Annex III EHSR mapping Machinery Regulation FAQ

EHSRs are the essential health and safety requirements in Annex III of Regulation (EU) 2023/1230. The general principles require the manufacturer to carry out a risk assessment, determine which Annex III requirements apply, and then design and construct the machinery or related product to eliminate hazards or minimise the relevant risks.

The mapping should start with the intended use, reasonably foreseeable misuse, product limits, hazardous situations, severity, probability, and required risk reduction. Annex III says the first chapter is general and applies to all machinery or related products, while the other chapters apply where the risk assessment shows more specific hazards such as mobility, lifting, underground work, lifting persons, or certain product categories.

A harmonised standard does not replace this applicability decision. It can provide a presumption of conformity only for the Annex III requirements it covers, so the EHSR map should record full, partial, or no standards coverage and identify the other technical evidence used for every remaining requirement.

These Regulation-specific Annex III duties apply from 20 January 2027. Products placed on the market before that date remain subject to the Machinery Directive transition in Article 52, so keep the first-placement date and the applicable legal basis with the map instead of retroactively relabelling an earlier file.

The Annex III general principles describe an iterative process: determine product limits, identify hazards and hazardous situations, estimate severity and probability, evaluate whether risk reduction is required, then apply risk reduction in this order: eliminate hazards through design and construction or, where elimination is not possible, minimise risks through design and construction, protect against the risks that remain, then inform users of residual risks, any required training and personal protective equipment.

That means the EHSR map should be hazard-led. A mechanical movement hazard might point to guards or protective devices; a control-system hazard might point to safety and reliability of control systems; a software or data-integrity hazard might point to protection against corruption; and a mobility hazard might require the mobility chapter in addition to the general chapter.

Software belongs in the Annex III map when it affects safety. The Regulation covers safety components as physical or digital components, including software, and Annex III includes specific requirements for protection against accidental or intentional corruption of hardware, software, and data that are critical to compliance with EHSRs.

For control systems, Annex III requires design and construction that prevent hazardous situations, including attention to faults in hardware or logic, errors in control-system logic, reasonably foreseeable malicious attempts where relevant, and limits of safety functions established through the manufacturer's risk assessment. Where safety-related software versions or interventions are relevant, the Regulation also grounds tracing-log and source-code or programming-logic evidence in defined circumstances.

Test the supplementary EHSRs against the real product and use. Record why each chapter applies or does not apply, then connect its design duties to drawings, material specifications, calculations, tests, cleaning or maintenance instructions, and residual-risk information.

Food, cosmetics, and pharmaceutical machinery needs evidence for material compatibility, cleanability, drainage or discharge, prevention of contamination, and instructions for cleaning, disinfecting, and rinsing. Lubricants or auxiliary substances that could contact products need a controlled design and maintenance basis. Hand-held and hand-guided machinery needs handling, control, stability, and vibration evidence. Portable fixing and impact machinery and woodworking machinery require their specific protective measures rather than a generic guarding statement.

Plant-protection machinery needs evidence covering operator and environmental exposure, filling and emptying, leakage, drift or unintended dispersion, distribution and calibration, cleaning, servicing, inspection, and the tests and instructions needed for safe adjustment. Mobile machinery needs visibility, operator position, travel control, stability, rollover or falling-object risks, braking, and information on vibration where applicable. Underground machinery, lifting machinery, and machinery lifting persons each require the corresponding strength, stability, control, access, carrier, anchorage, emergency, and marking checks.

Annex IV requires technical documentation to specify the means used to ensure conformity with applicable Annex III EHSRs. For machinery and related products, that documentation includes a complete product description, risk-assessment documentation, the list of applicable EHSRs, protective measures, residual risks, drawings and schemes, standards or common specifications applied, tests and calculations, instructions for use, declarations, production controls, and selected software or sensor-system evidence where relevant.

A useful EHSR map therefore has one row per applicable requirement or hazard cluster, with cross-references to the risk assessment, design evidence, verification evidence, instruction text, standards basis, residual-risk treatment, and declaration support. If a harmonised standard or common specification is only partly applied, the record should say which parts were applied and what other technical specifications close the remaining EHSR gap.

Annex III answers the question: which essential safety requirements apply to this product and how were the risks eliminated or reduced? Annex I answers a different question: is the product in a category that must follow one of the specified conformity-assessment procedures under Article 25?

Keep both analyses in the same compliance pack, but do not merge them. Annex I classification may affect whether a notified body route is needed, while Annex III mapping remains the substantive evidence that the applicable health and safety requirements have been addressed.