Guidance on data sharing - ECHA - Europa

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20 <strong>Guidance</strong> on data sharing Version 2.0 April 2012 2 Legal framework: relevant legal provisions 2.1 Data sharing and avoidance of tests The rules on data sharing and avoidance of unnecessary testing are provided in Title III and in Articles 40(3)e and 53 of the REACH Regulation, which should be interpreted in view of Recitals 33, 49, and 54 of the Regulation. As specified in Article 25(1), the objective of these rules is to avoid vertebrate animal testing, which must only be carried out as the last resort, and to limit the duplication of other tests. As a general rule, the REACH Regulation requires the sharing of information on the basis of a fair compensation. However, according to Article 25(3), after 12 years from the date of the submission of the study summaries and robust study summaries in the framework of a registration, this data may be used, without compensation, only for the purpose of registration by another manufacturer or importer. Article 25(2) defines the scope of the data sharing obligation by reference to the type of data to be shared. This obligation applies to technical data and information related to the intrinsic properties of substances. However, EU rules on competition law must be respected by the potential registrants. Therefore the article states that information related to the market behaviour of the registrants, in particular as regards production capacities, production or sales volumes, import volumes or market shares, must not be exchanged. This is to prevent concerted practices or the creation of the conditions for abuses of dominant position. 2.2 Data sharing and joint submission As specified in Recital 33, the “joint submission and the sharing of information on substances should be provided for in order to increase the efficiency of the registration system, to reduce costs and to reduce testing on vertebrate animals”. In order to enable test data to be shared, and thus avoid unnecessary testing and reduce costs, wherever practicable, registrations should be submitted jointly, in accordance with the rules on joint submission (Articles 11 and 19 of the REACH Regulation). Therefore Article 11 imposes the obligation for potential registrants of the same substance to jointly submit data and lists situations where the opt-out from the joint submission of data is possible if properly justified. Article 19 sets out similar provisions for isolated intermediates. NB: The joint submission obligations therefore have an impact on data sharing activities with subsequent registrants, especially in relation to data contained in dossiers already submitted by previous registrants. 2.3 Inquiry, (late pre-)registration and data sharing Whereas Article 25 provides for the principle of avoiding unnecessary testing, Chapters 2 and 3 of the same title III of REACH introduce specific mechanisms to share information among registrants. These mechanisms are different depending on the status of the substance. The rules for non-phase-in substances and non-pre-registered phase-in substances are laid down in Title III, Chapter 2 (Articles 26 and 27).
<strong>Guidance</strong> on data sharing Version 2.0 April 2012 21 Article 26 regulates the inquiry process as follows: 26(1) – inquiry to ECHA and information to be submitted; 26(2) – communication from ECHA in case of substances which were not previously registered; 26(3) – communication from ECHA of name and contact details of previous registrant(s) and potential registrant(s), and of existing data requirements, in case of substances previously registered less than 12 years earlier; 26(4) – communication from ECHA in case several potential registrants have made an inquiry about the same substance. Article 27 organises the data sharing process, as follows: 27(1) – potential registrant is to request information from previous registrant(s); 27(2) – obligation to make every effort to reach agreement for both parties; 27(3) – obligation to make every effort to share costs in a fair, transparent and non discriminatory way; 27(4) – communication between previous and potential registrants of information in case of agreement; 27(5) – communication with ECHA in case of failure to reach an agreement; 27(6) – decision of ECHA on whether to give permission to the potential registrant to refer to the information submitted by the previous registrant in his registration dossier; 27(7) – potential appeal against an ECHA decision under Article 27(6); 27(8) – extension by four months of the waiting period, upon request by the previous registrant (Art. 27(4) and 27(6)). The rules for phase-in substances (as per the definition given in Article 3(20)) are given in Title III, Chapter 3 of REACH. Article 28 describes the pre-registration of phase-in substances. The relevant provisions are as follows: 28(1) – submission of a pre-registration dossier to ECHA; 28(2) – pre-registration period; 28(3) – no extended registration deadline if no pre-registration; 28(4) - publication of the list of pre-registered substances comprising the names of the substances, including their EINECS and CAS number and other identifiers of substances that pre-registrants have indicated as being related substances, and the first envisaged registration deadline; 28(6) – late pre-registration period for first time manufacturer or importer;
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