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.
Other useful publications
Meetings of the European Competent National Authorities Implementing the Nagoya Protocol and the Corresponding EU Regulation
If you are interested in understanding more about the activities of the competent authorities in the European Union, you can refer to the reports of the first and second meetings of these authorities that were hosted by the BfN in 2017 and 2018. These documents address topics such as:
- how the competent authorities identify users
- how the user controls are organized
- lessons learned from user controls conducted in the past
- information about registered collections
What is a registered collection and how does an institution gain this status?
Best practices can help researchers and institutions with compliance.