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Machinery Regulation Glossary
Updated on 26 August 2026 · 43 entries, each referenced to its article
Regulation (EU) 2023/1230 is easily misunderstood when read in haste. Its vocabulary seems ordinary — machinery, manufacturer, instructions, guard —, yet each term is defined, and the definition rarely aligns with everyday usage. This glossary gathers forty-three terms that appear repeatedly across technical documentation and cross-references each back to its article.
A methodological note before beginning. The Regulation defines its terms in two places, with two distinct scopes. Article 3 sets out thirty-eight definitions that apply across the entire text (thirty-six in the initial publication, two added by Regulation (EU) 2024/2748). Annex III, Part A, adds nine definitions that apply solely to Annex III. This explains why "operator" designates a person in one case, and "economic operator" an undertaking in the other. Each entry indicates which of the two lists provides its foundation and clarifies when a term is not drawn directly from either.
A word whose article cannot be cited is not a regulatory term: it is trade jargon. Both hold equal value in a meeting, never in technical documentation.
Alphabetical index
A — C
Economic operator ·
Risk assessment and evaluation ·
Annex I (categories) ·
Market surveillance authority ·
Making available on the market ·
Safety component ·
Self-evolving behaviour ·
Internal production control ·
Partly completed machinery
D — F
EU declaration of conformity ·
EU declaration of incorporation ·
Protective device ·
Distributor ·
Technical documentation ·
Common specification ·
Technical specifications ·
Conformity assessment ·
Manufacturer ·
Safety function
I — N
Importer ·
Instructions for use ·
Digital instructions ·
Assembly instructions ·
Placing on the market ·
Reasonably foreseeable misuse ·
Machinery ·
CE marking ·
Inherently safe design measure ·
Substantial modification ·
Safety integrity level (SIL) ·
Performance level (PL) ·
Harmonised standard
O — Z
Operator ·
Notified body ·
Hazard ·
Exposed person ·
Presumption of conformity ·
Related product ·
Putting into service ·
Authorised representative ·
Essential health and safety requirement ·
Guard (fixed, movable, adjustable) ·
Risk ·
Residual risk ·
Intended use ·
Lifetime ·
Market surveillance ·
Danger zone
The actors
Eight roles, of which only four are "ECONOMIC OPERATORS". The distinction is not merely cosmetic: it determines who answers for what before an authority.
Art. 3, point 18Actors
Manufacturer
Anyone who manufactures — or has designed and manufactured — a product and markets it under their name or trademark; or who manufactures a product and puts it into service for their own use. The second prong often comes as a surprise: an industrial company building its own line, without ever selling it, is fully a manufacturer and must compile the complete documentation. The obligations are set out in Article 10: essential requirements, technical documentation under Annex IV, Part A, conformity assessment procedure, EU declaration, CE marking, and retention of records for at least ten years at the disposal of authorities (Art. 10(3)).
Not to be confused with the company that merely operates the machine, which only becomes a manufacturer if it manufactures, affixes its trademark (Art. 17), or carries out a substantial modification (Art. 18).
Art. 3, point 19 · Art. 12Actors
Authorised representative
Any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on their behalf in relation to specified tasks. Article 12(1) establishes a strict limit: the fulfilment of essential requirements and the drawing up of technical documentation cannot be delegated. The mandate allows at a minimum keeping documents available for ten years, responding to reasoned requests from authorities, and cooperating on actions taken to eliminate risks (Art. 12(2)).
Not to be confused with the importer, who purchases and places products on the market on their own account, whereas the authorised representative acts on behalf of a manufacturer who retains responsibility.
Art. 3, point 20 · Arts. 13 and 14Actors
Importer
Any person established within the Union who places on the Union market a product originating from a third country. The Regulation assigns them two distinct regimes, a point often overlooked in summary tables: Article 13 for machinery and related products, and Article 14 for partly completed machinery. The importer must verify that the conformity assessment procedure has been carried out, that the technical documentation exists, that markings and instructions are present, and must indicate their own contact details on the product.
Not to be confused with the distributor: the defining criterion is not placement within the supply chain, but the crossing of the Union border.
Art. 3, point 21 · Arts. 15 and 16Actors
Distributor
Any link in the supply chain, other than the manufacturer or importer, who makes a product available on the market. Here again, two articles apply: Article 15 for machinery and related products, and Article 16 for partly completed machinery. Their obligation of diligence is lighter than that of the importer, but not nonexistent: they must act "with due care in relation to the requirements of this Regulation" and not make available any product they have reason to believe is non-compliant.
Not to be confused with the manufacturer, with one major caveat: Article 17 turns the distributor into a manufacturer as soon as they sell under their own name or trademark, or modify a product already placed on the market in a manner that may affect its compliance.
Art. 3, point 22Actors
Economic operator
The collective term: the manufacturer, the authorised representative, the importer, or the distributor. Four figures, no more. This is the term used by the market surveillance articles to identify an authority's interlocutor: a company that merely operates machinery is not an economic operator, unless it becomes a manufacturer pursuant to Article 17 or 18.
Not to be confused with the operator of Annex III, who is a natural person at the controls of the machine.
Annex III, Part A, point (d)Actors
Operator
The person or persons installing, operating, adjusting, maintaining, cleaning, repairing, or moving machinery. The definition is deliberately broad: setup technicians, maintenance staff, and cleaning personnel are operators alongside machine operators. Direct consequence for risk assessment: maintenance, cleaning, and repair phases must be addressed, not merely the production cycle.
Not to be confused with the economic operator of Article 3, nor with "professional user" (Art. 3, point 36), who is anyone using machinery in the course of their work.
Art. 3, point 30 · Arts. 26 to 42Actors
Notified body
A conformity assessment body notified by a Member State to the Commission under this Regulation. Its intervention is not universal: it is triggered by the Annex I category and the procedure selected under Article 25. When it intervenes, its identification number follows the CE marking (Art. 24(3)): this is the visible sign on the rating plate that a third party was involved. Articles 26 to 42 have applied since 20 January 2024, three years prior to the rest of the Regulation, specifically to ensure that an operational network of bodies exists on the date of application.
Not to be confused with an accredited body or a testing laboratory: accreditation (Art. 3, point 26) is a prerequisite, not notification itself.
Art. 3, point 31 · Arts. 43 to 46Actors
Market surveillance
Ex-post public oversight. "market surveillance authority" is defined by reference to Article 3, point 4, of Regulation (EU) 2019/1020; Chapter VI of the Machinery Regulation (Arts. 43 to 46) establishes the national procedure, the Union safeguard procedure, and the handling of compliant products that nonetheless present a risk. Two technical terms derive from it: recall applies to products already made available to the user; withdrawal applies to products still in the supply chain (Art. 3, points 32 and 33).
A matter of dates: this Chapter VI already applies, since 19 July 2023, even to machinery placed on the market under Directive 2006/42/EC (Article 52(1)). It is one of the few parts of the Regulation already applicable before 2027, along notably with Chapter V on notified bodies, which has applied since 20 January 2024 (Article 54(a)).
The subject matters
What the Regulation governs. The question is never "is it a machine?", but "which of the three regimes applies: machinery, related product or partly completed machinery?", because the documents to be drawn up are not the same.
Art. 3, point 1Subject matters
Machinery
Six cases, from point (a) to point (f). Case (a) is classic: 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. Case (d) is the one often overlooked: an assembly of machines or partly completed machinery arranged and controlled so that they function as an integral whole in order to achieve the same end is one machine: the complete line, not just its individual stations. And case (f) is new: an assembly which only lacks the uploading of software intended for its specific application as intended by the manufacturer is already machinery.
Not to be confused with partly completed machinery: the criterion is the ability to perform a specific application on its own.
Art. 2(1)Subject matters
Related product
The Regulation does not define this term. Article 3 contains no entry for it: the concept is established by enumeration in Article 2(1), which refers to five categories: interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices. Each of these does have its own definition in Article 3. The practical consequence is substantial: throughout the text it states "machinery or related product", so that almost all obligations designed for machinery also apply to a sling or a light curtain sold separately.
To keep in mind: machinery, related products and partly completed machinery are collectively referred to as "products within the scope of this Regulation". The term is lengthy; it is also the only legally precise one.
Art. 3, point 10 · Art. 11Subject matters
Partly completed machinery
An assembly which cannot in itself perform a specific application and which is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment. Its documentation regime is distinct and comprehensive: technical documentation under Annex IV, Part B, an EU declaration of incorporation (Article 22, Annex V, Part B) and assembly instructions (Annex XI). It does not bear CE marking under this Regulation.
Not to be confused with an ordinary component: partly completed machinery remains subject to the "relevant" essential requirements of Annex III (Article 8, second paragraph), and the principles of safety integration in section 1.1.2 apply to it in all cases (Annex III, 1.1.1).
Art. 3, point 3 · Art. 7 · Annex IISubject matters
Safety component
A physical or digital component, including software, designed or intended to fulfil a safety function, placed on the market separately, the failure or malfunction of which endangers the safety of persons, but which is not necessary in order for the product to function or may be substituted by other components. Extending this to software is one of the substantive changes in the Regulation: a safety software component sold separately is a regulated product, requiring technical documentation, a declaration, and marking. Annex II provides an indicative list, which the Commission may amend via delegated acts (Article 7).
Not to be confused with a spare part: safety components intended to replace identical components and supplied by the manufacturer of the original machinery are excluded from the scope (Article 2(2)(a)).
Art. 3, point 4Subject matters
Safety function
A function that serves to fulfil a protective measure designed to eliminate a hazard or, where this is not possible, to reduce a risk, and the failure of which can result in an increase of that risk. The second half of the definition is the test: if the failure of the function does not aggravate anything, it is not a safety function. It is this term that governs the inventory of functions to be addressed in the technical documentation and, by extension, the perimeter of logic blocks and safety-related software whose source code may be required (Annex IV, point (m)).
Not to be confused with a safety component, which is an object placed separately on the market; the function, by contrast, may be performed by an integrated component.
Annex I · Art. 6 · Art. 25Subject matters
Annex I (categories)
The list of categories whose conformity cannot be self-declared unconditionally. Part A (six categories) mandates one of the procedures in Article 25(2), all involving a notified body: EU type-examination followed by conformity to type, full quality assurance, or unit verification. Part B (nineteen categories) allows internal production control, but only if the design applies harmonised standards or common specifications that cover all relevant essential requirements in full (Article 25(3)). Outside Annex I: internal production control (Article 25(4)).
What has changed: Part A now includes safety components and integrated systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions (Annex I, Part A, points 5 and 6).
Annex III, 1.2.1Subject matters
Self-evolving behaviour
The Regulation does not define the term; it describes and regulates it. Section 1.2.1 of Annex III addresses control systems of machinery "with fully or partially self-evolving behaviour or logic that are designed to operate with varying levels of autonomy" and imposes three duties on them: never cause the machinery to act outside its defined task and working space; record the data on the safety-related decision-making process for software-based systems and retain them for one year; and allow the machinery to be overridden at all times to maintain its inherent safety. The trace log of interventions and safety software versions uploaded must, for its part, be enabled for five years after the upload (1.2.1, point (f)).
Consequence for architecture: these retention periods are not best-practice recommendations, they are essential requirements. They must be designed into the selection of the controller, not left for the audit.
The acts
The operative verbs of the Regulation. They date the legal obligations: almost everything is counted from the date of placing on the market.
Art. 3, point 11Acts
Making available on the market
Any supply of a product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. Free provision offers no protection: a demonstration loan, provision under a service contract, or a prototype entrusted to a customer constitutes making available on the market. The term covers each successive supply, from the manufacturer to the ultimate distributor.
Not to be confused with placing on the market, which is only the first of those supplies. Note: in the Spanish version, Directive 2006/42/EC used "placing on the market" for that initial provision (Article 2(h)); the Regulation alters the meaning of the terminology.
Art. 3, point 12Acts
Placing on the market
The first making available of a product on the Union market. This is the pivotal date of the Regulation: it triggers the ten-year retention period for the technical documentation and declaration (Article 10(3)), online availability of digital instructions for use (Article 10(7)(c)), and the obligation to have affixed the CE marking beforehand (Article 24(2)). It also determines the governing regime: if placed on the market before 20 January 2027, the machine remains governed by Directive 2006/42/EC (Article 52(1)).
Not to be confused with delivery or invoicing: the criterion is the first supply on the Union market, not the associated commercial transaction.
Art. 3, point 13Acts
Putting into service
The first use, for its intended purpose, in the Union. The concept exists for the single scenario where no sale takes place: a manufacturer building a machine for own use never places it on the market, but puts it into service, whereupon Article 10 applies in full. For sold machinery, placing on the market and putting into service happen successively, and several obligations run from "placing on the market or putting into service".
Not to be confused with site acceptance or initial commissioning inspections carried out by an employer, which fall under national occupational safety legislation and not this Regulation.
Art. 3, point 16 · Art. 18Acts
Substantial modification
A modification, by physical or digital means, carried out after placing on the market, not foreseen by the manufacturer, which affects safety by creating a new hazard or increasing an existing risk, and requires either the addition of guards or protective devices necessitating a change to the existing safety control system, or additional protective measures to ensure stability or mechanical strength. The two prongs (a) and (b) are not examples: they are the sole triggers. Anyone crossing this threshold becomes a manufacturer for the purposes of Article 10 and must apply the relevant conformity assessment procedure (Article 18).
Two useful limits: a substantial modification that affects only one machine within an assembly makes the person a manufacturer only for that individual machine; and a non-professional user modifying their own machine for their own use is not covered (Article 18, last paragraph).
Art. 3, point 25 · Arts. 23 and 24Acts
CE marking
The marking by which the manufacturer indicates conformity with the applicable requirements. Its general principles are set out in Article 30 of Regulation (EC) No 765/2008 (Article 23); its rules for affixing are set out in Article 24: visible, legible and indelible on the product, affixed before placing on the market or putting into service. Where a notified body has intervened in accordance with Article 25, paragraph 2, points (a), (b) or (c), or paragraph 3, points (b), (c) or (d), its identification number follows the marking.
Not to be confused with proof of conformity: the marking is a declaration, not a certificate. What proves conformity is the technical documentation, and authorities will request it.
Art. 3, point 28 · Art. 25Acts
Conformity assessment
The process demonstrating whether the applicable essential requirements are fulfilled. Article 25 sets the choice of procedure, and this choice is not free: it derives automatically from the product's placement in Annex I. Five modules are involved: A (Annex VI), B (Annex VII), C (Annex VIII), H (Annex IX) and G (Annex X). Notified bodies must take into account the needs of SMEs when setting their fees (Art. 25(5)).
Not to be confused with the risk assessment: the latter determines which requirements apply; the former demonstrates that they are fulfilled.
Annex VI · Art. 25(4)Acts
Internal production control (Module A)
The procedure whereby the manufacturer guarantees and declares, under their sole responsibility and without a notified body, that the product fulfils the requirements. It comprises three obligations: drawing up the technical documentation of Annex IV, Part A; monitoring manufacturing so that it remains compliant with that documentation; and affixing the marking and drawing up the EU declaration, retaining it for ten years. It is the ordinary route for any product not listed in Annex I (Art. 25(4)).
Mind the wording: the Regulation states "internal production control". Annex VIII to Directive 2006/42/EC stated "internal checks on the manufacture". The module is the same; the citation is not.
Art. 3, point 34Acts
Lifetime
The period from the placing on the market or putting into service until the product is discarded, including the effective time of use and the phases of transport, assembly, dismantling, disabling and scrapping, as well as modifications foreseen by the manufacturer. It is the definition that gives meaning to the obligation to keep digital instructions for use accessible "during the expected lifetime" (Art. 10(7)(c)): it does not end on the last day of production.
Not to be confused with the ten-year period: the expected lifetime and the ten years from placing on the market are two cumulative periods; the longer one prevails.
Documents
Six documents, and one principle governing them all: each has a template or minimum content set out in an annex, and each may now be digital, subject to precise conditions.
Annex IV · Art. 10(2)Documents
Technical documentation ("technical file")
The document specifying the means used to ensure conformity. Part A of Annex IV applies to machinery and related products; Part B, to partly completed machinery. Fifteen items, from point (a) to (o), three of which are demanding: the description of the capabilities and limitations of sensor-fed, remotely driven or autonomous systems (n) and the source code or programming logic of safety-related software, provided upon a reasoned request from an authority (m), both unprecedented in the Directive, in addition to the internal measures implemented to maintain series production compliance (l), which the Directive already required (Annex VII, Part A, point 1(b)).
Mind the wording: the Regulation writes "technical documentation". "technical file" is common practice, inherited from the Directive: fine in a meeting, to be avoided in a legally binding document.
Art. 21 · Annex V, Part ADocuments
EU declaration of conformity
The act by which the manufacturer states that compliance with the essential requirements has been demonstrated and assumes responsibility for conformity (Art. 21(4)). It follows the model structure of Annex V, Part A, and contains the elements of the applied modules (Annexes VI, VIII, IX and X). Two points are frequently overlooked: it is continuously updated (Art. 21(2)), and where several Union acts require a declaration, a single declaration is drawn up covering all of them (Art. 21(3)).
What's new: it may be provided via an internet address or a machine-readable code, but must then remain accessible online for at least ten years (Art. 10(8)).
Art. 22 · Annex V, Part BDocuments
EU declaration of incorporation
The equivalent of the declaration of conformity for partly completed machinery: it states that compliance with the relevant essential requirements has been demonstrated, follows the model structure of Annex V, Part B, is continuously updated and engages the manufacturer's responsibility. It accompanies the partly completed machinery or is accessible via an internet address or machine-readable code, online for at least ten years (Art. 11(8)).
Not to be confused with a downgraded declaration of conformity: it is not equivalent to CE marking, and the integrator incorporating the partly completed machinery must draw up, on their part, the EU declaration of conformity for the final machinery. The Regulation adds the word "EU", which the Directive did not use.
Art. 3, point 17 · Annex III, 1.7.4Documents
Instructions for use
Information provided by the manufacturer to inform the user of the intended and proper use, precautions to be taken and safety aspects, and to ensure the product remains fit for purpose throughout its life cycle. They are drawn up in a language easily understood by users, determined by the Member State (Art. 10(7)). It is one of three requirements that apply in all cases, even if the corresponding hazard does not exist, alongside the principles of safety integration (1.1.2) and marking (1.7.3).
Not to be confused with the assembly instructions for partly completed machinery, nor with technical documentation, which is not intended for the user but for the authorities.
Art. 10(7)Documents
Digital instructions for use
The Regulation allows instructions to be provided in digital format, under four cumulative conditions: indicate on the machine how to access them; offer them in a format that allows them to be printed, downloaded and saved, accessible even in the event of a breakdown, including when integrated into the software; keep them online during the expected lifetime and for at least ten years following the placing on the market; and provide a paper version free of charge within one month to anyone who requests it at the time of purchase.
The overlooked exception: for machinery intended for non-professional users — or which, under reasonably foreseeable conditions, may be used by them — essential safety information for putting into service and safe use continues to be provided in paper format. The dedicated guide.
Annex XI · Art. 11(7)Documents
Assembly instructions
The specific document for partly completed machinery: it describes the conditions that must be met so that incorporation takes place without compromising health and safety, and provides the integrator with what is needed to draft the instructions for the final machinery: general description, drawings and diagrams for incorporation, warnings concerning ways in which it must not be used, assembly, installation and connection instructions. They may be digital under the same conditions as instructions for use, with online availability for at least ten years and a free paper version within one month upon request.
Not to be confused with instructions for use: their recipient is not the operator, but "the person who incorporates the partly completed machinery", and the required language is the one that person easily understands.
Standards
This is the area where approximations are most costly. A standard only becomes harmonised when its reference is published in the Official Journal under the applicable act; and as of 26 August 2026, none is yet published under the Regulation.
Art. 3, point 24 · Art. 20(1)Standards
Harmonised standard
The Regulation does not define it itself: it refers to Article 2, point 1(c), of Regulation (EU) No 1025/2012. In practice, a European standard drawn up at the Commission's request and whose reference has been published in the Official Journal. Both conditions matter: an EN ISO that is entirely relevant, but not cited, confers no presumption. It is this status — and not the technical content — that alters its legal value.
Not to be confused with an "applicable", "recognised" or "commonly used" standard: these terms do not exist in the text.
Art. 20Standards
Presumption of conformity
The legal effect, and nothing more: a product compliant with a harmonised standard — or with parts thereof — whose reference has been published in the OJEU is presumed to comply with the essential requirements covered by those parts (Art. 20(1)). The presumption is therefore partial by nature, and Annex IV, point (e), requires specifying which parts have been applied. It also extends to common specifications (para. 6) and, solely for sections 1.1.9 and 1.2.1, to a cybersecurity certificate issued under Regulation (EU) 2019/881 whose references have been published in the OJEU (para. 9).
Status as of 26 August 2026: no standard is cited under Regulation (EU) 2023/1230. Citations currently in force are under Directive 2006/42/EC, via consolidated Implementing Decision (EU) 2023/1586. Reliable documentation therefore maintains a dual status per standard.
Art. 20(3) and (6)Standards
Common specification
The Commission's safety net. Where a request for standardisation has not been accepted, has not delivered within the deadline or has produced a standard that does not comply with the request, and no reference has been published nor is expected to be published within a reasonable period, the Commission may adopt technical requirements by means of implementing acts (Art. 20(3)). They confer the same presumption as a harmonised standard (para. 6) and are repealed as soon as a harmonised standard covering the same requirements is published (para. 7).
Not to be confused with the technical specifications of Article 3, point 23: these denote any document setting technical requirements, with no legal effect of their own. The exact term used in the Regulation is "common specification", in singular or plural, not "common technical specification".
Art. 3, point 23 · Annex IV, point (f)Standards
Technical specifications
"a document that prescribes technical requirements to be fulfilled by products". The definition is intentionally broad and carries no standalone legal effect. Its purpose lies elsewhere: it is the term used in Annex IV, point (f), for what must be described in the documentation where harmonised standards have not been applied, or have only been partially applied. In other words, the absence of a cited standard does not permit a vacuum: it compels documenting the alternative route taken.
Not to be confused with a common specification, which is an implementing act of the Commission and does confer a presumption.
outside the RegulationStandards
Performance Level (PL)
The Regulation does not use this term: a full-text search in the Spanish text returns zero occurrences of “performance level”. PL is vocabulary from EN ISO 13849-1, which grades from a to e the ability of a safety-related part of a control system to perform its function. The Regulation, for its part, sets the objective in Annex III, 1.2.1 — a fault in the hardware or logic must not lead to hazardous situations — and leaves it to the standard to quantify it.
What must be checked: EN ISO 13849-1:2023 has been cited since 15 May 2024 under the Directive; EN ISO 13849-1:2015 ceases to confer presumption on 15 May 2027. Documentation that still cites the :2015 version must be revised.
outside the RegulationStandards
Safety integrity level (SIL)
A term also absent from the Regulation: neither “SIL” nor “safety integrity level” appears in the Spanish version of the text. It stems from the functional safety family — IEC 61508 for the general framework, IEC 62061 for its application to machinery — and grades from 1 to 3 (4 outside the machinery domain) the integrity of an electrical or programmable safety function. Using PL or SIL is a choice of demonstration method, not a regulatory obligation.
Acknowledged uncertainty: the citation status in the OJEU for standards in the 62061 family has not been verified in our repository of requirements and standards, which does not cover them. This must be checked against the summary list before making any declaration relying on them.
Safety
The vocabulary of Annex III. It applies only to Annex III, but Annex III is what you will be asked to demonstrate, requirement by requirement.
Art. 3, point 14 · Art. 8Safety
Essential health and safety requirement (EHSR)
The mandatory provisions of Annex III relating to design and construction. Article 8 makes them a condition for placing on the market. Three reading rules avoid most documentation errors. One: a requirement applies only if the corresponding hazard exists, except for sections 1.1.2, 1.7.3 and 1.7.4, which apply in all cases. Two: where the state of the art does not allow the objective to be achieved, the product is designed and constructed “as far as possible” to get close to it. Three: the annex consists of six chapters and must be examined in its entirety to know which ones apply to you.
Citation detail: in the Spanish version, Article 3, point 14, and the title of Annex III use the same phrasing, “essential health and safety requirements”. The reverse order, “essential health and safety requirements”, appears only once in the official text, in the introduction to Chapter 2 of Annex III.
Annex III, Part B, 1Safety
Risk assessment and risk evaluation
The Regulation speaks of a “iterative process of risk assessment and risk reduction” in five steps: determine the limits of the product, including intended use and reasonably foreseeable misuse; identify hazards and hazardous situations; estimate the risks; evaluate them to decide whether risk reduction is required; and eliminate hazards or reduce risks in accordance with the order of priority in section 1.1.2(b). Two extensions are specific to the Regulation: the assessment covers the foreseen evolution of the behaviour of machinery with self-evolving logic, and the risks resulting from interactions between machines forming an assembly within the meaning of Article 3, point 1(d).
Watch the wording: “risk analysis” is vocabulary from EN ISO 12100, not from the Regulation, nor even from Directive 2006/42/EC, which already used “risk assessment”. Useful for discussions, to be adjusted when citing.
Annex III, Part A, (a), (b), (c) and (e)Safety
Hazard, risk, danger zone, exposed person
Four words that are often used interchangeably and that Annex III clearly distinguishes. A hazard is a potential source of injury or damage to health: it is intrinsic and not measured. A risk is the combination of the probability and the degree of an injury or damage to health that can arise in a hazardous situation: it is quantified. A danger zone is any space within and/or around the product in which a person is subject to a risk to their health or safety. An exposed person is anyone wholly or partially in such a zone.
Why it matters: documentation that “eliminates a risk” without stating which hazard was removed and which zone was reduced proves nothing. The three terms must appear, distinguished, on each line of the assessment.
Annex III, 1.1.2(b)(iii)Safety
Residual risk
What remains after protective measures: the “due to any shortcomings of the protective measures adopted” risks. The Regulation does not treat this as a failure: it turns it into an information obligation. The manufacturer informs users of these risks, indicates whether special training is required and specifies if personal protective equipment is needed. The technical documentation must, where applicable, indicate them (Annex IV, point (b)(ii)).
The pitfall: Article 6(7)(b) makes the repetition of serious accidents related to residual risks a criterion for inclusion in Annex I, Part A. A residual risk widely tolerated across a sector can therefore eventually cause an entire machinery category to fall under mandatory notified body conformity assessment.
Annex III, 1.1.2(b)(i)Safety
Inherently safe design measure
The first of the three steps, and the only non-negotiable one: “eliminate hazards or, if that is not possible, to minimise all relevant risks” through inherently safe design and construction. Next come protective measures for risks that cannot be eliminated and, finally, information about residual risks. The order is mandatory — “in the order given” — and documentation that starts with a pictogram is recognisable at first glance.
Watch the wording: the Spanish expression «prevención intrínseca» does not appear in the Regulation; it comes from EN ISO 12100 vocabulary. The text states “inherently safe design and construction”.
Annex III, Part A, (f) · 1.4.2Safety
Guard (fixed, interlocking movable, adjustable)
A part of a machine used specifically to provide protection by means of a physical barrier. Three families in section 1.4.2. Fixed guards (1.4.2.1) are opened or removed only with tools, their fixing systems remain attached to the guards or to the machine, and where possible, they cannot remain in place without their fixings. Interlocking movable guards (1.4.2.2) are associated with an interlocking device. Adjustable guards restricting access (1.4.2.3) are limited to the areas strictly necessary for the work and are adjusted without tools.
Not to be confused with a protective device, which is by definition “other than a guard”. Reference standards: EN ISO 14120 for guards and EN ISO 14119 for interlocking, both cited under the Directive.
Annex III, Part A, (g) · 1.4.3Safety
Protective device
A device other than a guard that reduces the risk, either alone or in conjunction with a guard: light curtain, pressure-sensitive mat, two-hand control. Section 1.4.3 sets the intended effect: prevent moving parts from starting while the operator can access them, and prevent anyone from reaching them while they are moving.
Point to watch: “Protective devices designed to detect the presence of persons” are listed in Annex I, Part B, point 15, making their conformity assessment subject to specific procedures. However, under the Directive, no version of EN 61496-1 confers a presumption of conformity: the :2013 edition was withdrawn with effect from 19 September 2020 without replacement, and the :2020 edition has never been cited. Any ESPE documentation citing EN 61496-1 as harmonised is incorrect.
Annex III, Part A, (h) and (i)Safety
Intended use and reasonably foreseeable misuse
Intended use means the use “in accordance with the information provided in the instructions for use”: this binds the scope of demonstration to what the instructions state and turns drafting instructions into a design act, not mere documentation. Reasonably foreseeable misuse means use in a way not intended in the instructions, “but which may result from readily predictable human behaviour”. Both must be taken into account in the design (1.1.2(a) and (c)), delimit the product in the risk assessment, and appear in the technical documentation (Annex IV, point (a)).
What changes: restricting the instructions to restrict one’s liability does not work. The narrower the instructions, the wider the scope of foreseeable misuse becomes, requiring the machine to be designed to prevent incorrect use.
Seven words that the Directive did not use
Comparison carried out on the Spanish version of Directive 2006/42/EC published in OJ L 157 of 9.6.2006: the entries “absent” mean zero occurrences in that text. Since then, Directive (EU) 2024/2749 has introduced emergency procedures into the Directive (Articles 21b to 21g) that use “common specifications” and “economic operator” (in Spanish «operador económico», not «agente económico», the term of the Regulation): the table compares the original vocabulary.
The twelve annexes and what to look for in them
Dates as corrected
The Regulation applies from 20 January 2027, not the 14th
The text published in OJ L 165 of 29 June 2023 read “14 January 2027”. The corrigendum published in OJ L 169 of 4 July 2023, p. 35, corrected fourteen dates. The consolidated text (02023R1230-20230629) now states: application on 20 January 2027 (Art. 54); repeal of Directive 2006/42/EC with effect from 20 January 2027 (Art. 51(2)); Articles 26 to 42, notification of bodies, from 20 January 2024; Article 6(7) and Articles 48 and 52 from 19 July 2023; Article 6(2) to (6), (8) and (11) and Articles 47 and 53(3) from 20 July 2024; Article 50(1) from 20 October 2026.
Uncorrected HTML versions showing “14 January” are still in circulation. The legally binding date is the 20th. The guide to the Regulation.
Questions about the vocabulary itself
Why does the Regulation define its terms in two places?
Because there are two lists with different scopes. Article 3 provides thirty-eight definitions — thirty-six at publication, two added by Regulation (EU) 2024/2748 — that apply to the entire Regulation: machinery, partly completed machinery, manufacturer, placing on the market, substantial modification. Annex III, Part A, provides nine more that apply only to Annex III: hazard, danger zone, exposed person, operator, risk, guard, protective device, intended use, reasonably foreseeable misuse. That is why it is essential to know which list each term comes from: the “operator” in Annex III is a person, whereas the “economic operator” in Article 3 is an economic entity.
Where does the Regulation define “related product”?
Nowhere as a standalone definition. Article 3 contains no entry for “related product”: the concept is defined by enumeration in Article 2(1): interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices. Each of these five categories does, however, have its own definition in Article 3. Together with machinery and partly completed machinery, they form what the text terms “products within the scope of this Regulation”.
Do PL and SIL levels appear in the Regulation?
No. In the Spanish text, a full-text search yields no occurrences of “nivel de prestaciones”, “SIL” or “nivel de integridad de seguridad” (performance level or safety integrity level). The Regulation sets an objective — that a fault in the hardware or logic of the control system does not lead to dangerous situations, Annex III, Section 1.2.1(b) — and leaves quantification to the standards. PL originates from EN ISO 13849-1; SIL from the IEC 61508 and IEC 62061 series. Citing a PL in a declaration remains entirely legitimate: it is a means of demonstration, not a direct statutory requirement.
Should one say “technical file” or “technical documentation”?
The Regulation uses “technical documentation”: this is the title of Annex IV and the term used in Article 10(2). “technical file” is common usage inherited from the Directive, and causes no confusion in a meeting. However, in a legally binding document — an EU declaration of conformity, a response to a market surveillance authority, documentation submitted to a notified body — it is best to use the statutory term and cite Annex IV, Part A for machinery and related products, and Part B for partly completed machinery.
Can the vocabulary of Directive 2006/42/EC still be used in 2027?
Only in part. The Regulation introduces terms not used in the Directive — related product, economic operator, importer, distributor, substantial modification, common specifications, self-evolving behaviour — and alters others: “internal checks on the manufacture” in Annex VIII becomes “internal production control”, Module A, in Annex VI; “declaration of incorporation” becomes “EU declaration of incorporation”; and “placing on the market”, which in the Directive meant the initial making available, now designates any supply, whereas the initial making available is termed “placing on the market”. Directive 2006/42/EC is repealed with effect from 20 January 2027 (Article 51(2)). Documentation drafted using the legacy vocabulary is not rendered void, but cross-references to articles must be updated: Annex XII provides the correlation.
Sources
Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery, OJ L 165, 29.6.2023 — full text in English: Article 2 (scope), Article 3 (36 definitions at publication, 38 since Regulation (EU) 2024/2748), Articles 6 to 8, 10 to 18, 20 to 25, 51 to 54, Annexes I to XII. · Corrigendum, OJ L 169, 4.7.2023, p. 35, incorporated into the consolidated text — 02023R1230-20230629: fourteen dates corrected, including application on 20 January 2027. · Directive 2006/42/EC, English version published in OJ L 157, 9.6.2006 and consolidated version — 02006L0042-20190726, for vocabulary comparison (Annex VIII, “internal checks on the manufacture”; Article 2(h), “placing on the market”). · Status of standards: consolidated Implementing Decision (EU) 2023/1586 — 02023D1586-20260515; Decision (EU) 2024/1329 of 15.05.2024 (citation of EN ISO 13849-1:2023, cessation of :2015 on 15.05.2027); Decision (EU) 2019/1863 (withdrawal of EN 61496-1:2013 on 19.09.2020); Commission summary list. · Standard references verified on 26.08.2026; on that date, no standard is cited under Regulation (EU) 2023/1230. Definitions and article numbers on this page are taken from the official text, not from secondary sources.