Machinery Directive 2006/42/EC: The Complete Guide for Manufacturers
Machinery Directive 2006/42/EC is the central body of rules for the safety of machinery in the European Economic Area. It defines the essential health and safety requirements that every machinery manufacturer must meet. This guide explains the scope, the essential requirements and the conformity assessment procedures, and looks ahead to the transition to the new EU Machinery Regulation.
Background and significance
Machinery Directive 2006/42/EC was adopted by the European Parliament and the Council on 17 May 2006 and has been mandatory since 29 December 2009. It replaced the previous Machinery Directive 98/37/EC and harmonises the safety requirements for machinery in all EU member states as well as the EEA states Iceland, Liechtenstein and Norway.
The Directive pursues two equal aims: to guarantee the free movement of machinery within the single market and at the same time to ensure a high level of protection for the health and safety of users. Each member state has transposed the Directive into national law; in Germany through the Product Safety Act (ProdSG) in conjunction with the Machinery Ordinance (9. ProdSV).
In Switzerland the Machinery Ordinance (MaschV) applies, which is largely identical in substance to the Directive.
Scope: which products fall under the Machinery Directive?
Article 1(1) of the Directive defines the scope. The Directive applies to the following products:
Machinery
An assembly of linked parts or components, at least one of which moves, joined together for a specific application. Decisive is the presence of a drive system other than directly applied human or animal effort. Assemblies that only need to be installed and connected also fall under this.
Interchangeable equipment
Devices which the operator assembles to a machine after it has been put into service in order to change its function or add a new function. Example: an attachment for a tractor or an interchangeable tool for a CNC machine.
Safety components
Components which serve to fulfil a safety function and are placed on the market independently. Examples: light curtains, two-hand controls, protective hoods, roll-over protective structures (ROPS). Annex V of the Directive contains a non-exhaustive list.
Lifting accessories
Components or equipment not attached to the lifting machinery which allow the load to be held. Examples: slings, spreader beams, grabs, vacuum lifters.
Chains, ropes and webbing
Chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories.
Removable mechanical transmission devices
Transmission shafts for transmitting power between a self-propelled machine and a driven machine, including the associated guards.
Partly completed machinery
Assemblies which are almost machinery but cannot in themselves perform a specific function. Example: a drive system or a robot arm without a control system. Simplified requirements apply to partly completed machinery (Declaration of Incorporation instead of Declaration of Conformity).
Exclusions from the scope
Not covered by the Directive are, among others: safety components intended to be used as spare parts to replace identical components, fairground equipment, machinery specially designed for nuclear purposes, weapons, certain agricultural and forestry tractors and seagoing vessels. Electrical and electronic products of certain categories (household appliances, audio and video equipment, IT equipment) are also excluded insofar as they are covered by other specific directives.
Essential health and safety requirements
Annex I of the Directive contains the essential health and safety requirements (EHSRs). They are formulated as binding protection objectives, not as concrete technical solutions. The most important areas are:
Part 1: General principles
Integration of safety (three-step method), materials, lighting, handling, ergonomics, operating positions, control systems, protection against mechanical, electrical and other hazards, maintenance, information and markings, instructions.
Part 2: Foodstuffs machinery and machinery for cosmetics or pharmaceutical products
Additional hygiene requirements, material requirements for contact with foodstuffs, cleanability.
Part 3: Machinery with hazards due to its mobility
Requirements for mobile machinery, driving position, steering, braking, stability.
Part 4: Lifting operations
Stability, load-bearing capacity, control of movements, load handling, marking of lifting machinery and lifting accessories.
Part 5: Machinery for underground work
Special requirements for machinery used underground (mining).
Part 6: Lifting of persons
Requirements for machinery that carries or lifts persons, for example mobile elevating work platforms.
In the risk assessment the manufacturer must examine which of these requirements apply to the specific machine. Only the requirements that are actually relevant have to be met, but the examination and the reasoning must be documented.
Conformity assessment procedures
The Directive offers several conformity assessment procedures, depending on whether the machine is listed in Annex IV:
Machinery NOT in Annex IV
For the vast majority of machinery: the manufacturer carries out the conformity assessment entirely in-house.
No notified body required. This is the simplest and most common procedure.
Machinery IN Annex IV, with harmonised standard
Machinery in Annex IV has a higher hazard potential. If the manufacturer applies the relevant harmonised standards in full, the manufacturer may nevertheless carry out the conformity assessment in-house.
The full application of the harmonised standard must be documented.
Machinery IN Annex IV, without harmonised standard
If no harmonised standard is applied in full for an Annex IV machine, a notified body must be involved.
Notified bodies in Germany include, for example, TÜV, DGUV Test or various testing institutes.
The most important annexes of the Directive at a glance
| Annex | Content |
|---|---|
| Annex I | Essential health and safety requirements |
| Annex II | Declarations (A: EC Declaration of Conformity, B: Declaration of Incorporation) |
| Annex III | CE marking (design and proportions) |
| Annex IV | Machinery with a particular hazard potential (23 categories) |
| Annex V | Non-exhaustive list of safety components |
| Annex VII | Technical file (minimum content) |
| Annex VIII | Assessment of conformity with internal checks on the manufacture of machinery |
| Annex IX | EC type-examination by a notified body |
| Annex X | Full quality assurance |
Transition to EU Machinery Regulation (EU) 2023/1230
On 29 June 2023 the new EU Machinery Regulation was published in the Official Journal of the EU. It will fully replace Machinery Directive 2006/42/EC on 20 January 2027.
The most important changes of the Regulation compared with the Directive:
New risk categories: Cybersecurity requirements for machinery with digital elements and specific requirements for AI-based safety functions
Digital operating instructions: The operating instructions may be provided in digital form for the first time, with a free paper copy on request
Substantial modification: A clear definition of when a modification to an existing machine requires a new conformity assessment
Extended Annex IV (now Annex I of the Regulation): Six categories in Annex I Part A will in future always require a notified body, including for the first time AI-based safety functions
Stronger market surveillance: Extended powers for the authorities and stricter obligations for online marketplaces
The cut-over question: which legal act applies to my machine?
The only thing that counts is the date of placing on the market, not the putting into service: a machine placed on the market by 19 January 2027 runs entirely under the Directive; it remains permanently marketable afterwards and may be put into service at the customer's premises after the cut-over date (Article 52 of the Regulation). Machinery placed on the market from 20 January 2027 must comply with the Regulation; the Directive is then no longer a conservative alternative but inadmissible (Article 51(2) of the Regulation). There is no right to choose between the two legal acts at any point in time.
What manufacturers should do now
Up to the cut-over date, the Directive must be mastered with confidence, while the Regulation is prepared in parallel: analyse the new requirements (cybersecurity, Annex I Part A/Part B, digital operating instructions), review your existing processes and determine for every ongoing project whether the placing on the market will still take place before 20 January 2027.
Conclusion: the Directive as the foundation of machinery safety
For almost two decades Machinery Directive 2006/42/EC has defined the legal framework for machinery safety in Europe. Its basic principles (the risk-based approach, presumption of conformity through harmonised standards, the manufacturer's own responsibility) remain in place under the new EU Machinery Regulation as well.
For manufacturers this means: whoever masters the Directive with confidence today has a good foundation for the transition to the Regulation.
FAQ
Frequently asked questions about Machinery Directive 2006/42/EC
What is Machinery Directive 2006/42/EC?
When does the EU Machinery Regulation replace the Machinery Directive?
Which products fall under Machinery Directive 2006/42/EC?
When do I need a notified body for the conformity assessment of a machine?
What changes with the EU Machinery Regulation compared with the Machinery Directive?
Implement the Directive and the Regulation with confidence
CE-Copilot supports you in implementing the Machinery Directive and prepares you for the new EU Machinery Regulation, AI-assisted and in line with the standards.
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