Real or Counterfeit

A substantial number of face masks, claiming to be of KN95 standards, provide an inadequate level of protection and are likely to be poor quality products accompanied by fake or fraudulent paperwork. Face masks may also be known as filtering facepiece respirators.

KN95 is a performance rating under the Chinese standard GB2626:2006, the requirements of which are broadly the same as the European standard BSEN149:2001+A1:2009 for FFP2 facemasks. However, there is no independent certification or assurance of their quality. Products manufactured to KN95 rating are declared as compliant by the manufacturer ONLY.
Companies cannot be sell Personal protective equipment (PPE)  or supply as PPE unless it is CE marked. The only exception is for PPE that is organised by the UK Government for use by NHS or other healthcare workers where assessments have been undertaken by HSE as the Market Surveillance Authority.

Required action

Unless their supply has been agreed by HSE as the Market Surveillance Authority. KN95 must not be used as PPE at work.

Remove from supply immediately any masks that are not CE marked and cannot be shown to be compliant. Masks that have not had the necessary safety assessments, cannot be assured to have effectiveness in controlling risks to health for anyone buying or using them. They are unlikely to provide the protection expected or required.

Those that are CE marked. Suppliers must be able to demonstrate how they know the documentation and CE marking is genuine. The issue with the CE mark is that it has been known to have (in microscopic letters) Chinese Export underneath.

As you can see they look very similar. But, don’t be duped by this. As we know the defence of ignorance is not an excuse. At this time when any business is looking to cut costs, we must remain vigilant that we are still complying with the law.

Notified Body documentation must support the masks. It shows compliance with the essential health and safety requirements set by the Personal Protective Equipment Regulations (EU) 2016/425.

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