United Kingdom

HSE Safety Alert Issued Against KN95 Facemask

In June 2020, the Health & Safety Executive (HSE)[1] issued a safety alert, warning that KN95 facemasks must not be used as personal protective equipment (PPE) in the workplace.

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 and products manufactured to KN95 rating are declared as compliant by the manufacturer.

The HSE have found that a substantial number of face masks, claiming to be of KN95 standards, provide an inadequate level of protection, including against the ongoing coronavirus pandemic, and are likely to be poor quality products accompanied by fake or fraudulent paperwork. These face masks may also be known as filtering facepiece respirators.

The HSE has quarantined around 1.5 million KN95 masks, prevented 25 million items claiming to be FFP3 respirators entering the supply chain and prevented a further four lines consisting of many millions of items entering the supply chain.

PPE cannot be sold or supplied in the UK 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. 

It is therefore imperative that, as an organisation, you take immediate steps to remove any KN95 facemasks that have been purchased or are currently in use, and any other masks that are not CE marked, replacing them with CE marked PPE from a trusted supplier.

For PPE that is CE marked, suppliers must be able to demonstrate how they know the documentation and CE marking is genuine, supported by Notified Body documentation showing compliance with the essential health and safety requirements as required by the Personal Protective Equipment Regulations (EU) 2016/425.

Note: The safety alert does not relate to N95 masks which are manufactured to a US Standard and have been given permission for use specifically in UK healthcare settings.

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[1] The Health and Safety Executive (HSE) is Britain’s national regulator for workplace health and safety: www.hse.gov.uk