SAFETY & HAZARDOUS AREAS


UKCA AND CE MARKING: CLEARING UP CONFUSION


located within the EU. This requirement has been removed from


the UK legislation. There is now no requirement for a non-UK supplier to identify a UK person to compile the Technical File. It can now be undertaken by the original manufacturer in any country. The concern, emphasises Derek Coulson, is that UK Health & Safety Authorities will not be able to obtain Technical Files: “This means the End User must ensure that any equipment supplied meets all requirements and is safe, before putting it into service.” In July 2021, EU Regulation 2019/1020 will


Nigel Flowers, managing director, Sumitomo (SHI) Demag and CE specialist Derek Coulson team up to examine the future landscape of UKCA machinery certification, and how to avoid sleepwalking into a minefield of risks


Européenne) marking process when put into service in the European market (EU and EEA). The mark, designed to ease the free movement of machinery and show conformance with one or more European product safety Directives, just got a whole lot more complex. Following Brexit, from 1 January 2021, the


F


UKCA (UK Conformity Assessed) marking will replace the longstanding CE marking for goods sold within England, Wales and Scotland. As there’s no hard border in Ireland, free movement of people and goods continue to apply, as does the CE marking. Adding a further layer of complexity, in Northern Ireland a third logo – UKNI – will be used when goods subject to CE marking are performed by a GB Authorised Body (as per Article 7(3) of the Northern Ireland Protocol). Additionally, EU recognised notified bodies can also certify goods for the NI market. So, what do all these certification changes


10 OCTOBER 2021 | PROCESS & CONTROL


or over 25 years, machinery, injection moulding cells included, have been subject to the CE (Conformité


mean for a European-based machinery builder like Sumitomo (SHI) Demag supplying moulding systems, periphery equipment and robotics to customers located in Great Britain or Ireland? With a transitional UKCA period due to expire on 1 January 2022, UK companies are trying to decipher certification responsibilities, commercial risks and legal liabilities. Found on everything from plastic toys to


medical devices, lightbulbs to robots, the CE mark has for many businesses and consumers been a recognisable bedrock of safety. The introduction of the UKCA mark doesn’t change this, noted Nigel Flowers. “Aside from several subtle changes to the text in documents to reflect UK legislative requirements, the transposition to UKCA right now is largely an administrative change. The biggest impact will be determined by the location of the manufacturer.” Any UK company that exports into the EU


must now appoint a responsible person or entity to act as the person to compile the technical file for CE marking. This entity – any EU person or company - must be physically


require all non-EU based suppliers of CE Marked goods to supply through an importer or fulfilment centre, who must hold Technical Documentation, or they must have an EU Authorised Representative to fulfil the tasks for them. This EU AR must be identified on the Declaration and in some cases the manufacturers plate. This requirement will not apply in England, Scotland or Wales, but will be for suppliers to Northern Ireland. An English, Welsh or Scottish manufacturer must have an EU Authorised Representative from 16 July, 2021 if they wish to supply to Northern Ireland. For UK CA Marking, where a Declaration of


Conformity (DoC) or Declaration of Incorporation (DoI) previously referred to ‘harmonised standards’ with EN prefixes, these must now refer to ‘designated standards’. The standard numbers should be prefixed with BS to indicate they are British Standards. While CE marking requires machinery


instructions to be written in the language where each machine is used, UKCA marking insists the manual be written in English. The change with the greatest risk


implication relates to status. UK distributors bringing in equipment manufactured in the UK are now defined as ‘importers’. The compliance responsibility to adhere to the UKCA regime rests here. “If something safety- related happens, the party that’s located in the jurisdiction – in this instance the UK importer – takes on the liability,” said Coulson. “It all sounds fairly straightforward. And it is,


providing EU and UK safety certification standards remain completely aligned to each other,” said Flowers. Although divergence is not anticipated right now, it could happen in the future. It’s why most global companies, Sumitomo (SHI) Demag included, advocate working towards international ISO safety standards rather than national ones. Ireland is where the situation gets a little


more muddied. With the Northern Ireland rules allowing for free movement of people and goods across Ireland, most of the rules stay


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