2020-08-03
Pandemic related product alerts | wk 31
Regulatory
Introduction
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!
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 product is a particle filter mask from the brand 'Fitme' (link to alert). The country of origin of the product is China.
The product bears a CE marking but is not certified as protective equipment by a relevant body. The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. 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.
Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. - The second product is another particle filter mask. The brand is Owoge (link to alert). The country of origin of the product is China.
The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. 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.
Import of the article was rejected at the EU border. - The next product is a particle filter mask of unknown brand (link to alert). The country of origin of the product is China.
The product bears a CE marking but is not certified as protective equipment by a relevant body. The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. 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.
Import of the article was rejected at the EU border. - The 4th product is a particle filter mask of the brand 'Care U' (link to alert). The country of origin of the product is China.
The product bears a CE marking but is not certified as protective equipment by a relevant body. The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. 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 the relevant European standard EN 149.
Import of the article was rejected at the EU border. - On number 5, a particle filter mask of the brand 'YBW' (link to alert). The country of origin of the product is China.
The product bears a CE marking but is not certified as protective equipment by a relevant body. The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. 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 the relevant European standard EN 149.
Import of the article was rejected at the EU border. - At number 6, a particle filter mask of the brand 'Runbo' (link to alert). The country of origin of the product is China.
The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. 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.
Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. - The next product is a particle filter mask of unknown brand (link to alert). The country of origin of the product is China.
The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. 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.
Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. - On number 8, a particle filter mask of, again, unkown brand (link to alert). The country of origin of the product is China.
The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. 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.
Import of the article was rejected at the EU border. - The last product alert of this week is a particle face mask of an unknown brand (link to alert). The country of origin of the product is China.
The product bears a CE marking but is not certified as protective equipment by a relevant body. The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. 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 the relevant European standard EN 149.
Import of the article was rejected at the EU border.
More information
- Learn more on legislation filters masks and respitory devices must comply to by downloading the free ProductIP guide on this subject.
- Learn more on where to certify masks here.
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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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