In 2025, authorisation from the Danish Veterinary and Food Administration will be transferred to the Environmental Protection Agency
The Biocidal Products Regulation (BPR) entered into force on 1 September 2013. Once the BPR is fully implemented by 2025, the rules on biocidal products will be harmonized at EU level. This means, among other things, that the authorisation of disinfectants and teat disinfection products is transferred from being the DVFA's area of responsibility to that of the Danish Environmental Protection Agency. The transfer from the DVFA to the Danish Enviromental Protection Agency will be on an ongoing basis and will vary depending on the active substances of the products.
Assessment of active substances
Active substances used in disinfectants and teat disinfection products are subject to the review programme of active substances in the BPR. During the review process, a transitional regime takes place whereby these products are subject to the national rules of the Member States until all active substances are approved under the BPR. In Denmark, during the transitional period, disinfectants and teat disinfection products are regulated by Order No 859 of 23 August 2019 on the authorisation of disinfectants etc. in food businesses, etc., which is also known as the national apprvalscheme.
Once all active substances in a specific product have been approved under the BPR, the product must be approved in accordance with the BPR. The status of an active substance – in particular the date of EU authorisation – can be found on the website of the European Chemicals Agency (ECHA). Go to the European Chemicals Agency website
Consequences for a disinfectants in relation to authorisation the active substance and the specific product type
What is the situation in regards of authorisation of the active substance and the specific product type?
What consequences does the situation have in regards to the marketing of the product?
If the active substance and the specific product type are covered by the review programme, but not yet fully finalised.
The product can remain on the market until the active substance and product type are finalised under the review programme.
If the active substance and the specific product type are not included in the review programme.
The product must be removed from the market before 1 September 2017 .
If the review of the active substance and the specific product type has been finalized in the review programme as approved.
Authorisation under the BPR must be applied for before the date of authorisation of the last remaining active substance in the product.
If the review of the active substance and the specific product type has been finalized under the review programme as not approved.
The product must be removed from the market within 180 days of the decision on 'non-authorisation' by ECHA
The illustration shows when a product with an authorisation granted by the DVFA under the transitional regime must apply for authorisation under the BPR.
Placing on the market of disinfectants while applying under the Biocides Regulation
If a product is authorized under the national authorisation system, the product can be lawfully placed on the market pending product authorisation under the BPR. However, this presupposes that an application under the BPR has been submitted before the deadline for application.
Where several active substances have been used in a product, the application deadline for the last active substance for the specific product type shall apply. Therefore, if it is intended to keep the product on the market while the application is being processed under the BPR, it must be ensured that the product is approved under the national authorisation scheme before the deadline for the application of the active substance. It is therefore essential to keep up to date on the authorisation status of the active substances and the DVFA's processing time for authorisation.
If no application for authorisation is made by the deadline for the application of the active substance;
If no application is submitted to ECHA by the deadline for the application for the last active substance, the product may remain on the Danish market for no more than 180 days after that deadline. Placing on the market of the product after that date is not allowed and the national authorisation issued by the Danish Veterinary and Food Administration will no longer apply, as the product is now regulated under the BPR. The product may be used up to 365 days after the relevant application deadline.
Here you will find products approved under the BPR
Products approved under the BPR shall be marketed with the issued authorisation number. Approved products is listedon ECHA's website or in the Danish Environmental Protection Agency's database.
See approved products on the ECHA website: ECHA database
See approved products programmes in the Danish Environmental Protection Agency's database (BMD)