1. List of temporary authorisations delivered in the context of the fight against Covid-19

All the temporary authorisations delivered in the context of the fight against the coronavirus (Covid-19) are to be found here


2. List of authorisation holders of biocidal products intended for human hygiene (product-type 1) useful in the fight against the coronavirus


3. List of authorisation holders of biocidal products intended for the disinfection of surfaces (product-type 2) useful in the fight against the coronavirus


4. Due to the outbreak of the novel coronavirus (Covid-19) that has been officially acknowledged as a pandemic and a public health crisis, and pursuant to article 55 (1), first paragraph of Regulation (EU) n° 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, the Belgian competent authorities have decided to proceed with the grant of temporary authorisations for certain biocidal product types.

Eligibility criteria for temporary authorisations

  • Products used for human hygiene purposes (product type 1), specifically hydroalcoholic gels or solutions
  • Products used for the disinfection of surfaces (product type 2)

Application procedure

This application is free of charge and is to be submitted by email, according to the provisions below.

Your email should include:

  • The complete composition of the product (in %)
  • A draft label of the product
  • The safety data sheet of the product
  • An estimate of the stocks available for the Belgian market
  • The type and the size of the packagings of the product
  • If applicable, the required efficacy tests (*)
  • If your product is being subjected to an ongoing European procedure through R4BP3, please mention the R4BP3 case number.

Applications for multiple products are to be submitted through separate emails (i.e. 1 product per email).

Upon completion of the procedure no authorisation number will be assigned to the product. It is not required for these temporary authorisations.

(*) Efficacy

  • Regarding products used for human hygiene purposes (product type 1), specifically hydroalcoholic gels or solutions
    • If the alcohol content is ≥70% (V/V), no efficacy tests are required.
    • If the alcohol content is <70% (V/V), an efficacy test is required according to norm EN 14476.
  • Regarding products used for the disinfection of surfaces (product type 2)
    • Products with ethanol as an active substance:
      • If the ethanol content is <70% (V/V), an efficacy test is required according to norm EN 14476.
      • If the ethanol content is ≥70% (V/V), no efficacy tests are required.
    • Products with other active substances:
      • Efficacy tests are required according to the following norms: EN 1276, EN 1650, EN 14476, EN 13697 (Bacteria & yeast).

Further information/questions

For further information concerning temporary authorisations please consult article 55 (1), first paragraph of Regulation (EU) n° 528/2012 and article 21 of Royal Decree of 4 April 2019.

Furthermore, you can submit potential questions to info.biocides@health.fgov.be or our helpdesk. Our helpdesk will give priority to answering questions concerning Covid-19.

Additional information intended for chemists only 

Due to the difficulties with obtaining hydroalcoholic solutions that pharmacies are currently encountering, the Belgian competent authorities grant both public and hospital chemists an exceptional and temporary authorisation for the production of their own hydroalcoholic solutions according to the provisions of the World Health Organisation (WHO). For further information concerning the provisions and restrictions applicable to this authorisation please consult Royal Decree of 18 March 2020 concerning the preparation and the making available on the market of alcohol-based hand sanitisers for human hygiene purposes in the context of the fight against the spread of Covid-19.


5. Excise taxes

If you would like to produce hydroalcoholic gels, hand sanitisers or other alcohol-based disinfectants in Belgium, you also have to comply with the Belgian regulation regarding excise taxes. To find out about them, please consult the web page of the FPS Finances (only available in Dutch, French and German).