We feel it is necessary to warn each of you as to the precautions around buying or selling PPE in the current crisis – in particular RPE (Respiratory Protective Equipment). In the UK and EU, all RPE is classified as ‘High Risk Category III PPE’ and falls under the PPE Regulation 2016/425, embedded in statute as law. Due to RPE’s ‘High Risk’ PPE classification, both the importer and on-seller have a responsibility to ensure due diligence on the product/supply chain is done, and therefore ultimately take responsibility and legal liability for the product.
All PPE (including RPE) must be supplied with instructions for use and be appropriately tested and marked with a CE mark, including Notified Body Number. It must also be supplied with a Declaration of Conformity or a link to a website where a Declaration of Conformity can be downloaded. Without these, the product is illegal to use as protective equipment in the workplace. Be aware, just because it says it complies on the box or product, or somebody says it’s compliant, doesn’t mean it is valid and legal.
There are a huge number of counterfeit products being offered from China as being fit for use in the UK and claiming to be certified. Of particular concern, however – the KN95 is a Chinese Domestic standard for masks and does not correlate with EN149:2001.
It’s straightforward; if offered KN95 on it’s own or with any mixed up or unclear description claiming they match FFP2, FFP3 or EN149, DO NOT BUY THEM WITHOUT CHECKING VERY CAREFULLY AS THEY COULD BE ILLEGAL.
The UK has adopted EU Regulation 2020/403 that enables certain overseas PPE to be assessed by an EU PPE Scoped Notified body and fast-tracked into the UK supply chain for NHS/Government or other recognised Healthcare providers only. The allows the correct expert body to make the right call and not some commercial operator who wants a quick sale. They will have a limited time placed on the certification/approval as it is expressly designed to assist with the current Coronavirus pandemic. Don’t be deceived by spurious documentation. Please have it checked very thoroughly first. This also applies to American standards e.g. masks N95 or N99. There are many being offered, many of which are good products, but unless they have been approved by an EU PPE Notified Body scoped for PPE Regulation 2016/425 it is not legal to supply them as PPE or RPE in the UK or EU.
RPE or PPE supplied without correct accreditation could lead to a very substantial lawsuit.
We hope you are all staying safe and well and all the best with starting back at work.
The Venta Team.