Conformité Européenne (CE)
The CE mark is the official marking required by the European Community for products that will be sold, or put into service for the first time, anywhere in the European community. It proves to the buyer or user that a product fulfills all essential safety and environmental requirements for the product's intended use, as they are defined in the European Directives, primarily ISO Standards, but in the case of marine products, the Recreational Craft Directive as well.
In return for fulfilling the CE marking requirements, the manufacturer or its agent may cover the entire European market using only one approval procedure for the topics covered in the directives.
The member states of the EC cannot refuse any product that has been CE marked, unless fraud is suspected. For some products, however, national regulations may exist, as long as the topics covered in these national regulations are not covered by a pan-European Directive. An example is Ergonomics in Germany for PC-related equipment.
A manufacturer that is using the CE mark must:
- be European, or
- have an official department in the European Community, or
- have an official agent or representative that is willing to take the liability for the CE-marking.
The attachment of the CE mark to a product must be based on a formal compliance statement which usually takes the form of a Declaration of Conformity. The Declaration of Conformity is a "self-declaration" statement that must contain:
- who the manufacturer is
- what product the Declaration refers to
- what directives are involved
- what standards are applicable
- where test results can be found
- who the responsible individual is in the declaring company
The Declaration of Conformity should be available to the authorities at the point of entry on the European Market. This means that it should be signed by the manufacturer's European representative for companies outside the EC. Its main purpose is to show proof of liability for compliance with EC regulations involved to the authorities and customs.