Machinery Directive

The Machinery Directive, formally known as Directive 2006/42/EC of the European Parliament and of the Council, is a key piece of European Union legislation that lays down essential health and safety requirements for the design, construction, and placing on the market of machinery and related products to ensure a high level of protection for the health and safety of persons, including users, operators, and bystanders, while facilitating the free movement of such goods within the internal market.^[1] Adopted on 17 May 2006, entering into force on 29 June 2006 and applying from 29 December 2009, the directive recasts and repeals earlier frameworks, such as Directive 98/37/EC, to harmonize safety standards across EU member states and address evolving industrial risks through mandatory risk assessments and protective measures during machinery design.^[1] Manufacturers must conduct a conformity assessment—ranging from internal production control for low-risk items to full quality assurance systems or EC type-examination for higher-risk categories listed in Annex IV—before affixing the CE marking, which signifies compliance and allows unrestricted trade.^[1] Additionally, economic operators like importers and distributors bear responsibilities to verify compliance, maintain technical documentation for at least 10 years, and provide instructions in the official languages of the destination country.^[1] The directive's scope encompasses a broad range of products, including complete machinery, interchangeable equipment, safety components intended to fulfill essential safety functions, lifting accessories, removable mechanical transmission devices, and partly completed machinery, but excludes items such as medical devices, certain transport vehicles, and weaponry governed by other specific legislation.^[1] Essential requirements, detailed in Annex I, cover aspects like mechanical stability, electrical equipment safety, control systems reliability, noise and vibration limits, and ergonomic principles to minimize hazards from moving parts, sharp edges, or unintended emissions.^[1] Member states enforce these through market surveillance authorities, with non-compliant machinery subject to withdrawal or recall.^[2] As of November 2025, the Machinery Directive remains in effect for all machinery placed on the EU market until 20 January 2027, after which it will be fully replaced by the Machinery Regulation (EU) 2023/1230, a directly applicable regulation published on 29 June 2023 that builds on the directive by incorporating modern challenges such as cybersecurity risks, artificial intelligence integration, and software as safety components, while maintaining core safety principles and expanding conformity assessments for high-risk products.^[3] The regulation introduces new obligations for transparency in AI-driven machinery and resilience against digital threats, with a transitional period allowing existing CE-marked products under the directive to remain valid until the cutoff date or certificate expiry.^[3] This update aims to future-proof EU machinery standards amid technological advancements, ensuring continued protection and market harmonization.^[3]

Background and Context

Purpose and Objectives

The Machinery Directive 2006/42/EC establishes essential health and safety requirements for the design and construction of machinery to ensure a high level of protection for the health and safety of persons using the machinery, and where appropriate, for the protection of domestic animals and property, while simultaneously guaranteeing the free movement of such machinery within the internal market of the European Union.^[4] This primary objective addresses the need to minimize risks associated with machinery throughout its lifecycle, from manufacture to foreseeable use, thereby promoting safer working environments across EU member states.^[4] Secondary goals of the Directive include harmonizing the essential health and safety requirements applicable to machinery among member states to eliminate technical barriers to trade that arise from divergent national regulations.^[4] By applying the principles of the EU's New Approach to technical harmonization and standardization, the Directive relies on objective, non-discriminatory essential requirements supplemented by voluntary harmonized standards, which provide a presumption of conformity when followed.^[4] This framework facilitates the mutual recognition of compliance across borders, enhancing economic integration within the single market.^[4] The Directive was developed under Article 95 of the Treaty establishing the European Community (now Article 114 of the Treaty on the Functioning of the European Union) to resolve inconsistencies in national regulations that previously impeded intra-EU trade in machinery.^[4] It embodies a risk-based approach, requiring manufacturers to assess potential hazards and design machinery to be safe for its intended use, eliminating or reducing risks as far as possible through inherently safe design principles before relying on protective measures.^[4] This methodology ensures that safety is integrated from the outset, adapting to the state of the art in technology and sound technical rules in member states.^[4]

Legal Framework

The Machinery Directive, formally Directive 2006/42/EC, was adopted under Article 95 of the Treaty establishing the European Community, corresponding to Article 114 of the Treaty on the Functioning of the European Union (TFEU), which empowers the EU to adopt measures for the approximation of the laws, regulations, and administrative provisions of the Member States to ensure the establishment and functioning of the internal market.^[1] This legal basis, formerly Article 95 of the Treaty establishing the European Community (EC Treaty), facilitates the harmonization of essential health and safety requirements for machinery to promote free movement of goods while maintaining a high level of protection.^[1] The directive's preamble explicitly references this foundation, emphasizing the need for uniform rules to eliminate barriers to trade arising from divergent national legislation.^[1] As a directive, it is binding on Member States as to the result to be achieved but leaves to national authorities the choice of form and methods for transposition into domestic law, allowing flexibility in implementation while ensuring mandatory outcomes such as compliance with essential requirements.^[1] Member States are required to adopt and publish the necessary provisions by specified deadlines and communicate them to the Commission, with the directive applying directly from the date of transposition.^[1] This structure ensures that national laws achieve the directive's objectives without prescribing exact measures, thereby respecting subsidiarity principles under EU law.^[1] The Machinery Directive aligns with the EU's New Legislative Framework (NLF), established by Regulation (EC) No 765/2008 on accreditation and market surveillance of products, and Decision No 768/2008/EC on a common framework for conformity assessment procedures.^[5] These instruments provide horizontal rules for notified bodies, CE marking, and surveillance, which the directive incorporates to enhance consistency across product legislation.^[6] For instance, notified bodies designated by Member States under Article 14 of the directive must meet NLF criteria for accreditation and monitoring to certify conformity for certain high-risk machinery categories.^[1] Enforcement relies on Member States, which must designate and notify competent authorities and bodies for certification, surveillance, and investigation of non-compliant products, in line with NLF requirements.^[6] Penalties for infringements are established at the national level but must be effective, proportionate, and dissuasive, as mandated by Article 23, to deter violations such as placing non-conforming machinery on the market.^[1] The directive includes a safeguard procedure under Article 11, allowing Member States to restrict or prohibit market placement of dangerous machinery, with Commission oversight to resolve disputes.^[1] The Machinery Directive interacts with other EU harmonization directives to provide comprehensive coverage of product hazards, particularly complementing the Low Voltage Directive (2014/35/EU) for electrical safety risks and the Electromagnetic Compatibility Directive (2014/30/EU) for electromagnetic interference.^[1] The directive coordinates with other EU legislation, such as the Low Voltage Directive (2014/35/EU) for electrical safety and the Electromagnetic Compatibility Directive (2014/30/EU) for electromagnetic interference, requiring machinery to meet relevant provisions of those directives where applicable, as outlined in the recitals, to ensure comprehensive hazard protection without regulatory gaps.^[1] This coordinated approach prevents regulatory gaps in the internal market.^[1]

Scope and Definitions

What Constitutes Machinery

The Machinery Directive 2006/42/EC defines machinery 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.^[4] This definition emphasizes the functional integration of components to achieve a particular purpose, such as processing, handling, or transforming materials, and requires the presence of a non-manual power source like electric motors or hydraulic systems.^[4] The scope extends to several related categories explicitly included under the definition. Interchangeable equipment refers to devices assembled with machinery or tractors post-commissioning to alter or add functions, provided they are not mere tools.^[4] Safety components are independent market-placed elements that perform critical safety functions, whose failure could endanger persons, and which are not essential for basic operation.^[4] Lifting accessories encompass components or equipment, such as slings, placed between lifting machinery and loads to hold or integrate with them.^[4] Additionally, chains, ropes, and webbing designed for lifting purposes as part of such machinery or accessories are covered.^[4] Partly completed machinery is treated as an assembly that resembles machinery but cannot independently perform a specific application; drive systems exemplify this category and are intended solely for incorporation into or assembly with other machinery or equipment to form complete machinery under the Directive.^[4] Manufacturers of partly completed machinery must provide assembly instructions and affix the CE marking, accompanied by a declaration of incorporation rather than a declaration of conformity, distinguishing it from finished products.^[4] Representative examples of machinery include industrial robots for automated handling, machine tools for material shaping, and packaging machinery for product enclosure, all of which involve moving parts powered by non-human effort for defined applications.^[4] The definition also accounts for risk by focusing on intended use, encompassing not only the primary purpose but also reasonably foreseeable misuse that could arise in operational contexts.^[4] Certain products, such as motor vehicles regulated under separate type-approval directives, fall outside this scope.^[4] The Machinery Directive 2006/42/EC explicitly excludes certain products from its scope under Article 1(2) to delineate boundaries with more specialized legislation. These exclusions encompass safety components supplied as spare parts by the original machinery manufacturer, equipment for fairgrounds and amusement parks, machinery designed for nuclear purposes that could emit radioactivity, weapons including firearms, arms, and munitions (except industrial tools for fixing purposes such as nail guns or rivet guns), means of transport such as agricultural and forestry tractors (governed by Directive 2003/37/EC, now Regulation (EU) No 167/2013), seagoing vessels and mobile offshore units, machinery for military or police purposes, mine winding gear, and equipment for moving performers in artistic contexts.^[4] Additionally, products falling under other targeted EU directives are excluded to avoid regulatory duplication, including medical devices regulated by Directive 93/42/EEC (now Regulation (EU) 2017/745), pressure equipment under Directive 2014/68/EU, and equipment for use in potentially explosive atmospheres covered by Directive 2014/34/EU (ATEX).^[4]^[8] For instance, electrically operated medical furniture or diagnostic machinery is addressed solely under medical device rules, which impose stricter conformity assessments.^[8] Similarly, standalone low-voltage electrical equipment, such as household appliances or IT devices, falls under Directive 2014/35/EU rather than the Machinery Directive unless integrated as an essential part of machinery.^[4]^[8] Related products within the Directive's purview include safety components like guards, emergency stop devices, and protective barriers, which are treated as machinery if placed independently on the market but excluded if provided as identical replacement parts.^[4]^[8] These components must meet essential health and safety requirements when not tied to specific machinery, facilitating their use across various applications while ensuring compatibility. Interchangeable equipment and lifting accessories also qualify as related products, subject to the Directive if they connect to or are incorporated into machinery.^[8] Borderline cases, such as software, are not considered machinery on their own unless they directly control movements and associated hazards in a physical assembly, as clarified in Commission guidance documents.^[8] Standalone software for planning or simulation, like fence configuration tools, remains outside the scope and does not alter manufacturer responsibilities for hardware.^[8] The rationale for these exclusions lies in preventing overlap with sector-specific regulations that provide more stringent or tailored protections, such as pharmaceutical standards for medical machinery or explosion-proof requirements under ATEX, thereby streamlining compliance while upholding overall safety in the single market.^[4]^[8] This approach ensures that specialized directives apply where hazards demand nuanced controls, avoiding fragmented enforcement.^[8]

Historical Evolution

Original Directive 89/392/EEC

The Council Directive 89/392/EEC, adopted on 14 June 1989, established the initial European Union framework for harmonizing member states' laws relating to machinery safety.^[9] It was published in the Official Journal of the European Communities (OJ L 183, p. 9) on 29 June 1989.^[9] The directive's provisions became applicable from 31 December 1992, marking the start of mandatory compliance for manufacturers placing machinery on the EU market.^[9] A core innovation of the directive was the introduction of essential health and safety requirements (EHSR) outlined in Annex I, which set mandatory criteria for the design and construction of machinery to protect workers and users from hazards.^[9] It mandated manufacturers to conduct risk assessments during the design phase to identify and mitigate dangers, applying principles such as inherently safe design and protective measures.^[9] Additionally, the directive pioneered a modular conformity assessment system, detailed in Annexes II to VI, allowing manufacturers to select procedures like internal production control or EC type-examination based on machinery risk levels, thereby facilitating presumption of conformity through adherence to harmonized standards.^[9] At its inception, the directive's scope targeted assemblies of linked parts with at least one movable component, actuators, control systems, and power circuitry, intended for processing, treating, moving, or packaging materials, while excluding categories such as manually powered equipment, certain medical devices, and weaponry.^[9] It primarily addressed mechanical and general safety aspects, with electrical equipment safety integrated into the EHSR but complemented by separate directives like the Low Voltage Directive 73/23/EEC for comprehensive electrical compliance.^[9] The overarching aim was to eliminate technical barriers to trade by replacing fragmented national regulations with uniform EU-wide rules, promoting the free movement of safe machinery across member states.^[9] The original directive underwent initial minor amendments to refine its application. Council Directive 91/368/EEC of 20 June 1991 extended the scope to include safety components and lifting accessories, broadening coverage without altering the core structure.^[10] Subsequently, Council Directive 93/44/EEC of 14 June 1993 clarified definitions, such as for rolling over protective structures (ROPS) and falling object protective structures (FOPS), and aligned certain requirements, but stopped short of a full recast.^[11] This foundational framework had significant impact by enabling the development of the first generation of harmonized European standards, such as EN 292 on basic concepts and general principles for the design of safety in machinery, which provided manufacturers with practical guidance to meet the EHSR and presumption of conformity.^[12]

Consolidation as 98/37/EC

Directive 98/37/EC, adopted by the European Parliament and the Council on 22 June 1998, was published in the Official Journal of the European Communities (OJ L 207) on 23 July 1998. This directive represented a codification of the original Machinery Directive 89/392/EEC, integrating its amendments into a single, streamlined text to address the increasing complexity resulting from successive modifications and to enhance usability for manufacturers.^[13] The consolidation process incorporated amendments from Directives 91/368/EEC (Article 1 only), 93/44/EEC, and 93/68/EEC (Article 6 only), while clarifying the scope with respect to safety distances and ergonomic principles in the essential health and safety requirements (EHSR).^[14]^[13] The directive repealed Directive 89/392/EEC and the specified amendments, effective from 1 January 1999. It entered into force on 12 August 1998, 20 days after publication, with transposition into national law required by 1 January 2000. Key updates in the codified version expanded the EHSR to improve integration with the Low Voltage Directive (73/23/EEC), stipulating that machinery presenting primarily electrical risks is exclusively governed by the latter (Article 1(5)). Additionally, it introduced the concept of 'series production' within conformity assessment procedures, allowing internal production control for machinery manufactured in series under stable conditions (Annex V, Section 3).^[13]^[14] Transitional provisions permitted the continued validity of machinery conforming to the previous directives during the transposition period, enabling dual application of old and new rules until full implementation and supporting the continued development of harmonized standards. This approach ensured minimal disruption for ongoing certifications and market placements. The overall context of the codification was to rationalize the legal framework amid accumulating amendments, promoting consistent enforcement and facilitating the free movement of machinery across the European Union by simplifying compliance for economic operators.^[13]

Recast as 2006/42/EC

Directive 2006/42/EC, adopted by the European Parliament and the Council on 17 May 2006 and published in the Official Journal of the European Union (OJ L 157, p. 24) on 9 June 2006, represents a comprehensive recast of the previous Machinery Directive 98/37/EC. This recast repealed Directive 98/37/EC, with the repeal taking effect on 29 December 2009, to streamline and modernize the regulatory framework for machinery safety across the European Union.^[4] The primary rationale for the recast was to simplify the legislative text by eliminating expired national transpositions and obsolete provisions, thereby improving readability and consistency while adapting the directive to technical progress and emerging risks. It updated the essential health and safety requirements (EHSR) to address contemporary challenges, including enhanced provisions for ergonomics—such as improved workstation design and operator comfort to reduce fatigue—and environmental protection, like controls on emissions and resource use in machinery operation. Additionally, the recast aligned the directive with the New Legislative Framework (NLF), established under Regulation (EC) No 765/2008, to strengthen conformity assessment, market surveillance, and the role of harmonized standards in ensuring high levels of protection.^[6] Key structural changes included a reorganized Annex I, dividing EHSR into clearer categories: general principles, non-electrical hazards, electrical equipment, and control systems, to facilitate compliance for manufacturers. The directive introduced considerations for energy efficiency in design and operation, particularly for machinery impacting environmental performance, and extended its scope to cover specific lifting operations, such as mobile elevating work platforms and construction hoists, with tailored safety requirements. These updates aimed to harmonize requirements across member states while promoting innovation in safer machinery design.^[4] A transitional period allowed machinery conforming to Directive 98/37/EC to be placed on the market until 29 December 2009, enabling ongoing certifications under the previous framework during the shift. As of 2025, Directive 2006/42/EC remains in force, subject to ongoing amendments such as Directive 2009/127/EC, which added noise emission controls and environmental protections for pesticide application machinery effective from 27 June 2011.^[4]^[15]

Provisions of the 2006 Directive

Essential Health and Safety Requirements

The essential health and safety requirements (EHSRs) under the Machinery Directive 2006/42/EC form the core obligations for manufacturers to ensure machinery is safe for users, operators, and the environment throughout its lifecycle. These requirements, detailed in Annex I, apply to all relevant hazards identified through a risk assessment and must be integrated into the design and construction phase, prioritizing the elimination of risks at the source.^[1] Compliance with these EHSRs is mandatory for machinery placed on the EU market, enabling free movement while guaranteeing a high level of protection.^[1] Annex I is structured into two main parts: Section 1 outlines general principles applicable to all machinery, while Sections 2 through 5 provide supplementary requirements for specific categories and hazards. Section 1 begins with general principles emphasizing risk assessment and inherent safety, followed by subsections 1.1 through 1.7 that address specific design principles, such as stability to prevent tipping under normal use or foreseeable overloads, adequate lighting to avoid shadows or glare at workstations, and ergonomic operating positions to minimize fatigue.^[1] Subsection 1.2 covers control systems, requiring them to be reliable and intuitive; 1.3 focuses on non-electrical mechanical hazards like protection from moving parts; 1.4 specifies characteristics of guards and protective devices; 1.5 addresses other hazards including electrical isolation and overload protection; 1.6 deals with maintenance access and energy isolation; and 1.7 mandates clear information and warnings.^[1] Section 2 provides supplementary requirements for certain categories of machinery, such as hygiene features for foodstuffs machinery and automatic brakes to stop the tool upon risk of contact for woodworking machinery; Section 3 addresses hazards due to the mobility of machinery, such as protection against uncontrolled movements and roll-over; Section 4 covers requirements for lifting operations, including mechanical strength of components and control of movements to prevent load falls; and Section 5 provides requirements for underground machinery, such as risks from lack of stability, movement control, and exhaust emissions.^[1] Central to fulfilling the EHSRs is the risk assessment process, which manufacturers must perform to identify potential hazards across the machinery's lifecycle—from transport and assembly to operation, maintenance, and decommissioning. This involves estimating risk levels based on hazard severity and exposure probability, then applying protective measures in a hierarchical order: first, design for inherent safety to eliminate hazards; second, incorporate technical safeguards if elimination is impossible; and third, provide residual risk information via instructions. The process must be documented in the technical file, drawing on standards like EN ISO 12100 for iterative evaluation, and updated as design changes occur.^[1] The EHSRs are adaptable, applied proportionately to the machinery's risk level and only to those hazards present under intended or reasonably foreseeable conditions, considering the state of the art and technical feasibility. For instance, low-risk machinery may require minimal guarding, while high-risk types demand stringent controls; for partly completed machinery, only relevant sections of Annex I apply, with the assembler responsible for completing compliance. This scalable approach ensures practicality without compromising safety.^[1] Representative examples illustrate application: Guards under subsection 1.4 must be robust, fixed or interlocked, and capable of withstanding foreseeable forces, such as a metal enclosure resisting impact from ejected parts in a press machine. Controls in subsection 1.2 should be intuitive and positioned to avoid erroneous operation, like color-coded emergency stops that are readily accessible and mushroom-shaped for quick activation. Emissions addressed in subsection 1.5.12 must be minimized for the intended environment, such as installing filters on woodworking machinery to contain dust below hazardous thresholds, with data on residual levels provided in instructions.^[1]

Conformity Assessment and Procedures

The conformity assessment under the Machinery Directive 2006/42/EC ensures that machinery meets the essential health and safety requirements before being placed on the market, with procedures tailored to the level of risk posed by the machinery.^[4] Manufacturers must select and apply an appropriate procedure based on whether the machinery falls under Annex IV, which lists high-risk categories such as circular saws for working with wood and other materials, presses, and machinery for lifting persons.^[4] For low-risk machinery not listed in Annex IV, the process relies on self-assessment to promote efficiency, while high-risk machinery requires greater objectivity through third-party involvement to verify compliance.^[4] This risk-based approach balances regulatory oversight with practical implementation, ensuring uniform safety across the EU without overburdening manufacturers of simpler equipment.^[2] For machinery not covered by Annex IV, manufacturers apply the internal production control procedure outlined in Annex VIII.^[4] This involves conducting internal checks on the manufacture, including measures to ensure consistent production quality and compliance with relevant essential health and safety requirements, such as design verification and testing.^[4] The manufacturer draws up an EC declaration of conformity as per Annex II, part 1, section A, confirming that the machinery satisfies the Directive's provisions based on these internal assessments.^[4] No involvement of a notified body is required, allowing for self-certification that streamlines the process for lower-risk products like basic assembly tools or non-hazardous conveyors.^[4] Machinery listed in Annex IV undergoes more stringent procedures to address elevated hazards, with options depending on adherence to harmonized standards.^[4] If the machinery fully complies with relevant harmonized standards covering all essential health and safety requirements, manufacturers may still use the internal production control of Annex VIII.^[4] Otherwise, or if standards are not fully applied, they must choose between the EC-type examination procedure in Annex IX combined with internal checks from Annex VIII, or the full quality assurance procedure in Annex X.^[4] The EC-type examination (Annex IX) requires a notified body to evaluate a representative model of the machinery, issuing a certificate if it meets requirements, followed by manufacturer-led internal production checks for subsequent units.^[4] For example, this applies to high-risk items like circular saws, where the notified body reviews technical documentation and may conduct tests to confirm safety features such as guards and emergency stops.^[4] The full quality assurance procedure (Annex X) involves a notified body approving the manufacturer's entire quality system for design, production, and final inspection, enabling ongoing certification without per-unit examinations.^[4] Notified bodies play a critical role in high-risk assessments, serving as independent organizations designated by EU member states to perform type-examinations or quality system approvals.^[4] These bodies must meet the impartiality, competence, and operational criteria in Annex XI, including adequate resources and confidentiality safeguards, and are listed in the EU's NANDO database for transparency.^[4] Member states notify the European Commission of designations, ensuring only qualified entities handle verifications to maintain objectivity in conformity assessments.^[4] Certificates issued by notified bodies, such as EC-type examination reports, are valid for up to five years and subject to periodic review.^[4] Regardless of the procedure, all manufacturers must compile a technical file as specified in Annex VII, part A, to demonstrate compliance.^[4] This file includes a general description of the machinery, overall drawings, risk assessments identifying hazards and mitigation measures, lists of essential health and safety requirements with corresponding proofs (e.g., test results and calculations), and manufacturing details.^[4] The technical file must be kept available for inspection by authorities for 10 years after the last unit is placed on the market, facilitating market surveillance and post-market verification.^[4]

Roles and Responsibilities

Under the Machinery Directive 2006/42/EC, manufacturers hold primary responsibility for ensuring that machinery is designed and constructed to meet the essential health and safety requirements (EHSR) outlined in Annex I before it is placed on the market or put into service.^[4] This includes performing an appropriate risk assessment to identify potential hazards associated with the machinery's intended use and foreseeable misuse, as well as carrying out necessary research and tests to eliminate or reduce those risks.^[4] Manufacturers must also compile a technical file in accordance with Annex VII A, which documents the design, manufacture, and operation of the machinery, and retain it for 10 years after the machinery is placed on the market.^[4] Additionally, they are required to draw up an EC declaration of conformity as per Annex II A, affix the CE marking under Article 16 and Annex III, and supply instructions and any necessary information in a language easily understood by users, determined by the Member State of destination.^[4] An authorised representative, defined in Article 3(h) as a natural or legal person established in the EU who has received a written mandate from the manufacturer, performs specified obligations on the manufacturer's behalf, such as maintaining the technical file and declaration of conformity within the EU.^[4] The mandate must clearly delineate the tasks, and the representative assumes liability for those duties, enabling non-EU manufacturers to fulfill EU market access requirements.^[16] Importers, as economic operators placing machinery from outside the EU on the market, must verify that the manufacturer has correctly carried out the applicable conformity assessment procedures under Article 12, that the machinery bears the CE marking and required identification, and that it is accompanied by the EC declaration of conformity and instructions.^[4] They are obligated to ensure traceability by indicating their name, registered trade name or mark, and contact address on the machinery, its packaging, or an accompanying document, and to provide or ensure instructions are available in the official language(s) of the Member State where the machinery is to be used.^[4] Importers must retain a copy of the technical file for 10 years, report any risks to the manufacturer and competent authorities, and cooperate fully in any market surveillance investigations.^[16] Distributors, who make machinery available on the market without placing it there themselves, are required under Article 13 to act with due care in verifying, before supply, that the machinery bears the CE marking, is accompanied by the required EC declaration of conformity and instructions, and that the manufacturer and importer have complied with labeling, address, and documentation obligations.^[4] They must ensure that storage or transport conditions do not compromise the machinery's compliance, provide instructions in the appropriate language if not already available, and report any compliance doubts or risks to the manufacturer, importer, or authorities while cooperating in corrective actions.^[4] Assemblers who combine two or more items of machinery or partly completed machinery to form an assembly are treated as the manufacturer of the resulting machinery and assume all corresponding obligations, including risk assessment, technical file preparation, CE marking, and declaration of conformity for the complete unit.^[16] Users of machinery are responsible for operating and maintaining it in accordance with the manufacturer's instructions to ensure ongoing safety, reporting any serious accidents or risks to the manufacturer and authorities, and not modifying the machinery in ways that could affect its compliance unless they assume manufacturer-like duties for the changes.^[16] Strict product liability under Council Directive 85/374/EEC applies in parallel to the Machinery Directive, holding producers (including manufacturers, importers, and others in the supply chain) liable for damage caused by defects in machinery regardless of fault, provided the damage exceeds specified thresholds and the defect is proven.^[17] This regime complements the Machinery Directive's preventive focus by providing compensation mechanisms for affected parties, such as personal injury or property damage over €500.^[17]

Compliance and Enforcement

Harmonized Standards and CE Marking

Harmonized standards play a central role in demonstrating compliance with the Machinery Directive 2006/42/EC by providing a presumption of conformity with the relevant essential health and safety requirements (EHSR). These standards are developed by the European standardization organizations CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization) under a specific mandate from the European Commission.^[1] Once finalized, the references to these harmonized standards are published in the Official Journal of the European Union (OJEU), which activates their legal effect across EU member states.^[1] Their application remains voluntary, allowing manufacturers flexibility in choosing how to meet the EHSR, but adherence to a published harmonized standard grants a strong presumption that the machinery satisfies the corresponding requirements, simplifying the conformity assessment process.^[1] If a manufacturer does not fully apply a harmonized standard, they must justify the partial compliance and demonstrate how the alternative measures meet the EHSR, typically documented in the technical file.^[1] Furthermore, once a harmonized standard is withdrawn from the OJEU, the presumption of conformity no longer applies to machinery relying on it, requiring manufacturers to reassess and potentially update their designs or documentation.^[1] This framework ensures that standards evolve with technological advancements and safety insights while maintaining a balance between innovation and regulatory certainty. The CE marking serves as the visible indicator of conformity under the Machinery Directive, confirming that the machinery meets all applicable EHSR and can be legally placed on the EU market.^[1] It must be affixed in a clearly visible, legible, and indelible manner on the machinery itself or, if not feasible due to size, on its packaging or accompanying documents.^[1] The marking's minimum height is 5 mm, ensuring readability without imposing undue burden on small-scale products.^[1] Manufacturers apply the CE marking after completing the appropriate conformity assessment procedure and before placing the machinery on the market.^[1] When machinery falls under multiple EU directives requiring CE marking, a single mark suffices, provided compliance with all is ensured, avoiding redundancy while upholding comprehensive safety.^[1] Misuse of the CE marking, such as applying it without full compliance or alongside conflicting national symbols, is prohibited to prevent consumer deception and maintain the mark's integrity as a unified EU conformity symbol.^[1]

Declaration of Conformity and Technical File

The EU Declaration of Conformity serves as the manufacturer's formal attestation that the machinery complies with the relevant essential health and safety requirements (EHSR) set out in the Machinery Directive 2006/42/EC.^[4] Issued under Annex II, Part 1.A, this document must include the business name and full address of the manufacturer or their authorized representative established within the EU, along with the name and address of the person authorized to compile the technical file.^[4] It provides a clear description of the machinery, encompassing its generic denomination, function, model, type, serial number, and commercial name where applicable.^[4] The declaration explicitly states that the machinery fulfills the provisions of the Directive, referencing Annex I for the EHSR met, and notes any additional applicable directives.^[4] It also specifies the conformity assessment procedure followed, such as those outlined in Annexes VIII, IX, or X, and identifies any harmonized standards applied under Article 7(2) or other technical specifications used to achieve compliance.^[4] If a notified body was involved—particularly for machinery listed in Annex IV—the document includes the body's name, address, and identification number, along with details of the relevant certificate.^[4] The declaration concludes with the place and date of issue, as well as the name and signature (or equivalent identification) of the empowered person, and must be kept by the manufacturer or authorized representative for at least 10 years from the last date of manufacture.^[4] Complementing the Declaration of Conformity, the technical file required under Annex VII, Part A, comprises comprehensive documentation demonstrating that the machinery satisfies the Directive's requirements.^[4] This file includes a general description of the machinery, overall drawings, and detailed drawings of parts or control circuits essential to conformity, accompanied by descriptions and explanations necessary for their comprehension.^[4] It must contain a list of the applicable EHSR from Annex I, along with evidence of how compliance was achieved, such as design calculations, examination results, and test reports.^[4] Central to the file is the risk assessment documentation, detailing the methods used, hazards identified, protective measures implemented, and any residual risks.^[4] Additionally, it lists the harmonized standards, other technical standards, or specifications referenced, includes results from any tests on components or the completed machinery, and incorporates a copy of the operating instructions.^[4] For machinery incorporating partly completed machinery or other products, copies of relevant declarations of incorporation or conformity must be included.^[4] In cases of series manufacture, the file also documents internal measures ensuring consistent conformity, such as quality assurance procedures and ongoing research or test reports.^[4] The manufacturer or their EU-based authorized representative must retain this technical file for 10 years after the manufacture of the last unit, making it available to authorities upon request, and it may be compiled in electronic format provided it remains accessible and verifiable.^[4] For partly completed machinery—defined as assemblies intended for incorporation into machinery but not fully addressing all EHSR—a Declaration of Incorporation under Annex II, Part 1.B replaces the Declaration of Conformity.^[4] This declaration, issued by the manufacturer or authorized representative, includes the business name and address, a description of the partly completed machinery (including model, type, and serial number), and a statement that it must not be put into service until incorporated into machinery complying with the Directive.^[4] It lists the EHSR from Annex I that have been applied and fulfilled, along with any harmonized standards or technical specifications used, and references the assembly instructions in Annex VI.^[4] If applicable, it notes involvement of a notified body and includes the place, date, and signature of the empowered person.^[4] Supporting this is the relevant technical documentation under Annex VII, Part B, which mirrors much of the full technical file but focuses on conformity aspects: a general description, drawings and explanations, the list of applied EHSR with compliance evidence, risk assessment details (including protective measures and residual risks), referenced standards, test reports, and a copy of the assembly instructions.^[4] For series production, it includes measures for ongoing conformity and relevant test reports.^[4] Like the full technical file, this documentation must be retained for 10 years after the last unit's manufacture and kept available in the EU.^[4] Both the Declaration of Conformity (or Incorporation) and associated instructions must be provided in an official language of the EU Member State where the machinery is placed on the market or put into service, as determined by that state.^[4] The instructions, including warnings and maintenance details, are designated as "original instructions" if in the manufacturer's working language, or "translation of the original instructions" otherwise, with the original made available if requested.^[4] These documents must accompany the machinery and can be supplied in electronic format if it ensures easy access and readability for the end-user, without compromising legibility or availability.^[4] The CE marking, as the visible indicator of conformity, is affixed to the machinery and referenced in these documents to link the internal compliance evidence with external market placement.^[4]

Market Surveillance and Authorities

Market surveillance under the Machinery Directive 2006/42/EC is integrated with the EU's harmonized framework established by Regulation (EC) No 765/2008, which outlines requirements for the accreditation of conformity assessment bodies and the organization of market surveillance for products, including machinery. National market surveillance authorities (MSAs) in each Member State are tasked with monitoring the compliance of machinery after it is placed on the market, verifying adherence to essential health and safety requirements, the validity of CE marking, and the availability of supporting documentation such as the EU Declaration of Conformity and technical file. These authorities conduct risk-based inspections, including physical checks on products, requests for information from economic operators, and assessments of potential hazards, with powers to seize, withdraw, or recall non-compliant machinery to protect public health and safety.^[6]^[8] Notified bodies, responsible for conformity assessment procedures under the Directive for higher-risk machinery categories listed in Annex IV, are accredited by national accreditation bodies in line with Regulation 765/2008 to ensure their technical competence, impartiality, and independence. Oversight of these bodies involves continuous monitoring by designating authorities, including on-site audits and performance evaluations, as well as peer assessments coordinated at the EU level through the European co-operation for Accreditation (EA) and direct Commission supervision to maintain uniformity across Member States. If deficiencies are identified, accreditation may be suspended or withdrawn, and affected certificates can be revoked to prevent non-compliant products from circulating.^[6]^[8] Key reporting mechanisms include the Safety Gate rapid alert system (formerly RAPEX), operated under Regulation (EU) 2019/1020, which enables Member States and the Commission to swiftly exchange information on dangerous non-food products, such as machinery presenting serious risks to health or safety, facilitating coordinated responses across the EU. Under Article 11 of the Machinery Directive (the safeguard clause), Member States must immediately notify the Commission and other Member States if they prohibit or restrict the marketing or use of machinery due to identified non-compliance or risks, providing detailed justifications and evidence to trigger EU-wide consultations and potential harmonized measures. Manufacturers and other economic operators bear responsibilities to report known serious risks to competent authorities promptly, as reinforced by obligations in the broader product safety framework.^[18]^[4] Corrective actions against non-compliant machinery encompass temporary or permanent prohibitions on placement or use, mandatory recalls, or outright bans when a serious risk is confirmed, with decisions based on risk assessments and enforced by MSAs. Penalties for violations, including fines or criminal sanctions, are imposed according to national legislation in each Member State, ensuring proportionate deterrence while allowing for appeals. Inter-authority cooperation is supported by Administrative Cooperation (ADCO) groups, such as the Machinery ADCO, which convene regularly to share intelligence, align enforcement practices, and address cross-border issues without duplicating pre-market conformity roles.^[8]^[4] As of 2025, market surveillance mechanisms have been strengthened by the EU's Product Safety and Market Surveillance Package, particularly through Regulation (EU) 2019/1020 on market surveillance and compliance of products and the General Product Safety Regulation (EU) 2023/988, which enhance traceability, risk reporting for economic operators, and targeted oversight of online marketplaces to address emerging threats from digital sales channels.^[18]^[19]

Upcoming Machinery Regulation

Introduction to Regulation (EU) 2023/1230

Regulation (EU) 2023/1230, adopted by the European Parliament and the Council on 14 June 2023, establishes a comprehensive framework for the health and safety requirements applicable to machinery and related products placed on the market or put into service in the European Union. Published in the Official Journal of the European Union (OJ L 165) on 29 June 2023, this regulation repeals Directive 2006/42/EC and enters into force directly without the need for national transposition, ensuring uniform application across member states.^[20] The regulation expands the scope beyond traditional machinery to include related products such as interchangeable equipment and safety components, as well as partly completed machinery—clarified to encompass assemblies that are almost complete but lack only software or software updates to function as intended. It also incorporates new categories, notably AI-enabled software that exhibits fully or partially self-evolving behavior through machine learning and drives drive systems or creates hazards related to movement. This broadened coverage addresses emerging technologies while excluding items like medical devices and certain transport equipment already regulated elsewhere.^[20] Structurally, the regulation mirrors the organization of the previous directive but features updated annexes to reflect technological advancements; Annex III outlines the essential health and safety requirements (EHSR), now integrating provisions for cybersecurity to protect against risks from malicious third-party interference and software corruption. Additionally, it mandates the provision of instructions in a digital format, accessible online for at least 10 years, with paper copies available upon request to enhance usability and compliance. Annex I, Part A lists high-risk categories requiring third-party conformity assessment, including AI systems with self-evolving behavior and collaborative robots involving close human-machine interaction.^[20] The primary objectives of Regulation (EU) 2023/1230 are to safeguard health, safety, and environmental protection amid digital transformation by tackling cybersecurity vulnerabilities, AI-specific risks, and the integration of connected technologies in machinery. It promotes enhanced traceability through mandatory unique product identifiers, such as serial numbers or model details, to facilitate market surveillance and rapid identification of non-compliant products. By prioritizing risk-based assessments and conformity with harmonized standards, the regulation aims to foster innovation while maintaining high safety levels across the single market.^[20]

Key Differences from the Directive

The Machinery Regulation (EU) 2023/1230 marks a significant shift from the Machinery Directive 2006/42/EC by adopting the form of a regulation, which ensures direct and uniform application across all EU member states without the need for national transposition into domestic law, thereby enhancing consistency and reducing variations in implementation.^[20] In contrast, the 2006 Directive required member states to enact it through national legislation, leading to potential divergences in enforcement.^[4] A core update lies in the Essential Health and Safety Requirements (EHSR) outlined in Annex III, which expands beyond the 2006 Directive to address emerging technologies and societal priorities. New provisions mandate resilience against cyber threats, including protection from unauthorized access, manipulation, or corruption by malicious actors, with requirements for secure design, detection of interventions, and recovery mechanisms.^[20] For artificial intelligence, the regulation introduces transparency obligations for systems exhibiting self-evolving behavior through machine learning, ensuring users receive clear information on decision-making processes and limitations to mitigate safety risks.^[20] Software-related requirements are bolstered, compelling manufacturers to consider the safety implications of updates, including validation of their integrity and provision of secure update mechanisms throughout the machinery's lifecycle.^[20] Sustainability is integrated via enhanced emphasis on repairability and durability, such as designing machinery for easy disassembly, component replacement, and safe modifications to extend service life and minimize environmental impact.^[20] Conformity assessment procedures undergo substantial tightening, particularly for high-risk machinery. Under the regulation, all categories listed in Annex I—such as certain presses, lifts, and safety components—mandate involvement of a notified body for full quality assurance or EU-type examination, eliminating the self-assessment option available under the 2006 Directive for some high-risk items.^[20] Additionally, substantial modifications to machinery, including those affecting safety functions, now require external verification by a notified body or competent authority to confirm ongoing compliance, with periodic inspections mandated for specific high-risk types like explosive atmosphere equipment.^[20] Documentation obligations are modernized to support digital traceability and long-term accountability. Manufacturers must provide instructions, the EU Declaration of Conformity, and technical files in digital formats, accessible electronically and machine-readable where feasible, diverging from the primarily paper-based approach of the 2006 Directive.^[20] Retention periods for technical documentation remain 10 years after the machinery is placed on the market, consistent with the directive.^[20] The regulation broadens its scope to explicitly include standalone software as machinery when it performs safety functions or drives physical equipment, provided it meets the definition of directing or controlling under safety-critical conditions—a clarification absent in the 2006 Directive, which focused more on hardware-integrated systems.^[20] Responsibilities for economic operators are intensified, with importers and distributors facing stricter due diligence requirements, including verifying the presence of the serial number, conducting sample checks on documentation, and cooperating more closely with authorities on risk reporting.^[20] Furthermore, whistleblower protections are strengthened by mandating that member states apply Union-wide safeguards for individuals reporting suspected non-compliance or safety risks related to machinery, building on but exceeding the general framework of the 2006 Directive.^[20]

Implementation Timeline

The Machinery Regulation (EU) 2023/1230 entered into force on 19 July 2023, twenty days after its publication in the Official Journal of the European Union on 29 June 2023, following a corrigendum issued on 4 July 2023 to correct clerical errors, including adjustments to key dates.^[3] The regulation establishes a general application date of 20 January 2027, at which point it repeals and replaces the Machinery Directive 2006/42/EC.^[21] Until that date, the Directive remains fully applicable, allowing manufacturers to continue certifying and placing machinery on the market under its provisions.^[21] A transitional period ensures continuity for existing products: machinery, related products, and partly completed machinery placed on the market in conformity with the Directive before 20 January 2027 may continue to be made available on the market without further requirements under the new regulation.^[21] Certificates issued under the Directive, such as EC type-examination certificates, remain valid until their expiry date, even after 2027.^[21] Manufacturers may voluntarily declare conformity with the new regulation during the transition if they meet its requirements, enabling early adoption while still relying on the Directive for legal compliance.^[2] Certain provisions apply on a staggered basis to facilitate preparation. For instance, rules on the notification of conformity assessment bodies (Articles 26 to 42) take effect from 20 January 2024, penalties for non-compliance (Article 50(1)) from 20 October 2026, and market surveillance obligations (Chapter VI, including Article 52) from 19 July 2023.^[21] Specific requirements for high-risk AI-integrated machinery align with the general application date of 20 January 2027, integrating provisions from the AI Act without earlier mandatory enforcement for such systems under this regulation.^[21] Cybersecurity obligations for machinery, as outlined in Annex III, apply from 20 January 2027, though delegated acts may specify earlier dates for emerging high-risk categories if deemed necessary by the Commission.^[21] Harmonized standards cited under the Directive continue to provide a presumption of conformity until the Commission withdraws or replaces their references in the Official Journal, typically targeted for completion by 2027 to align with the regulation's requirements under Regulation (EU) No 1025/2012.^[22] After 20 January 2027, no new machinery may be certified under the Directive; instead, all placements on the market must comply with the regulation, while legacy products maintain their indefinite validity under transitional rules, supported by national market surveillance authorities for ongoing enforcement.^[21]^[2]