The key issue regarding compliance is how the masks are marketed. If masks are marketed as:
- Personal Protective Equipment or
- as having a specific medical function or
- make any specific claims as to efficacy or protection
Such claims will bring them into the jurisdiction of the Heath and Safety Executive or The Medicines and Healthcare products Regulatory Agency if used in the workplace and for consumer goods, Trading Standards. Masks within this group must comply with various standards and have supporting documentation.
If they are not marketed as above then the products can be sold simply as face coverings and the most likely audience would be consumers looking to wear them on walks, shopping or on public transport etc.
It is strongly advisable to ensure that purchasers and users of face coverings are made aware of the limitations of the products to avoid the possibility of them attributing greater protection offered by the products than is actually the case. We would therefore suggest that the following comments should go on any marketing and product packaging:
- These products are not personal protective equipment
- These products are not medical devices
- These products are not suitable for use in NHS or Care Home settings
Provided you let consumers know these things, then they can make up their own minds as to whether to buy the masks from your business.
In order to provide more information, you may use factual descriptions of the product with regards to the construction, layers and material used. However no description should be used which might suggest or imply certain levels of protection. You should take care to ensure the descriptions are accurate and remain accurate for each batch. You should also include care or usage instructions for example if they are they washable.
Labelling should be legible and in English.
The purpose of a face covering is not to protect the wearer but, if where someone is infected and has not yet developed symptoms, it may provide some protection for others in close contact. Evidence shows a face covering can help in reducing the spread of droplets and therefore potentially infecting others, and could help to reduce the spread of infection as lockdown measures start to be lifted. It is important to refrain from touching the face covering when wearing it, where possible, to avoid hand-to-mask transmission of the virus. Government guidance for the general public suggests the use of face coverings in enclosed spaces where social distancing is not possible.
Whilst a face covering would not be personal protective equipment or a medical device, it must still be safe for use by the user. Such products must therefore comply with the General Product Safety Regulations 2005 to ensure they are safe, for example the materials used must be non-toxic and ensuring cords do not present any risk of strangulation. For further information on complying with the General Product Safety Regulations 2005 please see the following Government advice.
If you wish to clarify any issues with the Health and Safety Executive they can be reached at: Health and Safety Executive – Contact.
If you wish to clarify any issues with the Medicines and Healthcare products Regulatory Agency they can be reached at: firstname.lastname@example.org
In addition the British Standards Institute has recently published guidance on all types of face masks and coverings which can be found at BSI guide to masks and face coverings for use in the UK during the COVID-19 pandemic.
If you are looking to sell face coverings to the public and need further advice please contact us by registering on our website.