Guidance on data sharing - ECHA - Europa

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22 <strong>Guidance</strong> on data sharing Version 2.0 April 2012 28(7) – submission of information on pre-registered substances by data holders. Article 29 structures the provisions for the formation (and functioning) of Substance Information Exchange Fora (SIEFs), as follows: 29(1) – participants in the SIEF; 29(2) – aim of each SIEF; 29(3) – overall approach - duties of the participants. Article 30 structures the provisions on the data sharing process of phase-in substances involving test data and requiring agreement between the SIEF participants as follows: 30(1) – data gap analysis by SIEF participants before testing is carried out – obligation to answer any request within one month; 30(2) – decision of the Agency specifying which member shall perform a test where no agreement is reached between the SIEF participants; 30(3) – data sharing dispute process in case the owner of a vertebrate study refuses to provide proof of the costs of the study or the study itself. In case the dispute occurs before submission of the registration dossier of the study owner the Agency can decide to prevent a registration being made by the owner of the study and to require the members of the SIEF to repeat the test under specific circumstances if the applicable conditions specified in article 30(3) are satisfied. In any case, when a data involving testing on vertebrate animals has already been submitted as part of a registration dossier, ECHA will give the party which has made every effort to reach an agreement permission to refer to the information in the registration dossier of the previous registrant(s); 30(4) – procedure related to refusal to share non-vertebrate animal studies; 30(5) – appeal against ECHA’s decision under Article 30(2) and (3); 30(6) – penalties by MS EAs. 2.4 Data sharing as an outcome of dossier evaluation decisions Article 53 sets out the obligation to share data as an outcome of dossier evaluation decisions for registrations. The decision taken by the Agency according to Article 53(1) is very similar to the decision taken by the Agency according to Article 30(2) deciding which parties in a SIEF must perform a test. 53(1) – decision of the Agency designating the party who must perform a test if no agreement is reached between the registrants and/or downstream users; 53(2) – cost sharing in case a registrant/downstream user performs the test;
<strong>Guidance</strong> on data sharing Version 2.0 April 2012 23 53(3) – provision of a copy of the full study report by the registrant/downstream user who performed the test; 53(4) – claims for remuneration. 2.5 Competition rules In addition to compliance with the provisions of the REACH Regulation, potential registrants must ensure that they comply with other applicable rules and regulations. This applies in particular to competition rules, as specified in Recital 48 and in Article 25 (2) of the REACH Regulation which refers to the notion of restriction of certain market behaviours. Recital 48 specifies that “This Regulation should be without prejudice to the full application of the Community competition rules”. Article 25(2) mentions that “(…) Registrants shall refrain from exchanging information concerning their market behaviour, in particular as regards production capacities, production or sales volumes, import volumes or market shares.” As discussed in section 7 of the present <strong>Guidance</strong> Document, in the context of REACH and information exchange, the most relevant provision is Article 101 of the Treaty on the Functioning of the European Union (TFEU), which prohibits agreements and practices that restrict competition. For more details, please consult the legal text available on the EUR-Lex web site.
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