What does Article 10 require?

Article 10 of Regulation 2023/1230 imposes three concrete obligations on the manufacturer or their authorised representative:

Does Article 10 of Regulation 2023/1230 apply now or only from January 2027?

Regulation 2023/1230 entered into force on 19 July 2023, but a transitional period allows machines compliant with Directive 2006/42/EC to continue to be placed on the market until 13 January 2027. From 14 January 2027, all new machines placed on the EU market must fully comply with Regulation 2023/1230, including Article 10 and the Annex III EHSRs in their new wording. Manufacturers designing machines today that will not reach the market until 2027 or later should base their design on the new Regulation now.

Do harmonised standards published under Directive 2006/42/EC still apply under Regulation 2023/1230?

In principle yes, until they are replaced. The European Commission will publish in the Official Journal a new list of harmonised standards under Regulation 2023/1230. Until that list is published or a standard is formally withdrawn, existing harmonised standards under Directive 2006/42/EC retain the presumption of conformity for the equivalent EHSRs in the new Regulation. It is advisable to monitor the status of each standard regularly in the Commission's NANDO database and the Official Journal of the EU (C series).

What are the main differences between the EHSRs in Regulation 2023/1230 and those in Directive 2006/42/EC?

The structure of Annex III of Regulation 2023/1230 is very similar to Annex I of Directive 2006/42/EC, which eases the transition. The main changes are: new EHSRs specifically addressing machines with software and digital control systems (including AI integrated into the machine), reinforced cybersecurity requirements for the control system, and clarifications for domestic-use machinery. For most conventional industrial machines, the applicable EHSRs are equivalent to those under the previous Directive, although manufacturers should review their technical file against the new numbering and wording of Annex III.

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Article 10 of the Machinery Regulation 2023/1230 — Essential Health and Safety Requirements (EHSRs): Hierarchy, EN Standards and Technical File

Equip IgeraSolutions

July 1, 2026

12 min read

Técnico de seguridad verificando requisitos esenciales RESS en línea de producción industrial

#artículo 10 reglamento máquinas 2023/1230#requisitos esenciales salud seguridad RESS maquinaria#Anexo III reglamento máquinas normas armonizadas#EN ISO 12100 EN 60204-1 maquinaria CE#IgeraIndustria RESS expediente técnico

Article 10 of the Machinery Regulation 2023/1230 — Essential Health and Safety Requirements (EHSRs): Hierarchy, EN Standards and Technical File

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