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. Following the outbreak of the coronavirus (Covid-19), the FPS Public Health has decided to deliver temporary authorisations for biocidal products that are effective against the coronavirus. 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.

The FPS Public Health has also decided to deliver temporary authorisations for some biocidal products that have proved to be effective in combatting the virus. These are disinfectants such as alcohol-based gels (product-type 1) and surface disinfectants (product-type 2). The list of products for which a temporary authorisation has been delivered is to be found here.


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 hydroalcoholic disinfectant solutions have to contain at least 70% alcohol to be effective against bacteria and some viruses like COVID-19. Use only authorised alcohol-based gels and carefully follow the safe-use directions.

The FPS Public Health publishes the contact details of the authorisation holders and dealers of biocidal products that are useful in combatting the coronavirus.

Those contact details are to be found on the following lists:

  • The list of temporary authorisation holders of biocidal products intended for human hygiene purposes (product-type 1) that are useful in combating the coronavirus
  • If you need biocidal products intended for human hygiene (PT1) purposes in low quantities, you may want to contact the suppliers/dealers listed here.

If you are a supplier of hydroalcoholic hand sanitizers and are able to supply them in small quantities (less than a pallet), we can add your contact details to the table. If you are interested, please send an email to covid19.gestautor@health.fgov.be.

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 FPS Public Health publishes the contact details of the authorisation holders and dealers of biocidal products that are useful in combatting the coronavirus.

Those contact details are to be found on the following lists:

  • The list of temporary authorisation holders of biocidal products intended for the disinfection of surfaces (product-type 2) that are useful in combating the coronavirus
  • If you need biocidal products intended for the disinfection of surfaces (PT2) in low quantities, you may want to contact the suppliers/dealers listed here.

If you are a supplier of surface disinfectants and are able to supply them in small quantities (less than a pallet), we can add your contact details to the table. If you are interested, please send an email to covid19.gestautor@health.fgov.be.

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. Fumigation

THE FPS Public Health has allowed the making available on the market of a  number of products used for fumigation (disinfection through air) and that have proved to be effective against viruses.

Please bear in mind that if the products are to be used in food stores, it is mandatory to use the type of products "PT4: food and feed area" for which a toxicity assessment has been carried out.


5. 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:

  • Disinfection tunnels do not fall under the temporary authorisation procedure.
  • 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 04/04/2019 ().

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).


6. Useful links and contact

Please send an email to info.biocides@health.fgov.be to contact us.

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. Delivery of temporary authorisations

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 delivery of temporary authorisations for certain biocidal product types.

ATTENTION!

As the production of disinfecting biocidal products is currently sufficient, the FPS Public Health no longer delivers temporary authorisations. The submission of applications for a temporary authorisation was possible until 12 April for biocidal products intended for human hygiene (product-type 1) and until 30 June for biocidal products intended for the disinfection of surfaces (product-type 2).

Further information/questions

For further information on temporary authorisations please refer to article 55 (1), first paragraph of Regulation (EU) n° 528/2012 concerning the making available on the market and use of biocidal products and article 21 of the 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 on Covid-19.


2. Extension of temporary registrations and granting of new temporary authorisations

Holders of temporary authorisations will be able to continue to make authorised biocidal products available on the Belgian market.
 
The conditions to be met differ according to the status of the active substances for the relevant product types in the Review programme:

  • If the active substance(s) of the biocidal product is (are) still under review under the Review programme for the relevant product types, please refer to the extension of temporary registrations section.
  • If all active substances of the biocidal product have been approved under the Review programme for the relevant product types, please refer to the granting of new temporary authorisations section. 

Extension of temporary registrations

The FPS Public Health has decided to extend the temporary authorisations (henceforth referred to as temporary registrations) that have already been granted for biocidal products of types 1 and 2 in accordance with Article 21 of the Royal Decree of 4 April 2019 regarding the making available on the market and use of biocidal products.

Temporary registrations only apply to biocidal products for which the active substance(s) is (are) still under review for the relevant product types under the Review programme. These temporary registrations will be automatically extended for a period of 180 days.

In addition to this extension, a second extension of 185 days may be added, provided that an application for registration  is submitted. To benefit from this 2nd extension, holders of a temporary registration must send a notification as proof of submission of the application for registration to covid19.Gestautor@health.fgov.be even if it has already been submitted or approved. This notification must include the following elements:

  • The name of the product for which the temporary registration has been granted,
  • The name of the product and the file number of the application for registration,
  • The e-mail acknowledging receipt of payment of the registration application.

As soon as registration is granted, the temporary registration expires automatically and immediately.

Granting of temporary authorisations 

The FPS Public Health has decided to grant new temporary authorisations for biocidal products of types 1 and 2 that have already been temporarily authorised in accordance with Article 55(1) of Regulation (EU) 528/2012 concerning the making available on the market and use of biocidal products.

Temporary authorisations only apply to products for which all active substance(s) have been approved for the relevant product types under the Review programme. These temporary authorisations will again be granted for a period of 180 days, in accordance with the European Commission.

If an application for authorisation is to be or has been submitted at the European level within this period, the holder of the temporary authorisation must send, to covid19.Gestautor@health.fgov.be, a notification including the following elements:

  • The name of the product for which the temporary registration has been granted,
  • The Case Number of the application entered in the European register (R4BP3).

As soon as authorisation at European level is granted, the temporary authorisation expires automatically and immediately.

Labels, packaging and safety data sheets

The labels, packaging and safety data sheets must comply with the biocide regulations in force in the two cases mentioned above.

In the case of temporary registrations, it is advisable to indicate on the label, throughout its period of validity, the words: "Temporary registration of [insert the date of signature of the act as stated on the act]".

In the case of temporary authorisations, it is advisable to indicate on the label, throughout its period of validity, the words: "Temporary authorisation of [insert the date of signature of the act as stated on the act]".

Phase-out period

Please note that as soon as a registration or temporary authorisation expires, the biocidal product can no longer be made available or used on the Belgian market. There is no legal deadline for the sale and disposal of stocks.

Article 95 of Regulation (EU) 528/2012

In order to respond quickly to the COVID-19 crisis, the FPS Public Health did not require temporary registrations and authorisations to meet the legal requirements of Article 95 of Regulation (EU) 528/2012.

However, with regard to applications for registration and authorisation, these legal requirements will have to be complied with. This means that a biocidal product can only be made available on the market if the supplier of the active substance or product is included in the list in Article 95 for the relevant product types.


3. Information to the attention of chemists

Since pharmacies are currently encountering difficulties with obtaining hydroalcoholic solutions, the Belgian competent authorities exceptionnaly grant both public and hospital chemists a temporary authorisation for the production of their own hydroalcoholic solutions according to the provisions of the World Health Organisation (WHO). For further information on 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.


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.

  • Regarding temporary registrations and authorisations, altered measures are applicable within the context of the COVID19 pandemic.
  •  Regarding registrations and authorisations, altered measures are not applicable. 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.