Authorisation process and fees
The authorisation proces usually takes 5-6 months if the application is complete. The process may be longer in the case that required information is lacking.
The fee for a product authorisation is DKK 7,900 as of 1. January 2023 cf. Danish Order No. 54 of 19. January 2023, § 48 No. 6.
For parallel authorisation of products which have been authorised within the last 5 years and for which toxocological assessment is not required the fee is DKK 3,000.
Please note that if the Danish Veterinary and Food Authority cannot finalise the authorisation before the date of the active substance approval at ECHA ("approval start date"), the application will be dismissed and the fee will be lost. This is because the formal responsibility is passed on to the Danish Environmental Protection Agency as the substances are approved under the scope of the Biocidal Products Regulation. You can find more information about the transitional measures elsewhere on this webpage.
Documentation for product efficacy in accordance with relevant european standards shall be forwarded when applying for authorisation of desinfectants used in the food industry or teat disinfectants. Disinfection products can fulfill the requirements for efficacy by having either a bactericidal or a fungicidal effect or both a bacterial and a fungicidal effect.
The technological effect of disinfectants used in the food industry and teat disinfectants can be documented by use of the following efficacy tests:
- DS/EN 13697: disinfectants used in the food industry with both bactericidal and fungicidal effects
- DS/EN 1276: disinfectants used in the food industry with only bactericidal effect
- DS/EN 1656: teat disinfectants or other products for disinfection of teats before or/and after milking