When storing and managing collections of genetic resources, it is important to know which activities may or may not be in scope of the EU ABS Regulation. We take a look at what the EU ABS Regulation and EU Guidance document say about storage and collection management.
Activities with genetic resources may be in scope of the EU ABS Regulation (Regulation (EU) 511/2014) when they are considered to be ‘utilisation of genetic resources’. This is defined by the Nagoya Protocol and EU ABS Regulation as: “to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology”. Many activities that are related to storage and collection management are not considered to be utilisation and are therefore out of scope of the EU ABS Regulation.
For example, the following activities do not involve research and development on the genetic and/or biochemical composition of genetic resources, are thus not considered utilisation and are therefore out of scope of the EU ABS Regulation:
- Storing genetic resources in a public or private collection (whether obtained from in situ conditions, from a market or shop in the country of origin, or from an ex situ collection). However, the legal ABS requirements of the country where the material is collected remain applicable.
- Quality checks including verification by DNA extraction and sequencing.
- Verification of the identity of material upon acceptance, for example by (taxonomic) identification and characterisation of genetic resources. However, when the characterisation or description of a genetic resource is combined with research on specific genetic and/or biochemical properties of the genetic resource, this qualifies as utilisation. See also: ‘Utilisation: taxonomic identification’.
- Phytopathology checks: assessing the health status of genetic resources and the presence of pathogens before storing these genetic resources in a collection.
For more information, see section 188.8.131.52 and Annex 2, section 3 of the EU Guidance document.
Good practices for collection holders
To help potential users of collection material, the EU Guidance document recommends some good practices for collection holders:
- Permits and mutually agreed terms may stipulate requirements for supplying a genetic resource to third parties. It is recommended that collections make the information on the permits available for potential users along with the genetic material.
- If the permits state that the transfer of material to third parties is not allowed, the material cannot be made available. Collections could make a reference in the collection catalogue to the Competent National Authority (CNA) that issued the original permit, so that the potential user can contact that CNA to negotiate access to the collection material or a genetic resource in the country of origin.
- If material deposited in a public collection has to be made available for non-commercial research by third-party users, e.g. in order to fulfil the requirement of valid publication of a new species under rules of nomenclature, it would be good practice to obtain permission from the provider country for transfer to third parties before the material is deposited.
- If the culture collection is asked by the depositors to send the strains out to third parties, it is good practice for the collection holder to refer the third party to the depositor for information on the ABS conditions for access.
- Many genetic resources have other organisms associated with them, such as parasites, pests, pathogens, symbionts or its microbiota. Collections may consider negotiating conditions of accessing genetic resources in a manner to address also associated organisms in the prior informed consent (PIC) and MAT. See also section 184.108.40.206 of the EU Guidance.
EU Register of Collections
The European Commission keeps a list of collections registered under Article 5 of the EU ABS Regulation: the EU Register of Collections. These collections apply standardised procedures for supplying genetic resources and related information. Obtaining genetic resources from a registered collection makes it easier for users to comply with ABS legislation, as users of this material are considered to have exercised due diligence as regards the seeking of information.
Collection holders in the EU may register their collection, or part of it, by applying to their country’s competent national authority (CNA). To qualify for inclusion in the EU Register of Collections, collection holders are obliged to supply genetic resources and related information only with appropriate documentation (PIC and MAT where applicable) and to keep records of all samples of genetic resources and related information supplied to third persons for their utilisation. If the provider country of genetic resources cannot be identified, a collection is advised to keep this material apart in its unregistered part. Further conditions are set up in Article 5(3) of the EU ABS Regulation.
For more information on EU registered collections, see the article: ‘Minimising your administrative burden: EU registered collections’.