The Biocidal Products Directive requires that all biocidal products must as a general rule be authorised before they can be imported, placed on the market or used. This is stated in Section 33(1) of the Danish Chemicals Act.
However, we are currently in a transitional period until the EU has evaluated all active substances. Products that are covered by the existing Danish authorisation scheme for biocidal products must therefore still be authorised in accordance with these rules while the transitional period is in force and the EU is evaluating the active substances in the products.
Application procedures under the transitional arrangements
Biocidal products containing active substances that are being evaluated by the EU, but have not yet been approved, are covered by what are known as the transitional arrangements, which have applied in Denmark since the Biocidal Products Directive entered into force in 2000.
Me-too authorisation
An enterprise that produces a new product containing an active substance already present in authorised products in Denmark may apply for what is known as a “me-too” authorisation. For such applications, it is sufficient to provide information on the formulated product, as long as documentation can also be supplied showing that the relevant active substance is identical to the active substance present in previously authorised products.
This procedure involves either obtaining a “letter of access” from the authorisation holder who markets the products that have already been authorised, or submitting an impurity profile for your own active substance. The impurity profile must specify 100 per cent of the composition of the manufactured material.
Parallel authorisation
If you wish to market a substance that is identical to a product that has already been authorised in Denmark, you may apply for parallel authorisation. In such cases, all you need to document is that the product is 100 per cent identical with the previously authorised product – possibly by means of a declaration from the authorisation holder for that product, or by means of an invoice showing that you are buying the product from the authorisation holder.
Parallel authorisation may only be granted for precisely the same use and the same dosage as the original product, and proposals for the label and user instructions must be submitted.
Products where the active substance is not included in the EU list of approved active substances
For products where the active substance is not included in the EU list of approved substances (the transitional arrangements), the application must contain the following:
- Form A for the product
- Form B for the active substance
- Original data referred to in Forms A and B. Original data will generally be in the form of test reports. Read more about the data requirements at the bottom of the page.
- Proposed Danish label, user instructions in Danish and safety datasheets for all co-formulants.
The Danish Environmental Protection Agency prefers to receive such applications electronically, as this will facilitate the administration process. Please submit files in Word or PDF format on a CD in duplicate.
Please send applications submitted by letter with CDs enclosed to:
Pesticides and Gene Technology
Danish Environmental Protection Agency
Strandgade 29
DK-1401 Copenhagen K Denmark
Data requirements
The data requirements are set out in § 16 and annex 1 of the Danish Statutory Order on pesticides.
If an existing active substance is not included in the EU list of approved substances within a given product-type, data on the active substance and product must be submitted in accordance with Annex 1 of the Danish Statutory Order on pesticides.
Fees
Fees are charged for applications under the existing Danish authorisation scheme. The fees are set out in Annex 3 of the Danish Statutory Order on pesticides