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
The following designated Competent Authorities in the EU Member States are responsible for implementing the EU ABS Regulation (new information will be added here as soon as it is communicated to the Commission).
Ministry of Environment and Water (for genetic resources from natural flora and fauna)(for due diligence declarations)
Ministry of Agriculture and Food (for agricultural and forestry genetic resources)
Ministry of Economy (for genetic resources from industrial microorganisms, viruses and cell cultures)
The Finnish Environment Institute
|Germany||Federal Agency for Nature Conservation/ Bundesamt für Naturschutz
Fachgebiet I 1.4 "Vollzug Nagoya-Protokoll"
|Hungary||National Inspectorate for Environment, Nature and Water
Mészáros utca 58/a, 1016 Budapest (postal address: Pf. 675, 1539 Budapest)
Tel: +36 1 224 9100 fax: +36 1 224 9163
Plant Health Directorate
Ministerie van Economische Zaken / Ministry of Economic Affairs
|Poland||Ministry of Environment,
Wawelska 52/54, 00-922 Warszawa
Tel: +48 22 36 92 479
National Environmental Protection Agency,
|Slovak Republic||Slovak Environmental Inspectorate (Slovenská inšpekcia životného prostredia)
Jeséniova 17D, 831 01 Bratislava
Tel.: 00 421 2654 22 408
Fax.: 00 421 2593 04 191
Ministry of the Environment and Spatial Planning (competent for genetic resources of species of wild flora and fauna) (for due diligence declarations)
Ministry of Agriculture, Forestry and Food (competent for genetic resources for agriculture, forestry and food)
Ministry of Education, Science and Sport (competent for research on genetic resources and traditional knowledge associated with genetic resources)
|Sweden||Swedish Environmental Protection Agency,
Valhallavägen 195, SE-106 48 Stockholm
Tel: + 46 10 698 10 00
e-mail: firstname.lastname@example.org ; email@example.com
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.
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.
Register of recognised best practices
"Best practices" in the sense of the ABS Regulation (Art. 8) 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. Once recognised as such by the Commission, best practices will be included in a dedicated register.
Register of collections
The procedural requirements for the registration of collections of genetic resources (Art. 5 of the EU ABS Regulation) are set out in the Implementing Regulation. Once Member States have recognised any collections under these provisions, they will be included in a dedicated register.
Guidance documents and Consultation Forum
A guidance document on the scope of the EU ABS Regulation has been adopted on 22 August 2016 and published in the Official Journal on 27 August 2016. 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 this guidance document. The issues raised in the guidance document were discussed in the Consultation Forum, the first meeting of which was held in January 2016.
Additional sectorial guidance documents on Cosmetics, Animal Breeding, Plant Breeding, Biocontrol, Pharmaceuticals, Food and Feed, Biotechnologies and Upstream Actors are being developed.