The national authorisation scheme
The Danish Veterinary and Food Administratrion authorises certain veterinary hygiene products within product type 3 (PT3) and disinfectants used in the food and feed area within product type 4 (PT4). These disinfectants are regulated in the Danish Order No. 8 of 3. January 2023 on approval of disinfectants etc. used in food establishments etc. The products can be combination products with both cleaning and disinfecting effect.
The products are approved based on an assessment of the efficacy towards microorganisms at the specified concentration of use. The authorisation is also based on a toxicological evaluation in order to ensure that use of the product does not lead to risk of hazardous residues in food stuff.
The products must not be placed on the market in Denmark before an authorisation has been granted by the Danish Veterinary and Food Administration.
The authorisation of a desinfection product can include either a biocidal effect or a fungicidal effect, or both bactericidal and fungicidal effect. A teat disinfectant can be authorised for use either prior to milking, after milking or both prior to and after milking.
Requirements for active substances
Different active substances can be used for different product types. The active substance used must be approved for the specific product type.
In order to get a product authorisation by the Danish Veterinary and Food Administration the active substances in the product must be included in the EU reassessment program for the relevant product type.
If all active substances in the product are assessed and approved by ECHA the application for product authorisation shall be forwarded to the Danish Environmental Protection Agency. The Danish Environmental Protection Agency can be contacted for support about the authorisation scheme under the Biocidal Products Directive.
The list of active substances listed in Annex I of the Biocidal Products Directive can be found in an electronic EU-list of active substances. The list contains substances that are approved according to the Biocidal Products Directive and the Biocidal Products Regulation.