For the following information, the assumption is made that genetic resources are accessed in a country that is Party to the Nagoya Protocol and has established access measures on genetic resources and traditional knowledge associated with genetic resources, and that all other geographic and temporal conditions have been met. Furthermore, it is assumed that any contractual obligations, as well as any obligations stemming from other legislation will be respected and transferred to subsequent users, where applicable. These assumptions are not repeated in the individual cases.
Out of scope of the EU ABS Regulation
- Genetic resources accessed prior to 12 October 2014 even if utilisation of those resources occurs on or after that date (Guidance 2.2).
- Genetic resources used in research and development activities that took place exclusively prior to the entry into force of the Protocol, access continues afterwards, but no research and development is carried out on or after 12 October 2014 (Guidance 2.2).
- Genetic resources not used for research and development (see also: When am I a user? and Guidance 2.2).
Genetic resources for which access and benefit-sharing is governed by specialised international instruments. This currently includes genetic material as listed below. However, some exceptions apply (see also: 'Which specialised international instruments are recognised under the EU ABS Regulation?' on this page and Guidance 2.3.1).
- PGRFA covered by Annex I of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), included into its multilateral system (MLS) and obtained from ITPGRFA Parties (SMTA signed).
- Any PGRFA accessed under an SMTA from International Agricultural Research Centres and other institutions that have signed agreements under Article 15 of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA).
- Genetic material covered by the WHO’s Pandemic Influenza Preparedness (PIP) Framework (Article 2(2) of the EU ABS Regulation).
- Genetic resources of human origin. Human genetic resources are not covered by the CBD and the Nagoya Protocol and are therefore out of scope (Guidance 2.3.1).
- Genetic resources traded or exchanged as commodities (such as agricultural, fisheries or forestry products – whether for direct consumption or as ingredients, e.g. in food and drink products) fall outside the scope of the EU ABS Regulation. However, when research and development is carried out on genetic resources which originally entered the EU as commodities, the intended use has changed and such new use may fall within the scope of the Regulation (Guidance 2.3.1).
- Genetic resources used outside of the EU, where the entire process of research and development takes or took place outside of the EU (Guidance 2.5).
- Genetic resources used for food and agriculture (Guidance 5.2):
- Pathogenic organisms or pests present on a human, an animal, a plant, a micro-organism, food, feed or any other material, which as such are introduced unintentionally to a place in the EU territory (Guidance 5.1.1).
Within scope of the EU ABS Regulation, but due diligence obligation considered partly or wholly complied with
- Genetic resources obtained from a registered collection under Article 5 of the EU ABS Regulation. Users of this material are considered to have exercised due diligence as regards the seeking of information. For the utilisation of this type of material, submission of a due diligence declaration may still be required (Guidance 3.5).
- Non-Annex I plant genetic resources for food and agriculture (PGFRA) that are supplied under the SMTA by a Party to the Nagoya Protocol that has determined that PGRFA which are under its management and control and in the public domain but not included in Annex I to the ITPGRFA will also be subject to the terms and conditions of the SMTA used in the ITPGRFA. A user of such material is considered to have exercised due diligence. For this type of material, a due diligence declaration is not required (EU ABS Regulation Article 4(4) and Guidance 5.2.1).
Examples of cases within scope of the US ABS Regulation, due diligence needs to be demonstrated
The following section discusses some examples that are within scope of the EU ABS Regulation. However, the list is non-exhaustive. If a specific example is not listed here, it may still be within scope of the EU ABS Regulation.
- Pathogenic organisms that are not covered by the Pandemic Influenza Preparedness (PIP) Framework (Guidance 5.1).
Plant genetic resources for food and agriculture (PGRFA; Guidance 5.2.1):
- Annex I PGRFA from countries which are Parties to the Nagoya Protocol but not to the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), and where access regimes apply to the PGRFA in question.
- Non-Annex I PGFRA from Parties to the Nagoya Protocol, whether or not they are also Parties to the ITPGRFA, where national access regimes apply to such PGRFA and they are not subject to SMTAs for the purposes set out under the ITPGRFA.
- Any PGRFA (including Annex I material) used for purposes other than those set out in the ITPGRFA (“research, breeding and training for food and agriculture”) from a Party to the Nagoya Protocol with applicable national access legislation.
‘Utilisation of genetic resources’ is defined in the Regulation (EU) No 511/2014 (the EU ABS Regulation, Article 3) and the Nagoya Protocol (Article 2) as “to conduct research and development (R&D) on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology, as defined in Article 2 of the Convention.” For the EU ABS Regulation, both basic and applied research may be considered utilisation.
Research and development
Certain upstream activities related to or carried out in support of research are not considered utilisation in the meaning of the EU ABS Regulation. The description of a genetic resource normally would also not amount to utilisation. However, if the description of a genetic resource is combined with research on that resource, i.e. to discover specific genetic and/or biochemical properties, this would qualify as utilisation in terms of the Protocol and the Regulation. As a type of ‘litmus test’, users should ask themselves whether what they are doing with the genetic resources creates new insight into 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’.
Article 2(e) of the Nagoya Protocol clarifies that ‘derivative’ means ‘a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity’. Examples of derivatives include proteins, lipids, enzymes, RNA and organic compounds such as flavonoids, essential oils or resins from plants.
Research and development on derivatives (whether or not containing functional units of heredity) is within scope of the EU ABS Regulation when they are derived from genetic resources accessed under the Protocol, covered by the required prior informed consent (PIC) related to genetic resources from which they were derived, and addressed in mutually agreed terms (MAT).
For more information, consult section 2.3.3 of the Guidance.
The EU ABS Regulation does not apply to genetic resources for which access and benefit-sharing is governed by specialised international instruments. This currently includes material covered by the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and the WHO’s Pandemic Influenza Preparedness (PIP) Framework (Article 2(2) of the Regulation).
However, the Regulation does apply to genetic resources covered by the ITPGRFRA and the PIP Framework, if they are accessed in a country that is not a Party to those agreements but is a Party to the Nagoya Protocol. The Regulation also applies where resources covered by such specialised instruments are utilised for purposes other than those of the specialised instrument in question, e.g. if a food crop covered by the ITPGRFA is utilised for pharmaceutical purposes.
For more information, consult sections 2.3.1, 5.1 and 5.2 of the Guidance.
Due diligence declaration at the stage of research funding
The first checkpoint (defined in Article 7(1) of the EU ABS Regulation) concerns the research stage, when a research project involving utilisation of genetic resources and/or traditional knowledge associated with genetic resources is subject to external funding in the form of a grant. The Regulation does not make a distinction between public and private funding. Internal budgetary resources of private or public entities are not considered to be external funding. The declaration needs to 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 funding project have been obtained, but in any case no later than at the time of the final report or in absence of such report, at the project’s end.
Due diligence declaration at the stage of final development of a product
The second checkpoint (defined in Article 7(2) of the Regulation) at which a due diligence declaration is to be submitted by users is the stage of final development of a product developed via the utilisation of genetic resources or traditional knowledge associated with genetic resources. The declaration is to be made once, at the first (i.e. earliest) of the following five 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.