests) performance 14

15. 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

16. TECHNICAL REGULATION of the CUSTOMS UNION «ON SAFETY OF TOYS» EU CU Directives 88/378, 2009/48 TRCU Certification by certification body, included into Unified Register (by third party) Application of harmonized standards Non-application ofharmonized standards Non-application of standardsincluding serial products batch Internal production control Expertise of ЕС-typeandconformity with ЕС-type Tests Tests Module А Analysis of production status Certification of quality management system Module В+С Inspection control Declaration of conformity Conformity certificateof unified format 16

17. 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 ofintergovernmental standards SanPiN 17

18. 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

19. TECHNICAL REGULATION of the CUSTOMS UNION«ON SAFETY OF LOW VOLTAGE EQUIPMENT» EU CU Directive 2006/95 TR CU Internal production control Certification • Lowvoltage equipment included in the List • In non-applicationof standards Module А Conformity certificate on unified form Declaration of conformity Declaration • Lowvoltage equipment that is not included in the List Declaration of conformity on unified form 19

20. TECHNICAL REGULATION of the CUSTOMS UNION«ON 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 ofquality management system Conformity certificate on unified form Inspection control Declaration of conformity on unified form 20

21. DEVELOPMENT OF COMMON INTERGOVERNMENTAL STANDARDS,INTERRELATED with the CUSTOMS UNION TECHNICAL REGULATIONS andEurAsECTECHNICAL REGULATIONS Development and implementation oftargeted programsfor development of intergovernmentalstandardsfor 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 intoThe Plan of EurAsEC intergovernmental standardization Development of intergovernmentalstandards, applicable for the purpose of conformity assessment (attestation) to the Customs Uniontechnical regulation

22. DEVELOPMENT of COMMON STANDARDS, INTERRELATED with the CUSTOMS UNION TECHNICAL REGULATIONS and the EurAsEC TECHNICAL REGULATIONS ТRSafety of low voltage equipment Draft list of standards(370) 93%harmonization Necessary to develop 300GOST based on ISO, IEC, EN, 40%from them based onISO, IEC, EN new versions Electrotechnical products ТRElectromagnetic compatibility of technical means Draft list of standards (9) 90%harmonization Necessary to develop 8GOST based on ISO, IEC, EN, 50% from them based on ISO, IEC, EN new versions In additionto prepare 30documents on the test methods of hygienic indicators Toys ТRSafety of toys 22

23. COMMON INTERGOVERNMENTAL STANDARDS For the purpose of meeting the requirementsof 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 cancelallnational (governmental) standardsthat are in conflict with intergovernmental standards • to notifyof the beginning of developmentof national (governmental) standardsand tocease their developmentwhen deciding on development of intergovernmental standards for a given object of standardization 23

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

25. Republic of Belarus− affiliate ofCEN 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 СEN More than 60 СEN ТCs (from 299) CEN/СLC/JWG 1 Energy audits CEN/SS C01 Food products CEN/SS F05Measuring 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 4258documents 13СENELEC ТCs (from 65) СENELEC СLC/TC 20 Electric cables CLC/TC 44X Safety of machinery. Electrotechnical aspects CLC/TC 61 Safety of household and similarelectrical appliance CLC/TC 62 Electrical equipment in medical practice CLC/TC 210Electromagnetic compatibility … Fund of СENELEC standards for 2007–2011 7470documents 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

26. Thank you for attention!