Safety Gate (Previously called RAPEX) 2020 PPE Recalls

In 2020, there was a large increase in the level of enforcement on the quality of PPE like face masks and coveralls throughout the EU. Safety Gate is a rapid alert system enables quick exchange of information between EU members about products posing a risk to the health and safety of consumers. The basis is established according to General Product Safety Directives 2001/95/EC (GPSD) and publishes a weekly report.

In the year 2020, from Jan 2020 to Dec 2020, there were a total of 164 notifications related to PPE. These were for face masks, particle filter masks and protective coveralls.

*cumulative number

The most common issue is that the PPE has not been certified by the appropriate notified body, resulting in 76 notifications. The next most frequent reason for failure is the product does not perform as claimed. This is mainly due to poor filtration performance and the mask not meeting the required standard.

The tables below summarise the particle filtration levels expected for filtering face pieces (FFP) masks and the bacterial filtration efficiency (BFE) required for medical masks.

Table 1 – Particle Filtration Efficiency for Particle Respirator Masks

Table 2 – Bacterial Filtration Efficiency for Medical Masks

The recall cases demonstrate the importance of testing the face mask to the correct standard and ensuring the product meets the standard performance requirements

Read more: https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/index_en.htm