Before conducting your field sampling you should check to see if you need to comply with the Nagoya Protocol/ABS regulations. Non-Compliance could lead to penalties, and the inability to publish or use research results. Please be aware of sampling outside the EU as regulations may differ.
It is strongly advised that you also look at the ABS guidance for fresh terrestrial sampling, fresh marine sampling, or sampling in ex-situ collections (depending on how you obtained the genetic resources) to determine if you need to comply with ABS and how to do so.
Please also browse the resource pages for more.
Secretariat of the Convention on Biological Diversity (2010). Introduction to Access and Benefit‑Sharing (ABS) [Brochure]. Available at: https://www.cbd.int/abs/infokit/brochure-en.pdf (Accessed: 28 August 2025).
Consortium of European Taxonomic Facilities (CETAF) ( 2019). Code of Conduct & Best Practice for Access and Benefit‑Sharing [Leaflet]. Available at: https://www.cetaf.org/wp-content/uploads/CETAF‑Code‑of‑conduct‑Best‑practice‑for‑ABS‑A4‑leaflet.pdf (Accessed: 28 August 2025).
Scarlett Sett & Dirk Neumann (2023). Biodiversity Genomics workshop on ABS Training Materials: Training Videos (1 & 2) and Presentations [Videos 1, Video 2 and presentation slides]. BGE Project.
European Parliament and Council of the European Union (2014). Regulation (EU) No 511/2014 of 16 April 2014 on compliance measures for users under the Nagoya Protocol (text with EEA relevance) [Regulation]. Official Journal of the European Union L 150, pp. 59–71. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0511 (Accessed: 28 August 2025).
ABS requires due diligence
Keep a record of:
The disposal method used
Any communications with the provider country competent authority
A declaration that the material is no longer in use and has been disposed of appropriately.
These records may be required if you are audited under the EU ABS regulation 511/2014.
Once disposal is initiated:
Do not transfer the specimen to another party for use, unless explicitly permitted by the MAT or national laws.
Prevent unintentional access
If you store data associated with the specimen (e.g. sequences), check whether the agreement requires limits on its use or access.
For specimens that were sourced from Indigenous People/ Local Communities or where obtained with traditional knowledge then objects should be handled transparently and including those communities associated with the specimen.
Align with ethical principles like CARE (Collective Benefit, Authority to Control, Responsibility, Ethics).
If you have documentation (e.g. permits, MTAs, PIC, MAT) check whether, you need to check:
Any restrictions on if the specimen can be disposed of and how.
The provider country requires return, notification or consent before disposal.
Even if the specimen does not have any associated permits, or there is no information that does not relate to the disposal then you will need to ask the provider countries competent authorities for advice.
You can find the ABS Clearing House to find the right contact.
ABS also covers transfer to others and how the specimen can be used.
Before doing anything with the specimen, you need to confirm:
Where the specimen originally came from (country of origin)
Whether it falls under the Nagoya Protocol or the provider country’s ABS laws.
If you or your institution signed a Prior Informed Consent (PIC), Mutually Agreed Terms (MAT) or a Material Transfer Agreement (MTA).
Before checking your ABS responsibilities, it helps to understand these commonly used terms:
Prior Informed Consent (PIC)
Permission from the provider country (usually through a national authority) to access its genetic resources. This must be obtained before collecting or using the material.
Mutually Agreed Terms (MAT)
A legally binding agreement between the user and the provider country, outlining how the material may be used and how benefits will be shared (e.g. co-authorship, sharing results, royalties).
Material Transfer Agreement (MTA)
Material Transfer Agreements (MTAs) are legal documents that set the terms for transferring biological materials—such as specimens or genetic samples—between organizations. They define the rights, responsibilities, and conditions related to the material’s use, including legal, ethical, and institutional obligations.
MTAs are essential for:
Ensuring proper credit and acknowledgment in research outcomes
Protecting ownership, intellectual property, and access to benefits
Defining the nature and conditions of the transfer
Clarifying liability and responsibility in case of misuse or loss
Complying with legal, ethical, and funding requirements (e.g., BGE project standards)
Digital Sequence Information (DSI)
Refers to digital genetic data such as DNA, RNA, or protein sequences. DSI is not currently regulated under the EU ABS Regulation, but some provider countries do consider it part of their ABS requirements. Always check local rules via the ABS Clearing-House.
DECLARE
The EU’s online platform for submitting due diligence declarations under the ABS Regulation, required when conducting research on ABS regulated genetic material, especially if using EU funding.
The EU Regulation 511/2014 on compliance measures for users of genetic resources and associated traditional knowledge, establishes rules governing compliance with ABS in accordance with the provisions of the Nagoya Protocol.The EU ABS Regulations defines “utilisation” as conducting research and development on the genetic and/or biochemical composition of genetic resources.
To determine whether you have compliance obligations under the EU ABS Regulation, these are the elements that need to be considered.
EU member states may have additional and stricter laws on access to genetic resources than what is stated in the EU Regulation on ABS.
A is for access
Each country decides if they regulate access to their genetic resources and how.
NOT implemented at EU Level – each Member State has the right to decide
Provider countries may request a prior informed consent (PIC) – it means asking for permission first.
The ABS National Focal Points should provide information on the country’s ABS rules and procedures.
B is for benefit-sharing
Benefit-sharing is based on mutually agreed terms (MAT) between the provider country and the user. Benefits could be monetary or non-monetary.
C is for compliance
Measures to control that the material, utilised within its jurisdiction, have been accessed legally.
Compliance obligations are determined at the EU level though the Regulation (EU) No 511/2014. It establishes the framework for member states on obligations for users of genetic resources within the EU.
The Convention on Biological Diversity (CBD), entered into force in December 1993. The CBD recognises that countries have sovereign rights over their natural resources, and its ‘third’ objective is the fair and equitable sharing of benefits arising from the utilisation of genetic resources, it means, between the users of genetic resources (commercial and non-commercial) and the countries providing those resources.
The Nagoya Protocol, which entered into force on the 12th October 2014, is a further supplementary agreement that aims to provide a clear, transparent and non-arbitrary international framework to implement the ‘third’ objective of the CBD. In other words, the Nagoya Protocol is the international framework for ABS and compliance. In the Annex of the Protocol, you can find examples of non-monetary and monetary benefits that could be shared from the utilisation of genetic resources and/or traditional knowledge of indigenous people and local communities associated with genetic resources. The ABS measures may cover genetic resources that are acquired in situ (from their natural origin in a country) and ex situ (meaning genetic resources that may be stored in an institute that is not in the country where it originally came from, or even if you buy them in the store).
ABS stands for Access and Benefit - Sharing. Access means requesting a permit to collect and utilise genetic resources (in-situ and ex-situ resources), and Benefits-Sharing means giving something back to the country where the material comes from (ref 1).
For proof of compliance and institutional audits:
Keep a record of:
The species, specimen type and origin
The reason for disposal
Correspondence with CITES aurthorities
Correspondence with institution authorities
The method and location of disposal
Also update collection management systems and institutional logs.
Before any action is taken, consult with your countries CITES management authority, so that they can advise you if:
You need a certificate for disposal.
There are record-keeping or reporting obligations
The specimen must be returned, quarantined or disposed of under supervision
Here is the EU CITES authorities list.
You also need to follow the procedures of your institution, that may have a further protocol for disposing of specimens.
CITES is implemented differently in each country via national laws. In the EU this is through:
EU Wildlife Trade Regulations (get directive number).
National CITES authorities are responsible for enforcing disposal and deaccessioning.
In practice, this means:
Even if a specimen is being destroyed or donated, permits may still be required
Disposal may be considered a “movement” or “transfer” depending on national law.
First, confirm whether the specimen is from a species listed in CITES Appendix I, II, or III.
You can do this by:
Searching the CITE Appendices (website)
Checking your original collection permits and specimen records
If the specimen is a derivative (e.g. DNA, tissue, bone), it may still fall under CITES control.
CITES (website) is regulated through the issue and control of export and import permits for a number of clearly defined species listed in three appendices I, II, and III. You can find these appendices on the CITES website (Appendices page) and also the EU Commission Wildlife trade law webpage.. The different appendices require different levels of permissions for export and import. Each nation state who is a party to CITES is responsible for the implementation of CITES in their own legal framework and therefore party’s may have stricter regulations than is codified by CITES. All parties have at least one management authority and one scientific authority.
You must apply to your national authority and ask for permission to use the material under Article 17. The authority can approve your request if they’re satisfied that the risks to public or animal health are properly controlled.
Once you’ve been authorised, you can only use the material for the purpose approved (e.g. your genomic research). You can’t decide later to use it for something else.
Keep records of permissions and authorisation.
If you're using animal by-products in your research, such as tissue, organs, or any material from animals not intended for human consumption, then you're working under rules set by the EU Animal by-products regulation (Regulation (EC) No. 1069/2009).
Normally, these materials are tightly regulated in terms of how they can be used and how they must be disposed of, to protect public and animal health. But Article 17 of this regulation allows for something called a derogation.
A derogation means you can get permission to use animal by-products for specific purposes outside of the usual strict rules but only if the competent authority in your country approves it in advance.
In the case of research, this is important, because it means you can use certain animal materials that would otherwise be restricted as long as it’s for:
Research
Diagnostic work
Educational use
Exhibitions or artistic purposes
This gives you more flexibility but only within certain limits.
Before doing anything with your material collecting, sequencing, transporting, or importing check if the species is currently listed as an IAS of Union Concern.Here you can consult the IAS list (EU IAS webpage)
The list is maintained by the European Commission. If the species is listed, strict restrictions apply.
Once you have received permission, dispose of the specimens/samples using the correct waste route and method that fully destroys it and prevents escape or spread.
Keep records of:
What was destroyed
When and how it was destroyed
Any authorisation or permit reference
This protects both you and your institution, especially if asked to demonstrate compliance later.
Sources JRC manual
Even if you are not planning to use, store or transfer the specimen, you may still need a permit.
This applies whether you're:
A researcher finishing up a project
A biobank or herbarium curator clearing out old holdings
A technician or lab manager handling stored DNA or tissue
Before doing anything, get in touch with your country’s IAS competent authority. They will advise whether:
You need a formal permit, or
A written authorisation for disposal will suffice
Some member state national competent authorities are listed in the European Alien Species Information Network (link)
Even if the specimen was collected before the species was added to the IAS list, or if it came from another collection it may not be automatically exempt. Check with the national competent authority.
The IAS regulation (Regulation (EU) No 1143/2014) mainly refers to live specimens of Invasive species, subspecies or lower taxon of animals, plants. Fungi or micro-organisms introduced outside its natural range. It can also refer to dead or preserved specimens that still have reproducible parts like seeds or spores. The regulation outlines the definitions, restrictions, permits, authorisations etc. It also mentions a list of IAS called the list of invasive alien species of Union Concern.
You must keep records of:
What was disposed of
When and how it was handled
Which waste handler or facility was used
This is particularly important if the material is classified as hazardous, or overlaps with other legal regimes (e.g. Access and Benefit-Sharing, Animal By-Products Regulation, CITES, or IAS Regulation). Please see the guide for these regulations under this genomics activity.
Some genomic materials may fall under hazardous waste rules, especially:
Infectious agents (e.g. bat tissues, pathogens)
Chemically preserved specimens (e.g. ethanol, formalin)
Genetically modified organisms (if applicable)
Please also review national and institutional regulations and protocols
The directive sets out a waste hierarchy in Article 4
Prevent waste if possible
Reuse where appropriate
Recycle Any recovery operation by which waste materials are reprocessed for their original purpose or other uses
Recover Includes processes such as incineration with energy recovery, anaerobic digestion, pyrolysis, or other operations where waste is used to generate energy or materials.
Dispose as a last resort (e.g. authorised incineration of tissue)
In research, this often means avoiding unnecessary waste generation and using safe disposal options when required.
Once you’ve finished using biological material,such as tissue samples, extracted DNA, or processed specimens, it’s considered waste under the Directive if:
You intend to discard it
It is no longer usable or needed
It has degraded or lost value for research
Even preserved or long-held material can become waste if disposal is the intention.
