1. ICPHSO Conference Michiko Jo 18 February 2010 Enforcement Update: Recent developments in the EU

2. 2 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 Overview GPSD and RAPEX: recap Statistics Recent developments –New RAPEX Guidelines –“Business Application” of GPSD –New Legislative Framework –Accreditation and conformity assessment –Market surveillance and border control –Common framework for future legislation Regulatory trends

3. 3 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 GPSD and RAPEX: recap Scope of GPSD (Directive 2001/95/EC) Stakeholders –Producers –Distributors –Competent authority –National Contact Point –The European Commission –The General Product Safety Directive Committee –European standardisation body RAPEX –Purpose –Coverage –Operation

4. 4 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 Statistics (2009) Notifying CountriesCountries of Origin Other 225 (13%) Unknown 124 (7%) China including Hong Kong 1012 (60%) EU & EEA 336 (20%) Other 913 (54%) UK 104 (6%) Bulgaria 122 (7%) Greece154 (9%) Germany 185 (11%) Spain 219 (13%)

5. 5 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 Statistics (2009) Product CategoriesTypes of Risks Electric shock 213 (11%) Choking 261 (14%) Injuries 405 (21%) Chemical 492 (26%) Other 341 (18%) Strangulation 183 (10%) Toys 471 (28%) Clothing, textiles and fashion items 395 (23%) Motor vehicles 146 (9%) Electrical appliances 137 (8%) Cosmetics 86 (32%)

6. 6 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 New RAPEX Guidelines Commission Decision 2010/15/EU Guidelines addressed to all authorities of the Member States including market surveillance and border control authorities Updates the guidelines adopted by Decision 2004/418/EC Effective from 15 February 2010 Features –New risk assessment method –Further details of information to be notified –Reaction/follow-up obligations of other Member States –Withdrawal and temporary removal of notifications –Confidentiality

7. 7 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 “Business Application” of GPSD Notification obligation under Article 5(3) Direct communication from producers/distributors to the competent authorities of all Member States concerned An additional method of notification (not mandatory) Practical issues

8. 8 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 New Legislative Framework Background Objective Package –Regulation (EC) No 765/2008 –Council Decision No 768/2008/EC –Regulation (EC) No 764/2008

9. 9 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 Accreditation and conformity assessment Regulation (EC) No 765/2008 Accreditation: an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity. Accreditation system –National level –Accreditation body –Conformity assessment body –European level –European co-operation for Accreditation –Peer evaluation

10. 10 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 Market surveillance and border control Regulation (EC) No 765/2008 Market surveillance: the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection. Market surveillance framework –Obligations of the Member States –Measures and criteria –Communications and information sharing Border control v market surveillance Amendment to the GPSD

11. 11 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 Common framework for the marketing of products Council Decision 768/2008/EC A general framework for future legislation to harmonise the conditions for the marketing of products Contents –General principles –Common definitions –Common assessment procedures –Obligations of certain stakeholders –Conformity assessment modules –Notification Example – New Toys Directive 2009/48/EC

12. 12 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 Regulatory Trends Cooperation and exchange of information with wider stakeholders e.g. border control authority, non-EU/EFTA countries Enhancement of credibility of conformity assessment/certification Enhancement of transparency Speed in action and information exchange Further clarity in the rules for consistent enforcement within the EU? (but note scope for differences at national level within the EU)

13. 13 / Doc ID: L_LIVE_EMEA1:7577679v2 © Simmons & Simmons 2009 simmons-simmons.com elexica.com