Article 7 of the Machinery Regulation 2023/1230: safety components, the Annex IV list and their CE marking obligations

Direct answer: Article 7 of Regulation (EU) 2023/1230 imposes on safety components — indicatively listed in Annex IV — the same essential obligations as a complete machine: compliance with the applicable requirements of Annex III, completion of the relevant conformity assessment procedure, their own CE marking, and their own independent EU Declaration of Conformity. Not every element that contributes to a machine's safety is a "safety component" in the legal sense: it only qualifies if it is placed on the market independently and its failure endangers the safety of persons. Confusing a safety component with an ordinary part is one of the most costly classification errors under the Regulation.

Article 7 relies directly on the definition in Article 3.3, which we already analysed in our article on the Regulation's key definitions: a safety component performs a safety function, is placed on the market separately, and its failure or malfunction endangers the safety of persons, without being necessary for the machine to function or being replaceable by an ordinary component. Article 7 translates that definition into concrete obligations and refers to Annex IV, the indicative list of products considered safety components for the purposes of the Regulation.

What products does Annex IV include as safety components?

Annex IV sets out an indicative list — not closed, unlike the exclusions in Article 2 — of products that the Commission considers safety components when placed on the market independently to perform a safety function. It is indicative because the Regulation acknowledges that technology evolves faster than any fixed list, and ultimately refers back to the functional definition in Article 3.3 to resolve cases not expressly listed.

How do I distinguish a safety component from an ordinary spare part?

The key question is not "does this element contribute to safety?" — almost any part contributes in some way — but three cumulative conditions from Article 3.3: first, it specifically performs a safety function; second, it is placed on the market independently, outside the context of a complete machine; third, its failure endangers the safety of persons and it is not simply replaceable by an ordinary component without that purpose.

What conformity assessment procedure does Article 7 require?

Article 7 refers to Article 25 and Annex I to determine the conformity assessment procedure applicable to each safety component. Most safety components classified as critical — those included in Annex I, Part A — require the involvement of a notified body, either through EU-type examination with production control, or through a full quality assurance system. Safety components not on that high-risk list may rely on internal production control under the manufacturer's sole responsibility, provided they fully apply harmonised standards.

IgeraIndustria in action: verifying safety components

IgeraIndustria lets you ask in natural language whether a specific component fits Annex IV, which conformity assessment procedure applies, and whether it requires a notified body under Annex I, always citing the exact applicable provision.

Why does it matter to treat safety software as a safety component?

One of the most significant novelties of Regulation 2023/1230 compared with Directive 2006/42/EC is the express inclusion of safety software in Annex IV, including software that forms part of risk-detection systems based on artificial intelligence. This means that a manufacturer who places on the market, independently, a software module intended to ensure a safety function — for example, a machine-vision system that stops a machine on detecting intrusion into a hazard zone — must treat it with the same obligations as a physical component: its own conformity assessment, CE marking and EU Declaration of Conformity.

A real case: an industrial automation company developed a predictive stop software module based on machine learning, intended for integration into various third-party production lines. For months it distributed the module as an "optional update" without its own conformity assessment, assuming that responsibility lay with the manufacturer of each final machine. On reviewing the classification under Article 7 and Annex IV, it became clear that the software performed a critical safety function and was placed on the market independently: it had to be treated as a safety component with its own technical file, which also connects to the essential requirements in Annex III that we cover in our article on Article 8.

Frequently asked questions about safety components and Annex IV

Does a safety component built into the machine at the factory need its own CE marking?

No, if it is integrated directly by the machine manufacturer and is never placed on the market independently. The Article 7 obligation for its own CE marking and EU Declaration of Conformity applies when the component is placed on the market as a separate product, capable of being integrated into different machines from different manufacturers.

What happens if a safety component is not literally listed in Annex IV?

Annex IV is indicative, not exhaustive. If the product meets the three cumulative conditions of Art. 3.3 — safety function, independent placing on the market, and failure that compromises the safety of persons — it is considered a safety component for the purposes of the Regulation even if not expressly listed, and the same Article 7 obligations apply to it.

Do identical spare parts from the original manufacturer need their own conformity assessment?

No. Article 2.2(a) expressly excludes safety components intended as identical spare parts, supplied by the original machine manufacturer to replace an equivalent component that has already been assessed. The exclusion no longer applies if the component is placed on the market for first installation or offered as a non-identical generic spare part.

Do all safety components need a notified body?

No. Only components listed in Annex I, Part A of the Regulation mandatorily require the involvement of a notified body. Safety components outside that list may rely on internal production control, provided they fully apply the relevant harmonised standards that confer a presumption of conformity.

Does AI-based safety software receive special treatment?

Annex IV expressly includes it as a category of safety component. In addition, if that software also fits the definition of a high-risk AI system under the Artificial Intelligence Regulation (EU) 2024/1689, both regulatory frameworks may apply simultaneously, requiring coordination between the conformity assessment procedures of both regulations.

Can IgeraIndustria identify whether my product is a safety component under Annex IV?

Yes. IgeraIndustria analyses the product's technical data sheet, checks it against the definition in Article 3.3 and the indicative list in Annex IV, and generates a report with the applicable conformity assessment procedure and whether it requires involvement of a notified body under Annex I.