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

CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 Subject matter

This Regulation 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 this 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 (the ‘Convention’).

Article 2 Scope

1. This Regulation applies to genetic resources over which States exercise sovereign rights and to traditional knowledge associated with genetic resources that are accessed after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the utilisation of such genetic resources and traditional knowledge associated with genetic resources.

2. This Regulation does not apply to genetic resources for which access and benefit-sharing is governed by specialised international instruments that are consistent with, and do not run counter to the objectives of the Convention and the Nagoya Protocol.

3. This Regulation is without prejudice to Member States’ rules on access to genetic resources over which they exercise sovereign rights within the scope of Article 15 of the Convention, and to Member States’ provisions on Article 8(j) of the Convention concerning traditional knowledge associated with genetic resources.

4. This Regulation applies to genetic resources and traditional knowledge associated with genetic resources to which access and benefit-sharing legislation or regulatory requirements of a Party to the Nagoya Protocol are applicable.

5. Nothing in this Regulation shall oblige a Member State to supply information the disclosure of which it considers contrary to the essential interests of its security.

Article 3 Definitions

For the purposes of this Regulation, the definitions of the Convention and the Nagoya Protocol as well as the following definitions apply:

(1)

‘genetic material’ means any material of plant, animal, microbial or other origin containing functional units of heredity;

(2)

‘genetic resources’ means genetic material of actual or potential value;

(3)

‘access’ means the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol;

(4)

‘user’ means a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources;

(5)

‘utilisation of genetic resources’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention;

(6)

‘mutually agreed terms’ means the contractual arrangements concluded between a provider of genetic resources, or of traditional knowledge associated with genetic resources, and a user, that set out specific conditions for the fair and equitable sharing of benefits arising from the utilisation of genetic resources or of traditional knowledge associated with genetic resources, and that may also include further conditions and terms for such utilisation as well as subsequent applications and commercialisation;

(7)

‘traditional knowledge associated with genetic resources’ means traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources;

(8)

‘illegally accessed genetic resources’ means genetic resources and traditional knowledge associated with genetic resources which were not accessed in accordance with the national access and benefit-sharing legislation or regulatory requirements of the provider country that is a Party to the Nagoya Protocol requiring prior informed consent;

(9)

‘collection’ means a set of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entities;

(10)

‘association of users’ means an organisation, established in accordance with the requirements of the Member State in which it is located, that represents the interests of users and that is involved in developing and overseeing the best practices referred to in Article 8 of this Regulation;

(11)

‘internationally recognised certificate of compliance’ means a permit or its equivalent issued at the time of access as evidence that the genetic resource it covers has been accessed in accordance with the decision to grant prior informed consent, and that mutually agreed terms have been established for the user and the utilisation specified therein by a competent authority in accordance with Article 6(3)(e) and Article 13(2) of the Nagoya Protocol, that is made available to the Access and Benefit-sharing Clearing House established under Article 14(1) of that Protocol.