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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

Part 3RIP 3.4 – DATA SHARING

Alan Eastwood, Economic Advisor, CIA

rip 3 4 scope
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

pre registration
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
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
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
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
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
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
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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