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When do the rules apply?

When am I a user?

Rules on access and benefit-sharing apply to all users of genetic resources in the Netherlands. A “user” is a natural or legal person who utilises genetic resources or traditional knowledge associated with genetic resources. You are considered to be a user of genetic resources if your activities fall under the definition of utilisation.

User under the Nagoya Protocol

The Nagoya Protocol states: ”Utilization of genetic resources means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology”. If you are not conducting research and development, you are not considered to be a user under this definition. For example, trade in genetic resources is not considered to be utilisation when no research or development takes place. Whether or not the genetic material is destroyed afterwards is irrelevant. Genetic resources obtained under the conditions of the SMTA of the ITPGRFA are only provided for the purposes of research, breeding and training in the field of food and agriculture. If you use the material for other purposes than for food and agriculture, you are a user under the above definition. Provider countries may have established different conditions for different types of utilisation in their access legislation.

User under the EU ABS Regulation

‘Utilisation of genetic resources’ is defined in the Regulation (EU) No 511/2014 (the EU ABS Regulation, Article 3) and the Nagoya Protocol (Article 2) as “to conduct research and development (R&D) on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology, as defined in Article 2 of the Convention.”

For the EU ABS Regulation, both basic and applied research may be considered utilisation. If you are a user in this sense, the Dutch government will monitor your compliance with the rules stemming from EU Regulation 511/2014. This does not apply to genetic resources from the crops and forages covered by Annex I of the ITPGRFA that are received under the SMTA. For use of genetic resources not covered by Annex I, but received 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 , you are deemed to have fulfilled the obligations under the EU Regulation.

Research and development

The description of a genetic resource normally would also not amount to utilisation. However, if the description of a genetic resource is combined with research on that resource, i.e. to discover specific genetic and/or biochemical properties, this would qualify as utilisation in terms of the Protocol and the Regulation. As a type of ‘litmus test’, users should ask themselves whether what they are doing with the genetic resources creates new insight into characteristics of the genetic resource which is of (potential) benefit to the further process of product development. If this is the case, the activity goes beyond mere description, should be considered research, and therefore falls under the term ‘utilisation’.

Examples of activities considered to be utilisation

The following activities are mentioned by the EU as examples of activities that are considered to be utilisation of genetic resources in the sense of the EU ABS Regulation. For more information, see section 2.3.3 of the Guidance.

  • Research on a genetic resources leading to the isolation of a biochemical compound used as a new ingredient (active or not) incorporated into a cosmetic product.
  • Breeding programme to create a new plant variety based on landraces or naturally occurring plants.
  • Genetic modification — creation of a genetically modified animal, plant, or microorganism containing a gene from another species.
  • Creation or improvement of yeasts, resulting from human action through a research and development process, to be used in manufacturing processes (but see below, example on application of biotechnology).

Examples of activities not considered to be utilisation

The following activities are mentioned by the EU as examples of activities that are not considered to be utilisation of genetic resources in the sense of the EU ABS Regulation. For more information, see section 2.3.3 of the Guidance.

  • Supply and processing of relevant raw materials for subsequent incorporation in a product where the properties of the biochemical compound contained in the genetic resources are already known, since  no research and development is carried out here. This is the case, for example, in the supply and processing of Aloe Vera, Shea nut or butter, rose essential oils, etc. for further incorporation into cosmetics.
  • Genetic resources as testing/reference tools. In this case the material is not the object of the research in itself but only serves to confirm or verify the desired features of other products developed or under development. This may include laboratory animals used to test their reaction to medical products, or laboratory reference material (including reference strains), reagents and samples of proficiency tests or pathogens used for testing the resistance of plant varieties. Caution: at an earlier stage, however, research and development may have been carried out on those genetic resources, with the aim of turning them into (better) testing or reference tools, and as such would be within the scope of the Regulation.
  • Handling and storing of biological material and describing its phenotype.
  • The application of biotechnology in a way which does not make the genetic resource in question the object of research and development. The use of yeasts in the brewing of beer, for example, is not to be considered as utilisation of that genetic resource when no research and development is carried out on the yeast, and it is used ‘as is’ in the process of brewing.

For more information, consult section 2.3.3 of the Guidance.

From when do these rules apply?

Importantly, the rules of the CBD and the Nagoya Protocol do not apply retroactively. This means that Access and Benefit-Sharing obligations do not apply to genetic resources that were in your possession before 28 December 1993, but may apply to all genetic resources acquired thereafter. If the country providing you with the genetic resources had or introduced rules or regulations for ABS after 1993, you have to comply or should have complied with them. 

The compliance measures laid down in the Nagoya Protocol and implemented through EU Regulation 511/2014 do not apply to genetic resources already in your possession before 12 October 2014. The EU rules only apply to genetic resources that were obtained and used on or after 12 October 2014. In other words, Access and Benefit-Sharing obligations exist since the coming into force of the CBD, but EU obligations only since 12 October 2014.

Do these rules apply to access from all countries?

The EU regulations only apply for access to genetic resources from countries that have ratified the Nagoya Protocol (reciprocity). If that is not the case, users in the Netherlands are not bound by the conditions of the Protocol when accessing genetic resources from the countries in question, and the Dutch authorities will not monitor compliance. However, these countries may still impose conditions on the access to and use of their genetic resources. In that case, you have to comply with these conditions. The only country that has not ratified the CBD, and will therefore neither ratify the Nagoya Protocol, is the USA. Many genetic resources accessed from collections held in the USA therefore come without strings attached as regards monitoring of their use. There may however be conditions for access or use derived from the national legislation that you need to comply with.

Do these rules also apply to plant genetic resources for food and agriculture?

In many cases, specific rules exist for accessing plant genetic resources for food and agriculture. These stem from the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), which has been signed and ratified by more than 145 countries including the Netherlands. The ITPGRFA is a specialised agreement in harmony with the CBD and the Nagoya Protocol. Access to public collections held in countries that are a Party to the ITPGRFA is often under the terms of the Standard Material Transfer Agreement (SMTA). In effect, this means that as a user you have to fulfil the conditions from that Agreement and the obligations under Article 4(3) of the EU Regulation.

Does genetic material acquired under the PIP Framework fall within the scope of the EU ABS Regulation?

No, because the PIP Framework has been recognised in the EU ABS Regulation as a specialised international access and benefit-sharing instrument, genetic material covered by the PIP Framework is not within the scope of the EU ABS Regulation.