Article 5 of Machinery Regulation 2023/1230: how much scope do Member States have to require additional protection during installation and use

Direct answer: Article 5 of Regulation (EU) 2023/1230 allows Member States to establish additional national requirements to protect people — including workers — during the installation or use of machinery and related products, provided those rules do not permit modifying the machine in a manner incompatible with the Regulation itself. It is a short provision, containing a single operative sentence, but with significant practical implications: a machine's CE conformity does not exhaust the legal obligations of the installer or of the employer putting it into service at their workplace.

Regulation 2023/1230, fully applicable from 20 January 2027, harmonises the design and manufacturing requirements for machinery across the European Union. But Article 5 expressly acknowledges that this harmonisation has a limit: it does not cover the conditions of installation, use and working environment, which remain within the competence of each Member State through its occupational health and safety legislation.

What exactly does Article 5 of the Machinery Regulation say?

The provision has two elements that are worth separating precisely. First, it recognises a positive competence: Member States may legislate on installation and use. Second, it imposes a negative limit: that national legislation cannot authorise modifications to the machine that are incompatible with Regulation 2023/1230 itself. In practice, the article functions as a clause allocating competences between European harmonisation of the product and national regulation of the working environment.

Why does this clause exist if the Regulation already harmonises design requirements?

The Machinery Regulation regulates the product: how a machine must be designed and constructed so that it can be lawfully placed on the market in the Union. It does not, however, regulate the subsequent use of that machine once it has been installed at a specific workplace. That second dimension — occupational health and safety — belongs to a different body of law, in Spain headed by Law 31/1995 on the Prevention of Occupational Risks and Royal Decree 1215/1997 on minimum health and safety requirements for the use of work equipment.

Article 5 prevents a legal vacuum from arising at that boundary: it explicitly allows a Member State to require, for example, additional training for operators, collective protections at the workplace, specific signage in the local language, or reinforced installation procedures, without this being regarded as an unjustified barrier to the single market or as an obligation contrary to the free movement of machinery that complies with the Regulation.

Design requirements (harmonised) versus installation and use requirements (national)

Distinguishing these two levels avoids one of the most common mistakes made by purchasing and occupational risk prevention departments: assuming that if a machine carries CE marking and an EU Declaration of Conformity — whose mandatory content we analyse in depth in our article on Article 16 of the Regulation — no further measures are needed at the company installing it.

What kind of additional national requirements typically appear in practice?

Although Article 5 does not give examples, experience applying Directive 2006/42/EC — to which Article 5 of the new Regulation gives near-literal continuity — allows us to identify the types of national requirement most frequently based on this legal foundation:

IgeraIndustria in action: distinguishing manufacturer obligations from user obligations

One of the most common points of confusion among SMEs installing machinery purchased from third parties is not knowing whether a specific requirement falls to the manufacturer — and should therefore already be covered by the EU Declaration of Conformity — or to the holder of the workplace itself under installation and use legislation.

What happens if a national requirement forces a modification of the machine?

An illustrative case: an automotive components factory in southern Spain received, following a labour inspection, a requirement to install an additional housing on a press that already carried CE marking and protections certified under Annex III. The company asked whether it was obliged to accept that modification without the manufacturer's authorisation. The answer, consistent with the limit set out in Article 5, was that the national authority may require additional protection measures in the working environment — a separate perimeter enclosure, for example — but cannot require the certified design of the machine to be altered without following a substantial modification procedure supervised by the manufacturer itself or a qualified third party, since an unauthorised modification could invalidate the original EU Declaration of Conformity.

This nuance — protection of the environment, yes; alteration of the certified product, no — is the key to reading the whole of Article 5, and explains why the European legislator drafted it as a single sentence with an explicit negative condition, rather than leaving national competence completely open.

Frequently asked questions about Article 5

Does Article 5 allow Spain to require different rules than France or Germany?

Yes. Since this is a competence recognised to each Member State over installation and use — not over product design — it is entirely possible for differences to exist between countries regarding required training, signage or organisational procedures, without this amounting to an infringement of the principle of free movement of goods, since the machine itself remains the same throughout the Union.

Can a Member State require an additional or different CE marking to the European one?

No. Article 5 does not authorise Member States to impose design, marking or conformity assessment requirements in addition to the harmonised CE marking. Their competence is strictly limited to installation and use conditions, not the product itself or its certification process, which are fully harmonised by the rest of the Regulation.

Who is responsible if an accident occurs due to failure to comply with a national installation requirement?

Responsibility generally falls on the holder of the workplace or the employer who installed the machine in breach of the national requirement, and not on the manufacturer, provided the machine itself correctly met the essential health and safety requirements of Annex III at the time it was placed on the market.

Must the manufacturer know the national installation requirements of each country where it sells?

It is not a direct legal obligation of the manufacturer under the Machinery Regulation, but as a matter of commercial practice it is advisable for the manufacturer to inform its distributors and importers of the existence of these additional national requirements, especially when they affect the installation instructions accompanying the machine under Art. 10.7.

Does this article also apply to partly completed machinery?

Article 5 refers to "machinery or related products", a category which, under the definition in Art. 2.1, includes finished machinery and the related products listed, but partly completed machinery is governed by its own specific regime for subsequent incorporation; in practice, national installation and use requirements apply once the partly completed machinery has been incorporated into a final machine and that machine is put into service.

Can IgeraIndustria identify which additional national requirements apply to my sector?

IgeraIndustria centralises the text of Regulation 2023/1230 and helps precisely distinguish which obligations relate to the machine's design (manufacturer's responsibility) and which to its installation and use (employer's responsibility), always citing the exact applicable article.