KANBrief 4/20

A critical view of the European standardization project for community face coverings

Since the global lockdown triggered by the corona pandemic in the spring of 2020, community face coverings have become a familiar sight. They are among the hygiene measures taken to contain the virus. Community face coverings are available for purchase, but can also be made by users themselves. They are also termed “mouth and nose coverings” (MNCs), reflecting their function; the term intentionally does not imply a protective action.

Germany’s SARS-CoV-2 Occupational Safety Rule defines MNCs as “textile garments which cover at least the nose and mouth and which are capable of significantly reducing the speed of respiratory flow or saliva/mucus/droplet ejection”. The barrier they provide in front of the mouth and nose reduces the scale and velocity with which breath, and thereby droplets and aerosols in it, enter the wearer’s surroundings. Since the SARS-CoV-2 virus is carried primarily on these droplets and aerosols, these face coverings reduce its distribution and the risk of infection it presents to other persons. Community face coverings thus primarily have the function of protecting other persons.

No protective action claimed

Community face coverings are classified neither as medical devices nor as personal protective equipment (PPE), since they do not provide the protection required of these products, nor is such protection claimed for them. In contrast to community face coverings, medical face masks for the protection of other persons (also termed surgical masks) (Medical Devices Directive 93/42/EEC EN 14683 Medical face masks – Requirements and test methods) and particle-filtering half masks (FFP masks) (EU PPE Regulation 2016/425 EN 149 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking) for protection of the wearer satisfy requirements set out in standards and legislation for the protective action. This has been confirmed in a communication from the responsible department of the European Commission’s Directorate-General Justice and Consumers to CEN, the European standards organization. In this communication, the Commission explains that community face coverings are covered by the European Directive on General Product Safety. This would not be the case if more specific safety rules applied in the EU to these products.

Community face coverings nevertheless form a part of the occupational safety and health measures set out in the German SARS-CoV-2 Occupational Safety Rule for protecting employees’ health during the pandemic. A clear reason for this is that masks with protective action were in short supply, particularly at the outbreak of the pandemic. What surgical masks and PPE were available were supplied primarily to medical personnel. In the private sphere and at the workplace, community face coverings were used as a temporary, makeshift measure.

Standardization project at CEN

CEN Workshop Agreement CWA 17553 (Community face coverings – Guide to minimum requirements, methods of testing and use) on community face coverings was published in June 2020. The CWA sets out minimum requirements for reusable or disposable community face coverings for use by the general public, and thus has the purpose of supporting potential commercial manufacturers. The minimum requirements cover material properties, dimensions/sizing, cleaning and marking, and also parameters such as filtration efficiency and breathing resistance. Test methods are formulated for some of these aspects. Technical Committee CEN/TC 248, Textiles and textile products, now intends to develop a technical specification (CEN/TS) based upon this CWA.

KAN takes a critical view of this standardization project. As already explained, community face coverings, particularly for use at the workplace, were introduced at a time at which the usual protective masks were not available in sufficient quantities. A standard would further consolidate this solution, which was born out of necessity. A concern in occupational safety and health circles is that the community face coverings will continue to be used when the pandemic is over or when standard protective masks are available once again in sufficient quantities. The content of the CWA also suggests that the safety criteria for community face coverings will more closely resemble those for surgical masks. This however is an unnecessary step, since an established and proven system exists in the form of the statutory and normative provisions governing medical face masks.

Work on the CEN/TS technical specification will begin shortly. Despite DIN’s abstention in the vote on the project owing to KAN’s vote to reject it, German OSH experts will be involved in this project. It is to be hoped that parallel arrangements do not emerge, and in particular that the existing proven solutions for protection at the workplace are not eroded.

Dr Michael Thierbach