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Q & A – for manufacturers

Here you can find answers to the most frequently asked questions by manufacturers regarding disinfectants


Should my disinfect​​​ant / teat disinfection product be approved?

The DVFA must approve disinfectants used on surfaces and equipment that come into contact with food (product type 4), as well as teat disinfection products (product type 3) before they can be placed on the market, in order to ensure that the product does not pose a risk. If your product is to be used for the above purposes, it must be authorised before it can be placed on the market.

The product shall be approved under the national authorisation scheme, unless all active substances in the product are approved under the review programme of the BPR. In the latter case, the product must be approved under the BPR and please contact the Environmental Protection Agency.

Please note that the Danish Veterinary and Food Administration does not approve the following products:

• Udder hygiene products (cleaning agents) from 1 September 2019
• Detergents
​• Hygiene products for humans (e.g. handdisinfection)
• Products for disinfecting drinking water
• Disinfection products for stables/animals


How do I know if my product is covered by the national authorisatio​​n scheme?

Your product is covered by the national authorisation scheme if:

  • ​​The product is a disinfectant used on surfaces and equipment coming into contact with food (product type 4) or a teat disinfection product (product type 3), and
    The active substances in the product are all covered by the review programme of the BPR and all active substances have not yet been finalised.

 

What are the criteria for labelling and placing o​​n the market disinfectants and teat disinfection products?

The criteria for the labelling and placing on the market of disinfectants and teat disinfection products are set out in Order No 859 of 23 August 2019 on the authorisation of disinfectants, etc. in food businesses, etc. See in particular § 2 on authorisation  and § 5 on labelling.

 

What are the requirements for disinfectants/teat disinfe​​ction products during the transitional period?

If your product contains active substances that are still under assessment, the product is still subject to the transitional regime. Under the transitional regime, disinfectants and teat disinfection products are regulated by the national authorisation scheme. The product shall therefore:

  • ​​Be notified to the Danish Working Environment Authority's product register
  • Be authorised by the Danish Veterinary and Food Administration and comply with Order No 859 of 23 August 2019 on the authorisation of disinfectants, etc. in food businesses, etc.
  • Comply with the Chemicals Act
  • Contain active substances from an active substance supplier which is registered in the Article 95 list

 

How do I fin​​​d out if my product has been approved by the DVFA?

On the DVFA website you can find lists of approved disinfectants and approved teat disinfection products. You will also be notified by the Danish Veterinary and Food Administration once a decision has been made regarding authorisation of your product.

 

Do you have to register ​as a supplier?

Whether you are a retailer, manufacturer, importer or distributor of biocidal products, the supplier of the active substance in your product must be registered in the so-called Article 95 list. The Article 95 list is the EU list of approved suppliers of active substances. If the active substance supplier is not registered on this list, your product is illegal to place on the market. However, the requirement shall not apply to products containing active substances from Annex 1 of categories 1 to 5 and 7.

If the supplier of the active substance is from an EU country, the supplier must be registered in the Article 95 list. If the supplier of the active substance is not established in the EU, the supplier must have a representative in the EU who is registered in the Article 95 list.

Manufacturers and importers of biocidal products shall be able to demonstrate that the product originates either from a listed product supplier or that the active substance is supplied by a listed company. In both cases, the supplier shall be listed in the product type to which the given biocidal product belongs.

When applying for product authorisation at the DVFA, you must be able to demonstrate that your active substance supplier is registered in the Article 95 list.

 

Who should be registered in th​​​​e Article 95 list?

The supplier of active substances contained in the biocidal product shall be registered in the Article 95 list of approved active substance suppliers within that product type.

If the active substance supplier is not established in the EU, the supplier must have a representative in the EU who is registered in the Article 95 list.

 

How do I know if ​​my active substance supplier is registered in the Article 95 list?

A list of registered active substance suppliers can be found on ECHA's website.

You can also ask your active substance supplier for evidence that they are registered in the Art. 95 list. A supplier's declaration is available on the ECHA website ('Letter of Supply'/Article 95 Los template) which the supplier can use for that purpose.

How do I register on the Article ​​95 list?

The Article 95 list is administered by ECHA.
Read more about the Article 95 list subject can be found on ECHA's website on suppliers of active substances


Only active substance suppliers established within the EU can be registered in the Article 95 list. Active substance suppliers outside the EU may be registered in the Article 95 list through a representative established within the EU.

Active substance suppliers may apply to be included in the Article 95 list in one of the following ways:

  • By submitting a dossier
  • By submitting a letter of access; or
  • If all data protection periods have expired, by submitting a reference to an existing dossier to ECHA.

The information submitted must comply with the data requirements for the active substances laid down in the Biocidal Products Directive or the BPR.

 

Which active​​ substances may I use in my product?

The active substances in your product must all be covered by the EU review programme and not be assessed as 'non-approved'.

 

How do I know if my active s​​ubstance has been approved?

On the ECHA website you can see the authorisation status of biocidal active substances in the review programmeme, as well as the product type against which the active substance is assessed. An active substance may be approved for some product types and not approved for other product types.

 

May my product contain active substances n​​ot covered by the review programmeme?

No. Only active substances covered by the review programmeme of the BPR may be used in biocidal products. When applying for product authorisation  at the Danish Veterinary and Food Administration, you must be able to demonstrate that the active substances in your product are approved or are under evaluation.

 

May my product contain acti​​​​ve substances that have not yet been finalized by the review programmeme?

Yes. Your product may contain active substances that are approved or under evaluation.

 

How should I act i​​​f my product contains more active substances?

A biocidal product is subject to authorisation  under the BPR only when all the active substances contained in that product have been approved for the relevant product type.

You can therefore place your product on the market under the national authorisation  scheme until all active substances in the product are fully evaluated. Remember to keep yourself informed about the authorisation  status of your product so that you know the deadlines for applying under the BPR.

 

When is the authorisation  deadline for disinfectants​​​? 

The deadline for authorisation depends on the active substances contained in the product. Once all active substances are approved by ECHA, there will be an authorisation  deadline at ECHA of around 1.5 years.

Once a deadline has been set for an active substance, the date of that period will appear on the ECHA database as 'Date of Authorisation '.

If the product has an authorisation  under the national authorisation  scheme and it is desired that the product can remain on the Danish market while the product is being approved under the BPR, then the application for authorisation  under the BPR must be submitted within ECHA's deadline.

If the product is not approved under the national authorisation  scheme, this authorisation  must be obtained before applying for product authorisation  under the BPR, if it is intended to market the product during BPR authorisation . As the processing of an application for authorisation  by the DVFA is approximately 5-6 months, the DVFA must therefore have the application approximately 6 months before the deadline set by ECHA.

 

What happens if an active substance in my pr​​oduct is not approved by ECHA?

Your biocidal product may contain only active substances that are approved or under evaluation under the review programmeme. If an active substance in your product is not approved, the product will no longer meet the criteria for authorisation  by the DVFA.

After publication of the non-authorisation  of an active substance, the product concerned may be placed on the market for 180 days, after which the placing on the market shall cease. The product may be used for a further 180 days thereafter.

 

What happens if I do not receive a​n application under the BPR by the deadline?

If you do not apply for an application for product authorisation  under the BPR by the deadline, then your product may be placed on the market for 180 days after that deadline, after which the placing on the market must cease until BPR authorisation  is finalized. The product may be used for a further 180 days thereafter.

 

What happens if I do not have my prod​​​uct approved under the national authorisation  scheme before the deadline for applying for the active substance in my product?

If the rules of the transitional regime are not complied with for the product concerned by the deadline for application for the active substance, the product shall not be placed on the market until the product is approved under the BPR.

 

What is an authorisatio​​​n  holder?

The Danish Veterinary and Food Administration considers the authorisation  holder to be the applicant unless otherwise informed.

Questions and Answers on product aut​​​​​​horisation

Read questions and answers about product authorisation  on the page:

Product authorisation  by the Danish Veterinary and Food Administration