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Are you a user of genetic resources?

Published on
August 22, 2022

If your activities with genetic resources fall under the definition of utilisation, you are considered to be a user. The EU ABS Regulation and EU Guidance document provide more information on what constitutes ‘utilisation of genetic resources’ within the European Union.

In short, utilisation of genetic resources means: “to conduct research and/or development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology.” This definition is used by the Nagoya Protocol and the EU ABS Regulation.

If your activities with genetic resources fall under the definition of utilisation, you are considered to be a user. This is independent of the users’ size or of the intent of the use (commercial or non-commercial) and applies to individuals, including researchers, and to organisations such as universities or other research organisations, as well as to small and medium sized enterprises and multinational companies.

Examples of activities that are considered to be utilisation under the EU ABS Regulation

(NB The ‘Guidance sections’ indicated in the examples below refer to sections of the EU Guidance document that provide more information on the specific examples.)

  • Research on genetic resources leading to the isolation of a biochemical compound used as a new ingredient (active or not) incorporated into a cosmetic product(Guidance section 2.3.3.2).
  • Genetic modification — creation of a genetically modified animal, plant, or microorganism containing a gene from another species(Guidance section 2.3.3.2).
  • Animal breeding which involves crossing and selection for the purpose of improving or changing the properties of established breeds (Guidance Annex II section 8.1).

Which activities are not considered utilisation?

There are some activities, related to research and development, that are not considered utilisation under the EU ABS Regulation. The EU Guidance, specifically Annex II, elaborates on these activities.

Below are a few examples of activities that are not considered to be utilisation in the sense of the EU ABS Regulation. However, if an activity mentioned below is combined with research on the specific genetic and/or biochemical composition of the genetic resource, specifically the function of the genes, the activity would qualify as utilisation.

Examples of activities that are ­not considered to be utilisation under the EU ABS Regulation

  • Trade and exchange of genetic resources as commodities. No research and development is carried out here (Guidance section 2.3.1.3).
  • (Taxonomic) identification and characterisation (Guidance Annex II chapter 6).

    • The activity of describing a genetic resource would normally not be considered utilisation under the EU ABS Regulation. However, if it is combined with research on that resource to discover specific genetic and/or biochemical properties, the activity would qualify as utilisation. As a type of ‘litmus test’, users should ask themselves if what they are doing with the genetic resource creates new insight into the characteristics of the genetic resource which is of (potential) benefit to the further process of product development. If this is the case, the activity goes beyond mere description, should be considered research, and therefore falls under the term ‘utilisation’.
  • Applying genetic resources as testing/reference tools. In this case the material is not the object of the research in itself, but only serves to confirm or verify the desired features of other products developed or under development (Guidance section 2.3.3.2, Annex II chapter 7).

Do note that some provider countries have established national access legislation for their genetic resources, with their own interpretation of ‘utilisation of genetic resources’, which may differ from the EU interpretation. This means that it is possible that activities which are not considered utilisation under the EU ABS Regulation are subject to national ABS rules of the provider country. Therefore it is recommended to contact the provider country’s National Focal Point (NFP) of the provider country to ask if any national ABS rules apply. The names and contact details of the NFPs of most countries are available on the ABS Clearing-House website.

For a more extensive overview of activities which are considered utilisation or not, see ‘When am I a user under the EU ABS Regulation?’ in the FAQ section of the ABS Focal Point website, and section 2.3.3 and Annex II of the EU Guidance.

Read more

For information on some of the sector-specific topics mentioned in the EU Guidance, see our previous articles: