Here you can find information about the tools and resources that can support you and your institution with compliance with Regulation (EU) No 511/2014.
The EU Guidance Documents – a must have resource!
The “New EU Guidance Document” was prepared by the European Commission in consultation with the competent authorities in the European Union. It is online and available in both English and German (and all other EU languages).
It is a must have resource for researchers working with biological material in the European Union and provides detailed information on:
- the scope of the EU Regulation and researchers’ core obligations under Regulation (EU) No 511/2014
- the concept of utilisation and examples of use cases
- sector specific issues for health and agriculture
The New Guidance Document complements the 2016 EU Guidance Document.
The EU Guidance document is not legally binding. Nevertheless, the competent authority in Germany uses this document to orientate itself when making relevant decisions about compliance.
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.
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”).
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.
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.