Regulation (EU) No 511/2014 of the European Parliament and of the Council 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 was adopted on 16 April 2014. Implementing the mandatory elements of the Nagoya Protocol in the European Union, it entered into force on 9 June 2014 and applies from the date the Nagoya Protocol itself entered into force for the Union, i.e. 12 October 2014.
For information on possible access measures adopted by EU Member States, please consult their country profile on the international ABS Clearing-House.
Designated Competent Authorities under the Regulation EU (No) 511/2014
Designated Competent Authorities in the EU Member States are responsible for implementing the EU ABS Regulation.
Commission Implementing Regulation
The Implementing Regulation contains measures on some specific aspects, as provided for in the EU ABS Regulation, in particular registered collections, best practices and monitoring of user compliance. It was adopted by the Commission on 13 October 2015, with entry into force on 9 November 2015.
With regard to the monitoring of user compliance, a web-based application (DECLARE) was created to allow users' submission of due diligence declarations online. The manual for users of DECLARE provides an explanation on its use. An audio-visual manual on the use of DECLARE is available too.
You will also find attached a privacy statement regarding the protection of your personal data in DECLARE.
The Implementing Regulation was developed with the support of the EU Member States' representatives in the ABS Committee. Before presenting its draft Regulation to the Committee, the Commission also gathered input from stakeholders on a discussion paper and its annexes reflecting ideas to be included in the draft. Subsequently stakeholders were invited to submit written comments on the paper. Some 50 organisations participated in this targeted consultation (click on the links in the list to see written submissions). The Commission prepared short summaries of stakeholders' written submissions and of its proposal for taking into account the views expressed during the consultation.
"Best practices" under the terms of the EU ABS Regulation (Art. 8 of EU ABS Regulation) 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 EU ABS Regulation. The procedural requirements for the recognition of best practices are set out in the Implementing Regulation. Applications for recognition of best practices can be sent to the Commission's functional mailbox ENV-F3-NAGOYA-ABS@ec.europa.eu. Once recognised as such by the Commission, best practices will be included in the Register. Currently there is one recognised best practice in the Register.
Register of collections
A registered collection (Art. 5 of the EU ABS Regulation) refers to a collection which has demonstrated the capacity to apply standardised procedures for exchanging samples of genetic resources (and related information), to supply genetic resources (and related information) to 3rd persons with documentation providing evidence that the genetic resources have been accessed in accordance with applicable ABS legislation, to keep records of samples etc. The procedural requirements for the registration of collections of genetic resources are set out in the Implementing Regulation. The European Commission is responsible for establishing and maintaining the Register of collections within the Union, whereas the Member States are responsible for verifying that the collection meets the criteria set out in the EU ABS Regulation and granting the status of registered collection. Once Member States have recognised any collections in line with Article 5 of the Regulation, they are included in a dedicated Register. Currently there are three registered collections in the Register.
Guidance documents and Consultation Forum
Guidance document C(2020)8759 on the scope of application and core obligations of Regulation (EU) No 511/2014 (EU ABS Regulation) has been adopted on 14 December 2020. It incorporates and complements the previously adopted guidance document of 2016.
The new document clarifies the temporal, geographical and material scope for the application of the EU ABS Regulation and explains the core obligations under the Regulation. With regard to the material scope and the concept of utilisation, the Commission Notice provides for a general understanding of the requirements of the Regulation concerning research and development activities in all commercial and non-commercial sectors, whereas Annex II provides for additional details on the concept of utilisation covering specific sectorial aspects. Annex I provides for an o verview of the conditions for the applicability of the EU ABS Regulation. This guidance document is only intended to assist citizens, businesses 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, and it should be used in conjunction with this legislation.
A report on utilisation practices among the upstream actors (collections, researchers at universities, etc), prepared by a contractor, was one of the many elements that fed into the guidance document. The issues raised in the guidance document were discussed with the ABS Consultation Forum, the first meeting of which was held in January 2016.
Implementation and enforcement
Article 16(2) of the EU ABS Regulation requires the Commission to submit to the European Parliament and the Council a report on the application of the Regulation, including an assessment of its effectiveness. The first EU ABS Regulation Implementation Report was adopted on 24 January 2019. It covers the first three years of application of the EU ABS Regulation, i.e. the period between October 2014 and August 2017, which is reduced to two years of application for provisions concerning due diligence (Art. 4), monitoring of user compliance (Art. 7) and compliance checks (Art. 9). It is based on information from the national reports submitted by all 28 Member States to the Commission, as well as other information available. Member States’ National Reports are available here:
In order to ensure a uniform implementation of the EU ABS Regulation across the European Union and provide a platform for cooperation between the Member States Competent Authorities as well as with the European Commission, the Commission has set up the ABS Expert Group. The Group meets approximately four times a year to share information, best practices and lessons learnt, and to develop guidance for the users of genetic resources. A summary record of the meetings of the ABS Expert Group is published in the Register of Commission Expert Groups.
In November 2017, the European Commission organized a workshop in Brussels with a view to provide an opportunity to Parties to the Nagoya Protocol to exchange views and experiences on current and arising challenges in implementing both access and compliance regimes, towards a more coherent interpretation and implementation of the concepts and provisions of the Protocol. Partners from provider countries were invited to present their access measures. Also, users and EU Competent National Authorities were invited to share their perspectives. All presentations given by participants to the workshop are summarized in a report.
Studies, reports and other material
In the context of a contract service, the Commission tasked Milieu Ltd to carry out a preliminary analysis of the implications of the compliance obligations under the EU ABS Regulation for users of genetic resources in the EU. The report focuses on the identification and analysis of the positive and negative consequences of compliance with the EU ABS Regulation (EU) for both public research institutions and industry, including for small and medium-sized enterprises (SMEs).
The Commission has commissioned two independent studies on legal and policy aspects and on the technical aspects to explore possible ways to address digital sequence information (DSI), in preparation of the CBD COP 15 and NP COP-MOP4 negotiations. The studies have been carried out by independent experts and do not represent nor prejudge the position of the EU and its Member States. The information in the studies aim to inform the discussion around this topic, and by no means prejudge the outcomes of the next negotiations.