The Machinery Directive 2006/42/EC

What applies, and what is replaced by the Machinery Regulation?

The Machinery Directive 2006/42/EC has been the central EU legislation governing how machines should be designed, assessed, and CE marked before they are placed on the market since 2009. The directive has laid the foundation for today's machinery safety work - but is gradually being replaced by the new Machinery Regulation (EU) 2023/1230.

Pedagogical overview - what the directive means

What is the Machinery Directive?

The Machinery Directive is EU legislation that specifies the essential health and safety requirements (EHSR) that all machines within the EU must meet.

It applies to:

• Machines

• Safety components

• Interchangeable equipment

• Lifting accessories

• Chains, ropes, belts

• Partially completed machines

CE marking - the foundation of the directive

The CE marking is the manufacturer’s declaration that the machine meets all applicable directives. To affix the CE mark, you must:

1. Conduct a risk assessment according to EN ISO 12100.

2. Ensure that the machine meets the essential health and safety requirements (Annex I).

3. Establish a technical file with documentation.

4. Create an EC declaration of conformity.

5. Label the product with the CE symbol and the manufacturer's details.

Tip: You can view the CE mark as a "safety signature" - but it only applies if your documentation withstands scrutiny and the machine actually meets the fundamental health and safety requirements.

Annex I - The heart of the Machinery Directive

Annex I defines what a machine must meet in order to be considered safe. It includes among other things:

• Mechanical risks (pinching, cutting, falling)

• Electrical risks

• Noise, vibrations, emissions

• Ergonomics and human factors

• Maintenance and accessibility

Examples:

"A machine, its components, and accessories must be stable enough not to overturn, fall or make uncontrolled movements during transport, assembly, disassembly, and any other activity concerning the machine." (Annex I, point 1.3.1).

"A control system must be designed and manufactured so that hazardous situations cannot arise." (Annex I, point 1.2.1).

The difference versus the new Machinery Regulation (EU) 2023/1230

In short: The Machinery Directive laid the foundation - the Machinery Regulation builds the future.

Technical overview - The Machinery Directive for industry professionals

1. Definitions and scope of application

The directive applies according to Article 1:
a) Machines.
b) Interchangeable equipment.
c) Safety components.
d) Lifting devices.
e) Chains, hoists, ropes, and webs.
f) Removable mechanical power transmission devices.
g) Partially completed machines.

Exceptions: Certain laboratory equipment, certain vehicles, military equipment, special equipment on marketplaces/amusement parks, etc.

Keep in mind: Partially completed machines must be delivered with a declaration of incorporation (Annex II 1B), not with CE marking.

2. Assessment of conformity (Annex VIII)

The manufacturer can:

• Perform internal control (self-assessment), or

• Engage a notified body if the machine requires third-party assessment.

Example: Presses, wood processing machines, and vehicle lifts often require third-party assessment.

3. Technical manufacturing documentation (Annex VII)

Must include, among other things:

• Drawings and diagrams

• Risk assessment

• Testing reports

• User manual

• EC declaration

• List of applied standards (EN ISO 12100, EN ISO 13849-1, etc.)

Noex tip: Digitalize everything. A well-structured digital technical file makes assessment easier - and already meets the requirements of 2023/1230.

4. Essential health and safety requirements (Annex I)

Examples of requirements:

• 1.1.2 Principles of safety integration

  Machines must be designed and manufactured so that they can function as intended and be used, set up, and maintained without posing a risk to persons when these tasks are performed under anticipated circumstances and also taking into account reasonably foreseeable misuse.

  
  

• 1.2.1 Safety and reliability of a control system

  A control system must be designed and manufactured so that hazardous situations cannot arise.

  
  

• 1.5.13 Emission of hazardous materials and substances

  A machine must be designed and manufactured so that risks of inhalation, ingestion, contact with skin, eyes, and mucous membranes, as well as penetration through the skin by hazardous materials and substances produced by the machine can be avoided.

Think this way: The directive is function-based - it states what you should achieve, not how. Therefore, harmonized standards (EN ISO 12100, EN ISO 13849-1, EN ISO 62061, etc.) are used to demonstrate that the requirements are met.

5. Shortcomings and pitfalls in application

   Common mistakes:

   • No clear distinction between machines and subsystems.

   • Risk assessment lacks traceable connection to the essential health and safety requirements (EHSR).

   • User manuals written for the general public - not for users.

   • Older CE marks without traceable technical files.

Tip: Use Noex's risk module to link each risk directly to the corresponding EHSR point.

If you do not comply with the Machinery Directive

The following may occur:

• Market surveillance can halt sales

• The manufacturer is held liable for accidents

• Import ban throughout the EU

• Liability for damages due to inadequate risk assessment

• Sick leave & production stoppage

• Fines

Example: In 2021, several automatic gate systems were recalled after the control system did not comply with EHSR 1.2.1 (unexpected start).

FAQ Machinery Directive 2006/42/EC

1. What is the purpose of the Machinery Directive?
   Answer: To ensure that all machines within the EU are safe, correctly designed, and marked before they reach the market.

   
   

2. Does the Machinery Directive still apply after 2027?
   Answer: No, it is replaced by the Machinery Regulation (EU) 2023/1230. However, CE markings performed before the transition continue to apply until the machine is changed.

   
   

3. Must I update my technical documentation?
   Answer: Yes, if the machine is modified, moved, or integrated into a new system. It is not enough to use old documentation.