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There are currently more than 800 harmonised standards listed in the Official Journal of the European Union in accordance with the Machinery Directive 2006/42/EC. These technical standards ensure a high level of safety and protection for the users of machinery and other persons exposed to the machinery.
By being listed as a harmonised standard, these standards carry a presumption of conformity. This means that users of these documents can assume that the solutions and measures described in the standards are suitable for fulfilling the legal requirements of the directive, for which they were developed by the European standardisation organisations CEN/CENELEC on behalf of the EU Commission.
The need for harmonised standards was also substantiated by the new publication of the Machinery Regulation in June 2023. This is the subject of this article.
Changed requirements as part of the Machinery Regulation
Most of the legal requirements of the Machinery Directive can also be found in the new Machinery Regulation (EU) 2023/1230. However, the revision has also resulted in amended or completely new essential health and safety requirements (EHSRs for short), such as "Protection against corruption" (Annex III, 1.1.9) or "Risk of contact with live overhead lines" (Annex III, 3.5.4.), so that harmonised standards must at least be reviewed and, if necessary, adapted to the new requirements of the regulation. You can find an overview of the most important changes to the new Machinery Regulation 2023/1230 in our technical article on the new Machinery Regulation.
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Changeover to the new Machinery Regulation
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The topic of harmonised standards was already communicated in the first draft of the new Machinery Regulation 2021, which was published for public comment. In a position paper, CEN/CENELEC pointed out the difficulty of adapting all harmonised standards to the new requirements within the 30-month period set by the European Commission until the date of application. At that time, an extension of the deadline from 30 to 36 months was proposed, but this was not taken into account when the regulation was finally published in June 2023.
Presumption of conformity under the Machinery Directive = presumption of conformity under the Machinery Regulation?
At the end of 2023, the planned adaptation of the harmonised standards took a new turn: Instead of fully revising all existing harmonised standards before the date of application of the Machinery Regulation, an interim solution is being pursued whereby a large proportion of the existing standards will also be cited under the Machinery Regulation. Where these standards already cover the corresponding essential health and safety requirements of the Machinery Regulation, they can also provide a presumption of conformity under the new Regulation. However, newly introduced requirements cannot be covered by these documents without revision. Where gaps exist, references to standards may therefore be published with restrictions on the presumption of conformity.
According to CEN and CENELEC, the review is being carried out as part of a so-called ‘gap analysis’. The individual technical committees tasked with drawing up harmonised standards under the Machinery Regulation are thus required to review the changes to the EHSRs relevant to their standards and incorporate them within a timeframe set by the Commission.3According to the latest information from the European Commission, the majority of the harmonised standards currently listed in the Official Journal of the EU under the Machinery Directive are also to be cited under the Machinery Regulation in the fourth quarter of 2026. Provided these standards cover the relevant essential health and safety requirements of the MR, they can thus also give rise to a presumption of conformity under the new Regulation. Where gaps remain, restrictions on the presumption of conformity may be necessary.More than 600 of the approximately 800 harmonised standards have now been assessed as part of the gap analysis. According to the latest communicated schedule, the analysis of the remaining standards is expected to be completed by the end of the third quarter of 2026.4
In addition to the review of existing standards, the standardisation request also provides for their scheduled revision. As part of this revision, the technical committees are to take into account the requirements of the Machinery Regulation in addition to the EHSRs under the Machinery Directive. The timeframe is tighter for new harmonised standards specifically addressing the new requirements introduced by the Machinery Regulation. According to information provided by the European Commission in August 2026, no corresponding harmonised standards had yet been submitted to the Commission by the European standardisation organisations, in particular for the new requirements relating to cybersecurity and artificial intelligence.
New editions of European standards published during the transitional period before 20 January 2027 that are intended to support both the Machinery Directive and the Machinery Regulation need to take the requirements of both legal acts into account. In addition to the existing Annex ZA (linking a European standard to the EHSRs of Directive 2006/42/EC), these documents are therefore expected to also include an Annex ZB for Machinery Regulation (EU) 2023/1230. Users of standards may already be familiar with this use of two Annex Z sections from the previous transition from Machinery Directive 98/37/EC
Standardisation request to CEN/CENELEC
On 20 January 2025, the European Commission adopted the final standardisation request. This decision, addressed to CEN and CENELEC, provides the basis for the development of harmonised standards (hENs) in support of Machinery Regulation (EU) 2023/1230.
To fulfil the standardisation request, CEN and CENELEC are to develop harmonised standards covering the relevant requirements of the Machinery Regulation. As outlined above, it must be taken into account whether these standards are intended to cover EHSRs newly introduced by the Machinery Regulation or requirements already contained in the Machinery Directive. The standardisation mandate also explicitly addresses interfaces with other regulations:
In order to fulfil the standardisation request, CEN and CENELEC are to develop harmonised standards covering the relevant requirements of the Machinery Regulation. As outlined above, it must be taken into account whether these standards are intended to cover EHSRs newly introduced by the Machinery Regulation or requirements already contained in the Machinery Directive.
The detailed annex to the standardisation request, which lists the relevant safety requirements of the Machinery Regulation, is therefore divided into two groups:
Annex I focuses on the new product categories and technology fields introduced by the Machinery Regulation whose safety objectives are to be covered by NEW harmonised standards. For these priority standardisation activities, Phase 1 of the standardisation request originally envisaged adoption by CEN or CENELEC by 20 January 2026. However, this schedule could not be met for all standardisation activities:
Annex II lists the product categories and technology fields already covered under the Machinery Directive whose safety objectives are to be addressed by revising EXISTING harmonised standards that already provide a presumption of conformity under the Machinery Directive within the framework of Implementing Decision (EU) 2023/1586. Phase 1 of the standardisation request likewise originally set 20 January 2026 as the deadline for confirming existing standards or adopting corresponding successor standards.
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Our 2-day seminar Efficient CE marking and risk assessment of machinery and plants deals with requirements for safe design of machinery – and covers both the Machinery Directive 2006/42/EC and the new Machinery Regulation (EU) 2023/1230.
Outlook
The European Commission adopted the standardisation request on 20 January 2025. The adoption of priority standards envisaged for Phase 1 by 20 January 2026 could not be achieved for all standardisation activities.
Attention is now primarily focused on the first publication of references to harmonised standards under the Machinery Regulation. According to the latest information from the European Commission, the majority of the harmonised standards currently cited under the Machinery Directive are expected to also be cited under the Machinery Regulation in the fourth quarter of 2026. This is intended to provide a broad standards framework in time for the date of application of the Machinery Regulation on 20 January 2027.
You can open and download the full text of the standardisation request via the following links:
Standardisation requestmachinery regulation (main text)
Standardisation request (Annexes)
At the latest meeting of the Machinery Expert Group, CEN and CENELEC provided an update on their standardisation activities relating to the new Machinery Regulation. This update was included in the MEG meeting minutes published at the end of June.
The gap analysis is progressing: since February 2025, more than 600 of the approximately 800 harmonised standards have been assessed. According to the latest communicated schedule, the analysis of the remaining standards is expected to be completed by the end of the third quarter of 2026.
A revision of Annex Z, which describes the relationship between a harmonised standard and the EHSRs of the relevant legal act, is also planned. In future, it is intended to list all relevant requirements in order to provide a clearer overview. The new template has already been made available to the technical committees developing standards in support of the Machinery Regulation.
Among the new standards addressing the newly introduced cybersecurity requirements, prEN 50742 on protection against corruption currently has a high priority. The final vote is currently scheduled for September 2026, with final publication potentially following in November.
At the MEG meeting, it was also announced that a further 67 standards, including numerous outstanding ISO and IEC standards, are expected to be published in the Official Journal under the Machinery Directive. This could represent one of the final major updates to the list of harmonised standards under the Machinery Directive before the first references to harmonised standards under the new Machinery Regulation are published.
Footnote:1 See CEN/CENELEC webinar on the new Machinery Regulation2 See KAN Brief 03/2023 of the Commission for Occupational Health and Safety and Standardisation3 See CEN/CENELEC Webinar "Gap analysis"4 See CEN/CENELEC Update "Harmonized standards in support of the Machinery Directive– State of play"
Posted on: 2026-08-25 (last amendment)
Daniel Zacek-Gebele, MSc Product manager at IBF for additional products and data manager for updating standards data on the Safexpert Live Server. Studied economics in Passau (BSc) and Stuttgart (MSc), specialising in International Business and Economics. Email: daniel.zacek-gebele@ibf-solutions.com | www.ibf-solutions.com
Christian Aumann, Dipl.-Ing. (FH) Specialist for CE marking and Safexpert. Since 2023 in product management at IBF. Before that, he worked as a design engineer in special machine construction and as an occupational safety expert (SiFa). Studied mechanical engineering at the OTH Regensburg with a focus on production and automation technology.
Email: christian.aumann@ibf-solutions.com | www.ibf-solutions.com
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