Helpdesk Biocides | Chemicals | Products

Q : What is the purpose of the Royal Decree?  

The aim of the Royal Decree is to control the conditions under which air purification systems are placed on the market as part of the fight against aerosol viruses outside medical use. 

Q : How can I prove that my purification system complies with the obligations set out in the decree? 

Manufacturers wishing to prove that their air purification system complies with the obligations set out in the decree must use the recognition label provided by the public service. Once this label has been obtained, the recognised air purification system will be published on the FPS Public Health website in a list of recognised air purification systems.   

Q : How can I apply for a label of recognition for my purification system(s)? 

To obtain a label of recognition, the manufacturer or person responsible for placing an air purification system on the market must submit a technical file via the "Air Purifiers" computer application.

 Once the purification system has been recognised, the application automatically generates a label of recognition that can be downloaded.  

Q: If I don't receive or apply for a recognition label, do I have to withdraw my system from the market? 

If your system has not been recognized by the FPS, or if your system is covered by the Royal Decree but you have not applied for recognition, you must remove from your various communication media any pre-existing efficacy and/or safety claims that have not been recognized by the FPS. Once these changes have been made, your system can continue to be marketed in Belgium.

Q : Is there a manual for the "Air Purifiers" computer application?  

Yes, the manual is available via the following link: https://www.health.belgium.be/en/practical-guide-submitting-request-recognition

Q : How long does it take for the experts to analyse my technical file? 

There is no time limit for the FPS Public Health's response time after submitting an application for recognition. You can follow the status of your application in the "Air Purifiers" application.     

Q : What quality criteria must my application meet? 

Only complete applications will be considered.  
 All test and measurement reports used as evidence must be complete, dated, signed and produced by an independent third party. Commercial brochures and/or videos are not considered scientific evidence. 

Q : How long is a recognition label valid for? 

The period of validity for to be integrated and stand-alone air purification systems is indefinite. For systems approved with a derogation, the label is valid for 3 years.  

Q : My system has already been approved by the FPS Public Health. Do I have to submit a new application? 

Yes, the new Royal Decree introduces new requirements for the efficiency of air purification systems. 

Q: Can I apply for a single seal of approval for several purification systems? For example, for a whole series of different purification system models?  

No, you need to submit one application per purification system. 

Q: Can I apply for recognition for a system already on the market? 

A: No. There will be a transition period concerning the actual presence on the market of purification systems and compliance with the conditions for placing on the market (art 3, art 4, art 5, art 6).

This transition period runs from June 05 to December 31, 2024. So, during this period, you can submit your applications for recognition and requests for derogation concerning purification systems already on the market.

As of January 1, 2025, for equipment equipped with one or more of the purification techniques referred to in Article 5 (derogations), applications for derogation must be submitted to the competent authority before the purification systems are placed on the market. The purpose of this prior derogation request is to ensure that purification systems which may present health risks are not placed on the market.

With regard to compliance with the conditions for placing on the market set out in Articles 3 and 4 and obtaining the label, it is strongly recommended that the application for recognition be submitted before the system is placed on the market. Should this not be the case, and in the event of a market inspection, a temporary suspension of marketing may be required, pending the application for recognition and the award of the label, or the adaptation of efficacy and safety claims.

Q : What information do I need to apply for a recognition label?  

The following information is required: 

1. Product name ; 
2. Contact details and identification of the person responsible for placing the product on the market; 
3. The system manual in the national languages, describing the conditions for maintenance, use and installation; 
4. Information on how to combat viruses: HEPA filter/EPA filter/electrostatic precipitator/UV-C ; 
5. Trials, tests and reports on the levels of effectiveness against aerosol viruses on the complete system, carried out by an accredited laboratory and in accordance with the standards listed in the Royal Decree.  
6. Scientific proof that the product is harmless to the health of the user, the installer and the public, so that no adverse health effects can be identified. 
7. Information on ventilation rates (if with fan), CADR and acoustic level.  

Q : What types of purification systems are there? 

There are two types of purification systems: 

• The to be integrated purification system
• The stand-alone purification system. 

Q : What is a to be integrated purification system?  

This is an assembly of one or more air purification techniques that can be installed in the ventilation, heating or air conditioning system of a building or vehicle. 

Q : What is an stand-alone purification system?  

A unit comprising one or more air purification techniques, which may or may not be linked to a ventilation, heating or air-conditioning system, can be moved or fixed to a wall or ceiling, operates independently and can be installed in a room in a building or in a vehicle. 

Q : What air purification techniques are recognised by the Royal Decree as presenting no risks to the health of users and/or the public?  

There are three purification techniques recognised by the Royal Decree: 

• (H)EPA filters, 
• Electrostatic precipitators, 
• UV-C system.  

Q : What are the efficiency levels required for (H)EPA filters? 

• For a to be integrated air purification system, the filters must meet at least EPA standard class 12 (99.5%) or higher. 
• For a stand-alone air purification system, the filters meet HEPA standards of class H13 (99.95%) or higher. 

Q : What are the efficiency levels required for electrostatic precipitators? 

• For a to be integrated air purification system, the efficiency of electrostatic precipitators meets at least EPA class E12 (99.5%), throughout the range of flow rates of the unit in which it will be installed. 
• For a stand-alone air purification system, the efficiency of electrostatic precipitators is at least that of class H13 HEPA filters (99.95% ) throughout the unit's operating flow range. 

Q : What are the efficiency levels required for UV-C systems?  

• For an air purification system to be integrated, the system inactivates the test organism, with an efficiency at least equivalent to that of EPA class E12 filters (99.5%) over the entire flow rate range of the appliance in which the lamps will be installed. 
• For a stand-alone air purification system, the system inactivates the test organism in the air stream at a rate of at least 99.95% over the entire flow rate of the system. 

Q : Which test body should be used to test the effectiveness of an air purification system? 

Bacillus subtilis spores are used as a substitute for the various viruses present in aerosols. 

Q : What information should be included in the technical manual for the air purification system? 

Depending on the techniques used, the technical manual must include : 

• instructions and conditions for replacing the (H)EPA filter(s), 
• instructions and conditions for replacing the precipitator collection system, 
• maintenance instructions and frequency of UV-C lamp replacement. 

The (technical) documentation for an air purification system to be integrated with UV-C also includes the precautions to be taken in terms of exposure if the casing is opened. 

For a stand-alone air purification system with UV-C, the requirement to install the system only in a room where ventilation is at least equal to two air changes per hour appears in the technical manual or in the packaging. 

Q : Are there any checks on the conformity of systems after they have received a label of recognition? 

Yes, the public service carries out compliance checks on systems in shops or on online shopping platforms. To carry out this check, tests and measurements must be carried out by an accredited laboratory. 

Q : How are systems compliance checked? 

1. The manufacturer or person responsible for placing stand-alone or to be integrated air purification systems on the market shall make two identical devices available to the public free of charge. 
2. The public service seals the two systems. The manufacturer or the person responsible for placing stand-alone or to be integrated air purification systems on the market delivers the first appliance to the accredited laboratory; the second appliance is kept by the manufacturer or the person responsible for placing stand-alone or to be integrated air purification systems on the market. 
3. The accredited laboratory forwards the analysis report to the relevant department. 

The second device is delivered to the accredited laboratory for cross-examination. 

Q : Who is responsible for paying the monetary costs associated with monitoring system compliance? 

All costs are borne by the manufacturer or the person responsible for placing the air purification systems on the market. 

Q: Are there other techniques accepted besides (H)EPA filters, electrostatic precipitators and UV-C systems? 

The following air purification techniques are prohibited on the market, but the Minister may authorise derogations on the basis of advice from the public service. 

1. Systems using the generation and dosed release of ozone in a given location; 
2. Systems using cold plasma ; 
3. Systems using UV-C light with wavelengths below and above the 240-280 nm limit; 
4. Systems combining UV and photo-catalytic solids (mainly TiO2); 
5. Systems using air ionisation without precipitate capture ; 
6. Systems using metered release of hydrogen peroxide into the space or air stream. 

Q : How do I apply for a derogation for one of the techniques mentioned above?  

Derogation requests are submitted via the "Air Purifiers" computer application.  

Q : How long are derogation requests valid for?  

Derogations are valid for three years from the date they are granted. 

Q : What are the reasons for refusing a derogation request? 

The Minister may refuse an application for a derogation for lack of evidence that the product is effective against aerosol viruses or for lack of evidence that the product is harmless to the health of the user, installer or the public in areas where the effects of the product are expected. 

Q: If an exemption has not been granted for my system, do I have to withdraw it from the market?

Yes, your system must be withdrawn from the market and cannot be sold in Belgium.

Q: Can I submit a derogation request for a system already on the market? 

A: No. There will be a transition period concerning the actual presence on the market of purification systems and compliance with the conditions for placing on the market (art 3, art 4, art 5, art 6).

This transition period runs from June 05 to December 31, 2024. So, during this period, you can submit your applications for recognition and requests for derogation concerning purification systems already on the market.

As of January 1, 2025, for equipment equipped with one or more of the purification techniques referred to in Article 5 (derogations), applications for derogation must be submitted to the competent authority before the purification systems are placed on the market. The purpose of this prior derogation request is to ensure that purification systems which may present health risks are not placed on the market.

With regard to compliance with the conditions for placing on the market set out in Articles 3 and 4 and obtaining the label, it is strongly recommended that the application for recognition be submitted before the system is placed on the market. Should this not be the case, and in the event of a market inspection, a temporary suspension of marketing may be required, pending the application for recognition and the award of the label, or the adaptation of efficacy and safety claims.

Q : What information do I need to submit a derogation request? 

The following information is required: 

1. Identification of the applicant: first and last name, business address, telephone number, business email address; 
2. For a to be integrated air purification system: proof that the system is at least as efficient as a system with an EPA class E12 filter (99.5%); 

For a stand-alone air purification system: proof that the system is at least as effective as a system with an H13 HEPA filter (99.95%);  

1. Proof that the product's efficacy levels on aerosol viruses are valid for a given period of use and the measures taken to guarantee these efficacy levels over time;               
2. Proof that the system is safe for the health of the user, the installer and the public.  

Proof that the technical documentation includes a description of the conditions for installing and using the product in the environment to be treated, a description of the conditions under which the product cannot be used and a description of the conditions for disposing of equipment contaminated by the virus.