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Draft Royal Decree determining the conditions for the placing on the market of air purification systems for the control of aerosol-transmissible viruses for purposes other than medical purposes

Notification Number:

2023/0525/BE (Belgium)

Date received:

01/09/2023

End of Standstill:

04/12/2023

Draft Text:

FR BG HR CS DA EN ET FI GA DE EL HU IT LV LT MT PL PT RO SK SL ES SV NL

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Communication from the Commission - TRIS/(2023) 2555

Directive (EU) 2015/1535

Notification: 2023/0525/BE

Notification of a draft text from a Member State

Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt

Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna

MSG: 20232555.EN

1. MSG 001 IND 2023 0525 BE EN 01-09-2023 BE NOTIF

2. Belgium

3A. SPF Economie, PME, Classes moyennes et Energie
Direction générale Qualité et Sécurité - Service Bureau de Liaison - BELNotif
NG III – 2ème étage
Boulevard du Roi Albert II, 16
B - 1000 Bruxelles
be.belnotif@economie.fgov.be

3B. SPF Santé publique, Sécurité de la Chaîne alimentaire et Environnement,
Direction générale de l'Environnement, Division des produits et des produits chimiques,
Avenue Galilée, 5/2
1210 Bruxelles

4. 2023/0525/BE - S00S - HEALTH, MEDICAL EQUIPMENT

5. Draft Royal Decree determining the conditions for the placing on the market of air purification systems for the control of aerosol-transmissible viruses for purposes other than medical purposes

6. Air purification equipment for the control of aerosol-transmissible viruses

7.

8. The draft Royal Decree is adopted within the framework of the Product Standard Act (Act of 21 December 1998) which makes it possible to determine, inter alia, the conditions for placing the products on the market.

The draft in question aims to lay down conditions for the placing on the market of air purification equipment used for purposes other than medical purposes. The conditions for placing on the market include levels of efficiency against aerosol-transmissible viruses and non-hazardousness in populations present in the locations where this equipment is installed.

The draft is based on Opinion 9616 of the High Council for Health, published on 15 February 2021, as well as Opinion 73.799/3 of the Council of State of 5 July 2023.

9. The purification of air by various means and technologies requires ensuring efficiency requirements against aerosol-transmissible viruses and non-hazardousness in persons present in the locations where this equipment is installed.

This draft replaces a similar draft order notified to the European Commission under reference 2022/0528/B. As the draft notified under that reference has undergone substantial changes, a new notification is necessary. This was also advised by the Council of State in its Opinion 73.799/3 of 5 July 2023.

The amendments shall relate to:
1. an extension of the scope. The initial draft targeted SARS-CoV-2 and this has been extended to aerosol-transmissible viruses. The reasoning stems from the fact that manufacturers’ marketing communications are often misleading and could harm consumers. By extending the scope to all viruses, on the one hand, we simplify the laboratory test conditions to demonstrate effectiveness, and on the other hand the marketing communication is simplified.

2. the scope of the original draft included the conditions for placing CO2 meters on the market. These provisions have been withdrawn from this draft to be included in a separate order on the conditions for placing CO2 meters on the market;

3. The categorisation of the equipment into two groups, ‘mobile’ and ‘non-mobile’, has been replaced by ‘integrated’ and ‘autonomous’;

4. The adaptation of the clause prohibiting the placing on the market in respect of certain systems using UV-C light and limiting in time the derogation granted by the Minister to a maximum of three years and the adaptation of the conditions for obtaining a derogation;

5. The introduction of a label as the only means of communication of air purification systems for the control of aerosol-transmissible viruses recognised by the public authority (the Public Health Service).

10. References to reference texts: 2021/0226/B, 2021/0704/B

The reference texts had to be sent as part of the previous notification:
2021/0226/B
2021/0704/B

11. No

12.

13. No

14. No

15. No

16.
TBT aspects: No

SPS aspects: No

**********
European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu

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