Help tool for the EU ABS Regulation

The genetic resources you work with 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.

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.

1a Is the genetic resource utilised for research and development that took place either partly or entirely within the European Union?
For more information on what constitutes utilisation for research and development, see ABS Focal Point
A_This genetic resource is outside the scope of the EU ABS Regulation.

However, if the utilisation of the genetic resource entirely took place outside the European Union, the Convention on Biological Diversity (CBD) may apply.
B_This genetic resource is outside the scope of the EU ABS Regulation.

However, if the genetic resource was obtained before 12 October 2014 and after 29 December 1993, the Convention on Biological Diversity (CBD) may apply.
2a When the genetic resource was accessed, is or was the providing country Party to the Nagoya Protocol?
Consult the ABS Clearing-House to determine whether the providing country is Party to the Nagoya Protocool.
2b Does the providing country regulate access to genetic resources?
Consult the ABS Clearing-House to determine whether the country of origin has established access measures
C_This genetic resource is outside the scope of the EU ABS Regulation.

However, it is recommended to keep information relevant to the genetic resource to show that the genetic resource has been obtained from this country.
D_This genetic resource is 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).
Please choose 'No' to continue

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”) from a Party to the Nagoya Protocol with applicable national access legislation, use of the genetic resource may be in scope of the EU ABS Regulation.
E_This genetic resource is outside the scope of the EU ABS Regulation when used under the conditions specified in the Pandemic Influenza Preparedness (PIP) Framework.
Please choose 'No' to continue

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 this is not the case, use of the genetic resource may be in scope of the EU ABS Regulation.

3b 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 on the ABS Focal Point website
F_Users of this material are considered to have exercised due diligence. It is not necessary to submit a due diligence declaration.

Use the genetic resources obtained only in accordance with the conditions as stated in the SMTA.
G_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 the genetic resources obtained only in accordance with the conditions agreed with the providing country, and carefully document the use you make of them.
4a 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"
H_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 the genetic resources obtained only in accordance with the conditions agreed with the providing 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.
I_Due diligence requirements are not fulfilled.   

It is recommended that utilisation of the genetic resource is discontinued until the requirements are met. If it is not possible to meet the requirements, stop using the genetic resource.
J_Text not available yet    

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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 ABS Focal Point website and the Guidance document published by the EU.

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.