CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director SOCMA VISIONS

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEFs and Consortium Management SIEFs – How are they supposed to work? Consortium formation – a way to cut costs Technical issues –Antitrust –First import rule –Substance identification –Strategies to reduce testing –Intellectual property rights What’s Next?

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Substance Information Exchange Forum (SIEF) ECHA establishes a SIEF for each pre-registered substance SIEF identifies potential registrants and data holders of same substance Access to a dedicated, closed substance-related web page via REACH-IT (Jan ?) –Provides contact details (e.g. of OR) –Expected registration deadlines –Substance identification

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF (cont’d.) Communication among potential registrants and data holders maximizes efficiency of future collaborations Main function is to facilitate opportunities for data sharing and agreement on C & L One member agrees to be SIEF facilitator

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF (cont’d) First task is to agree on substance identification to ensure intent to register the same substance Each registrant must ensure it is in the single, correct SIEF per substance identity information Take care not to disclose CBI (e.g. proprietary processing knowledge) but note CBI constituents > 0.1% in case they modify the classification

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Consortium Management Voluntary Forms from a SIEF but may include others A way to cut costs

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT How to Form a Consortium? A lead company takes the initiative Identify stakeholders Determine scope and feasibility Establish operating rules and cost-sharing arrangements Commit via participation agreement/contract

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Consortium Issues Worldwide data search Ownership of data Data sharing negotiations (e.g. 3 rd party, HPV coalition) Data compensation Supply chain communication Other regulations (e.g. Biocide Products Directive)

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Managing the Process Data compilation and evaluation Dossier preparation Testing needs – contract laboratories, test protocols, reporting Exposure scenarios, risk assessments, CSRs Registration documents, IUCLID 5

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Benefits of a Consortium Reduced costs Pooling resources Increased efficiency Leverage with authorities Full supply chain compliance SMEs benefit particularly

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Benefits EU competition laws (antitrust) Membership flexibility, member driven Expands industry resources and knowledge base Networking Fair share participation

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT First Import Rule For companies that newly manufacture, import, or use a phase-in substance (on EINECS or ELINCS) After the December 1, 2008 pre-registration deadline Allows late market entrants to obtain phase-in status by submitting required pre-registration information

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT First Import Rule Deadlines Submit required pre-registration information within six months of crossing the one metric ton threshold But, at least 12 months before applicable deferred registration deadline for phase-in substances: –December 2010 for > 1000 t/y, > 100 t/y R50/53, or > 1 t/y CMR –June 2013 for 100 – 1000 t/y –June 2018 for 1 – 10 t/y and 10 – 100 t/y

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Effective Strategies for Substance Identification Guiding principle is whether pre-registered substances have same chemical identity to ensure they share same hazard data Chemical identity based on composition and/or manufacturing process and is represented by chemical name Confirm identity by CAS or EINECS number, or no longer polymer Be alert for substances having more than one CAS number Supply chain due diligence to establish contractual confirmation of substance identification All potential registrants must know the composition of the substance to establish identity and participate in the correct SIEF

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Confirm Relevancy of Hazard Data If hazard data not suitable (e.g. very different physical properties) then substances regarded as different. If substances regarded as the same at this stage, then knowledge about impurities becomes relevant (e.g. carcinogenic would influence classification). In such a case, registrants can agree to have more than one classification in the registration dossier, which they can submit jointly. When there is disagreement about substance identification or endpoint data, registrant may opt-out of the joint registration.

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Strategies to Reduce Testing Define information needs for the appropriate tonnage band Determine availability of data among consortium members Determine availability of data from 3 rd -party data holders –HPV –OECD/SIDS

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Assess Data Gaps Assess adequacy of available data Consider adaptations to data needs: –Testing not scientifically necessary –Testing is not technically possible –Exposure driven testing Apply read across, QSAR, modeling where feasible

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Intellectual Property Rights Protect your IPR Assign “ownership” or become co-owner of data Retain ownership but authorize use of data by a third party Retain ownership and provide access to data by letter You have the right to request compensation Compensation amount reflects level of access or ownership

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT Confidential Business Information IPR refers to Confidential Business Information: –Secret –Commercial value –Subject to reasonable steps to keep secret And, Copyright: –e.g. scientific article or study

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT How to Protect CBI? Confidentiality agreement within SIEF or consortium Use TPR for pre-registration and data sharing Opt out from joint submission Pay fee to ECHA for protection of specified data at registration

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT WHAT’S NEXT?

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT REACH – USA??? OMG!!! NO WAY

CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT THANK YOU For Further Information Tucker Helmes