2021-02-08
Pandemic related product alerts | wk 5
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!
Summary
- Learn more on legislation applicable to UV-C lights and how to proof compliance with our free ProductIP guide on UV-C light.
- Learn more on legislation applicable on hand gel and sanitizing wipes with our free ProductIP Guide on hand gels and sanitizing wipes.
- Learn more on legislation filters masks and respitory devices must comply to by downloading the free ProductIP guide on this
- Learn more on where to certify masks here.
Content
The product alerts publsihed here are always published on Safety Gate: the rapid alert system for dangerous non-food products.
If you are an economic operator* for these products, product recalls can help you make better products and prevent problems with market surveillance authorities.
1. Product alerts on Hand disinfectants.
- The first product is a 'Hand Desinfectant' of the brand 'ibcccndc'. It was sold with the name 'Pilot Dezinfekcijas lidzeklis'. Barcode: 6956654074413, Batch number: MFD 2020-03-13. The country of origin is China. Link to product alert.
Risk type: Burns, Chemical, Fire, Health risk / other
The product contains an insufficient amount of ethanol (measured values: 11% by volume). Consequently, it does not kill bacteria or viruses, which could then reach the user, increasing the risk of infection. Moreover, the product contains methanol (measured value: 26% by weight), which is acutely toxic to the central nervous system and to the eyes. Furthermore, the required hazard pictograms and warnings are missing. Users have therefore no information on the toxicity and flammability of the product. The packaging is not fitted with child-resistant fastening. Ingestion or contact with methanol may lead to blindness and death. / The product does not comply with the Biocidal Products Regulation.
Measures taken by economic operators: Removal of this product listing by the online marketplace (By: Other) The product is sold online, in particular via AliBaba Group. - The second product is a 'Hand Desinfectant' of the brand 'Guardson ApS'. It was sold with the name 'Guardian Hand & Skin Guardian Hand & Skin'. Tracebility information is also not known. The country of origin is Germany. Link to product alert.
The product contains Polyhexanide (PHMB) (declared concentration: 0.8%). PHMB is not authorised for use in human hygiene and causes damage to organs through prolonged or repeated contact, as well as serious eye damage; it is also harmful if swallowed. The product does not comply with the Biocidal Products Regulation.
Measures ordered by public authorities (to: Other): Withdrawal of the product from the market
2. A list of particle filter masks.
- The first article is a particel filter mask of the brand 'YOMASI KN95' (Barcode: unknown, Batch number: 0371-27939196). The country of origin 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: Retailer) - The second is a particle filter mask of unknow brand. Traceability information is also unknown. The country of origin is China. Link to product alert.
The product is accompanied by a declaration of conformity to Regulation (EU) 2016/425 and to the European standard EN 149:2009, but it has not been certified as such by the relevant European body. Consequently, the product might not fulfil the health and safety requirements and properly protect when combined with additional 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: Importer): Import rejected at border - The third product is a particle filter mask of unknown brand. It was sold under the name 'Protective Mask KN95'. Barcode: 6973247460002. The country of origin is China. Link to product alert.
The product is accompanied by a declaration of conformity to Regulation (EU) 2016/425 and to the European standard EN 149:2009, but it has not been certified as such by the relevant European body. Consequently, the product might not fulfil the health and safety requirements and properly protect when combined with additional 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: Retailer): Ban on the marketing of the product and any accompanying measures, Withdrawal of the product from the market - The fourth product is another particle filter mask, of the brand 'Xina'. Traceability information in unknown. It was sold under the name 'Protective Mask KN95'. The country of origin is China. Link to product alert.
The product bears a CE marking but is not certified as protective equipment by the relevant European 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 and with the relevant European standard EN 149.
Measures ordered by public authorities (to: Retailer): Ban on the marketing of the product and any accompanying measures, Withdrawal of the product from the market - The last product of this week is a particle filter mask of the brand 'UEACON'. Barcode: 3295249103358. Country of origin 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: Distributor)
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