The declaration of conformity for the purposes of mandatory CE marking

A man with a hard hat and protective vest is holding a mobile device, on which a CE mark is visible.

If you want to place safety components, plant or machinery on the market, you will need to deal with the applicable legal requirements and domestic law. Whichever country you are in - the essential requirements for safe plant and machinery are always intended to increase health and safety at work, even if the specific country's level of requirements and implementation is not consistent.

Completely different regulations, directives, standards and laws exist, depending on the country or economic community. When placing machinery on the market, the manufacturer confirms that it complies with these in the form of a declaration of conformity, for example. 

Declaration of conformity in the European Union

If you are placing products on the market within the European Union, you must produce a declaration of conformity if your product falls under a relevant EU directive - such as the Machinery Directive for example. In the declaration of conformity, the manufacturer or his authorised representative established in the Community declares that all relevant European internal market directives have been considered and all applicable conformity assessment procedures have been applied. Only then may the CE mark be affixed to the product.

Where a product falls under the scope of several directives that require CE marking, the CE mark indicates that the product is assumed to conform with the provisions of all these directives. So affixing the CE mark is always the duty of the manufacturer, or a representative or importer if the manufacturer is not established in the European Economic Area.

The CE mark is a symbol in its own right. Products with a CE mark may be freely traded within the EU. National regulations may contain further regulations for operators. As such, the CE mark is a building block for the free movement of goods in Europe.

Legal principles

The obligation to affix the CE mark and submit a declaration of conformity extends to all products that are destined for the single market and fall under the scope of directives that stipulate this mark. A CE mark should therefore be affixed to the following products that fall under the scope of a directive:

  • All new products, irrespective of whether they were manufactured in member states or in third countries and are placed for the first time on the market within the EU
  • Used products imported from third countries and second-hand products within the EU, which are therefore placed on the market in the EU for the first time.
  • And products that have undergone significant change, which fall under the scope of EU directives as new products

CE marking under the Machinery Directive

The Machinery Directive is one of the most important documents on the essential safety requirements for machinery in the European Union. According to the Machinery Directive, a machine manufacturer is anyone who assembles machine parts of various origin and places them on the market under his name.

A machine operator can also assume the role of the manufacturer (consciously or unconsciously), if he changes the machine so significantly that it is to be regarded as a new. The manufacturer or his authorised representative takes responsibility for implementing the administrative procedures for the entire plant:

  • Compiling the technical information for the declaration of conformity
  • Producing the technical documentation
  • Providing operating instructions
  • Affixing the CE mark on a suitable position on the plant and issuing a declaration of conformity for the entire machine
With a declaration of conformity and CE mark, the manufacturer confirms that the product meets all the relevant directives.

8 steps to the declaration of conformity and CE mark

The conformity assessment procedure is a defined process that regulates the free movement of goods within the Europe Union. It comprises the following eight steps:

Step 1: Categorise the product

  • Is the product subject to the Machinery Directive?
  • Is the product listed in Annex IV of the Machinery Directive? Annex IV of the Machinery Directive lists "particularly hazardous" machinery such as presses, woodworking machinery, service lifts, etc. Special conformity assessment procedures must be observed in this case.

  • Is it a subsystem or partly completed machinery? The manufacturer issues a declaration of conformity for functional machines that meet the full scope of Annex I of the Machinery Directive. For partly completed machinery or subsystems, e.g. robots, which cannot yet meet the full scope of Annex I, the manufacturer issues a declaration of incorporation in accordance with Annex II B. This must accompany all partly completed machinery. A risk assessment must also be performed and assembly instructions provided in accordance with Annex VI. In practical terms it "bans it from being put into service", as it is partly completed machinery and does not meet the requirements.

  • Is it a safety component? If yes, then a CE mark must be affixed.

Step 2: Check the application of additional EU directives: If other EU directives are involved, which cover different aspects, the provisions of these CE-relevant directives must also be met for the declaration of conformity. For example, if electrical equipment is also included, the requirements of the Low Voltage Directive and possibly the EMC Directive are involved and are therefore subject to CE marking.

Step 3: Ensure that safety regulations are met: The machine manufacturer is obliged to comply with the essential health and safety requirements in accordance with Annex I of the Machinery Directive. The formulation of these requirements is relatively abstract, but specifics are provided through European standards. The EU publishes lists of harmonised standards. Application of these standards is voluntary, but compliance does provide presumption of conformity with the regulations. This can substantially reduce the amount of evidence required, and a lot less work is needed for the risk assessment.

Step 4: Perform the risk assessment: The manufacturer is obliged to carry out a risk assessment. The contents and scope of risk assessments are not specified in any directive, but the standard EN ISO 12100 describes the general procedure.

Step 5: Validation: Validation is one of the most significant steps in the conformity assessment procedure and therefore the declaration of conformity. It is essential for proving that all safety regulations have been met.

Step 6: Compile the technical documentation: Technical documentation in accordance with the Machinery Directive can be quite extensive, depending on the complexity of your product. It must be retained for at least ten years after the machine is placed on the market and must be available to present to the relevant national authorities.

Step 7: Issue the declaration of conformity: By issuing the EU declaration of conformity, the manufacturer declares that he has considered all the directives that apply to the product.

Step 8: Affix the CE mark: The CE mark may be affixed once the EU declaration of conformity has been issued. The CE mark must be visible, legible and indelible. It’s important that the CE mark is clearly distinguishable from any other CE marks, on components for example. To avoid confusion with any other markings, it is advisable to affix the CE marking for the complete machine to the machine type plate, which must also contain the name and address of the manufacturer.

EC declaration of conformity versus EU declaration of conformity

Reference is made to either an EC or EU declaration of conformity, depending on the applied directive. The different designations are historical. Directives that were last updated before the cut-off date of 1 December 2009, still have the designation EC, for European Community. After the cut-off date, EC became EU, European Union, due to the Treaty of Lisbon.

That's why the Machinery Directive, its official title being Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on Machinery, and amending Directive 95/16/EC, is consistent in requiring an EC declaration of conformity.

Further information on the declaration of conformity

Contact

Pilz Automation Safety Canada L.P.
6695 Millcreek Drive, Unit 8
Mississauga, ON, L5N 5R8
Canada

Telephone: +1 905 821 7459
E-Mail: info@pilz.ca

Technical Support

Telephone: +1 888-315-PILZ (315-7459)
E-Mail: tech@pilz.ca

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