Users and utilization of genetic resources
Are you user of genetic resources and traditional knowledge?
Many products contain genetic resources. Before a products reaches the consumers, a chain of companies and scientists developed the products by utilizing genetic resources. This is the case for several pharmaceuticals, cosmetics, enzymes and food products. The users is a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources. Owners or holders of collections of genetic resourcs are also users.
When is an activicy in scope of the ABS-regulation?
Research and development in a genetic resource originating from a country with access-rules and ratified as a party to the Nagoya-protocol is in scope of the EU-regulation. Also the genetic resources must be accessed when the protocol was put into force the 12. october 2014 or later.
When a genetic resources is utilized for research and development, the following conditions must be met before an activity is in scope of the EU-regulation:
- The provider country has ratified as party to the Nagoya Protocol.
- The provider country has established access-rules on acquisition of genetic resources
- The genetic resources are accessed 12. october 2014 or later.
If the conditions above apply, it is important to determine whether a genetic resource is covered by the EU regulation on ABS. The genetic resource or associated traditional knowledge will be in scope of the EU regulation if the genetic resource is utilized for the development of a product, for research or for the purpose of storing the genetic material in a collection (e.g. museums, botanical gardens or private collections).
When are you not a user of genetic resources?
Trade and exchange of genetic resources as commodities (such as agricultural, fisheries or forestry products — whether for direct consumption or as ingredients, e.g. in food and drink products) fall outside the scope of the EU Regulation. The trade, use or procesing of e.g. Aloe vera, Shea or other known ingredients in the preparation of cosmetics is not in scope of the EU regulation, when it doesn't include new research or product development.
How to comply with the legislation on genetic resources as user?
If you already use or consider accessing genetic resources or use associated traditional knowledge from other countries, you should inform about your obligations. The same applies when you collect genetic material for a collection with origin in other countries.
The Danish Environmental Protection Agency is the competent national authority on ABS
The Danish EPA is the competent national authority on the EU regulation on ABS in Denmark. The EPA carries out checks on user compliance on utilization and benefit sharing of genetic ressources.