1. The New Legislative Framework Jacques McMillanJacques McMillan Head Of UnitHead Of Unit DG Enterprise and IndustryDG Enterprise and Industry Regulatory approach for the free movement of goodsRegulatory approach for the free movement of goods

2. The New Legislative Framework Present Situation  Some 700 old approach texts  25 New approach texts  Missing chapters  Incoherence  Confusion

3. The New Legislative Framework LEVEL OF SAFETY + QUALITY OF PRODUCTS + QUALITY OF OPERATORS + QUALITY OF 3RD PARTIES + QUALITY OF ACCREDITATION + QUALITY OF MARKET SURVEILLANCE + QUALITY OF CONTROLS OF 3RD COUNTRIES -------------------------------------------------------------------- == SAFE PRODUCTS -------------------------------------------------------------------- (CE MARKING)

4. The New Legislative Framework 2007 PROPOSALS  Overall coverage NEW/OLD  Missing chapters  Coherence for existing legislation  Consumer & industrial products  Standardisation unchanged  Horizontal texts with no direct modification of existing legislation  DECISION/REGULATION

5. SCOPE - DECISION  Sui generis  Excluded: feed/food, cosmetics, tobacco, plant health & protection, human blood & tissues, medicinal products human & veterinary, chemicals  Need adaptations: medical devices, construction products & marine equipment

6. SCOPE - REGULATION  Accreditation Products & services  Market Surveillance Exclusions for : food - feed, human blood, cells, tissues & agricultural products via the product definition in Article 15. Exception does not cover border controls  Lex specialis - pharmaceuticals, aviation, drug precursors, medical devices & motor vehicles given as examples in recitals  CE marking

7. The New Legislative Framework DECISION – (sui generis) Framework – instructions for legislator & reference articles Definitions & obligations for operators & traceability of products Notification process Conformity assessment procedures & rules CE marking Safeguard mechanisms

8. The New Legislative Framework REGULATIONAccreditation  Obligations for MS – the system  Obligations for accreditation bodies  Role of EA & peer evaluation  Link to EU legislation

9. The New Legislative Framework REGULATION Market surveillance – Member States  Obligation to withdraw dangerous products  Obligation to have the powers, authority & means (even to destroy)  Obligation to inform  Obligation to organise cooperation between authorities  Role of customs/control of products from 3rd countries

10. The New Legislative Framework REGULATION Market surveillance – Commission  Follow up & coordinate national implementation  Coordinate national infrastructures & programmes  Rapid information system  Overall database

11. Timetable Adoption Commission:14 Feb 2007Adoption Commission:14 Feb 2007 Adoption Council/EP 9 July 2008Adoption Council/EP 9 July 2008 Entry into force 20 days after pubEntry into force 20 days after pub Publication 13 August 2008Publication 13 August 2008 Regulation applicable from 1/01/2010Regulation applicable from 1/01/2010 Implementing measuresImplementing measures Alignment/review of sectoral directives?Alignment/review of sectoral directives? The New Legislative Framework

12. New Legislative Framework  Regulation (EC) 765/2008 of EP & CS of 9 July 2008 – for accreditation & market surveillance (OJ L218/30 of 13/08/2008)  Decision (EC) 768/2008 of EP & CS of 9 July 2008 on common framework for the marketing of products (OJ L218/82 of 13/08/2008)  Regulation (EC) 764/2008 of EP & CS of 9 July 2008procedures for application of certain natioanl technical rules to products marketed in another Member State (OJ L218/21 of 13/08/2008)