02.11.2020 // General news
Overview on the standardization of community masks
We have been seeing them more and more often: colourful face masks made out of fabric. Face masks are intended to prevent the transmission of COVID-19 by minimizing the spread of virus-containing droplets of pre- and asymptomatic individuals, especially in enclosed spaces and when social distancing rules cannot be observed, for example on public transit.
Fabric masks, also known as community masks, can be purchased in nearly every shop. There are even online instructions available on how to sew your own community mask. However, following reports questioning the effectiveness of common surgical face masks and respiratory masks as well as the poor filtration efficiency of commercially available community masks, it is not clear how well such masks protect the wearer and those around them.
Why do we need a standard for community masks?
The term «community mask» is not a protected or legally defined term. Thus, anyone can market products using the keyword «community mask», regardless of how well the mask protects the wearer and their environment from droplets and aerosols. While harmonized standards exist for surgical face masks and respiratory masks, which clearly state the requirements that such masks must meet, there are no such standards for community masks. Due to the lack of legal regulation, there is confusion among manufacturers and consumers regarding the minimum level of protection that must be provided by community masks. A standard could create clarity on the requirements and test procedures for community masks by acting as a voluntarily technical regulation and thus increase legal certainty as well. Furthermore, a standard would create the same conditions for all market players and represent state-of-the-art technology for community masks. Moreover, uniform test procedures for community masks would enable a comparison between different community masks regarding a given parameter (e.g. filtration efficiency). The ability to make a comparison would also pave the way for the establishment of labels that would allow customers to easily distinguish between high- and low-quality community masks.
Who sets the standard?
Normative documents, such as standards, are not developed by legislators, a government agency or a national regulator, but rather by the interested parties themselves. This is called a bottom-up approach. All parties interested in the topic of community masks can be involved on the standard committee and contribute their expertise to the development the normative document. In order to ensure that the market accepts the normative document, the Swiss Association for Standardization (SNV) aims to include as many different stakeholders as possible in the standardization process, including: manufacturers and producers, retailers, universities, research and scientific institutes, associations, NGOs, government agencies and offices and consumers.
What has happened to date?
The European Committee for Standardization (CEN) has defined the initial minimum requirements and testing methods for community masks in the form of a CEN Workshop Agreement (CWA), a normative document with a limited consensus. This was done at the request of the European Commission (EC). This CWA is not a European standard (EN) and its content must not conflict with any EN. The CWA was published in June 2020 and is valid for three years with a maximum lifespan of six years. The CEN technical board decided on 29 September 2020 that this CWA will be transformed into a Technical Specification (TS) by the CEN technical committee (TC) 248 for textiles and textile products. This decision was made because a CWA only has a limited consensus and is therefore not a suitable long-term solution. An EN is not suitable either because it would take too long to develop. Switzerland will have the opportunity to participate in the development of this European TS through the national mirror committee (NK) INB/NK 108 for textiles.
On the national level, the Swiss National COVID-19 Science Task Force provided initial recommendations for the minimum requirements for community masks in a recommendation paper. Furthermore, the SNV has started an initiative to develop a national normative document as soon as possible. The development of the European TS might take some time, as there will be more stakeholders involved at the European level than at the national level. Thus, a national normative document could fill the gap until a European standard is available. During the Roundtable on 24 September 2020, various stakeholders from industry and research institutes conducted an initial open discussion on community masks. The kick-off meeting was held on 22 October 2020, with stakeholders from different industries showing an interest in actively developing a national normative document.
Which national normative document is the right approach?
There are three different national normative documents: the Swiss standard (SN), the Swiss rule (SNR) and the Swiss guide (SG) (Table 1). An SN is not a fast solution for the standardization of community masks since it comes with a mandatory public survey, which must last for a minimum of three months. Additionally, an SN is developed exclusively by SNV members in the framework of an official standardization committee. Furthermore, more formal rules have to be followed during the development of an SN compared to an SNR. On the other hand, an SNR can be published much faster since only a consensus within the working group, consisting of various Swiss stakeholders, is required and not a public survey. An SNG is not considered suitable for the standardization of community masks, as this type of document does not contain any normative requirements.
Therefore, the SNR is the right choice for the standardization of community masks. The goal is to publish the SNR in the first quarter of 2021 in order to have a sound foundation for taking part in the drafting of the European TS that is to be developed by CEN/TC 248.
Will the Swiss rule become legally binding?
In general, standards are not legally binding. However, it is common for laws and regulations to refer to normative documents. Many legal regulations only specify the essential requirements for a product. The use of the Swiss rule is voluntary, but if the law refers to the rule in a law or a regulation, the rule might become legally binding.
Will there be market supervision for community masks?
Market supervision of respiratory masks is carried out by the State Secretariat for Economic Affairs (SECO), while Swissmedic supervises the market for surgical masks. So far, there is no legal basis for the supervision of the market for community masks, especially in terms of performance, and no federal office has been put in charge. On the European level, market supervision will be carried out as part of the General Product Safety Directive (GPSD).
Will there be a label?
The term «label» must be distinguished from «labelling». In contrast to labels, which are voluntary, «labelling regulations» (and goods declaration) are government instruments that must be followed.
The SNV itself does not issue labels. Manufacturers whose products meet the requirements of the Swiss rule can declare that their products meet the requirements of the Swiss rule as part of a self-declaration.
Overview of the different national normative documents
Table1: SN 18011:2017 «Aufbau und Gestaltung von Schweizer Normen SN, Schweizer Regeln SNR und Schweizer Guidelines SNG» describes the structure and layout rules for an SN, SNR and SNG (only parts of the original table are displayed).
What role does the SNV take during the development of the SNR?
The SNV is the official standardization body in Switzerland. The SNV is a neutral, independent and private association. Moreover, the SNV takes care of the standardization process as a whole. In particular, the SNV contacts potential stakeholders, supports experts during the development of the SNR and ensures that all rules and guidelines are followed. In addition, the SNV is responsible for publishing the SNR at the end of the process. The SNV also connects the national level of standardization to the European level by adding the technical content of the SNR to the CEN/TC 248 for Textiles and textile products for the development of the planned European TS.
First, developing a normative document for community masks at the national level has the advantage that fewer stakeholders are involved, the time to publication is shorter compared to the European process and the requirements in the document can be tailored to the specific Swiss needs. Moreover, if the SNR is finalized early enough, the national mirror committee to the European textile standards committee can use the technical content (normative content) of the SNR to influence the development of the European TS.
Help shape the Swiss rule!
A successful kick-off meeting with various stakeholders was held on 22 October 2020. The goal of the working group is to publish the SNR by the end of 2020 or beginning of 2021. The working group meetings will start in calendar week 47, with weekly or biweekly meetings. The SNV invites all interested stakeholders to participate actively and free of charge in drafting the planned SNR in an open, consensus-based process. If you are interested in joining, please get in touch with us.
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