ESF would like to bring to your attention that the obligation (or recommendation) to wear FFP2 masks for the general public might not result in the intended protection and could even be a step back, due to the created false sense of protection. We urge all involved authorities to carefully consider all aspects and make sure that a potential obligation (or recommendation) is accompanied by the necessary supporting measures.
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There is no doubt that properly worn respiratory protective devices offers a higher level of protection against the COVID-19 virus for the wearer compared to medical masks or community face coverings. Originally FFP3 masks were recommended, but due to shortages, also FFP2 were deemed to be sufficient. In most cases, the masks used are disposable, even if reusable solutions e.g. face pieces with filters are available on the market and offer in some cases even better protection. Protective masks or other types of respiratory protection are designed to protect the wearer of the device. They are in the scope of the Regulation (EU)2016/425 for Personal Protective Equipment (PPE). Based on the type of risk they protect against, they are category III PPE and thus subject to the strictest conformity assessment procedures, including an EU type examination (module B) as well as follow-up of the production (module C2 or module D) by a Notified Body. Given the filtration and tight fit of the masks, they will also limit the spreading of the virus in the exhaled air, even if not tested as such. For this reason, valved FFP2 or FFP3 masks are not recommended when used in settings where the COVID-19 virus is potentially present.
Other types of masks are either designed to avoid, to some level, that the wearer spreads the virus, but not to protect the wearer of the mask. Medical masks are typically designed to avoid contamination with bacteria and viruses potentially spread by the wearer of the mask when sneezing or breathing. The filtration from inside to outside is tested. These masks are in the scope of the Directive 93/42/EEC for Medical Devices (to be repealed by Regulation (EU)2017/745). Given the functionality of these medical masks, they are class I Medical Device (unless sterile, which is usually not the case) and thus subject to conformity assessment procedures that do not include the involvement of a Notified Body. Community face coverings are neither PPE nor Medical Device and are designed to minimize the spreading of the virus by the wearer when sneezing or breathing, while no specific levels are set in harmonised standards as for the other types of masks. There is a big variation in the filtration effect of these face coverings. Different organisations have set up quality marks for this type of product to help the public in their choice.
Given the functionality masks are designed for, it is clear that only FFP3 or FFP2 masks are designed to protect the wearer (compared to community face coverings or disposable medical masks). The standard setting the requirements (EN 149) reflects this in the different tests performed on the masks. An important test is the inward leakage test (TIL) ensuring that the air inhaled by the wearer passes the filter. To achieve that, the mask must fit very well on the face of the wearer and a tight seal is necessary. To make that possible, often several sizes are made available by the manufacturers.
As the leakage is an essential factor, following the instructions given by the manufacturer is key. Currently, in occupational use, fit testing of each individual wearer is highly recommended (if not obliged by the Occupational Health and Safety legislation), this to make sure that the correct fit for each individual is guaranteed, but also that each wearer has been trained in the correct use.
For all types of disposable masks, it is important to replace them regularly, they are typically designed to be worn for a working shift. And even if studies have shown that the COVID-19 virus is no longer active on surfaces after a couple of days, other contamination (such as e.g. bacteria) does create hygienic challenges. Therefore, it is good practice to replace the masks and not keep it aside to reuse at a later time.
For the same reason, timely and correct cleaning/washing of reusable masks (e.g. textile face coverings) is important.
Concerns when obliging FFP2 (or FFP3) masks for the general public.
When recommending the use of FFP2 masks or making it compulsory for the general public in the fight against the COVID-19 virus, the above mentioned concerns need to be taken into account, which must lead to :
Unless the above is realised, the obligation (or recommendation) to wear FFP2 masks for the general public will not result in the intended protection and could even be a step back, due to the created false sense of protection.
We urge all involved authorities to carefully consider all aspects and make sure that a potential obligation (or recommendation) is accompanied by the necessary supporting measures. The European Safety Federation is available to cooperate and support any action (e.g. training/information) to improve the protection of all citizens, be it in a professional or private setting.
Secretary General, on behalf of the members
sent to :
 Facial Hairstyles and Filtering Facepiece Respirators : https://www.cdc.gov/niosh/npptl/pdfs/FacialHairWmask11282017-508.pdf
 See e.g. ESF reflection paper PPE-20-1-10 submitted to the PPE expert group : https://circabc.europa.eu/ui/group/e34f47d0-f6b1-422a-ba5c-4da1f56d4ddc/library/d0669f67-ec8d-43d9-99b3-7a977e2a2788/details
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The information contained in this communication (letter, e-mail, on the ESF website or in documents available for download on the ESF website or as attachment to letter or e-mail, etc..) is intended for guidance only and whilst the information is provided in utmost good faith and has been based on the best information currently available, is to be relied upon at the users own risk.ESF will not accept any direct or indirect liability deriving from it. No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted for damages of any nature whatsoever resulting from the use of or reliance on the information. The guidance is based on available legislation and information and the interpretation of that legislation/information by ESF. Each company based on its own decision-making process may decide to use the guidance in full, partially or not, as it suits its needs but no liability shall be attributable to ESF.