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Eaton: CE-marking, CE-Kennzeichnung

The CE marking confirms that a product meets all EU-wide requirements for safety, health and environmental protection. For machines, this means in particular that they meet the requirements of the Machinery Directive as well as other relevant EU Directives. The CE marking was introduced in 1995 and serves as a type of passport for machines. Only machines bearing this marking can be sold and operated in the EU. 

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Why is the CE marking not considered a mark of quality?

The CE marking is usually affixed to the machine by the manufacturer. The manufacturer is responsible for ensuring that all legal requirements have been met and that the machine is safe. The CE marking should therefore not be confused with a quality mark.

Which EU directives are relevant to CE marking?

The essential requirements for the safety of machines are set out in Machinery Directive 2006/42/EC. It applies throughout the European Economic Area and governs the placing on the market and commissioning of, among other things, machines and plants as well as safety components placed on the market individually.

Any instance of making technical equipment, products or goods available to others is considered to be placing them on the market within the meaning of the Machinery Directive. For this reason, any imported goods covered by one of the applicable directives must also bear the CE marking.

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Placing on the market and thus the requirement for a CE marking applies to the following machines:

  • New machines manufactured in the EU.
  • Existing machines that are being modified or modernised.
  • New and existing machinery imported from a third country and sold or operated within EU territory.
  • New and modified machines that are made available to others free of charge.

However, the European Machinery Directive is not the only directive that is relevant to CE markings, as other directives also apply. These include:

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Figure 1: EU Directives on CE marking

However, these Directives are only a kind of superordinate law, which must then be transposed into national law by all EU member states. Above all, the Directives serve to create a uniform and binding legal basis. Directives define only the basic requirements; the technical details and subtleties are defined in standards.

These European standards (EN standards) are reflected in the national standards of the respective EU member states. If the manufacturer of a machine or plant complies with these standards, the manufacturer may "presume" that the relevant Directives have also been fulfilled. For this purpose, the relevant EN standards are listed in the "Commission communication in the framework of the implementation of the Directive" document. 

How can I prove that my machine is safe?

EN standards define testable and thus verifiable requirements. EN standards are divided into three main groups:

The basic standards - known as A-type standards - define the basic safety requirements. EN ISO 12100 is the relevant machine safety standard in this case. It gives machine and plant manufacturers a general overview of the basic concepts and general principles necessary for designing safe machines (i.e. for machines that are safe within the scope of their intended use). It also provides basic guidelines for carrying out a machine risk assessment.

Group standards or B-type standards deal with both design aspects, such as clearances or surface temperatures, and with functional aspects, such as controlled stops or two-hand operation. These standards are applicable to a variety of machine groups. These standards include:

  • EN ISO 13849-1: This standard specifies the safety requirements for safety-related parts of control systems. The engineer receives a guide containing the corresponding design principles that also covers the integration of these components.
  • EN IEC 62061: This standard defines the requirements for the design, integration and validation of safety-related electrical, electronic and programmable electronic control systems for machines. The degree of functional safety is  described according to the so-called Safety Integrity Level (SIL).
  • EN IEC 60204-1: This standard is specified by both the Machinery Directive and the Low Voltage Directive as being applicable for the electrical equipment of machines. It applies to electrical, electronic and programmable electronic equipment and systems for machines that are not portable by hand during operation of the machine. The EN 60204-1 standard applies to the entire electrical installation of a machine, starting from the point where the incoming power cable connects to the terminals or the main switch.

The third main group in the field of EN standards for machine safety is made up of product standards (C type). These standards describe in concrete terms the requirements for individual machine types and contain detailed safety requirements. These standards can be used to test and prove machine safety. 

As part of the CE marking process, the manufacturer independently determines which of the specific EU requirements are relevant for the machine being manufactured and whether said machine meets these requirements. The manufacturer also clarifies whether the machine needs to be verified by an independent body. If the manufacturer has verified everything accordingly and found that all of the requirements have been fulfilled, the manufacturer can then issue technical documentation, affix the CE marking and draw up the Declaration of Conformity. By issuing the EU Declaration of Conformity, the manufacturer confirms compliance with the safety requirements of the Directives and EN standards applicable to the product and assumes the legally binding responsibility for this.
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Figure 2: The three main groups of EN standards for machine safety
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Figure 3: Decision tree - substantial modifications to machines

How is the CE marking affixed to the machine?

The appearance of the CE marking is subject to specific requirements: It must be at least five millimetres in height so that it is easy to read. The CE marking must be of the same quality as the manufacturer’s mark and must be applied using the same technique. In addition, only one CE marking may be affixed to each machine. The CE marking design that must be used is shown in Annex III of the Machinery Directive or can be downloaded as a template.

What should be taken into account when modifying an existing machine?

If an existing machine is converted or modernised (i.e. retrofitted), it may be necessary to go through the conformity evaluation procedure again. The crucial question here is whether the change constitutes a substantial modification to the machine. If this is the case, then the responsibility for the "new" machine passes to the party who carried out the change, which may also be the operator. A substantially modified machine is considered to be a new machine, and must be re-evaluated according to the Machinery Directive, undergo a new conformity evaluation procedure and receive updated documentation (e.g. in the form of operating instructions) and a new CE marking from the party now responsible for it.

A good tool for deciding what constitutes a substantial modification is the interpretation paper available for download from the German Federal Institute for Occupational Safety and Health (BAuA). 

The bottom line

CE marking is essential for anyone who wants to place a machine on the market in the European Economic Area. However, it is not a mark of quality but rather a legally binding confirmation by the manufacturer of a machine that it has taken into account all Directives applicable to the safety of the machine. Manufacturers can ensure that their machines are safe by making sure that the designs fulfil the relevant harmonised standards.

Learn more about functional safety for machinery

The safety manual uses example circuits to show how functional safety can be implemented with electrical, electronic and programmable components and systems in safety applications. It shows how different safety levels (SIL or PL) can be achieved. International import standards EN ISO 13849-1 and IEC 62061 for the safety of machines and systems are explained with practical examples.

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