Guidance on data sharing - ECHA - Europa

<strong>Guidance</strong> on data sharing
Version 2.0 April 2012
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These activities can involve a review of all available data (including publicly available data). This review can
be delegated to one individual member (or to an external expert), subject to the assent of others. This may
allow participants to determine and agree on classification and labelling, selection of studies and testing
proposals to be submitted, to agree the content of a possible joint chemical safety report and guidance for
safe use, etc. Consequently, it is recommended that SIEF members work together in the identification of
existing information (including publicly available data) and data needs, the generation of new information,
and the preparation of the joint registration dossier (“collective route”). This option is acknowledged as
being very time-consuming, so lead registrant and SIEF participants are free to organise themselves for the
benefit of all. However the criteria of fairness, transparency and non discrimination must always prevail in
the negotiations.
In case there is a disagreement regarding a specific endpoint, a potential registrant has according to Article
11(3), the possibility to opt out from the joint submission for the particular endpoint. Subsequently the potential
registrant does not have to rely upon the full data set prepared and may submit data he already owns
or which he considers is more scientifically reliable, relevant and adequate, than the data chosen in the jointly
submitted dossier. Opting out does not relieve the potential registrant from his obligation to make available
and share data or to be part of the joint submission.
3.3.2 Fulfil the information requirements for Registration
Data sharing must first be reviewed with reference to the information requirements for Registration. Essentially,
REACH requires manufacturers and importers to collect data on the substances they manufacture
or import, to use these data to assess the risks related to these substances and to develop and recommend
appropriate risk management measures for using the substance throughout its life cycle. Documenting these
obligations requires them to submit a registration dossier to ECHA.
Fulfilling the information requirements for Registration is essentially a four step process, which consists of:
• Gathering existing information
• Considering information requirements
• Identifying information gaps
• Generating new information or submitting a testing proposal in line with REACH obligations
The participants of the SIEF are free to organise these steps as they best see fit.
3.3.3 The collective route
It is important to stress that REACH gives potential registrants the flexibility to decide how they organise
their data sharing and joint submission obligations. This section of the <strong>Guidance</strong> describes how data sharing
can be organised collectively within a SIEF with the view to meet the objectives discussed in section 3.3.1
above, including both the obligations related to data sharing and the preparation for the joint submission of
data at Registration.
The following steps are only indicative:
• Step 1 Individual gathering of available information to potential registrants
• Step 2 Agreement on the form of cooperation/cost sharing mechanism