1. RUSSIAN LEGISLATION AS A TOOL OF REDUCING TECHNICAL BARRIERS TO ELECTRICAL EQUIPMENT TRADING S.V. Pugachev Deputy Head Federal Agency on Technical Regulation and Metrology

2. Stimulation of economic development and market protection as major targets of technical regulation Improved efficiency of market protection from hazardous products Reduced administrative and economic pressure on manufacturer Reduced technical barriers to trade Harmonized technical legislation Expanded capabilities of manufacturers

3. TECHNICAL REGULATION

4. System problems of enforcing Federal Law on Technical Regulation (over the period from July 1, 2003 to May 1, 2007) Inconsistency of the Law (in terms of individual key provisions) with WTO/TBT Agreement, international and European principles and approaches in the area of technical regulation Lack of clear differentiation of legal areas in laws on technical regulation, environmental protection, occupational and fire safety, health… Use of obsolete model to generate mandatory technical requirements – development of directly applicable prescriptive technical regulations containing exhaustive requirements Lack of continuity when using normative technical documents Problems of transition period: “freezing” of normative and technical documents

5. OECD and APEC review of applicability of international standards for technical regulation purposes «Use of irrelevant regulations may cause a substantial growth of costs and operational inefficiency of both individual sector and economy as a whole … Direct results of irrelevant regulation in a particular sector may result in higher costs, higher prices, wrong allocation of resources, lack of innovative product improvement suggestions and unsatisfactory quality of services»

6. Types of technical regulations (APEC and OECD classification) Prescriptive regulations shall be only approved in the presence of exclusively limited possibilities of achieving the target or when the problem is… static. Performance-based technical regulations precisely specify the target but allow the item being regulated to determine its own method of achieving the result…ensure flexibility in achieving the target. Such regulations are the least limiting form of trade regulation and are approved by members of APEC (APEC guidelines for development, approval and revision of technical regulations) and members of WTO (Clause 2.8 of WTO/TBT Agreement). To solve the problem of conformity and control a reference to alternative prescriptive standards (the so called “solutions aimed at conformity achievement”) is used.

7. Recommendations of the United Nations Economic Commission for Europe (UN ECE) concerning standardization policy (Recommendation “D” of UN ECE (UNESCO, UNECE TRADE/WP.6/2002/7 of June 14, 2002.) The governments of ECE member countries should whenever possible use references to national standards in their laws… and encourage more extensive application of “reference to standards” while drawing the attention of their competent authorities to the benefits of this method and various ways of its application. Benefits: Contributes to elimination of trade barriers and prevents their creation Simplifies and accelerates legislative business Promotes more simple process of amending technical specifications subject to technological advancement

8. Documents (recommendations) of international organizations (two-tier model) Recommendations of the United Nations Economic Commission for Europe (UN ECE) concerning standardization policy Review of applicability of international standards for technical regulation purposes made by the Organization for Economic Cooperation and Development (OECD) Recommendations of the Asia-Pacific Economic Cooperation (APEC) conference for good practices of technical regulation ISO/IEC Guide 15 “ISO/IEC code of principles on “reference to standards” Report of the European Commission Directorate-General “Use of reference standards in legislation with emphasis on European law” ISO/IEC Draft Guide “Use of ISO and IEC Standards for technical regulations” (considered by ISO Standardization Management Board in February 2006)

9. RUSSIA-EC SUMMIT Road Map on the Common Economic Space (approved by V.V. Putin, President of Russia, and EC leaders on May 10, 2005) 1. General issues of commercial and economic cooperation 1.1. Industrial products regulation dialog (standardization, technical regulation and conformity assessment procedures) Target: development of harmonized and compatible standards, regulations and conformity assessment procedures… This dialog is aimed at further transparency of regulation, exchange of information between regulators to promote step-by-step approximation of relevant laws (including technical regulation) and practices in clearly specified priority industrial sectors of mutual interest to be defined by joint effort and whenever possible on the basis of New Approach.

10. Basic principles of New Approach ( European Council Resolution 85/ЕС 136/01 dated May 7, 1985) Product Directives specify general (essential) safety requirements; specific characteristics are defined by European standards voluntary for use and duly developed by the following organizations: CEN, CENELEC, ETSI; products manufactured in accordance with harmonized European standards (Directive) are viewed as meeting general (essential) requirements of the Directive (presumption of conformity principle); if the product manufacturer is not willing to use a harmonized standard or such standard is not available, he must prove the conformity of his products to general (essential) requirements of the Directive usually with the help of a third party; a list of European standards harmonized with the Directive is published in the Official Journal of Europe, official edition of the European Council; products may be marketed in EC countries only after conformity assessment; market surveillance is done by public authorities.

11. Major advantages of New Approach developers and legislators find it much easier to agree upon general (essential) requirements rather than technical details; the use of essential requirements in technical regulations (directives) prevents unfair lobbing in the interests of individual groups; the manufacturers are not confined to a single solution of meeting the requirements of technical regulations (directives) and may select their own technical solution provided it meets the safety level specified in the regulation; technical regulations (directives) do not require regular updating in connection with technical innovations and revised international requirements for products.

12. Legislation (documents) of CIS countries related to technical regulation (two-tier model) Law of the Republic of Belarus on Technical Normalization and Standardization Law of Ukraine on Standards, Technical Regulations and Conformity Assessment Procedures Law of the Republic of Moldova on Product Conformity Assessment Law of the Republic of Kazakhstan on Technical Regulation Agreement on Technical Barriers in the free trade zone (singed by the leaders of CIS countries in 2000) Recommendations of the Eurasian Council for standardization, metrology and certification concerning references to standards in documentation and standards designation in marking (RMG 50-2000)

13. Extract from Minutes No 12 of the Meeting of the Russian Government dated April 13, 2006 on technical regulation progress 2.…update a set of arrangements concerning implementation of the Federal Law on Technical Regulation for 2006 having provided in particular for: - improvement of technical regulation legislation, including specified mandatory requirements for products and related production process characteristics as well as potential differentiation of requirements specified in technical regulations and requirements of other statutory acts possibly referred to in technical regulations; 4.…ensure the application of common practices and approaches in technical regulation harmonization agreements…within CIS, Single Economic Space and Eurasian Economic Community, etc. 5.…ensure that in May 2006 a draft Federal Law on changes and amendments to the Federal Law on Technical Regulation be submitted to the Government of the Russian Federation…

14. Stages of approving changes and amendments to the Federal Law on Technical Regulation The draft law was prepared as resolved by the Government of the Russian Federation, supported by the Russian Union of Industrialists and Entrepreneurs, Federation of Independent Trade Unions of Russia, Russian Union of Scientific and Engineering Non- Governmental Organizations, Association of Civil Engineers of Russia, Association of Automanufacturers of Russia, Russian Union of Chemists, International Union of Metallurgists and other non- governmental organizations and associations Supported at the enlarged meeting of the Committee Chairmen Board of the Chamber for Commerce and Industry of the Russian Federation Supported at the meeting of the Committee for Innovations, Hi-Tech Scientific and Engineering Projects of the Public Chamber of the Russian Federation Passed by the State Duma in its third reading on April 6, 2007, approved by the Federation Council on April 18, 2007 and signed by the President of the Russian Federation on May 1, 2007 (published in Russian Gazette on May 11, 2007)

15. MAJOR CHANGES proposed in the Law on Changes and Amendments to the Federal Law on Technical Regulation (No 65-FZ of May 1, 2007) CLARIFIED SCOPE OF LAW (occupational safety, manufacturing processes…, arrangements made for soil conservation…, preventive health care) TECHNICAL REGULATION SYSTEM (item description, exhaustive requirements, types of safety, there should be forms and rules of conformity assessment, international standards should be used) CONTENT OF TECHNICAL REGULATIONS (general/special technical regulations, priority technical regulations, resolutions passed on an ongoing basis) PRESUMPTION OF CONFORMITY AND APPLICABILITY OF DOCUMENTS TO MEET THE REQUIREMENTS OF REGULATIONS STANDARDIZATION SYSTEM (standardization objectives, TC composition and regulations) ATTESTATION SYSTEM (declaration registration procedure, simplified procedure of certificate extension…) GOVERNMENT SUPERVISION SYSTEM (no overlapping of functions, clarified authorities and rights of supervising bodies) TRANSITION PERIOD PROBLEMS (status of conformity assessment procedures confirmed, single lists of products for certification and declaration introduced, changes allowed to be made in regulatory and legal documents)

16. WTO/TBT AGREEMENT Technical regulation – document specifying characteristics of goods or related processes and methods of production, including applicable administrative provisions to be absolutely observed… Explanatory note The definition contained in ISO/IEC Guide 2 is not isolated, it is underlain by the so called “building block” system

17. Definition of technical regulation from ISO/IEC Guide 2:2004 (“building block” system under WTO/TBT Agreement) Technical regulation – regulation that provides technical requirements, either directly or by referring to or incorporating the content of a standard, technical specification or code of practice.

18. HARMONIZED EUROPEAN STANDARDS (EN) THAT ENSURE CONSUMPTION OF CONFORMITY TO EC DIRECTIVES (list published in EC official journal) LOW VOLTAGE (73/23/ЕЕС) SIMPLE PRESSURE VESSELS (87/404/ЕЕС) ELECTROMAGNETI C COMPATIBILITY (89/336/ЕЕС) MACHINERY (98/37/ЕС) ATEX (94/9/ЕС) PRESSURE EQUIPMENT (97/23/ЕС)

19. Role of standards in reducing technical barriers to trade Code of practice for development, approval and application of standards (Appendix to WTO/TBT Agreement) A 10-per cent increase in the level of harmonization of standards between the countries steps up bilateral trading volume by 3% (WTO Report on world trade (2005) …successful operation of IECEE CB Scheme suggests that national standards are adequately harmonized with relevant IEC Standards (Rules of Procedure IECEE 02)

20. Development concept of national standardization system Decree No 266-r of the Government of the Russian Federation dated February 28, 2006 Standardization is a key factor supporting the national social and economic policy, it promotes fair competition, innovations, reduces technical barriers to trade, improves life safety level, protects health and property of individuals, ensures consumer protection, environmental protection and saving of all resources

21. CONTENT OF TECHNICAL REGULATIONS ARTICLE 7: INSTEAD OF EXHAUSTIVE LIST OF PRODUCTS A TECHNICAL REGULATION MUST CONTAIN A LIST AND/OR DESCRIPTION OF REGULATION ITEMS A REGULATION MUST CONTAIN FORMS AND RULES OF CONFORMITY ASSESSMENT (IT MAY CONTAIN ATESTATION SCHEMES, CERTIFICATE EXTENSION PROCEDURES) MANDATORY REQUIREMENTS CONTAINED IN A TECHNICAL REGULATION ARE NOT EXHAUSTIVE TYPES OF SAFETY COVERED BY REGULATIONS TO BE DEVELOPED ARE NO LONGER LIMITED INTERNATIONAL STANDARDS MUST BE USED FULLY OR PARTIALLY AS A BASIS FOR TECHNICAL REGULATIONS

22. NATIONAL STANDARDS AND TECHNICAL REGULATIONS FEDERAL LAW ON TECHNICAL REGULATION Article 16. Rules for development and approval of national standards Before any technical regulation becomes effective the national standardization body shall approve a list of national standards and/or codes of practice. And “voluntary use” of national standards and/or codes of practice is a sufficient condition for meeting the requirements of relevant technical regulations. When national standards and/or codes of practice are used to meet the requirements of technical regulations, assessment of conformity to technical regulations may be done by attesting their conformity to national standards and/or codes of practice.

23. USE OF DOCUMENTS ON A VOLUNTARY BASIS TO MEET THE REQUIREMENTS OF TECHNICAL REGULATIONS THE CONCEPT OF ”CODE OF PRACTICE” HAS BEEN INTRODUCED Code of practice – document in the area of standardization containing technical rules and/or description of processes of designing (including research), production, construction, installation, setting-up, operation, storage, transportation, marketing and disposal of products and applicable on a voluntary basis The code of practice development and approval procedure is specified by the Government of the Russian Federation IMPLEMENTATION OF PRESUMPTION OF CONFORMITY PRINCIPLE FOR ASSESSMENT OF CONFORMITY TO REGULATIONS THE GOVERNMENT OF THE RUSSIAN FEDERATION APPROVES A LIST OF STANDARDS CONTAINING RULES AND METHODS OF TESTING, RULES OF SAMPLING Where such standards are not available (in respect of individual requirements or items), the Government of the Russian Federation shall approve the rules and methods themselves

24. SOLUTION OF TRANSITION PERIOD PROBLEMS IT IS SPECIFIED THAT DURING THE TRANSITION PERIOD CONFORMITY ASSESSMENT AND MARKING OF PRODUCTS WITH A MARK OF CONFORMITY IN THE MANDATORY AREA SHALL BE DONE IN ACCORDANCE WITH PRE-ESTABLISHED PROCEDURES AUTHORITIES OF THE RUSSIAN GOVERNMENT FOR MAINTAINING A SINGLE LIST OF PRODUCTS SUBJECT TO MANDATORY CERTIFICATION AND A SINGLE LIST OF PRODUCTS SUBJECT TO DECLARATION HAVE BEEN DEFINED IT IS ALLOWED TO MAKE CHANGES IN STATUTORY ACTS OF THE RUSSIAN FEDERATION AND REGULATORY DOCUMENTS OF FEDERAL EXECUTIVE AUTHORITIES

25. Approved changes and amendments to the Federal Law on Technical Regulation will ensure: consistency of the law with international practices and international agreements signed by the Russian party higher efficiency of the technical regulation reform and attainment of the reform objectives: protection of consumers followed by reduced administrative pressure on manufacturers and reduced technical barriers to trade required level of safety requirements during the transition period (before technical regulations are approved)

26. Participation of Russia in IEC attestation systems (schemes) ( Decree No 526-r of the Government of the Russian Federation dated April 17, 2006) IEC System for Conformity Testing and Certification of Electrical Equipment and Components (IECEE) 47 countries involved, 8 Russian laboratories recognized, about 40 international certificates issued Russia joined IECEE in 1985 IEC Quality Assessment System for Electronic Components (IECQ) 22 countries involved, 3 Russian laboratories recognized, 7 manufacturers assessed Russia joined IECQ in 1983 IEC Certification Scheme for Explosive Atmospheres (IECEx) 20 countries involved, 1 Russian laboratory and 1 certification body recognized in 2004 Russia joined IECEx in 1996

27. STATUS OF CERTIFICATION SYSTEM FOR ELECTRICAL EQUIPMENT (CSEE) (established in May 1992) The System operates over 680 standards for electrical equipment (altogether there are over 3000 стандартов for electrical equipment) The System covers: - 287 types of products subject to mandatory certification - 47 types of products subject to declaration of conformity The System comprises over 380 accredited testing laboratories and 190 accredited certification bodies CSEE operates Certification Rules. GOST R Certification System. Certification Procedures for Electrical Equipment (approved by the Gosstandart of Russia under No 36 on July 16, 1999, registered with the Ministry of Justice under No 1885 on September 2, 1999) In terms of its structure, regulatory base, rules, procedures and regulations CSEE has been harmonized with IECEE

28. Correspondence table for IEC and GOST (GOST R) standards applicable under IECEE CB Scheme and GOST R Certification System

29. By January 1, 2010 the following priority technical regulations shall be approved (Clause 1 of Article 9 of the Federal Law on Technical Regulation): machinery; low voltage; construction materials and building products; buildings and structures; drugs; elevators; power plants and mains; overpressure equipment; electromagnetic compatibility; wheeled vehicles; medical products; personal protective equipment; chemical products; foodstuffs; gas fuel operated equipment; ATEX; packaging.

30. Development of Low Voltage Technical Regulation The technical regulation development program approved by the Government of the Russian Federation, decree No 1421-r dated November 6, 2004 Airing of the draft: February 2005 – April 2005. About 300 comments from 36 organizations received, 85% of comments implemented Approval in consultation with 6 ministries (departments) Findings received from: expert committee, Institute of Legislation and Comparative Jurisprudence under the Government of the Russian Federation, Legal Department of the President of the Russian Federation, Department of the Government of the Russian Federation The Technical Regulation approved at the meeting of the Government Panel for Technical Regulation in November 2006

31. Source documents for Technical Regulation development New Approach Low Voltage Directive 73/23/EEC Directive Application Guide – official publication of the European Commission IECEE rules and procedures (Russia joined IECEE in 1985: Decree No 2236-R of the USSR Council of Ministers dated October 24, 1985, Decree No 526-R of the Government of the Russian Federation dated April 17, 2006) Regulatory base – 240 standards of the International Electrotechnical Commission

32. 9 Leninsky Prospect Moscow V-49, GSP-1, 119991 Tel.: 236 0553, fax: 236 4395 Е-mail: svpugachev@gost.ru http://www.gost.ru