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Natural and legal persons who utilise genetic resources (or traditional knowledge associated with genetic resources) in Germany, i.e. who conduct research or development on the genetic or biochemical composition of genetic resources, including through the application of biotechnology, must meet certain due diligence obligations under Regulation (EU) No 511/2014. These due diligence obligations apply regardless of the size of the research institution or of whether the research or development is undertaken for commercial or non-commercial purposes.

Guidance document on the scope of application and core obligations of Regulation (EU) No 511/2014 (Notice No 2016/C 313/01)

Scope

It should first be noted that not every utilisation of genetic resources (or of traditional knowledge associated with them) comes within the scope of the Regulation. Instead, the scope of the Regulation is restricted in material, personal, geographic and temporal terms. Thus, for example, the due diligence obligations under the EU Regulation only apply if the following (cumulative) requirements are met:

Cumulative requirements for application of the EU Regulation

  • The access to the genetic resource, meaning its acquisition, must have taken place on or after 12 October 2014, the entry into force of the Nagoya Protocol and the EU Regulation (the time of utilisation is not relevant).
  • The genetic resource must not be a human genetic resource.
  • It must not be a genetic resource to which specialised international ABS rules apply (such as the International Treaty on Plant Genetic Resources for Food and Agriculture or the Pandemic Influenza Preparedness Framework).
  • The acquired genetic resource must be subject to the sovereign rights of the provider country, meaning it must have been obtained within the national jurisdiction of that country (including its exclusive economic zone) and not on the high seas or in the Antarctic.
  • The provider country must be a Party to the Nagoya Protocol.

  • The provider country must additionally have regulated access to its genetic resources and the specific genetic resource must be subject to that regulation.

  • The utilisation of the genetic resource concerned must take place within the EU (or for the purposes of German law, in Germany).

Utilisation

Utilisation of genetic resources within the meaning of the EU Regulation means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology (Article 3(5) of the EU Regulation). 

It is not a utilisation within the meaning of the EU Regulation, for example, if genetic resources are ‘solely’ kept, transferred or traded without the natural or legal person concerned carrying out research and/or development themselves.

Due diligence

If the EU Regulation applies, natural and legal persons who utilise genetic resources (or traditional knowledge based on genetic resources) in Germany must exercise due diligence (Article 4(1) of the Regulation). The purpose of this due diligence obligation is to ensure that users of genetic resources (or of traditional knowledge associated with genetic resources) satisfy themselves that the access to the genetic resources did not take place in breach of the provider country’s ABS legislation and that any benefits are shared in accordance with the mutually agreed terms.

Points to watch in complying with the due diligence obligation under Article 4(1) of the EU Regulation

  • Documentation: Users must seek, keep and transfer to subsequent users the information on the legality of access and on benefit sharing listed in Article 4(3)(a) and (b) of the Regulation. The retention period is 20 years after the end of the period of utilisation (Article 4(6)). 
  • Risk assessment: When the information in their possession is insufficient or uncertainties about the legality of access and utilisation persist, users must, in order to satisfy the due diligence obligation, subsequently obtain an access permit or its equivalent and establish mutually agreed terms on benefit sharing, or discontinue utilisation (Article 4(5)).
  • Risk reduction: Finally, users can reduce the risk of non-compliance with the due diligence obligation by obtaining their genetic resources from a registered collection (Article 4(7)) and/or by implementing a best practice (Article 9(1)).

Declarations

In addition to exercising due diligence in accordance with Article 4(1) of Regulation (EU) No 511/2014, users of genetic resources (or of traditional knowledge associated with genetic resources) must also submit due diligence declarations at two different stages:

  • At the research funding stage (see Article 7(1) of the EU Regulation read in conjunction with Article 5 and Annex II of Implementing Regulation (EU) 2015/1866).
    Submission of a declaration under Article 7(1) of the EU Regulation is mandatory since 10 May 2018.

  • At the stage of final development of a product (see Article 7(2) of Regulation (EU) No 511/2014 read in conjunction with Article 6 and Annex III of Implementing Regulation).
    Submission of a declaration under Article 7(2) of EU Regulation is mandatory since 12 October 2015.

Both due diligence declarations under Article 7 of the EU Regulation can be submitted via the EU-wide web-based tool DECLARE.

User guide/Questions and answers – DECLARE NAGOYA IT system
Access to DECLARE

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