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FAQs - Frequently Asked Questions


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Here you can find answers to frequently asked questions about the Nagoya Protocol and ABS.

Questions

The Nagoya Protocol and ABS in general

ABS implementation in Germany and the EU

Access to genetic resources outside of the EU

Utilisation/ scope of Regulation (EU) No 511/2014

Obligations on users

Internationally recognised certificate of compliance

Registered collections

Best practices

Science and research

Patenting and commercialisation

Who does what

Further information

Answers

The Nagoya Protocol and ABS in general

1. What is the Nagoya Protocol?

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity is a novel instrument in international nature conservation.

It is a binding international agreement  governing access to genetic resources and traditional knowledge associated with them and the fair and equitable sharing of benefits arising from their utilisation. The Nagoya Protocol is based on the requirements on access and benefit sharing (ABS) in the Convention on Biological Diversity (CBD).

The Nagoya Protocol was adopted on 29 October 2010 at the tenth conference of the parties to the CBD. It entered into force on 12 October 2014.

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2. What is meant by ‘access and benefit sharing’ (ABS)?

‘Access and benefit sharing’ (ABS) is the technical term for access to genetic resources and the fair and equitable sharing of benefits from their utilisation, the third objective of the Convention on Biological Diversity (CBD).

ABS serves under the CBD as an instrument to ensure that better consideration is given to the value of biodiversity in research for and the production of novel products and, by placing a value on genetic resources, to give economic incentives for the conservation and sustainable use of nature.

Under the ABS principles enshrined in the CBD and further elaborated in the Nagoya Protocol, genetic resources are subject to the sovereign rights of the provider countries. Parties to the Protocol are meant to create the conditions which facilitate access (not necessarily unpaid and unconditional access) to genetic resources by other parties. At the same time, they are authorised to make access to their genetic resources conditional on their consent and to require fair and equitable sharing of the benefits from the utilisation of those resources.

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3. Are there specialised ABS rules for specific sectors?

Alongside the access and benefit sharing (ABS) rules under the Convention on Biological Diversity (CBD) and the implementing provisions in the Nagoya Protocol, specialised international ABS rules may exist for specific sectors and may take precedence over the stipulations of the Nagoya Protocol.

Access to and utilisation of genetic resources for food and agriculture may be subject to the specialised ABS rules under the Food and Agriculture Organization of the United Nations (FAO) International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA).

Detailed information on ITPGRFA is provided on the ITPGRFA Secretariat website and on the website of the Federal Office for Agriculture and Food (BLE).

In the case of influenza viruses, the World Health Organization (WHO) access and benefit sharing rules laid down in the Pandemic Influenza Preparedness (PIP) Framework may take precedence.

Detailed information on the PIP Framework is provided on the WHO website.

The application of specialised international ABS rules is subject to the basic rule, however, that they must be consistent with and do not run counter to the objectives of the CBD and the Nagoya Protocol (Article 4(4) of the Nagoya Protocol); this is recognised both for ITPGRFA and for PIP. In addition, the genetic resources must be used in the instance at hand for the specific purposes of the applicable specialised ABS rules.

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4. What is the ABS Clearing House?

The ABS Clearing House is an international institution established to support implementation of the Nagoya Protocol by sharing information on access and benefit sharing (ABS), enhancing transparency and providing for legal certainty, and bringing providers together with users. 

The ABS Clearing House provides information on the following:

The ABS Clearing House is administered by the Secretariat of the Convention on Biological Diversity (CBD). 

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ABS implementation in Germany and the EU

5. How is the Nagoya Protocol implemented in Germany and the EU?

The European Union (EU) ratified the Nagoya Protocol on 16 May 2014 and laid down uniform measures for users to ensure compliance with the stipulations of the Nagoya Protocol in the Union in Regulation (EU) No 511/2014 of 16 April 2014.

In Implementing Regulation (EU) 2015/1866 of 13 October 2015, the European Commission additionally laid down rules for the implementation of Regulation (EU) No 511/2014 as regards the register of collections, monitoring user compliance and best practices.

In Germany, supplementing the legislation at EU level, the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No. 511/2014 entered into force on 1 July 2016. Among other things, the Implementing Act contains stipulations on responsibilities in Germany, the powers of the competent authorities, and penalties for non-compliance with user obligations.

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6. Is access to genetic resources and traditional knowledge associated with genetic resources regulated in Germany and the EU?

Under the access and benefit sharing (ABS) provisions of the Convention on Biological Diversity (CBD) and the Nagoya Protocol, parties are free to decide whether to regulate access to genetic resources and traditional knowledge associated with them.

At EU level, Regulation (EU) No 511/2014 lays down measures to ensure that access to genetic resources (and traditional knowledge associated with them) that are utilised within the EU takes place in accordance with the ABS rules in force in the provider country and that any benefits are shared fairly and equitably.

Unlike a number of other EU Member States, Germany has not enacted any legislation separately regulating access to genetic resources or questions of benefit sharing, and hence access to genetic resources (both in situ and ex situ resources) in Germany is not subject to prior informed consent (PIC) from a German authority or to mutually agreed terms (MAT).

Access to genetic resources within the territory of the Federal Republic of Germany is thus fundamentally free and is solely subject to the general constraints of public law (such as nature conservation law) and where applicable private law. It should be noted, however, that genetic resources obtained via a German collection (ex situ resources) may nonetheless be subject to PIC and MAT obligations of the country where they were originally (in situ) collected.

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7. How is the utilisation of genetic resources and traditional knowledge associated with genetic resources regulated in Germany and the EU?

The utilisation of genetic resources and traditional knowledge associated with genetic resources is tied in Germany and the EU to certain obligations (due diligence obligations, obligations to make declarations and obligations to provide assistance) (see below, 14. What is meant by the due diligence obligation?, 15. How specifically can users meet the due diligence obligation?, 18. What are the obligations on users with regard to declarations? and 19. What are the obligations on users with regard to assistance?). These obligations are laid down in Regulation (EU) No 511/2014 and further clarified in Implementing Regulation (EU) 2015/1866 and in the German Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No. 511/2014. 

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Access to genetic resources outside of the EU

8. What about access to genetic resources and traditional knowledge associated with genetic resources in countries outside of the EU?

As states have sovereign rights over their genetic resources, access to genetic resources is subject to the national law of the country providing them. 

Under the principles on access to genetic resources and fair and equitable sharing of benefits (access and benefit sharing, or ABS) enshrined in the CBD and reaffirmed in the Nagoya Protocol, provider countries are authorised:

  • To make access to genetic resources conditional on their prior informed consent (PIC) (Article 15(4) of the CBD; Article 6(1) of the Nagoya Protocol); and 
  • To grant such access on mutually agreed terms (MAT) (Article 15(3) of the CBD; Article 5(1) of the Nagoya Protocol).

Provider countries can thus make access to genetic resources conditional on specific terms while requiring fair and equitable sharing of benefits arising from the utilisation of genetic resources.

In addition, access to traditional knowledge associated with genetic resources that is held by indigenous and local communities may be subject to their PIC and MAT or approval and involvement (Article 7 of the Nagoya Protocol). Indigenous and local communities’ customary laws, community protocols and procedures may also have to be taken into consideration (Article 12 of the Nagoya Protocol).

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9. Where can I find information on how access is regulated in other Parties to the Nagoya Protocol

Information about national rules on access and benefit sharing (ABS) and about competent authorities is available from the ABS Clearing House. The ABS Clearing House is an international institution established to support implementation of the Nagoya Protocol by sharing information on ABS, enhancing transparency and providing for legal certainty, and bringing providers together with users. 

The ABS Clearing House provides information on the following:

The Federal Agency for Nature Conservation (BfN) additionally serves as a point of contact and source of advice for all users and collections in Germany.

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Utilisation/ scope of Regulation (EU) No 511/2014

10. What are genetic resources and what is traditional knowledge associated with genetic resources?

Regulation (EU) No 511/2014 defines genetic resources as genetic material of actual or potential value, whereby genetic material is  any material of plant, animal, microbial or other origin containing functional units of heredity (Article 3(1) and (2) of the Regulation).

Traditional knowledge associated with genetic resources means traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is described as such in the mutually agreed terms applying to the utilisation of genetic resources (Article 3(7) of the Regulation).

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11. What is meant by the utilisation of genetic resources and by the utilisation of traditional knowledge associated with genetic resources?

Under Regulation (EU) No 511/2014, the utilisation of genetic resources means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology (Article 3(5) of the Regulation).

Biotechnology is defined in Article 2(d) of the Nagoya Protocol as any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.  This means that research and development on what are referred to as derivatives counts as utilisation within the meaning of Regulation (EU) No 511/2014 if the derivatives originate from genetic resources for which prior informed consent (PIC) has been given and the derivatives are also the subject of mutually agreed terms (MAT). The Nagoya Protocol defines a derivative as 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 (Article 2(e) of the Nagoya Protocol). Examples of derivatives include proteins, lipids, enzymes, RNA, and organic compounds such as flavonoids, essential oils or plant resins.

It is to be noted that the Regulation covers both (pure) research and (pure) development activities; it is not necessary for both types of activity to be present as cumulative criteria. However, the Regulation does not cover all research on genetic resources. It only covers research on the genetic and/or biochemical composition of genetic resources, meaning that the mere description of a genetic resource in phenotype-based research such as morphological analysis normally is excluded.

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12. What users (or utilisations) and what genetic resources (and associated traditional knowledge) are specifically meant?

  • Material scope

Regulation (EU) No 511/2014 defines genetic resources as genetic material of actual or potential value, genetic material being any material of plant, animal, microbial or other origin containing functional units of heredity (Article 3(1) and (2) of the Regulation).

The Regulation does not cover human genetic resources or genetic resources to which specialised access and benefit sharing (ABS) rules apply (see above, 3. Are there specialised ABS rules for specific sectors? and below, 13. Examples).

Traditional knowledge associated with genetic resources means traditional knowledge held by an indigenous or local community that is relevant for the utilisation of (research and/or development on) genetic resources and that is also described as such in the mutually agreed terms applying to the utilisation of the resources concerned (Article 3(7) of the Regulation).

  • Personal scope

A user is a natural or legal person who or which utilises genetic resources or traditional knowledge associated with genetic resources (Article 3(4) of the Regulation).

The deciding factor in whether Regulation (EU) No 511/2014 applies is thus whether a natural or legal person conducts research or development on the genetic or biochemical composition of genetic resources. Applicability of the Regulation does not depend, however, on the type of legal entity (as regards the user), organisation size, or the purpose of the research and/or development (commercial, non-commercial or purely scientific).

That also means that persons who merely store, pass on or trade in genetic resources (or traditional knowledge associated with them), without conducting research and/or development themselves, do not come under the Regulation. Similarly, scientists who solely conduct hands-off research are not covered by the Regulation.

  • Geographic scope

Utilisation of genetic resources only falls under the scope of the Regulation (EU) No 511/2014 if it takes place inside an EU Member State.

Also, the Regulation only covers the utilisation of genetic resources that are subject to the sovereign rights of a state. This also means that genetic resources from regions outside of national sovereignty – the high seas, the deep seabed and the Antarctic Treaty region – are not covered by the Regulation.

Finally, genetic resources (and traditional knowledge associated with them) are only covered if accessed in the sovereign territory of a party to the Nagoya Protocol that has issued ABS rules. Those ABS rules must also apply to the specific genetic resource (or the specific traditional knowledge) that has been acquired.

Information on parties to the Nagoya Protocol and any national access rules is provided by the ABS Clearing House (see above, 4. What is the ABS Clearing House? and 9. Where can I find information on how access is regulated outside of the EU?).

  • Temporal scope

The Regulation only applies to genetic resources (and traditional knowledge associated with them) accessed as of 12 October 2014 (when the Nagoya Protocol entered into force).

If the access to genetic resources (or traditional knowledge associated with them) took place before 12 October 2014, their utilisation is outside the scope  of the Regulation even if the utilisation took place later than 12 October 2014. It should be noted, however, that even if Regulation (EU) No 511/2014 does not apply, users must still give due consideration to any rules prevailing in the provider country.

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13. Examples

Examples of users/ activities  that come/do not come under the Regulation are given in the EU Guidance Document on the Scope of Application and Core Obligations of Regulation (EU) No 511/2014.

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Obligations on users

14. What is meant by the due diligence obligation?

A due diligence obligation generally speaking is an obligation to proceed with care and apply due diligence; its purpose is to avoid unnecessary risks in business relations and liability for negligence.

The purpose of the due diligence obligation under Regulation (EU) No 511/2014 is to ensure that users of genetic resources (or of traditional knowledge associated with genetic resources) satisfy themselves that access to genetic resources (or to traditional knowledge associated with them) does not take place in breach of the provider country’s ABS legislation and that any benefits are shared in accordance with the mutually agreed terms (Article 4(1) of the Regulation).

The due diligence obligation under the Regulation thus constitutes a risk management system consisting of three elements: Documentation, risk reduction and risk assessment.

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15. How specifically can users meet the due diligence obligation?

The due diligence obligation under Regulation (EU) No 511/2014 constitutes a risk management system consisting of three elements:

  • Documentation:

To meet the due diligence obligation, users must seek, keep and transfer to subsequent users the following documentation/information: 

The internationally recognised certificate of compliance (see below, 22. What is the internationally recognised certificate of compliance? and 23. What does the certificate demonstrate?) and information on the content of the mutually agreed terms (Article 4(3)(a) of the Regulation).

Where no internationally recognised certificate of compliance is available, the following information and documentation must be sought, kept and transferred to subsequent users (Article 4(3)(b) of the Regulation):

  • Date and place of access;
  • Description of the genetic resources or of the traditional knowledge associated with them;
  • The source from which the genetic resources (or traditional knowledge associated with them) were directly obtained, as well as subsequent users;
  • The presence or absence of rights and obligations relating to access and benefit sharing (ABS), including regarding subsequent applications and commercialisation;
  • Access permits, where applicable;
  • Mutually agreed terms, including benefit-sharing arrangements, where applicable.

Information relevant to access and benefit sharing must be kept for 20 years after the end of the period of utilisation (Article 4(6) of the Regulation).

  • Risk reduction:

Users are also considered to have exercised due diligence with regard to seeking information if they are subject to the terms and conditions of the standard material transfer agreement for the purposes set out under the FAO International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and if the further requirements under Article 4(4) of the Regulation are met.

The same applies for users obtaining a genetic resource from a collection included in the register of collections under Article 5 of the Regulation (Article 4(7) of the Regulation) (see below, 24. What is the register of collections?). The web-based register of collections within the Union is maintained by the European Commission.

Users can additionally reduce the risk of non-compliance with the due diligence obligation by applying a best practice within the meaning of Article 8 of the Regulation (or Article 20(2) of the Nagoya Protocol) (see below, 29. What is meant by a best practice?). The web-based register of recognised best practices is maintained by the European Commission.

  • Risk assessment 

When the information in their possession is insufficient or uncertainties about the legality of access and utilisation persist, users must obtain an access permit or its equivalent and establish mutually agreed terms.

If this is not possible, they must discontinue utilisation (Article 4(5) of the Regulation).

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16. What has to be done if utilisation is already taking place, but not enough information is available about access and benefit sharing or if there are doubts about the legality of the genetic resource concerned and about access and utilisation?

When the information is insufficient or uncertainties about the legality of access and utilisation persist, users must obtain an access permit or its equivalent and establish mutually agreed terms.

If this is not possible, they must discontinue utilisation (Article 4(5) of Regulation (EU) No 511/2014).

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17. How long does information relating to access and benefit sharing have to be kept?

Information relevant to access and benefit sharing must be kept for 20 years after the end of the period of utilisation (Article 4(6) of Regulation (EU) No 511/2014).

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18. What are the obligations on users with regard to declarations?

Since 10 May 2018 recipients of research funding in connection with the utilisation of genetic resources (or of traditional knowledge associated with genetic resources) are obliged to submit, at the research funding stage, a due diligence declaration in accordance with Article 7(1) of Regulation (EU) No 511/2014 read in conjunction with Article 5 of Implementing Regulation (EU) 2015/1866 (for further information on the time and place of declaration, see below, 32. What has to be considered for science/ research purposes?).

At the stage of final development of a product developed using genetic resources (or traditional knowledge associated with them), users must submit a due diligence declaration in accordance with Article 7(2) of the EU Regulation read in conjunction with Article 6 of the Implementing Regulation (see below, 34. What has to be considered with regard to product approval?). Submission of a declaration under Article 7(2) of EU Regulation is mandatory already since 12 October 2015.

Due diligence declarations under Article 7(1) and (2) of the EU Regulation can be submitted via the EU-wide web-based tool DECLARE.

User guide/Questions and answers – DECLARE NAGOYA IT system
Access to DECLARE

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19. What are the obligations on users with regard to assistance?

Users of genetic resources (and of traditional knowledge associated with them) must offer all assistance necessary to facilitate the performance of the checks to verify whether the users comply with their due diligence and declaration obligations (Article 9(5) of Regulation (EU) No 511/2014).

In particular, users required to provide information must present the required documentation and samples of genetic resources during checks (Section 1(3), sentence 2, of the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014).

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20. How is compliance with the due diligence obligations and the obligations to make declarations monitored?

The Federal Agency for Nature Conservation periodically carries out checks on a risk-based approach and in case of substantiated concerns to verify that users comply with their due diligence and declaration obligations  (Article 9 of Regulation (EU) No 511/2014) (see above, 15. How specifically can users meet the due diligence obligation? and below, 32. What has to be considered for science/  research purposes? and 34. What has to be considered with regard to product approval?).

Due consideration is given to whether users have obtained genetic resources from a collection (see below, 24. What is the register of collections?) or have reduced the risk of non-compliance by applying a best practice (see below, 29. What is meant by a best practice?).

Checks can include on-the-spot checks and checks of selected documentation and samples; users must offer all assistance necessary to facilitate the performance of the checks (Article 9(5) of the Regulation) (see above, 19. What are the obligations on users with regard to assistance?).

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21. What sanctions can be expected in the event of non-compliance with the user obligations?

The following measures can be taken in the event of non-compliance with the user obligations under Regulation (EU) No 511/2014, under Implementing Regulation (EU) 2015/1866, under the German Implementing Act (Act Implementing the Obligations under the Nagoya Protocol, Implementing Regulation (EU) No 511/2014) and under secondary legislation issued under the Implementing Act: 

Firstly, the Federal Agency for Nature Conservation (BfN), as the competent national authority, can make orders to remedy breaches (remedial action) (Section 2(1) of the Implementing Act).

Secondly, if a user fails to take the remedial action ordered, BfN can seize an unlawfully utilised genetic resource, prohibit specific utilisation activities, or confiscate the resource (Section 2(2) and (3) of the Implementing Act).

Intended or negligent non-compliance with the information, assistance or due diligence obligations under Regulation (EU) No 511/2014 and with any orders issued by the competent national authority is a regulatory offence subject to a fine of up to €50,000 (Section 4 of the Implementing Act).

Moreover, the fine can claim any economic profit gained from the unlawful utilisation of genetic resources or traditional knowledge associated with them (Section 17(4) of the Act on Regulatory Offences).

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Internationally recognised certificate of compliance

22. What is the internationally recognised certificate of compliance?

The internationally recognised certificate of compliance is a permit (or equivalent) issued at the time of access as evidence that the genetic resource it covers (or the traditional knowledge associated with the genetic resource) has been accessed in accordance with access and benefit sharing (ABS) rules of the provider country and that mutually agreed terms have been established for the user and the utilisation specified therein.

An internationally recognised certificate of compliance must be issued by the competent authority in the provider country and published at the ABS Clearing House (on which see above, 4. What is the ABS Clearing House? and below, 40. Where can I find more information?).

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23. What does the certificate demonstrate?

The internationally recognised certificate of compliance counts as prove that the genetic resources it covers (or the traditional knowledge associated with them) have been lawfully accessed and that mutually agreed terms have been established for the user and the utilisation specified therein.

Under Article 4(3)(a) of Regulation (EU) No 511/2014, a user of genetic resources (or of traditional knowledge associated with them) is considered to have met the due diligence obligation if he seeks, keeps and transfers to subsequent users the internationally-recognised certificate of compliance, as well as information on the content of the mutually agreed terms (see above, 14. What is meant by the due diligence obligation?).

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Registered collections

24. What is the register of collections?

Collections such as botanical gardens are important providers of genetic resources (and of traditional knowledge associated with them) used in the European Union. 

The register of collections is a voluntary, web-based tool in the European Union to assist users in complying with their due diligence obligations (Article 5 of Regulation (EU) No 511/2014). If a collection is registered as a ‘recognised collection’, this is intended as a guarantee that the collection will provide users with the necessary documentation and information together with the genetic resources (see above, 14. What is meant by the due diligence obligation?).

The register contains, for each collection or part of a collection, the information listed in Article 2 of Implementing Regulation (EU) 2015/1866 (such as registration code, name, contact details and short description).

The web-based register of collections within the Union is maintained by the European Commission.

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25. What are the requirements for registration?

Under Article 5(3) of Regulation (EU) No 511/2014, a collection must demonstrate the following in order to be registered:

  • Standardised procedures for exchanging genetic resources (and traditional knowledge associated with them) with other collections and for supplying genetic resources to third parties;
  • Genetic resources and related information supplied to third persons only in conjunction with documentation on the legality of access and benefit sharing;
  • Records kept of all samples of genetic resources and related information supplied to third persons for their utilisation;
  • Use of unique identifiers (where possible) for resources supplied to third persons;
  • Tracking and monitoring tools.

Under Article 3(3) of Implementing Regulation (EU) 2015/1866, the verification of registration criteria may include on-the-spot checks, examination of selected documentation and samples, and interviews with relevant persons.

Once a collection located within the sovereign territory of the Federal Republic of Germany is included in the register, the collection holder is required to notify BfN of any significant changes to the information given in the registration request.

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26. What is the procedure for registering a collection?

To register a collection located within the sovereign territory of the Federal Republic of Germany, the collection holder must submit a request to the Federal Agency for Nature Conservation (BfN), providing the information listed in Annex I to Implementing Regulation (EU) 2015/1866.

Provided that the criteria for registration under Article 5(3) of Regulation (EU) No 511/2014 are met, BfN transfers the information in the request to the Commission, which includes the information in the register.

Once a collection is included in the register, the collection holder is required to notify BfN of any significant changes to the information given in the registration request; BfN in turn notifies the Commission.

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27. What are the benefits of registration?

Users who obtain genetic resources from a registered collection are considered to have exercised due diligence as regards the seeking of information (Article 4(7) of Regulation (EU) No 511/2014).

This is without prejudice to the due diligence declarations under Article 7(1) and (2) of the Regulation (see above, 18. What are the obligations on users with regard to declarations? and below, 32. What has to be considered for science and research purposes? and 34. What has to be considered with regard to product approval?).

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28. How are registered collections monitored?

The Federal Agency for Nature Conservation (BfN) periodically carries out checks on a risk-based approach and in case of substantiated concerns in order to verify that collections included in the register and located within the sovereign territory of the Federal Republic of Germany continue to meet the registration requirements under Article 5(3) of Regulation (EU) No 511/2014.

Verification may include on-the-spot checks, examination of selected documentation and samples, and interviews with relevant persons; the collection holder and staff must provide all necessary assistance (Article 4 of Implementing Regulation (EU) 2015/1866).

If checks indicate that the registration requirements are no longer met, BfN identifies remedial action in consultation with the collection holder (Article 4 of the Implementing Regulation). If the remedial action does not lead to compliance, BfN notifies the Commission, which removes the collection concerned from the register (Article 5(4) of the Regulation).

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Best practices

29. What is meant by a best practice?

A best practice within the meaning of Article 8 of Regulation (EU) No 511/2014 is a combination of procedures, tools or mechanisms recognised by the European Commission and developed by associations of users or other interested parties (parties with a legitimate interest) in order to enable the users to comply with their due diligence and declaration obligations under Article 4 and 7 of the EU Regulation.

Best practices can also be recognised internationally under Article 20(2) of the Nagoya Protocol.

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30. What is the procedure for having a best practice recognised?

Applications for recognition of best practices must be submitted to the European Commission, providing the information listed in Annex IV to Implementing Regulation (EU) 2015/1866 (Article 8(1) of the Implementing Regulation).

The Commission sends a copy of the application and supporting documentation to the Federal Agency for Nature Conservation, which may submit comments within two months.

The Commission informs the applicant of the indicative time limit within which a decision on the application will be taken, of any revision to the time limit, and at least every six months of the status of the application.

The Commission must be notified of any changes to a best practice for which recognition has been granted (Article 8(3) of Regulation (EU) No 511/2014).

In the event of repeated or significant cases of non-compliance with the due diligence obligations under Article 4 and 7 of the Regulation, the European Commission examines whether they relate to deficiencies in the best practice; if appropriate, recognition as a best practice may be withdrawn (Article 8(4) of the Regulation).

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31. What are the benefits of best practices?

The Federal Agency for Nature Conservation takes into account that users reduce the risk of non-compliance with the due diligence obligations under Article 4 and 7 of Regulation (EU) No 511/2014 by applying a best practice within the meaning of Article 8 of the Regulation (or Article 20(2) of the Nagoya Protocol).

In this context, the European Commission maintains a web-based register in which recognised best practices are published (Article 8(6) of the Regulation).

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Science and research

32. What has to be considered for science/ research purposes?

Since 10 May 2018 recipients of research funding involving the utilisation of genetic resources (or of traditional knowledge associated with genetic resources) are obliged to submit, at the stage of research funding, a due diligence declaration in accordance with Article 7(1) of Regulation (EU) No 511/2014 read in conjunction with Article 5 of Implementing Regulation (EU) 2015/1866.

Research funding is defined as any financial contribution by means of a grant to carry out research, whether from commercial or non-commercial sources (Article 5(5) of the Implementing Regulation). Internally funded research is not considered to be research funding within the meaning of Article 7(1) of the EU Regulation.

The due diligence declaration must normally be submitted after the first instalment of funding has been received and all the genetic resources (and traditional knowledge associated with genetic resources) that are utilised in the funded research have been obtained, but no later than at the time of the final report (or in absence of such report, at the project end).

Due diligence declarations under Article 7 of the EU Regulation can be submitted electronically via the EU-wide web-based tool DECLARE. The due diligence declaration at the stage of research funding must contain the information listed in Annex II of the Implementing Regulation. It is then to be submitted to the Federal Agency for Nature Conservation (BfN) as the competent authority if the recipient of the research funding is established in the Federal Republic of Germany or, where the recipient is established outside of the European Union, if the research is carried out in the Federal Republic of Germany (Article 5(1) of the Implementing Regulation).

User guide/Questions and answers – DECLARE NAGOYA IT system
Access to DECLARE

Multiple users can submit a single declaration if they carry out joint research activities that are funded from the same source (Article 5(3) of the Implementing Regulation).

The content of the due diligence declaration is transmitted by BfN to the ABS Clearing House, the Commission and the competent authorities in the provider countries, while respecting the confidentiality of commercial and industrial secrets (Article 7(3) and (5) of the Regulation read in conjunction with Article 7 of the Implementing Regulation).

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Patenting and commercialisation

33. What has to be considered when applying for a patent?

If an invention is based on biological material of plant or animal origin or  where such material has been used, the patent application should include information on the geographical origin of such material, if known (Section 34a of the German Patent Act).

Simultaneously with the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014, an amendment to the Patent Act also entered into force on 1 July 2016 inserting a new Section 34a(2) into the Patent Act. This stipulates that the Patent Office must notify the Federal Agency for Nature Conservation as competent national authority of the information on geographical origin.

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34. What has to be considered with regard to product approval?

At the stage of final development of a product developed using genetic resources (or traditional knowledge associated with them), users must submit a due diligence declaration in accordance with Article 7(2) of Regulation (EU) No 511/2014.

For users established in the Federal Republic of Germany, the due diligence declaration has to be submitted to the Federal Agency for Nature Conservation (BfN) as the competent national authority, providing the information listed in Annex III to Implementing Regulation (EU) 2015/1866 (Article 6(1) of the Implementing Regulation).

Due diligence declarations under Article 7 of the EU Regulation can be submitted electronically via the EU-wide web-based tool DECLARE.

User guide/Questions and answers – DECLARE NAGOYA IT system
Access to DECLARE

The due diligence declaration in accordance with Article 7(2) of the Regulation has to be submitted only once prior to the first of the following events:

  • Market approval or authorisation is sought for a product;

  • Notification of a product before it is placed on the Union market for the first time; 

  • The first time a product is placed on the Union market;

  • Sale or transfer of the result of the utilisation within the European Union;

  • Sale or transfer of the outcome of the utilisation outside of the European Union after utilisation within the Union has ended (Article 6(2) of the Implementing Regulation).

Failing to submit such a declaration, or failing to do so correctly, completely or at the latest four weeks prior to the end of the utilisation is a regulatory offence (Section 4(2)(3) of the national Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014).

The content of the due diligence declaration is transmitted by BfN to the ABS Clearing House, the Commission and the competent authorities in the provider countries, while respecting the confidentiality of commercial and industrial secrets (Article 7(3) and (5) of the Regulation read in conjunction with Article 7 of the Implementing Regulation).

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Who does what

35. What is the role of the Federal Agency for Nature Conservation?

The Federal Agency for Nature Conservation (BfN) is the competent national authority in Germany for the enforcement of the Nagoya Protocol, Regulation (EU) No 511/2014 and the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014 (Section 6(1) of the Implementing Act). BfN is also the point of contact and provides advice for all users and collections in Germany.

Enquiries on enforcement:


Logo of the Federal Agency for Nature Conservation

Federal Agency for Nature Conservation (BfN)
Division I 1.3
Competent National Authority for the Nagoya Protocol
Konstantinstr. 110
D-53179 Bonn

Tel.:    +49 (0) 228 8491 1211
Fax:    +49 (0) 228 8491 1229
Email:  Nagoya-CNA@bfn.de

 

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36. What is the role of the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety?

Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) is the national focal point with responsibility for international reporting under the Nagoya Protocol (Section 6(4) of the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014).

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37. What is the role of the Federal Office for Agriculture and Food?

Determinations concerning the organisation of enforcement with regard to genetic resources for food and agriculture and related decisions are made by the Federal Agency for Nature Conservation in agreement with the Federal Office for Agriculture and Food (Section 6(2) of the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014).

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38. What is the role of the Robert Koch Institute?

genetic resources and related decisions are made by the Federal Agency for Nature Conservation in agreement with the Robert Koch Institute (Section 6(3) of the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014).

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Further information

39. Forms

The information required for an application for inclusion in the register is provided in Annex I of Implementing Regulation (EU) 2015/1866.

The information required for recognition of a best practice is provided in Annex IV of Implementing Regulation (EU) 2015/1866.

A template for a due diligence declaration at the stage of research funding is provided in Annex II of Implementing Regulation (EU) 2015/1866. The declaration can be submitted electronically via the EU-wide web-based tool DECLARE.

User guide/Questions and answers – DECLARE NAGOYA IT system
Access to DECLARE

A template for a due diligence declaration at the stage of final development of a product is provided in Annex III of Implementing Regulation (EU) 2015/1866. The declaration can also be submitted electronically via the EU-wide web-based tool DECLARE.

User guide/Questions and answers – DECLARE NAGOYA IT system
Access to DECLARE

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40. Where can I find more information?

An international clearing house on access and benefit sharing (the ABS Clearing House) has been established and is administered by the Secretariat of the Convention on Biological Diversity (CBD). 

The ABS Clearing House supports the implementation of the Nagoya Protocol by sharing information on access and benefit sharing (ABS), enhancing transparency and providing for legal certainty, and bringing together providers with users. The ABS Clearing House provides information on the following:

Further information on model contractual clauses, codes of conduct and guidelines are found among other things on the CBD Secretariat website.

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Competent National Authority

Federal Agency for Nature Conservation (BfN)
Division I 1.3
Konstantinstr. 110
D-53179 Bonn
Tel.:   +49(0)228 8491 1211
Fax:   +49(0)228 8491 1229
Email: Nagoya-CNA@bfn.de

Booklet on Nagoya Protocol

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Cover booklet on Nagoya Protocol

Flyer on Nagoya Protocol

Poster on Nagoya Protocol

Last Change: 17/12/2015

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