The objective is to establish sufficient guarantees so that citizens can access, in an informed manner and in non-abusive economic conditions, certain protection products.
Specifically, the order establishes the procedure for setting the maximum amount of public sale of medical devices (surgical masks and gloves), as well as those products necessary (hygienic masks and hydroalcoholic solutions) for the protection of the health of the population.
It is a text that has been worked together by the Ministries of Health; Consumption; Economic Affairs and Digital Transformation; Estate; Industry, Commerce and Tourism; the National Commission of Markets and Competition (CNMC); as well as with the autonomous communities.
From now on, the Interministerial Commission on Drug Prices will be the one who, by agreement, will set this maximum amount for sale to the public. To do this, its members will meet electronically in extraordinary session within forty-eight hours from the publication of this order. The amount of each product will be published in the BOE.
In addition, the Order published today determines the information that must be established in the labeling of hygienic masks. Among the minimum data required are the company data; product denomination; container content; composition; recommended period of use; essential features including size if relevant; manufacturing batch; place of origin; health warnings; recommendations for use, placement and maintenance; Technical specifications; bacterial filtration efficiency and breathability; and final price.
For justified reasons of space, the mandatory data may appear in the instructions, brochures or documents that accompany the product.
Citizens must pay special attention to two values on the label: the efficacy of bacterial filtration, that is, the effectiveness of the mask as a barrier against bacterial penetration, which must be equal to or greater than 90%. And secondly, breathability, that is, the differential pressure that is needed to pass air through the mask. It must be less than 60 Pa / cm2.
In the case of reusable hygienic masks, the labeling must indicate the maximum number of washes as well as a method of washing or sanitizing. The unit sale of surgical masks that are not individually packaged can only be carried out in pharmacy offices, guaranteeing adequate hygiene conditions that safeguard the quality of the product.
The order establishes that citizens "must have sufficient information for the purchase of products that prevent infection, pursuing the aim that it can distinguish between those that are suitable from those that are not and must access them in conditions that avoid abusive price situations, taking into account the current market situation ".
Regarding consumer information, it is essential that the consumer can correctly differentiate the information on the label. Hence the need for it to be effective, truthful, and sufficient about its essential characteristics.
Check here the order published in the BOE: https://www.boe.es/boe/dias/2020/04/19/pdfs/BOE-A-2020-4525.pdf