Whether you manufacture air purification systems or import them, you must comply with the legislation in force in Belgium if you wish to place such systems on the market

New legislation for systems used to combat viruses in aerosol

From 18 May 2024, criteria will apply to the marketing of air purification systems that use technologies capable of eliminating aerosols from contaminated air or deactivating viruses. These criteria are set out in the Royal Decree of 9 February 2024.

This legislation provides users with an additional guarantee of the quality of air purification systems that combat viruses in aerosol . Thanks to a recognition label awarded to each recognised air purification system, users can easily identify systems whose high effectiveness against viruses in aerosol and safety have been recognised by the FPS.

Are all air purification systems that combat viruses in aerosol affected? ​

No, only systems with an efficiency equivalent to that of class E12, H13 or higher filters.

  • See the full text here for more details on the criteria for applying this legislation.
My air purification system had already been approved by the FPS during the COVID-19 pandemic. Do I have to reintroduce a dossier? ​

Yes, the Royal Decree of 9 February 2024 introduces new requirements for the efficiency and safety of air purification systems.
No automatic recognition is planned for dossiers that had already been approved under the ministerial order of 12 May 2021 provisionally determining the conditions for marketing air purification products as part of the fight against SARS-CoV-2 other than for medical use.


If your air purification system is covered by this Royal Decree, and you wish to advertise its effectiveness against viruses in aerosol, you must use the recognition label provided by the FPS (instead of or in addition to any pre-existing promotional material or claims concerning its operation, provided they do not contradict the label).

To obtain this label, and therefore have your system recognised by the FPS Public Health, you need to submit an application for recognition.

Obligations vary depending on the air purification techniques used by your system.

  • If your system uses an air purification technique based on the use of EPA or HEPA filters, an electrostatic precipitator with a collection system or a UV-C system (240-280 nm), you can apply directly for recognition.
  • If your system fights viruses in aerosol with an efficacy equivalent to the above-mentioned classes, and if it consists of one or more of the following techniques, an application for a derogation is required before your product can be placed on the market.

The following techniques require an exemption:

  • Systems using the production or dosed release of ozone in the space in question;
  • Cold plasma systems;
  • Systems using UV-C light with wavelengths below and above 240-280 nm;
  • Systems combining UV and photo-catalytic solids (mainly TiO2 );
  • Systems using air ionisation without precipitate collection;
  • Systems using metered release of hydrogen peroxide into the space or air stream.

These techniques are considered by the High Council of Health to be less well-known,less reliable and possibly dangerous for your health.
 

How do I apply for recognition or exemption?

All applications for recognition or exemption must be submitted via the Air Purifiers application.

Using Air Purifiers for the first time
  • The first step is to create a local administrator account (at least one per company) in the Air Purifiers application.
  • Then, to activate your local administrator role, complete this form (FR/NL/DE/EN) and send it to airpurifiers-app@health.fgov.be.

Once their account is operational, local administrators will be able to create user accounts on behalf of their company. Each user will be able to submit requests for recognition or exemption.

Local administrator modification

It is not possible to change the information relating to the local administrator.

  • If you wish, for example, to change the contact email address, you must create a new user and ask the FPS to assign him the role of local administrator by completing this form (FR/NL/DE/EN) and sending it to airpurifiers-app@health.fgov.be.
Practical guide to preparing and submitting an application

A practical guide has been produced to help you prepare and submit your applications for recognition and exemption. It includes a list of the evidence to be provided depending on the type of technology used by your system, advice on submitting proof of quality, and a step-by-step procedure for submitting your application in the Air Purifiers application

Be sure to submit a complete dossier, including all the evidence required for its analysis. All test and measurement reports used as evidence must be complete, dated, signed and carried out by an accredited laboratory. There are also requirements concerning the content of the technical manual. Find all the information in the practical guide.

Monitoring your application for recognition or exemption

You can check the status of your application via the Air Purifiers application.
There are different statuses:

  • Submitted: Your application has been submitted and can no longer be modified.
  • Processing: Your file is currently being analysed by the experts.
  • To be completed: Your application must be completed because some information is missing or insufficient.  You will then have to submit it again.
  • Approved: Your application for recognition or exemption has been approved. Your air purification system is recognised by the FPS.
  • Not approved: Your application for recognition or exemption has not been approved. Your air purification system must be withdrawn from the market (in the case of an application for exemption) or it is not recognised by the FPS (in the case of an application for recognition).
  • Cancelled: Your air purification system is not covered by the Royal Decree of 9 February 2024.

 

What are the obligations at the end of this process?

 
If your system has been recognised by the FPS
  • You will receive a label in pdf format via the application Air Purifiers. This contains the identification of your system (model name, reference number of the recognition application) and information about its effectiveness (minimum and maximum achievable CADR) and the noise produced when the system is used.
    • You must use this label by affixing it on the packaging of your air purification system, in the technical manual and/or on the online sales site. This should be available to consumers before purchasing this device.
    • The label should be used in print in dimensions 9 x 9 cm.
    • Existing claims of effectiveness and harmlessness may continue to appear on your various communication media, if they do not contradict the information on the label. Otherwise, they should be removed or amended.
  • You may only refer to this recognition process through this label or the associated pictogram. No other claims or interpretation, written or textual, of this label may be used.
  • The pictogram may be used individually without the full label. The pictogram can be requested via email (airpurifiers-app@health.fgov.be) in high resolution. This can be used in communications as a supplement to the label, not as a replacement. It may therefore only be used if the label has already been applied to the system somewhere in accordance with the regulations.
  • Your system will appear on the list of air purification systems recognised by the FPS.
    This list will be published on this site shortly.
If your system has not been recognised by the FPS

(or if your system is covered by the Royal Decree but you have not applied for recognition):

  • You must remove all claims of efficacy against viruses in aerosol and/or harmlessness from your product, its packaging, and the website on which it is sold. Once these changes have been made, your system can continue to be marketed in Belgium.
  • Your system will not be awarded a label and will not appear on the list of recognised systems.
If an exemption has been granted for your system
  • This exemption is valid for 3 years.
  • To renew it, you must submit a new application before the 3 years have ended. Provided your application was submitted during the period of validity of the derogation, your system is authorised to remain on the market while the experts analyse the dossier, even if the response is given after the end date of the initial derogation. If the label has expired and no new application for derogation has been submitted, the system may not come on the market after the expiry date of the label.
  • Once the label has expired, it may not be on any communication.
  • Your system is automatically recognised by the FPS. You should therefore follow the instructions above concerning recognised systems.
If no exemption has been granted for your system
  • Your system must be withdrawn from the market and may not be sold in Belgium.

 

Do you have any questions about the recognition process?
Do you have any other questions about indoor air quality?