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Access and Benefit Sharing

Assistance for users

Assistance for users of genetic resources

Which rules do users of genetic resources for food and agriculture in Germany have to respect in order to comply with ABS legislation? What are the obligations regarding access to genetic resources or related traditional knowledge? You will find an initial overview here; if you have any questions about ABS in agriculture and nutrition, please do not hesitate to contact us.

The Federal Agency for Nature Conservation is responsible for the national enforcement and is available for further information (National Focal Point Nagoya Protocol).

Who is a user within the meaning of the EU regulation?

According to the EU-ABS-Regulation

•    users are natural or legal persons using genetic resources or traditional knowledge associated to
     genetic resources.
•    use is defined as carrying out research and development activities on the genetic and/or biochemical
      composition of genetic resources, including through the application of biotechnology (see Article 3 (4)
      and (5) of EU Regulation No 511/2014).

Due diligence obligations of users according to EU-regulation

Users of genetic resources in Germany have due diligence obligations under Regulation (EU) No. 511/2014 (see Article 4):

Any person exercising a utilization activity covered by the Regulation and utilizing a genetic resource or associated traditional knowledge, which is also within the scope of this Regulation, has to make sure that access to the resource or traditional knowledge has taken place in accordance with the ABS rules of the provider country.

In case of doubt, i.e. if there are uncertainties regarding the legality of genetic resources, the user must obtain the necessary information from the provider country or stop using the resource.

Further information on due diligence obligations is available on the website of the Federal Agency for Nature Conservation.

Due diligence declarations

If the genetic resource / associated traditional knowledge used is covered by the Nagoya Protocol, the EU ABS Regulation requires that due diligence declarations be sent to the authority (see Article 7 of EU Regulation No 511/2014).

The EU ABS Regulation specifies two checkpoints for due diligence declarations

A) Upon receipt of research funding
All recipients of research funding involving the utilisation of genetic resources or associated traditional knowledge shall declare that they exercise due diligence (in accordance with Article 5 of Implementing Regulation (EU) No 2015/1866).
B) At the stage of final development of a product
At the stage of final development of a product developed via the utilisation of genetic resources or associated traditional knowledge, users shall declare to the competent control authorities that they have complied with the due diligence obligations (pursuant to Article 6 of Implementing Regulation (EU) No. 2015/1866).

With the publication of the general order on the declaration of due diligence pursuant to Article 7 (1) of Regulation (EU) No 511/2014, all research funding recipients in Germany that fall within the scope of the Regulation are now obliged to issue a due diligence declaration in accordance with Article 7 (1) of Regulation (EU) No 511/2014 to the Federal Agency for Nature Conservation (BfN).

The due diligence shall be made after receipt of the first funding instalment, but not later than at the time of the final report or at the project end (Article 5 of Implementing Regulation (EU) No 2015/1866).
In Germany, these declarations are to be addressed to the Federal Agency for Nature Conservation. It is recommended that the due diligence declaration be submitted to the BfN electronically via the online form "DECLARE" of the European Commission. The European Commission has developed a user manual available through DECLARE.
Further information on due diligence requirements and the declarations to be submitted can be found on the website of the Federal Agency for Nature Conservation.

How do you as a user of genetic resources find out if you have due diligence obligations?

The EU ABS Regulation applies if the following criteria are met:
1.    genetic resources and / or related traditional knowledge are used
2.    it 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 use of biotechnology")
3.    the exploitation activities take place within the EU; the genetic resources are subject to sovereign
       of a Contracting Party to the Nagoya Protocol which has established access legislation in
       accordance with the Nagoya Protocol
4.    the access took place after the entry into force of the Nagoya Protocol (12 October 2014)
5.    the resources are not covered by a specialised international agreement, such as the Multilateral
       System of the International Treaty on Plant Genetic Resources for Food and Agriculture

Further information is available in the Guidance document of the European Commission on the scope of the EU ABS Regulation.

Do you use plant genetic resources for the purpose of research, breeding and training for food and agriculture?

If so, you may not have due diligence obligations because you are in the scope of the International Treaty on Plant Genetic Resources for Food and Agriculture Find out here whether this applies to you: Key questions on the applicability of the International Plant Treaty versus the EU ABS Regulation.