Any biocidal product that is to be made available on the market, like hand sanitizers and surface disinfectants, has first to be authorised by the FPS Public Health. You will find here all the information on the making available on the market, purchase and proper use of these biocidal products.

 

Purchase and use of ALCOHOL-BASED GELS and disinfectants

Alcohol-based gels, hydroalcoholic solutions and disinfectants are biocidal products: means to destroy harmful organisms. Improper use may cause harm to your health and the environment. In addition, it may lead to the development of beacterial resistance to the active substances. Biocidal products are to be authorised by the FPS Public Health, Safety of the Food Chain and Environment. The FPS Public Health evaluates the composition of the product and also checks whether the label contains the required safe-use directions. By doing so the FPS Public Health aims to limit the environmental and health risk.

 

1. Authorised biocidal products      

All the authorised biocidal products are published on the list of authorised products.

2. Purchase and use of hand sanitizers (product-type 1)

Use alcohol-based and hydroalcoholic solutions wisely: keep distance and preferably wash your hands with water and soap!

Alcohol-based gels with disinfecting properties are biocidal products: improper use of these products or use levels may be harmful. They can lead to the development of bacterial resistance. So use hydroalcoholic gels and solutions carefully as indicated on the label. Keep a minimum distance of 1,5 meter and wash your hands with water and soap!

If there is no soap or water in the vicinity for your employees or customers, you may use hydroalcoholic gel. According to the recommendations of the WHO (World Health Organization), hydroalcoholic disinfectants intended for health care use have to contain at least 80% of ethanol or 75% of isopropanol to be effective against bacteria and some viruses like COVID-19 (see WHO guidelines on hand hygiene in health care).
 
Hydroalcoholic solutions with a lower concentration intended for use by the general public are authorized in Belgium, provided (when applicable) that the efficacy of the hand rub formulation against bacteria and enveloped viruses has been proven with scientific data. All biocidal products authorized in Belgium can be found on our website.

The pallets of products that are delivered to the end user have to include the product’s safety data sheet, a label that is in compliance with the legislation and proof that the product is authorised.

Repackaging of hydroalcoholic gels packaging for internal use within a business or an institution

Usually, hydroalcoholic gels are delivered to businesses or institutions in large industrial packagings, which are not easy to use on the work floor on a daily basis. Normally, authorised biocidal products may only be placed on the market and used in volumes that have been previously approved by the Biocidal Products Department. Considering this, the Biocidal Products Department may accept the repackaging of hand hygiene gels into smaller packagings insofar the following conditions are met:

  • The large quantity packaging has already been approved by the Biocidal Products Department;
  • The already validated label must be present on the new packaging and may under no circumstances be changed;
  • The biocidal product that has been repackaged is exclusively for internal use (on the work floor, in production, when homeworking);
  • The biocidal product is not to be resold after its repackaging into smaller packaging.

3. Purchase and use of surface disinfectants (product-type 2)     

Any detergent available on the market may be used for cleaning working surfaces, floors, walls... But only authorised biocidal products may be used for the disinfection of spaces and surfaces within your company. The conditions of use mentioned on the label and in the act are to be observed strictly. It might, for instance, be necessary to protect or remove food from the treated area or to rinse the treated surfaces thoroughly with drinking water.

You will find further detailed information in our guide to the use of surface disinfectants. The FPS Public Health recommends private individuals to keep cleaning their houses with a regular detergent. If a housemate is infected or possibly infected, it is recommended to disinfect with bleach water the hard surfaces that are often touched.

The pallets of products that are delivered to the end user have to include the product’s safety data sheet, a label that is in compliance with the legislation and proof that the product is authorised.

4. Disinfection tunnels

In its advice on SARS-COV-2 and the use of ozone tunnels to "disinfect" trolleys and customers, the Superior Health Council issued an unfavourable advice on the introduction and generalisation of this technique in Belgium. Indeed, there is a lack of clear and proven scientific proof of the effectiveness of disinfection tunnels. Moreover, the risk of toxic manifestations (especially pulmonary) for the most fragile people, even at very low doses, is too high. This advice also applies to disinfection tunnels that use other biocidal active substances than ozone.

On the basis of this advice, the Biocides Department has decided to process the applications for authorisation/registration as follows:

  • If the active substance is approved at European level (see ECHA website), the application for authorisation falls under the European procedure.
  • If the active substance is included in the European review programme for active substances and if its evaluation is ongoing, then the application falls under the national procedure. In this case, the application for authorisation will be subject to a full scientific evaluation in accordance with Article 10 of the Royal Decree of  4 April 2019.

The active substance must meet at least one of the above conditions. Otherwise, the biocidal product that contains it may not be registered or authorised on the Belgian or European market. It is nevertheless possible to apply for recognition of a new active substance at European level (see ECHA website).

5. Useful links and contact

You can contact our helpdesk for further information.

In order to assist companies with the gradual recovery of economic activities, social partners of the High Council for Prevention and Protection at work, the Policy Unit of the Minister of Employment and experts of the FPS Employment have jointly elaborated a generic guide.

 

Production and making available on the market of biocidAL PRODUCTS (Covid-19)

1. Information intended for chemists

The 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 is no longer applicable since 20 September 2020.

In consequence, alcohol-based hand sanitisers made by public and hospital chemists  may no longer be made available on the Belgian market without prior authorisation from the FPS Public Health.

For further information, please refer to the pages about the European authorisation procedures or the national registration procedures.

4. Excise taxes

If you wish to produce in Belgium hydroalcoholic gels, hand sanitisers and other alcohol-based disinfectants, you have to follow the Belgian excise regulations (only available in French, Dutch and German) and more specifically the denaturation methods to be applied.

Solely the methods below are accepted for the denaturation of alcohol to be processed into (type 1 or 2) biocidal products:

  • either 3 l of ether per hl of pure alcohol;
  • or 3 l of isopropyl alcohol + 1 g of denatonium benzoate per hl of pure alcohol;
  • or 78 g of tert-Butyl alcohol + 1 g of denatonium benzoate per hl of pure alcohol;
  • or 2 l of isopropyl alcohol + 2 l of butanone per hl of pure alcohol;
  • or the addition of euro-denaturant, i.e. 1 l of isopropyl alcohol + 1 l of butanone + 1 g of denatonium benzoate per hl of pure alcohol.