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Procedure for approval of a disinfectant or teat disinfection product

Here you will find a brief outline of what you need to apply for authorisation of a disinfectant or teat disinfection product.

​​​​You should b​e aware of t​he following when applying for authorisation of disinfectants and/or teat disinfectants:

  • Ensure that you comply with the Chemicals Act and that your future marketing (including labelling) is in accordance with Order No 859 of 23 August 2019 on the authorisation of disinfection products, etc. in food businesses, etc.

  • Ensure that your active substance supplier is registered in the Article 95 list.

  • Check the list of active su​​bstanc​​es included in the EU review programme to ensure that the active substances in your product type are accepted.
    Please note that ethanol is prohibited as active substance in teat disinfection products and udder hygiene as of 1 March 2010.

  • If all active substances in your product are approved, you must apply for authorisation under the BPR. Contact the Danish Environmental Protection Agency for information on authorisation under the BPR.

Documenta​tion

When applying for authorisation of disinfectants or teat disinfection products, evidence must be submitted that the product has a technological effect in accordance with applicable European standards. Disinfectants can meet the requirements of technological efficacy by having either a bactericidal or fungicide effect or both.

The technological effect of disinfectants and teat disinfection products/sprays can be demonstrated using the following efficacy tests:

  • DS/EN 13697: disinfectants to be used in food businesses and have both a bactericidal and fungicide effect.
  • DS/EN 1276: disinfectants to be used in food businesses and have only a bactericidal effect.
  • DS/EN 1656: teat dips, teat sprays or other products for disinfection of teats before and/or after milking.​​​​

 

Applicationform

​​This form must be used when you need authorisation disinfectants in food businesses that come into contact with food. The authorisation  covers disinfectants for the whole food area, pre-milking udder hygiene products and post-milking pattedyp/patte sprays.  ​

Application form for the authorisation of disinfection and teat disinfectants (in English)

or

Application form for the authorisation of disinfection and teat disinfectants (in Danish)​

You must send the completed form by e-mail to: des-godkend@fvst.dk . The Danish Veterinary and Food Administration sends a confirmation and an invoice upon receipt of your application. 

​​Report the product to the Danish Working Environment Authority's product register.

Authorisation ​​process and price

The authorisation process usually takes 5-6 months, unless there is missing information/documentation in the application. 

As of 1 January 2020, the case handling fee is DKK 13,300, For parallel authorisations of products that are no more than 5 years old and do not require further toxicological assessment, the fee is DKK 5,000.