Commission Implementing Regulation (EU) 2016/9Show full title

Article 4 Fairness and non-discrimination

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.