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EU ABS Regulation: in or out of scope?

Published on
September 22, 2020

When are your activities with genetic resources in or out of scope of the EU ABS Regulation? In this article, we highlight some examples of activities with genetic resources that are in or out of the scope of the EU ABS Regulation.

The EU ABS Regulation (Regulation (EU) 511/2014) only applies when all three following conditions are met:

  • the genetic resource was accessed on or after 12 October 2014;
  • the genetic resource originated from a country that is a Party to the Nagoya Protocol and has established applicable ABS legislation;
  • research and/or development has been carried out on the genetic and/or biochemical composition of genetic resources within the EU (‘utilisation of genetic resources’).

If these three conditions are met, your activities with genetic resources may be in scope of the Regulation.

Examples of situations in scope of the EU ABS Regulation

The following activities are in scope of the EU ABS Regulation if they are carried out in the EU with genetic resources accessed on or after 12 October 2014 from a country that is a Party to the Nagoya Protocol and has established applicable ABS legislation.

  • Research on genetic resources leading to the isolation of a biochemical compound used as a new ingredient incorporated into a cosmetic product.
  • Breeding programme to create a new plant variety based on landraces or naturally occurring plants.
  • Genetic modification — creation of a genetically modified animal, plant, or microorganism containing a gene from another species.

Examples of situations out of scope of the EU ABS Regulation

Genetic resources are not in scope of the EU ABS Regulation when they were obtained before 12 October 2014 and/or not obtained from a country that is a Party to the Nagoya Protocol and has established applicable ABS legislation.

Furthermore, some activities are not considered utilisation of genetic resources in the sense of the EU ABS Regulation, even if the genetic resources were accessed on or after 12 October 2014 from a country that is a Party to the Nagoya Protocol and has established applicable ABS legislation.

  • Human genetic resources are not covered by the Convention on Biological Diversity (CBD) and the Nagoya Protocol, and their utilisation is therefore out of scope of the EU ABS Regulation.
  • When genetic resources covered by an EU-recognised specialised ABS instrument (the ITPGRFA and the PIP Framework) are utilised in accordance with these instruments, they are out of the EU ABS Regulation’s scope.
  • When genetic resources traded as commodities are used for direct consumption or as ingredients of, for instance, food or drinks, they fall outside the scope of the Regulation because there is no utilisation. However, research and/or development on these genetic resources may be in scope.
  • When genetic resources only serve as testing or reference tools, they are not in scope of the EU ABS Regulation. Examples include laboratory animals used to test the effectivity of medical products, laboratory reference material (including reference strains) or pathogens used for testing the resistance of plant varieties.

More examples of situations that are in or out of scope are given on the ABS Focal Point website: ‘What is the scope of the EU ABS Regulation?

Out of scope of the EU ABS Regulation? Also check national ABS legislation of the provider country!

Even when your activity with genetic resource falls outside the scope of the EU ABS Regulation, national ABS legislation or regulatory requirements of the provider country still apply. As a user, you should comply to the rules of the provider country. Otherwise, you may be called to account by the authorities of that country at a later stage.

More information on the scope of the EU ABS Regulation is found on the ABS Focal Point website, in particular the sections ‘EU Regulation 511/2014’ and 'When am I a user?'.