Tool to help you comply with the EU ABS Regulation

Your activities with genetic resources may be in scope of EU Regulation 511/2014 (the EU ABS Regulation). The aim of this tool is to help you determine if your activities are in scope of the EU ABS Regulation and, if this is the case, your obligations under the Regulation.

The terms in bold are explained in the list of important terms below the tool. More information can be found on the pages linked to in the tool.

This interactive help tool is also available as a printable flowchart. The flowchart is to be used in combination with the information available on this page.

Are you unsure which answers apply to your activities or genetic resources? Feel free to contact the ABS Focal Point.

Please note: this tool provides information based on the EU ABS Regulation. It does not cover national rules and regulations of provider countries.

1. What genetic resource are you working with?
This genetic resource falls outside the scope of the CBD, the Nagoya Protocol and the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the CBD, the Nagoya Protocol and the EU ABS Regulation.
2. Is the genetic resource utilised either partly or entirely within the European Union?
This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation.

However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you are supposed to respect the national rules and regulations of the provider country.

More information can be found on the ABS Focal Point website.
This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation.

However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you are supposed to respect the national rules and regulations of the provider country.

More information can be found on the ABS Focal Point website.
4. When the genetic resource was accessed, is or was the provider country a Party to the Nagoya Protocol?
Consult the ABS Clearing-House to determine whether the provider country is a Party to the Nagoya Protocol.
This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation.

However, even if this genetic resource falls outside the scope of the EU ABS Regulation, you are supposed to respect the national rules and regulations of the provider country.

It is recommended to keep information relevant to the genetic resource to show that the genetic resource has been obtained from this country.

More information can be found on the ABS Focal Point website.
5. Has the provider country established applicable access measures on genetic resources?
Consult the ABS Clearing-House to determine whether the provider country has established applicable access measures
This genetic resource falls outside the scope of the EU ABS Regulation. When obtaining and using this genetic resource, there are no obligations related to the EU ABS Regulation.

It is recommended to keep information relevant to the genetic resource to show that the genetic resource has been obtained from this country.

More information can be found on the ABS Focal Point website.
6. Is the utilisation of the genetic resource covered by a specialised international ABS instrument that has been recognised in the EU ABS Regulation?
More information on specialised international ABS instruments can be found on the ABS Focal Point website.
This genetic resource falls outside the scope of the EU ABS Regulation when used under the conditions specified in the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA). When obtaining and using this genetic resource in accordance with the ITPGRFA, there are no obligations related to the EU ABS Regulation.

Access to plant genetic resources (PGRFA) within the Multilateral System (MLS) is provided under the conditions specified in Article 12.3 of the ITPGRFA.

If the genetic resource is used for purposes other than those set out in the ITPGRFA ("research, breeding and training for food and agriculture"), use of the genetic resource may be in scope of the EU ABS Regulation. In this case, please select 'No' at the previous question to continue.

More information can be found on the ABS Focal Point website.
This genetic resource falls outside the scope of the EU ABS Regulation when used under the conditions specified in the Pandemic Influenza Preparedness (PIP) Framework. When obtaining and using this genetic resource in accordance with the PIP Framework, there are no obligations related to the EU ABS Regulation.

Article 3 of the PIP Framework states:
  • 3.1 This Framework applies to the sharing of H5N1 and other influenza viruses with human pandemic potential and the sharing of benefits.
  • 3.2 This Framework does not apply to seasonal influenza viruses or other noninfluenza pathogens or biological substances that may be contained in clinical specimens shared under this Framework.
If the PIP Framework does not apply, use of the genetic resource may be in scope of the EU ABS Regulation. In this case, please select 'No' at the previous question to continue.

More information can be found on the ABS Focal Point website.
7. Has the genetic resource been accessed under an internationally recognised certificate of compliance (IRCC) or under the standard material transfer agreement (SMTA) of the ITPGRFA?
More information on the IRCC and SMTA can be found in the FAQ - Important terms on the ABS Focal Point website.
When you access plant genetic resources from countries that issue their plant-genetic resources for food and agriculture under the conditions of the SMTA, including those not listed in Annex I of the ITPGRFA, you are considered to have exercised due diligence. It is not necessary to submit a due diligence declaration.

Use and transfer the genetic resources obtained only in accordance with the conditions as stated in the SMTA.
If the situation above does not apply, use of the genetic resource may be in scope of the EU ABS Regulation. In this case, please select 'No' at the previous question to continue.

More information can be found on the ABS Focal Point website.
Users of this material are considered to have exercised due diligence regarding the collection of information. You may need to submit a due diligence declaration.

Keep the IRCC number and transfer this to any subsequent users.

Use and transfer the genetic resources obtained only in accordance with the conditions agreed with the provider country, and carefully document the use you make of them.

More information can be found on the ABS Focal Point website.
8. Is the genetic resource obtained from a registered collection under the EU ABS Regulation?
An overview of the registered collections can be found in the European Commission's Register of Collections.
9. Were prior informed consent (PIC) and mutually agreed terms (MAT) obtained?
More information on PIC and MAT can be found in the FAQ - Important terms on the ABS Focal Point website.
Users of this material are considered to have exercised due diligence regarding the collection of information. You may need to submit a due diligence declaration.

Keep relevant information and documents for at least 20 years, and transfer this information to any subsequent users.

Use and transfer the genetic resources obtained only in accordance with the conditions agreed with the provider country, and carefully document the use you make of them.

Relevant information.

Relevant information includes an internationally recognised certificate of compliance (IRCC), as well as information on the content of the mutually agreed terms relevant for subsequent users. If an IRCC is not available, this constitutes information and relevant documents on:
  1. the date and place of access to genetic resources or traditional knowledge associated with genetic resources
  2. the description of the genetic resources or of traditional knowledge associated with genetic resources utilised
  3. the source from which the genetic resources or traditional knowledge associated with genetic resources were directly obtained, as well as subsequent users of genetic resources or traditional knowledge associated with genetic resources
  4. the presence or absence of rights and obligations relating to access and benefit-sharing including rights and obligations regarding subsequent applications and commercialisation
  5. access permits, where applicable
  6. mutually agreed terms, including benefit-sharing arrangements, where applicable
More information can be found on the ABS Focal Point website.
Due diligence requirements are not fulfilled.

You are required to obtain prior informed consent (PIC) and establish mutually agreed terms (MAT) or discontinue utilisation of the genetic resource.

More information can be found on the ABS Focal Point website.

Important terms

Genetic resources

‘Genetic resource’ means genetic material of actual or potential value. ‘Genetic material’ means any material of plant, animal, microbial or other origin containing functional units of heredity.

Internationally Recognised Certificate of Compliance (IRCC)

An internationally recognised certificate of compliance (IRCC) is a certificate published on the ABS Clearing-House website by the provider country. An IRCC provides evidence that the user has accessed a genetic resource legally and in accordance with prior informed consent (PIC) and that mutually agreed terms (MAT) have been established, as required by the domestic ABS legislation or regulatory requirements of the provider country.

More information on IRCC can be found on the page Important terms.

Mutually Agreed Terms (MAT)

Mutually agreed terms (MAT) are laid down in a contract between the users and providers of genetic resources. The MAT define the conditions governing the use of genetic resources and benefit-sharing. MAT may take the form of a material transfer agreement (MTA).

More information on MAT can be found on the page Important terms.

Prior Informed Consent (PIC)

Prior informed consent (PIC) means approval for access to and utilisation of genetic resources by the authorities of the country where access is sought (the Competent National Authority, CNA).

More information on PIC can be found on the page Important terms.

Provider country

In the sense of the EU ABS Regulation, ‘provider country’ means the country of origin of the genetic resource or any (other) Party to the Protocol that has acquired the genetic resource in accordance with the Convention on Biological Diversity. ‘Country of origin’ means the country which possesses the genetic resource in in-situ conditions.

Standard Material Transfer Agreement (SMTA)

The Standard Material Transfer Agreement (SMTA) is an MTA in a mandatory form for parties wishing to provide and receive material from the Multilateral System (MLS) of the ITPGRFA.

More information on the SMTA can be found on the page Important terms.

Utilisation of genetic resources

‘Utilisation of genetic resources’ means ‘to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology’.

For more information on what constitutes utilisation, see the Guidance document published by the EU and When am I a user? on the ABS Focal Point website.

Disclaimer: The National Focal Point accepts no liability for the contents of this website. The information presented on this website can therefore not be used as the basis for any claims.