The European Union (EU) has recently recalled several particle
filter masks for non-compliance via its Rapid Alert System for dangerous
non-food products (RAPEX).
Market surveillance performed by EU Member States has found that these
masks failed to conform to requirements in:
- Regulation (EU)
2016/425 – Personal Protective Equipment (PPE)
- EN 149 – harmonized standard for respiratory protective devices
- Insufficient particle filter retention to match claims
- Uncertified products bearing the CE mark
- Face masks claimed to protect against viral particles, but their
filtering capacity was uncertified and their use as biocidal products was
Filtering facepieces (FFP or face masks) should protect the wearer
from inhaling airborne liquid and solid particles.
Non-conforming products should be:
- Rejected for importation
- Withdrawn from the market and recalls
- Temporarily banned
- Marked with appropriate warnings
- Banned from being marketed in the EU
RAPEX provides EU citizens and businesses with information about products
that pose a serious risk to their health and which fail to meet EU legislative
Medical PPE Services
SGS offers a
full range of services to help manufacturers and suppliers of medical PPE
deliver high quality, safe, and compliant products to markets around the world.
Learn more about SGS Medical PPE
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RAPEX Recall Particle Filter Masks from Markets SafeGuardS.
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For further information contact:
Consumer and Retail — Softlines
US & Canada Softlines Business Head
Tel: +1 973 461 7919
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