EU ABS Regulation (EU Regulation 511/2014)
What is the scope of the EU ABS Regulation?
The scope of the EU ABS Regulation (EU Regulation 511/2014) is explained in the Regulation itself, with the EU Guidance providing more detailed information and many practical examples in the main body of the text and in Annex II.
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.
For more information, see Article 2 of the EU ABS Regulation (EU Regulation 511/2014). Further information may also be found in the indicated sections of the Guidance. To help you determine if your activities with genetic resources are in scope of the EU ABS Regulation, the ABS Focal Point has developed an interactive tool. Find the help tool on this page.
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 (section 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 (section 2.2).
- Genetic resources not used for research and development (see also: 'When am I a user?' on this page and Guidance section 2.3.3).
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 section 188.8.131.52 and 5.2.1).
- Plant genetic resources for food and agriculture (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).
- PGRFA received under an SMTA from third persons/entities who themselves received them under an SMTA from the multilateral system of the 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 (section 184.108.40.206).
- 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). 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 (section 220.127.116.11).
- Genetic resources for which the entire process of research and development takes or took place outside of the EU (section 2.5).
- 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 (section 18.104.22.168).
- Laboratory strains. The creation of a strain (which may over time become a new laboratory strain) based on material in scope of the EU ABS Regulation is itself in scope of the EU ABS Regulation. After a strain has become a laboratory strain and is made publicly available to others, its further use is out of scope of the EU ABS Regulation. However, contractual agreements agreed in PIC and MAT concerning benefit sharing resulting from further use of newly developed laboratory strains need to be respected (Annex II section 7.5).
- Commercial plant varieties that have been legally placed on the EU market. Further use of these varieties in plant breeding does not fall within the scope of the EU ABS Regulation, as the subsequent breeder relies on a new and different genetic resource, different from the initial genetic resource. This includes new varieties that are protected by a plant variety right according to the UPOV Convention (Annex II section 8.4).
- Products (offspring) of animal breeding may also fall outside the scope of the EU ABS Regulation. For instance, subsequent use of these products in breeding activities does not fall within scope of the EU ABS Regulation if these products have been registered in a breeding book of an officially EU recognised breeding organisation as a new line or breed or if they are commercial products of in-house breeding programmes. However, the creation of these products may be in scope of the EU ABS Regulation (Annex II section 8.6).
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 (section 3.7).
- Plant genetic resources for food and agriculture (PGFRA) not included in Annex 1 of the ITPGRFA 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 section 5.2.1).
Examples of cases within scope of the EU 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 (section 5.1).
Plant genetic resources for food and agriculture (PGRFA; section 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. This includes PGRFA that were initially accessed for research, breeding and training for food and agriculture, but are now used for non-ITPGRFA purposes due to a change in intent.
- Genetic resources that have been accessed initially without the intent of utilisation in the sense of the EU ABS Regulation, but are subsequently selected for utilisation (Annex II section 2.1).
When am I a user under the EU ABS Regulation?
‘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’.
Examples of activities considered to be utilisation in the meaning of the EU ABS Regulation
The following activities are mentioned by the EU as examples of activities that are considered to be utilisation of genetic resources in the sense of the EU ABS Regulation. For more information, see section 2.3.3 and Annex II of the Guidance.
- 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 (section 22.214.171.124).
- Breeding programme to create a new plant variety based on landraces or naturally occurring plants (section 126.96.36.199).
- Genetic modification — creation of a genetically modified animal, plant, or microorganism containing a gene from another species (section 188.8.131.52).
- Creation or improvement of yeasts, resulting from human action through a research and development process, to be used in manufacturing processes (but see below, example on application of biotechnology; section 184.108.40.206).
- Animal breeding which involves crossing and selection for the purpose of improving or changing the properties of established breeds (Annex II section 8.1).
Examples of activities not considered to be utilisation in the meaning of the EU ABS Regulation
The following activities are mentioned by the EU as examples of activities that are not considered to be utilisation of genetic resources in the sense of the EU ABS Regulation. However, in all cases, national ABS rules of the provider country may remain applicable. 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.
For more information, see section 2.3 of the Guidance and the indicated sections of the Guidance’s Annex II.
- Trade and exchange of genetic resources as commodities. No research and development is carried out here (section 220.127.116.11).
- Acquisition of animals by farmers for direct production purposes, without breeding or other forms of research and development (Annex II chapter 2).
- Collection management, including storage of genetic resources in a public or private collection, verification of the identity of genetic resources and assessment of their health status and the presence of pathogens (Annex II chapter 3).
- Rearing and culturing of genetic resources without intentional selection, e.g. of microorganisms or insects for biocontrol or of farm animals. The optimisation of the conditions under which genetic resources are reared or cultured is also considered not to constitute utilisation (Annex II chapter 4).
- Trading, transfer and exchange of genetic resources. Thus, someone who only transfers material is not a user and has no obligations under the EU ABS Regulation. However, contractual terms and conditions still apply, and may include clauses about transfer of the genetic resource (Annex II chapter 5).
Identification and characterisation (Annex II chapter 6).
- Taxonomic identification of biological or genetic material, by morphological or molecular analysis, including through use of DNA sequencing, is not considered to constitute utilisation, as long as it does not involve the discovery of specific genetic and/or biochemical properties (section 18.104.22.168, Annex II section 6.1).
- Characterisation is the description and documentation of the distinctive nature or features of genetic resources. If this does not involve the discovery of specific genetic and/or biochemical functions, it does not qualify as utilisation (Annex II section 6.2).
- Large-scale screening, when it involves the evaluation of samples against a specific criterion and is based on simple binary questions (i.e. does this sample match the criterion, or not?). When, however, research no longer focuses on screening out certain samples, but is concentrated on identifying the qualities and properties, this amounts to utilisation (Annex II section 6.5).
- Behavioural studies, as long as no research and development is carried out on the genetic and/or biochemical composition of these genetic resources but only on their behaviour (Annex II section 6.6).
- Testing of a final product (including regulatory tests), e.g. to verify if it meets product standards. If tests on final products do not lead to further development or change of the composition or properties of the product, and they are not considered to constitute research and development in the meaning of the EU ABS Regulation. However, in cases in which test results lead or contribute to further development or alteration, these tests do constitute utilisation in the meaning of the EU ABS Regulation (Annex II section 10.1).
- Supply and processing of relevant raw materials for subsequent incorporation in a product where the properties of the biochemical compound contained in the genetic resources are already known, since no research and development is carried out here. This is the case, for example, in the processing of tomatoes to produce a purée or a juice and the supply and processing of Aloe Vera, shea nut or butter, rose essential oils, etc. for further incorporation into cosmetics (Annex II section 9.2).
- 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. This may include laboratory animals used to test their reaction to medical products, laboratory reference material (including reference strains), reagents and samples of proficiency tests or pathogens used for testing the resistance of plant varieties. Caution: at an earlier stage, however, research and development may have been carried out on those genetic resources, with the aim of turning them into (better) testing or reference tools, and this research and development would be within the scope of the Regulation (section 22.214.171.124, Annex II chapter 7).
- Handling and storing of biological material and describing its phenotype (section 126.96.36.199).
- The application of biotechnology in a way which does not make the genetic resource in question the object of research and development. The use of yeasts in the brewing of beer, for example, is not to be considered as utilisation of that genetic resource when no research and development is carried out on the yeast, and it is used ‘as is’ in the process of brewing (section 188.8.131.52).
For more information, see section 2.3.3 and Annex II of the Guidance.
When do I submit a due diligence declaration?
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 declarations can be submitted through the EU-wide tool DECLARE, for which a user guide is available.
For more information, see section 4.1 of the Guidance and Article 5 of the Commission Implementing Regulation (EU) 2015/1866.
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.
Due diligence declarations can be submitted through the EU-wide tool DECLARE, for which a user guide is available.
For more information, see section 4.2 of the Guidance and Article 6 of the Commission Implementing Regulation (EU) 2015/1866.
Which specialised international instruments are recognised under the EU ABS Regulation?
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, see sections 184.108.40.206, 5.1 and 5.2 of the Guidance.
What to do if a provider country has ratified the Nagoya Protocol, but has not established any access measures?
The Regulation only applies to genetic resources from provider countries which are Parties to the Nagoya Protocol and have established applicable access measures on genetic resources. If no access measures have been established, access to and utilisation of these genetic resources are outside the scope of the EU ABS Regulation.
For more information, see section 2.1.2 of the Guidance.
What to do when it is not possible to identify the provider country?
In some cases, despite best efforts being applied, the provider country cannot be identified, which means it is not possible to determine what, if any, national legislation or regulation applies. As the EU ABS Regulation does not forbid utilisation of genetic resources of unknown origin, utilisation may take place in such circumstances. However, if new information arises that does allow the provider country of the genetic resources being utilised to be identified, the user obligations of the EU ABS Regulation do apply. If required by the provider country, the user must then obtain PIC and MAT, or discontinue utilisation.
For more information, see section 3.3 of the Guidance.
Does the work of service providers fall within the scope of the EU ABS Regulation?
It is common practice that some research and development activities are carried out by service providers. Examples are DNA or protein sequence determination, DNA or protein synthesis and investigation of bioactive compounds and extraction methods.
Performing these activities could make the service providers users in the meaning of the EU ABS Regulation, which would mean that they have to fulfil the due diligence obligations of the EU ABS Regulation. However, under certain conditions it could be agreed between service providers and service requestors that these due diligence obligations are the responsibility of the service requestor only. If the following conditions are met and are explicitly set out in the service agreement, it is the service requestor that is considered to be the user in the meaning of the EU ABS Regulation, and it is the service requestor who has to fulfil the due diligence obligations:
- The service provider can only perform the activities as listed and specifically described in the service agreement, and is not granted the right to perform any other research and development or exploitation activities on the genetic resources provided or the results obtained by performing the services under the service agreement;
- The service provider has the obligation to return or destroy all material and all information pertaining to the research and development at the end of the service agreement. If a copy is kept for archiving purpose, the entity subcontracting the service will be informed thereof;
- The service provider is not granted any rights on the genetic resources or any proprietary rights related to the results obtained by performing the services under the service agreement;
- The service provider does not have the right to transfer material or information to any third party or another country and has an obligation to keep all information received and generated under the service agreement confidential (including no right to publish); and
- The service requestor has the obligation to comply with all obligations under the EU ABS Regulation related to the material provided to the service provider.
However, if one or more of these conditions are not met, it is possible (depending on the activities carried out) that the service provider is to be considered a user and that the service provider has to fulfil the due diligence obligations of the EU ABS Regulation.
For more information, see section 3.5.2 of the Guidance.
Do derivatives fall within the scope of the EU ABS Regulation?
Article 2(e) of the Nagoya Protocol clarifies that the term ‘derivative’ refers to ‘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.
Access to derivatives is in scope of the EU ABS Regulation when there is an ascertainable level of continuity between a derivative and the genetic resource from which it was obtained. This is the case when access to a derivative is combined with access to a genetic resource from which that derivative was or is obtained or when research and development on such derivatives is addressed in mutually agreed terms (MAT) transferred to the user. Continuity is considered to exist in the following situations:
- The research and development activities conducted using a derivative form part of a research project covering the genetic resource and include obtaining the derivative.
- A user has obtained the derivative or commissioned a third party to obtain the derivative from a genetic resource in a research collaboration or as a specific service (e.g. under a service agreement).
- The derivative is acquired from a third party and it is transferred with PIC and MAT conditions that cover the respective research and development activities using the derivative.
Such continuity is not considered to exist (and research and development is out of scope of the Regulation) when:
- The derivative is acquired from a third party as a product or traded and obtained as a commodity and it is transferred without PIC and MAT conditions that cover research and development activities on the derivative, or without any access to a specific genetic resource.
For more information, consult section 2.3.4 of the Guidance.
Do (invasive) alien species and biocontrol organisms fall within the scope of the EU ABS Regulation?
The EU ABS Regulation may apply to alien species whether or not they may become invasive, and to alien species which are introduced to the environment intentionally as well as those introduced unintentionally. Once alien species have established (i.e. self-sustaining in the wild), they are considered as occurring in in situ conditions in that country. The country where access from in situ conditions takes place is the provider country whose rules should be followed, even if the species is not native to that country.
The same is the case for released biocontrol organisms when they are established in the country where they were released.
For more information, consult sections 2.1.4 and 2.1.5 of the Guidance.
Does the human microbiota fall within the scope of the EU ABS Regulation?
The term ‘human microbiota’ is used here to refer to all microorganisms (such as bacteria, fungi, and viruses) residing on or in the human body, and ‘microbiome’ to the collective genomes of those microorganisms (i.e. the collective genetic resources).
When studies focus on the unique composition or functionality of the microbiota from an individual human as a whole, and do not focus on individual taxa, such studies are considered to be out of scope of the EU ABS Regulation. However, when research and development activities are carried out on individual taxa isolated from a sample of the human microbiota, this isolate no longer represents the unique microbial composition characteristic of an individual human, and the studies are considered within scope of the EU ABS Regulation.
For more information, consult section 220.127.116.11 of the Guidance.
Does phylogenetic analysis fall within the scope of the EU ABS Regulation?
Phylogenetic analysis is a type of data analysis which visualises ancestor-descendant relationships between samples. It can be performed on all kinds of data, including gene functionality data. Research involving phylogenetic analysis using genetic resources may be aimed at identifying variation in identity of the species within and between populations and be similar to taxonomic identification. Similarly, it may be aimed at identifying such variation between species or taxa above species such as genus, tribe or family and grouping the analysed entities.
Where phylogenetic analysis does not entail research and development into the genes, and the function of the genes or DNA sequences (if known at all) is neither investigated nor of interest, it is considered to be out of scope of the EU ABS Regulation. However, if research is carried out on the function of the genes, then such activity falls within the scope of the EU ABS Regulation.
For more information, consult section 6.3 of the Guidance’s Annex II.
What about associated organisms on an (accessed) genetic resource?
An associated organism is any organism residing in or on another one, such as parasites, pests, pathogens, symbionts or its microbiota. In some cases, conditions for utilisation of associated organisms are specified in PIC and MAT applicable to the genetic resource obtained. If PIC and MAT do not contain information concerning the utilisation of associated organisms, the user is advised to contact the provider country and clarify whether requirements to obtain PIC and MAT apply to the utilisation of such organisms associated with the genetic resources accessed.
For more information, consult section 18.104.22.168 of the Guidance.