The Ministry of Consumption reminds that, following the recommendations of the scientific community, healthy people without contact with COVID-19 should use the hygienic mask model, without renouncing the recommendations of the Ministry of Health regarding physical distance and hygiene. For those who have been infected, have symptoms or are positive asymptomatic, the use of surgical masks is recommended.
Thus, the third group – the EPI type, among which is the FFP2 – are recommended only for people in contact with the virus and for vulnerable groups, always under medical prescription.
Two weeks ago, the Ministry of Consumer Affairs published a guide with keys for the acquisition and use of masks. In this way, it is sought that citizens make a purchase and a responsible and conscious use of the product, that they be informed of what types are on the market and which is the most useful for their personal situation, depending on their degree of contact with the virus.
This guide establishes that the Personal Protective Equipment (PPE), sold in pharmacies and specialized establishments, is recommended for professionals in contact with the virus and certain vulnerable groups, always on medical prescription. The European Center for Disease Prevention and Control (ECDC), the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) coincide with this recommendation of the Government of Spain.
It should be noted that, in the case of FFP2 type masks, it is necessary for the user to be aware that this type of PPE can make breathing more difficult than hygienic or surgical masks, so non-specialized personnel may tend to touch and reposition them continuously. , with the consequent risk of contamination. On the other hand, as it is material mainly intended for professionals, it can generate a false sense of security, which relaxes the maintenance of other security measures and prevention of essential compliance, such as physical distance and hand washing.
Finally, it should also be noted that people who are physically active or some people with respiratory difficulties may not tolerate its use. For this reason, its social use, by those who are not professionals, must be carried out with a medical prescription.
Consumption insists on the need to follow the instructions and recommendations of the Government of Spain in the use of masks, thus contributing to the safety of all citizens.
Mandatory information
Consumption also remembers that it is essential that all masks contain a label with the mandatory information according to the applicable legislation. This includes data regarding its reuse and, if applicable, the permitted uses and number of washes that can be done without the product suffering, as well as the method of washing the mask.
In the case of masks labeled with the European standard for personal protective equipment, the packaging labeling must contain manufacturer's data, protection class (FFP1, FFP2 or FFP3), the phrase "see the information supplied by the manufacturer", the indication R or NR in case it is reusable or non-reusable, storage, use, cleaning, maintenance and disinfection conditions.
Consumption warns that it is mandatory that all the information that accompanies the product is written, at least, in Spanish. Otherwise, it can cause security problems for the user. For example, it could happen that there are people allergic to certain materials that are wearing masks with information in English and Chinese. This obligation in the use of the language responds to the fact that all the information related to security, such as the composition of the product, is understood by the user.
The security obligations are applicable regardless of whether the product is made available to the consumer for consideration or free of charge, in the context of a commercial activity, whether new, used or reconditioned.
In addition, the information that accompanies the mask should clarify to the user the useful life of the product and the conditions in which to use the product in that period of time. It should be remembered that the recommendation of the Government of Spain, endorsed by the WHO, is that – for reasons of comfort and hygiene, and unless the manufacturer indicates otherwise – the mask should not be used for more than four hours. And, in any case, it should always be replaced when it gets wet, dirty or deteriorates. Also, cleaning instructions must be attached.
Regarding its certification, the Ministry of Consumption reminds that before using an EPI mask, if it includes the CE marking, it must be verified that it is accompanied by the four digits that indicate the conformity of a recognized Notified Body provided for in the EU regulation (2016/425).
When the protection class is a non-European standard for non-medical masks, they can only be marketed in certain cases, as provided in the Resolution of April 23, 2020 of the General Secretariat for Industry and Small and Medium Enterprises referring to personal protective equipment in the context of health crisis. But, in no case, could the mask be marked with the EN 149: 2001 + A1: 2009 standard since the consumer would be being misled, since in these cases the mask has not been evaluated according to said standard or has not been reached to complete.
In these two cases, the CE marking can be shown, but the four digits that indicate the conformity of a recognized Notified Body provided for in EU regulation (2016/425) must always be included. This reference is mandatory, according to regulations.
For all these reasons, the Ministry of Consumption asks all administrations to follow the recommendations of the Government of Spain and to comply with the applicable legislation on PPE, the assumptions established in the Resolution of April 23, 2020 of the General Secretariat of Industry and Small and Medium-sized Enterprises, and the basic legislation on information and guarantees for the Defense of Consumers and Users.
