Department Name: EPD – PPE Team Bulletin No: STSU1 – 2020 Issue Date: June 2020 Target Audience: All industry Key Issues: Quality of KN95 face masks and lack of compliance with European standards
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. These 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 and products manufactured to KN95 rating are declared as compliant by the manufacturer.
Personal protective equipment (PPE) cannot be sold or supplied 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.
KN95 must not be used as PPE at work as their effectiveness cannot be assured.
Masks that are not CE marked and cannot be shown to be compliant must be removed from supply immediately. If these masks have not been through the necessary safety assessments, their effectiveness in controlling risks to health cannot be assured for anyone buying or using them. They are unlikely to provide the protection expected or required.
If any are 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.
Relevant legal documents
Personal Protective Equipment Regulations (EU) 2016/425
Personal Protective Equipment (Enforcement) Regulations 2018