Spanish Government issues new requirements for Hygienic Masks (Orden CSM/115/2021)

The main changes from the last measures that regulated the distribution and labelling of these products (“Orden SND/354/2020”) are:

1.    Obligation to inform the consumer:
The labelling must display the tested filtration efficiency and breathing resistance data, identify the laboratory that has carried out these tests and reference the test report and technical specification (test method) followed. This laboratory report must be linked to a batch or, if not, the "operador económico" (the responsible party), which must prove production conformity since it was validated by the laboratory (up to a maximum of 3 years).

The filtration efficiency must be demonstrated and adequate breathing resistance must be guaranteed for the mask’s lifespan, by obtaining a report issued by a laboratory that guarantees compliance with technical documents adopted by recognised standardisation bodies.
The text of the order itself refers to technical specifications that define the requirements with respect to filtration and breathability for this type of mask: UNE 0064-1:2020, UNE 0064-2:2020, UNE 0065:2020 or the document UNE-CWA 17553:2020.

2.    Commercialization Requirements:

a.    The effectivity of the mask’s filtration must be demonstrated, and optimal breathing resistance must be guaranteed throughout the mask’s lifespan. This is done through a lab report that endorses the compliance of the technical documentation adopted by renown standards agencies. The main text of the “Orden” makes references to the technical specifications that define the requirements about filtration and breathability for these kinds of masks: UNE 0064-1:2020, UNE 0064-2:2020, UNE 0065:2020 or the document UNE-CWA 17553:2020.
b.    It must be guaranteed that the materials that make contact or which might be inhaled won’t cause health issues or discomfort.
c.    Masks must not have exhalation valves.
d.    Reusable masks must have washing and drying methods that can ensure proper sterilization. This can be done through sanitary authority recommendations or through documental demonstrations. 
e.    In the specific case of masks intended for lip-reading:

• Masks must provide a clear view of the covered area as well of avoiding a significant reduction of voice loudness.
• Evaluations of breathing resistance must be tested.
• Information about voice distortion effects must be included on the tags.

3.    Laboratory requirements
Laboratories must use testing systems that comply with UNE-EN ISO/IEC 17025 "Requisitos generales para la competencia de los laboratorios de ensayo y calibración". They must also be accredited in accordance with this standard within a maximum period of six months, having applied for accreditation to the relevant national accreditation body.
As a certification and testing entity, Applus+ offers homologation of “mascarillas higiénicas” through:
a) Testing of specific samples (batch conformity) according to applicable standards (UNE 0065, UNE 0064-1, UNE 0064-2 and UNE-CWA 17553).
b) Certification of products with A+ Mark (valid for 3 years), which includes product testing, documentary review and evaluation of production conformity by means of an audit. This certification allows the use of the A+ mark on your product and on the information that accompanies it, demonstrating the conformity of the product's production since it was endorsed by the laboratory report, as indicated in “Orden CSM/115/2021”.