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SOCMA CHEMSTEWARDS COMPLIANCE SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director SOCMA VISIONS 202-721-4154 [email protected] MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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? MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 2009 - ?) – Provides contact details (e.g. of OR) – Expected registration deadlines – Substance identification MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE Consortium Management • Voluntary • Forms from a SIEF but may include others • A way to cut costs MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE Consortium Issues • Worldwide data search • Ownership of data • Data sharing negotiations (e.g. 3rd party, HPV coalition) • Data compensation • Supply chain communication • Other regulations (e.g. Biocide Products Directive) MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE Benefits of a Consortium • Reduced costs • Pooling resources • Increased efficiency • Leverage with authorities • Full supply chain compliance • SMEs benefit particularly MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE Benefits • EU competition laws (antitrust) • Membership flexibility, member driven • Expands industry resources and knowledge base • Networking • Fair share participation MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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. MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE Strategies to Reduce Testing • Define information needs for the appropriate tonnage band • Determine availability of data among consortium members • Determine availability of data from 3rd-party data holders – HPV – OECD/SIDS MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE 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 MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE WHAT’S NEXT? MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE REACH – USA??? OMG!!! NO WAY MORE FOR MEMBERS - VISIT WWW.SOCMA.COM SOCMA CHEMSTEWARDS COMPLIANCE THANK YOU For Further Information Tucker Helmes 202-721-4154 [email protected] MORE FOR MEMBERS - VISIT WWW.SOCMA.COM