Guidance on data sharing - ECHA - Europa

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32 <strong>Guidance</strong> on data sharing Version 2.0 April 2012 They may subsequently come to the conclusion that they have the same substance and merge into one SIEF. Similarly, members of a (pre-)SIEF may also conclude that the substances they are dealing with are not the same (hence they do not correspond systematically to the identifiers of the pre-SIEF). In such a case they may have to split the SIEF to reflect the differentiation of the substances. The page displays the following information: • Substance identification • The corresponding entry in EINECS, i.e. IUPAC name or substance description; • EINECS and CAS numbers; • The individual details of the potential registrant(s), i.e.: oo Identity and contact details via an .xml file (or those of the Third Party Representative if he elected not to disclose his company name for this substance); oo The tonnage band, the status, the role, the preregistration number and the envisaged registration deadline; oo Whether he was the first to indicate his willingness to act as a facilitator in the SIEF formation. • The other substances in relation to which data can be shared (read-across). Hence pre-registrants can see their own pre-SIEF participants but also the participants from the “read-across” pre-SIEFs. When another legal entity subsequently pre-registers a substance with the same identifier, it is automatically added to the same dedicated web-page. The new potential registrant sees all other potential registrants of the same 9 substance. For more details, please consult the REACH-IT Industry User Manual on “Pre-SIEF” available on the SIEF section of the ECHA website. At this stage, it is already possible for potential registrants having pre-registered a substance with the same identifier and appearing on the same web-page to contact each other and start first discussions, e.g. on substance identity and SIEF formation. For more details, please consult the fact sheet ”SIEF Formation and Data sharing” which is available on the ECHA website in the REACH 2013 section and in the SIEF section. You need to also consider that your SIEF may be already active (for more information please see section 3.3.7). 9 Wherever in this section reference is made to the same substance, this refers to a substance/substances pre- registered with the same identifier. This does not mean that this substance/these substances are necessarily the same for the purpose of SIEF formation and registration.
<strong>Guidance</strong> on data sharing Version 2.0 April 2012 33 3.2.2 The SIEF A SIEF will be formed for each pre-registered substance when the discussion on the sameness confirms that the participants have indeed the same substance and when they agreed on the chemical identifier to be used. The roles, rights and obligations of the participants in the SIEF differ and are further described in section 3.2.3. As indicated in its name, a SIEF is a forum to share data and other information on a given substance. The aims of the SIEF are to: • Facilitate data sharing for the purposes of registration, thereby avoiding the duplication of studies, and • Agree on the classification and labelling of the substance concerned where there is a difference in the classification and labelling of the substance between the potential registrants. Participants in a SIEF are free to organise themselves as they see fit to carry out their duties and obligations under REACH, i.e. to share data, especially those involving vertebrate animal testing. The organisation used for the SIEF co-operation may also be used to jointly submit the relevant information. The choice of the form of cooperation between SIEF participants is based on the principle of contractual freedom. NB: Even if the formation of the SIEF takes place at a given point in time, its management is an iterative process with new members joining in a continuous manner. The concept is further clarified in section 5.5.5. For more information, please also consult section 8 of this guidance document. 3.2.3 The SIEF Participants Several categories of parties are “participants” in SIEFs, as specified in Articles 29 and 30. These are (1) “potential registrants” and (2) “data holders” (including downstream users and Third Parties). Registrants who registered the substance earlier and all parties according to Article 15 are also participants of the SIEF. The obligations of potential registrants and data holders are described below. 3.2.3.1 Potential registrants Potential registrants are those parties who have (late) pre-registered by submitting Article 28(1) information to ECHA on a given phase-in substance. These include: • manufacturers and importers of phase-in substances having (late) pre-registered that substance. • Producers and importers of articles having (late) pre-registered that phase-in substance if intended to be released from articles. • Only Representatives of non-EU manufacturers having (late) pre-registered that phase-in substance.
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