1 European Regulatory Approach to Free Movement of Goods Daniel PIERRE General Director

2 PACKAGE OF MEASURES: European Parliament adopted on 21 February legislative instruments REGULATION DECISION (sui generis) directly and immediately applicableto be used for revision of sectoral legislation + drafting of new legislation

3 Timetable Parliament has adopted the package 4 to 6 months before it is finally published (following translations etc) Comes into force 20 days after publication in the Official Journal of the EU It shall apply from 1 January 2010

4 Regulation – Key Points As a European Regulation, it is effectively a law It is directly applicable on to Member States and to national accreditation bodies nominated by the Member States Applies to voluntary and regulated sectors EA’s role is indirect, and will be managed through an Agreement between EA and the Commission/EFTA

5 Regulation – Key Points Accreditation bodies shall: Be completely independent from commercial motivations – not-for-profit organisation Be independent and impartial Not be involved in conformity assessment activities Demonstrate a high level of competence via participation in the EA (European co- operation for accreditation) peer evaluation system

6 Regulation – Key Points Public authority activity One national accreditation body per Member State No competition between accreditors and between accreditors and accredited CABs Subject to EA Peer Evaluation Cooperation between national accreditation bodies through EA

7 European Commission’s Expectations EA The same criteria that are applied in an EA Peer Evaluation of an EA Member are applied to any bilateral agreement with EA through a Contract of Cooperation If an AB does not meet the same requirements of the Regulation that an EA Member must meet, EA should not have a bilateral agreement with it

8 European Commission’s Expectations EA Cross Frontier Policy Policy will be revised to be in line with the requirements of the Regulation EA Members will terminate accreditations that fall outside the requirements of the new Regulation in order that the AB remains within the law (ABs will no doubt arrange transfer to other appropriate ABs)

9 European Commission’s Expectations Acceptability of Reports EA Members, in support of assessing Notified Bodies or for EU Regulations, should accept accredited reports/certificates from organisations accredited by ABs that meet the same requirements as European national accreditation bodies (i.e. in line with the requirements of the Regulation)