Article 29 of Machinery Regulation 2023/1230: the presumption of conformity and the risk of manufacturing without a published harmonised standard

Direct answer: Article 29 of Regulation (EU) 2023/1230 establishes that machinery manufactured in accordance with a harmonised standard, or parts of it, whose reference has been published in the Official Journal of the European Union, is presumed to conform with the essential health and safety requirements of Annex III covered by that standard. It is a presumption, not an automatic certainty: it covers only what the standard actually regulates, and the manufacturer remains responsible for demonstrating compliance with any requirement not covered. The most common practical problem is that, for many new machinery categories or those with artificial intelligence components, no harmonised standard published under the new Regulation yet exists, which forces the manufacturer to demonstrate conformity through other means during the transitional period. In this article we explain how the presumption works, what happens without a harmonised standard, and what role the common specifications the Commission may adopt play.

Regulation 2023/1230, fully applicable from 20 January 2027, retains the presumption-of-conformity mechanism characteristic of the European "New Approach", already present in Directive 2006/42/EC, but for the first time combines it with the possibility for the Commission to adopt common specifications when the harmonised standardisation process does not progress at the necessary pace.

How exactly does the presumption of conformity work?

Article 29(1) links the presumption to three cumulative elements: first, a harmonised standard drawn up in accordance with Regulation (EU) No 1025/2012 on European standardisation must exist; second, the Commission must have published its reference in the Official Journal of the European Union; and third, the manufacturer must have designed and manufactured the machinery in accordance with that standard, or with the parts of it that are applicable. Once these three elements are met, the machinery is presumed to satisfy the essential health and safety requirements of Annex III that the standard specifically covers — not necessarily all the requirements applicable to that machinery category, if the standard only regulates a partial aspect of the risk.

This presumption is of a iuris tantum EUR-Lex — Regulation (EU) 2023/1230 This content is for informational purposes only and does not constitute legal or engineering advice. For the conformity assessment of your machinery, consult a notified body or a qualified industrial safety engineer. nature: it admits proof to the contrary. A market surveillance authority may, following a specific analysis, conclude that despite the application of the harmonised standard, the machinery does not actually meet the corresponding essential requirement, triggering the safeguard procedure provided for in the Regulation for harmonised standards that prove insufficient in practice.

What happens if my machinery category still has no published harmonised standard?

This is, in practice, the most delicate scenario of the 2027-2029 period. As Regulation 2023/1230 replaces Directive 2006/42/EC, existing harmonised standards must be reviewed and republished under the new legal framework before they continue to grant a presumption of conformity with respect to the new Regulation. While CEN and CENELEC complete that review process — mandated by the Commission through standardisation requests — and the Commission publishes the new references, there is a real risk of a gap: manufacturers of entire machinery categories may find themselves without any harmonised standard in force under Regulation 2023/1230 covering their product.

In that case, the manufacturer is not exempted from demonstrating conformity: it simply loses the shortcut of the presumption. It must justify compliance with each essential requirement of Annex III through its own risk analysis, tests, technical calculations and, for the categories in Annex I Part A, through the involvement of a notified body under the procedures we detail in our article on Article 25 and the conformity assessment modules. The absence of a harmonised standard does not reduce the substantive requirements; it only removes the fast track for proving them.

What are common specifications and when does the Commission adopt them?

Article 29(2) introduces a tool that is new compared with Directive 2006/42/EC: when no harmonised standard has been published for an essential health and safety requirement, or when the European standardisation body does not respond adequately to the Commission's mandate within a reasonable time, the Commission may adopt, through implementing acts, common specifications covering that requirement. Machinery manufactured in accordance with those common specifications, or parts of them, enjoys the same presumption of conformity as if it had been manufactured in accordance with a harmonised standard, as established by Article 29(3).

This mechanism seeks to prevent a regulatory gap from blocking the placing on the market of innovative machinery — especially machinery with machine-learning components or advanced safety functions — during the years in which traditional harmonised standardisation, inherently slower, has not completed its review under the new Regulation.

A practical case: the packaging machine with no harmonised standard available

Envasados Riera S.L., a fictitious manufacturer of automatic packaging lines for the food industry, developed a new packaging machine in 2027 with a foreign-body detection system based on machine vision. When starting the technical file, the quality department found that the specific EN standard for that type of detection system was still under review by the CEN technical committee and had no reference published in the Official Journal linked to Regulation 2023/1230. Faced with the lack of an available presumption of conformity, Envasados Riera documented its own detailed risk analysis for the essential requirement affected, commissioned specific independent tests, and kept an exhaustive record in the technical file of which parts of Annex III were justified by presumption — through other standards already published for the rest of the machine — and which required its own justification. This traceability proved key months later, when the market surveillance authority requested the complete file.

IgeraIndustria in action: checking the status of the presumption of conformity

Can the presumption of conformity of a harmonised standard be challenged?

Yes. Although Article 29 grants a presumption, the Regulation provides for a formal objection procedure against harmonised standards that a Member State or the Commission itself considers do not adequately cover the essential requirements they claim to cover. When such an objection succeeds, the Commission may decide to maintain, restrict or withdraw the reference of that standard from the Official Journal, with the effect that machinery manufactured after that decision in accordance with the disputed standard no longer benefits from the presumption for the affected part, although machinery already placed on the market is not automatically deemed non-compliant on that basis alone.

Frequently asked questions about Article 29

Where can I check which harmonised standards are published for Regulation 2023/1230?

The European Commission periodically publishes and updates, in the C series of the Official Journal of the European Union, the list of references of harmonised standards that grant a presumption of conformity for each harmonisation legislative act, including Regulation (EU) 2023/1230. It is essential to check the version in force on the date of manufacture, as the list is revised frequently.

Does the presumption of conformity exempt me from carrying out a risk analysis?

No. Risk analysis is an independent, prior obligation generally required by Annex III, and it must be carried out for the whole machine, not only for aspects not covered by harmonised standards. The presumption of conformity facilitates the documentary justification that a specific requirement is met, but it does not replace the hazard-identification process inherent to the design.

What is the practical difference between a harmonised standard and a common specification?

The harmonised standard is drawn up by a European standardisation body (CEN, CENELEC or ETSI) through sectoral technical consensus, under a Commission mandate. The common specification is adopted directly by the Commission through an implementing act, without going through that standardisation process, precisely to fill gaps when ordinary standardisation does not progress in time. For purposes of the presumption of conformity, Article 29 grants them the same legal effect.

Does partially applying a harmonised standard give a partial presumption?

Yes, Article 29(1) expressly provides that conformity with parts of a harmonised standard grants a presumption with respect to the essential requirements that those specific parts cover. The manufacturer must separately justify, through other means, the essential requirements not covered by the parts of the standard actually applied.

What risk do I take on if I place machinery on the market without waiting for the harmonised standard to be published?

No manufacturer is obliged to wait for the publication of a harmonised standard before placing machinery on the market: conformity can be demonstrated through the manufacturer's own analysis at any time. The risk is not one of timing, but of the burden of proof: without a presumption, the market surveillance authority may demand a more detailed and specific technical justification for each essential requirement, which increases the time and cost of the technical file and the conformity assessment process.

Can IgeraIndustria notify me when a harmonised standard relevant to my machinery is published?

IgeraIndustria cross-checks the machinery category declared by the manufacturer with the list of references published in the OJEU and indicates whether presumption-of-conformity coverage currently exists or whether the corresponding essential requirement is still pending a harmonised standard or common specification, so the manufacturer can decide which route to use to justify each aspect of Annex III.

Last updated: July 2026 | Author: Jordi Bassols, Industrial Safety Engineer, COEIC Registered | Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery, Article 29 (OJEU L 165, 29.6.2023); Regulation (EU) No 1025/2012 on European standardisation; Directive 2006/42/EC (in force until 19.1.2027). This article is for informational purposes only and does not constitute legal or engineering advice. IgeraIndustria — free trial.