2021-03-03
Pandemic related product alerts | wk 9
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.
Particle filter mask(s).
- The first product alert is for a partile filter masks, sold under the name 'DISPOSABLE FACE MASKS', of the brand 'ELMED'.
Traceability information: Barcode: 8681371811345, Batch number: TMSK013-2033, Type / number of model: TP-MSK-013 (Non Sterile)
Type risk: Health risk / other
The country of origin is Turkey. Link to product alert.
Reason for the alert:
The product bears a CE marking but is not certified as protective equipment by a relevant body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. Also, the labeling is confusing because on the cardboard box the mask is declared a “non-medical” one , while in the same time is mentioned the standard EN 14683:2019. 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), Ban on the marketing of the product and any accompanying measures
Date of entry into force 27/10/2020 - The second product alert is for a respiratory face-mask, claiming to pertain to categories N95, KN95, and FFP2. It was marketed under the name 'Starkit, of the brand 'bd BADO'.
Traceability information: Barcode: 4260299695776, Batch number: MK472890002, Type / number of model: Art. Nr. Mask N98-4, STKM-N9W01
Type risk: Health risk / other
The country of origin is China. Link to product alert.
Reason for the alert:
The particle/filter retention of the material is insufficient (measured values: as low as to 41 %) 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), Withdrawal of the product from the market
Date of entry into force 01/02/2021 - The third product alert is for a Disposable face mask. It was marketed under the name 'Disposable Protective Mask (Non-Medical Use)', of the brand 'Hongren'.
Traceability information: Type / number of model: HRM-06, other traceability information not known.
Type risk: Health risk / other
The country of origin is China. Link to product alert.
Reason for the alert:
The product advertises a protective potential against (viral) particles but its filtering capacity has not been certified 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 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: Importer), Import rejected at border
Date of entry into force 24/02/2021 - The next product alert is for a 'Non-medical 3 layers disposable protective mask'. It was marketed under the name 'Disposable Face Mask with Earloops', of the brand 'OUKE'.
Traceability information: Barcode: 6426485336405. Other traceability information not known.
Type risk: Health risk / other
The country of origin is China. Link to product alert.
Reason for the alert:
The product advertises a protective potential against (viral) particles but its filtering capacity has not been certified 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 protective measures. The product does not comply with the Regulation on personal protective equipment and with the relevant European standard EN 149.
Measures ordered by public authorities (to: Retailer): Withdrawal of the product from the market
Date of entry into force 15/02/2021 - The last product alert of this week is for a Non-medical 3 layers disposable protective mask for children over 3 years old. It was marketed under the name 'Disposable daily protective mask for children', of the brand 'MAIKEN'.
Traceability information: Barcode: 3874000016746, Batch number: 3874000016746.
Type risk: Health risk / other
The country of origin is China. Link to product alert.
Reason for the alert:
The product advertises a protective potential against (viral) particles but its filtering capacity has not been certified 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 protective measures. The product does not comply with the Regulation on personal protective equipment and with the relevant European standard EN 149.
Measures ordered by public authorities (to: Retailer): Withdrawal of the product from the market
Date of entry into force 15/02/2021
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