So much information is out there surrounding Covid-19 it can be a bit overwhelming to stay on top of it all. Now country leaders and trusted institutions are recommending face masks and asking people to wear them when they go outside to flatten the curve. Disinfection and hygiene improving products are one important key element for preventing the spread of the viruses and bacteria.
Naturally, this has caused the market to be flooded with all types of face masks and uncertainty. Also the interest for antimicrobial treated PPE has grown considerably.
Are you aware of the differences in face masks and the regulatory requirements that need to be adhered to when producing and marketing such PPE (Personal Protection Equipment) items in the different countries? We have done our research and put together a comprehensive free guide about exactly these topics to offer direction and clarify regulatory issues and concerns.
Three main types of masks and their regulatory requirements (EU/EEA/Switzerland/UK)
Community Masks: Any type of DIY mask made out of various textile fabrics according to instructions often downloaded off the internet. They are not verified and do not meet the relevant standard requirements for mouth-nose protection or PPE. It is not permitted to promote these types of masks as a medical device or PPE. Be careful what claims you make to not give this impression to consumers. Community masks with an antiviral or antibacterial effect are considered a textile treated with a biocidal product however, if certain claims are made, the textile itself might also have to be registered as a biocidal product.
Medical Oral Nose Protection MNS / Operation Masks: A higher level of face masks primarily used to protect third parties from being exposed to the wearers potentially infectious droplets. MNS masks are on the market as medical devices and are therefore subject to the medical device law and must undergo a verification process to receive the CE mark. This type of mask is classified as Medical Devices class 1 and fall under the requirements of the applicable medical device regulation need to be followed, this also includes the prove of efficacy of claims and intended use as well as consumer safety. Items that fall under the medical device regulation are not under the scope of the BPR.
Filtering Half Masks (FFP): These masks are intended to protect the wearer from particles, droplets and aerosols. There are types with and without exhalation valves, only those without valves filter both exhaled and inhaled air protecting both the wearer and other persons. In order to legally market FFP masks in Europe, a conformity assessment procedure according to PPE Regulation (EU) 2016/425 must be carried out. The PPE regulation is not excluded from the BPR, if they are treated with a biocidal product the regulatory situation is the same as for community masks. Regulations for the US see below.
Claims in summary: Anti-virus and antibacterial claims can be made on a face mask if the effects the claims are advertising are scientifically proven. Furthermore, the regulatory requirements of the type of masks need to be fulfilled. Biocidal products used to treat the face mask need to be approved for that intended uses.
Regulation for the US
Face masks, face shields, and respirators are medical devices when they are intended for a medical purpose, such as prevention of infectious disease transmission including uses related to Covid-19. Masks that claim to prevent infection, have antiviral or antimicrobial properties, make claims about these properties and are treated with an active substance are considered class II devices and require FDA clearance. Examples of product codes that fit these categories are FXX, OUK, or ORW. Mask that do not claim such properties or prevention of infectious diseases do not need FDA approval.
For all countries the regulatory framework is complex and needs to be followed exactly to avoid fines or problems with the national authorities. SANITIZED AG provides support and guidance.
If you are a supplier or manufacturer of PPE including face masks and textiles with antiviral and antimicrobial properties for the purpose of managing the Covid-19 pandemic make sure to download our free Regulatory Guide “Treatment of PPE (personal protection equipment) with biocidal products“ It offers detailed and easy to understand information about the above mentioned types of mask and their current regulatory requirements in various countries.
In our Regulatory Guide you will learn more about:
- Regulatory situation for face masks
- Information about the different types of masks
- Treatment of face masks with biocidal products
- Overview for face masks treated with a biocidal product and making claims for EU/EEA/Switzerland/UK
- Claim situation in EU/EEA/Switzerland/UK
- Face mask regulations in the US
- Claims for face masks in the USA