Issues to take into account when selling respiratory protective equipment

The authorities have received several inquiries related to placing respiratory protective equipment and face masks on the market. Despite the current high demand for protective equipment, the sale of products that do not conform to requirements is prohibited. Companies intending to place protective equipment on the market must be aware of and ensure conformity with requirements.

Civil masks that prevent the spread of droplets but do not protect the wearer from external factors are not considered personal protective equipment (PPE). If a product does not fulfil the requirements for PPE, consumers must not be given the false impression that the product in question would constitute a type of PPE.

Respiratory protective equipment are classified as category III PPE. Respiratory protective equipment protect the wearer against severe health hazards caused by impurities in the air, including particles, aerosols, bacteria and viruses. Examples of respiratory protective equipment include filtering facepieces that conform to the standard EN 149. They are divided into three classes based on filtration efficiency: FFP1, FFP2 and FFP3. They are commonly used as protective equipment against microbes found in aerosols in the surrounding air.

PPE must conform to the health and safety requirements of EU Regulation 2016/425 on personal protective equipment. The requirements will be met, if respiratory protective equipment is designed, manufactured and equipped in accordance with the relevant harmonised standards?

The manufacturer is responsible for ensuring the conformity of respiratory protective equipment. If a party other than the product’s effective manufacturer sells a respiratory protective equipment under its own brand or trademark, said party is subject to the manufacturer’s obligations. In this case, the company must apply for an EU type-examination certificate for the PPE jointly with the original manufacturer.

Requirements for respiratory protective equipment

Respiratory protective equipment sold in Finland must include:

• An EU type-examination certificate (the type examination process is described in detailed on the Tukes website and in the PPE Regulation)
• EU declaration of conformity, in Finnish and Swedish (template in Annex IX of the PPE Regulation)
• user instructions in Finnish and Swedish
• CE marking and identification number of the relevant notified body on the PPE
• manufacturer and product identifier on the PPE.
• technical documentation drawn up by the manufacturer (see Annex III of the PPE Regulation for more information). The manufacturer draws up technical documentation for the type examination.

When purchasing respiratory protective equipment

Contracting the coronavirus is possible also from handling materials and surfaces contaminated with the sputum of an infected person, and infection cannot fully be prevented with respiratory protective equipment. However, if you choose to purchase a respiratory protective device, make sure that:

• it is appropriate for the intended use and seals tight on your face
• the respiratory protective device is equipped with a CE marking that ends in a 4-digit number
• the respiratory protective device comes with user instructions in Finnish and Swedish.

Further information:

Personal protective equipment intended for consumer use:

Asta Koivisto, Tukes, tel. +358 29 5052 187, [email protected] (from 23 March 2020 onward)

Pipsa Korkolainen, Tukes, tel. +358 29 5052 125, [email protected] (16–20 March 2020)

Personal protective equipment intended for professional use

Pirje Lankinen, Ministry of Social Affairs and Health, tel. +358 29 5163 488, [email protected]

Tapani Vänni, Ministry of Social Affairs and Health, tel. +358 29 5163 219, [email protected]

Links:

Personal protective equipment on the Tukes website

Website of the Finnish Institute of Occupational Health: How can I prevent coronavirus infection? Do I need a face mask or respiratory protective device?

Updated 1 April at 9.45: added note that respiratory protective devices are Class III PPE.