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Berkeley Class 2009 Final

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Klaus Berend
TechnologieGesundheit & Medizin
1 von 59
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
Basics ,[object Object],[object Object],[object Object],[object Object]
Chemicals Policy – Legal Basis ,[object Object],[object Object],[object Object],[object Object]
Historic development of EU chemicals legislation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Grown over a long time, starting in 1967 with hazard assessment …
Historic development of EU chemicals legislation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Risk Management: restrictions and bans
Historic development of EU chemicals legislation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],What to do with existing substances ?
Stocktaking in 2001 ,[object Object],[object Object],[object Object],[object Object],[object Object],Problem: the chemicals management system was inefficient … Very much like TSCA ….
Aims of New Chemical Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object],White Paper on the Strategy for a Future Chemicals Policy
REACH objectives ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Scope of the Regulation ,[object Object],[object Object],[object Object]
Registration ,[object Object],[object Object],[object Object],[object Object],[object Object],No formal acceptance by authorities - industry retains responsibility
Substances in Articles (Article 7) ,[object Object],[object Object],[object Object],General obligation to register ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Agency may require registration Obligation to notify the Agency ,[object Object]
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
SIEF – Data sharing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],11/12/09
The Downstream User ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Evaluation ,[object Object],[object Object],[object Object],[object Object],[object Object]
Risk Management: Authorisation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Risk Management: Restrictions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
European Chemicals Agency: ECHA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
REACH – current status ,[object Object],[object Object],[object Object],[object Object],Pre-registrations received > 2 700 000 Companies > 65 000 Substances > 146 000 Preliminary numbers for the Registration procedure
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 !!!
REACH – current status (continued) ,[object Object],The first 15 substances included in the Candidate list of Substances of Very High Concern ( SVHC ) (28 October 2008) First step for the Authorisation procedure 7 SVHCs prioritised Recommendation to COM (01/06/09)
Distribution of responsibilities for chemicals in the Commission ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Chemicals in DG Enterprise ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Grundlagen
Tasks of Unit G.2 - Legislation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Tasks of Unit G.2 - legislation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Tasks of Unit G.2 - legislation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Tasks of Unit G.2 - legislation ,[object Object],[object Object],[object Object],[object Object],[object Object]
Tasks of Unit G.2 – sustainable development ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Tasks of Unit G.2 – sustainable development ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Tasks of Unit G.2 – competitiveness ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
EU chemicals industry – Some key figures ,[object Object],[object Object],[object Object],[object Object],[object Object]
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?
[object Object],[object Object],[object Object],Why has REACH global implications ?
Co-operation with important trade partners ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
EU – China Working Group on Chemicals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
EU – China Working Group on Chemicals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
EU – Russia Working Group on Chemicals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
EU – Russia Working Group on Chemicals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Co-operation with USA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Co-operation with USA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Co-operation with Canada ,[object Object],[object Object],[object Object],[object Object],[object Object]
Co-operation with Canada ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Case for global norms for Chemicals Regulation?
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Case for global norms for Chemicals Regulation?
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)
GHS – Global Context ,[object Object],[object Object],[object Object],[object Object],[object Object],A Global Initiative
GHS Status Worldwide – early 2009 preparation Implementation activities
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Challenges of Implementing Global Norms
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Case for Global Norms for Chemicals Regulation?
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Case for Global Norms for Chemicals Regulation?
Case for Global Norms for Chemicals Regulation? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case for Global Norms for Chemicals Regulation? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case for Global Norms for Chemicals Regulation? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Conclusion ,[object Object]
However : many countries including the US continue to object to REACH in the WTO TBT context ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Further Information ,[object Object],[object Object],[object Object],[object Object],11/12/09

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Berkeley Class 2009 Final

  • 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
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  • 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
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  • 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 !!!
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  • 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?
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  • 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)
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  • 50. GHS Status Worldwide – early 2009 preparation Implementation activities
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