If you sell civil masks such as cloth masks to consumers, please note at least the following issues. These issues apply to masks that have not been placed on the market as PPE or medical devices.
– Civil masks such as cloth face masks sold to consumers must fulfil the requirements of the Consumer Safety Act (920/2011) and the Government Decree on information to be supplied in respect of consumer products and services (613/2004). All information about civil masks essential considering safety must be provided clearly and understandably for consumers, both in Finnish and in Swedish. This information must be provided with the product and so that consumers can obtain the information required before making any purchase decision.
– The purpose of use of the product must be presented clearly, such as reducing the spread of droplets into the environment. Presenting a purpose of use that is not the actual purpose cannot be used to circumvent existing legislation.
– The product’s operating instructions must have the necessary information on the safe use of the product, such as to whom the mask is or is not suitable, how to put it on safely, how to change it, what factors affect the protection, washing instructions, etc. According to current knowledge, it must be possible to wash civil masks at 60 °C at minimum. The company is responsible for ensuring that the use of the mask is safe and hygienic with the washing instructions given.
– The product information must highlight that the product is not a PPE and that if users need to protect themselves from the virus, they also need to acquire respiratory protective equipment suitable for the purpose.
– If the product is not a PPE, it must not have references to personal protection standards of protection classes such as FFP2 or EN 149, or any other kind of misleading information on protection.
– Providing conflicting information on the product or images that could give users the impression that the product protects its user is prohibited. If the product information given or the marketing material can give the impression that the product can be used as a PPE, it must fulfil the requirements set for personal protective equipment. This also applies to references to use for medical purposes (such as surgical masks and the use of terms such as “surgical” and “medical”).
– If the product’s exhalation filtration efficiency (%) has been tested (e.g. in accordance with the CWA specification), it can be indicated in product information. However, the product information cannot indicate that the product protects its user. If any specification or other recommendation applicable to civil masks is used in manufacturing, this can be indicated in product information, provided that the product does not give the impression that it is a type of PPE or medical device.
– If the mask is marketed as possessing antibacterial or other biocidal properties or to have been manufactured from an antibacterial material, see section “Requirements for chemicals”.
– General consumer goods cannot have a CE mark, even if the product standards of personal protective equipment or medical devices had been used in designing and manufacturing the general consumer goods as applicable.
See also the instructions by Tukes on information provided on general consumer goods (in Finnish).