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Technical Regulation in the EU; concepts, examples and procedures

Deregulation to the Economy and removal of Administrative Barriers, Russian Federation EuropAid/114008/C/SV/RU. Technical Regulation in the EU; concepts, examples and procedures. Moscow, March 9 th 2005. Technical Regulation in the EU; concepts, examples and procedures.

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Technical Regulation in the EU; concepts, examples and procedures

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  1. Deregulation to the Economy and removal of Administrative Barriers, Russian Federation EuropAid/114008/C/SV/RU Technical Regulation in the EU; concepts, examples and procedures Moscow, March 9th 2005

  2. Technical Regulation in the EU; concepts, examples and procedures Purpose of this presentation 1.- Discuss concepts, meanings and impacts 2.- Shed light on ‘how to do it’ as action options Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  3. EU single market • 10 principles for a single market • Buy what you want, where you want • If it does not work, send it back • High safety standards for food and other consumer goods • Know what you are eating • Contracts should be fair to consumers • Sometimes consumers can change their mind • Making it easier to compare prices • Consumer should not be misled • Protection while you re on holiday • Effective redress for cross-border disputes • 2. Purpose: quality of life of EU citizens and residents • 3. Result: increased standardisation across the EU and new procedures. Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  4. EU single market • Basic operational principles of the single market • Minimum administrative barriers • Strict & harmonised technical standards and procedures Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  5. EU New and Global Approach • Terminology: New Approach to standardisation; Global Approach to certification and testing) • History: 1985, milestone year • Before 1985: national and “EU” products. • National technical specifications and conformity controls • EU products: only those that common technical specifications and conformity controls were agreed by all member states, and new Directives were produced Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  6. EU New and Global Approach • Up to 1985: European common market a special part of the national markets. Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  7. EU New and Global Approach • After 1985, White Paper (COM(85)310): • Basic document for the creation of the European internal market • Needs for radical change, in view of the Single Market, December 31st 1992 = 7 years to make the necessary changes (reforms) • Institutional adaptations • Legislative adaptations • Procedural adaptations Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  8. EU New and Global Approach • Technical Regulations and Conformity Assessment Procedures • Technical Regulations are measuring tools assuring that products approximate essential requirements • Conformity Assessment (Global Approach): a 7 step procedure for assuring Technical Regulations are satisfied. • Third party or entrepreneur may cover parts of the 7-step procedure. Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  9. EU New and Global Approach • Essential components of the operation of the internal market • National standards and Standardisation Centres • National Centres for Accreditation • National Centres for Certification • Metrology • Public-private partnerships (PPP) legally possible Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  10. Outline of national quality systems operations SME SME SME Assessement conforming procedures (risk assessment) Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  11. Good practice example, Tcheck • Step 1: Signing of Protocol with the EU ‘ Agreement on Conformity Assessment and Acceptance of Industrial Products [PECA] • In force since 1/7/2001 • Basic pre-conditions • Align national legislation to the EU • Notification system to prove its equivalence to the EU notification systems • Step 2: Reforms undertaken • Legal background (technical regulations) • Standardisation • Metrology • Conformity assessment procedures (‘compliance assessment’, ‘risk assessment’) • Market surveillance • Accreditation Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  12. Good practice example, Tcheck • Step 2: Reforms undertaken • Legal background (technical regulations) • Basic priority: full compatibility with the EC system-based on Article 75 of the EU treaty • Provisions relating to Health and Safety (HSE risks) are made via different Acts. Implementing of such Regulations under the direct responsibility of different Ministries; through Ministerial Decrees and Governmental Orders. • Missing: coordination and unification tools • Step 3 : Technical harmonisation programme • Adopted in 1996 • Set specific timetable for transposition of EC Technical Regulations • Unified system of translation into Check • New and Global Approach systematically taken into account Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  13. Good practice example, Tcheck • Step 4: Legal actions and implementation • Horizontal Act on Technical Requirements for Products /Act 22/1997Coll., as amended), defines • Environement for application of the NA and GA; • Role of State and relevant executive bodies in Standardisation, Accreditation and Conformity Assessment • Declaration of conformity in regulated areas • Implementation of Governmental Orders: 19 New Approach Directives [NAD] have been transposed up to now (2001) • Other horizontal law: General Product Safety, Product Liability • Sectoral law: transposition of Old Approach Directives [OAD] • Source of information: Libor Dupal, Check Office for Standards, Metrology and Testing; 2001 presentation Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  14. Good practice example, Tcheck • Some first achievements, Standardisation • Fully compatible system with the EU • Clear legal separation of mandatory technical regulations from voluntary technical standards • Public enquiry, consensus building, implementation of EN into national standards, withdrawal of conflicting standards • The definition of harmonised standards as a tool for presumption of conformity with legal requirements • More than 90% EN transposed as CSN (65% translated) • Funding: public funding has been decreasing, income through increase of own commercial activities • Source of information: Libor Dupal, Check Office for Standards, Metrology and Testing; 2001 presentation Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  15. Good practice example, Tcheck • Some conclusions on the Check strategy, basic principle seekms to be an ‘integrated approach’ , i.e. tackling the issues from all necessary sides • Horizontal Laws • Ministries ‘interprete’ Horizontal Laws and apply them • HSE Regulations implemented by Ministries • Specific timetable for adaptation • Maximum compatibility • Legislative reform with radical changes • Unification and coordination tools directly in place • Long term procedure, about 14 years Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  16. Good practice example, Poland • Polish Centre for Testing and Certification • Five economic operators • Legislation • Supporting Institutions • Public Authorities, EU and National • Consumer protection • Industry and trade Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  17. Good practice example, Poland • Polish Centre for Testing and Certification • Legislation • Law of 22/7/1999: Amended law on testing and certification • Law of 22/1/2000 on general and product safety • Law of 2/3/2000 on protection of certain consumer rights and liability for damage caused by dangerous products • Law of 28/4/2000 on conformiy asessment system, accreditation, and amendments to certain acts Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  18. Good practice example, Poland • Polish Centre for Testing and Certification • Bodies involved and key regulations • Council of Ministers • Minister of Economy • Minister of Finance Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  19. Good practice example, Poland • Structure of the Polish Centre for Testing and Certification Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  20. Good practice example, Poland • Polish Centre for Testing and Certification, Product certification • Obligatory • safety mark B • Voluntary • CB certificate • CCA certificate • Quality mark Q • Mark of conformity with Polish standard PN • Certificate of conformity with other standardisation document • Ecological mark EKO • Safety mark B Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  21. Good practice example, Poland • Polish Conformity Assessment System • Present (2003); products • Obligatory certification • Certification for Mark B • Manufacturer’s declaration verification • Voluntary certification • Market surveillance • Future; products • Obligatory certification • Third party • CE marking • Manufacturer’s declaration • National requirements • Voluntary certification • Market surveillance • Source of information: Wojciech Henrykowski, Joanna Tkaczyk; Polish Centre for Testing and Certification, 2001 presentation to EOTC Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  22. Good practice example, Poland • SME awareness and feedback • Will changes improve long term quality of Polish products? • Will Polish products have better acceptance in the EU? • Awareness of the contents of the ‘White Book’ that would be implemented in Poland? • Do you know the principles of the functioning of conformity assessment in ‘regulatory area’ in EU countries? • Source of information: Wojciech Henrykowski, Joanna Tkaczyk; Polish Centre for Testing and Certification, 2001 presentation to EOTC Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  23. Good practice example, Poland • Some conclusions on Polish Centre for Testing and Certification and Polish Conformity Assessment System • Horizontal laws HSE nd consumer protection • Law establishing testing and certification • Well structured institutional base • Step –by- step development and long term planning (since early 1990’s). Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

  24. Effects of Regulation and Technical Harmonisation • Example, Construction sector • Savings typically between 100e to 1000 e million annually • From • Price competition • Increased choice of products • Economies of scale • Long term product and process development • Source of information: Effects of Regulaiton and Technical Harmonisation on the Intra-Community Trade in Construction Products, EC, DG Enterprise, 2000. Deregulation to the Economy and removal of Administrative Barriers, Russian FederationEuropAid/114008/C/SV/RU

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