RAPEX: Particle filter mask FFP2 - serious risk

Friday, 11 September 2020 20:20 RAPEX
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Report No 37 published on 11 September 2020, alert number INFO/00127/20

Description: disposable protective mask FFP2 which is sold in white cardboard packaging containing 50 pieces.

Risks: the face mask FFP2 may involve serious risks because it bears a CE marking and declares a presumed protection against particles and micro-organisms. However, its filtering capacity has not been certified by a competent body. As a result, the product may not meet health and safety requirements and therefore not adequately protect if not combined with additional protective measures.

The product does not comply with Regulation (EU) 2016/425 on personal protective equipment.

Action adopted: the measures adopted consist in banning on the marketing of the product and any accompanying measures (Luxembourg).


 Regulation (EU) 2016/425   Optimum level of protection
The optimum level of protection to be taken into account in the design is that beyond which the constraints imposed by the wearing of the PPE would prevent its effective use during the period of exposure to the risk or the normal performance of the activity.   Classes of protection appropriate to different levels of risk
Where differing foreseeable conditions of use are such that several levels of the same risk can be distinguished, appropriate classes of protection must be taken into account in the design of the PPE.


3560 Friday, 11 September 2020 20:33

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