[For the Dutch version, see the ABS Focal Point website.]
[Voor de Nederlandse versie, zie de website van het ABS Focal Point.]

Welcome to the eleventh ABS Focal Point newsletter. In this newsletter we update you on the most recent discussions on digital sequence information (DSI), explain what an IRCC is and delve deeper into when you are considered to be a user of genetic resources.

• Further discussions on Digital Sequence Information (DSI).
• The internationally recognised certificate of compliance (IRCC) of the Nagoya Protocol.
• Are you a user of genetic resources?

Further discussions on Digital Sequence Information (DSI)

• encouragement of more deposits of data in databases;
• the use of country tags indicating the origin of the genetic resources from which DSI was generated;
• the provision of legal certainty and clarity for providers and users of DSI;
• the solution to be efficient, feasible and practical;
• the solution to be adaptable to future technology changes;
• the solution to be mutually supportive of other ABS instruments;
• the promotion of research and innovation, and technical and scientific cooperation, capacity-building and technology for the purpose of conservation and sustainable use of biodiversity;
• taking into account the the rights of indigenous peoples and local communities over their traditional knowledge associated with genetic resources;
• the monetary and non-monetary benefits arising from the use of DSI on genetic resources to be used to support conservation and sustainable use of biodiversity;
• access to DSI in public databases to remain open, as this supports research and innovation.

The internationally recognised certificate of compliance (IRCC) of the Nagoya Protocol

You may have heard the terms ‘IRCC’ or ‘internationally recognised certificate of compliance’ in the context of ABS and the Nagoya Protocol. What are IRCCs and how do they make it easier for users to fulfil their due diligence obligations?

What is an IRCC?
An internationally recognised certificate of compliance (IRCC) is a document published on the ABS Clearing-House website (ABSCH) by the provider country. This document, which is visible for everybody, is meant for monitoring and providing transparency on the utilisation of genetic resources under the Nagoya Protocol. An IRCC provides evidence that the user has accessed a genetic resource legally and in accordance with prior informed consent (PIC) and that mutually agreed terms (MAT) have been established, if required by the domestic ABS legislation or regulatory requirements of the provider country.

Additional information may be included, for instance on the conditions for third party transfer, as is specified in this IRCC. A published IRCC does not always provide all the elements mentioned above, for instance because some information is considered confidential. For example, this IRCC does not list the person or entity to whom PIC was granted. The ABSCH provides a list of all IRCC published by provider countries.

How can I use an IRCC?
After you have obtained PIC and MAT, ask the competent national authority (CNA) of the provider country to publish an IRCC on the ABS Clearing-House website. When a compliance check is carried out, you can easily refer to the IRCC number to show that you have performed your due diligence obligations as a user of genetic resources.

If this is not feasible, users need to document and provide information to show that they have applied due diligence. In this case, you need to go through the steps laid down in EU ABS Regulation (Regulation (EU) 511/2014), Article 4, paragraph 3, which specifies the information you need to collect to fulfil your obligations in this field. As it can take some effort to collect and keep this documentation, having an IRCC helps you to minimise your administrative burden.

IRCCs on the ABS Clearing-House
Since the Nagoya Protocol came into force in 2014, over 4000 IRCCs have been published on the ABS Clearing-House by twenty-five provider countries. The number of certificates of compliance published on the ABSCH has more than tripled in the past two years. The countries that have published the most IRCC are India (2927), France (587) and Spain (146).

Are you a user of genetic resources?

If your activities with genetic resources fall under the definition of utilisation, you are considered to be a user. The EU ABS Regulation and EU Guidance document provide more information on what constitutes ‘utilisation of genetic resources’ within the European Union.

In short, utilisation of genetic resources means: “to conduct research and/or development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology.” This definition is used by the Nagoya Protocol and the EU ABS Regulation.

If your activities with genetic resources fall under the definition of utilisation, you are considered to be a user. This is independent of the users’ size or of the intent of the use (commercial or non-commercial) and applies to individuals, including researchers, and to organisations such as universities or other research organisations, as well as to small and medium sized enterprises and multinational companies.

Examples of activities that are considered to be utilisation under the EU ABS Regulation

(NB The ‘Guidance sections’ indicated in the examples below refer to sections of the EU Guidance document that provide more information on the specific examples.)

• Research on genetic resources leading to the isolation of a biochemical compound used as a new ingredient (active or not) incorporated into a cosmetic product (Guidance section 2.3.3.2).
• Genetic modification — creation of a genetically modified animal, plant, or microorganism containing a gene from another species (Guidance section 2.3.3.2).
• Animal breeding which involves crossing and selection for the purpose of improving or changing the properties of established breeds (Guidance Annex II section 8.1).

Which activities are not considered utilisation?
If you are not conducting research or development, you are not considered to be a user under the definition of the EU ABS Regulation.

There are some activities, related to research and development, that are not considered utilisation under the EU ABS Regulation. The EU Guidance, specifically Annex II, elaborates on these activities.

Below are a few examples of activities that are not considered to be utilisation in the sense of the EU ABS Regulation. However, if an activity mentioned below is combined with research on the specific genetic and/or biochemical composition of the genetic resource, specifically the function of the genes, the activity would qualify as utilisation.

Examples of activities that are ­not considered to be utilisation under the EU ABS Regulation

• Trade and exchange of genetic resources as commodities. No research and development is carried out here (Guidance section 2.3.1.3).
• (Taxonomic) identification and characterisation (Guidance Annex II chapter 6).
  • The activity of describing a genetic resource would normally not be considered utilisation under the EU ABS Regulation. However, if it is combined with research on that resource to discover specific genetic and/or biochemical properties, the activity would qualify as utilisation. As a type of ‘litmus test’, users should ask themselves if what they are doing with the genetic resource creates new insight into the 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’.
• Applying 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 (Guidance section 2.3.3.2, Annex II chapter 7).

Do note that some provider countries have established national access legislation for their genetic resources, with their own interpretation of ‘utilisation of genetic resources’, which may differ from the EU interpretation. This means that it is possible that activities which are not considered utilisation under the EU ABS Regulation are subject to national ABS rules of the provider country. Therefore it is recommended to contact the provider country’s National Focal Point (NFP) of the provider country to ask if any national ABS rules apply. The names and contact details of the NFPs of most countries are available on the ABS Clearing-House website.

For a more extensive overview of activities which are considered utilisation or not, see ‘When am I a user under the EU ABS Regulation?’ in the FAQ section of the ABS Focal Point website, and section 2.3.3 and Annex II of the EU Guidance.

Read more
For information on some of the sector-specific topics mentioned in the EU Guidance, see our previous articles:

• Animal breeding and the EU ABS Regulation
• Scope of the EU ABS Regulation: characterisation and phylogenetic analysis
• Utilisation: taxonomic identification and testing and reference tools