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Access and Benefit Sharing

Regulation (EU) No 511/2014

The EU Regulation implementing the Nagoya Protocol

Contracting Parties to the Nagoya Protocol shall take measures to ensure that the users of genetic resources within their territory comply with the ABS provisions. Regulation (EU) No 511/2014 (EU-ABS Regulation) provides the framework for the joint implementation of this control obligation under the Nagoya Protocol within all EU Member States. It has been in effect since October 2014 and is thus directly applicable in all member states.

Scope of the EU-ABS Regulation

The EU ABS Regulation is applicable if the following criteria are met:

1) The respective material accessed is a genetic resources and/or related traditional knowledge.
2) The genetic resource is used within the meaning of Regulation (EU) No 511/2014 (="carrying out
    research and/or development activities on the genetic and/or biochemical composition of genetic
    resources, including through the application of biotechnology").
3) The utilisation takes place within the EU; the genetic resources are subject to the sovereignty of a
    Contracting Party to the Nagoya Protocol; the genetic resource in question is subject to access
    legislation according to the Nagoya Protocol of the providing country.
4) Access took place after the entry into force of the Nagoya Protocol (12 October 2014).
5) The genetic resource in question is not covered by any special regulation, such as the Multilateral
     System of the International Treaty on Plant Genetic Resources for Food and Agriculture.

ABS-Clearinghouse, the internet platform of the CBD Secretariat

The ABS internet platform operated by the CBD Secretariat (ABS Clearinghouse) provides an overview of the Contracting Parties to the Nagoya Protocol and their domestic ABS provisions.

Users have due diligence obligations

Users have due diligence obligations

Users, for which the EU ABS Regulation is applicable, have to exercise due diligence:

•    Due Diligence: A user has to exercise due diligence in accordance with Article 4 of the EU-ABS
      Regulation to ensure that he only uses genetic material that has been acquired in accordance with
      the Nagoya Protocol. In case the user has any doubt about the legality of access and utilisation, he
      is obliged to obtain the appropriate permission and establish mutually agreed terms, or discontinue
•    Due Diligence Declaration: There are two points in time at which a user has to demonstrate to the
      national enforcement authority that he has exercised due dilligence:
             1.    When receiving external research funding involving the utilisation of genetic resources.
             2.    At the final stage of product development (as a result of the utilisation of a genetic

Due Diligence Declarations can be submitted to the enforcement authority via the EU Commission's online portal "DECLARE".

Implementation of the EU-ABS Regulation in Germany

The EU-ABS Regulation has been in force since October 2014 and is thus directly applicable in the Member States. The German Implementation Law adopted by the Federal Council in November 2015 came into force on 1 July 2016. Among other things, it identifies the competent authorities and specifies the obligations of users as well as sanctions in the event of infringements.

The competent national authority for the implementation of the Nagoya Protocol and the EU-ABS Regulation in Germany is the Federal Agency for Nature Conservation (BfN). For further information on the Nagoya Protocol, its implementation at European and national level and resulting obligations for users in Germany are available at BfN's website.

BLE’s responsibility within the national implementation

In accordance with the National Implementation Act, the competent national authority shall make any determinations concerning the organisation of the enforcement in Germany and related decisions with regard to genetic resources for food and agriculture in agreement with the Federal Office for Agriculture and Food (BLE). The responsible department for such agreements is the BLE Information and Coordination Centre for Biological Diversity (IBV).