Article 45 of Machinery Regulation 2023/1230: cooperation between EU market surveillance authorities

Direct answer: Article 45 of Regulation (EU) 2023/1230 requires market surveillance authorities in different Member States to exchange information, coordinate inspections and act jointly against non-conforming machinery circulating in more than one EU country, relying on the shared information systems ICSMS and Safety Gate. For a manufacturer, this means that an issue detected by the authority of a single country stops being a local problem: within days it can trigger reinforced controls across the rest of the internal market. In this article we explain how this cooperation works, what data is shared between authorities, and what it means for a company exporting machinery to several Member States.

Why does the Regulation refer to another regulation instead of regulating cooperation directly?

Direct answer: Article 45 does not reinvent its own cooperation system because a horizontal framework already exists for all market surveillance of industrial products in the EU, Regulation (EU) 2019/1020. Rather than duplicating rules, the legislator chose to integrate the Machinery Regulation into that general framework, ensuring that Spanish, French, German or Polish authorities work with the same procedure and the same IT tools, regardless of whether the product under surveillance is a machine, a toy or an electrical appliance. This legislative technique, increasingly common in EU harmonisation legislation, avoids fragmentation and ensures that cooperation between authorities does not depend on ad hoc bilateral agreements.

As we already explained when analysing Article 50 on the penalty regime, penalty law remains a national competence, but detection and management of product risk —which is what Article 45 regulates— is indeed harmonised through Regulation 2019/1020. This distinction is key: two countries may penalise the same infringement differently, but both share the same information about the risk detected and coordinate the corrective measures applicable to the product.

What are ICSMS and Safety Gate, and what information do they share?

These are the two main IT tools underpinning the cooperation set out in Article 45:

When a surveillance authority —for example, the Directorate-General for Industry of a Spanish autonomous community— detects that a machine presents a risk, it enters the file into ICSMS, where it becomes visible to the rest of the European authorities: which product, which manufacturer, what defect was detected, which harmonised standards it fails to meet, and what corrective measure has been adopted or proposed. If the risk is serious for people's health or safety, a notification is also triggered in Safety Gate, which in the most critical cases can lead to public disclosure of the risk detected.

What steps does a coordinated action between authorities of two countries follow?

→ If your engineering firm manages compliance for manufacturers exporting to several Member States, try IgeraIndustria free for 14 days and find out which cross-authority cooperation obligations apply to your file, citing the exact article of Regulation 2019/1020 and 2023/1230.

Case study: the issue that crossed three borders in a week

A manufacturer of mobile elevating work platforms based in the Basque Country —whom we will call, anonymously, Altura Industrial S.A.— sold the same model in Spain, Portugal and Italy. Following an accident with no fatalities, the Italian surveillance authority detected that the platform's locking system failed to meet the essential stability requirement of Annex III when operated on a slope steeper than 5%. Italy entered the file into ICSMS on the same day of the finding. Within less than a week, the Spanish and Portuguese authorities had identified, through the system, that the same model was marketed in their territories, and requested additional technical information from Altura Industrial before the company had voluntarily notified the issue in those two countries. Coordination between the three authorities allowed a coordinated preventive withdrawal in all three jurisdictions within fifteen days, instead of the months that a country-by-country approach without information exchange would have taken.

Frequently asked questions about Article 45

Does Article 45 create a single European market surveillance authority?

No. Each Member State keeps its own national market surveillance authority, with full competence over its territory. Article 45 does not centralise that competence; rather, it requires those national authorities to cooperate, exchange information and, where appropriate, coordinate joint actions through the mechanisms of Regulation 2019/1020.

Can an authority from another country directly inspect my facilities in Spain?

Not directly. Each authority acts within its own national territory. What Article 45 allows is for a foreign authority to request that the Spanish authority carry out checks, and for both to share the results through ICSMS. The physical inspection on Spanish territory is always carried out by the competent Spanish authority.

Am I entitled to know whether my file is registered in ICSMS?

The manufacturer or economic operator affected by a market surveillance measure has the right, under the general principles of Regulation 2019/1020, to be informed of the findings of the assessment and to submit representations before a final measure is adopted. Direct access to the ICSMS system, however, is reserved to the authorities, not to economic operators.

What is the difference between a notification in ICSMS and an alert in Safety Gate?

ICSMS is the operational file-management platform between authorities, with detailed technical information for administrative use. Safety Gate is the rapid alert system reserved for serious risks to health or safety, with faster notifications and, in many cases, part of the information published for the awareness of the general public and other market operators.

Does the cooperation under Article 45 also apply to machinery imported from outside the EU?

Yes. Regulation 2019/1020 includes specific provisions for cooperation with customs authorities at the EU's external borders, precisely to detect non-conforming machinery before it enters the internal market. The exchange of information on products from third countries relies on the same systems, including enhanced customs controls when there is a history of incidents with a specific manufacturer.

How can a company anticipate a coordinated action between authorities?

The most effective measure is to maintain a single, coherent technical file for each model, kept up to date across all the markets where it is sold, so that any response to one authority is consistent with the information already provided to another. Proactively detecting and correcting a documentation or technical issue, before it escalates into an inspection, significantly reduces the likelihood of the file escalating into a coordinated multi-state action.

Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery (OJEU L 165, 29.6.2023), Article 45; Regulation (EU) 2019/1020 on market surveillance and compliance of products, Articles 11 to 21 and 34; Regulation (EU) 2023/988 on general product safety. This article is for informational purposes only and does not constitute legal advice.