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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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The European Union’s System for the Regulation, Evaluation and Authorization

of Chemicals (REACH)

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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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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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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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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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Administration

• European Chemicals Agency (ECHA) to administer system at European Community level

• Classification and labeling• Rules on access to information

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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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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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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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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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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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Downstream Users (DUs)

• Requirements for DUs – consideration and communication of information

• Right to make uses known to suppliers• Confidentiality

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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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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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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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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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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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California’s Green Chemistry Initiative

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New Legislative Initiative

• Adopts REACH-like strategy to chemicals management in California

• Signed into law on September 29, 2008

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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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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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Current Status and New Developments

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Contact Information

Kevin HaroffShook Hardy & Bacon LLP333 Bush Street, Suite 600

San Francisco CA 94104-2828Office: (415) 544-1961

Mobile: (415) 336-6494Email: kharoff@shb.com / kharoff@mac.com