Guidance on data sharing - ECHA - Europa

<strong>Guidance</strong> on data sharing
Version 2.0 April 2012
35
• Downstream users who may be in possession of data, and thus have a lot to contribute in the collection
of data to be used for registration, possibly in relation to intrinsic properties, but in particular in relation to
quantification of exposure and estimation of risks. Hence, downstream users need to be involved as early as
possible in the data sharing process. In accordance with the provisions of Article 28(7) of the REACH Regulation,
downstream users may submit information on pre-registered substances as well as any other relevant
information for those substances, with the intention of becoming a member (data holder) of the corresponding
SIEF.
Information from downstream users may help potential registrants to waive certain tests based on lack of
exposure (absence of risks for instance, or irrelevance of test type due to no exposure). Indeed, exposurebased
waiving is fundamental to reducing the need for animal testing.
NB: Downstream users are advised to establish contact with their suppliers and to obtain information
as soon as possible regarding the formation of a corresponding SIEF, rather than wait for potential
registrants to contact them. Specifically, when downstream users have valuable data regarding safety,
including hazard data, uses, exposure and risks, it is recommended that they communicate as early as
possible with their suppliers in order to ensure to best possible use of their data.
• Other third parties holding information on phase-in substances, such as:
oo
Trade or industry associations, sector specific groups and consortia already formed.
oo
Non Governmental Organisations (NGOs), research laboratories, universities, international or
national agencies.
oo
Manufacturers of a substance who have no interest in registering a substance under REACH because
they do not produce or place it on the market in Europe (e.g. a non-EU manufacturer who does not export
into the EU).
When indicating in the REACH-IT system the pre-registered substances on which they hold information, the
data holders will have the possibility to indicate other types of information, in particular with regards to
safety, such as hazard data and information on uses. They can usefully indicate their intention to share data
for read-across where relevant. On the pre-SIEF page (in REACH-IT) the data holder will not see the identities
of the pre-SIEF members, but his information (contact details and data available) are visible for the
pre-SIEF member(s), who then need to decide whether to contact the data holder.
It must be underlined that REACH does not provide for data holders to have an active role in deciding on
the studies to be included in the joint submission and on classification and labelling proposals. Data holders
will not be involved in pre-SIEF discussions. They will be considered as members of the relevant SIEF once
formed.
Potential registrants may only start investigating data availability once the SIEF is formed and when they
have identified data gaps (see section 3.3 below). In any case potential registrants are likely to first review
the data they have in their possession before contacting any data holder mainly to fill data gaps. At this
stage, they can launch requests for missing data (this is mandatory if the missing data involve vertebrate
animal testing). Potential registrants must bear in mind that there may be several SIEFs corresponding to
the entry in the list of pre-registered substances. Requests must consequently be sent to all data holders
corresponding to the entry in the list of pre-registered substances, and possibly those in another entry if the
final SIEF is the result of a merger of several pre-registered substances.