Subject matter
Article 1
This Regulation lays down specific duties and obligations for parties to agreements where the sharing of information and associated costs are required under Regulation (EC) No 1907/2006.
Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data and data-sharing in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)
Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data and data-sharing in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Transparency
Article 2
1. Where multiple registrants of the same substance or participants in a Substance Information Exchange Forum (SIEF) are obliged to share information in accordance with their duties under Regulation (EC) No 1907/2006, they shall make every effort to reach an agreement on the sharing of the information. This data-sharing agreement, which involves only persons or entities subject to that Regulation, shall be clear and comprehensible to all parties and shall include the following sections: (a) the itemisation of the data to be shared, including the cost of each data item, a description indicating the information requirements in Regulation (EC) No 1907/2006 to which each cost corresponds and a justification of how the data to be shared satisfies the information requirement; (b) the itemisation and justification of any cost of creating and managing the data-sharing agreement and the joint submission of information between registrants of the same substance as required by Regulation (EC) No 1907/2006 (hereinafter referred to as ‘administrative costs’) applicable for that data-sharing agreement; (c) a cost-sharing model, which shall include a reimbursement mechanism. 2. Where a data-sharing agreement already exists on the date of entry into force of this Regulation, parties to that agreement may, by unanimous consent, waive their obligation to itemise the data as described in points (a) and (b) of paragraph 1. A potential registrant of a substance for which a data-sharing agreement has already been reached by previous registrants, who requests a study or set of studies to be shared in accordance with Articles 27 and 30 of Regulation (EC) No 1907/2006 shall not be bound by an existing waiver, unless he provides his signed consent to it to the previous registrants, and shall have the right to request itemisation as described in points (a) and (b) of paragraph 1. Where such a request is made, the previous registrants shall: (a) itemise all relevant costs incurred after the date of entry into force of this Regulation as described in points (a) and (b) of paragraph 1; (b) provide proof of the cost of any study, completed before the date of entry into force of this Regulation, that is requested in accordance with Article 30(1) of Regulation (EC) No 1907/2006; (c) make every effort to provide itemisation of all other relevant costs, including administrative costs and study costs not covered in point (b), incurred before the date of entry into force of this Regulation as described in points (a) and (b) of paragraph 1. The itemisation of costs shall be provided to the potential registrant without undue delay. 3. Where registrants of the same substance have shared information and submitted it jointly in accordance with Regulation (EC) No 1907/2006, they shall document yearly any further costs incurred in relation to the operation of their data-sharing agreement. The annual documentation shall contain the sections indicated in paragraph 1 and include, for the purposes of the reimbursement mechanism, a record of any compensation received from new registrants. In the absence of detailed documentation of costs incurred or compensation received before the entry into force of this Regulation, parties to an agreement shall make every effort to collate proof, or to make the best approximation, of such costs and compensation for each year since the commencement of that agreement. Such annual documentation shall be kept by the registrants for a minimum of 12 years following the latest submission of a study and shall be made available free of charge upon request from any party to the data-sharing agreement concerned within reasonable time and in full consideration of the requirements related to applicable registration deadlines.
One substance, one registration
Article 3
1. Without prejudice to Articles 11(3) and 19(2) of Regulation (EC) No 1907/2006, the Agency shall ensure that all registrants of the same substance are part of the same registration under that Regulation. 2. Where the Agency permits a potential registrant of a substance that has already been registered to refer to requested information in accordance with Articles 27(6) and 30(3) of Regulation (EC) No 1907/2006, the Agency shall ensure that any subsequent submission of information by that potential registrant is part of the existing joint submission for that substance. 3. Where a potential registrant has complied with his obligations under Articles 26 or 29 of Regulation (EC) No 1907/2006 and has ascertained that he is not required to share tests on vertebrate animals for the purposes of his registration, he may decide to invoke Articles 11(3) or 19(2) in order to submit separately all or part of the relevant information in Article 10(a) of that Regulation. In such cases, the potential registrant shall inform any previous registrants of that substance of his decision. He shall also inform the Agency which shall ensure that this separate submission, made in accordance with Article 11(3) or 19(2) of Regulation (EC) No 1907/2006, remains part of the existing registration for that substance in accordance with paragraph 1.
Fairness and non-discrimination
Article 4
1. Pursuant to Articles 27(3) and 30(1) of Regulation (EC) No 1907/2006, any registrant of a substance shall only be required to share the costs of information that such registrant is obliged to submit to the Agency to satisfy his registration requirements under that Regulation. This condition applies also to administrative costs. 2. The cost-sharing model referred to in Article 2(1)(c) shall apply to all registrants of that substance, including the possibility of future registrants joining the data-sharing agreement at a later stage. The cost-sharing model shall include for all registrants of a particular substance provisions for sharing any costs resulting from a potential substance evaluation decision. The following factors shall also be considered in agreeing on a particular cost-sharing model: the number of potential registrants estimated to register for that substance; and the possibility of future additional information requirements for that substance, other than those resulting from a potential substance evaluation decision. In the event that a cost-sharing model includes the possibility to cover the costs of future additional information requirements for that substance, other than those resulting from a potential substance evaluation decision, this possibility shall be justified and indicated separately from other costs in the data-sharing agreement. Compiling information for the purposes of establishing substance sameness should not be the subject of any cost sharing between previous registrants and potential registrants. 3. Pursuant to Articles 27 and 30 of Regulation (EC) No 1907/2006, if the participants to a data-sharing agreement cannot agree to such a cost-sharing model, each participant shall pay an equal share of the costs required for their participation. Reimbursement of part of such costs paid shall still occur as if a reimbursement mechanism has been agreed subject to the first subparagraph of paragraph 4. 4. The reimbursement mechanism referred to in Article 2(1)(c) shall be envisaged in every cost-sharing model and shall include a method of proportional redistribution to each participant of their share of costs paid where a potential registrant joins that agreement in the future. The reimbursement mechanism shall also take account of the following factors: the possibility of future additional registration requirements for that substance, other than those resulting from a potential substance evaluation decision; and the economic viability of certain reimbursements where the costs of reimbursement are higher than the amount to be reimbursed. 5. Where a data-sharing agreement already exists on the date of entry into force of this Regulation, parties to that agreement may, by unanimous consent, waive their obligation to include a reimbursement mechanism in their cost-sharing model. A potential registrant who intends to participate in an existing data-sharing agreement shall not be bound by an existing waiver unless he provides his signed consent to it to the previous registrants and shall have the right to obtain the inclusion of a reimbursement mechanism in the cost-sharing model in accordance with this Regulation. 6. Any registrant who has ceased his activities pursuant to paragraph 2 or 3 of Article 50 of Regulation (EC) No 1907/2006 may still be required to share costs resulting from a substance evaluation decision in accordance with Article 50(4) of that Regulation.
Dispute Resolution
Article 5
1. When settling a data-sharing dispute pursuant to Articles 27(5) and 30(3) of Regulation (EC) No 1907/2006, the Agency shall take account of the parties' compliance with the obligations set out in Articles 2, 3 and 4 of this Regulation. 2. This Regulation operates without prejudice to the full and complete application of the Union competition law.
Entry into force
Article 6
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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