Machinery Directive 2006/42/EC

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

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

Educational Overview - What the Directive Entails

What is the Machinery Directive?

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

It applies to:

• Machinery

• Safety Components

• Interchangeable Equipment

• Lifting Accessories

• Chains, Ropes, Straps

• Partly Completed Machinery

CE Marking - The Foundation of the Directive

CE marking is the manufacturer's declaration that the machinery meets all applicable directives. To apply the CE marking, you must:

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

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

3. Prepare a technical file with documentation.

4. Draft an EC Declaration of Conformity.

5. Label the product with the CE mark and manufacturer's information.

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

Annex I - The Core of the Machinery Directive

Annex I defines what a machine must meet to be considered safe. It covers, among other things:

• Mechanical Hazards (crushing, cutting, falling)

• Electrical Hazards

• Noise, Vibrations, Emissions

• Ergonomics and Human Factors

• Maintenance and Accessibility

Example:

"A machine, its components, and accessories shall be stable enough that they do not tip, fall, or make uncontrolled movements during transport, assembly, disassembly, and any other activities concerning the machine." (Annex I, point 1.3.1).

"A control system shall be designed and constructed to prevent hazardous situations from arising." (Annex I, point 1.2.1).

The Difference with 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

The directive applies according to Article 1:
a) Machinery.
b) Interchangeable Equipment.
c) Safety Components.
d) Lifting Accessories.
e) Chains, Chains, Ropes, and Webbing.
f) Detachable Mechanical Transmission Devices.
g) Partly Completed Machinery.

Exceptions: certain laboratory equipment, some vehicles, military equipment, special equipment at markets/amusement parks, etc.

Note: Partly completed machinery must be delivered with a declaration of incorporation (Annex II 1B), not with CE marking.

2. Conformity Assessment (Annex VIII)

The manufacturer can:

• Perform internal control (self-assessment), or

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

Example: Presses, woodworking machines, and vehicle lifts often require third-party review.

3. Technical Construction File (Annex VII)

Must include, among other things:

• Drawings and Schematics

• Risk Assessment

• Test Reports

• User Instructions

• EC Declaration

• List of Applied Standards (EN ISO 12100, EN ISO 13849-1, etc.)

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

4. Essential Health and Safety Requirements (Annex I)

Examples of requirements:

• 1.1.2 Principles for Integrating Safety

  Machines shall be designed and constructed so they can operate as intended and be used, adjusted, and maintained without posing a risk to persons, assuming these tasks are performed under foreseeable circumstances and considering reasonably foreseeable misuse.

  
  

• 1.2.1 Safety and Reliability of Control Systems

  A control system shall be designed and constructed so hazardous situations do not occur.

  
  

• 1.5.13 Emission of Hazardous Substances and Materials

  A machine shall be designed and constructed so as to prevent inhalation, ingestion, contact with skin, eyes and mucous membranes, and penetration through the skin of hazardous substances and materials produced by the machine.

Think about it like this: The directive is function-based - it tells you what to achieve, not how. Therefore, harmonized standards (EN ISO 12100, EN ISO 13849-1, EN ISO 62061, etc.) are used to demonstrate compliance with the requirements.

5. Deficiencies and Pitfalls in Application

   Common mistakes:

   • No clear demarcation 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 markings without a traceable technical file.

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 Control can halt sales

• The Manufacturer is Held Responsible for Accidents

• Import Ban throughout the EU

• Liability for Compensation for Lacking Risk Assessment

• Sick Leave & Production Stops

• Penalties

Example: In 2021, a number of automatic gate systems were recalled after the control system did not meet 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 machinery within the EU is safe, properly designed, and marked before reaching 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 carried out before the transition continue to apply until the machine is modified.

   
   

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