CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under...
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Transcript of CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under...
![Page 1: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/1.jpg)
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
![Page 2: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/2.jpg)
CHEMSTEWARDSSOCMA COMPLIANCE
MORE FOR MEMBERS - VISIT WWW.SOCMA.COM
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?
![Page 3: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/3.jpg)
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
![Page 4: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/4.jpg)
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
![Page 5: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/5.jpg)
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
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CHEMSTEWARDSSOCMA COMPLIANCE
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Consortium Management
• Voluntary
• Forms from a SIEF but may include others
• A way to cut costs
![Page 7: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/7.jpg)
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
![Page 8: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/8.jpg)
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)
![Page 9: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/9.jpg)
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
![Page 10: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/10.jpg)
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
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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
![Page 12: CHEMSTEWARDS SOCMA COMPLIANCE MORE FOR MEMBERS - VISIT SIEF and Consortium Management Issues under REACH Dr. C. T. Helmes Senior Director.](https://reader035.fdocuments.in/reader035/viewer/2022062518/56649f165503460f94c2ca25/html5/thumbnails/12.jpg)
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
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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
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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
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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.
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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
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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
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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
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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
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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
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CHEMSTEWARDSSOCMA COMPLIANCE
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WHAT’S NEXT?
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CHEMSTEWARDSSOCMA COMPLIANCE
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REACH – USA???
OMG!!! NO WAY
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CHEMSTEWARDSSOCMA COMPLIANCE
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THANK YOU
For Further Information
Tucker Helmes202-721-4154