normakte / Risk assessment to EN ISO 12100
The Machinery Regulation requires a risk assessment – EN ISO 12100 describes how to do it. This is how the two fit together, and how the assessment becomes evidence in the technical documentation.
The Regulation sets the whether and the framework: before the machinery is designed, the applicable essential requirements are identified through a risk assessment, in an iterative process. EN ISO 12100 – a type-A standard with basic concepts and general design principles – describes the how. It provides terminology, procedure and aids for identifying hazards, but no machine-specific solutions; those are found in type-B and type-C standards.
| Step | Regulation | Content | Into the file |
|---|---|---|---|
| 1. Determine the limits | Annex III Part B point 1(a) | intended use and reasonably foreseeable misuse; use, space and time limits; all life phases | description of the machine, intended purpose, user groups, assumptions |
| 2. Identify hazards | (b) | hazards and hazardous situations, systematically for all tasks: transport, assembly, setting, operation, cleaning, maintenance, fault finding, decommissioning | hazard list with situation and task concerned |
| 3. Estimate risks | (c) | severity of possible injury or damage to health and probability of its occurrence | method used, data basis, result per hazard |
| 4. Evaluate risks | (d) | is risk reduction required to meet the objective of the Regulation? | decision with reasons |
| 5. Reduce risks | (e), 1.1.2(b) | in the prescribed order: design, technical protective measures, information for use – then reassess | measures with the related Annex III requirement, standards applied, evidence, residual risks |
A packaging machine with a guard door. Hazardous situation: crushing at the gripper when an operator clears a jam with the door open. Estimation: serious hand injury possible, intervention several times per shift. Reduction: interlocking movable guard preventing start-up while the door is open (Annex III 1.4.2); setting mode at reduced speed only while the control device is actuated (1.2.5). Residual risk: instructions on how to proceed in the event of a blockage (1.7.4.2 point 1(q)).
The example shows the structure of a line, not the right solution for your machine. The technical assessment remains a task for specialists.
The assessment covers hazards that may arise during the life cycle and are foreseeable at the time of placing on the market because the machine’s behaviour or logic evolves by design. It also covers risks from interactions between machines functioning as an assembly (Annex III Part B, point 1). According to recital 32, software updates foreseen at the time of placing on the market should also be taken into account.
For control systems: the limits of safety functions are defined as part of the risk assessment (Annex III 1.2.1(d)). With connected machinery, protection against corruption is added (1.1.9).
The technical documentation under Annex IV Part A contains the risk assessment documentation: the procedure followed, the applicable essential requirements, the protective measures that meet them and the residual risks. EN ISO 12100 lists similar items in its section on documentation, such as the assumptions made, the data basis of the estimation and the result. For partly completed machinery the general principles apply as well (Annex III Part B, point 5), documented under Annex IV Part B.
Standards are voluntary. The risk assessment itself is mandatory. Presumption of conformity only arises from standards whose references are published in the Official Journal (Art. 20(1)); check the status for the Regulation.
The manufacturer must ensure it is carried out. Specialists can be engaged; responsibility stays with the manufacturer.
Yes. The general principles apply to the risk assessment of the manufacturer of partly completed machinery (Annex III Part B, point 5).
No. If the machine is also a product with digital elements, the risk assessment under Regulation (EU) 2024/2847 is added as a separate assessment.
As part of the technical documentation, for at least ten years after placing on the market (Art. 10(3)).
Every Annex III requirement linked to a measure, a standard and evidence – and the residual risks ready for the instructions. Trial file free until 20.01.2027.
Sources. Regulation (EU) 2023/1230, OJ L 165, 29.6.2023, including the corrigendum of 1.4.2025; Directive 2006/42/EC for the previous regime.
The information has been checked against the official text, paraphrased and shortened; only the official text is authentic.
normakte is a drafting and calculation aid; it replaces neither conformity assessment, nor a notified body, nor a technical assessment by a specialist, nor legal advice.