FOCUS Regulations & standards
CHANGES TO SAFETY REGULATIONS
Darren Hugheston- Roberts, Senior Manager – Digital & Industry Solutions at TÜV SÜD, gives an insight into the new EU Machinery Regulation, and the measures that should be taken to ensure compliance
T
he EU Machinery Regulation (EU) 2023/1230 will replace the current Machinery Directive (Directive 2006/42/EC) on 20 January 2027. The UK government has announced that CE marking for machinery will be extended from 20 January 2027 CE marked products in the UK will also need to comply with the new EU Regulations. At the point of writing this article, no announcement has been made if UK regulations will be updated to align UKCA requirements with the EU. However, the UK government has recently issued a call for evidence to inform its decision making on the subject.
The advent of IIoT and Industry 4.0 has seen smarter machinery and highly connected factories coming online. However, the old Machinery Directive was not up to date with the current state-of-the-art and was of new safety and security risks presented by a connected equipment and a smart manufacturing environment. New areas addressed by the Regulation
therefore include the cybersecurity of safety control systems and of software related to the conformity assessment of (AI) in safety functions; autonomous and remote-controlled mobile machinery; and collaborative robots (‘cobots’). For example, under the topic of requirements for the protection against interference. This means that the remote linking of a device must not lead to dangerous situations. The regulation also distinguishes between unintentional (employees who make changes without malicious intent) and intentional corruption (hacking/ social engineering). This brings machinery requirements in line with other EU laws, such as the Cyber Resilience Act and update to the RED concerning cyber security.
30 November/December 2025 | Automation
CHANGES TO SAFETY REGULATIONS
In addition, the Machinery Regulation Anyone who makes a “substantial all obligations associated with this role, in particular they will need to carry out a new conformity assessment. It does also include a sensible approach where only the considered if the risk to health and safety has increased.
“Businesses affected by the new Regulation are strongly advised to begin addressing it now”
A further major change included in the Machinery Regulation is the mandatory which applies to at least six product categories, ranging from vehicle servicing lifts to safety components with fully or partially self-evolving behaviour using machine learning. This involves the machinery types and related products listed in the Regulation’s Annex 1-A, that are considered to be high risk. High risk machinery detailed within Annex options as Annex IV machinery within the Machinery Directive.
The scope of the new Machinery Regulation has also been expanded in comparison to its predecessor, as it spans concrete obligations for all market participants. For example, distributors of new and used machinery will also need to address the topic in more depth in future. The new Regulation also reduces the administration burden on machinery manufacturers, as the instruction manual for a machine no longer needs to be printed, but it must be downloadable and printable. The machinery manufacturer must also supply printed operating instructions within a month of them being requested. While the Regulation has entered
into force throughout all EU Member States, it does have a transition period of three years, after which its application becomes mandatory. This means that the new requirements must be applied from January 20, 2027. In our experience, the lengthy transitional period means that the majority of manufacturers will be slow to address the new requirements. However, as it comes into force in little over a year and implementation is likely to be a time- the new Regulation are strongly advised to begin addressing it now.
TÜV SÜD
www.tuvsud.com
automationmagazine.co.uk
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