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2020-08-10

Pandemic related product alerts | wk 32

Pandemic related product alerts | wk 32
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. 

This week only 2 product alert, from different product categories: (1) hand desinfectant and (2) medical face mask.

  1. The first product alert is a hand desinfectant from the brand 'MissLife', under the name 'MissLife Hand Cleanser Gel' (link to alert). 
    The product contains methanol (measured value: 11.6 %), 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 and the Classification, Labelling and Packaging (CLP) Regulations.
    The product was imported from China. Measures ordered by public authorities (to: Other): Destruction of the product
  2. The second product is a medical face mask, under the name of 'Medical Sterile Mask' (link to alert).
    The product claims to meet the requirements of a surgical mask 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 thus not properly protect if not combined with additional measures. The product does not comply with the requirements of the Medical Devices Directive and of the relevant European standard EN 14683. 
    The product was imported from China. 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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