Which guidelines, standards, and tests are relevant for community masks?
As a temporary measure to contain the COVID 19 pandemic, many countries, states, and cities around the world have mandated the wearing of face masks in certain public places. These include public places like bus and train stations, stores and libraries, etc. Millions of people, therefore, rely on such a mask every day, and many of them want a reusable fabric mask, both to save money and avoid waste. Washable fabric masks, such as those made of cotton or synthetic fiber, are designed to meet this demand while also giving the user a good look. But what are the requirements for community masks before they can be put into circulation? Do these masks have to be tested by a testing laboratory according to certain standards? Does this require certification by a specific certification body? And what else needs to be considered for the sale of cotton masks or other fabric masks?
What are community masks?
Are community masks similar to respiratory face masks that are tested according to the EN 149 standard? Or are they similar to medical mouth masks tested to EN 14683? The answer is, neither. Community masks usually are labeled by the manufacturer as face coverings for everyday use and must not be advertised or sold as PPE or medical masks.
What regulations apply to community masks?
Masks made entirely of textile (community masks), might be covered by Regulation (EU) No. 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fiber names (Textile Labelling Regulation). This regulation establishes labeling requirements for textile products, such as for the declaration of the material used. Marketers must also ensure conformity with Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of December 18, 2006, concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), for example, in the selection of dyes, disinfectants or other substances used in the manufactory of the community masks. However, since these face coverings are not personal protective equipment or medical devices, neither Regulation (EU) 2017/745 on medical devices nor Regulation (EU) 2016/425 on personal protective equipment (PPE Regulation) are relevant for these products. In case of doubt, the market surveillance authority can provide information on which regulations must be observed for a specific community mask.
What laboratory tests are available for community masks?
To be sure that a new community mask meets important legal requirements, as well as the user's needs, various tests can be performed by qualified testing laboratories. One important category here is testing procedures for chemical safety. In these tests, the material of the masks is examined for potentially harmful substances. Quality tests represent another type of possible test procedure. These essentially test how well the community mask performs its function. Specifically, in this case, this means how effectively and reliably they can contribute to infection protection. Various players such as testing laboratories and national standards organizations also provide further testing and information services. The French standards body AFNOR, for example, has compiled recommendations for self-manufactured and purchased community masks in AFNOR Spec - Masques barrières (S76-001).
Chemical safety of community masks
When it comes to manufacturing community masks, it should be ensured that the permissible limit of potentially toxic and hazardous substances is not exceeded.
Azo dyes, for example, are banned in textiles throughout Europe because they can contain carcinogenic amines. The use of the biocide dimethyl fumarate, which can cause allergic reactions, is also prohibited in Europe. Pentachlorophenol, which is also used as a fungicide in some cases in the textile industry, has ecotoxicological properties and may therefore not exceed a concentration of 5 mg/kg in textiles under German law.
Moreover, plastic elements should not be contaminated with excessive levels of toxic heavy metals, such as lead or cadmium. The same applies to certain toxic organotin compounds or partially carcinogenic polycyclic aromatic hydrocarbons, which were frequently used as plasticizers in the past. In any case, it also makes sense to test for a selection of the "substances of very high concern (SVHC)" referred to in the REACH regulation.
Quality testing of community masks
Even though community masks cannot usually meet the high requirements placed on medical masks, it can make sense to apply the tests provided for MNS to community masks as well. Specifically, the EN 14683 standard can serve as a basis here. One example is a test of bacterial filtration performance, in which the mask to be tested is penetrated with an aerosol containing bacteria in order to test what proportion of bacteria it is filtered out. Breathing resistance testing can also be relevant given the wide variety of textile materials used in community masks.
Testing laboratories for community mask testing
During the COVID-19 pandemic, laboratories that provide testing for respirators are very busy almost worldwide. This makes it all the more difficult to find a testing laboratory that can perform the community mask testing you need. A time-saving option may be to enlist the help of organizations that have a large international network of competent laboratories. One example of this is the testxchange platform, which is accepting requests for testing of community masks, medical masks or personal protective equipment free of charge and without obligation for the duration of the COVID 19 pandemic in order to find a suitable solution in a timely manner. If you too would like to have your community masks tested, it is best to submit a free request on the platform, or alternatively contact testxchange by email or by phone at +49 30 346558100.