This document provides an introduction and overview of the European Union's REACH chemical regulation program and California's new Green Chemicals Initiative. It summarizes the key elements of REACH including registration requirements, data sharing obligations, evaluation processes, and restrictions on chemicals of concern. It also outlines California's new legislative efforts to adopt aspects of the REACH model and prioritize safer chemical alternatives. Contact information is provided for further discussion.

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
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2. The European Union’s System for the
Regulation, Evaluation and Authorization
of Chemicals (REACH)
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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
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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
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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
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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
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7. Administration
• European Chemicals Agency (ECHA) to
administer system at European Community
level
• Classification and labeling
• Rules on access to information
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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)
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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
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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”
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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
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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
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13. Downstream Users (DUs)
• Requirements for DUs – consideration and
communication of information
• Right to make uses known to suppliers
• Confidentiality
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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
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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
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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
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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
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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
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19. California’s Green Chemistry Initiative
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20. New Legislative Initiative
• Adopts REACH-like strategy to chemicals
management in California
• Signed into law on September 29, 2008
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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
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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
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23. Current Status and New Developments
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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
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