1. UC Berkeley, Class on Health Risk Assessment, Regulation and Policy Berkeley, 2 November 2009 Klaus Berend, Visiting EC Fellow Chemicals Policy in the EU – history, current situation, the role of risk assessment and global perspectives Disclaimer : views expressed are personal and do not necessarily represent the views of the Commission

14. When to register? 100 - 1000 t/a 31 May 2013 Entry into force 1 June 2007 Registration of ‘new’ substances ≥ 1t/a 31 May 2018 ≥ 1000 t/a CMR ≥1 t/a R50/53 ≥100 t/a 30 Nov. 2010 Pre-registration 1 June 2008 – 1 Dec. 2008 Agency published List 1.1. 2009 C&L notification (independent of tonnage) 01/01/2011 Timeline REACH phase-in period (not in scale) Note that phase-in registration required pre-registration! SIEF Substance Information Exchange Forum

22. SIEFs: today’s main challenge Substance Exchange Information Forum (SIEF) ~10 000 substances envisaged to be registered by 2010 80% of all the SIEFs have between 10-99 companies/ importers or legal entities < 20% have appointed the Lead Registrant The clock is ticking !!!

26. Grundlagen

35. REACH applies equally to chemicals manufactured domestically in the EU and imported ….. the EU is a big importer of chemicals Why has REACH global implications?

48. Case for global norms for Chemicals Regulation? Transport liquid: slightly toxic; solid: not classified EU Harmful (St Andrew’s Cross) US Toxic CAN Toxic Australia Harmful India Non-toxic Japan Toxic Malaysia Harmful Thailand Harmful New Zealand Hazardous China Not Dangerous Korea Toxic Substance - oral toxicity LD 50 = 257 mg/kg Situation for C & L of the same substance prior to GHS In GHS: GHS Danger (Skull & Cross Bones)

50. GHS Status Worldwide – early 2009 preparation Implementation activities