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UKCA marking of PPE products
SATRA offers CE and UKCA conformity assessment for PPE being placed on the EU and UK markets.
Image © iStockPhoto.com | kadmy
The United Kingdom (UK) left the European Union (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 personal protective equipment (PPE) goods onto the market in Great Britain (GB – consisting of England, Scotland and Wales). The PPE Regulation (EU) 2016/425 has been brought into UK law to become ‘Regulation 2016/425 on personal protective equipment, as amended to apply in GB’.
For Category II and Category III PPE, third-party certification is required and all categories of PPE will need to carry the new UKCA (United Kingdom Conformity Assessed) mark. The process is very similar to that currently used for CE marking, which requires the manufacturer to work with an EU-based Notified Body for Categories II and III PPE. The UK equivalent of a Notified Body is an ‘Approved Body’. SATRA received Approved Body status in the UK on 1st January 2021 and can therefore issue UKCA certification.
The UK legislation involves the use of a new UKCA mark (shown in figure 1), which needs to be used as a means of showing conformity 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 member state).
As mentioned, the UK’s equivalent of the CE mark is the UKCA mark. This means that to place PPE on the market in Europe (that is, the UK and EU 27 member states), a manufacturer will need to affix both the UKCA and CE marks. For Category II and Category III PPE, the manufacturer must work with a Conformity Assessment Body (CAB), which for the EU is a ‘Notified Body’. In terms of UKCA marking, there is a new transitional phase which allows EU type-examination certificates and Module C2 or Module D decisions under Regulation (EU) 2016/425 from an EU Notified Body such as SATRA Technology Europe Limited, to be used as the basis of UKCA marking. For this easement to apply, the Notified Body certification must be in place on 1st January 2023 and it will only last until that certificate expires or until 31st December 2027 – whichever comes sooner. At that time, a UKCA certificate from a UK Approved Body (for instance, SATRA Technology Centre Limited) will be necessary. 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 or the new 'UKNI' mark, and not the new UKCA mark.
In terms of the transition to the new UKCA marking system for the GB market (the UK excluding Northern Ireland), there are several notable phases.
1st January to 31st December 2022
- it is possible to place on the GB market products carrying either the UKCA mark or a CE mark
- for Category II and Category III PPE, the UKCA marking can be on the basis of CE certificates issued by EU Notified Bodies (therefore no need for a UKCA certification from a UK-based Approved Body)
- the UKCA mark can be affixed to a document accompanying the PPE, such as the packaging, instead of having to mark the product itself.
1st January 2023 to 31st December 2025
- it will only be possible to place on the GB market products carrying the UKCA mark – CE marking will no longer be accepted
- for Category II and Category III PPE, the UKCA marking can be on the basis of CE certificates issued by EU Notified Bodies (hence no need for a UKCA certification from a UK-based Approved Body). However, for this to apply, the certification must have been in place on 1st January 2023 and, when this EU Notified Body certificate expires, a UKCA certification from a UK Approved Body will be necessary
- the UKCA mark can be affixed to a document accompanying the, PPE such as the packaging, instead of having to mark the product itself.
From 1st January 2026
- it will only be possible to place on the GB market products carrying the UKCA mark – CE marking no longer be accepted
- for Category II and Category III PPE, the UKCA marking can be on the basis of CE certificates issued by EU Notified Bodies (there will be no need for a UKCA certification from a UK-based Approved Body). However, for this to apply the certification will have to of been in place on 1st January 2023 and, when this EU Notified Body certificate expires (or on 31st December 2027 whichever is the sooner), a UKCA certification from a UK Approved Body will be necessary
- the UKCA mark must be affixed to the PPE itself unless this is not practicable to do (for instance single use gloves and earplugs). In these cases, the UKCA mark must be affixed to smallest commercially available packaging.
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.
SATRA is world-renowned for its testing and certification services in the field of personal protective equipment (PPE). 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 the CE mark to be affixed to products. SATRA is also able to conduct conformity assessment work and issue UKCA certifications from its Approved Body in the UK.
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