Machinery regulation gets an update

FOR THE UK market, The Supply of Machinery (Safety) Regulations 2008 continues to be in alignment with the EU Machinery Directive 2006/42/EC. The UK government has announced that CE marking for machinery will be extended indefinitely beyond 2024, meaning that from 20 January 2027 these CE marked products would also need to comply with the new EU Machinery Regulations. However, at the time of writing, no announcement has been made about whether the UK’s The Supply of Machinery (Safety) Regulations 2008 will be updated to align UKCA requirements with the EU, but it can be assumed that any UKNI+CE marking must be aligned to the new EU Regulation.  

The new EU Regulation expands the scope of the current Machinery Directive in the European Union, introducing more concrete machinery safety provisions that are a legal requirement for machinery manufacturers and other economic operators. This gives machinery end-users more legal certainty by defining binding requirements imposed on the design, construction and placing into operation of machinery and related products.

The current Directive gives more flexibility in meeting its requirements and has therefore allowed different interpretations by regional authorities, this created legal uncertainties for machinery manufacturers and users of the Directive, when exporting to different jurisdictions. The introduction of a ‘Regulation’ means that it must be applied in the same way in all member states, so that different national interpretations cannot be made.

Terminology changed

Some terminology has also changed, particularly as there was often confusion as the Machinery Directive used the generic term ‘machinery’. The new Regulation instead refers to "machinery and related products" and defines the term "machine" separately from "related products". This means that there should now be no room for confusion when undertaking a conformity assessment.

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 therefore insufficient to tackle the emergence of new safety and security risks presented by a connected equipment and 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 the machinery; use of artificial intelligence (AI) in safety functions; autonomous and remote-controlled mobile machinery; and collaborative robots (“cobots”).

For example, under the topic of cybersecurity, 1.1.9 of Annex III defines 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 cybersecurity.

Common oversight

The functionality or performance of a machine will be changed if it is interlinked with other equipment as part of an assembly. This is a common oversight machinery end-users make, as they do not realise that this creates a complex assembly that must be CE or UKCA marked. However, machinery modification remains a grey area as the Machinery Directive contains no specific guidelines to advise machinery owners when a change is considered ‘substantial’, and they are consequently left to make their own conclusion.

Fortunately, the Machinery Regulation further clarifies what is meant by the substantial modification of products. Anyone who makes a "substantial modification" to a machine is considered a manufacturer and must therefore fulfil all obligations associated with this role. In particular, they must carry out a new conformity assessment. When modifications are made to a machine, only the conformity of the modification needs to be considered if the risk to health and safety has increased

A further major change included in the Machinery Regulation is the mandatory Notified Body conformity assessment, 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 with Annex 1-B, remains with the same conformity options as Annex IV machinery within the Machinery Directive.

Scope expanded

The scope of the new Machinery Regulation has also been expanded in comparison to its predecessor, as it spans the entire supply chain and specifies 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.

However, the Machinery Regulation will ease conditions in other areas. For example, the possibility of digital assembly and operating instructions and the EU Conformity Assessment will significantly reduce administration work and costs for machinery manufacturers. However, while the instruction manual no longer needs to be printed, it must be downloadable and printable. It’s also important to note that the machinery manufacturer must also supply printed operating instructions within a month of them being requested. For "non-professional users", it is mandatory to provide printed safety information.

For those familiar with the Machinery Directive, the order of articles and appendices have changed in the new Regulation. For example, Annex IV in the Machinery Directive defined when a notified body had to be involved in the conformity assessment procedure. This is now in Annex I of the Machinery Regulation.

The new Regulation also redefines terminology. For example, many considered the term ‘machinery’ in the Machinery Directive as too generic, and it often caused confusion. This is because the Machinery Directive used "machinery" a as an umbrella term, for all products within its scope except partly completed machinery, and for "machinery” as specifically defined in Article 2a (2006/42/EC). Instead, the new Regulation refers to "machinery and related products" and defines the term "machine" separately from "related products", which include interchangeable devices, safety components, load handling attachments, chains, ropes and belts. As the new Machinery Regulation separately refers to "machinery and related products" or "partly completed machinery", this means that there should no longer be any confusion during a conformity assessment.

While the Regulation has entered into force throughout all EU Member States, it does have a transition period, after which its application becomes mandatory. This means that the new requirements must be applied from 20 January 2027. In our experience, the lengthy transitional period means that the majority of manufacturers will be slow to begin addressing the new requirements. However, as implementation is likely to be a time-consuming process, companies affected by the new Regulation are strongly advised to waste no time and start tackling it now.

Darren Hugheston-Roberts is head of machinery safety at TÜV SÜD

www.tuvsud.com/uk