Insights · August 2026
From 20 January 2027 the new Regulation replaces the Machinery Directive 2006/42/EC, with no transitional period
Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC from 20 January 2027. Moving from a directive to a regulation means direct application in all Member States, with no national transposition required, with the aim of harmonising how the rules are interpreted across the internal market.
One point to bear in mind when planning: there is no transitional period. Machinery placed on the market up to 19 January 2027 remains subject to Directive 2006/42/EC; machinery placed on the market from 20 January 2027 must comply with the new Regulation. For manufacturers with long product development cycles, the time left to adapt design, technical file and documentation is now limited.
| Area | What the Regulation provides |
|---|---|
| Scope | No longer just “machinery”, but “machinery and related products”: partly completed machinery, interchangeable equipment, safety components (including software), lifting accessories, chains, ropes and webbing |
| Annex I — high risk | Replaces Annex IV of the Directive. Expanded list, intended to be updated over time, with stricter conformity assessment procedures and involvement of a notified body for the listed products |
| Substantial modification | Definition extended to modifications made by physical or digital means after placing on the market, creating a new hazard or increasing an existing risk. Whoever makes the modification is treated as a new manufacturer, with the related obligations |
| Software and cybersecurity | Safety-related software is treated with the same criteria as safety components; requirements introduced on protection against tampering and data corruption |
| Self-evolving systems | Dedicated requirements for machinery and components with self-evolving behaviour (artificial intelligence), collaborative robots and autonomous guided vehicles, including assessment of the risks arising from coexistence with operators |
| Digital documentation | Instructions and the declaration of conformity may be supplied in digital format, with the obligation to make a paper version available on the user's request |
The subject does not only concern machinery manufacturers in the strict sense. Racking integrated into automated warehouses falls within the scope of the Machinery Regulation, as also noted by the Italian CSLLPP guidelines on steel racking. Likewise, the new definition of substantial modification has concrete effects on anyone reconfiguring, extending or interfacing existing plants: an intervention that introduces new hazards may make the user take on the role of manufacturer, with the duty to carry out a risk assessment, compile a technical file and apply the CE marking.
Stefano Luise Engineering S.r.l. supports manufacturers and users with risk assessment, preparation of the technical file and structural verification of components, in continuity with the work carried out on pressure equipment, lifting appliances and structures for automated warehouses.
Regulation (EU) 2023/1230 • Machinery Directive 2006/42/EC • Italian Legislative Decree 81/2008 • CSLLPP Guidelines — Steel racking
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