Machinery Regulation (EU) 2023/1230

Last reviewed: May 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inclusive, Directive 2006/42/EC continues to apply; from 20 January 2027, the Regulation applies and the Directive is repealed (Article 50 of Regulation 2023/1230). Certain provisions, including those on Notified Bodies and the Commission's powers to adopt implementing acts, applied earlier — Notified Body provisions have been in force since 14 January 2024.

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 IV): 14 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. Manufacturers may place products on the market under either Directive 2006/42/EC (until 19 January 2027) or — by anticipation — under the Regulation once Notified Bodies are designated and harmonised standards have been published in the OJEU for it. Products lawfully placed on the market before 20 January 2027 under Directive 2006/42/EC remain so under Article 50(2) of the Regulation; they are not retroactively subject to the Regulation.

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) explicitly includes "software ensuring a safety function" within the scope of safety components. 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 for the same use as the original parts and supplied by the original manufacturer; equipment for use in fairgrounds and amusement parks; certain marine equipment covered by the Marine Equipment Directive; firearms (including those for civilian use covered by Directive (EU) 2021/555); means of transport (motor vehicles, agricultural and forestry vehicles, two- and three-wheel vehicles, aircraft, water-borne vessels other than those in Article 2(1)); and certain electrical equipment covered exclusively by the Low Voltage Directive (specifically: household appliances intended for domestic use, audio and video equipment, IT equipment, ordinary office machinery, low-voltage switchgear and control gear, and electric motors). Manufacturers of these excluded electrical products apply only the Low Voltage Directive and EMC Directive, 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:

• Part 1 — General EHSRs. Principles of safety integration; lighting; markings; mobility; risk assessment.
• Part 1.1 — Risk assessment. 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).
• Part 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.
• Part 1.3 — Mechanical hazards; Part 1.4 — protective measures; Part 1.5 — physical, chemical, biological hazards; Part 1.6 — maintenance; Part 1.7 — information.
• Parts 2–6 — Supplementary EHSRs for foodstuffs, hand-held and portable machinery, machinery for working wood, mobile machinery (Part 3), lifting (Part 4), underground work (Part 5), and lifting persons (Part 6).

Cybersecurity and AI

Annex III, Part 1.2.1, requires that control systems be designed so that "corruption of communication that could lead to a hazardous situation is prevented", and that the connection to other equipment, including remote connections, does not lead to a hazardous situation. This is the first explicit cybersecurity requirement in machinery law. Part 1.1.6 addresses machinery that "evolves" — i.e., machinery whose behaviour can change after placing on the market — requiring that any evolution remains within the limits assessed at the time of conformity assessment, or that a fresh assessment is performed if it does not.

Annex I: high-risk machinery and category lists

Annex I of Regulation 2023/1230 lists categories of high-risk machinery for which third-party conformity assessment is mandatory if harmonised standards are not applied in full. This replaces Annex IV of Directive 2006/42/EC. The list includes:

• Removable mechanical transmission devices and their guards;
• Guards for removable mechanical transmission devices placed on the market separately;
• Vehicle servicing lifts;
• Devices for lifting persons or persons and goods involving a risk of falling from a vertical height of more than three metres;
• Portable cartridge-operated fixing and other impact machinery;
• Machinery for the manufacture of pyrotechnic articles.

Annex I distinguishes two parts: Part A lists the original 23 categories (carried over with limited changes from former Annex IV); Part B contains a new sub-list of machinery embedding "safety-related software" or AI components performing safety functions, for which third-party assessment may be required regardless of standards applied — this is the most substantive structural change.

Conformity assessment procedures

Article 25 and Annex XI set out the conformity assessment procedures. For machinery not in Annex I, the manufacturer applies Module A (internal production control). For machinery in Annex I:

• If harmonised standards covering all relevant EHSRs have been applied in full, the manufacturer may use Module A. Otherwise:
• The manufacturer must use Module B (EU type-examination) combined with Module C (conformity to type based on internal production control), or Module H (full quality assurance).

For Annex I Part B (safety-related software/AI), the Regulation tightens the conditions under which Module A is available — in practice, third-party assessment is the default unless very specific harmonised standards exist. The Commission's standardisation request M/396 (revised under Regulation 2023/1230) covers the development of harmonised standards for the new requirements; new editions of EN ISO 12100, EN ISO 13849-1, and product-specific Type C standards are being developed to align with the Regulation.

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(8) requires the technical documentation to be kept for ten years after the last unit was placed on the market and made available to authorities on reasoned request. See technical documentation.

EU Declaration of Conformity

Article 10(5) and Annex V (Part A for machinery, Part B for partly completed machinery) set the Declaration's contents. In addition to the elements required by Annex III of Decision 768/2008/EC, the Declaration must include the name and address of the person authorised to compile the technical file, who must be established in the Union, and where applicable the EU type-examination certificate number and the issuing Notified Body. Article 10(7) explicitly allows the Declaration to be supplied in digital format — 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 IV Part B). The CE mark is not affixed; partly completed machinery is not in itself ready for use.

Marking and labelling

Article 17 requires machinery to bear the CE marking and, where applicable, the four-digit identification number of the Notified Body. Beyond the CE marking, machinery must bear at minimum:

• The business name and full address of the manufacturer and, where applicable, of the authorised representative;
• Designation of the machinery (e.g., type);
• Designation of series or type;
• Serial number, where applicable;
• Year of construction;
• Identification of any specific category that places it within Annex I.

Markings must be visible, legible, and indelible. The instructions for use must be supplied in the official language(s) of the Member State of destination — a long-standing requirement carried over from Directive 2006/42/EC. Article 10(7) explicitly permits instructions to be supplied in digital format, provided that paper instructions are made available on request without additional cost and that essential safety information for users is always 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 requirement. Annex III, Part 1.2.1 — protection of control systems against communication corruption.
• Evolving machinery (AI/machine learning). Annex III, Part 1.1.6 — limits on post-market evolution.
• Annex I structure. Part B for safety-related software/AI machinery.
• Digital format for instructions and Declaration. Article 10(7).
• Substantial modification. Article 18 explicitly defines when modification triggers a fresh conformity assessment, codifying the prior Blue Guide interpretation.
• Notified Body framework. Strengthened designation and surveillance under Articles 26–46.

The Commission is developing implementing and delegated acts under Articles 19, 21, and 47 to specify cybersecurity essential requirements, the list of Annex I Part B categories, and the procedure for substantial modifications. Several are expected to be adopted before the general date of application in January 2027.

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 1(2)(g) of the Machinery Regulation excludes certain electrical products covered exclusively by LVD; 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 installations covered by the Lifts Directive, which excludes them from the Machinery Regulation under Article 2(2).
• AI Act (Regulation (EU) 2024/1689) — for machinery embedding AI systems classified as high-risk under the AI Act.

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, 2017) — to be superseded by guidance specific to Regulation 2023/1230 — Commission.