Introductory text

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union^f1, and in particular Article 5(5), Article 7(6) and Article 8(7) thereof,

Whereas:

Regulation (EU) No 511/2014 establishes rules governing compliance with access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources in accordance with the provisions of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (the ‘Nagoya Protocol’). The effective implementation of that Regulation will also contribute to the conservation of biological diversity and the sustainable use of its components, in accordance with the provisions of the Convention on Biological Diversity.

Articles 5 and 8 of Regulation (EU) No 511/2014 provide for voluntary tools, namely registered collections and best practices, to assist users in complying with their due diligence obligation. Identifying and registering collections which effectively apply measures that result in supplying genetic resources and related information only with documentation providing evidence of legal access and ensuring the establishment of mutually agreed terms, where required, is expected to assist users in complying with that obligation. Users which obtain genetic resources from a collection included in the register should be considered to have exercised due diligence as regards the seeking of information. Identifying and recognising as best practices measures that are particularly suitable for achieving compliance with the system of implementation of the Nagoya Protocol, at an affordable cost and with legal certainty, is also expected to assist users in fulfilling the due diligence obligation. The effective implementation of a recognized best practice by users should be considered by the competent authorities in their checks on user compliance. In order to ensure uniform conditions for the implementation of those provisions, detailed rules are required regarding the procedures to be followed in the case of a request for registration of a collection or part thereof and regarding recognition of best practices.

Where an applicant wishing to be included in the register is a member of a network of collections, it is useful that such applicant provides information on any other collections or parts thereof from the same network that were or are the subject of an application in other Member States. In order to facilitate the fair and consistent treatment of applicants in different Member States, when verifying the collections or parts thereof, the competent authorities of the Member States that have been made aware of such applications in relation to different collections or parts thereof within a network should consider exchanging information with the authorities of those Member States in which applications have been made by other members of the network.

Regulation (EU) No 511/2014 applies to genetic resources and to traditional knowledge associated with genetic resources. The material for the utilisation of which a due diligence declaration is required includes: genetic resources, traditional knowledge associated with genetic resources and a combination of both.

In order to ensure uniform conditions for the implementation of provisions on monitoring user compliance, detailed rules are required regarding the declarations to be made by recipients of funding for research involving the utilisation of genetic resources and traditional knowledge associated with genetic resources, as well as regarding the declarations to be made by users at the stage of final development of a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources.

When monitoring user compliance at the stage of research funding, it is important to ensure that recipients of funding understand their obligations under Regulation (EU) No 511/2014 and that they exercise due diligence. It is equally important to provide information to the Access and Benefit-Sharing Clearing House (‘ABS Clearing House’), and to ensure that such information is useful for the functioning and implementation of the Nagoya Protocol. Where an internationally recognised certificate of compliance is not available, other relevant information should be submitted. In order to balance the objectives of submitting useful information to the ABS Clearing House and of not overburdening the recipients of funding for research, only information which is essential for the identification of genetic resources should be exchanged at this check-point.

The monitoring of user compliance is effective when carried out in the Member State where the utilisation takes place. It is therefore appropriate that the declaration of due diligence is submitted to the competent authority of the Member State where the recipient of funding is established, as this is where the research involving utilisation of genetic resources and traditional knowledge associated with genetic resources typically takes place.

The unnecessary multiplication of due diligence declarations should be avoided. Therefore, a declaration made by recipients of research funding may cover more than one genetic resource or any traditional knowledge associated with genetic resources. A single declaration may also be made by several users jointly conducting research involving the utilisation of genetic resources and traditional knowledge associated with genetic resources funded by one grant. In this context, a special role should be given to the project co-ordinator, who should be responsible for submitting the declarations on behalf of the users concerned. In the light of Article 12 of Regulation (EU) No 511/2014, the competent authority receiving the declarations submitted by the project co-ordinator should exchange the information with its counterparts in the other Member States concerned.

In order to monitor user compliance under Article 7(2) of Regulation (EU) No 511/2014, the final stage of utilisation, meaning the stage of final development of a product should be determined. The stage of final development of a product can be identified with legal certainty as having been completed at the time when either market approval or authorisation is sought or a notification required prior to placing for the first time on the Union market is made or, where neither market approval or authorisation nor a notification is required, at the time of placing for the first time on the Union market a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources. In some cases, it may not be the user that is requesting market approval or authorisation, making a notification or placing a product for the first time on the Union market. In order to effectively address all activities that utilise genetic resources and traditional knowledge associated with genetic resources within the Union, the due diligence declaration should, in those cases, be made by the user selling or transferring in any other way the result of the utilisation. Effective monitoring of user compliance within the Union should also address cases where the utilisation has ended in the Union and its outcome is sold or transferred in any other way outside the Union without placing a product on the Union market.

Those different events that give rise to the due diligence declaration by the user at the stage of final development of a product are exclusive of each other, and therefore the declaration should only be made once. As the stage of final development of a product is reached before any of those events occur, the due diligence declaration should be made prior to the first event occurring.

The information provided in the due diligence declarations is to be submitted by the competent authorities to the ABS Clearing House pursuant to Article 7(3) of Regulation (EU) No 511/2014. Where an internationally recognised certificate of compliance is not available, other relevant information provided in accordance with Article 17(4) of the Nagoya Protocol, as specified in Article 4(3)(b) of Regulation (EU) No 511/2014, should be submitted. In order to ensure efficient operation of the Nagoya Protocol and the ABS Clearing House in particular, only information which will facilitate the monitoring by the competent national authorities referred to in Article 13(2) of the Nagoya Protocol should be exchanged.

A due diligence declaration is required only for genetic resources or traditional knowledge associated with genetic resources obtained from a Party to the Nagoya Protocol that has established relevant access and benefit-sharing legislation or regulatory requirements pursuant to Article 6(1) and Article 7 of the Nagoya Protocol.

In the light of the novelty of measures introduced, it is appropriate to review this Regulation. In this context, the reports referred to in Article 16(1) of Regulation (EU) No 511/2014 may prove useful and therefore should be taken into account, where available.

The measures provided for in this Regulation are in accordance with the opinion of the ABS Committee,

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