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  • GNP HuB
    • About
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  • ABS
    • Understanding the ABS world – infographic
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    • Tools & Resources for ABS
    • ABS Stories
  • Compliance
    • Video: ABS compliance supports your science
    • Do I have compliance obligations?
    • What are my obligations?
    • Tools & Resources for Compliance
    • User checks
    • Implications of non-compliance
  • Your institution
    • Institutional measures for compliance – infographic
    • Guidelines for institutions
    • Who can I contact at my institution?
    • Registered collections
    • Compliance Stories
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Guidelines for Institutions

Best Practice

What are recognized best practices?

“Best practices” are intended to help researchers and institutions with compliance. They are:

  • procedures, tools or mechanisms for institutions

 

  • are developed and  overseen by associations of users or other interested parties

 

Best practices can be recognized by the European Commission in accordance with Regulation (EU) 1866/2015  (“the Implementing Regulation”).

So far, there is only one recognised best practice in the European Union’s Register. This is the CETAF Code of Conduct and Best Practice.

 

How can Best Practice help me?

By following registered best practices, researchers reduce the risk of non-compliance with the obligations under the EU law. If an institution follows Best Practice, this is taken into account by the competent authority in Germany when it conducts a user check.

 

How can best practices be recognized?

Applications for recognition of best practices are submitted to the European Commission’s Nagoya Protocol Unit. A copy of the application and supporting documentation are sent to the BfN (and the competent authorities in other member states) for comments.

The Commission informs the applicant of the indicative time limit for the process and provides an update on the status of the application at least every six months.

This process to have Best Practice can take a considerable period of time and involve multiple rounds of revisions.

 

Removal from the register

If there are repeated or significant cases of non-compliance with the due diligence obligations by researchers who are following best practices, the European Commission will look into whether these infringements relate to any deficiencies in the best practice. If so, the recognition as a best practice can be withdrawn from the register.

 

CETAF Code of Conduct

The CETAF Code of Conduct and Best Practice

So far, the CETAF Code of Conduct and Best Practice is the only recognised best practice in the European Union. The document is publicly available and can, in principle, be used by anyone.

The  Consortium  of  European  Taxonomic  Facilities (CETAF)  is  a  networked  consortium  of non-commercial scientific institutions and collections across Europe.  The members include zoological , botanical,  palaeobiological, and  geological collections. To support its members with the challenges associated with managing ABS obligations, CETAF developed the Code of Conduct and Best Practice. One challenge for CETAF was to develop a useful document that took into account the diversity of the member institutions and their needs.

 

Developing the Code of Conduct & Best practice 

The process was led and organized by a working group from institutions across Europe. Work started in 2011, with the first draft being submitted to the EU Commission in 2015.

There were a couple rounds of comments by the competent authorities of various member states and relevant revisions before the European Union Commission formally recognized it. The final version of the CETAF Code of Coduct & Best Practice was added to the Commission’s register in 2019.

 

Implementation

All CETAF institutions have agreed to implement the Best Practice and Code of Conduct.  Some institutions have adopted it one to one, whereas other institutions have chosen to adapt the Best Practice to the needs of their own institution.

Awareness-raising and training was provided for the member institutions on the Code of Conduct and Best Practice to help with implementation.

 

Annexes

The document has seven annexes which include a number of useful tools. These are:

  • Annex 1 – Best Practice guidelines for establishing ABS measures at an institutional level

 

  • Annex 2 – A template for describing your project and proposed research, which could be used when communicating with the authorities in the country where the material comes from

 

  • Annex 3 – A basic glossary of terms commonly used in the “ABS world”

 

  • Annex 4 – A list of typical benefits arising from non-commercial research

 

  • Annex 5 – “ABS Checklists” for researchers and institutions for different stages of the research process, including the planning, implementation and follow-up phases

 

  • Annex 6 – Four different model Material Transfer Agreements

 

  • Annex 7 – A template for a data use statement

 

The German Nagoya Protocol HuB is financed by the Federal Agency for Nature Conservation (Bundesamt für Naturschutz) with funds from the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz)

 

 

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  • Some countries also have ABS laws even though they are NOT Party to the Nagoya Protocol. You still must comply with these laws!
  • Some countries in the EU also have specific national ABS laws.
  • If your research will involve traditional knowledge, you must take into account the national ABS rules in this regard.

In cases of non-compliance the National Authority (BfN) can:

  • confiscate the material.
  • prohibit further use and transfer of the material for research.
  • prohibit the publication or sharing of any results of utilization.
  • issue a fine of up to 50,000 EUR.

Check out more about the implications of non-compliance.

How do I check?

  • Start with the country profile in the ABS Clearing House (ABSCH).
  • Check out the legislative, administrative or policy measures section. If no measures can be found here, the interim reports might also contain relevant information. Tip! filter by country.
  • Be careful though. This information is not always complete or up to date. Some countries have ABS laws but they are not listed in the ABSCH.

To play safe and ensure legal clarity, always contact the ABS national focal point and/or the competent national authority. Tip! filter by country.

No answer?

  • Try contacting the national focal point of the Convention on Biological Diversity (CBD).
  • Ask collaboration partners in the country for help – easier for them to contact the authorities in their own country and language!
  • Ask colleagues who have worked in that country before.
  • Use the internet to find resources.
  • Contact the German Federal Agency for Nature Conservation (BfN). They have information about ABS and may be able to assist.

For research done in Germany, the German Federal Agency for Nature Conservation recommends using the DECLARE portal.

An account is required. Check with your institution as it may already have one.

This video and the user guide are very useful to start!

Starting your project before ABS permits have been granted is a violation of the EU Regulation and can get you in trouble if your institute is being checked by the German National Authority (BfN)!

In this regard, you have obligations under the EU ABS Regulation if:

  • You collected the material…
  • The collaborator who gave you the material collected it…
  • The material obtained from a collection was originally collected…
  • The shop or company where you bought the material collected it…

on or after 12 October 2014

This date is key because it is when the Nagoya Protocol entered into force.

When you obtain material from a collaborator, collection or trader, it is important to verify if there are benefit-sharing obligations linked to it.

For example: research on specific genetic or biochemical properties, gene function, gene expression, genetic modification, genome editing, breeding based on traits and their associated genes, among others.

The EU Regulation does not apply when research does not involve the study of the genetic or biochemical composition, e.g. storing biological materials in a collection, mere culturing of organisms, taxonomic identification, morphological or anatomical characterization, among others.

See the guidance document for more information and examples on “utilisation”.

Also check our FAQs section on it.

ABS obligations may or may not apply depending on the type of research. There could be exemptions for non-commercial or basic research.

Keep in mind that exemptions for local researchers may not apply if they conduct their research abroad (e.g. guest researchers bring material from their home country to study it in Germany).

Within the European Union, obligations stem from Regulation (EU) No 511/2014.

The EU Guidance Document contains information on scope, obligations and understanding whether your material/research is covered, including many practical examples. It is available in all EU languages and is a must-have resource.

Not all countries that are Party to the Nagoya Protocol regulate access, e.g. Germany. In such cases, you are free to use the genetic resources obtained from these countries without getting ABS permits.

You are obliged by the EU and German law to support user checks by the German Federal Agency for Nature Conservation.

Failure to support a user check is an administrative offence.

When you transfer the material to another person or institution:

  • Search if there are ABS documents relating to the material you have.
  • Check if the transfer to third parties is permitted.
  • Transfer also the information, e.g. a copy of the ABS permit or the number of the internationally recognized certificate of compliance (IRCC) published on the ABS Clearing House.

Having a good documentation system will save you headaches in the future.

Read the documents and understand your obligations as well as any conditions and restrictions on use of the material.

Keep in mind your commitments on benefit-sharing!

The due diligence declaration informs the competent authority in Germany that your research and material is Nagoya Protocol relevant and that you have complied with your ABS obligations.

Check out more about it!

“Derivative” means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity.

Some examples are: RNA, proteins (including enzymes), lipids, organic compounds (e.g. essential oils or resins) and other products of metabolism.

Also check our FAQs section on it.

In this regard, you have obligations in the EU if the country where the material comes from was a Party to the Nagoya Protocol and had ABS regulations at the time of access.

Why is ABS important?

Access and Benefit Sharing (ABS) measures ensure that research results support provider countries to:

  • Make informed decisions on conservation, sustainable use and management of their biodiversity.
  • Implement innovative solutions for productive activities, contributing to sustainable development.
  • Build capacities for national research.
  • Other benefits as agreed.

Even if ABS does not apply to your research project, you must be able to provide the German Federal Agency for Nature Conservation with the documentation that supports your conclusion. This will speed up possible compliance checks. Tip! save email correspondence with the provider country authorities on this regard.

For some countries, this can be determined by checking the date of entry into force of the national ABS legislation and compare it with when the material was collected in the field.  If you collected before the legislation went into force, you could be out of scope. However, in some countries “access” can also mean receiving material from an ex-situ collection or even when you start to use it (even if it was collected and left the provider country long ago). Keep this in mind!

Some laws only cover certain types of organisms or organisms collected in certain areas.

Check when:

  • you collect material outside of Germany
  • a collaborator gives you material from another country
  • you get material from a collection in Germany
  • you buy material from a shop or a company
  • traditional knowledge from indigenous peoples or local communities will be used for your research