Spain is tightening the requirements of so-called hygienic masks and will ban the sale of face masks that have not passed tests from an accredited laboratory.

The ban will come into effect within a month after the publication of the new law in the BOE official gazette which will detail the tighter specifications regarding quality and the composition of materials.

According to government sources, the current regulations, issued on 19 April 2020, were intentionally lax, as Spain was immersed in the first wave of the pandemic and faced a shortage in the supply of masks. As a result they preferred to lower the quality requirements of the masks to guarantee the arrival of the product, especially from Asia.

Now that the authorities consider that worldwide production can meet demand, they believe it is time to standardise the requirements of the masks to higher standards so that they can be marketed as hygienic.

When the new order comes into force no mask may be sold without wrapping, as happened in the first days of the pandemic, when sellers opened the packages themselves to sell individual masks.

The labelling that accompanies the packaging must clearly specify, at least in Spanish, the type of product, type of use, usage times and maximum number of washes during the product's life.

The manufacturer must not include any type of claim or advertising phrase on the package beyond the exact description of the product “to avoid confusion or deception”.

It must also specify the mask’s technical specification such as filtering capacity, permeability, resistance to breathing or whether they contain added substances, such as anti-viral substances, and the possible risks that these products entail.

Disabilities and children

The new law will also regulate the “other hygienic masks” for “special uses”, such as those for deaf-mutes, people with disabilities and children.

Face masks to facilitate lip reading will be authorised to include a transparent part in which inhaled or exhaled air is not allowed to pass through, and this must be clearly indicated on the label. In addition, the materials must allow a clear view of the mouth and must avoid fogging by breathing or any reduction of the volume of the voice.

Hygienic masks for children will have to clearly specify what age they are designed for and carry the phrase: "Warning: Use under adult supervision."

The new guidelines will also include filters that are marketed separately from the rest of the mask fabric. The manufacturer must specify which fabric has been used to determine the degree of filtration.