Face masks

Product definition

The main focus of this factsheet is the type of face masks which are used to protect or mitigate the virus transmission risk.
Face masks can fall into three main categories:

• Masks that offer protection to the wearer against atmospheric agents such as dust, usually referred to as protective masks, in the scope of Regulation (EU) 2016/425 on personal protective equipment;
• Masks that do not offer protection to the wearer but are used to reduce the risk of infection of patients in a medical setting, usually referred to as medical masks, in the scope of Regulation (EU) 2017/745 on medical devices. Further guidance is available here This will depend on the classification, and further guidance is available here.
• Masks that do not offer protection but are used to reduce the risk of infection or contagion in a community setting, usually referred to as community face coverings, in the scope of Directive 2001/95/EC on general product safety

Common risks of face masks

The most obvious risk with protective masks are that it does not offer the level of protection claimed or expected by the user, whose health may be affected because of reliance on the stated or expected level of protection. Some of these are listed below:

• The masks do not fit the face of the user, the head harness is loose, or the seals are not tight enough, resulting in masks that are loose and do not filter the inhaled air.
• Lack of efficacy of filtration in removing harmful atmospheric substances or protecting against biological hazards.
• There is insufficient air flow, and the user does not get enough oxygen leading to breathlessness or lack of efficacy as the mask has to be removed.

There are other common risks that can be applicable to all types of masks:

• Presence of fibres or other particles of the filtration material that can be inhaled and present a risk to the user’s health.
• Sharp edges, burrs or abrasive materials leading to minor injury to the face or ears.
• Poor instructions or labelling leading to incorrect usage. Users may believe that they are being protected or protecting others when they are not.
• Poor instructions on handling and disposal leading to increased risk to the environment and to the public health.

Examples of dangerous products

Specific examples of measures taken against dangerous face masks offered for sale in the European Union are available on the Safety Gate website. Type ‘face mask’ into the free text search box (but without the quotation marks). A better understanding of mistakes made in the safety assessment of face masks, or their manufacture can help avoid their repetition.

Main applicable legislation

Legislation and guidance documents applicable specifically to masks intended to offer protection can be found on the European Commission website here.

Other legislation and guidance are available specifically in relation to those masks which are intended to reduce risk in a medical setting.

There are no specific legal requirements in relation to community face coverings other than that they are safe for the expected and foreseeable use taking into consideration the vulnerability of the user. Please note that every product must be safe for consumers, according to the General Product Safety Directive (GPSD) of the EU.

Conformity assessment of face masks

The conformity assessment of protective masks requires the intervention of a notified body that will issue an EU-type examination certificate after verifying that the design of the product meets the requirements of the PPE Regulation. Afterwards, during the production phase, the notified will either perform supervised product checks at random intervals or assess the quality system of the production process. In addition to this, the economic operator responsible for placing medical masks on the EU market may need to register with national authorities.

When protective masks are designed according to harmonised standards they shall be presumed to be in conformity with the essential health and safety requirements of the PPE Regulation, which will facilitate the conformity assessment process.

The production control can be based on random product checks at supervised intervals, quality assurance of the production process or product, unit verification, or full quality assurance.

A list of EU notified bodies for protective masks can be found on the NANDO website.

Conformity assessment of medical masks does not require the intervention of a notified body, unless these devices are placed on the market in sterile condition. Relevant harmonised standards are also available.

Other legislation of relevance:

While manufacturer’s need to familiarise themselves with all the laws which apply to their specific products, the following summarises some further key applicable laws:

• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) – restricts chemical substances in goods. REACH places responsibility on the industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers are required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database.
• Please note that every product must be safe for the consumers, according to the General Product Safety Directive (GPSD) of the EU.

Applicable standards

“Harmonised standards” exist in the EU for protective and medical masks. Masks which are correctly classified and complying with these standards are presumed to be in conformity with the relevant essential safety requirements if the standards are referenced in the Official Journal of the European Union (OJEU).

Note: The full text of European standards can only be purchased from a national standardisation body. The following site of CEN (the European standardisation organisation) provides links to the national standardisations bodies’ websites. In addition, the China Standards Information Services Network can be used to access European standards.

Different masks are used for different applications and to protect against a wide range of hazards. The manufacturer must be clear about the hazards against which the mask is intended to protect and also the level of protection offered. A full list of the harmonised standards in support of Regulation (EU) 2016/425 is available here

A search in the xls file using the term ‘mask’ will provide all of the relevant harmonised standards which provide a presumption of conformity.

Masks which are medical devices:
A full list of the harmonised standards in support of Regulation (EU) 2017/745 is available here.

Masks which are community face coverings:
There is no harmonised standard for these products, but CEN, the relevant European standardisation body, offers guidance on testing here.

However, the standard series covers other safety issues and manufacturers are strongly advised to consult all parts. It is important to note that the latest edition of the standard referenced in the OJEU (including any amendments) should be applied.

Mandatory labelling & warnings

The following are obligatory and should be placed on the product or where permitted on the packaging:

• CE marking for protective and medical masks
• Information to identify the manufacturer and importer
• Category/Class of protection offered for PPE or medical devices
• The type, batch or serial number of the product
• Where applicable, the identification number of the EU notified body involved in the production control phase (PPE only)
• An indication of whether or not the product is reusable
• Where applicable, the number and year of publication of the relevant EN harmonised standard
• The year of the end of shelf life

General safety requirements

To ensure safety of face masks, there is also a range of general requirements to be fulfilled. These are explained in the following factsheets and need to be read in conjunction with this factsheet:

• CE marking
• Conformity assessment
• Declaration of conformity
• EU consumer protection
• EU market surveillance
• Product safety checklist
• Recall procedures
• Risk management
• Safety Gate/RAPEX
• Selling online
• Technical file
• Testing
• Using a third party