CE marking of machinery: what Directive 2006/42/EC actually requires

CE marking a machine is not a logo to stick on nor a formality to outsource: it is a declaration by which someone takes on responsibility, stating that the machine meets precise requirements. Most of the trouble companies run into comes from a single question settled wrongly at the outset: who is the manufacturer? This article follows Directive 2006/42/EC article by article, sets out what it actually requires, and flags what it does not say.

Who is the manufacturer: the question that costs the most

This is the starting point, and the one most often got wrong. Article 2(i) defines the manufacturer as any natural or legal person who designs or manufactures machinery and is responsible for its conformity with a view to placing it on the market under their own name or trademark, or for their own use.

Those last four words change everything. A plant that builds an assembly station for its own production line buys nothing from anyone: it is a manufacturer within the meaning of the directive, with every obligation that entails. This is the most common situation and the hardest to accept, because nothing in the organisation signals that it has just entered the scope of a directive.

The text goes further. Where no such manufacturer exists, any person who places the machinery on the market or puts it into service is considered the manufacturer. Responsibility does not vanish for want of a holder: it shifts to whoever makes the product available. Buying machinery outside the Union and installing it on your own site very often means taking on that role.

Machinery, partly completed machinery, safety component: three distinct regimes

The directive does not treat these three the same way, and the confusion is paid for in missing documents on audit day.

Partly completed machinery, defined in Article 2(g), is an assembly which is almost machinery but cannot in itself perform a specific application; a drive system is one. It is solely intended to be incorporated into other machinery. Its manufacturer does not affix CE marking and does not draw up an EC declaration of conformity. Article 13 imposes three other deliverables: the relevant technical documentation of Annex VII, part B, the assembly instructions of Annex VI, and a declaration of incorporation under Annex II, part 1, section B.

The point systematically forgotten sits in paragraph 2 of that same Article 13: the assembly instructions and the declaration of incorporation accompany the partly completed machinery until it is incorporated, and then form part of the technical file of the final machinery. Whoever assembles must therefore have collected and kept them, not merely received them.

A safety component meets the definition in Article 2(c): it serves to fulfil a safety function, is independently placed on the market, its failure endangers the safety of persons, and it is not necessary for the machinery to function. Annex V gives an indicative list.

The six obligations of Article 5

Before placing machinery on the market or putting it into service, the manufacturer or their authorised representative must do six things. The directive lists them without hierarchy, but they follow a logical order.

• Ensure the machinery satisfies the relevant essential health and safety requirements of Annex I.
• Ensure the technical file of Annex VII, part A, is available.
• Provide the necessary information, in particular the instructions.
• Carry out the relevant conformity assessment procedure under Article 12.
• Draw up the EC declaration of conformity under Annex II, part 1, section A, and ensure it accompanies the machinery.
• Affix the CE marking in accordance with Article 16.

The word "relevant", applied to the essential requirements, is not a softener: it means the manufacturer must first determine which ones apply to the machine, which presupposes a documented risk assessment. Without that list, none of the five following points holds.

Which conformity route: with or without a notified body

Article 12 organises the choice, and that choice turns on a single question: is the machinery listed in Annex IV?

Annex IV lists categories, not brands: circular saws for woodworking, presses, moulding machinery, earth moving machinery, vehicle servicing lifts and protective devices, among others. Reading it before designing avoids discovering at the end of a project that a notified body had to be involved, with the delay and cost that implies.

The technical file: what Annex VII actually says

Annex VII, part A, describes a file that must demonstrate conformity and cover the design, manufacture and operation of the machinery. It includes a general description, the overall drawing and the drawings of the control circuits, the detailed drawings with calculation notes and test results, the documentation on the risk assessment describing the procedure followed, the list of applicable essential requirements, the protective measures adopted and the residual risks, the standards used stating which requirements they cover, a copy of the instructions and a copy of the EC declaration of conformity.

Three rules in point 2 deserve to be known before organising your archiving.

• Ten years at least. The file must remain available to the competent authorities of the member states for at least ten years after the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.
• Neither permanent nor necessarily European. The file need not be located within the Union, nor be permanently available in material form. It must however be capable of being assembled and made available within a time commensurate with its importance, by the person named in the EC declaration of conformity.
• Not producing it counts against you. Point 3 is explicit: failure to produce the file, following a duly reasoned request by the national authorities, may constitute sufficient grounds for doubting the conformity of the machinery.

That last sentence carries the heaviest consequence. It shifts the burden: it is no longer a matter of proving a defect in the machine, it is enough that the file cannot be found for the doubt to be well founded.

The EC declaration of conformity: ten elements, and two traps

Annex II, part 1, section A, sets the content of the declaration. It comprises ten elements, including the business name and full address of the manufacturer, the description and identification of the machinery with its model, type and serial number, the express statement that it meets the relevant provisions, the references of the harmonised standards used, the place and date, and the signature of the person empowered to draw it up.

Two points go unnoticed and come back to bite on audit.

The first is point 2: the declaration must give the name and address of the person authorised to compile the technical file, who must be established in the Community. That is not necessarily the signatory, and it is not a formality: it is the person the authorities will ask for the file. A declaration naming none, or naming someone outside the Union, is incomplete.

The second appears at the head of the annex: the declaration relates exclusively to the machinery in the state in which it was placed on the market, and excludes components added and operations carried out subsequently by the final user. The manufacturer therefore does not cover what the operator adds afterwards, and the operator cannot shelter behind a declaration that no longer describes their machine.

Modifying existing machinery: the directive is silent, the regulation is not

This is the most frequent question, and it deserves an exact answer rather than a reassuring one. The phrase « substantial modification » appears nowhere in Directive 2006/42/EC: the term has zero occurrences in the text. The concept long lived in the application guide published by the European Commission and in national authority guides, interpretative documents with no normative force.

Regulation (EU) 2023/1230 ends that situation: it defines substantial modification in the body of the text, at Article 3, point 16. It is a modification of machinery or a related product, by physical or digital means, after placing on the market or putting into service, which is not foreseen or planned by the manufacturer and which affects safety by creating a new hazard or increasing an existing risk, so as to make one of the following necessary:

• the addition of guards or protective devices whose implementation requires modification of the existing safety control system;
• the adoption of additional protective measures to ensure stability or mechanical strength.

This definition is narrower than everyday usage of the term, and that is its value: it gives a criterion you can hold up. Adding a guard that bolts on without touching the safety control system does not fall within it. A conversion that forces you to rework that system does.

The consequence is set out at Article 18: the natural or legal person who makes a substantial modification is considered a manufacturer and becomes subject to the obligations of Article 10 for the machinery concerned. That person declares conformity under their sole responsibility and applies the assessment procedure of Article 25. Two qualifications bound the scope: where the modification affects only the safety of one machine forming part of an assembly, the obligations cover only the affected machine, as demonstrated by the risk assessment; and a non-professional user who modifies their own machinery for personal use is not considered a manufacturer.

What to retain for the period ahead: until 20 January 2027 the reasoning rests on guides; from that date it rests on an article.

What changes on 20 January 2027

Directive 2006/42/EC is repealed with effect from 20 January 2027 by Regulation (EU) 2023/1230 of 14 June 2023 (Article 51, paragraph 2). The regulation applies from that same date, except for provisions already in application, notably Articles 26 to 42 on notified bodies, applicable since 20 January 2024 (Article 54).

A regulation, not a directive. The text is binding in its entirety and directly applicable in all Member States (Article 54). No national transposition, therefore no lag from one country to the next and no drafting differences across the twenty-seven.

Software becomes a safety component. Article 3, point 3, now defines a safety component as a component « physical or digital, including software », designed to serve a safety function and placed independently on the market. Safety software sold on its own therefore falls within scope, with the obligations that follow.

Cybersecurity becomes an essential requirement. Point 1.1.9 of Annex III, headed « Protection against corruption », requires that connecting another device, including a remote one, does not create a hazardous situation; that software and data essential to conformity be identified as such and adequately protected against accidental or intentional corruption; that the machinery be able to state at any time which software it needs to operate safely; and that it collect evidence of legitimate or illegitimate intervention in that software. Nothing of the kind existed in the 2006 text.

A category with no self-certification route. Annex I takes the role of the former Annex IV and splits into two parts. Part B keeps the familiar logic with nineteen categories: saws, surface planing machines, presses, moulding machines, logic units serving safety functions, roll-over and falling-object protective structures may still go through internal production control (module A), on condition that harmonised standards or common specifications covering all relevant requirements are applied in full (Article 25, paragraph 3). Part A leaves no self-certification route: EU type-examination, full quality assurance, or unit verification, without exception (Article 25, paragraph 2). It holds six categories: four come from the twenty-three of the former Annex IV, including removable mechanical transmission devices, their guards, vehicle servicing lifts and portable cartridge-operated fixing machinery. The last two are new: safety components with fully or partially self-evolving behaviour using machine learning approaches, and machinery whose integrated systems have that same character.

Instructions may be digital. Article 10, paragraph 7, allows it, under cumulative conditions: state on the machinery how to access them; present them in a format allowing the user to print, download and save them on a device so they remain available during a breakdown; and keep them accessible online for the whole expected lifetime and for at least ten years after placing on the market. At the user's request at the time of purchase, the paper version remains due, free of charge, within one month.

The two regimes will coexist for a long time. Article 52 provides for it: products placed on the market in accordance with the directive before 20 January 2027 continue to be made available, and EC type-examination certificates issued under its Article 12 remain valid until they expire. An industrial site will therefore fall under both texts for years, and a technical file compiled today keeps its full value.

For machinery designed today and delivered in 2027, the question arises now, at the design stage, not at delivery.

Getting support

HEMC supports manufacturers on the design of special purpose machines and on bringing them into compliance: risk assessment, compiling the technical file, choosing the conformity route and preparing the EC declaration. To discuss it, talk to our consultants.

This article is provided for information and does not constitute legal advice. Article and annex references are established from the text of Directive 2006/42/EC published in the Official Journal of the European Union L 157 of 9 June 2006 and from the consolidated text of Regulation (EU) 2023/1230 as at 29 June 2023, incorporating the corrigendum published in Official Journal L 169 of 4 July 2023. Only the texts published in the Official Journal are authoritative.