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CHEMSTEWARDSSOCMA COMPLIANCE
MORE FOR MEMBERS - VISIT WWW.SOCMA.COM
SIEF and Consortium Management Issues under
REACH
Dr. C. T. HelmesSenior Director
SOCMA VISIONS202-721-4154
CHEMSTEWARDSSOCMA COMPLIANCE
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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?
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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Consortium Management
• Voluntary
• Forms from a SIEF but may include others
• A way to cut costs
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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)
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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Benefits of a Consortium
• Reduced costs• Pooling resources• Increased efficiency• Leverage with authorities• Full supply chain compliance• SMEs benefit particularly
CHEMSTEWARDSSOCMA COMPLIANCE
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Benefits
• EU competition laws (antitrust)• Membership flexibility, member
driven• Expands industry resources and
knowledge base• Networking • Fair share participation
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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.
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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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
CHEMSTEWARDSSOCMA COMPLIANCE
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WHAT’S NEXT?
CHEMSTEWARDSSOCMA COMPLIANCE
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REACH – USA???
OMG!!! NO WAY
CHEMSTEWARDSSOCMA COMPLIANCE
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THANK YOU
For Further Information
Tucker Helmes202-721-4154