Machinery Regulation (EU) 2023/1230

Last reviewed: October 2026 · Legal status verified against EUR-Lex.

Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery is the principal piece of EU law on the safety of machinery. It replaces Directive 2006/42/EC (the Machinery Directive) and applies from 20 January 2027. The Regulation was published in the Official Journal of the European Union on 29 June 2023 (OJ L 165, 29.6.2023, p. 1) and entered into force on the twentieth day following publication. Until 19 January 2027 inclusive, Directive 2006/42/EC continues to apply; from 20 January 2027, the Regulation applies and the Directive is repealed (Article 51(2) of Regulation 2023/1230). Certain provisions applied earlier: the rules on the notification of conformity assessment bodies (Articles 26 to 42) have applied since 20 January 2024 (Article 54, as corrected by the corrigendum of 4 July 2023).

Legal status and timeline

• Adoption: 14 June 2023 (Council and Parliament).
• Publication in the OJEU: 29 June 2023 (OJ L 165).
• Entry into force: 19 July 2023.
• Application of Notified Body provisions (Chapter V, Articles 26–42): 20 January 2024.
• General date of application: 20 January 2027.
• Repeal of Directive 2006/42/EC: 20 January 2027.

The transitional regime is asymmetric. Conformity assessment bodies were able to apply for designation under the Regulation from January 2024, so that designated Notified Bodies are in place ahead of the application date. There is no option to apply the Regulation early: products placed on the market up to and including 19 January 2027 must comply with Directive 2006/42/EC, and products placed on the market from 20 January 2027 must comply with the Regulation. Under Article 52(1), Member States may not impede the making available of products placed on the market in conformity with Directive 2006/42/EC before 20 January 2027; they are not retroactively subject to the Regulation. Under Article 52(2), EC type-examination certificates issued under Article 12 of the Directive remain valid until they expire.

Scope: products covered

Article 2(1) of Regulation 2023/1230 applies to:

• Machinery — defined in Article 3(1) as "an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application".
• Interchangeable equipment — items mounted on machinery or on a tractor to modify or add a function, not a tool.
• Safety components — components placed on the market separately whose failure or malfunction endangers safety, including software performing a safety function.
• Lifting accessories — components not attached to lifting machinery but enabling load-holding.
• Chains, ropes and webbing — when designed and constructed for lifting purposes.
• Removable mechanical transmission devices.
• Partly completed machinery — an assembly that is almost machinery but cannot perform a specific application on its own, intended to be incorporated into other machinery.

Inclusion of software

Article 3(3) defines a safety component as "a physical or digital component, including software", designed or intended to fulfil a safety function and independently placed on the market. This is a substantive extension over Directive 2006/42/EC, under which standalone safety software occupied a contested place. Under the Regulation, safety software placed on the market separately is itself a safety component requiring CE marking, technical documentation, and (where applicable) a Notified Body assessment.

Exclusions

Article 2(2) excludes inter alia: safety components intended as spare parts to replace identical components and supplied by the original manufacturer; specific equipment for use in fairgrounds or amusement parks; weapons, including firearms; means of transport by air, on water and on rail networks, motor vehicles, two- or three-wheel vehicles and agricultural and forestry tractors within their type-approval regulations (in each case except for machinery mounted on them); seagoing vessels and mobile offshore units and machinery installed on board; mine winding gear; and certain electrical and electronic products insofar as they fall within the scope of the Low Voltage Directive or the Radio Equipment Directive (household appliances intended for domestic use which are not electrically operated furniture, audio and video equipment, IT equipment, ordinary office machinery other than additive printing machinery for producing three-dimensional products, low-voltage switchgear and control gear, and electric motors). Manufacturers of these excluded electrical products apply the Low Voltage Directive or Radio Equipment Directive (and the EMC Directive where relevant), not the Machinery Regulation.

Essential health and safety requirements

Annex III sets out the essential health and safety requirements (EHSRs). The structure follows that of Annex I of Directive 2006/42/EC but with significant additions:

• Chapter 1 — General EHSRs, applicable to all machinery: general remarks (section 1.1, including principles of safety integration, lighting, ergonomics and protection against corruption) and the sections listed below.
• Risk assessment (Annex III, Part B, general principles). Manufacturers must identify hazards, estimate risks, evaluate risks, and eliminate or reduce risks by design, then by safeguarding, then by user information (the hierarchy is unchanged from the predecessor).
• Section 1.2 — Control systems. Includes new provisions for software safety, cybersecurity protection where it affects safety, and machine-learning components that may evolve over the lifecycle.
• Section 1.3 — Mechanical hazards; section 1.4 — guards and protective devices; section 1.5 — other hazards (electrical, physical, chemical, biological); section 1.6 — maintenance; section 1.7 — information.
• Chapters 2–6 — Supplementary EHSRs for machinery for foodstuffs, cosmetics or pharmaceutical products, portable hand-held or hand-guided machinery, woodworking machinery and machinery for applying plant protection products (Chapter 2), mobility (Chapter 3), lifting (Chapter 4), underground work (Chapter 5), and lifting persons (Chapter 6).

Cybersecurity and AI

Annex III, section 1.1.9 ("Protection against corruption"), requires that the connection of another device, including via a remote device, does not lead to a hazardous situation, and that safety-critical software, data and hardware components are adequately protected against accidental or intentional corruption, with evidence of interventions collected. Section 1.2.1 further requires control systems to withstand reasonably foreseeable malicious attempts from third parties leading to a hazardous situation. These are the first explicit cybersecurity requirements in machinery law. For machinery with fully or partially self-evolving behaviour or logic, the general principles require the risk assessment to cover hazards from its intended evolution that are foreseeable at the time of placing on the market, and section 1.2.1 requires that the control system does not cause the machinery to perform actions beyond its defined task and movement space and that it can be corrected at all times to maintain its inherent safety.

Annex I: high-risk machinery and category lists

Annex I of Regulation 2023/1230 replaces Annex IV of Directive 2006/42/EC and lists the categories of machinery and related products that are subject to stricter conformity assessment. It is split into two parts with different consequences.

Part A — Notified Body always required (6 categories)

1. Removable mechanical transmission devices including their guards;
2. Guards for removable mechanical transmission devices;
3. Vehicle servicing lifts;
4. Portable cartridge-operated fixing and other impact machinery;
5. Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions;
6. Machinery with embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed on the market independently, in respect only of those systems.

Part B — Notified Body required unless harmonised standards are applied in full (19 categories)

Part B carries over most of the former Annex IV list, for example circular and band saws for wood, hand-fed surface planing machinery, manually loaded presses (including press brakes) for the cold working of metals, injection and compression moulding machinery, machinery for underground working, refuse collection vehicles with manual loading, devices for lifting persons or persons and goods involving a hazard of falling from a vertical height of more than three metres, protective devices designed to detect persons, roll-over and falling-object protective structures, and safety components including logic units for safety functions.

Conformity assessment procedures

Article 25 sets out the routes; the modules themselves are in Annexes VI to X.

The Part A entries for machine-learning safety functions are the most significant structural change: for these systems, third-party assessment is mandatory regardless of the standards applied. The Commission has issued a standardisation request for harmonised standards supporting the Regulation, and new editions of EN ISO 12100, EN ISO 13849-1 and product-specific type-C standards are being developed to align with it. See conformity assessment modules for what each module involves.

Technical documentation

Annex IV sets the contents of the technical file (referred to as the "technical construction file" in industry usage). Part A applies to machinery; Part B to partly completed machinery. The Part A file must contain:

• A general description of the machinery;
• The overall plan, control circuit drawings, full detailed drawings with calculations, test results, certificates;
• Documentation on the risk assessment, including a list of EHSRs that apply and a description of measures taken to eliminate or reduce risks;
• Standards and technical specifications used, indicating EHSRs covered;
• Technical reports giving the results of tests carried out by the manufacturer or a chosen body;
• A copy of the instructions for use;
• For series production, the internal measures used to ensure conformity of all machinery produced.

Article 10(3) requires the technical documentation and the EU Declaration of Conformity to be kept at the disposal of market surveillance authorities for at least ten years after the machinery has been placed on the market or put into service; where relevant, source code or programming logic must be made available on reasoned request. See technical documentation.

EU Declaration of Conformity

Article 21 and Annex V (Part A for machinery, Part B for partly completed machinery) set the Declaration's contents. In addition to the elements of the model in Annex III of Decision 768/2008/EC, the Declaration must include, for lifting machinery that can only be assembled at the place of use, the address of that place, and where applicable the Notified Body's name and number and the EU type-examination certificate reference. Article 10(8) explicitly allows the manufacturer to give, in the instructions, an internet address or machine-readable code where the Declaration can be accessed instead of supplying it physically — one of the key procedural modernisations of the Regulation. See EU Declaration of Conformity.

Partly completed machinery

For partly completed machinery, the manufacturer issues an EU Declaration of Incorporation (Annex V Part B) rather than a full Declaration of Conformity, and supplies assembly instructions (Annex XI). The CE mark is not affixed; partly completed machinery is not in itself ready for use.

Marking and labelling

Article 24 requires machinery to bear the CE marking and, where a Notified Body is involved, its four-digit identification number. Beyond the CE marking, machinery must bear at minimum (Article 10(5) and (6), Annex III section 1.7.3):

• The manufacturer's name, registered trade name or registered trade mark, and postal address and website, e-mail address or other digital contact;
• Designation of the model, series or type;
• Batch or serial number or other identification element, where one exists;
• Year of construction (the year in which the manufacturing process was completed);
• Where applicable, marking for use in potentially explosive atmospheres and the mass of parts handled with lifting equipment.

Markings must be visible, legible, and indelible. The instructions for use must be in a language easily understood by users, as determined by the Member State concerned. Article 10(7) explicitly permits instructions to be supplied in digital format, provided that the user can obtain a paper copy free of charge within one month on request made at the time of purchase and that, for machinery intended for or reasonably foreseeably used by non-professional users, the safety information essential for putting into service and safe use is supplied on paper.

Recent and upcoming changes

Material changes from Directive 2006/42/EC to Regulation 2023/1230:

• Regulation, not Directive. Direct application across Member States; no national transposition required. This eliminates the inconsistencies between Member State implementations of the Directive.
• Inclusion of software safety functions. Safety software placed on the market separately is now a safety component.
• Cybersecurity essential requirements. Annex III, sections 1.1.9 and 1.2.1 — protection against corruption and against reasonably foreseeable malicious attempts.
• Self-evolving machinery (AI/machine learning). Annex III, general principles and section 1.2.1 — risk assessment of intended evolution and limits on the task and movement space.
• Annex I structure. Part A (six categories, Notified Body always required, including machine-learning safety functions) and Part B (19 categories, Module A allowed only with full application of harmonised standards).
• Digital format for instructions and Declaration. Article 10(7) and (8).
• Substantial modification. Article 3(16) defines a substantial modification and Article 18 treats the person who carries it out as a manufacturer, who must carry out a fresh conformity assessment, codifying the prior Blue Guide interpretation.
• Notified Body framework. Strengthened designation and surveillance under Articles 26–42.

The Commission may amend the Annex I list by delegated act (Article 6) and has issued a standardisation request so that harmonised standards supporting the Regulation are available for the general date of application in January 2027. Until standards citing Regulation 2023/1230 are published in the OJEU, the Annex I Part B route through Module A is only open where such standards exist.

Related legislation

Machinery is rarely covered only by the Machinery Regulation. Typical stacking:

• EMC Directive 2014/30/EU — for electromagnetic compatibility of electrically powered machinery.
• Low Voltage Directive 2014/35/EU — Article 2(2)(p) of the Machinery Regulation excludes certain electrical products falling within the scope of the LVD or RED; for most industrial machinery, LVD's safety requirements are absorbed into the Machinery Regulation but it remains a useful technical reference.
• Radio Equipment Directive 2014/53/EU — for machinery containing wireless modules.
• ATEX Directive 2014/34/EU — for machinery intended for use in potentially explosive atmospheres.
• Pressure Equipment Directive 2014/68/EU — for machinery integrating pressure equipment above the thresholds.
• RoHS Directive 2011/65/EU — for the electrical and electronic equipment within machinery.
• Outdoor Equipment Noise Directive 2000/14/EC — for outdoor machinery emitting noise.
• Lifts Directive 2014/33/EU — for lifts permanently serving buildings and structures; as more specific legislation, it displaces the Machinery Regulation for the risks it covers (Article 9).
• AI Act (Regulation (EU) 2024/1689) — following amendment by Regulation (EU) 2026/1744 (Digital Omnibus on AI, in force since 27 July 2026), the Machinery Regulation is listed in Section B of AI Act Annex I, so the AI Act's high-risk requirements do not apply directly to machinery; instead, the Commission is to insert equivalent health and safety requirements for high-risk AI systems into Annex III of the Machinery Regulation by delegated acts, by 2 August 2028.

Sources

• Regulation (EU) 2023/1230 of 14 June 2023 on machinery — EUR-Lex consolidated text.
• Directive 2006/42/EC on machinery (predecessor) — EUR-Lex.
• European Commission — Machinery sector (Single Market and Standards).
• Commission Notice — Blue Guide 2022 — EUR-Lex.
• Commission Guide to application of the Machinery Directive 2006/42/EC (edition 2.2, 2019) — to be superseded by guidance specific to Regulation 2023/1230 — Commission.