Published on: Mon 19 October 2020

Pandemic related product alerts | wk 42

What do you need to ask when buying or producing face masks? What legislation is applicable to face masks? What are market surveillance authorities (MSA's) looking for? By analysing the weekly reposrt of Safety Gate we summarise for you what to look for. Products that don't cause hassle, ProductIP helps you!

It has been quiet for a couple of weeks on the fron of pandemic related product alerts, published on Safety Gate: the rapid alert system for dangerous non-food products. This week there are however newly published alerts. 

If you are an economic operator* for these products, product recalls can help you make better products and prevent problems with market surveillance authorities. 

  • The first particle filter mask is of the brand 'ERA MASKE - BASARAN' (type ERA1300 FFP3 NR, barcode 8681248449145). The country of origin of the product is Turkey. Link to product alert
    The particle/filter retention of the material is insufficient (measured value ≤ 50% in the penetration test and ≤ 76% in the penetration test). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.
    Measures ordered by public authorities (to: Other): Ban on the marketing of the product and any accompanying measures.
  • The second product alert, is another particel filter mask. It is of the brand 'Shield' (Type / number of model:  PM2.5 SHIELD 8100). The country of origin of the product is China. Link to product alert
    The product advertises a protective potential against (viral) particles but its filtering capacity has not been certified by a relevant (European) body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.
    Measures taken by economic operators: Withdrawal of the product from the market (By: Importer).
  • The third (and last) pandemic related product alert is of unknown brand and unknown type and batch number. The country of origin of the product is China. Link to product alert
    The product bears a CE marking but is not certified as protective equipment by the relevant body. Consequently, the product might not fulfill the health and safety requirements and properly protect when combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation.
    Measures ordered by public authorities (to: Importer): Import rejected at border

More information

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* Economic operator means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation.

 


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