Spanish Regulations Regarding Hygienic Face Masks

The Spanish Ministry of Health published on April 19, 2020 a Ministerial Order intended to regulate both the prices and the pre-contractual / labelling information to be provided to the consumers purchasing, among others, face masks. Section 4 of the Order sets out information duties about the hygienic masks addressed to consumers.  

Merchant Obligations 

• The Minimum data that shall be required in the labelling of hygienic face masks are the following:

• Corporate data: corporate name and domicile.

• Usual name of the product: name by means of which the product is known so its nature can be fully identified.

• Contents of the package: number of units if the package contains several face masks.

• Composition.

• Period of use recommended.

• Essential characteristics of the product, including the size, if relevant, and whether it is reusable or non-reusable.

• Warnings, among others "This product is neither individual protection equipment nor a medical device".

• Production lot, when the manufacturing process is made under identifiable series.

• Usage instructions on how to put on, use and maintenance, handling, and disposal of the face masks.

• Place of origin, in the event that its omission could mislead the consumer.

• If it meets the technical specifications UNE 0064-1: 2020, UNE 0064-2: 2020 or UNE 0065: 2020, which establish the minimum requirements that hygienic, non-reusable and reusable face masks must meet in terms of the materials used for its design, elaboration, preparation, marking and use or any equivalent standard.

• Testing data related to the efficacy of bacterial filtration (BFE), and of breathability (Differential pressure), (Pa / cm2), including the test number and the laboratory used in case a test has been performed.

•  If it is a reusable hygienic face mask, a maximum number of washes must be indicated, as well as a method of washing or sanitizing.

• Complete final price in accordance with article 20.c) of the consolidated text of the Spanish Consumers law (General Law for the Defence of Consumers and Users, approved by Royal Legislative Decree 1/2007, of November 16).

• The information on the label must not be misleading or deceptive by means of inscriptions, signs, anagrams or drawings, nor will they leave any doubt as to the true nature of the product.

• The labelling must be placed clearly and durably on the packaging of the item(s), recommending the smallest packaging available commercially, or on the product provided it is perfectly visible to the consumer through the packaging. Also, if the sale takes place over the Internet, this information must also be displayed on the website.

Additionally, by virtue of the referred Ministerial Order, the certain masks are subject to a maximum retail price of € 0.96 per unit (taxes included). Please note that this maximum retail price, or any other that is determined at any time by the Interministerial Medicine Prices Commission, will be in force until it is decided otherwise by the Spanish Health Minister.

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