Regulation (EU) No 511/2014 of the European Parliament and of the CouncilShow full title

Article 7 Monitoring user compliance

1. The Member States and the Commission shall request all recipients of research funding involving the utilisation of genetic resources and traditional knowledge associated with genetic resources to declare that they exercise due diligence in accordance with Article 4.

2. At the stage of final development of a product developed via the utilisation of genetic resources or traditional knowledge associated with such resources, users shall declare to the competent authorities referred to in Article 6(1) that they have fulfilled the obligations under Article 4 and shall simultaneously submit:

(a) the relevant information from the internationally-recognised certificate of compliance; or

(b) the related information as referred to in Article 4(3)(b)(i)-(v) and Article 4(5), including information that mutually agreed terms were established, where applicable.

Users shall further provide evidence to the competent authority upon request.

3. The competent authorities shall transmit the information received on the basis of paragraphs 1 and 2 of this Article to the Access and Benefit-Sharing Clearing House, established under Article 14(1) of the Nagoya Protocol, to the Commission and, where appropriate, to the competent national authorities referred to in Article 13(2) of the Nagoya Protocol.

4. The competent authorities shall cooperate with the Access and Benefit-Sharing Clearing House to ensure the exchange of the information listed in Article 17(2) of the Nagoya Protocol for monitoring the compliance of users.

5. The competent authorities shall take due account of the respect of confidentiality of commercial or industrial information where such confidentiality is provided for by Union or national law to protect a legitimate economic interest, in particular concerning the designation of the genetic resources and the designation of utilisation.

6. The Commission shall adopt implementing acts to establish the procedures for implementing paragraphs 1, 2 and 3 of this Article. In those implementing acts, the Commission shall determine the stage of final development of a product in order to identify the final stage of utilisation in different sectors. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2).