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  • GNP HuB
    • About
    • Network
    • Library
    • Podcasts
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    • News
    • Calendar
  • ABS
    • Understanding the ABS world – infographic
    • Build your ABS Strategy – checklist
    • Benefit-sharing
    • Video: Nagoya For Newbies
    • ABS – dealing with practical challenges
    • 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
  • FAQs and more
    • FAQ
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Registered collections

Slide Registered collections make life easier!

What is a registered collection?

A registered collection is special instrument to promote compliance with the Regulation (EU) No 511/2014.

Collections like botanical gardens, collections of microorganisms and natural history museums provide researchers with biological material for research purposes. There are also collections at many universities.

These collections can choose to become registered – it is a voluntary process. A collection may register its entire collection or just part of it.

A registered collection:

  • ONLY supplies biological material with documentation providing evidence that the material was accessed in accordance with any applicable access and benefit-sharing laws and, where relevant, on the basis of a benefit-sharing agreement;

 

  • applies standardised procedures for exchanging samples with other collections and for supplying samples for research purposes;

 

  • uses tracking and monitoring tools for exchange of samples and information with other collections; and

 

  • keeps records of samples and information supplied for research and uses unique identifiers, where possible, to make the material traceable.

How can a registered collection help me?

Registered collections can make life much easier! They support researchers with their compliance obligations by providing the information and ABS documentation relating to a sample. In other words, the collection takes over the “seeking information” part of your obligations.

Researchers who obtain material from a registered collection are considered to have exercised due diligence with respect to seeking information. Although this is only one part of your due diligence obligations, obtaining ABS documentation is usually by far the most complicated and time consuming part.

There is no getting past the EU Regulation, even in the non-commercial research sector. Having collections that can provide ABS documentation is becoming an increasingly attractive option for many researchers who want legal certainty with respect to the material they are using.

What are my obligations if I get material from a registered collection?

Registered collections provide researchers with any necessary ABS information and documentation but the compliance obligations remain with the researcher. That means that researchers still have to:

  • comply with the documentation;

 

  • keep the information and documentation for 20 years (from the time the research ends);

 

  • transfer the information and documentation on to others if the material is given to someone else;

 

  • submit a due diligence declaration (if relevant); and

 

  • support the competent authority if a user check is conducted.

 

Which collections are already registered?

All registered collections can be found in the European Commission’s register. The register contains information like the registration code, name, contact details and short description of the registration.

So far, only several collections in Europe have become registered. The Leibniz-Institute German Collection of Microorganisms and Cell Cultures is the only registered collection in Germany and it was the first in Europe. For more information about DSMZ’s registered collection, click here.

 

Becoming a registered collection in Germany

As the competent authority, the German Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN) is responsible for assessing requests by collections in Germany to become registered. If satisfied that the requirements are met, BfN notifies the European Commission that the collection should be placed on the register of collections.

These requirements for becoming registered can be found in Regulation (EU) 1866/2015 (often just referred to as “the Implementing Regulation”).

To learn more about the process, you can contact the BfN directly.

 

Checks on registered collections

BfN is required to periodically carry out checks to verify that registered collections in Germany continue to meet the requirements of being registered. If not, the collection can be removed from the register.

The German Alliance ABS advisory platform for academic research is funded by members of the Alliance of Science Organisations. The project sponsoring members of the Alliance are the German Research Foundation (DFG), the German Rectors’ Conference (HRK), the Helmholtz Association of German Research Centres (HGF), the Leibniz Association, the German National Academy of Sciences Leopoldina and the Max Planck Society.

 

 

 

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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