Guidance: Utilizing genetic resources (Nagoya protocol) - Swedish Environmental Protection Agency

Utilizing genetic resources

Guidance on the utilization of genetic resources in research and product development.

Guidance

How do I comply with the EU ABS Regulation?

  • BASIC OBLIGATIONS

    Steps to determine whether you need to file a declaration.

  • 1.

    Find out whether the EU ABS Regulation is relevant for your research.

    Who is in scope of the Nagoya Protocol?
  • 2.

    If your research is within scope of by the EU ABS Regulation, go to the ABS Clearing-House to: a) Determine whether the provider country is party to the Nagoya Protocol and whether there is any ABS legislation for genetic resources and/or associated traditional knowledge. b) Obtain the contact information for the national focal point (NFP) and competent national authorities (CNA) in the country that holds the genetic resource and/or the associated traditional knowledge. The ABS Clearing-House should have information on how to apply for access – such as a flow chart or a where you can find more information on how to apply for access. If not, proceed to step 3.

    Using the ABS Clearing-HouseABS Clearing-House website
  • 3.

    Contact the national focal point in your provider country and seek advice as to: a) How to apply for Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) and if there are any specific requirements or conditions attached to these permits. b) Other specific and relevant national legislation that requires further permits.

    Using ABS Clearing-House
  • 4.

    Apply for PIC and establish MAT if required. During the research period, the conditions stated in the MAT and other relevant legislation must be fulfilled.

  • 5.

    During the period of your research you shall declare due diligence to the Swedish Environmental Protection Agency.

    User Manual (pdf 1 MB)
  • 6.

    If you launch a product in the market as a result of this research, you shall, before the product is introduced in the market or at the time of the product approval, submit a second declaration to the Swedish Environmental Protection Agency.

    User Manual (pdf 1 MB)
  • OTHER OBLIGATIONS

    Other obligations under the EU ABS Regulation.

  • 7.

    Keep your permits (PIC AND MAT) and any other information relevant to access and benefit-sharing for 20 years after the research is concluded.

  • 8.

    Inform subsequent users of the conditions as described in PIC and MAT.

Laws/Regulations

Definitions

Background