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Part 3 RIP 3.4 – DATA SHARING

Part 3 RIP 3.4 – DATA SHARING. Alan Eastwood, Economic Advisor, CIA. RIP 3.4 – SCOPE. Pre-registration – but not the detail of substance naming (RIP 3.10) SIEF formation – at this point you do have to agree on what your substance actually is

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Part 3 RIP 3.4 – DATA SHARING

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  1. Part 3RIP 3.4 – DATA SHARING Alan Eastwood, Economic Advisor, CIA

  2. RIP 3.4 – SCOPE • Pre-registration – but not the detail of substance naming (RIP 3.10) • SIEF formation – at this point you do have to agree on what your substance actually is • SIEF operation and rules for data sharing – but not detail of what you need to assemble (RIP 3.3) • Cost sharing, confidentiality issues, competition regulations • Rules for joint submission of dossiers • Opt out provisions In short, the procedures rather than the contents

  3. DATA SHARING – THE ESSENTIALS

  4. PRE-REGISTRATION • From 1 June to 30 November 2008 (inclusive) • Must provide: • Company identification: name, address, contact • Substance identity (EINECS, CAS, ….) • Tonnage band • For all legal entities • Not obligatory to pre-register: can register direct, but only after “inquiry” at ECB; must suspend production until full dossier lodged. Same applies if pre-reg deadline missed • Not obligatory to register after pre-reg – but can’t evade data sharing obligations

  5. NOTIFICATION OF OTHER PRE-REGISTRANTS; PUBLICATION OF LIST OF SUBSTANCES • Pre-registrants will be informed of each new company notifying the “same” substance (according to EINECS, CAS, etc) • After the end of the pre-registration period the Agency will publish, by 1 Jan 2009, a list of the substances that have been pre-registered (but not the individual manufacturers/importers involved) plus “read-across” related substances • Other parties can then notify the Agency of their interest in offering data – and check substances they use have indeed been pre-registered

  6. SIEF FORMATION • Key process is establishing “sameness” of substances in context of data sharing. Membership of the same pre-registration group will not automatically lead to membership of the same SIEF. This could be a major organisational, as well as technical, challenge (hope for a good facilitator!) RIP 3.4 gives advice; important amplification of Art 29 in para 4.5 • Other data holders can offer, but not demand, data and receive payment for it • The Agency will take no part in overseeing SIEF formation, nor be aware of which SIEFs exist – unless participants use REACH IT optional fields • Can share data on different substances (“read across”), but registrations must be separate

  7. OPERATION OF THE SIEF • Objective is to avoid unnecessary duplication of testing (especially animal testing) and to agree classification and labelling for the substance • Neither REACH itself nor RIP 3.4 prescribes any particular operational model. RIP 3.4 describes how various “consortia” patterns could evolve • It is the Agency’s preferred outcome that each SIEF should lead to one joint submission (OSOR), but opt outs are possible • Legal agreements will be necessary – but no help from REACH itself • Will also need a “treasurer”

  8. PRACTICALITIES OF SIEF OPERATION • Obligations on requesting to share data, and on responding • Guidelines on cost sharing models and possible formulae in RIP 3.4; REACH text stipulates in simple terms how to resolve disagreements • Confidential Business Information aspects • Competition law – no collusion!

  9. REGISTRATION: JOINT SUBMISSION • Choice of Lead Registrant (not necessarily identical to SIEF facilitator) – would expect LR to be one of largest tonnage members of SIEF • Specification of dossier contents (separate; joint; optional) • Opt outs • Disproportionate cost • Protection of confidential information to avoid “substantial commercial detriment” • Disagreement with LR over choice of information

  10. TIMETABLE; STATUS • Draft RIP 3.4 to Commission early June (after 3 SEG meetings) • Posted on ECB web site 10 July for public consultation to 17 Aug (so just closed) • Competent Authorities to discuss/endorse at meeting 3-4 Sep RIPs provided in good faith, having been approved by Commission. Nevertheless REACH text remains the only legal basis

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