New regulations for the sale of REUSABLE HYGIENIC MASKS

Feb 13, 2021Elena Llorens Martínez
New demands for the marketing of hygienic masks.
Nueva normativa para la venta de mascarillas higiéncias
Once again we are obliged to record the new requirements for the sale of hygienic masks by the government published on 02/11/2021 in the BOE:

Order CSM/115/2021, of February 11, which establishes the requirements for information and marketing of hygienic masks.

The Minister of Consumer Affairs has signed on 2/11/2021 the Ministerial Order establishing the requirements for information and marketing of hygienic masks. Spain strengthens its regulations, limiting the concept of hygienic mask. From now on, for the mask to be marketed as hygienic, it will have to be tested in accredited laboratories that certify these characteristics.

All hygienic masks must indicate on their packaging what standards, technical specifications, work agreements or other technical documents of a recognized standardization body have been followed for the manufacture of the final product or its materials.

They will also indicate the data tested on the filtration efficiency of the material, the resistance to breathing or air permeability and the laboratory used to carry it out. In reusable products, the data obtained before and after the washing cycles indicated by the manufacturer must appear. It must indicate the place of origin of the product. The commercialization of hygienic masks outside the original packaging is prohibited, as well as in any other format that does not guarantee compliance with the requirements of the Order.

Regarding the filters marketed separately from the rest of the fabric that makes up the mask, the obligation to cover the largest possible surface and without areas through which the inhaled and exhaled air can pass without filtering is included. You will also need to specify which specific fabric has been used to obtain the bacterial filtration and breathability data. The mask-filter assembly must comply with the standard.

For children's masks, the labeling must reflect the approximate age of use, based on the anthropometric data of the Spanish population, as well as the indication: "Warning: Use under adult supervision". As for their manufacture, they must also comply with the technical specifications UNE-EN 14682:2015.

Regulations in the EU

In addition to Spain, different European countries have developed their own technical specifications on hygienic masks. The European Committee for Standardization (CEN) has taken these requirements into account to prepare the CWA 17553/2020 standard, which serves as a guide to establish the minimum requirements for hygienic masks to ensure the limitation of the risk of contagion. It is a voluntary agreement and, therefore, there is no European harmonized regulation in this regard. For this reason, some member states have chosen either to regulate or to prohibit the use of hygienic masks in certain spaces.

In France, since January 27, the sale of masks for non-sanitary use has been prohibited. Likewise, the use in schools of non-surgical masks, FFP2, or type 1 hygienic masks (filtration greater than 90%) has been prohibited. In other words, what in Spain will be called hygienic masks from the entry into force of this order, corresponds to the French type 1 hygienic masks that are not prohibited. Those that have been prohibited in France, in Spain cannot be called hygienic, because there are more demanding regulations.

WE ARE OBLIGATED TO REMARK THAT OUR MASKS ARE NO LONGER HYGIENIC AND REUSABLE AFTER A NUMBER OF WASHES DEPENDING ON EACH MODEL.NAMELY; AS SOON AS THE VALUES ARE BELOW 90%, THEY WILL NO LONGER BE CONSIDERED REUSABLE HYGIENIC (TYPE 1) BECOME HYGIENIC FOR SINGLE USE THAT IS WHY WE HAVE SPECIFIED THE NUMBER OF WASHES ACCORDING TO THE NEW REGULATION.

REPORTS ON THE MASKS WE SELL ON THE WEBSITE OF LENZO:

INNER FABRIC: 80% Polyester and 20% Polyamide. TEC7191
OUTER FABRIC: 100% LINEN with standard 100 by oeko-tex certification
10 WASHES. (AITEX)

BREATHABILITY WITH THE LINEN:

BAMBOO MASKS: COMPOSITION:
45% BAMBOO VISCOSE (Biodegradable)
55% RECYCLED POLYESTER
5 WASHES (AITEX)

VISCOSE MASK: COMPOSITION:
55% VISCOSE
45% POLYESTER
5 WASHES (AITEX)

REPORT ON LENZO FILTERS FOR USE WITH COVERS/MASKS.
*10 washes (AITEX)

iNFORME AITEX FILTROS PARA MASCARILLAS

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