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 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

DATA SHARING – THE ESSENTIALS

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

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

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

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”

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!

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

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