西班牙卫生部于 2020 年 4 月 19 日发布了一项部长令,旨在规范价格和要提供给购买口罩的消费者的合同前/标签信息。该法令第 4 节规定了向消费者提供的卫生口罩的信息义务。  


  • 卫生口罩标签要求最少提供以下信息:

    • 企业数据:企业名称和地址。

    • 产品的惯用名称:众所周知的产品名称,以便完全识别产品性质。

    • 包装内容物:如包装中包含多个口罩,需列明单位数量。

    • 成分。

    • 建议使用期限。

    • 产品的基本特性,包括尺寸(如相关)以及可重复使用还是不可重复使用。

    • 警告,如“本产品既不是个人保护设备也不是医疗设备”以及其他。

    • 产品批号,按可识别序列进行制造过程的时间。

    • 使用说明,关于如何佩戴、使用和维护、处理和处置口罩。

    • 原产地,如有遗漏会误导消费者。

    • 是否符合 UNE 0064-1: 2020、UNE 0064-2: 2020 或 UNE 0065: 2020 技术规范,它们确定了卫生的不可重复使用和可重复使用的口罩必须满足的最低设计、加工、制备、标记和使用要求,或任何同等标准。

    • 与细菌过滤(BFE)的功效和透气性(压差)(Pa / cm2)相关的测试数据,包括测试编号和进行测试的实验室。

    •  如果是可重复使用的卫生口罩,则必须列明最多清洗次数,以及清洗或消毒的方法。

    • 完整的最终价格,遵循西班牙消费者法(11 月 16 日颁布的第 1/2007 号皇家法令批准的《保护消费者和用户的普通法》)综合文本第 20.c)条。

  • 标签上的信息不得通过铭文、符号、字谜或图画引起误导或欺骗,也不得对产品的真实性质留有任何疑问。

  • 标签必须清晰、持久地附着在产品的包装上,建议使用市售的最小包装;或者在消费者可以通过包装完全看到的情况下,也可以附着在产品上。 另外,如果销售是通过网络进行的,则此信息也必须显示在网站上。

此外,根据相关的部长令,某些口罩的最高零售价为每单位 0.96 欧元(含税)。请注意,此最高零售价或部际药品价格委员会在任何时候确定的任何最高零售价将一直有效,直到西班牙卫生部长另行决定为止。


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.