Guidance on data sharing - ECHA - Europa

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30 <strong>Guidance</strong> on data sharing Version 2.0 April 2012 Some substances were pre-registered and did not previously have an EC Number assigned (or for which a pre-registrant did not indicate the existing assigned EC Number). Consequently REACH-IT allocated automatically a numerical identifier, the so-called “list number”, to substances for which no previous EC number entry is given by the legal entity submitting the “dossier” in question (be it a pre-registration, inquiry or a registration). The format of the list numbers is similar to that of an EC Number. For example, 6xx-xxx-x is allocated in case the CAS RN only was provided, and 9xx-xxx-x where no CAS RN or any other numerical identifier (i.e. only substance chemical name) was provided. These list numbers do not have any legal status and cannot be regarded as valid and legally approved EC numbers. Consequently they are considered only as “technical” identifiers to simplify the processing of dossiers (whether inquiries, registrations or others). Therefore, until the substance identification is done by ECHA, those list numbers are not to be used in documentation other than correspondence between ECHA and the registrant, i.e. not in the extended-SDS. Indeed the vast majority of list numbers have not been checked for correctness, validity or for whether the conventions outlined in the <strong>Guidance</strong> for identification and naming of substances under REACH have been complied with. Substances can also be assigned a list number by ECHA’s Substance Identification team after an inquiry (the format in this case is 7xx-xxx-x). All other EC numbers (i.e. those published in the OJ) are official and may continue to be used by registrants: • 2xx-xxx-x EINECS (European Inventory of Existing Commercial chemical Substances) • 3xx-xxx-x EINECS • 4xx-xxx-x ELINCS (European List of Notified Chemical Substances) • 5xx-xxx-x NLP (No-Longer Polymers) Following the publication of the list, “data holders”, as defined in section 3.2.3.2 below, may wish to share the information they have at their disposal. They can do so by joining a pre-SIEF for that substance and indicating to the other pre-Registrants which data are available. For more details, please consult REACH-IT Industry User Manual on “Pre-SIEF”, available on the ECHA website at http://www.echa.eu/web/guest/regulations/ reach/substance-registration/substance-information-exchange-fora. NB: Data holders have been requested to submit information on pre-registered substances as early as possible after 1 January 2009. There is no requirement in REACH for a data holder to notify ECHA of their willingness to join a SIEF with a view to sharing data. If data holders wish to share data, it is however highly recommended that they identify themselves as early as possible after the publication of the list of pre-registered substances to facilitate the data sharing process. The earlier data holders indicate their interest, the more likely will it be that the potential registrants will be able to share relevant data from data holders in time before the compilation of the Registration dossier. Hence for data sharing purposes, data holders can identify themselves and join the SIEF even after a joint submission has been submitted. REACH-IT offers the possibility to further describe the data that is held by data holders, especially on precisely what form of the substance was tested so that the other SIEF members can better identify the relevance of the study. Whilst giving due consideration to the potential CBI issues this might raise, data holders are encouraged to use this possibility where applicable.
<strong>Guidance</strong> on data sharing Version 2.0 April 2012 31 Request by downstream users of phase-in substances not appearing on the list of (pre-) registered substances The publication of the list of pre-registered substances also gives the opportunity for downstream users to ascertain that all substances they need in their own processes are on the list and that at least one legal entity in EU has expressed an intention to register. NB: Downstream users checking the list of pre-registered substances can never be sure that the substances present on the list of pre-registered substances have been pre-registered by their current supplier or that their supplier will eventually register. Manufacturers and importers are therefore encouraged to communicate to the downstream users as early as possible their intention to register the substance. Likewise, downstream users are encouraged to contact their suppliers as soon as possible in order to find out about their intentions and where necessary look for alternative future sources of supply. Downstream users are also advised to consult the list of registered substances prior to contacting the ECHA Helpdesk, should their substance(s) be missing from the list. For more details please consult the <strong>Guidance</strong> for Downstream Users. 3.2 Formation of Substance Information Exchange Forum (SIEF) REACH provides for the formation of “Substance Information Exchange Forums” (SIEFs) to share data among manufacturers and importers of pre-registered phase-in substances as well as allowing downstream users and other stakeholders (data holders) who have relevant information (and are willing to share it in exchange for fair compensation) to share this information with potential registrants. This sub-section specifies who the participants in a SIEF are, what their rights and duties are, and how and when a SIEF is formed. REACH includes provisions related to the appointment of a lead registrant for joint submission purposes (Art. 11(1)). The designation of the lead registrant as well as the SIEF management is under the responsibility of the SIEF participants. Please be aware that SIEF formation is industry’s responsibility. 3.2.1 The pre-SIEF page and the available information When a potential registrant pre-registers a substance corresponding to an EINECS entry (or other identifiers) and is the first one to do so, REACH-IT triggers the creation of a dedicated web-page (pre-SIEF page). At this point in time, this page can only be seen by the potential registrant(s) of that substance or, in case of read across, by the potential registrant(s) of the structurally related substance(s) (with a view to exchanging each other’s contact details). Several pre-SIEFs may operate in parallel, although they are covering the same substance. This might not immediately come to the attention of members of these pre-SIEFs. Therefore, potential registrants are advised to review the entries in the pre-registration list and to assess their relevance to their own activities, as forming a single SIEF can also be done by using the read-across facility provided by REACH-IT. Indeed REACH-IT allows the potential registrant(s) to indicate that read-across is possible between structurally related substances.
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