Questions and answers - authorisation of disinfectants

Biocidal products are categorised in four main groups and 22 product types. The categorisation is based on the properties of the products.

Different active substances can be used in the different product types. In case an active substance is not authorised for use in a specific product type, this combination between active substance and product type is not legal and the product cannot be authorised. 

It is therefore important that you are aware of which product type your product belongs to and which active substances that can be used. 

The Danish Veterinary and Food Administration authorises certain products within product type 3 and 4. 

Disinfectants used on surfaces that come into contact with food (product type PT4) and teat disinfectants (product type PT3) shall be authorised by the Danish Veterinary and Food Administration before placing on the market in Denmark. This follows from the Danish Order no. 8 of 3. January 2023 about authorisation of disinfectants etc. in food establishments etc. The Danish Veterinary and Food Administration is responsible for authorisation of these products until all active substances in the product in question have been approved under the re-assessment programme of the Biocidal Products Regulation. When all active substances have been approved the responsibility for authorisation is transferred to the Danish Environmental Protection Agency.

The Danish Veterinary and Food Administration does not authorise the following type of products:

• Udder hygiene products (udder cleaning products)
• Cleaning products
• Hygiene products for humans (e.g. hand disinfection)
• Products for disinfection of drinking water
• Disinfectants for animals and housing areas for animals

If your product contains active substances which are being assessed under the Biocidal Products Regulation, the product is covered by the transitional measures. During this period disinfectants and teat disinfectants are regulated under the national authorisation scheme and the products must:

• be authorised by the Danish Veterinary and Food Administration and comply with the requirements set out in Danish Order No. 8 of 3. January 2023 on authorisation of disinfectants etc. in food establishments etc. 
• comply with the chemical law in Denmark
• be notified to the Danish Working Environment Authority

The authorisation holder must ensure, that the active substance supplier is registered on the Article 95-list 

A product authorisation granted by the Danish Veterinary and Food Administration does not have any time limit. Renewal of an authorisation is thus not required. Please note, that authorisations granted by the Danish Veterinary and Food Administration are repealed when the active substances are fully regulated under the Biocidal Products Regulation. This means, that if your product has been authorised under the Biocidal Products Regulation (via the Danish Environmental Protection Agency/ECHA), the authorisation granted by the Danish Veterinary and Food Administration is no longer applicable.

Yes. There is no requirement in the national rules stating that the applicant must be based in Denmark. .

If all active substances in the product are approved under the Biocidal Products Regulation, then the product shall be authorised in accordance with this regulation. Under the BPR it is required that the authorisation holder is established within the EU.

No. If changes are made to an authorised product - regardless of whether it is a change in composition, use, trade name etc. - this requires a new authorisation from the Danish Veterinary and Food Administration. It is not possible to amend the trade name of an authorised product without prior approval. In case a company wishes to change the trade name or add trade names, a new application must be forwarded to the Danish Veterinary and Food Administration. 

It is possible to market different product sizes under the same trade name, provided that the product composition, use and concentration of active substance(s) etc. are identical for the different size variants. 

Yes. The request for change must come from the original authorisation holder. The company that originally applied for authorisation must confirm to the Danish Veterinary and Food Administration that they wish to transfer the authorisation to another company. The new company will then take over the authorisation for the product in question. 

Suppliers of active substances in biocidal products shall be registered on the Article 95-list of approved active substance suppliers within the relevant product type.

If the active substance supplier is not based within the EU, the supplier must have an EU representative on the Article 95-list.

On the website of the European Chemicals Agency (ECHA) you can find the list of registered active substance suppliers.
Go to the list: registered active substance suppliers.

You may also ask your active substance suppliers for verification that they are registered on the Article 95-list. On ECHA's website a declaration template is available for this purpose ("Letter of Supply"/Article 95 LoS template").

The deadline for application for authorisation under the Biocidal Products Regulation depends on the active substances used in the product. When all active substances have been approved by ECHA there will be a deadline for application for product authorisation of approximately 18 months.

When a deadline has been set for an active substance it will appear on ECHA's website as "Date of Approval".

If a product is authorised under the national authorisation scheme it can stay on the market in Denmark while product authorisation is ongoing under the Biocidal Products Regulation. However, the application for authorisation under the Biocidal Products Regulation must be submitted before the deadline set by ECHA. 

If a product is not yet authorised under the national authorisation scheme and you wish to place your disinfectant on the market prior to an authorisation being granted under the Biocidal Products Regulation, then you need to apply for authorisation under the national authorisation scheme. As the processing time for handling applications at the Danish Veterinary and Food Administration is approximately 5-6 months, the application should be handed in about 6 months prior to the deadline set by ECHA. If the application cannot be processed by the Danish Veterinary and Food Administration before the deadline set by ECHA, it cannot be finalised and the application fee will be lost. You will thus have to wait for the authorisation to be granted under the Biocidal Products Regulation before the product can be placed on the market.

Biocidal products may only contain active substances that are approved or are under re-assessment under the Biocidal Products Regulation. If an active substance in your product is not or cannot be approved, then the product will no longer fulfill the requirements for authorisation under the national authorisation scheme. 

When an active substance has been assessed as not approved, biocidal products containing the substance must be placed on the market no longer than 180 days of the non-approval entering into force. Use of the product may only be continued for another 180 days efter that.

If an application for authorisation under the Biocidal Products Regulation is not submitted before the deadline, then you may continue to place the product on the market for 180 days after the applicable deadline. After this period the product must no longer be placed on the market. 

From the time the product is no longer placed on the market, use of the product is permitted for another 180 days. 

The Danish Veterinary and Food Administration does not authorise products containing colorants that are not approved for use in food stuffs. A colorant must be approved for use in food stuffs if used as an ingredient of disinfectants that may come into contact with food. 

Fragrances are considered unwanted substances in disinfectants that may come into contact with food. If a fragrance or essential oil is added to the product it must be documented that the substances have a technological purpose in the product. 

Disinfectants used on surfaces that may come into contact with food and teat disinfectants must be authorised before placing on the market.

If the active substances are not yet approved under the Biocidal Products Regulation, the authorisation of the product shall be granted by the Danish Veterinary and Food Administration according to national rules. If all active substances have been approved the authorisation of the product shall be granted according to the Biocidal Products Regulation. Then the authorisation process is under the responsibility of the Danish Environmental Protection Agency.

Product authorised by the Danish Veterinary and Food Administration:

• The authorisation number granted by the Danish Veterinary and Food Administration shall be included in the label on the product. The product shall also appear on the lists of authorised disinfectants used in the food industry or authorised teat disinfectants on the website of the Danish Veterinary and Food Administration. Note that the lists are updated at a quarterly basis.

Products authorised under the Biocidal Products Regulation:

• The authorisation number shall be included in the label of the product. Products authorised under the Biocidal Products Regulation can be found on the website of the European Chemicals Agency (ECHA) and/or in the database of the Danish Environmental Protection Agency of biocides and pesticides.

Listeria bacteria can develop resistance against disinfectants in the same way that bacteria can become resistent towards antibiotics. 

As a consequence a company should change the selection of disinfectants used on a frequent basis - or change between two or more types - in order to prevent the presence of listeria. This is an important measure to avoid development of listeria bacteria that become resistant towards the disinfectant used. The longer time a single type of product is used, the bigger risk for development of resistant bacteria.

As a rule of thumb it is recommended to change between two different disinfectants every month.

It is also important to ensure that the used disinfectants are effective towards listeria. Some disinfectants are only effective towards gram negative bacteria, and listeria is a gram positive bacteria. You may seek advice with the supplier of the disinfectants.

Products are authorised based on their efficacy and safety. For products authorised by the Danish Veterinary and Food Administration or by the Danish Environmetal Protection Agency/ECHA, satisfactory effect has been documented for the claimed use. It is therefore essential that

• the product is used for the purpose stated on the label
• the instructions of use are followed

If you use a disinfectant that is not authorised you cannot be sure that the product has satisfactory efficacy. Furthermore it cannot be ruled out that the product may pose a food safety risk .

You may transfer a disinfectant from the original packaging to a smaller container in order to prevent spill and excess use. However, the Danish Veterinary and Food Administration recommends that you always keep the original packaging which contains the instructions of use and other relevant information on the label, and that you label the new container with the product name, instructions for use, possible hazard label and the authorisation number provided by the Danish Veterinary and Food Administration. Be extra careful that you comply with instructions for time of contact if this is stated in the instruction of use on the original product.

Note that for combination products which can be used both for cleaning and disinfection, the cleaning and disinfection shall be done as seperate processes. Rinsing with water is required after cleaning, but not necessarily after disinfection.

If your company uses external service providers for cleaning and disinfection you should request that the supplier uses authorised disinfectants.