Germany has not adopted access legislation according to the Nagoya Protocol. Therefore, access to genetic resources in Germany does not require "Prior Informed Consent” (PIC) and "Mutually Agreed Terms" (MAT) (see also Nagoya Protocol). However, other public and private law provisions apply which may prohibit or restrict access to genetic resources or make it subject to authorisation. For further information, please visit the information pages of the Federal Agency for Nature Conservation (see ABS information at BfN).
The EU-ABS Regulation has been in force since October 2014 and is thus directly applicable in the Member States. In Germany, it is supplemented by the "Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No. 511/ 2014".
Scope of the EU-ABS Regulation
The EU ABS Regulation is applicable if the following criteria are met:
- The respective material accessed is a genetic resources and/or related traditional knowledge.
- 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").
- 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.
- Access took place after the entry into force of the Nagoya Protocol (12 October 2014).
- 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.
Users have due diligence obligations
Users, for which the EU ABS Regulation is applicable, have to exercise due diligence. Due Diligence Declarations can be submitted to the enforcement authority via the EU Commission's online portal "DECLARE".
- 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 utilisation.
- 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:
- When receiving external research funding involving the utilisation of genetic resources.
- At the final stage of product development (as a result of the utilisation of a genetic resource).
Implementation of the EU-ABS Regulation in Germany
Germany has not adopted access regulations under the Nagoya Protocol. Thus, access to genetic resources in Germany is not dependent on having "PIC" and "MAT" (see Nagoya Protocol). However, other regulations under public and private law apply which may prohibit or restrict access to genetic resources or make it dependent on authorisation. More detailed information on this can be found on the information pages of the Federal Agency for Nature Conservation (see ABS information at BfN).
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).
Further information on the Nagoya Protocol, its implementation at European and national level and the resulting obligations for users is available at BfN's website.
In accordance with the German Implementation Act, the competent national authority shall make any determinations concerning the organisation of 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).