Regulations
Essential health and safety requirements under Machinery Regulation (EU) 2023/1230
New essential health and safety requirements in the Machinery Regulation: AI, cybersecurity, ergonomics and documentation.
Regulation (EU) 2023/1230 does not replace the foundations of machinery safety, but it updates the framework of essential health and safety requirements. The most important change concerns the ability of the new text to deal with connected machines, software systems, autonomous functions, collaborative environments and digital documentation.
For manufacturers, the work to be done is concrete: to re-read the risk analysis and the technical file in the light of Annex III of the Regulation, verifying what requirements change, which are already covered and which require new design or document evidence. Reference Reference
From the old Annex I to the new Annex III
In Directive 2006/42/EC, essential health and safety requirements are contained in Annex I. In the Machinery Regulation, the requirements are laid down in Annex III. The general structure remains recognizable for those who already work on machine safety, but some points are updated to respond to the latest technologies. Reference
This means that a machine already designed with a good risk analysis starts from a useful base, but it is not automatically ready for the Regulation. It requires a technical gap analysis, not only a formal revision of legislative references.
Requirements that really change
Cybersecurity and protection against corruption
Requirement 1.1.9 introduces protection against corruption. The manufacturer must consider whether an accidental or intentional corruption of digital systems can compromise machine safety. This aspect concerns connected, updateable machines, integrated into industrial networks or controlled by complex software.
Safety-related software and control systems
The 1.2.1 requirement is read more modernly: control systems must remain safe and reliable even with respect to external influences and changes that may result from connections, updates or digital interactions. For safety functions, the software cannot be treated as an accessory element.
Autonomous systems and AI
Machines with autonomous functions, adaptation capabilities or advanced algorithms must be evaluated against the predictability of behaviour and the safety limits defined by the manufacturer. The problem is not only “use AI”, but demonstrate that the behaviour of the machine does not generate uncontrolled risks during the life cycle.
Ergonomics and shared environments
The Regulation considers man-machine interaction more closely in shared environments. The machine must be designed taking into account human behaviour, collaborative workspaces, mechanical risks and possible effects on safety and operator.
Documentation and instructions
Documentation plays an even more central role. Digital instructions for use, technical file, declarations, test reports, software and description of the solutions adopted must be consistent with each other. Conformity must be demonstrable, not only declared.
How to update risk analysis
The update must start from a matrix between Annex III requirements, identified hazards, risk reduction measures and supporting evidence. It is useful to distinguish between already covered requirements, requirements to be updated and requirements not applicable with a documented technical justification.
- Map the essential requirements applicable.
- Identify the new risk areas introduced by the Regulation.
- Check harmonised standards, technical standards and applied solutions. Reference
- Upgrade risk analysis and technical file.
- Verify consistency of instructions for use, statement, test reports and software documentation.
How Waves Engineering can support you
Waves Engineering supports manufacturers with Annex III gap analysis, risk analysis update, technical file review and documentation verification. The objective is to arrive at the date of application of the Regulation with a coherent and ready document system for placing new products on the market.
FAQ
What is the date of application of the Machinery Regulation?
The Regulation applies from 20 January 2027. From that date Directive 2006/42/EC is repealed.
Does Annex III replace Annex I to the Machinery Directive?
Yes, in the new Regulation, the essential health and safety requirements are contained in Annex III.
Do I have to do all the risk analysis again?
Not always from scratch, but a gap analysis should be performed to verify whether the current analysis correctly covers new or modified requirements.
