Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices

This Regulation lays down detailed rules concerning the implementation of Articles 5, 7 and 8 of Regulation (EU) No 511/2014 which refer to the register of collections, the monitoring of user compliance, and to best practices.

The register established by the Commission in accordance with Article 5 of Regulation (EU) No 511/2014 shall include the following information for each collection or part thereof: (a) a registration code assigned by the Commission; (b) name given to the collection or part thereof and its contact details; (c) name and contact details of the holder; (d) category of the collection or part thereof; (e) short description of the collection or part thereof; (f) link to database, where available; (g) institution within competent authority of the Member State that verified the capacity of the collection to comply with Article 5(3) of Regulation (EU) No 511/2014; (h) date of inclusion in the register; (i) other existing identifier, where available; (j) where applicable, date of removal from the register.

1 A request for inclusion of a collection or a part thereof in the register, referred to in Article 5(2) of Regulation (EU) No 511/2014, shall contain the information specified in Annex I to this Regulation. Following the inclusion in the register of a collection or a part thereof, the collection holder shall notify the competent authority of any significant changes that influence the collection's capacity to comply with the criteria set out in Article 5(3) of Regulation (EU) No 511/2014 and of any changes to the information previously submitted on the basis of Part A of Annex I to this Regulation.

2 Where an applicant is a member of a network of collections, when applying for inclusion of a collection or a part thereof in the register, the applicant may inform the competent authorities about any other collections or parts thereof from the same network that were or are the subject of an application in other Member States for inclusion in the register. When verifying the collections or parts thereof, the competent authorities of Member States that have been made aware of such applications, shall consider exchanging information with the competent authorities of those Member States where the other applications from the network have been made.

3 The verification referred to in Article 5(2) of Regulation (EU) No 511/2014 may include the following: (a) on-the-spot checks; (b) examination of selected documentation and records of a collection or part thereof, which are relevant for demonstrating compliance with Article 5(3) of Regulation (EU) No 511/2014; (c) examination of whether selected samples of genetic resources and related information of the collection concerned have been documented in accordance with Article 5(3) of Regulation (EU) 511/2014; (d) examination of whether the collection holder has the capacity to consistently supply genetic resources to third persons for their utilisation in accordance with Article 5(3) of Regulation (EU) No 511/2014; (e) interviews with relevant persons, such as the collection holder, staff, external verifiers, and users obtaining samples from that collection.

4 For the purposes of the notification referred to in Article 5(2) of Regulation (EU) No 511/2014, the competent authority shall provide the Commission with the information submitted by the collection holder on the basis of Part A of Annex I to this Regulation. The competent authority shall notify the Commission of any subsequent changes to that information.

1 The verification referred to Article 5(4) of Regulation (EU) No 511/2014 by the competent authorities shall be effective, proportionate and capable of detecting cases of non-compliance with Article 5(3) of that Regulation. It shall be conducted on the basis of a periodically reviewed plan developed using a risk-based approach. The plan should provide for a minimum level of checks and allow for differentiation in the frequency of checks.

2 Where there are substantiated concerns that a collection or part thereof included in the register no longer meets the criteria set out in Article 5(3) of Regulation (EU) No 511/2014, the competent authority shall carry out additional verification.

3 The verification referred to in paragraph 1 and 2 may include the following: (a) on-the-spot checks; (b) examination of selected documentation and records of a collection or part thereof, which are relevant for demonstrating compliance with Article 5(3) of Regulation (EU) No 511/2014; (c) examination of whether selected samples of genetic resources and related information have been documented and supplied to third persons for their utilisation in accordance with Article 5(3) of Regulation (EU) No 511/2014; (d) interviews with relevant persons, such as the collection holder, staff, external verifiers, and users obtaining samples from that collection.

4 The collection holder and its staff shall provide all assistance necessary to facilitate the verification referred to in paragraphs 1, 2 and 3.

5 Remedial actions or measures referred to in Article 5(4) of Regulation (EU) No 511/2014 shall be effective and proportionate and address shortcomings which, if left unaddressed, would permanently compromise the capacity of a registered collection to comply with Article 5(3) of that Regulation. They may require the collection holder concerned to put in place additional tools or to improve its capacity to apply existing tools. The collection holder shall report to the competent authority on the implementation of the identified remedial actions or measures.

1 A recipient of funding for research involving the utilisation of genetic resources and traditional knowledge associated with genetic resources shall make the due diligence declaration requested pursuant to Article 7(1) of Regulation (EU) No 511/2014 to the competent authority of the Member State in which the recipient is established. If the recipient is not established in the Union and the research is carried out in the Union, the due diligence declaration shall be made to the competent authority of the Member State in which the research is carried out.

2 The due diligence declaration shall be made by submitting the completed template set out in Annex II. It shall be made after the first instalment of funding has been received and all the genetic resources and traditional knowledge associated with genetic resources that are utilised in the funded research have been obtained, but no later than at the time of the final report, or in absence of such report, at the project end. The time of submission of such declaration may be further specified by the national authorities.

3 Where the same research project is funded from more than one source or involves more than one recipient, the recipient(s) may decide to make only one declaration. That declaration shall be submitted by the project co-ordinator to the competent authority of the Member State in which the project co-ordinator is established. If the project co-coordinator is not established in the Union and the research is carried out in the Union, the due diligence declaration shall be made to the competent authority of one of the Member States in which the research is carried out.

4 Where the competent authority that receives the declaration referred to in paragraphs 2 and 3 is not responsible for its transmission pursuant to Article 7(3) of Regulation (EU) No 511/2014, it shall forward that declaration to the competent authority responsible for such transmission without undue delay.

5 For the purposes of this Article and Annex II, ‘funding for research’ means any financial contribution by means of a grant to carry out research, whether from commercial or non-commercial sources. It does not cover internal budgetary resources of private or public entities

1 For the utilisation of genetic resources and traditional knowledge associated with genetic resources users shall make the due diligence declaration pursuant to Article 7(2) of Regulation (EU) No 511/2014 to the competent authority of the Member State in which the user is established. That declaration shall be made by submitting the completed template set out in Annex III to this Regulation.

2 The due diligence declaration referred to in paragraph 1 shall only be made once, prior to the first of the following events occurring: (a) market approval or authorisation is sought for a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources; (b) a notification required prior to placing for the first time on the Union market is made for a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources; (c) placing on the Union market for the first time a product developed via the utilisation of genetic resources and traditional knowledge associated with genetic resources for which no market approval, authorisation or notification is required; (d) the result of the utilisation is sold or transferred in any other way to a natural or legal person within the Union in order for that person to carry out one of the activities referred to in points (a), (b) and (c); (e) the utilisation in the Union has ended and its outcome is sold or transferred in any other way to a natural or legal person outside the Union.

3 For the purposes of this Article and Annex III, ‘result of the utilisation’ means products, precursors or predecessors to a product, as well as parts of products to be incorporated into a final product, blueprints or designs, based on which manufacturing and production could be carried out without further utilisation of the genetic resource and traditional knowledge associated with genetic resources.

4 For the purposes of this Article and Annex III, ‘placing on the Union market’ means the first making available of a product developed via utilisation of genetic resources and traditional knowledge associated with genetic resources on the Union market, where making available means the supply by any means, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. Placing on the market does not include pre-commercial trials, including clinical, field or pest resistance trials, nor the making available of unauthorised medicinal products in order to provide treatment options for individual patients or groups of patients.

1 In accordance with Article 7(3) of Regulation (EU) No 511/2014, and unless the information is confidential within the meaning of Article 7(5) of Regulation (EU) No 511/2014, the competent authorities shall transmit to the ABS Clearing House the information received on the basis of Part A of Annexes II and III to this Regulation without undue delay and at the latest one month after the information has been received.

2 Where essential information, such as on the user and utilisation, on the place of access, or on the genetic resource, without which the record could not be published on the ABS Clearing House, is considered confidential, the competent authorities shall consider instead transmitting that essential information directly to the competent national authorities referred to in Article 13(2) of the Nagoya Protocol.

3 In accordance with Article 7(3) of Regulation (EU) No 511/2014, the competent authorities shall transmit to the Commission the information received on the basis of Annexes II and III to this Regulation, unless such information is confidential within the meaning of Article 7(5) of Regulation (EU) No 511/2014.

4 Where the Commission is not provided access to this information on a permanent basis through electronic means, such transmission shall be made once every six months, starting from 9 November 2016.

1 An application submitted in accordance with Article 8(1) of Regulation (EU) No 511/2014 shall be made to the Commission by providing the information and supporting documentation specified in Annex IV to this Regulation.

2 An interested party that does not represent users but is involved in the access, collection, transfer or commercialisation of genetic resources or in developing measures and policy related to genetic resources shall provide with its application information, as specified in Annex IV to this Regulation, on its legitimate interest in developing and overseeing a combination of procedures, tools or mechanisms, which, when effectively implemented by a user, enables that user to comply with the obligations provided for in Articles 4 and 7 of Regulation (EU) No 511/2014.

3 The Commission shall send a copy of the application and supporting documentation to the competent authorities of all the Member States.

4 The competent authorities may submit comments to the Commission regarding the application within two months of receiving the documents referred to in paragraph 3.

5 The Commission shall acknowledge receipt of an application and provide the applicant with a reference number within 20 working days from the date of receipt of the application. The Commission shall provide the applicant with an indicative time limit within which a decision on the application will be taken. The Commission shall inform the applicant if additional information or documentation is required in order for it to carry out the assessment of the application.

6 The applicant shall submit to the Commission any additional information and documentation requested without undue delay.

7 The Commission shall send a copy of the documents referred to in paragraph 6 to the competent authorities of all the Member States.

8 The competent authorities may submit comments to the Commission regarding the information or documentation referred to in paragraph 6 within two months of receiving the copy of those documents.

9 The Commission shall inform the applicant each time it revises the indicative time limit within which a decision on the application will be taken due to the necessity to obtain additional information or documents for the assessment of the application. The Commission shall inform the applicant in writing of the status of the assessment of the application at least every six months.

1 Where the Commission decides to grant recognition as best practice under Article 8(2) of Regulation (EU) No 511/2014 or to withdraw the recognition of best practice under Article 8(5) of that Regulation, the Commission shall inform of that decision without undue delay the association of users or the other interested parties, as well as the competent authorities of the Member States.

2 The Commission shall state reasons for its decision to grant recognition as best practice or to withdraw the recognition of best practice and it shall publish that decision in the register established under Article 8(6) of Regulation (EU) No 511/2014.

1 Where the Commission is informed, pursuant to Article 8(3) of Regulation (EU) No 511/2014, of any changes or updates made to a recognized best practice, the Commission shall send a copy of that information to the competent authorities of all the Member States.

2 The competent authorities may submit comments to the Commission regarding such changes or updates within two months of receiving the information.

3 The Commission shall assess, taking into consideration the comments referred to in paragraph 2 of this Article, whether the changed or updated combination of procedures, tools or mechanisms still enables users to comply with their obligations provided for in Articles 4 and 7 of Regulation (EU) No 511/2014.

4 The competent authorities shall inform the Commission without undue delay of any information resulting from checks carried out pursuant to Article 9 of Regulation (EU) No 511/2014 indicating non-compliance with Articles 4 and 7 of that Regulation, which may indicate possible deficiencies in the best practice.

1 Where the Commission receives substantiated information regarding repeated or significant cases of non-compliance with Articles 4 and 7 of Regulation (EU) No 511/2014 by a user implementing a best practice, the Commission shall request the association of users or the other interested parties to submit observations regarding the alleged non-compliance and whether those cases indicate possible deficiencies in the best practice.

2 Where the association of users or the other interested parties submit observations, they shall do so within three months.

3 The Commission shall examine those observations and any supporting documentation and send copies thereof to the competent authorities of all the Member States.

4 The competent authorities may submit comments to the Commission regarding those observations and supporting documentation within two months of receiving the copy of those documents.

5 Where the Commission examines possible deficiencies in a best practice and cases of non-compliance with the obligations provided for in Articles 4 and 7 of Regulation (EU) No 511/2014, as referred to in Article 8(4) of that Regulation, the association of users or the other interested parties subject to examination shall co-operate with the Commission and assist it in its actions. Where the association of users or the other interested parties subject to examination fails to do so, the Commission may, without further consideration, withdraw recognition of the best practice.

6 The results of the examination carried out by the Commission shall be conclusive and shall include any remedial actions to be taken by the association of users or the other interested parties. The examination may also result in a decision to withdraw recognition of the best practice.

The Commission shall review the functioning and effectiveness of this Regulation, taking into account the experience gathered in its implementation and with a view to its potential revision. Such review should consider the impact of this Regulation on micro, small and medium-sized enterprises, public research institutions and specific sectors, as well as relevant developments at the international level, in particular those related to the ABS Clearing House.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.