Regulations: Nagoya Protocol on access and benefit sharing (ABS)
Guidance for those conducting research and development on genetic resources.
A Defra guidance document on the provisions and implementation of the UK’s ABS Regulations has been produced. Please see the section below titled ‘Guidance on the UK ABS Regulations’.
From 1 January 2021, United Kingdom (UK) stakeholders involved in accessing genetic resources from Parties to the Nagoya Protocol are required to follow new UK processes which are outlined below.
Overview
The Nagoya Protocol provides a framework for the effective implementation of one of the three objectives of the Convention on Biological Diversity: the fair and equitable sharing of benefits arising out of the utilisation of genetic resources. It recognises that benefits derived by users of genetic resources should be shared with those who provide them, with the ultimate objective being the conservation and sustainable use of biodiversity.
Although a Party to the Nagoya Protocol, the UK has chosen not to exercise sovereign rights for accessing its genetic resources under the Nagoya Protocol. There is no requirement to establish Prior Informed Consent (PIC) or negotiate Mutually Agreed Terms (MAT) with the UK government for any utilisation of UK genetic resources. However, you may need to comply with other UK legislation, which should be considered prior to any collection of sovereign UK genetic resources.
What is covered
The regulations apply when research and development is conducted on genetic resources and / or associated traditional knowledge (aTK). A genetic resource is any plant, animal, microbial or material of other origin which contains functional units of heredity and is of actual or potential value.
Human genetic resources are not covered by the Nagoya Protocol.
A variety of sectors conduct activities that are in scope of the regulations in the UK, which apply to both commercial and non-commercial research. Those sectors include:
- animal breeding
- bio-control
- biotechnology
- collections
- cosmetic and personal care
- food and feed
- pharmaceutical
- plant breeding
- research institutions
Extent of obligation
The UK ABS Regulations apply to any company, organisation or individual (the user) conducting research and development on genetic resources and / or aTK where the genetic resources and / or aTK:
- was accessed on or after 12 October 2015
- was accessed from a country that is party to the Nagoya Protocol and has access and benefit sharing (ABS) legislation
- is not already governed by a specialised international instrument (such as the PIP Framework or the ITPGRFA)
The user of the genetic resource and / or aTK is responsible for undertaking due diligence. This is to ensure that the material is accessed in accordance with applicable legislation of the providing country. The user is also responsible for the submission of a due diligence declaration as required.
How to comply
A company, individual or organisation wishing to use a genetic resource and / or aTK from a country that is a party to the Nagoya Protocol must exercise due diligence to show that relevant country requirements have been met. Depending on the national measures that apply, the user may need to demonstrate prior informed consent (PIC) to access the genetic resource and assent to mutually agreed terms (MAT) for undertaking research and development. These terms will also provide for benefit sharing, whether this is in monetary or non-monetary form, as well as addressing aTK associated with a genetic resource.
The Access and Benefit Sharing Clearing House (ABSCH) is a platform for exchanging information on access and benefit sharing measures that countries have established, as well as supporting the tracking of genetic resources between provider and user. It assists the implementation of the Nagoya Protocol and parties are required to place national legislation on it to provide legal clarity. Users of genetic resources should use this information source as part of their due diligence process.
Compliance self-assessment tool
OPSS has created a free self-assessment tool that aims to help users understand their requirements and record information related to compliance. You do not need to return the completed form.
Making a due diligence declaration
There are two checkpoints in the research and development phase where users of genetic resources submit a due diligence declaration:
1) when in receipt of research funding in the form of a grant, for work involving utilisation of genetic resources and / or aTK
and
2) at the stage of final development of a product developed via the utilisation of genetic resources and / or aTK with such resources where:
a) market approval or authorisation is sought for a product developed via the utilisation of genetic resources and aTK
b) a notification required prior to placing for the first time on the UK market is made for a product developed via the utilisation of genetic resources and aTK
c) placing on the UK market for the first time a product developed via the utilisation of genetic resources and aTK 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 UK in order for that person to carry out one of the activities referred to in points (a), (b) and (c)
or
e) the utilisation in the UK has ended and its outcome is sold or transferred in any other way to a natural or legal person outside the UK.
All recipients of research funding involving the utilisation of genetic resources and aTK must submit a due diligence declaration to Defra.
Information on how to and who should submit a due diligence declaration can be found in the next section.
This requirement is directed at any recipient established in the UK that receives a financial contribution by means of a grant to carry out research, whether from commercial or non-commercial sources. The declaration should be made after the first instalment of funding has been received and all the genetic resources and aTK that are utilised in the funded project have been obtained, and no later than at the time of the final report or project end.
Users of genetic resources and / or aTK must also submit a due diligence declaration to Defra at the stage of final development of a product, developed from the utilisation of genetic resources and / or aTK.
The conditions under which this declaration would be required are set out in the legislation.
Where research and development is undertaken in the UK, due diligence declarations must be submitted to Defra.
Best practice and registered collections
Under the Nagoya Protocol, best practices and registered collections may become recognised (although no registered collections currently exist in the UK). The conditions for best practice recognition and registered collection status can be found under the Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1393).
Please contact Defra at [email protected] for any enquiries related to best practices and registered collections.
Process for submitting due diligence declarations, applying for best practice and registering a collection in the UK
From 1 January 2021, UK stakeholders involved in accessing genetic resources from Parties to the Nagoya Protocol are required to follow new UK processes for the following.
- submitting a due diligence declaration
- applying for best practice recognition
- registering a collection in the UK
The following document provides simple instructions to meet each of those processes.
Best Practices
“Best practices” under the terms of the UK ABS Regulation (Art. 8 of UK ABS Regulation (as amended)) are procedures, tools or mechanisms, developed and overseen by associations of users or other interested parties, which – when effectively implemented – help users of genetic resources to comply with the obligations of the UK ABS Regulation. The procedural requirements for the recognition of best practices are set out in the Implementing Regulation. Once recognised as such by Defra, best practices will be included in the . Currently there are two recognised best practices in the Register.
The role of the Office for Product Safety and Standards (OPSS)
OPSS has been appointed by Defra to enforce the regulations in the UK.
Our approach to addressing non-compliance by those we regulate is set out in our Enforcement Policy, which should be read alongside guidance on the specific enforcement actions available to us under the UK’s ABS regulations, and associated rights to make representations or appeal.
Read our guidance on enforcement actions and associated rights
Where to find out more
- Access and Benefit Sharing Clearing House (ABSCH)
- Nagoya Protocol on Access and Benefit-sharing (a Protocol to the Convention on Biological Diversity). This includes the text of the Nagoya Protocol and helpful factsheets.
Guidance on the UK ABS Regulations
The following document has been produced by Defra to provide guidance on the provisions and implementation of the UK’s ABS Regulations. This guidance document is not legally binding; its sole purpose is to assist citizens, academia, and businesses in the application of the ABS Regulations.
Regulations in force in the UK
- Nagoya Protocol (Compliance) Regulations 2015 (S.I. 2015/821) as amended
- Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1393)
- Environment and Wildlife (Legislative Functions) (EU Exit) Regulations 2019 (S.I. 2019/473)
- Regulation (EU) No. 511/2014: compliance measure for users
- Regulation (EU) 2015/1866: register of collections, monitoring user compliance and best practices
Contact us
If you have a specific enquiry about compliance or wish to contact us regarding suspected non-compliance please email [email protected].
Alternatively you can contact our helpdesk on 0121 345 1201.
Or in writing to:
Office for Product Safety and Standards
4th Floor Cannon House
18 The Priory Queensway
Birmingham
B4 6BS
United Kingdom
Updates to this page
Published 2 June 2015Last updated 30 June 2023 + show all updates
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Link added to new guidance on enforcement actions and associated rights.
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Information added on Best Practices and associated UK Register uploaded.
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Defra guidance document on the application of the ABS Regulations added.
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Forms for due diligence declarations and the self-assessment of compliance updated.
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Updated at the end of the transition period to reflect amendments to the regulations and the new UK processes for making due diligence declarations, applying for best practice recognition, and registering a collection in the UK.
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EU Exit update
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Updated to reflect that due diligence can now be submitted through the new EU IT system DECLARE.
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First published.