[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 second ABS Focal Point newsletter. In this newsletter you can find:

• New interactive tool to help you comply with the EU ABS Regulation.
• Accessing genetic resources: ABS procedures on the ABS Clearing-House.
• EU ABS Regulation: in or out of scope?
• Minimising your administrative burden: specialised ABS instruments.
• New EU Guidance document expected.

Your activities with genetic resources may be in scope of the EU ABS Regulation (EU Regulation 511/2014). The ABS Focal Point has developed an interactive tool to help you determine if your activities are in scope of the EU ABS Regulation.

Additionally, the help tool provides a short overview of your obligations under the Regulation if your activities are within scope. The page also contains a printable flowchart that is to be used in combination with the information on the page and a list which explains important terms used in the tool.

An increasing number of countries publish their ABS procedures on the ABS Clearing-House. These national records provide concise information on how users can apply for access to the country’s genetic resources and traditional knowledge.

The aim of the ABS procedures is to provide an overview of the application process, including details about where to apply, application requirements, a step-by-step description of the procedure, required documents and whether there are application fees.

Currently, seventeen countries have published ABS procedures: Belarus, Benin, Bhutan, Cameroon, Costa Rica, the Dominican Republic, France, India, Kenya, Malta, Panama, Peru, South Africa, Sudan, Switzerland, Uruguay and Zimbabwe. The ABS procedures can be accessed through the ‘Country profiles’ under ‘PRO’ and through this Search page.

When are your activities with genetic resources in or out of scope of the EU ABS Regulation? In this article, we highlight some examples of activities with genetic resources that are in or out of the scope of the EU ABS Regulation.

The EU ABS Regulation (Regulation (EU) 511/2014) only applies when all three following conditions are met:

• the genetic resource was accessed on or after 12 October 2014;
• the genetic resource originated from a country that is a Party to the Nagoya Protocol and has established applicable ABS legislation;
• research and/or development has been carried out on the genetic and/or biochemical composition of genetic resources within the EU (‘utilisation of genetic resources’).

If these three conditions are met, your activities with genetic resources may be in scope of the Regulation.   

Examples of situations in scope of the EU ABS Regulation

The following activities are in scope of the EU ABS Regulation if they are carried out in the EU with genetic resources accessed on or after 12 October 2014 from a country that is a Party to the Nagoya Protocol and has established applicable ABS legislation.

• Research on genetic resources leading to the isolation of a biochemical compound used as a new ingredient 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.

Examples of situations out of scope of the EU ABS Regulation

• Human genetic resources are not covered by the Convention on Biological Diversity (CBD) and the Nagoya Protocol, and their utilisation is therefore out of scope of the EU ABS Regulation.
• When genetic resources covered by an EU-recognised specialised ABS instrument (the ITPGRFA and the PIP Framework) are utilised in accordance with these instruments, they are out of the EU ABS Regulation’s scope.
• When genetic resources traded as commodities are used for direct consumption or as ingredients of, for instance, food or drinks, they fall outside the scope of the Regulation because there is no utilisation. However, research and/or development on these genetic resources may be in scope.
• When genetic resources only serve as testing or reference tools, they are not in scope of the EU ABS Regulation. Examples include laboratory animals used to test the effectivity of medical products, laboratory reference material (including reference strains) or pathogens used for testing the resistance of plant varieties.

More examples of situations that are in or out of scope are given on the ABS Focal Point website: ‘What is the scope of the EU ABS Regulation?’

Out of scope of the EU ABS Regulation? Also check national ABS legislation of the provider country!

Even when your activity with genetic resource falls outside the scope of the EU ABS Regulation, national ABS legislation or regulatory requirements of the provider country still apply. As a user, you should comply to the rules of the provider country. Otherwise, you may be called to account by the authorities of that country at a later stage.

More information on the scope of the EU ABS Regulation is found on the ABS Focal Point website, in particular the sections ‘EU Regulation 511/2014’ and 'When am I a user?'.

EU-recognised specialised ABS instruments (currently the ITPGRFA and the PIP Framework) can help you to minimise the administrative burden while complying with ABS rules. When genetic resources are obtained and used in accordance with these instruments, there are no obligations related to the EU ABS Regulation.

When genetic resources are covered by an EU-recognised specialised ABS instrument (ITPGRFA or PIP Framework), their use falls outside the scope of the EU ABS Regulation (Regulation (EU) 511/2014). Which genetic resources are covered by these instruments, and how can they be accessed?

ITPGRFA

The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) deals specifically with plant genetic resources for food and agriculture (PGRFA). The ITPGRFA is recognised as a specialised ABS instrument by the Nagoya Protocol and the EU ABS Regulation.

The core of the ITPGRFA is the multilateral system (MLS), a shared pool of genetic resources of 64 important crops and forages that are listed in Annex I of the ITPGRFA. Genetic resources included in the MLS are available for research, breeding and training for food and agriculture purposes. If the genetic resource is used for other purposes, use of the genetic resource may be in scope of the EU ABS Regulation.

Access to genetic resources in the MLS is provided on the basis of the ITPGRFA’s standard material transfer agreement (SMTA) with fixed conditions regarding use and benefit-sharing. Some countries issue their PGRFA under the conditions of the SMTA, including PGRFA not listed in Annex I of the ITPGRFA. When you access these genetic resources under the SMTA, you are considered to have exercised due diligence as required by the EU ABS Regulation.

For more information, consult the ITPGRFA document and the ABS Focal Point page on the ITPGRFA.

The Pandemic Influenza Preparedness (PIP) Framework is an international instrument that aims to improve pandemic influenza preparedness and response by establishing a system for 1) the global sharing of H5N1 and other influenza viruses with human pandemic potential and 2) access to vaccines and sharing of other benefits.

The PIP Framework establishes a global multilateral system for Access and Benefit-Sharing (ABS) regarding potential pandemic influenza materials. It applies to H5N1 and other influenza viruses with human pandemic potential, but not to seasonal influenza viruses or other non-influenza pathogens, such as SARS-CoV-2, the causal agent of COVID-19. Genetic resources are accessed through a multilateral system using standard material transfer agreements (SMTA1 and SMTA2).

The PIP Framework is recognised as a specialised ABS instrument in the EU ABS Regulation. When genetic material is covered by the PIP Framework, there are no obligations related to the EU ABS Regulation. It is not yet officially recognised under the Nagoya Protocol, although it may be accepted as a specialised instrument in the future.

For more information on the PIP Framework, consult the PIP Framework page on the ABS Focal Point website.

For more information on specialised ABS instruments, consult sections 2.3.1, 5.1 and 5.2 of the Guidance document.