Research with and on genetic materials of animal or plant origin
The Nagoya Protocol is an instrument of international law that aims to "ensure the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources, in particular through appropriate access to genetic resources and appropriate transfer of relevant technologies, taking into account all rights over those resources and technologies, and through appropriate funding, in order to contribute to the conservation of biological diversity and the sustainable use of its components". (Article 1, Nagoya Protocol).
Use cases
Research fields, examples:
- Nutrition
- Agriculture
- Horticulture
- Geoscientific research
- Medicine (human pathogens)
- Cosmetics
- Bio-based energy sources
- Molecular biology
- Genetic analyses (with non-human material)
- Paleonthology
- microbiology
- Synthetic biology
Use the checklist (de/en) (under Supporting material) to check whether your research project is relevant to Nagoya.
According to EU Regulation (511/2014), Article 3 (Definitions 1, 2 and 7), the Nagoya Protocol refers to research on and with
- genetic materials, i.e. any material of plant, animal, microbial or other origin containing functional units,
- genetic resources (i.e. genetic material with actual or potential value, but also
- traditional knowledge associated with genetic resources from an indigenous or local community that is relevant to the utilisation of genetic resources.
When conducting research with and on genetic materials and resources, both the legal requirements on the European side and those of the provider countries must be observed. Particularly relevant on the European side:
- The EU Regulation, which is directly binding for all researchers: EU Regulation (511/2014)
- The Implementing Regulation laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, the monitoring of user compliance and best practices informs users how and what to document and how to ensure due diligence. The annex to the regulation also contains templates: EU Implementing Regulation (2015/1866).
- The (German) Act Implementing the Obligation under the Nagoya Protocol and Implementing Regulation (EU) No. 511/2014 defines the tasks and powers, orders and remedial measures as well as provisions on fines. The competent authority for this in Germany is the Federal Agency for Nature Conservation: Act Implementing the Obligations under the Nagoya Protocol and Implementing Regulation (EU) No. 511/2014.
- Theguide to the scope of application and core obligations of Regulation (EU) No. 511/2014 explains the scope of application and core obligations of the Regulation as well as the duty of care and the submission of the declaration of compliance. EU Guideline
- List of countries that have signed the Nagoya Protocol: List of countries,country map.
Researchers must continue to comply with the laws and regulations of the providing countries. This applies regardless of whether the providing countries have signed the Nagoya Protocol or not. To find out more about this, researchers can access the page of the Federal Agency for Nature Conservation to the ABS Clearing House. Here you will also find extensive further information on the utilisation of genetic resources.
If the requirements of the EU Regulation (511/2014) are not met, its provisions (due diligence obligation with regard to obtaining, storing and forwarding documents, Art. 4, and obligation to submit a due diligence declaration, Art. 7) do not apply.
The requirements for the applicability of the regulation are
- Access in a state party to the Nagoya Protocol after 12 October 2014 and
- at a time when ABS regulations apply there for the specific genetic resource that is to be utilised, and
- Utilisation of this genetic resource in the EU.
If only one condition is not met, the EU Regulation does not apply. [Reply from the BfN, 18/03/2024]
The signing of the Protocol alone does not lead to an obligation to implement the Protocol, but only its adoption (ratification) by means of a further legal act (cf. on the status of ratification procedures) (BfN response, 5 April 2024).
EU Regulation No. 511/2014 therefore does not apply if access to genetic resources takes place in a country that has national ABS (Access Q Benefit Sharing) regulations but is not a party to the Nagoya Protocol. Nevertheless, users of genetic resources must comply with these national ABS regulations when accessing genetic resources. However, there is no official review of this within the EU due to the lack of applicability of the aforementioned EU Regulation (BfN response of 5 April 2024).
The responsibility lies with the researchers.
? see the checklist under "Support and assistance from the HU".
Support at Humboldt-Universit?t
Humboldt-Universit?t will support you if your research falls under the Nagoya Protocol.
The checklists
The checklist will help you to decide whether your research is subject to the EU Regulation (511/2014). You fall under the scope of application if you answer yes to all of the following questions. Even if your research does not fall under the EU Regulation, you must comply with the national provisions of the provider country that apply independently of the Nagoya regime.
If you want to apply for a research project or are conducting research in another context and you have determined from the checklist (see link button below) that it is Nagoya-relevant, be sure to read the further information on the intranet and please contact the Research Service Centre at nagoya.szf? Please insert an @ at this point ?hu-berlin? Please insert a period at this pointde.
Check requirements
Before projects can be applied for, the requirements resulting from the Nagoya Protocol must be researched and documented. Funding bodies expect applicants to show that they are informed, e.g. by mentioning the national contact point or how benefit sharing is to be realised. The resources concerned can only be utilised once all requirements from the Nagoya Protocol have been met. As the processes for obtaining Prior Informed Consent (PIC) from the donor countries and, if necessary, drawing up various contracts take a long time, it is advisable to obtain information as early as possible.
Submit the signed form
Please remember to sign and submit the form version of the checklist from the intranet when applying for projects that are relevant to Nagoya.
Depending on the requirements of the providing country, different documents may have to be prepared, which must also be presented in the event of possible controls (compilation according to DFG (German Research Foundation (DFG). (2021). Explanatory notes on dealing with the legal requirements of the Nagoya Protocol and Regulation (EU) No. 511/2014 in universities and other research institutions. p. 30 f.).
- Prior Informed Consent (PIC): Declaration of consent from the providing state to conduct the research project.
- Mutually Agreed Terms (MAT): This contract regulates the utilisation of the genetic resource as well as, for example, the place of collection, scope, objective, time frame of utilisation and, if applicable, the responsible persons.
- Material Transfer Agreement (MTA): A contract that regulates the export of the material and, if applicable, regulations on what to do with the material after the project has been completed.
- Research Permit: Combination of PIC and MAT in one document. An export licence can also take the place of an MTA.
- Internationally Recognised Certificate of Compliance (IRCC): Providing countries can submit their PIC and MAT to the ABS Clearing House. They are then published there as an IRCC.
- Due Diligence Declaration: For research projects with project funding, a due diligence declaration must be submitted at the earliest after the first funding has been provided and the genetic resources or traditional knowledge relating to them has been obtained and at the latest four weeks before the end of utilisation. The due diligence declaration is submitted via the Research Service Centre via the EU's DECLARE portal. HU researchers must first complete a corresponding form with the necessary information.
Information on the countries: Clearing House
Further information on the intranet
Nagoya checklists & forms
External support
The responsibility for compliance with the Nagoya Protocol and any other ABS regulations lies with the researchers. There are numerous excellent external sources of information and support on the Nagoya Protocol:
The German Nagoya Protocol HuBis funded by members of the Alliance of Science Organisations (German Research Foundation, German Rectors' Conference, Helmholtz Association of German Research Centres, Leibniz Association, National Academy of Sciences and Max Planck Society). The project supports researchers to better understand all legal obligations of the Nagoya Protocol. The Nagoya Protocol HuB can also advise you individually on your questions.
Information on specific countries:
- DFG explanations for researchersDFG (2021): Explanatory notes on research and/or development projects involving access to genetic resources and/or traditional knowledge associated with genetic resources
- DFG explanatory notes for universities and research institutionsDFG (2021): Explanatory notes on dealing with the legal requirements of the Nagoya Protocol and Regulation (EU) No. 511/2014 in universities and other research institutions. Publication of the DFG Standing Senate Commission on Key Questions relating to Biological Diversity (SKBV). Bonn.
- DFG model contract clauses: German Research Foundation (DFG). (2019). Model Clauses for Mutually agreed terms on access to genetic resources and benefit sharing. Published by the Permanent Senate Commission on Fundamental Issues of Biological Diversity of the German Research Foundation.
- DFG FAQs on the Nagoya Protocol
Extensive information can also be found on the website of the Federal Agency for Nature Conservation (BfN). The BfN can also advise you individually on your questions.
Questions and answers
The retention obligation arises from Art. 4 para. 3 sentence 1 Regulation (EU) No. 511/2014 (hereinafter referred to as the EU ABS Regulation) and only relates to the documents. The aforementioned regulation does not impose any retention obligations for the material. [Reply from the BfN, 18/03/2024]
Internal budget funds of private or public organisations are not "research funds" within the meaning of Art. 7 para. 1 of the EU Regulation (511/2014). In the case of self-financed research involving the utilisation of genetic resources within the scope of the EU ABS Regulation, no due diligence declaration pursuant to Art. 7 para. 1 must therefore be submitted.
Even if no due diligence declaration according to Art. 7 para. 1 EU Regulation (511/2014) has to be submitted, the due diligence obligation from Art. 4 applies to all research involving the utilisation of genetic resources within the scope of the EU ABS Regulation. This can be checked by the BfN as part of user inspections. [Reply from the BfN, 18/03/2024]
Questions about the Nagoya Protocol
Please always send any enquiries about the Nagoya Protocol to our contact email: nagoya.szf? Please insert an @ at this point ?hu-berlin? Please insert a period at this pointde
You can find more information on the intranet