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The EU Rapid Alert System for dangerous non-food products (RAPEX) has recently issued notifications of numerous particle filter masks that do not comply with the Personal Protective Equipment Regulation and the relevant European Standard EN 149, resulting in their recalls from the EU markets.

SAFEGUARDS | Personal Protective EquipmentNO. 105/20

 SG 10520 Mask2

Filtering facepiece (FFP) masks are one type of personal protective equipment intended to protect the wearer from inhaling airborne liquid and solid particles. However, after recent market surveillance conducted by EU Member States, the EU RAPEX issued multiple notifications of non-conformity against the Personal Protective Equipment Regulation (EU) 2016/425 and the relevant European harmonized standard EN 149 for respiratory protective devices. 

According to the notifications, filtering facepiece (FFP) masks non-conformities are related to several issues:

  • Products claim their particle filter retention of the material, but the performance is insufficient;
  • Products bear a CE marking but are not certified as protective equipment by a relevant body;
  • Products advertise their biocidal protective potential against viral particles and other micro-organisms, but neither the filtering capacity was certified nor their use as biocidal products was authorised by the relevant European bodies and legislations

Further noted is authorities, filtering facepiece (FFP) masks identified as non-conforming can then be:

  • Rejected to import at borders
  • Withdrawn from the market and recalled from end users
  • Temporarily banned on the supply
  • Marked on the product with appropriate warnings on the risks, or
  • Banned on the marketing and any accompanying measures in EU markets.

The EU rapid alert system (RAPEX) aims to provide information for consumers about products which pose a serious risk and is subject to European legislations which are to ensure a consistent, high level of protection for the health and safety of consumers.

Reference

[1] Safety Gate: Rapid Alert System for dangerous non-food products – Weekly Report

[2] SGS – Consumer Goods and Retail – Product Recalls

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