March 5, 2021

The Government tightens the requirements to sell hygienic masks, which will have to pass laboratory tests

Hygienic masks are going to have to pass stricter filters from now on to be marketed. The Ministry of Consumer Affairs will sign an order this Thursday that toughens the requirements to be able to put it on the market this type of non-sanitary products, of which there is a great variety and that are usually made of textile material. As explained by the department headed by Alberto Garzón in a press release, it will come into effect one day after its publication, but 30 days later “only those tested by an accredited laboratory” and those already in circulation may be marketed as hygienic masks. They will have that time to adapt.

Although already a previous order from April established labeling and marketing requirements, not only covered hygienic masks based on the specifications set by the Spanish Association for Standardization (UNE), which established filtration and breathability requirements, but also included “those that could follow similar standards, but without obligation to have carried out efficacy trials. ” From now on, only those that meet the technical requirements may be marketed under the name of a hygienic mask, while “until now any product could be called a hygienic mask,” emphasizes the Ministry, which has narrowed its definition.

The laboratories that test the masks must have a system in place for the tests in accordance with the standards developed by the UNE and must be accredited for these checks “by the national accreditation body corresponding to the country where they are located”. Community consumer authorities may impose sanctions on laboratories that do not comply, which can lead to “closure for five years.”

“It is necessary to promulgate this Order in order to expand the requirements of this type of products in order to guarantee the safety of consumers without symptoms of coronavirus and who are not in contact with sick people,” says the text, which It also specifies the definitions for “mask accessories” and “filters”.

The order also delves into the labeling obligations that were already included in the previous one and prohibits them from being sold “outside the original container” or in any format “that does not guarantee compliance with the requirements.” The information to be included includes which standards and technical specifications or other documents “adopted by a recognized standardization body”, such as the UNE, have been followed for the manufacture of the product. Also, the “tested” data related to filtration or breathability efficiency and “the laboratory used to carry it out”. Those that are reusable must include “the data obtained before and after the total washing cycles indicated by the manufacturer, following the recommended washing and drying method”, specifies Consumption.

The approval of the order by the Ministry occurs in full debate over the use of FPP2 masks, which has been opened in neighboring countries after making them mandatory in certain spaces. The autonomous governments of Galicia and the Community of Madrid even asked the Ministry of Health to review the recommendations in this regard. Asked about this matter, Fernando Simón, director of the Center for Health Alerts and Emergencies, pointed out that “as long as they comply with the UNE standard” the masks that are in our country “we consider that they protect enough.”


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