UKCA marking of PPE products update
Examining the latest information regarding changes to the UKCA and CE marking of PPE for the UK and European markets.
Image © iStockPhoto.com | breakermaximus
Now that the United Kingdom is no longer obliged to enforce EU legislation, there are new requirements for the marking of personal protective equipment (PPE) – such as safety footwear – for sale in the UK. This article outlines the latest information regarding the legal changes.
The UK left the EU on 31st January 2020, and was in a transition phase where EU legislation still applied until the end of December 2020. Since that time, the UK has adopted its own legislation with regard to placing PPE goods onto the UK market. The European PPE Regulation (EU) 2016/425 has been brought into UK law to become the UK PPE Regulation (EU) 2016/425 (as brought into UK law and amended). For category II and III PPE (such as safety footwear), third-party certification is required and all categories of PPE need to be marked with a new UKCA mark. The process is very similar to that currently used for CE marking which requires the manufacturer to work with a UK ‘Approved Body’ for categories II and III.
SATRA received Approved Body status in the UK on 1st January 2021 and can now carry out conformity assessment work in support of UKCA marking. Manufacturers of PPE can certify their products for sale in the European Union (EU) by working with SATRA’s notified body in Ireland (an EU 27 member state), thus enabling them to CE mark their products. SATRA is also able to conduct conformity assessment work for manufacturers who want to mark their products as being ‘United Kingdom Conformity Assessed’ (UKCA) for sale in the UK.
While the UK PPE Regulation (EU) 2016/425 (as brought into UK law and amended) is a copy of EU law, it is expected that over time there will be a gradual divergence away from such rulings. The UK legislation involves the use of a new UKCA mark (shown in figure 1), which needs to be placed on products as a means of showing conformance with applicable UK legislation. SATRA Technology Centre Limited in the UK is now a UK Approved Body with the reference AB0321 – the prefix ‘AB’ denoting ‘Approved Body’. SATRA is still able to offer CE marking services through SATRA Technology Europe Limited, which will remain a Notified Body (number 2777) based in Ireland (an EU 27 member state).
The UK’s equivalent of the CE mark is the previously-mentioned UKCA mark. This means that to sell category II and III PPE in both the UK and EU 27 member states, a manufacturer will need an EU type-examination certificate under Regulation (EU) 2016/425 from an EU Notified Body such as SATRA Technology Europe Limited, plus a UKCA certificate from a UK Approved Body – for instance, SATRA Technology Centre Limited. Hence, SATRA is well placed to provide both certifications in the most efficient manner, and our staff in both Ireland and the UK will be able to organise this for our customers.
Although it is part of the UK, products being sold into Northern Ireland will still require CE marking, and not the new UKCA mark.
In terms of the transition to the new UKCA marking system for the UK market (excluding Northern Ireland), there are several notable phases.
1st January 2021 to 31st December 2022
During this time, it will be possible to place on the UK market either products carrying the UKCA mark or a CE mark. However, where that CE mark needs to be supported by certification from a Notified Body (that is, for category II and III PPE), that Body must be based in an EU 27 member state. It will no longer be possible to place CE-marked products on the UK or EU market where the supporting CE certification is from a UK-based Notified Body. Effectively, all CE certifications issued by UK Notified Bodies expired on 31st December 2020. During this time, the manufacturer can affix the UKCA mark to the packaging instead of the product.
From 1st January 2023
After 1st January 2023, it will only be possible to place on the UK market products carrying the UKCA mark. The UKCA mark must ordinarily be affixed to the product. However, if this is not possible (for instance, due to the characteristics of the product), the UKCA mark can be placed on the packaging instead of the product.
It is important to note that the UK’s withdrawal from the EU did not affect the validity of existing or future test reports issued by SATRA’s testing facilities in the UK. These test reports will continue to be accepted for certification purposes by SATRA Technology Europe Limited and other PPE Notified Bodies. This is because testing that supports PPE certification does not need to be carried out in the EU.
The testing laboratories at SATRA are accredited by the United Kingdom Accreditation Service (UKAS) to the internationally-recognised standard ISO/IEC 17025:2017 – ‘General requirements for the competence of testing and calibration laboratories’. UKAS, along with other European Accreditation Bodies, is a signatory of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement.
The withdrawal of the UK from the European Union has required new national legislation which, initially, mirrors that of the EU. This requires PPE being placed on the UK market, excluding Northern Ireland, to carry a new UKCA mark. This legislation became effective on 1st January 2021. SATRA is now in a position to certify PPE products for both CE marking and UKCA marking, enabling manufacturers to continue to supply PPE into both the European and UK markets.
How can we help?
Please contact SATRA’s PPE team (firstname.lastname@example.org) for further information on testing and certification of PPE for the European and UK markets.
This article was originally published on page 42 of the February 2021 issue of SATRA Bulletin.