Risk AssessmentEU

EU Machinery Regulation (EU) 2023/1230 Risk Assessment Method

An Annex III-aligned workflow you can execute per product family.

Output: hazard log + protective measures map + residual risk and instructions evidence.

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Author

Sorena AI

Published

Feb 21, 2026

Updated

Feb 21, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 21, 2026

Updated Feb 21, 2026

Overview

Annex III makes risk assessment the engine of compliance: you perform it to determine which essential health and safety requirements apply, then design and construct to eliminate or minimize risks using a defined priority order. The goal isn't a generic risk document - it's a reproducible chain: limits -> hazards -> risks -> controls -> verification evidence -> residual risk communication.

Section 1

1) Define the limits (what the machine is, what it does, and where it lives)

Start by defining boundaries. Most downstream disagreements come from undefined limits: intended use, environment, operators, and foreseeable misuse.

Operational output: a 'limits' section that becomes the header for your hazard log.

Intended use and operating modes; reasonably foreseeable misuse patterns.
Lifecycle phases: transport, assembly, installation, commissioning, operation, maintenance, cleaning, disabling, scrapping.
People and access: operators, bystanders, exposed persons; danger zones.
Energy sources: electrical, hydraulic, pneumatic, mechanical, stored energy; control system architecture (software, sensors, remote control).

Section 2

2) Identify hazards and hazardous situations (make it exhaustive, then prune)

Hazards are potential sources of injury or damage to health; hazardous situations are how people end up exposed.

Don't rely on a standard's checklist alone - map hazards to your specific configuration and work tasks.

Mechanical hazards: crushing, shearing, entanglement, impact, ejection, stability.
Electrical hazards (including control system failures) and energy isolation hazards.
Ergonomic, thermal, noise/vibration, radiation, hazardous substances, environmental hazards where applicable.
Software/autonomy hazards: unsafe states due to updates, data dependency, or interaction between machines.

Section 3

3) Estimate and evaluate risks (severity x probability) and decide what must be reduced

Estimate risk by combining severity and probability. Then evaluate whether risk reduction is required in line with the Regulation's objective.

Operational output: a consistent scoring rubric and a 'risk acceptability' policy.

Use consistent scales (e.g., severity 1-5, probability 1-5) across product lines.
Document assumptions that affect probability (training, supervision, environment constraints).
Flag high-severity scenarios for design review, independent review, and test evidence focus.

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Section 4

4) Apply safety integration hierarchy (the order matters)

Annex III sets a priority order for protective measures. Use this hierarchy as your control selection policy.

Evidence should show the rationale for why a hazard wasn't eliminated and what was chosen instead.

1) Inherently safe design: eliminate hazards or minimize risk by design and construction.
2) Protective measures: guards, protective devices, control system safety functions.
3) Information: residual risk warnings, training requirements, PPE needs, safe-use limitations.

Section 5

5) Verify controls and document residual risks

Controls are only as strong as their verification evidence. Tie each protective measure to tests/inspections/examinations and store evidence IDs in the hazard log.

Residual risks must be communicated through marking and instructions where applicable.

Control -> verification method -> acceptance criteria -> evidence ID (test report, inspection record, calculation).
Residual risk register linked to instructions sections and warning labels.
Production controls for series production (how you ensure the built machine matches the assessed design).

Section 6

6) Special cases: autonomy, self-evolving behavior, and system-of-systems interaction

Annex III explicitly requires risk assessment to include hazards that might arise during the lifecycle due to intended evolution of behavior (including varying autonomy), and risks from interactions between machines arranged and controlled to function as an integral whole.

Operational output: an 'evolution hazards' annex and a 'system interaction' hazard set.

Software update hazards: planned updates and configuration changes that affect safety behavior.
Data dependency/opacity/autonomy/connectivity: identify failure modes that increase probability/severity.
Interaction hazards: coupled machines where combined behavior introduces new hazards (coordination, deadlocks, emergent hazards).

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