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How can I comply with the rules and minimise the administrative burden?

User obligations

In the European Union, the compliance aspects of the Nagoya Protocol are implemented through EU Regulation 511/2014 (EU ABS Regulation). As a user, you must fulfil the user obligations laid down in Article 4 of the EU ABS Regulation. In short, these obligations include the following:

  1. As a user, you shall exercise due diligence to make sure that the genetic resources and traditional knowledge associated with genetic resources that you utilise have been accessed in accordance with applicable ABS legislation or regulatory requirements, and that the benefits arising from such use are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements, in particular of the country providing your genetic resources.
  2. Genetic resources and traditional knowledge associated with genetic resources shall only be transferred and utilised in accordance with mutually agreed terms.
  3. As a user, you shall seek, keep and transfer to subsequent users an internationally recognised certificate of compliance, as well as information on the content of the mutually agreed terms relevant for subsequent users; or, if an internationally recognised certificate of compliance (IRCC) is not available, information and relevant documents on:

    (i) the date and place of access to genetic resources or traditional knowledge associated with genetic resources;

    (ii) the description of the genetic resources or of traditional knowledge associated with genetic resources utilised;

    (iii) the source from which the genetic resources or traditional knowledge associated with genetic resources were directly obtained, as well as subsequent users of genetic resources or traditional knowledge associated with genetic resources;

    (iv) the presence or absence of rights and obligations relating to Access and Benefit-Sharing including rights and obligations regarding subsequent applications and commercialisation;

    (v) access permits, where applicable;

    (vi) mutually agreed terms, including benefit-sharing arrangements, where applicable.

Minimising your administrative burden

When complying with the rules, you should first check whether your organisation or company has established a policy on accessing genetic resources.Your organisation may already document some or all of the information you are required to have under an internal quality scheme.

The use of genetic resources covered by a EU-recognised specialised ABS instrument (ITPGRFA or PIP Framework) falls outside the scope of the EU ABS Regulation.

Your organisation may also be part of a user community whose best practice has been recognised by the EU Commission under EU Regulation 511/2014. In such cases, follow that policy or best practice. If recognition is possible and your user community’s best practice has not yet been recognised, establishing and gaining approval may also reduce your administrative burden. A selection of best practices and codes of conduct can be found on the page Downloads and links.

If you have obtained a genetic resource from a collection included in the register of collections within the European Union, you are considered to have exercised your due diligence obligations with regards to collecting information.

If possible, minimise your administrative burden by obtaining access to genetic resources under an internationally recognised Certificate of Compliance (IRCC) or under the Standard Material Transfer Agreement (SMTA) of the ITPGRFA. When you access plant genetic resources from countries that issue their plant-genetic resources for food and agriculture under the conditions of the SMTA, including those not listed in Annex I of the ITPGRFA , you are considered to have exercised due diligence (see Article 4(4) of the Regulation). More formally, this means that users acquiring PGRFA from a country that is a Party to the Nagoya Protocol which has determined that PGRFA under its management and control and in the public domain, not listed in Annex I to the ITPGRFA, shall also be subject to the terms and conditions of the SMTA of the ITPGRFA, shall be considered to have exercised due diligence.

In short

You can minimise your administrative burden:

  • by using genetic resources that are covered by a EU-recognised specialised ABS instrument (ITPGRFA or PIP Framework). Use of this material is outside the scope of the EU ABS Regulation.
  • by accessing genetic resources under an internationally recognised Certificate of Compliance (IRCC);
  • by establishing fixed procedures in your user community and having these procedures recognised as best practice;
  • by integrating your documentation obligations in an existing internal quality management scheme, for example by joining a user community which already has a recognised best practice;
  • by accessing genetic resources from the Multilateral System of the ITPGRFA and signing the Standard Material Transfer Agreement.

You are deemed to have complied (in part) with your due diligence obligations under EU law when:

  • accessing genetic resources from a registered collection in the European Union. You have then met your due diligence obligations regarding the collection of information;
  • receiving plant genetic resources ( not listed in Annex I of the ITPGRFA) under the conditions of the SMTA of the ITPGRFA from countries that issue plant-genetic resources for food and agriculture, including those not listed in Annex I of the ITPGRFA, under the conditions of the SMTA. This procedure ensures that you are considered to have exercised due diligence (see Article 4(4) of the Regulation).

If you access genetic resources from the Multilateral System of the ITPGRFA by signing the fixed Standard Material Transfer Agreement, all your obligations are included in this Agreement.