Commission Implementing Regulation (EU) 2016/9Dangos y teitl llawn

Article 2 U.K. Transparency

1. Where multiple registrants of the same substance F1 ... 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 [F2 existed before 25 January 2016], 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. [F3 A waiver under Article 2(2) of the EU Implementing Regulation which is in effect immediately before IP completion day has effect on and after IP completion day as a waiver under this Article of this Regulation (and here “EU Implementing Regulation” means Commission Implementing Regulation (EU) 2016/9 as it has effect in EU law). ]

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 [F4 Article 27] 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 [F5 on or after 25 January 2016] as described in points (a) and (b) of paragraph 1;

(b) provide proof of the cost of any study, completed before [F6 25 January 2016, that is requested];

(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 [F7 25 January 2016], 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 [F8 (whether to ECHA or the Agency)] 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.

[F9 In this paragraph the term “ECHA” has the same meaning as in Regulation (EC) No 1907/2006.]

Textual Amendments

F1 Words in Art. 2(1) omitted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 5 para. 2(2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 2(2) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 5 para. 2(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 2(2) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 5 para. 2(3)(a)(ii) (as amended by S.I. 2020/1313, reg. 6(2)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 2(2) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 5 para. 2(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 2(2)(a) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 5 para. 2(3)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 2(2)(b) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 5 para. 2(3)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 2(3) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 5 para. 2(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 2(3) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 5 para. 2(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 2(3) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 5 para. 2(4)(c); 2020 c. 1, Sch. 5 para. 1(1)