Machinery Regulation (EU) 2023/1230: specific requirements and what to do before January 2027

What changes and when

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.

The specific requirements introduced

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

Why it also concerns warehouses and plants

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.

What to do now

• Map the products in your catalogue and check whether they fall under the new Annex I, with the resulting conformity assessment procedures;
• Update the risk assessment and the technical file against the Regulation's essential requirements;
• Review instructions and documentation, considering the move to digital format in compliance with the applicable obligations;
• Define an internal procedure for managing substantial modifications to machinery and plants already in service;
• Plan market placement around the 20 January 2027 deadline.

How we support companies

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.

Regulatory references

Regulation (EU) 2023/1230  •  Machinery Directive 2006/42/EC  •  Italian Legislative Decree 81/2008  •  CSLLPP Guidelines — Steel racking

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