Which Member State requirements have been checked beyond the EU-level legal analysis?

Which Member State requirements have been checked beyond the EU-level legal analysis?

The statement sets out how Member States apply the Regulation to air cleaners, in the words of their own documents.

Italy: the Istituto Superiore di Sanità, Rapporto ISS COVID-19 n. 12/2021 of 20 May 2021, section 6, concerns treatment systems that work by physical systems or equipment, and states that they are not among the authorised biocidal products and are not medical devices, and may be freely sold provided that they comply with the Consumer Code. The Ministry of Health circular of 11 June 2021 on air purification products states that such a product may be placed on the market under the responsibility of the manufacturer. The Decree of the President of the Council of Ministers of 26 July 2022, sections 2 and 6.7 of its Annex, names electrostatic filtration among the air purification technologies for schools. Spain: the Ministry of Health information note of November 2020 on air purifiers states that all those based exclusively on filtration systems are considered physical methods and are therefore outside the scope of the Biocides Regulation. Belgium: the Royal Decree of 9 February 2024 sets the conditions for placing on the market air purification systems for the fight against airborne viruses outside medical uses, regulates them as equipment, and does not mention Regulation (EU) No 528/2012. Those are the Member States addressed here. Requirements in any other Member State are not addressed.

Source: C-POLAR Technologies, Inc. — Statement of Regulatory Status for NanoFlashing™ Air Filter, 11 September 2026; Istituto Superiore di Sanità — Rapporto ISS COVID-19 n. 12/2021, 20 May 2021, section 6, https://www.iss.it/documents/20126/0/Rapporto+ISS+COVID-19+12_2021.pdf/4eeb2ce8-648d-b045-4a8c-5dfe1fc7b56a?t=1622470558049; Ministerio de Sanidad — Nota informativa sobre dispositivos purificadores de aire, November 2020, https://www.sanidad.gob.es/areas/sanidadAmbiental/biocidas/docs/informativa_docs/notapurificadores.pdf; Arrêté royal du 9 février 2024, Moniteur belge, 17 April 2024, https://www.ejustice.just.fgov.be/eli/arrete/2024/02/09/2024003119/moniteur.

Reviewed on 21 September 2026.