The EU Machinery Regulation is changing the approach to machine safety. Here are the areas machine builders, manufacturers and operators should be reviewing now.
Machinery is changing.
Software increasingly performs functions once handled entirely by hardware. Machines are more connected. Remote access, industrial networks, robotics, artificial intelligence and the Industrial Internet of Things are becoming part of everyday automation.
The legislation governing machinery placed on the European Union market is changing with it.
From 20 January 2027, Regulation (EU) 2023/1230, the EU Machinery Regulation, becomes mandatory, replacing the existing Machinery Directive 2006/42/EC within the EU.
For businesses that manufacture machinery for the EU market, integrate machinery, substantially modify existing equipment or operate machinery that may subsequently be changed, now is the time to understand what is different and consider whether action is required.
At BPX, our Safe & Secure programme is designed to help customers understand this changing landscape and connect them with the products, training, technical knowledge and specialist support they need.
What is changing under the EU Machinery Regulation?
The Machinery Regulation retains the fundamental objective of machinery safety, but updates the regulatory framework to reflect the way modern machinery is designed, connected and operated.
Some of the most important changes include:
- Substantial modifications are specifically addressed
Modifying an existing machine can have implications beyond simply replacing or upgrading a component.
The Machinery Regulation introduces a definition of a substantial modification and addresses the legal consequences where a change affects a machine’s compliance with the applicable health and safety requirements.
Where a modification is considered substantial, the person making that modification may assume manufacturer responsibilities and a new conformity assessment may be required.
This makes it increasingly important to consider safety and compliance implications before significant modifications are made, rather than treating them solely as an engineering upgrade.
If you are planning to modify an existing machine, some useful questions to ask are:
- What is being changed and why?
- Does the modification introduce a new hazard?
- Does it increase an existing risk?
- Are safety functions or protective measures being changed?
- Does the modification affect the machine’s original conformity?
- Has the change and the reasoning behind it been properly documented?
The answer will depend on the particular machine and modification, but identifying these questions early can help prevent problems later.
- Software can be a safety component
Machine safety can no longer be considered purely in terms of physical components.
Under the new Machinery Regulation, the definition of safety components encompasses physical and digital components and software.
That reflects a wider change in automation.
Safety-related functions can increasingly depend on software, configurable devices and interconnected control systems. Changes to software therefore need to be considered with the same care as changes to the physical safety architecture.
For machine builders and operators, this makes software management, configuration control and documentation increasingly important parts of the machinery safety lifecycle.
- AI, IoT and robotics enter the machinery safety conversation
Technologies including artificial intelligence, the Internet of Things and robotics are specifically recognised within the updated regulatory environment.
That does not mean every connected or robotic application suddenly becomes unsafe.
It does mean that risk assessment needs to reflect the technologies actually being used in modern machinery.
As machines become more adaptive, connected and autonomous, safety assessments need to consider how those technologies can influence machine behaviour and the risks associated with their use.
- Machinery safety and cybersecurity are becoming connected
This is one of the most significant changes for modern automation.
The Machinery Regulation introduces requirements around protection against corruption and recognises that a cybersecurity threat must not be allowed to compromise a machine’s safety functions.
In practical terms, Safety and Security can no longer always be considered separately.
Consider a machine with:
- an industrial Ethernet connection
- remote maintenance access
- networked PLCs or safety controllers
- connected HMIs
- industrial PCs
- configurable drives
- software-based safety functions
- connections between operational technology and wider IT systems
The safety system itself may be correctly designed, but it is also important to understand whether unauthorised or unintended changes to connected systems could affect the safe operation of the machine.
This is why machinery safety increasingly needs to form part of a wider conversation about OT cybersecurity and Industrial Security.
It is also an area we will explore further as part of BPX Safe & Secure.
- Documentation is changing too
The new regulation also reflects the move towards digital information.
Operating instructions may be supplied digitally, subject to the requirements of the Regulation, and declarations and certain other documentation can also be provided electronically.
But digital does not mean documentation becomes less important.
Quite the opposite.
As machinery, software and connected systems become more complex, maintaining clear and traceable information about assessments, modifications, safety decisions and configuration becomes increasingly valuable.
What should businesses be doing now?
20 January 2027 may still sound some distance away, but businesses designing machinery, planning upgrades or supplying equipment into the EU should avoid treating it as a last-minute compliance exercise.
A useful approach is to work through five stages.
- Gain an overview
Start by understanding what the Machinery Regulation changes and how relevant those changes are to your organisation.
Consider:
- Do you build machinery?
- Do you export machinery or equipment into the EU?
- Do you integrate machines or production lines?
- Do you substantially modify existing machinery?
- Are you introducing more connected, software-driven or remotely accessible automation?
The answers help determine where deeper investigation may be worthwhile.
- Review where you may be affected
Every machine and application are different.
Look at your existing and planned machinery and consider areas such as:
- recent or planned machine modifications
- existing risk assessments
- guarding and access
- emergency-stop systems
- interlocks and guard locking
- safety relays and safety controllers
- safety-related drive functions
- presence detection and light curtains
- obsolete or unsupported safety equipment
- safety-related software
- industrial network connectivity
- remote access
- cybersecurity risks that could affect safe operation
- existing technical documentation
The objective at this stage is not to assume that everything needs replacing.
It is to identify where questions exist and where further advice may be required.
- Build the right knowledge
Technology is only one part of machinery safety.
The people designing, operating, maintaining and modifying machinery need to understand their responsibilities and the principles behind the systems they work with.
BPX provides access to machinery and automation training from specialist manufacturers, including courses covering machinery safety, risk assessment, PUWER, conformity assessment, CE/UKCA requirements and safety-related control systems.
Investing in competence can help engineering teams make better decisions long before a component reaches the purchasing stage.
- Turn identified risks into action
Once an issue or potential improvement has been identified, the next step may involve anything from further specialist assessment to a relatively straightforward product upgrade.
Depending on the application, this could involve:
- risk and hazard assessment
- reviewing an existing safety concept
- upgrading obsolete safety equipment
- introducing appropriate guarding or access control
- selecting safety switches or interlocks
- safety relays or configurable safety controllers
- light curtains or other protective devices
- safety-related drive functionality
- changes to machine control architecture
- improving industrial network security
- considering Safety and Security together within a connected machine
BPX works with leading industrial automation and machinery safety manufacturers and can help customers identify appropriate technologies and bring in specialist manufacturer expertise where required.
- Keep a clear record
Machinery safety is not simply about fitting the correct component.
Risk assessments, design decisions, software changes, modifications, validation and other relevant information should form part of a structured machinery safety process.
If you are making changes now, consider whether somebody reviewing the machine in several years’ time would be able to understand:
- What changed?
- Why was it changed?
- What risks were considered?
- How were the chosen safety measures determined?
- What testing or validation was completed?
- Where is the supporting information stored?
Good documentation provides continuity as equipment and engineering teams change over the machine’s lifecycle.
A practical machinery readiness check
If you’re unsure where to begin, start with these questions:
- Has the machine been modified since it was originally commissioned?
- Are further modifications planned before or after January 2027?
- Is the existing machinery risk assessment still representative of the machine as it operates today?
- Are any safety components obsolete or approaching end of life?
- Have software or programmable systems become part of safety-related functions?
- Is the machine connected to other machines, networks or IT systems?
- Can anyone access it remotely?
- Could a cybersecurity incident potentially affect a safety function?
- Are engineers responsible for the machine appropriately trained in current machinery safety requirements?
- Can you readily locate the documentation covering previous safety-related changes?
A “no”, “don’t know” or “we need to check” does not automatically mean a machine is non-compliant.
It does, however, give you a useful place to start.
How BPX can help
BPX supports machine builders, manufacturers, system integrators and industrial end users across the lifecycle of industrial automation and control systems.
If the Machinery Regulation, an upcoming machine modification or an ageing safety system has raised questions within your business, talk to BPX.
We can help you explore the requirement and identify the appropriate next step, whether that’s product selection, an upgrade or migration, machinery safety training, technical support or bringing in specialist manufacturer expertise.
You can also use the BPX website to:
- Explore machinery safety and industrial automation products
- Find upcoming machinery safety and automation training
- Access technical support and services
- Find and contact your local BPX team
Don’t wait until January 2027 to start asking the questions.
Is your machinery ready for 2027?
Understand what is changing. Identify where you may be affected. Build the right knowledge. Plan appropriate improvements. Keep the evidence behind your decisions.
Talk to BPX about your machinery safety requirements and we’ll help you find the right route forward.