When is Directive 2006/42/EC replaced by Regulation (EU) 2023/1230?

Regulation (EU) 2023/1230 was adopted on 14 June 2023 and published in the Official Journal on 29 June 2023. Full application is set for 20 January 2027, the date on which Directive 2006/42/EC is repealed under its Article 50. A few provisions, mainly those covering the designation of notified bodies and the Commission's delegated powers, apply earlier. Machinery placed on the market before 20 January 2027 under Directive 2006/42/EC can continue to circulate under the transitional provisions of Article 50.

Which machines are listed in Annex IV of Directive 2006/42/EC?

Annex IV lists twenty-three categories of machinery considered as high-risk, including circular saws for wood and meat, surface planing machines, thicknessers, band saws with mobile cutting tools for wood, presses, press-brakes, injection moulding machines, machinery for underground work, refuse collection vehicles, vehicle servicing lifts, portable cartridge-operated fixing tools, presence-detection protective devices, safety logic units and rollover or falling-object protective structures (ROPS and FOPS). For these machines, plain self-assessment is not allowed.

What conformity assessment routes exist under 2006/42/EC?

For machinery outside Annex IV, the manufacturer performs an internal conformity assessment (Article 12 paragraph 2) using harmonised standards published in the OJEU, which carry the presumption of conformity with the Annex I essential requirements. For Annex IV machinery, three routes are available: self-assessment remains possible if harmonised standards cover the machine in full and are applied (Article 12 paragraph 3), failing which EC type-examination by a notified body (Article 12 paragraph 4) or full quality assurance under module H (Article 12 paragraph 4 point b) become mandatory.

What is the difference between a complete machine and partly completed machinery?

A complete machine is an assembly fitted, or intended to be fitted, with a drive system other than directly applied human or animal effort, composed of linked parts for a defined application and ready to function. It bears the CE marking and is accompanied by an EU declaration of conformity (Annex II point 1 A). Partly completed machinery, defined in Article 2 point g, is an assembly that cannot perform a specific application on its own and is intended to be incorporated into another machine. It does not carry the CE marking under 2006/42/EC and is accompanied by a declaration of incorporation (Annex II point 1 B) and assembly instructions. The directive applies to the final assembled machine.

Which standard structures the machine risk assessment?

EN ISO 12100 is the base standard. It describes the method in three steps: identification of hazards (mechanical, electrical, thermal, ergonomic, environmental), risk estimation (severity, frequency, avoidability) and risk evaluation (tolerable or not). It defines the risk-reduction hierarchy: inherent design prevention, protective measures and complementary devices, user information. Risk assessment is iterative and documented in the machine technical file under Annex VII.

Does a machine under 2006/42/EC already need to comply with the Cyber Resilience Act?

Regulation (EU) 2024/2847 (CRA) applies to products with digital elements placed on the EU market. An industrial machine equipped with a network interface, a programmable logic controller or embedded software falls within CRA scope from its full application on 11 December 2027. Regulation 2023/1230 on machinery also introduces its own cybersecurity requirements applicable to safety functions, complementary to the CRA. The two texts coexist and apply in parallel: compliance with one does not exempt from the other.

What is the declaration of incorporation for partly completed machinery?

The declaration of incorporation, under Annex II point 1 B, certifies that the partly completed machinery meets the Annex I essential requirements applicable to it and that it shall not be put into service until the final machine in which it is to be incorporated has been declared in conformity. It is accompanied by assembly instructions enabling correct integration. The manufacturer of the final machine takes over the global risk assessment and overall conformity. The declaration of incorporation does not authorise CE marking of the partly completed machinery under the machinery directive.

Is Directive 2014/33/EU on lifts replaced by 2023/1230?

No. Directive 2014/33/EU remains a separate text dedicated to lifts permanently installed in buildings and constructions. Regulation 2023/1230 explicitly excludes lifts within the meaning of 2014/33/EU from its scope. Lifting equipment not covered by 2014/33/EU (lifting tables, industrial goods hoists, overhead cranes, manual hoists) remains under the machinery directive and then under 2023/1230. The boundary between the two texts is clarified in recital 51 of Regulation 2023/1230.

Machinery Directive 2006/42/EC and Regulation (EU) 2023/1230

Author Hugues Orgitello Last updated 27 May 2026 ~15 min read

Guide - Machinery Directive

Directive 2006/42/EC has governed the placing of machinery on the European market since 2009, covering machines, safety components, lifting accessories and partly completed machinery. Adopted under the New Approach, it sets the baseline of Essential Health and Safety Requirements (EHSRs) and organises the presumption of conformity through harmonised standards listed in the Official Journal. On 14 June 2023 the European legislator replaced it with Regulation (EU) 2023/1230, applicable from 20 January 2027. This guide presents the current scope of 2006/42/EC, the Annex IV list of high-risk machinery, the conformity assessment routes, the reference harmonised standards (EN ISO 12100, EN 60204-1, EN ISO 13849-1, EN ISO 14119), the handling of partly completed machinery, and details the key changes brought by Regulation 2023/1230, including the new cybersecurity and artificial intelligence requirements together with the transition timeline.

Scope of Directive 2006/42/EC

Directive 2006/42/EC applies to equipment placed on the EU internal market. Article 1 defines four product categories, each with its own obligations regarding assessment, marking and documentation.

Category	Definition (Article 2)	CE marking	Declaration
Machinery	Assembly fitted with a drive system other than human or animal effort, composed of linked parts, ready for a defined application	Yes	EU declaration of conformity (Annex II 1 A)
Safety components	Components placed separately on the market, serving a safety function whose failure may endanger the safety of persons	Yes	EU declaration of conformity (Annex II 1 A)
Lifting accessories	Components or equipment not attached to the lifting machine, placed between the machine and the load or on the load	Yes	EU declaration of conformity (Annex II 1 A)
Partly completed machinery	Assembly that cannot perform a specific application on its own, intended to be incorporated into other machinery or partly completed machinery	No	Declaration of incorporation (Annex II 1 B) + assembly instructions

The scope covers industrial robots, machine tools, presses, manufacturing automation, conveyors, pumps, compressors, construction equipment, mobile elevating work platforms, powered industrial trucks, agricultural machinery, hand-held power tools and many motor-driven domestic appliances. Excluded products include, among others, motor vehicles covered by Regulation 2018/858, machinery specifically designed for nuclear use, electrical equipment of the Low Voltage Directive 2014/35/EU in the absence of moving parts, and lifts within the meaning of Directive 2014/33/EU.

The articulation with general CE marking is treated in the CE marking guide. The transversal procedure is described in the CE procedure and the directive-by-directive scope in CE scope.

Essential Health and Safety Requirements (Annex I)

Annex I structures the requirements into thirteen thematic sections, from design principles to specifics for lifting, mobility, agri-food applications and hand-held machinery. The EHSRs are not optional: every applicable requirement must be identified, addressed and traced in the technical file.

Section	Theme
1.1 to 1.7	General: risk assessment, materials, lighting, ergonomics, seating, signals and markings
2	Requirements for specific categories: agri-food, pharmaceutical and chemical, hand-held machinery, woodworking machinery
3	Hazards due to mobility
4	Hazards due to lifting operations
5	Machinery intended for underground work
6	Hazards due to the lifting of persons

Section 1.1.2, titled "Principles of safety integration", organises the hierarchy applicable to the designer:

Eliminate or reduce hazards through design and construction (inherent prevention).
Take protective measures in relation to hazards that cannot be eliminated.
Inform users of residual hazards through warning notices, markings and instructions.

This hierarchy is strictly ordered: no warning measure can substitute for a protective measure that was technically possible. The rule also structures market-surveillance case law: a machine that relies primarily on warnings where design could have eliminated the hazard is considered non-compliant with the EHSRs, irrespective of the presence of the CE marking.

Annex IV: high-risk machinery

Annex IV lists categories of machinery for which the legislator considered the risk high enough to exclude pure self-assessment and require a traced conformity route, generally with notified-body involvement or a formal quality system.

Sub-category	Examples
Wood and similar materials	Circular saws with one or several blades, table-mounted band saws, surface planing machines, thicknessers, portable chain saws
Metal and plastics	Presses, press-brakes, injection or compression moulding machinery for plastics or rubber with manual loading
Underground equipment	Hydraulic powered roof supports, locomotives and brake-vans for use in mines
Lifting and handling	Manually loaded household refuse vehicles, vehicle servicing lifts, lifting devices for persons with a vertical fall risk of more than three metres
Safety devices and components	Safety logic units, electro-sensitive or optoelectronic protective devices (light curtains, area scanners), ROPS and FOPS
Portable cartridge-operated devices	Hand-held fixing tools, other impact machinery

The complete list contains twenty-three entries. Any machine falling within one of these categories must follow a regulated route, with no possibility of free self-declaration based solely on internal analysis.

Conformity assessment routes

Article 12 organises three routes, depending on whether the machine falls under Annex IV and on the manufacturer's choice.

Machinery outside Annex IV

A single route applies: conformity assessment with internal checks of manufacture (Article 12 paragraph 2). The manufacturer compiles the Annex VII A technical file, performs the risk assessment under EN ISO 12100, applies relevant harmonised standards, conducts the necessary tests, issues the EU declaration of conformity and affixes the CE marking. No notified body is involved.

Machinery listed in Annex IV

Three routes are available:

Conditional self-assessment (Article 12 paragraph 3 point a): applicable if the machine is designed and built in full compliance with the harmonised standards published in the OJEU that cover all the applicable Annex I EHSRs. If a single EHSR is not covered by an applied harmonised standard, this route closes.
EC type-examination (Article 12 paragraph 4 point a): examination by a notified body of a specimen machine. The body issues an EC type-examination certificate valid for five years (renewable). The manufacturer then produces units conformant to the approved type under internal control.
Full quality assurance (Article 12 paragraph 4 point b), module H: the manufacturer operates a quality system covering design, production, final inspection and testing, certified and audited by a notified body. This route suits series manufacturers with a mature QMS.

Configuration	Route	Notified body
Outside Annex IV	Internal checks (Article 12.2)	No
Annex IV, harmonised standards cover all EHSRs	Self-assessment (Article 12.3 a)	No
Annex IV, harmonised standards partial or not applied	EC type-examination (Article 12.4 a)	Yes
Annex IV, series manufacturer with certified QMS	Full quality assurance H (Article 12.4 b)	Yes

For the general modular routes of the Union, see the modular conformity assessment Decision 768/2008 guide.

Harmonised standards: mapping

Directive 2006/42/EC relies on a dense corpus of harmonised standards, structured by EN ISO 12100 into three types: type A (general concepts), type B (transversal safety concepts or devices) and type C (detailed specifications by machine category).

Standard	Type	Subject	Role in assessment
EN ISO 12100	A	General design principles, risk assessment, risk reduction	Foundation standard, applies to every machine
EN 60204-1	B	Safety of electrical equipment of machines	Machine-side electrical safety: shock protection, equipotential bonding, isolation, signage
EN ISO 13849-1	B	Safety-related parts of control systems, performance levels (PL)	Determination of the required PL and achieved PL for each safety function
EN IEC 62061	B	Functional safety of electrical, electronic and programmable systems, SIL	Alternative or complement to EN ISO 13849-1 for complex functions
EN ISO 13855	B	Positioning of safeguards with respect to approach speeds of the human body	Calculation of safety distances (light curtains, pressure mats)
EN ISO 14119	B	Interlocking devices associated with guards	Selection, design and installation of interlocks
EN ISO 13851	B	Two-hand control devices, design and selection principles	Two-hand control design
EN ISO 14120	B	Fixed and movable guards, general requirements	Design of guards and protective enclosures
EN ISO 10218-1 and -2	C	Industrial robots, safety	Industrial robotics
ISO/TS 15066	C	Collaborative robots (cobots), permissible forces and pressures	Cobotics, complement to EN ISO 10218
EN 81 series	C	Lifts, goods hoists	Covered by Directive 2014/33/EU rather than the machinery directive

EN IEC 62061 has been substantially revised: the new edition aligns more closely with IEC 61508. For the general mechanics of functional safety in electrical and programmable electronic systems, the IEC 61508 and SIL guide details the allocation chain across process, architecture and certification. For automotive, the ISO 26262 guide presents the neighbouring sector-specific application.

The EN ISO 12100 risk assessment remains the pivot. Type C standards covering a specific machine category explicitly refer back to EN ISO 12100 for initial assessment and to EN ISO 13849-1 or EN IEC 62061 for safety functions. The dossier construction follows the sequence: Annex I EHSRs -> hazard identification per EN ISO 12100 -> selection of relevant type B and type C standards -> determination of required PL or SIL -> design and testing -> Annex VII A technical file.

Risk assessment under EN ISO 12100

The standardised method, applicable to every machine within scope of the directive, is structured into three successive and iterative activities.

Hazard identification: for each lifecycle phase (assembly, transport, commissioning, setting, normal operation, degraded operation, cleaning, maintenance, dismantling), list mechanical hazards (crushing, shearing, cutting, drawing-in), electrical hazards (direct or indirect contact, discharge), thermal (burns, explosion), substance-related, noise, vibration, radiation, ergonomic and environmental hazards.
Risk estimation: for each identified hazard, estimate severity of harm (from minor reversible to fatal), frequency of exposure, probability of occurrence and possibility of avoiding harm. The rating is documented.
Risk evaluation: compare the estimated risk with the tolerable level. If not tolerable, apply risk reduction measures following the section 1.1.2 hierarchy and re-estimate. The process continues until tolerability is reached for every hazard.

Iteration is essential: introducing a protective measure can create new hazards (for instance, a movable guard creates a trapping hazard during opening), which must in turn be assessed. The technical file retains the trace of iterations, choices and their justifications.

CE marking, EU declaration of conformity and technical file

After assessment and implementation of the measures, the manufacturer materialises conformity through three elements.

CE marking

The marking is affixed to the machine in a visible, legible and indelible manner, with the minimum regulatory height of five millimetres. For the transversal rules on placement, enlargement and proportions, see the CE marking dimensions and visual rules guide.

EU declaration of conformity (Annex II 1 A)

The declaration cites Directive 2006/42/EC, identifies the machine (commercial name, serial or batch number, manufacturer), lists the applied harmonised standards (with reference and year), mentions where applicable the notified body involved and the certificate number, and is dated and signed by an authorised representative. For products covered by multiple directives, a single declaration cites all applicable acts (LVD, EMC, RED where relevant).

Technical file (Annex VII A)

The file contains:

A general description of the machine.
Overall drawing, control circuit diagrams, detailed drawings together with calculation notes, test results and certificates.
Documentation on the risk assessment (identified hazards, estimates, retained measures, residual risks).
Applied harmonised standards and the list of covered EHSRs.
Technical reports and tests.
A copy of the instructions for use.
For series production, internal measures for maintaining conformity.

The file must be available to national authorities within a reasonable time (typically fifteen days) and retained for ten years after the manufacture of the last unit.

Instructions for use

The instructions are drawn up in the official language(s) of the Member State of placing on the market. They cover installation, commissioning, normal operation, setting, maintenance, dismantling, residual risks, personal protective equipment to wear, declared noise and vibration values. The absence of instructions in the required language constitutes a formal non-conformity frequently raised by market surveillance.

Partly completed machinery and declaration of incorporation

Partly completed machinery is distinguished from a machine by its inability to perform a specific application on its own. An articulated robot without end-effector or controller, a hydraulic sub-assembly intended for a press, a conveyor module designed for integration into a production line are typical instances of partly completed machinery.

The partly completed machinery manufacturer issues:

A declaration of incorporation under Annex II 1 B, listing the Annex I EHSRs that have been met among those applicable, and those that the integrator must address.
Assembly instructions describing how to integrate the partly completed machinery while preserving conformity.
A relevant technical file (Annex VII B) retained for ten years.

The partly completed machinery does not carry the CE marking under the machinery directive (it may nevertheless bear the marking under other directives, such as EMC or LVD). The integrator takes over the overall risk assessment and conformity of the final assembly. This upstream-downstream delegation requires a solid technical dialogue between partly-completed-machinery manufacturer and integrator, materialised by the assembly instructions.

Regulation (EU) 2023/1230: what changes

The regulation adopted on 14 June 2023 and published on 29 June 2023 replaces Directive 2006/42/EC. Full application is set for 20 January 2027. Article 50 organises the repeal of the directive and Article 52 the transitional provisions.

The main changes are as follows.

Legal form: regulation instead of directive

Moving from directive to regulation removes the national transposition step: the text applies directly and uniformly across the twenty-seven Member States from 20 January 2027. The fragmentation of national transpositions observed since 2009 disappears.

Cybersecurity

The regulation integrates explicit cybersecurity requirements for safety functions. Annex III section 1.1.9 requires that machinery connected to a network cannot have its safety altered by a cyber attack. The protection of safety components against remote corruption or manipulation becomes an essential requirement, indispensable for the presumption of conformity. The regulation refers to the Cyber Resilience Act for the horizontal cybersecurity baseline of digital products: the two texts apply in parallel for a connected machine, without full overlap but with reinforced consistency.

Artificial intelligence systems

The regulation introduces specific provisions for machines containing an AI system performing a safety function. Such machines are automatically listed in the new Annex I (high-risk machinery category), which closes the self-assessment route and requires notified-body involvement. The criterion of "AI software performing a safety function" is aligned with the AI Act (Regulation (EU) 2024/1689) where the machine itself is a product subject to both texts.

Revised high-risk list

The former Annex IV of 2006/42/EC is restructured into Annex I of the regulation (high-risk machinery) and Annex II (medium-risk machinery). Several categories are added or redefined, notably machinery incorporating AI that performs a safety function, optoelectronic protective devices, safety logic units and certain lifting equipment.

Electronic documentation

The regulation allows the instructions for use in electronic form, provided they remain accessible for the machine lifetime and a paper version can be requested. For machinery for non-professional use, the paper version remains mandatory by default. This evolution sits within the broader logic of dematerialised technical and documentary dossiers, addressed sectorally in the e-label vs physical label guide.

Synthetic comparison

Topic	Directive 2006/42/EC	Regulation (EU) 2023/1230
Legal form	Directive (national transposition)	Regulation (direct effect)
Application date	29 December 2009	20 January 2027
High-risk machinery	Annex IV (23 categories)	Annex I (revised list, AI and optoelectronics added)
Cybersecurity	Absent from the text	Explicit requirements in Annex III
AI performing a safety function	Not addressed	Listed, notified body mandatory
Instructions for use	Paper mandatory	Electronic permitted (except consumer use)
Partly completed machinery	Declaration of incorporation	Declaration of incorporation retained
Assessment routes	Self-assessment, EC type-examination, module H	Routes preserved, categories redistributed
Transitional provisions	n/a	Article 52: machinery placed on the market before 20 January 2027 under 2006/42/EC continues to circulate

Transition timeline 2024 - 2027

Article 51 of the regulation organises a progressive entry into application.

Date	Step	Effect
29 June 2023	Publication in the OJEU	The regulation legally exists
19 July 2023	Entry into force (+ 20 days)	Transitional provisions start running
20 January 2024	+6 months	Application of provisions on Commission delegated powers and notifying authorities
20 October 2026	+42 months	Designation and accreditation of notified bodies able to examine under the new regime
20 January 2027	+44 months, full application	Directive 2006/42/EC is repealed. Any machine placed on the market beyond this date is assessed under Regulation 2023/1230
Transitional period	Article 52	Machines placed on the market before 20 January 2027 under 2006/42/EC continue to circulate under the rules in force at their date of placing

The notion of placing on the market follows the Blue Guide meaning: first making available of an individual unit on the Union market. Storage of units awaiting sale does not constitute placing on the market; conversely, delivery to a first customer (even a reseller) marks the placing on the market of that unit. This reading guides the handling of transition units: a unit physically available on 19 January 2027 but delivered on 21 January 2027 is placed on the market after 20 January 2027 and therefore falls under the regulation.

Intermediate stocks held by importers and distributors benefit from the transitional provision only if placing on the market in the strict sense occurred before the deadline. This nuance is one of the main sources of uncertainty for manufacturers holding large series; a precise mapping of units and their legal status is recommended from 2026 onwards.

Sector-specific standards: robots, cobots, lifts, 3D printing

Industrial robots

The EN ISO 10218 series (parts 1 and 2) is the harmonised reference for industrial robots and robotic systems. Part 1 addresses the robot itself (safety architecture, stop functions, speed limiting, validation), part 2 addresses the integration of the robot into a cell (cell configuration, detection devices, integration-level validation). The joint revision ISO 10218-1:2025 and ISO 10218-2:2025 updates the consistency with EN ISO 13849-1 and integrates several collaborative concepts.

Collaborative robots (cobots)

For configurations where the robot shares its workspace with a human operator without permanent physical separation, ISO/TS 15066 complements EN ISO 10218-2. The document specifies admissible forces and pressures on the various parts of the body in case of contact, and structures the four collaborative modes (safety-rated monitored stop, hand-guiding, speed and separation monitoring, power and force limiting). A cobot line requires a dedicated application analysis; the mere presence of a certified cobot does not presume cell conformity.

Lifts

Lifts within the meaning of Directive 2014/33/EU (lifts permanently installed in buildings) are out of scope of the machinery directive and of Regulation 2023/1230. They fall under their own regime with their own assessment modules. The EN 81 series (EN 81-20 and EN 81-50 for lifts for persons and goods) is the harmonised reference. Industrial goods hoists, lifting tables, overhead cranes and manual hoists that are not permanently installed remain by contrast within machinery scope.

3D printing

Additive manufacturing machines (industrial 3D printing, laser sintering, fused deposition modelling) are machines within the meaning of 2006/42/EC and remain in its scope. No type-C harmonised standard has yet been published specifically for this category in the OJEU. The manufacturer applies EN ISO 12100, EN 60204-1, EN ISO 13849-1 and selects on a case-by-case basis the relevant type-B standards (laser radiation EN 60825, fume extraction, explosive atmospheres ATEX in case of metal powders). The absence of a type-C standard requires reinforced justification in the technical file, and self-assessment, although technically possible, is more exposed to challenge.

Common pitfalls

Risk	Consequence	Action
Confusing machine and partly completed machinery	CE marking improperly affixed or declaration missing	Document the status against Article 2 and operational function
Mis-classifying an Annex IV machine as non-Annex IV	Improper self-assessment, regulatory non-conformity	Verify the exhaustive Annex IV list before route selection
Missing iteration in risk assessment	New hazards introduced by measures left untreated	Document each iteration and its outcome
Applying 2006/42/EC where Regulation 2023/1230 is required	Non-compliance from 20 January 2027	Map transition units and their legal status
No cybersecurity coverage of safety functions (post-2027)	EHSR section 1.1.9 not met, CRA exposure	Integrate cybersecurity into the risk assessment from 2025
Incomplete or untranslated instructions for use	Formal non-conformity, withdrawal or recall by surveillance	Cover all official languages of target markets
Technical file not maintained after placing on the market	Inability to demonstrate conformity in an enquiry	Hold the file for ten years, versioned archival
Confusing 2006/42/EC and 2014/33/EU for lifting equipment	Wrong assessment route, adverse surveillance	Verify the criterion of permanent installation

The spilma glossary covers the key terms (machine, partly completed machinery, safety component, EHSR, EC type-examination, module H, declaration of incorporation) with their reference definitions.