February 26, 2021

The Government tightens the requirements to sell hygienic masks

Consumption will toughen the requirements in the sale of masks hygienic in a new order, for which only those products may be marketed as tested by accredited laboratories, and those that are not and do not comply with the regulations may face the closure sanction for five years.

According to sources from the Ministry of Consumption, the head of this department will sign this Thursday the new order, which establishes a transitional period to adapt the labeling and accreditation of laboratories, and which establishes a new combined model of materials that allows lip reading and guarantees “real protection” against SARS-CoV-2.

The order will enter into force the day after its publication in the BOE, although the masks that are on the market before will have a period of thirty days to adapt to the regulations, although afterwards they may no longer be marketed under the name of hygienic masks. .

This order reinforces the one approved on April 19, 2020, which lists a series of labeling and marketing requirements for masks not considered surgical, or FFP, and that, according to Consumption, was released “at a time out of stock national of this type of products “.

Now, when, according to this department, there is the capacity to cover about 90% of the demand, it is necessary to enact this new order to expand the requirements and guarantee the safety of consumers without symptoms of coronavirus and that they are not in contact with sick people.

What are the news of the order ?:

– They are contemplated more labeling obligations and commercialization that were already included in the previous regulations, for example, in relation to information on the composition of this type of product, the recommended period of use or the number of times it can be washed.

– Define concepts such as a facial mask (or community facial cover), mask accessories and filters.

Regarding additional requirements for masks and accessories:

– Any hygienic mask must indicate the technical specifications, tested data on filtration, resistance to breathing or permeability to air and the laboratory, among other aspects.

Reusable products must include at least the data obtained before and after the total washing cycles indicated by the manufacturer.

In no case, according to the sources, the labeling data may include references to other types of products that may give rise to deception about the true nature of the product (for example, that we are before a Special Protection Team).

And in the event that chemical substances or mixtures (such as virucidal substances) are incorporated into hygienic masks, their safety must be guaranteed by a risk assessment.

Hygienic masks They cannot go outside the original container.

– Exceptionally, in masks that have areas designed to allow correct lip reading, which do not allow the passage of inhaled or exhaled air, it will be allowed that the efficiency of particle filtration does not refer to those areas, provided that it is indicated on the label itself.

But these must meet additional requirements: Materials should allow clear vision and avoid fogging or lowering of the voice; Risks must be evaluated to ensure that the product does not obstruct breathing, and the label will indicate whether there is a speech-distorting effect.

– In the event that masks are intended for people with disabilitiesThese must have adjustable elements with velcro on the head to avoid chafing behind the ears, with adapters (ear protectors) or with any other element that facilitates the autonomy of people with psychomotor difficulties.

– In the case of face masks for children, They must include references to the approximate age of use based on the anthropometric data of the Spanish population, and the indication: “Warning: Use under the supervision of an adult”.

– Filters sold separately from the rest of the mask fabric should cover the largest possible surface of the mask and specify which fabric has been used to obtain the data on bacterial filtration and breathability.


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