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The New Legislative Framework

This overview delves into the New Legislative Framework (NLF) focusing on Regulation 765/2008/EC and Decision 768/2008/EC. The implementation phases, adoption, and objectives of this framework are outlined. The review was proposed to address the uneven application of Directives across Member States, aiming to combat non-conforming products and enhance market trust. Key elements covered are market surveillance, accreditation, CE marking importance, and common obligations. The Regulation and Decision outline crucial definitions, conformity assessments, safeguard clauses, and accreditation and market surveillance requirements. The applicability starting from January 1, 2010, and the impact on economic operators and Member States are highlighted.

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The New Legislative Framework

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  1. The New Legislative Framework Rita L’Abbate Unit C1: Regulatory approach for the free movement of goods

  2. Overview • The New Legislative Framework (NLF) • The Regulation • The Decision • Implementation phase…

  3. New Legislative Framework - Texts OJ L218 - 13.08.08 : • Regulation 765/2008/EC - requirements for accreditation and market surveillance relating to the marketing of products • Decision 768/2008/EC - a common framework for the marketing of products

  4. Timeframe/Process • Adoption : 9 July 2008 • Publication in OJEU – 13 August 2008 • Entry into force 20 days after publication • Date of application of Regulation 765/2008 is 1 Jan 2010 • Decision ‘sui generis’ = by issue/by sector

  5. Why did we propose the review? Experience shows Directives do not function in the same way in all Member States …. • Different levels of controls in Member States • Unequal treatment, distortion of competition • Many non conforming products bearing CE marking Lack of trust in marking • Different ways of controlling notified bodies - no transparency • Differing definitions, unclear obligations for importers distributors…

  6. Main elements covered by the Review • Market surveillance • Accreditation - Notified Bodies • Role and significance of CE marking • Common definitions & obligations • Safeguard clause

  7. NLF- 2 Complementary legislative tools DECISION • Definitions • Obligations for economic operators • Conformity Assessment Procedures • marking • Notified bodies • Safeguard mechanisms Basis for future legislation REGULATION • Accreditation • Market Surveillance • Internal • Imported products • General principles • Financing elements Applicable 1 Jan 2010

  8. The Regulation & the Decision DECISION • Covers elements already included in legislation • Sui Generis Decision -applies to EU legislator, Commitment • No immediate effects for Member States or individuals • Better Regulation tool: model Articles - “toolbox” • Applies to new legislation or revisions of legislation REGULATION • Covers elements not already included in sectoral legislation • Creates direct rights and obligations for Member States and individuals • Becomes law in all Member States on 1 January 2010 • Member States need to be ready to apply

  9. Regulation –main objectives • Accreditation • Enhance mutual confidence in certificates and quality of conformity assessment bodies • Common transparent rules for assessing the competence of conformity assessment bodies • Market surveillance • Make our internal market legislation more effective by ensuring better control of this legislation • Ensure equal conditions for economic operators • Common minimum requirements • Enhanced cooperation and information exchange amongst market surveillance authorities of MS

  10. Regulation – Accreditation (1) Objectives are • to create confidence in accredited certificates thus establishing trust in the market place • to ensure ONE accreditation certificate for whole territory of EU • to introduce a horizontal framework for accreditation and to lay down principles for its operation and organisation at Community level to ensure uniform application

  11. Regulation – Accreditation (2) • Accreditation = Assessment of competence of conformity assessment bodies (laboratories, testing and inspection bodies..) • Scope: no exemptions – accreditation of all conformity assessment bodies • Organisational framework: no general obligation to be accredited • Single accreditation body per Member State

  12. Regulation – Accreditation (3) • Accreditation - a public authority activity • No competition • Accreditation in the Member State of establishment • Requirements for accreditation bodies • Peer evaluation • EA (European co-operation for accreditation)

  13. Regulation – market surveillance (1) • Scope • “harmonised products” • exceptions: food, feed, human blood, cells, tissues and agricultural products • lex specialis

  14. Regulation – market surveillance (2) • Organisational requirements • Infrastructures, resources, powers • complaint procedures, monitoring of accidents • Market surveillance programmes

  15. Regulation – market surveillance (3) • Surveillance measures • appropriate product checks on “adequate scale” • Right to enter premises, ask for documentation • Warning of users

  16. Regulation – market surveillance (4) • Restrictive measures • Withdrawal/recall products posing a “serious risk” • Rapid information of all Member States • Hear economic operator • Possibility to destroy products • Penalties

  17. Regulation – market surveillance (5) • Communication and co-ordination • Exchange of information • Rapid information on dangerous products • Comprehensive database • Cooperation • Obligation to cooperate with other MS • Mutual assistance • Joint initiatives, training programmes, sharing of resources

  18. Regulation – market surveillance (6) Control of products entering the Community • Customs must carry out checks at external borders on an adequate scale • Suspension of release for free circulation if product • is not properly marked • presents a serious risk • Information of market surveillance authorities • Possibility of destruction

  19. Regulation – CE marking • marking – General principles • Complementary to rules in legislation • Only on products for which affixing is foreseen in legislation • Affixing = responsibility for conformity • Relationship to other marks • Obligation for MS to protect marking

  20. Decision – toolbox for future legislation • General principles and reference provisions for the drawing up of Community harmonisation • General guidelines for legislator • Essential requirements instead of technical details • Choice of conformity assessment procedures • Model provisions

  21. Decision – model articles (1) • Definitions • placing on the market, manufacturer, importer, etc • Obligations of economic operators • Differentiation according to role • Manufacturer, Authorised representative • Importers and distributors NEW! • Traceability provisions

  22. Decision – model articles (2) • Conformity assessment • Marking • Rules and conditions for affixing – form of the marking

  23. Decision – model articles (3) • Notified Bodies • Requirements for notifying authorities • Notification criteria/ role of accreditation • Notification process – electronic notification • Obligation of notified bodies • Subsidiaries and sub-contracting • Control requirements COMM/MS de-notification • Co-ordination GNBs

  24. Decision – model articles (4) • Safeguard clause procedure • Notification of measure – time for objections • No objections – all MS must take relevant action • Objection: Matter decided at EU level – Commission decision

  25. Implementation phase- priorities • Regulation – 1 January 2010 • Accreditation – relationship with EA • Market surveillance • Information exchange systems (RAPEX and database) • Lex specialis – how does it work? • Guidelines: e.g. market surveillance programmes • Decision • “automatic” alignment of legislation under review (e.g. toys safety) • Alignment of legislation not up for review?

  26. Web site addresses • New Legal Framework: http://ec.europa.eu/enterprise/newapproach/ review_en.htm • New internal market package: http://ec.europa.eu/enterprise/regulation/internal_market_package/index_en.htm • Questions: Entr-reg-approach-for-free-circ@ec.europa.eu

  27. THANK YOU FOR YOUR ATTENTION

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