Application for authorisation under the old Danish authorisation scheme
Pending the EU evaluation of all the active substances in the products, certain biocidal products are covered by the old Danish authorisation scheme and must be authorised under these rules until all active substances in the product have been approved under the BPR
In principle, pursuant to the BPR all biocidal products must be authorised before import, sale or use.
However, in a transitional period, until all the active substances have been evaluated by the EU, national legislation as applicable before the entry of force of the Biocidal Products Directive (in 2000) is still in use. This regulation was introduced in Denmark in 1980.
Certain products covered by the old Danish authorisation scheme must still be authorised under these rules during the transitional period. Only products containing active substances under review in the Product Type (PT) concerned can be taken into consideration.
Autorisation is required during the transitional period for the following products against
- wood-destroying fungi
- algae growth
- slime-forming organisms in pulp
- rabbits, mice and rats
- pests on domestic animals (lice, fleas and the like)
- textile pests
- pests in timber and woodwork
- insects, snails and slugs, mites, and earthworms, and
- repellents against mosquitoes and other insects etc. or against wild birds and animals.
This scheme will continue for the individual products until a decision has been taken to approve the active substance(s) for use in the EU. After approval, the products must be authorised under the new BPR rules.
All other products MUST be registered at the Danish Product Registry.
Requirements for the application
For products with an active substance not yet approved under the BPR (the transitional measures), your application must include the following:
- Form A for the product
- Form B for the active substance
- The original data referred to in the A and B forms. Original data will typically take the form of test reports. Read more about the data requirements at the bottom of this page. See Guide to Efficacy Studies.
- Draft instructions for use in Danish.
- Safety data sheets for the active substance and all co-formulants in Danish or English, classified according to the CLP-Regulation.
- CLP-classification of the product including calculations or product study summaries for justification.
- If a consultant is handling the application on behalf of the applicant a letter of attorney must be submitted.
The Danish EPA would prefer to receive the application electronically to facilitate the case processing. Files in Word or PDF format must be submitted on CD in two (2) copies.
Please submit your applications by letter enclosing a CD to:
Pesticides & Biocidal Products
DK-5000 Odense C
The data requirements are specified in the Danish Statutory Order on Pesticides, Section 14 and Annex 1.
If an existing active substance has not yet been approved pursuant to the BPR within a given product type, data must be submitted for the active substance and the product according to Annex 1.
The Danish EPA will charge fees for applications under the Danish transitional scheme. The fees will cover any costs incurred by the Danish EPA when processing the applications.
See the current fees here.