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Due diligence obligations of users Information for users

Anyone carrying out an utilisation activity covered by the EU Regulation  using genetic resources or traditional knowledge associated with them must ensure that no ABS rules of the provider country have been breached in accessing them.

Due diligence obligations of users according to the EU-Regulation

(Source: Scott Graham, unsplash.com)

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.

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

If yes, then you may not have any due diligence obligations to fulfil because the material you are using is within the scope of the International Plant Treaty. Find out here whether this applies to you: Guiding questions on the applicability of the Plant Treaty versus the EU Regulation.

Due diligence declaration

If the genetic resource used or the associated traditional knowledge falls under the Nagoya Protocol, the EU ABS Regulation stipulates that due diligence declarations must be submitted to the Competent National Authority (see Article 7 of EU Regulation No. 511/2014). In Germany, these declarations are to be addressed to the Federal Agency for Nature Conservation. It is recommended to submit the due diligence declaration to the BfN electronically via the online form "DECLARE" of the EU Commission. The European Commission provides further information and a user manual for DECLARE here.

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).

Note

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).