Transcript Document

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
PUBLICATION ALL
PRE-REG SUBST
PRE-REGISTRATION
SUBSTANCE
EQUIVALENCE
POTENTIAL
REGISTRANTS
DATA SHARING;
AGREE C&L
OPT OUT
AGREE LEAD
REGISTRANT
REGISTRATION
SIEF
OTHER DATA
HOLDERS
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