European Commission The New Legislative Framework Jacques McMillan Head of Unit Directorate General for Enterprise and Industry Regulatory approach for the free movement of goods & market surveillance

2 The New Legislative Framework  Commission adopted Proposal 14 Feb 2007  Formal EP Council adoption 9 July 2008  Publication in OJEU 13 August 2008  Entry into force 20 days after publication  Date of application of Regulation 1 Jan 2010  Decision ‘sui generis’ = can be used immediately

The New Legislative Framework Origin of Proposals  Some 700 old approach texts  25 New approach texts  Missing chapters  Incoherence  Confusion

4 The New Legislative Framework REGULATION  Accreditation  Market surveillance - internal - imported products  general principles  Financing elements Applicable from 1 Jan 2010 Lex Specialis sectorals/GPSD DECISION  Definitions / obligations  Notification (criteria / process / accreditation)  Conformity assessment procedures  Safeguard mechanisms (& market surveillance)  marking Basis for future legislation

5 The New Legislative Framework Accreditation  No exclusions Market Surveillance  Exclusions for : food - feed, human blood, cells, tissues and agricultural products via the product definition in Article 15  Other sectors  Lex specialis - pharmaceuticals, aviation, drug precursors, medical devices and motor vehicles given as examples in recitals

The New Legislative Framework Accreditation  Public authority activity  1 national accreditation body (NAB) per Member State  Prevention of competition for NABs  Set of requirements for NABs  EA (European co-operation for accreditation)  Cross border accreditation (EA role)  Peer evaluation (EA role) Rules applicable to mandatory & voluntary areaRules applicable to mandatory & voluntary area 6

The New Legislative Framework  National authorities must oversee NAB & ensure proper means at disposal & corrective actions when needed. Regular monitoring  Accreditation = preferred way of demonstrating competence of CABs  Need of documentary evidence to demonstrate competence if accreditation not used 7

8 The New Legislative Framework  Follow national adaptations of systems  Guidelines signed between Commission, EA, EFTA & National Authorities 1 April 2009  Framework contract for EA/COM  Inter-service Steering Group for accreditation  Publication of bodies (NANDO)  Rules for peer evaluation

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

10 The New Legislative Framework  Agreement on application of article 15 Sectoral legislation ~ GPSD  Review of RAPEX in light of Regulation  ICSMS – use for article 23  Co-ordination infrastructures  Customs link to market surveillance  Operation of safeguard clauses / mechanisms

11 The New Legislative Framework  On going work to ensure consistent application  - Accreditation: Contract with COM Peer evaluation/cross border accreditation  - Market Surveillance: RAPEX/ICSMS general implementation & nat. programmes role of customs, serious risk, risk assessment, adequate/appropriate checks etc  Preparation of multi annual programme

12 The New Legislative Framework Discussions started on alignment  Revision process  By issue / by sector / by text  Omnibus/Package

The 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)