Reach And Green Chemistry

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Introduction to the EU REACH Program and California’s Green Chemicals Initiative - REACH & Beyond: Workshop on the Changing Nature of Chemicals Management - December 15, 2008, Sunnyvale, California

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Reach And Green Chemistry

  1. 1. Introduction to the EU REACH Program and California’s Green Chemicals Initiative REACH & Beyond: Workshop on the Changing Nature of Chemicals Management December 15, 2008 Sunnyvale, California 1
  2. 2. The European Union’s System for the Regulation, Evaluation and Authorization of Chemicals (REACH) 2
  3. 3. Existing EU Chemicals Legislation • Patchwork of historic Directives and Regulations • Different rules for “existing” and “new” chemicals based on 1981 cut-off • Concern over allocation of responsibilities • Protracted process of implementation 3
  4. 4. New Chemical Strategy • 2001 Future Chemicals Policy (COM (2001) 88) • Balance of objectives within overall framework of sustainable development – Protect of health and environment – Enhance competitiveness of EU chemicals industry – Prevent internal market fragmentation – Increase transparency – Integrate with international efforts – Promote non-animal testing – Conform with EU obligations under the WTO 4
  5. 5. Chemicals Management Strategy • Guiding principal – industry (not government) in best position to assure that chemicals do not adversely affect health and environment • Single system for existing and new chemicals • Distinction between “phase-in” and “non- phase-in” substances 5
  6. 6. Basic Elements • All substances covered unless exempted • Requires manufacturers and importers to develop and maintain relevant information • Use of data-sharing • Downstream users brought into system • Focus on substances with high concern properties • Regulatory restrictions 6
  7. 7. Administration • European Chemicals Agency (ECHA) to administer system at European Community level • Classification and labeling • Rules on access to information 7
  8. 8. Registration • Obligation to provide registration dossier • Exemptions for substances regulated under other legislation or otherwise deemed to present low risks • Registration documents – Technical dossier (substances in quantities > 1 ton) – Chemical safety report (quantities > 10 tons) 8
  9. 9. Technical Requirements • Information requirements – Quantities of 1-10 tons: • Carcinogens, mutagens, reproductive toxicants, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) • Potentially dangerous to health or environment and used in dispersive uses – Quantities of 10-100 tons – Quantities of 100 tons or more • Chemical safety reports 9
  10. 10. Registration Process • Joint submission of information as default • Opt-out provisions where – Joint submission is too costly – Disagreements in technical interpretations – Confidentiality concerns • Light registration for certain intermediates • Application in stepwise process (deadlines) • Rules for “articles” 10
  11. 11. Data Sharing • Pre-registration of phase-in substance (June 2008 – December 2008) • Use of pre-registration “Substance Information Exchange Forum” (SIEF) • Allowances for downstream users 11
  12. 12. Supply Chain Information • Primary tool: safety data sheets (SDSs) • Allowances for commercially sensitive information • Application of requirement to PBT and vPvB substances and preparations • New information 12
  13. 13. Downstream Users (DUs) • Requirements for DUs – consideration and communication of information • Right to make uses known to suppliers • Confidentiality 13
  14. 14. Evaluation • Dossier evaluation – Compliance checking – Checking of testing protocols • Substance evaluation – Clarification of identified potential risks – Guidance on the prioritization of substances for further evaluation • Decision-making 14
  15. 15. Authorization • Substances of very high concern – CMR category 1 and 2 – PBTs and vPvBs – Probably causing equivalent serious effects to health or environment • Two step authorization procedure – Listing of substances to be included or exempted – Applications for authorization 15
  16. 16. Restrictions • Potential restrictions include – Manufacturing restrictions – Conditions on marketing or using substances – Activities not restricted are allowed – Potential application of Community-wide restrictions • Existing restrictions (e.g., for asbestos) are carried over 16
  17. 17. European Chemicals Agency (ECHA) • Manages registration process, dossier evaluations, coordinates substance evaluation process • Provides expert opinions on authorization and restriction procedures • Handles exemption requests • Administrative organization • Operational as of June 1, 2008 17
  18. 18. Implementation Strategy • June 1, 2008 – review of rules for chemical safety reports and exemptions • December 1, 2008 – review rules for PBTs and vPvBs • June 1, 2012 – review scope of regulation • June 1, 2013 – review rules on endocrine receptors • Beyond 18
  19. 19. California’s Green Chemistry Initiative 19
  20. 20. New Legislative Initiative • Adopts REACH-like strategy to chemicals management in California • Signed into law on September 29, 2008 20
  21. 21. AB 1879 • Authorizes Department of Toxic Substances Control (DTSC) to – Develop process for identifying and prioritizing chemicals of concern – Create methods for analyzing alternatives to existing hazardous chemicals – Take actions ranging from “no action” to restrictions of bans • Creates Blue Ribbon Science Panel 21
  22. 22. Other Legislation • SB 509: creates online Toxics Information Clearinghouse • SB 484 (2005): requires disclosure of chemicals in cosmetics • SB 1379 (2006): initiates bio-monitoring program to measure and catalogue human exposure to chemicals 22
  23. 23. Current Status and New Developments 23
  24. 24. Contact Information Kevin Haroff Shook Hardy & Bacon LLP 333 Bush Street, Suite 600 San Francisco CA 94104-2828 Office: (415) 544-1961 Mobile: (415)336-6494 Email:kharoff@shb.com / kharoff@mac.com 24

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