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This is how hygienic masks should be to enjoy the Consumption approval

February 12 from 2021 - 11: 41

The Minister of Consumption, Alberto Garzón, has signed the Ministerial Order establishing the information and marketing requirements for hygienic masks. After obtaining the mandatory authorizations from the World Trade Organization (WTO) and the European Union (EU), Spain thus strengthens its regulations, limiting the concept of a hygienic mask and includes regulations for those that allow lip reading to people with hearing disabilities . This definition serves to establish which products will be able to be marketed as such and the technical requirements that they must meet.

With this order, which will enter into force with its publication in the Official State Gazette (BOE), Consumption deepens its labeling and marketing obligations. From now on, for the mask to be marketed as hygienic, it will have to be tested in accredited laboratories that certify these characteristics. Likewise, the order incorporates actions of the market surveillance authorities to ensure compliance with the new regulations.

Additional requirements for masks, accessories and filters

With the order in force, all hygienic masks must indicate on their packaging which standards, technical specifications, work agreements or other technical documents of a recognized standardization body have been followed for the manufacture of the final product or its materials.

They will also indicate the data tested on the filtration efficiency of the material, the resistance to respiration or air permeability and the laboratory used to carry it out. In reusable products, the data obtained before and after the washing cycles indicated by the manufacturer must be included.

The data indicated must always refer to the final good placed on the market and the economic operator will be responsible for the traceability of the product, as well as for the laboratory to comply with the obligations. Likewise, it must indicate the place of origin of the product when its omission may give rise to error. In no case the labeling may include references to other types of products that give rise to deception about the nature of the product.

The marketing of hygienic masks outside of the original container is also prohibited, as well as in any other format that does not guarantee compliance with the requirements of the Order.

In relation to filters marketed separately from the rest of the fabric that makes up the mask, the obligation is included to cover the largest possible surface and without areas where inhaled and exhaled air can pass unfiltered. You will also need to specify which specific fabric was used to obtain the bacterial filtration and breathability data. The mask-filter assembly will have to comply with the standard.

Lip reading, psychomotor difficulties and children's masks

Exceptionally, in masks that have parts designed to allow lip reading and that do not facilitate the passage of inhaled or exhaled air, the indicated particle filtration efficiency will be allowed not to refer to those areas, provided that it is indicated in the own label. However, these masks must meet other additional requirements such as allowing a clear vision without fogging, which ensure that the product does not obstruct breathing and must be indicated on the label if there is a distorting effect on speech.

In the case of hygienic masks for people with disabilities, they must have adjustable elements with velcro on the head to avoid chafing behind the ears, with adapters (ear protectors), or with any other element that facilitates the autonomy of people with difficulties psychomotor.

For children's masks, the labeling must reflect the approximate age of use, based on the anthropometric data of the Spanish population, as well as the indication: "Warning: Use under the supervision of an adult". Regarding their manufacture, they must also comply with the technical specifications UNE-EN 14682: 2015. AND

Obligations for laboratories and market surveillance

The certification laboratories must have implemented, at least for the tests, a system in accordance with the UNE-EN ISO / IEC standard and be accredited by the national entity corresponding to the country where it is located. It is a strict requirement and equivalent, but not identical, to the one that up to now is required of laboratories that certify personal protective equipment (PPE).

Market surveillance authorities will be able to verify both that the masks on the market comply with the content of the order and that the testing laboratories have sufficient competence. They may require all the information about the product and the tests carried out. They may also request staff training and any other aspect that may be necessary to guarantee the correct performance of the tests and the results obtained.

Transitional period and penalties

The content of the order will come into effect the day after its publication in the BOE. Masks that have been put on the market previously will have a period of 30 days to adapt. After this period, they can no longer be marketed under the name of hygienic masks.

Likewise, the laboratories that certify the characteristics of the masks will have six months for accreditation before the corresponding national authority, a minimum period to carry out the procedures. However, to guarantee the control of the laboratories during the transitional period, they must prove that they have the UNE regulations in place and that they have requested their accreditation from the national authority. Laboratories are not exempted from the obligation to comply with the standard during the transitional period, but rather they have to demonstrate that they are in the process of obtaining the corresponding certificate.

To do this, they will issue a certification to the company requesting their services and must attach the accreditation request, a confirmation of the complete delivery of the request and the payment of fees.

In accordance with the General Law for the Defense of Consumers and Users, non-compliance with the rules regarding labeling, packaging and advertising of goods and services is an infringement. The CCAA can initiate disciplinary proceedings against companies that market masks without respecting the labeling regulations and withdraw the products from circulation.

From the entry into force of the order, laboratories that prove the characteristics of hygienic masks without complying with the provisions of the standard are exposed to be sanctioned with closures of five years.

Regulations in the EU

In addition to Spain, different European countries have developed their own technical specifications on hygienic masks. The European Committee for Standardization (CEN) has taken these requirements into account to develop the CWA 17553/2020 standard, which serves as a guide to establish the minimum requirements for hygienic masks to ensure the limitation of the risk of contagion. It is a voluntary agreement and, therefore, there is no harmonized European regulation in this regard. For this reason, some member states have chosen either to regulate or to prohibit the use of hygienic masks in certain spaces.

In France, since January 27, the marketing of masks for non-sanitary use is prohibited. Likewise, the use in schools of non-surgical masks, FFP2, or type 1 hygienic masks (filtration greater than 90%) has been prohibited. That is to say, what in Spain will be called hygienic masks as of the entry into force of this order, corresponds to type 1 French hygienic masks that are not prohibited. Those that have been prohibited in France, in Spain cannot be called hygienic, because there is a more demanding regulation.

The European Commissioner for Health and Consumption, Stela Kyriakides, based on the examinations of the European Center for Disease Prevention and Control (ECDC), indicated on February 3 that there is not enough evidence to recommend the use of masks FFP2 for the general public. The recommendation for the healthy population without contact with the virus is the use of a hygienic mask that meets the standards of the technical standard CWA 17553, as it is now being regulated in Spain.

Consumption approved in April 2020 the order that established the labeling and marketing requirements of all masks that were not considered surgical or FFP. Due to the lack of stock in this phase of the pandemic, the norm covered all those of the UNE norms and those of similar norms, but without the obligation of bacterial respiration or breathability efficacy tests.

At this time, after the adaptation of the national industry, Spain covers 90% of the demand and all the market surveillance work. For this reason, and with the new varieties of masks and accessories, Consumption expands the requirements of this product to guarantee the safety of people without coronavirus symptoms and who are not in contact with sick people.

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