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My obligations

If Regulation (EU) No 511/2014 applies to you, you have due diligence obligations in Germany. These compliance obligations are ADDITIONAL to the access and benefit-sharing obligations (ABS) in the country which provided the material for research.

If the relationship between ABS laws abroad and the EU law is not clear, check out our “ABS World” infographic.

Other useful resources

Slide Due diligence - what's that?

Due diligence is about ensuring transparency in research. Researchers should know exactly what obligations are attached to the material (and/or traditional knowledge) they are using for their research so that they can comply with them.

For you, this means:

  • gathering and using information about research material and ABS in a systematic way

 

  • being thorough and giving your “best possible efforts” to get information

 

  • making decisions in a reasonable way

 

  • changing or adapting ways of doing things, as required. This might include adopting new rules and measures

 

  • paying attention to the application and enforcement of rules

 

What do I have to do?

Seek, keep and transfer information about ABS
Submit a due diligence declaration
Support user checks by the German government

 

Seek, keep and transfer information

Your first obligation is about getting information and documents (if required), keeping this information for a set period and transferring the information and documents to subsequent recipients of the material.

Seeking information

1.

Find out whether ABS applies to the material you are planning to use for your research, irrespective of whether you sample in the field, buy it, or get it from a collection or another researcher.

2.

If so, get the required ABS documentation.

This may mean that you have to obtain a permit (prior informed consent) directly from the country where the material comes from and sign a benefit-sharing agreement.

If you are getting the material from an intermediary – a collection, commercial source, another researcher or a local collaborator – ask them to provide you with a copy of the ABS documents and check that these documents cover your planned activities. If not, you will have to go back to the provider country and organize the required documentation.

Check out our Frequently Asked Questions (FAQs) about what to do if you are missing information and how to fulfil your due diligence obligations.

If ABS does not apply to you, there is no need to prove it but it is highly recommended to keep records of any enquiries made to the national authorities in the country providing the material.

Keeping information

You are required to keep the information for 20 years from the end of the period of utilisation. This refers to the end of the research activities. Depending on the situation, this could be the point when the actual research activities stop or when the results are finalized/published. If at a later stage the research continues, the 20 year period starts again.

If the competent authority conducts a check of your institution in 15 years’ time, will you or the institution still know where to find this information?

 

Transferring information

Are there ABS documents relating to the material you have? When you transfer this material to another person or institution, you must transfer 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, to the recipient (assuming that the transfer is permitted).

 

 

Slide Good document management systems are key!

 

Submit a due diligence declaration

What is a due diligence declaration?

A due diligence declaration submitted to the competent authority of the EU Member State where:

  • your institution is established; or

 

  • where the research is carried out if the institution that received the research funding is not established in the European Union.

 

The declaration informs the competent authority about your research and compliance with your obligations under the EU law.

In Germany, these declarations are received by the German Federal Agency for Nature Conservation (Bundesamt für Naturzschutz, BfN). The information included in the declaration is then submitted to the ABS Clearing House (assuming the information is not confidential).

 

Is it compulsory for academic researchers?

Three questions:

  • Does your research fall within the scope of  Regulation (EU) No 511/2014?

 

  • Did you receive third party funding for your research? It is irrelevant whether the funding comes from a public or private source.

 

  • Was your research ongoing or did it start on or after 10 May 2018?

 

If you answered yes to all of these questions, then it is compulsory for you to submit a due diligence declaration.

A due diligence declaration is not required for research funded through core funding of an institution. Even if a due diligence declaration is not necessary, all other obligations still apply.

When do I have to submit a due diligence declaration?

A due diligence declaration is submitted by researchers during the so-called “funding stage”of research. What does this mean?

  • At the earliest, it can be submitted after the first installment of funding has been received AND all the material (and associated traditional knowledge) to be used in the research has been obtained.

 

  • At the latest, it can be submitted at the time of the final report on the research. If there is no final report, the due diligence declaration should be submitted by the time the research project ends.

Slide It's easy and takes just a few minutes!

How do I submit a due diligence declaration?

The German Federal Agency for Nature Conservation recommends that researchers submit their due diligence declaration electronically using the DECLARE portal established by the European Commission.

The EU Commission has developed the DECLARE user manual and a short video to help researchers with submitting their due diligence declaration.

It only takes a few minutes to set up your DECLARE account and roughly 10 minutes to submit the due diligence declaration this way.

Does your institution have a centralized DECLARE account for submitting due diligence declarations? You should check with the Nagoya Protocol contact person at your institution.

If you are doing a joint research project with other institutions in the European Union, it is also possible for the project leaders to submit a due diligence declaration for the whole consortium.

Information submitted to the ABS Clearing House has to be in one of the six UN languages (Arabic, Chinese, English, French, Russian, Spanish). If the information is not confidential and the declaration/permit is not in one of these languages, you are encouraged to submit a translation.

What information is in a due diligence declaration?

There are two parts to the due diligence declaration in the DECLARE system. Part A includes the information transferred to the ABS Clearing House. Part B includes your signed declaration, which is not transferred to the Clearing House.

In Part A of your declaration, you need to:

  • indicate whether the declaration relates to a “genetic resource” and/or associated traditional knowledge

 

  • describe the subject matter of the research – here you can use the project title and a short description. Alternatively, you can enter identification code of your research grant.

 

  • provide information about the ABS documentation for your material. For this, you have two different options:

1.

Provide the number of your Internationally Recognized Certificate of Compliance.  You need to enter the two-letter country code and then the identifier number.

Look for this certificate under the country profile in the ABS Clearing House OR

2.

Provide information about your national permit. Enter the place of access (always the country where the material originally came from, not an intermediary country), a description of the material and/or associated traditional knowledge you are using for your research, and the number of the national permit (if available).

In Part B of the declaration, you do the following:

  • Declare that you are in possession of the required information (either the Internationally Recognized Certificate of Compliance or the national permit and associated documents)

 

  • Declare that that you will keep this information and transfer it to third parties who receive the material from you

 

  • Indicate whether your research funding is private or public

 

  • Indicate where the research took place in the European Union

 

  • Indicate the place where the declaration is being made

The BfN will contact you and request a copy of any national permits etc. after your declaration has been lodged.

What if information is confidential?

 

Some information could be confidential and should not be shared. In the DECLARE system it is possible to mark the following items as confidential:

  • the researcher (aka “user”)

 

  • the resource or associated traditional knowledge

 

  • the place of access

 

  • the details about the access permit

 

Confidential information is only visible to those people with access to your DECLARE account and the competent authority in Germany, i.e. the German Federal Agency for Nature Conservation (BfN). This information is not transferred to the ABS Clearing House. If the information is considered essential for creating a notification about compliance in the EU (the so-called “checkpoint communique”), the BfN will contact the competent authority in the provider country directly.

Support user checks

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.

What does supporting a user check mean? You may have to:

  • answer questions and provide information, including copies of documents

 

  • allow authorized staff to enter premises and conduct inspections

 

  • provide samples of material
Click here for more information about user checks!

Other useful resources

Websites:

The BfN page on legal questions gives explanations about due diligence obligations. 

You can find a number of useful resources on the EU Commission’s Nagoya Protocol website.

 

Simply explained videos:

This video gives a quick overview of the EU’s DECLARE portal.

 

Checklist:

This BfN checklist provides an overview of steps that need to be followed for due diligence (in German).

 

Guidance Document:

The EU Guidance Document can help you to understand what you need to do to fulfill your obligations.

 

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