Directives and Regulations
Harmonised standards and the Machinery Regulation
How harmonised standards will work under Regulation (EU) 2023/1230 from 20 January 2027 and what machinery manufacturers should prepare.
The Machinery Regulation will become applicable on 20 January 2027. Technical standards, however, will not automatically cross midnight with it. A standard currently harmonised under Directive 2006/42/EC will not, for that reason alone, provide a presumption of conformity with Regulation (EU) 2023/1230.
This raises many questions: the same machine, the same standard and the same technical solution, but with a different legal basis. For manufacturers, the useful question is therefore: “what legal effect will each reference applied to machinery have on the date of placing on the market?”
In brief
- Regulation (EU) 2023/1230 will replace Directive 2006/42/EC from 20 January 2027.
- A presumption of conformity with the Regulation will arise only from standards, or parts of standards, whose references are published in the Official Journal in relation to the new Regulation.
- A standard cited only under the Directive may remain technically useful, but it will not automatically provide the presumption established by Article 20 of the Regulation.
- A published standard, a harmonised standard and a standard cited for a specific legislative act are not the same thing.
- For certain machinery in Annex I, Part B, the availability of harmonised standards covering all relevant requirements also affects whether internal production control may be used.
One standard, three different questions
The expression “harmonised standard” is often used as though it described a permanent quality of a document. It does not. At least three questions must therefore be distinguished:
- Has the standard been published? CEN, CENELEC or an international standards body may have made a new edition available.
- Has its reference been published in the Official Journal of the European Union? Commercial publication of the standard does not in itself create a presumption of conformity.
- For which act and which requirements was it cited? The legal effect concerns the stated legislation, the covered provisions and any limits or warnings attached to the citation.
In other words, a standard does not receive a European passport valid for ever. It receives a visa, with a precise destination and conditions.
What changes on 20 January 2027
Article 20 of the Regulation states that products conforming to harmonised standards, or parts of them, whose references have been published in the Official Journal are presumed to conform to the essential health and safety requirements in Annex III covered by those standards. The familiar logic remains: use is voluntary and the presumption is limited to what the standard actually covers.
The legislative reference changes. The current consolidated list was built in support of Directive 2006/42/EC. The recent update introduced by Implementing Decision (EU) 2026/2015 has legal effect under that Directive and until its repeal. It cannot simply be renamed “the Regulation list”.
This does not mean that the technical solutions will suddenly become incorrect on 20 January. A standard cited only under the Directive may continue to represent a relevant technical specification or the state of the art. In the absence of a citation under the new Regulation, what disappears is the automatic evidential effect of the presumption of conformity. The manufacturer will need to demonstrate more explicitly how the chosen solution satisfies the applicable requirements of Annex III, until the relevant references are published in the Official Journal in support of Regulation (EU) 2023/1230.
What we know today — and what we do not
On the consultation date of this article, 9 September 2026, the Commission’s official machinery harmonised standards page lists publications relating to Directive 2006/42/EC; it does not yet present a separate implementing decision containing the list for Regulation (EU) 2023/1230.
The Commission now states, however, that a new implementing decision is being prepared, that the first list under the Regulation is expected before the end of 2026 and that it will include the vast majority of standards currently cited under the Directive. Where those standards do not yet fully address new or updated essential health and safety requirements, the extent of their coverage will be clarified.
The technical process is nevertheless under way. In 2024, the Commission published a draft standardisation request to CEN and CENELEC for standards to be developed or adapted in support of the Regulation. Technical committees are reviewing scopes, hazards covered and Annex ZA content, which will link normative clauses to the new requirements of Annex III.
These indications cannot, however, be used to assign legal effect to individual references in advance. A draft, a work programme, an Annex ZA under preparation or even an already published standard is not the same as a citation. Until the reference appears in the relevant official act, it is incorrect to present it as harmonised under the Regulation.
Reading between the lines
The official facts end here. Considered together, however, they offer several strategic indications that engineering teams should not ignore.
The Directive has not been “frozen” while waiting for the Regulation. The Union continued to update its list during the final months of application. This signals operational continuity: machinery placed on the market by 19 January 2027 still needs up-to-date references with a usable legal effect.
Technical continuity does not mean automatic continuity of legal effect. If the old list could simply be carried across wholesale, there would be no need to reassess standards against Annex III or prepare dedicated links. Work on the Annex ZA content instead points towards review standard by standard and requirement by requirement.
It is prudent to expect a moving system rather than a final snapshot. This is an inference, not a Commission announcement: given the number of references and the assessment process involved, the first list may not resolve every sector at the same time. Some references may arrive or be updated through later publications.
“The vast majority” is reassuring, but it does not mean “all”. Moreover, the announced need to clarify coverage of new or updated requirements indicates that some references may enter the new list with limitations that must be read carefully. Continuity is likely to be broad, but neither automatic nor indiscriminate.
The real risk is not having no standards, but assigning the wrong effect to them. A project may be technically sound yet still contain an inaccurate declaration, use an unavailable conformity assessment route or lack a requirements matrix capable of demonstrating why the solution satisfies the Regulation.
Seen in this light, the Directive’s final standardisation activity is not a contradiction. It is the sound of a bridge still being used at one end while it is tested at the other.
Three scenarios to manage in the technical documentation
1. A standard cited under the Regulation
This is the straightforward case: check the edition, scope, requirements covered, any restrictions and the effective date. When correctly applied, the standard provides a presumption only for the specified requirements. Risk assessment remains necessary for everything outside that coverage.
2. A standard cited under the Directive, but not the Regulation
The standard may remain a valid technical reference, but it should be described as an applied technical specification, not as a standard providing a presumption of conformity with the new act. The documentation must establish the link between hazards, Annex III requirements, protective measures, calculations, tests and validation.
3. A new edition published but not yet cited
The latest date on the cover is not enough. The new edition must be compared with the previously applied one, the state of the art considered and the choice justified. The same principle applies today to the forthcoming revision of ISO 12100 and prEN 50742: a draft may be important, but enthusiasm cannot promote it to a published or harmonised standard.
The sensitive point in Annex I, Part B
For most machinery not listed in Annex I, Article 25 allows internal production control. For categories in Annex I, Part B, however, Module A may be used only where the machinery has been designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements.
If that coverage is absent or incomplete, the manufacturer must use one of the other available procedures: EU type-examination followed by conformity to type, full quality assurance, or unit verification. Here, a missing or incomplete citation does not merely affect how evidence is organised: it can change the conformity assessment route and require the involvement of a notified body.
Manufacturers should therefore classify their product ranges against Annex I now, rather than waiting for the list to discover that the planned route is no longer available.
An operational plan that does not depend on guessing the Official Journal
- Separate projects by placing-on-the-market date. The legislative reference is not determined by the project name or order date.
- Create a standards matrix. For every reference, record its edition, status, cited legislative act, requirements covered, restrictions and verification date.
- Map Annex III to the evidence. Link every applicable requirement to technical measures, drawings, calculations, tests, validation and information for use.
- Identify critical dependencies. Prioritise type-C standards, safety functions, interlocking devices, safety distances, programmable systems and protection against corruption.
- Plan a check before issuing the declaration. A standard’s status may change between design and placing on the market; the final review should be dated and traceable.
This matrix complements the Machinery Regulation gap analysis and prevents technical conformity from being confused with the legal effect of citation.
Three statements not to use lightly
- “European harmonised standard”, without stating the relevant act and edition.
- “Compliant with the Regulation because it complies with the standard”, where the standard does not cover every applicable requirement.
- “The Directive list will continue to apply”, without a legal basis transferring the presumption to the new Regulation.
The transition does not require twenty years of engineering to be discarded. It requires something more demanding: separating what remains technically sound from what will need to be demonstrated again.
Sources and references
- Regulation (EU) 2023/1230, consolidated text as at 29 May 2026, particularly Articles 20, 25, 51, 52 and 54.
- European Commission, official machinery harmonised standards page.
- European Commission, standardisation request notification system.
- CEN-CENELEC, Machinery Regulation standardisation — Q&A report.
