Article 50 of Machinery Regulation 2023/1230: the penalty regime and its transposition in Spain

Article 50 of Regulation (EU) 2023/1230 does not set out a closed catalogue of fines: it obliges each Member State to establish its own penalty regime for infringements committed by economic operators —manufacturers, authorised representatives, importers and distributors— and requires those penalties to be effective, proportionate and dissuasive, potentially extending to criminal liability in the most serious cases. Spain, like the other Member States, had to notify the European Commission of the rules and transposition measures by 14 October 2026, an obligation that has already entered into force because Article 50(1) itself is one of the few provisions of the Regulation that applies early, from 14 October 2023.

The fact that the penalty regime is not harmonised at European level does not mean it is irrelevant for companies operating in several Member States. On the contrary: it means that the same infringement —an incomplete EU Declaration of Conformity, a poorly affixed CE marking or a non-existent technical file— can have very different economic and criminal consequences depending on the country where it is detected. In this article we review exactly what Article 50 requires, how its transposition is progressing in Spain, and which types of infringements carry the greatest penalty risk.

Why doesn't the Regulation set specific fine amounts?

Regulation (EU) 2023/1230 is, by its legal nature, directly applicable in all Member States without the need for transposition of its technical content —essential requirements, conformity assessment procedures, CE marking. However, administrative and criminal penalty law remains, to a large extent, a national competence. That is why the European legislator opted for a technique that is common in the EU's new market surveillance framework, aligned with Regulation (EU) 2019/1020: setting common principles (effectiveness, proportionality, dissuasion) and leaving to each Member State the task of setting the amounts, the procedures and, where applicable, the criminal classification.

This approach has an important practical consequence for any engineering firm or manufacturer selling in several countries of the European Economic Area: there is no single European "price list" of penalties for non-compliance with the Machinery Regulation. Each national market surveillance authority will apply its own penalty rules, which can generate significant asymmetries between, for example, Germany, France, Italy and Spain for the same material infringement.

How is Article 50 being transposed in Spain?

In Spain, the penalty framework for industrial safety —including machinery— has traditionally rested on Law 21/1992 on Industry and its implementing regulations, with infringements classified as minor, serious and very serious depending on the risk generated and the conduct of the economic operator. The transposition of Article 50 of Regulation 2023/1230 is expected to be articulated through the adaptation of that existing framework —or through a specific legal or regulatory rule— to expressly incorporate the infringements arising from the new Regulation, replacing references to Royal Decree 1644/2008, which transposed Directive 2006/42/EC and is being phased out as the new regime rolls out its full application.

As we already explained in our analysis of Article 21 on the legal architecture of the EU Declaration of Conformity, the Spanish industrial safety system distinguishes between formal infringements —incomplete documentation, absence of marking, traceability defects— and material infringements, linked to placing machinery on the market that poses a real risk to people's health or safety. This distinction is key to understanding the proportionality criterion required by Article 50 of the Regulation: not every documentary irregularity deserves the same penalty response as a machine that, in practice, could cause an accident.

What exactly does "effective, proportionate and dissuasive" mean?

This formula —standard in European Union penalty law for more than two decades, and also used in regulations such as the GDPR or the Market Surveillance Regulation— sets three criteria that national authorities must respect when designing and applying their penalty regime:

1. Effective: the penalty must genuinely deter repetition of the infringement and not be limited to an affordable cost that the company absorbs as a "business expense". A symbolic fine compared to the profit obtained from marketing non-compliant machinery would not meet this criterion.
2. Proportionate: the penalty must be commensurate with the severity of the infringement, the size of the company, the number of units marketed and the risk generated. An SME that makes an isolated formal error should not receive the same treatment as a multinational that markets machinery en masse without a technical file.
3. Dissuasive: they must discourage both the specific offender and the rest of the sector's economic operators. This is the criterion that justifies serious infringements being able to lead to criminal penalties, especially when there is harm to people's health or safety.

IgeraIndustria in action: penalty risk map by country

For manufacturers exporting to several Member States, IgeraIndustria helps anticipate which types of documentary issues are most likely to result in a penalty depending on the destination country, prioritising corrections before an inspection.

Case study: the avoided penalty of an agricultural machinery SME

A manufacturer of agricultural mowers in Castilla y León —whom we will call, anonymously, Maqagro S.L.— received an inspection visit from the regional industry authority in 2025 following a complaint from a competitor. The inspection found that the EU Declaration of Conformity for one model did not correctly cite the current version of the harmonised standard EN ISO 4254 applicable to agricultural machinery, and that the technical file lacked an up-to-date risk assessment matrix. As this was a formal infringement, with no evidence of material risk to people, the authority opted for a correction request with a thirty-day deadline instead of opening a direct penalty procedure. Maqagro corrected the documentation within the deadline and avoided the penalty, but the case illustrates that the boundary between a formal and a serious infringement depends largely on how quickly the manufacturer reacts.

Frequently asked questions about Article 50

Does Article 50 set a minimum or maximum penalty amount?

No. Regulation 2023/1230 does not establish specific amounts. It only requires that national penalties be effective, proportionate and dissuasive, leaving each Member State to set the exact amounts in its own domestic industry or product safety legislation.

Can there be criminal liability for marketing non-compliant machinery?

Yes. Article 50(1) itself expressly provides that penalties "may include criminal penalties for serious infringements". In Spain, this can connect with provisions of the Criminal Code relating to offences against workers' safety or against public health when the marketing of non-compliant machinery causes injury or seriously endangers people.

Who can be penalised: only the manufacturer, or also the importer and the distributor?

Article 50 expressly refers to infringements "by economic operators", a category that the Regulation defines broadly and includes the manufacturer, the authorised representative, the importer and the distributor. Each of them has specific obligations —set out in Articles 10, 11, 13, 14 and 15 of the Regulation— whose breach can give rise to an independent penalty.

What is the difference between Article 50 and the Article 43 procedure?

Article 43 governs the national procedure followed by a market surveillance authority when it detects that a product presents a risk: assessment, corrective measures, possible withdrawal. Article 50 is the legal basis that allows, in addition to those corrective measures, an economic or criminal penalty to be imposed on the responsible economic operator. They are complementary: Article 43 manages the risk of the product on the market; Article 50 penalises the infringing conduct.

Can the penalty be applied retroactively to machines marketed before 2027?

For machines legally marketed under Directive 2006/42/EC before 14 January 2027, the transitional provisions of Article 52 of the Regulation apply, allowing that machinery to remain on the market without requiring retroactive adaptation to the new requirements. However, if the machine already failed to comply with Directive 2006/42/EC at the time it was marketed, the applicable penalty regime remains the one in force at that time, not that of the new Regulation.

How can a company reduce its exposure to the Article 50 penalty risk?

The most effective approach is documentary prevention: keeping the technical file complete and up to date (art. 22), ensuring that the EU Declaration of Conformity correctly cites the current harmonised standards (art. 16), verifying traceability across the entire supply chain (art. 19), and periodically auditing CE marking. The sooner issues are detected and corrected, the lower the likelihood that an inspection will classify them as a serious infringement.

Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery (OJ L 165, 29.6.2023), Articles 50 and 54; Regulation (EU) 2019/1020 on market surveillance; Law 21/1992 on Industry. This article is for informational purposes only and does not constitute legal advice.