chemstewards socma compliance more for members - visit sief and consortium management issues under...

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

[email protected]



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?



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



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



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



Consortium Management

• Voluntary

• Forms from a SIEF but may include others

• A way to cut costs



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



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)



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



Benefits of a Consortium

• Reduced costs• Pooling resources• Increased efficiency• Leverage with authorities• Full supply chain compliance• SMEs benefit particularly



Benefits

• EU competition laws (antitrust)• Membership flexibility, member

driven• Expands industry resources and

knowledge base• Networking • Fair share participation



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



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



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



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.



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



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



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



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



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



WHAT’S NEXT?



REACH – USA???

OMG!!! NO WAY



THANK YOU

For Further Information

Tucker Helmes202-721-4154

[email protected]

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