What is the Machinery Directive?
The Machinery Directive (2006/42/EC) is the European directive that sets the essential health and safety requirements machinery must meet before it is placed on the market or put into service in the EU. It covers the design, construction, risk assessment, technical file, EC declaration of conformity and CE marking of machines. The Directive has applied since 29 December 2009 and will be replaced on 20 January 2027 by the Machinery Regulation (EU) 2023/1230.
The aim of the Machinery Directive is to protect people from the hazards of machinery, such as mechanical, electrical, thermal and ergonomic risks, while allowing machines to move freely within the European single market.
🗓️ When does the Machinery Directive apply and what replaces it?
The first European Machinery Directive (89/392/EEC) dates from 1989. After several amendments it was codified in 1998 into a single text, Directive 98/37/EC. That in turn was replaced by 2006/42/EC, a substantive revision that, among other things, defined partly completed machinery more sharply.
| Date | Milestone |
|---|---|
| 1989 | First Machinery Directive 89/392/EEC |
| 1998 | Codified as Directive 98/37/EC |
| 17 May 2006 | Directive 2006/42/EC adopted |
| 9 June 2006 | Published in the Official Journal (L 157) |
| 29 June 2008 | Deadline for transposition into national law |
| 29 December 2009 | Applies; 98/37/EC repealed |
| 20 January 2027 | Replaced by the Machinery Regulation (EU) 2023/1230 |
Because it is a directive, each Member State transposed it into national law. In the Netherlands this is the Warenwetbesluit machines; market surveillance of machinery for professional use is carried out by the Netherlands Labour Authority (Nederlandse Arbeidsinspectie), while the NVWA covers consumer products.
🧱 Which products does the Machinery Directive cover?
Under Article 2, machinery is an assembly of linked parts, at least one of which moves, fitted with a drive system other than directly applied human or animal effort and joined together for a specific application. That includes production machines, conveyors, packaging machines, robot cells and complete production lines. Besides “ordinary” machinery, the Directive defines several other product categories:
| Category | Example | What does the manufacturer supply? |
|---|---|---|
| Machinery | Packaging machine, press, robot cell | EC declaration of conformity + CE marking |
| Assembly of machinery | Production line of several linked machines | One declaration and CE marking for the whole |
| Partly completed machinery | Robot arm without gripper or guarding | Declaration of incorporation + assembly instructions, no CE marking |
| Safety component | Light curtain, emergency stop device, logic unit | Declaration of conformity + CE marking |
| Interchangeable equipment, lifting accessories, chains | Attachment for a tractor | Declaration of conformity + CE marking |
Excluded are, among others, household appliances, IT equipment, ordinary office machinery, low-voltage switchgear and controlgear and electric motors: these fall under the Low Voltage Directive.
🧠 What does the Machinery Directive require?
- Essential health and safety requirements (EHSR, Annex I)
- Physical safety, operation and maintenance
- Electrical and pneumatic safety
- Emergency stop, guarding, signalling and warnings
- Instructions in the official language of the country of use (“original instructions” or “translation of the original instructions”)
- Technical file (Annex VII)
- General description, overall drawings and control circuit diagrams
- Documentation of the risk assessment and the protective measures taken
- Standards applied, test reports, user and maintenance instructions
- Kept for at least ten years after the last unit was manufactured
- CE Marking (Annex III)
- EC declaration of conformity (Annex II, part A)
- CE marking at least 5 mm high, next to the manufacturer’s name
- Verification of compliance with all applicable directives, such as the EMC Directive and, for explosive atmospheres, ATEX
- Conformity assessment (Article 12)
- Most machinery: internal checks by the manufacturer itself (Annex VIII)
- Annex IV machinery: a stricter procedure, possibly involving a notified body
A core principle of Annex I is the hierarchy of measures: first eliminate or reduce hazards through inherently safe design, then apply protective measures such as guards, and only then inform users about residual risks. The manufacturer must also take reasonably foreseeable misuse into account.
🔍 Which machines require a stricter assessment?
Annex IV lists 23 categories of higher-risk machinery, such as circular saws and band saws for woodworking, presses and press brakes for cold working of metal and injection or compression moulding machines for plastics and rubber (both with manual loading or unloading), vehicle servicing lifts, protective devices designed to detect persons and logic units to ensure safety functions. The last category touches automation directly: a safety PLC or safety relay is an Annex IV product.
| Procedure | Annex | When |
|---|---|---|
| Internal checks on manufacture | VIII | Machinery outside Annex IV; also Annex IV machinery built fully to harmonised standards |
| EC type-examination by a notified body | IX | Annex IV machinery; IX or X is mandatory if harmonised standards were not applied or only partly applied |
| Full quality assurance | X | Alternative to IX; the notified body’s number then follows the CE marking |
🔄 What is the difference between the Machinery Directive and CE marking?
| Aspect | Machinery Directive | CE marking |
|---|---|---|
| Purpose | Safety of machinery within the EU | Visible evidence that the product meets all applicable EU legislation |
| What does it require? | Risk assessment, technical file, EHSR, conformity assessment | Affixing the CE marking after an EC declaration of conformity |
| Relationship | CE marking is mandatory for machinery under the Directive | The Machinery Directive is one of several directives that lead to CE marking |
🏭 What does the Machinery Directive mean for industrial automation?
For industrial automation, the Machinery Directive is the legal foundation under almost every machine project:
- Electrical equipment - the electrical equipment of the machine, including the control cabinet, follows IEC 60204-1; separate switchgear assemblies such as an MCC or main distribution board are additionally built to IEC 61439. NEN 1010 covers the fixed installation up to the machine, not the machine itself.
- Safety functions - a standard PLC is not intended for safety functions. These are implemented with a safety PLC or safety relay and designed to ISO 13849 (Performance Level) or IEC 62061 (SIL), often in a fail-safe arrangement.
- Operation - operation via an HMI requires clear operating modes and an emergency stop to NEN-EN-ISO 13850; a control fault must never lead to a hazardous situation or an unexpected start.
- Components - MCCs, motor starters, soft starters, sensors and actuators must meet their own product standards.
- Guarding - interlocks on doors to ISO 14119 and safety distances for light curtains to ISO 13855.
For electrical hazards, Annex I refers to the safety objectives of the Low Voltage Directive, but conformity assessment runs solely through the Machinery Directive. A machine therefore does not get a separate low-voltage declaration.
🛠️ How do you place a machine on the market under the Machinery Directive?
- Determine the status - is the product machinery, an assembly, partly completed machinery or a safety component? Is it listed in Annex IV?
- Carry out the risk assessment - in line with ISO 12100: define the limits of the machine, identify hazards, estimate and evaluate risks, and reduce them in the order design, safeguarding, information.
- Design the safety functions - determine the required PL or SIL for each function and validate the result, for example with a calculation in SISTEMA.
- Apply harmonised standards - type A (ISO 12100), type B (ISO 13849, IEC 62061, IEC 60204-1) and, where available, a type C product standard. This gives a presumption of conformity.
- Compile the technical file and the instructions - including diagrams, software versions and residual risks.
- Sign the declaration and affix the CE marking - and keep everything for at least ten years.
The European Commission publishes a Guide to application (edition 2.2, October 2019) that explains concepts such as assemblies of machinery and safety components in more detail.
🔐 Does the Machinery Directive set cybersecurity requirements?
Not explicitly. Annex I does require control systems to withstand faults and external influences, and a fault in the control logic must not create a hazard. However, access via remote access or an unprotected HMI can change safety settings. In practice, manufacturers therefore already add access control, passwords on safety parameters and IEC 62443 measures.
The Machinery Regulation makes this a hard requirement from 2027: protection against corruption (Annex III, 1.1.9) and resilience against malicious attempts by third parties (1.2.1). The Cyber Resilience Act also applies to products with digital elements.
Users should take note too: anyone who substantially modifies a machine can become its manufacturer. Record changes to control software through change management. Safe use on the shop floor falls under occupational health and safety law, in particular the Use of Work Equipment Directive 2009/104/EC (in the Netherlands chapter 7 of the Arbobesluit), with measures such as lock-out tag-out. Where the Machinery Directive addresses the manufacturer, these rules address the employer.
❓ Frequently asked questions
When does the Machinery Directive expire?
The Machinery Directive 2006/42/EC is repealed on 20 January 2027, when the Machinery Regulation (EU) 2023/1230 starts to apply. Machinery lawfully placed on the market before that date does not need to be reassessed. New machinery must comply with the Regulation from that date.
Does partly completed machinery get CE marking?
No, partly completed machinery does not receive CE marking under the Machinery Directive. The manufacturer supplies a declaration of incorporation and assembly instructions instead. The builder of the final machine carries out the risk assessment and affixes the CE marking to the whole.
How long must the technical file be kept?
Under the Machinery Directive, the technical file must remain available to the authorities for at least ten years. The period runs from the date of manufacture of the machine or, for series production, of the last unit. The EC declaration of conformity must also be kept for ten years.
Does every machine need a notified body?
No, for most machinery the manufacturer carries out the conformity assessment under the Machinery Directive itself through internal checks on manufacture. Only Annex IV machinery, such as presses and logic units for safety functions, may need a notified body. That is mandatory when harmonised standards have not been fully applied.
Who enforces the Machinery Directive in the Netherlands?
In the Netherlands, the Machinery Directive is transposed into the Warenwetbesluit machines. The Netherlands Labour Authority supervises machinery for professional use. For machinery intended for consumers, the NVWA is the supervisory authority.
Does a production line as a whole fall under the Machinery Directive?
Yes, when several machines are linked so that they function as a whole, they form an assembly of machinery within the meaning of the Machinery Directive. The party that assembles the line assesses the risks of the integration, draws up one declaration of conformity and affixes the CE marking to the whole.
📌 In summary
The Machinery Directive 2006/42/EC defines how a machine is safely designed, assessed, documented and CE marked before it reaches the EU market. For automation engineers, it is all about risk assessment, well-designed safety functions and a complete technical file; from 20 January 2027 the Machinery Regulation takes over, adding cybersecurity as a new requirement.