A new version of this application has just been released.
This update may include important fixes, new features, or visual improvements.
To avoid unexpected behavior and ensure you’re working with the latest information, please refresh the page.
Click Refresh Now to update immediately.
Your version: 2026.30.0
Loading...
This record has been deleted. Since it is linked to a published record, it is available here for reference purposes only.
Commission notice — Guidance document on the scope of application and core obligations of Regulation (EU) No 511/2014 of the European Parliament and of the Council on the compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union
This document is intended to provide guidance on the provisions and implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union (‘the EU ABS Regulation’ or ‘the Regulation’) and Commission Implementing Regulation (EU) 2015/1866 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices (‘the Implementing Regulation’).
The EU ABS Regulation implements in the EU those international rules (contained in the Nagoya Protocol) which govern user compliance — i.e. what users of genetic resources have to do in order to comply with the rules on access and benefit-sharing (ABS) established by the countries providing genetic resources. The Nagoya Protocol also contains rules concerning access measures — but those are not covered by the EU ABS Regulation and accordingly are not addressed in this guidance document.
Certain aspects of the EU ABS Regulation and the Implementing Regulation needed further clarification. The guidance document was developed in cooperation with EU Member States' representatives gathered in the "ABS Expert Group" and it was also subject to feedback from stakeholders gathered in the "ABS Consultation Forum". The guidance document is not legally binding; its sole purpose is to provide information on certain aspects of the relevant EU legislation. It is thus intended to assist citizens, businesses and national authorities in the application of the EU ABS Regulation and the Implementing Regulation.
ABSCH-MSR-EU-201808-5Legislative, Administrative or Policy MeasureEU ABS Regulation - REGULATION (EU) No 511/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union
This document has been updated. This is not the latest published version.
Click here to view the latest version of the record.
This Regulation establishes rules governing compliance with access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources in accordance with the provisions of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (the ‘Nagoya Protocol’). The effective implementation of this Regulation will also contribute to the conservation of biological diversity and the sustainable use of its components, in accordance with the provisions of the Convention on Biological Diversity (the ‘Convention’).
This Regulation applies to all EU Member States, regardless of their individual ratification of the Nagoya Protocol.
Due to the division of competences between the EU and its Member States, some elements related to the compliance measures (such as the penalties, authorities in charge of the compliance checks) are not directly provided for in the EU ABS Regulation but are or will be implemented by each EU Member State.
This Regulation implements the obligatory compliance measures of the Nagoya Protocol. It does not establish access rules at EU level. For EU Member States that decide to establish access rules, these will be found in the legislation of the respective EU Member State (see their respective Country Profile).
ABSCH-MSR-EU-204508-5Legislative, Administrative or Policy MeasureCommission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices
This document has been updated. This is not the latest published version.
Click here to view the latest version of the record.
On the basis of powers granted in Regulation 511/2014 (the "basic" EU ABS Regulation), this Implementing Regulation specifies further the compliance rules established by the basic Regulation and establishes procedures to be followed when applying for recognition of the voluntary compliance support mechanisms.
The Implementing Regulation clarifies when, to whom and which information is to be submitted when filing the due diligence declarations required by the basic Regulation. Furthermore, it establishes the procedures to be followed when a collection applies to become a "registered collection", and when an association of users or other interested parties apply for recognition of "best practices".
This Regulation, like the basic Regulation, is directly applicable in all EU Member States and implements the compliance measures of the Nagoya Protocol. Access rules, if established by EU Member States, can be found in the legislation of the respective Member State (see their Country Profiles).
This guidance document is intended to assist users of genetic resources and national authorities in the application of the EU ABS Regulation and the Implementing Regulation. It does not replace, add to or amend the provisions of the EU ABS Regulation and of the Implementing Regulation. It should not be considered in isolation but used in conjunction with this legislation.
SCOPE OF THE MEASURE
Traditional knowledge associated with genetic resources ( Sections 1.2 and 2.3.2 )
Provisions on temporal scope ( Section 2.2 )
ALL TYPES OF GENETIC RESOURCES
No provisions for this element
AREAS OF ACCESS OF THE GENETIC RESOURCE
No provisions for this element
ACCESS
No provisions for this element
BENEFIT-SHARING
No provisions for this element
COMPLIANCE
Compliance with domestic legislation or regulatory requirements of the other Party (Article 15 and 16) ( Entire document )
Issues related to monitoring the utilization of genetic resources (Article 17) ( Entire document )
- Information on scope of compliance measures (Entire document)
RELATIONSHIP WITH OTHER INTERNATIONAL INSTRUMENTS
Plant genetic resources for food and agriculture exchanged using the standard material transfer agreement of the International Treaty on Plant Genetic Resources for Food and Agriculture ( Sections 2.3.1 and 5.2 )
Any other element relevant to relationship with other international instrument
- WHO PIP Framework (Sections 2.3.1 and 5.1)
OTHER
Competent national authority/ies ( No specific article )