Masks treated with biocidal products: a review of regulations

What is the purpose of the biocidal products used on some masks?    

Masks are treated for two purposes: to protect the user or to protect the fabric. Note that this treatment is not part of the technical requirements in place for ensuring the efficacy of masks.
The distinction between the two objectives described above is important as it determines the category of each mask and the associated regulatory requirements, bearing in mind that these categories apply only to non-surgical masks. Depending on the manufacturer’s claims, the purpose of the treatment, the labelling and presentation, the mask may be considered either as a biocidal product in itself, or as a treated article under the European Biocidal Products Regulation:

• if a treated mask claims to protect the wearer against viruses and bacteria, the European Commission believes that it should be viewed first and foremost for its biocidal function and that it is therefore a biocidal product itself. If the manufacturer wishes to sell the mask in France, it must comply with European and French regulations on biocidal products. In particular, this means declaring the mask on the Simmbad database and to the INRS, and providing appropriate labelling.
• if the treated mask does not claim to protect the user (e.g. if the purpose is to protect or disinfect the fabric), it is considered as a treated article. This type of mask can be marketed in France providing that the biocidal substance used is authorised for this type of treatment under European regulations, and that it is correctly labelled. No declaration is required.

What is the role of ANSES regarding masks treated with biocidal products?

ANSES is the organisation with competence for issuing marketing authorisations (MAs) for biocidal products in France. However, not all treated masks fall within the prerogative of ANSES, or the regulations on biocidal products. Surgical masks, for example, are medical devices, regulated by the French Health Products Safety Agency (ANSM). The work of ANSES and the application of the regulations on biocidal products concern FFP2 masks, which are considered as personal protective equipment, and so-called community masks, or other alternative fabric masks, a category created as part of the fight against COVID-19.

Further, the Agency only examines MA applications for products containing biocidal substances that have been approved at European level. Most of the substances used in masks are still undergoing assessment. To date, ANSES has issued no marketing authorisations for treated masks claiming to protect the user against microbial infection. However, these masks can be marketed under certain conditions (see below).

Moreover, in October 2020, ANSES was asked by several ministries to give an opinion on the masks sold by the company Hanes, containing silver-zinc zeolites. The results of this expert appraisal cannot be extrapolated to other masks, particularly those treated to provide better user protection against COVID-19.

Because millions of people have been using masks on a daily basis since the start of the COVID-19 pandemic, in spring 2021 ANSES conducted a survey among manufacturers and distributors of fabric masks for the general public and FFP protective masks. Its aim was to identify any biocidal treatments applied to the masks and check that they complied with the regulations. The vast majority of respondents reported that their masks were not treated with biocidal substances. The Agency nevertheless found several cases in which a biocide was used that was not authorised under the European regulations. It therefore invited these companies to comply with the regulations.

What do existing regulations say?

The antimicrobial substances used in textiles fall under the European Biocidal Products Regulation. These substances must be approved at European level. Owing to the gradual implementation of the regulation, most active substances are still under assessment. Products containing substances under assessment are marketed under the transitional regime, without a marketing authorisation. If no evaluation dossier is submitted or in the event of a non-approval decision, the marketing and use of products containing the substance in question is prohibited.

What are the obligations of companies that wish to market a mask treated with a biocidal product in France?

If the treated mask is considered as a biocidal product, it is currently marketed under the transitional regime. The organisations placing it on the French market are required to meet a certain number of obligations:

• declare the mask on the Simmbad base;
• declare it on the SYNAPSE online reporting base, managed by the INRS;
• provide appropriate labelling (see guidelines on the labelling of biocidal products).

More generally, the manufacturer must be able to support any claims relating to the masks they market.
In compliance with the French Public Health Code, manufacturers and importers of biocidal products must also report any cases of poisoning of which they become aware, via the French Ministry of Health's portal for reporting adverse health events.