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In cases of non-compliance the National Authority (BfN) can:
To play safe and ensure legal clarity, always contact the ABS national focal point and/or the competent national authority. Tip! filter by country.
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)!
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:
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.
“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:
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.