Machinery Regulation EU 2023/1230 is set to replace the existing Machinery Directive and becomes fully applicable from January 2027.
The existing legislation underpins CE marking for machinery and safety components.
Currently, when new equipment lands on site with a CE plate and a Declaration of Conformity, the Machinery Directive is usually sitting behind it. At the centre of this is Annex I, the Essential Health and Safety Requirements, setting out what a machine has to achieve in terms of guarding, control integrity, safe cleaning, ergonomics and information for use.
Manufacturers show they meet these requirements by applying harmonised standards.
So what is changing under the new Machinery Regulation, and why does it matter for day-to-day process automation work?
The key shift is in the word “Regulation”. Unlike a Directive, this does not need to be written into national law in 27 different ways.
It applies directly and identically across all Member States and, for anyone working across multiple sites or countries, it gives a single rulebook to work to. But the scope is also broader. The text still talks about machinery, but it adds “related products” and AI-enabled machinery.
In a process plant this means we are not just talking about the physical CIP skid, mill or blender. It also covers safety PLCs, stand-alone safety functions, and software that has a safety or control role, including AI-based monitoring or optimisation if it influences the process.
The new Annex III, which sets out the Essential Health and Safety Requirements under the Machinery Regulation, has been restructured and modernised. You now see much more explicit language around software lifecycle, connectivity, data integrity and cyber protection.
Another major change is the clearer treatment of “assemblies of machinery” and “substantial modification”. Most projects in existing plants are not greenfield machines, they are modifications: adding a new step into an existing process, upgrading an agitator drive and its safety functions, migrating a PLC due to obsolescence, or linking new utilities into a DCS.
The Regulation spells out that these kinds of assemblies and substantial changes can trigger a need for new conformity assessments, and that the modifier becomes the manufacturer for the modified scope.
Finally, responsibilities are spread more widely. The Regulation includes manufacturers, importers, distributors and users as economic operators. System integrators and end users who integrate or significantly modify equipment are now clearly within the legal framework, not just the OEM.
What does change is that the definition of machinery and related products now explicitly includes digital and software elements.
So if the PLC or DCS has a safety element, it brings issues like firmware and software updates directly into the machinery safety conversation.
It is important to see the Machinery Regulation in context. It does not replace ATEX, PED, EMC, etc.; it sits alongside them. Many machines will have to comply with multiple directives and regulations.
Annex III introduces requirements on protection against corruption, safe behaviour under foreseeable faults, and the way updates are managed over the life of the system.
Over the life of a typical process installation, we will:
- patch operating systems and firmware
- adjust logic to stabilise a clean-in-place cycle
- change trip levels and timers on a mill or agitator
- add alarms and interlocks, or modify recipes
Each individual change can look minor. A timer tweak here, an extra alarm there, an updated library from a vendor. But if you roll forward twelve or eighteen months, the combined effect can be a control system that behaves very differently from the one originally assessed and CE-marked.
Getting ready for 2027:
- Map installed base and flag assets in the Machinery Regulation scope
- Define economic operator roles and technical file owners
- Build substantial modification screening into MoC / projects
- Update URS/specs to bake in Machinery Regulation EU 2023/1230, IEC 61511, ISO 13849, IEC 62443
- Establishing a Digital Filing System for docs, software and test records
- Align OT cyber, safety and asset programmes to Annex III
- Train teams and prioritise high-risk equipment before 2027
If you would like to know more about the EU Machinery Regulation (2023/1230) and get more information sent to your inbox, get in touch – email contact@bonner.ie