The CE Mark is required in the European Union (EU) for demonstrating compliance with the New Approach Directives. Refer to Guide to the New Approach Directives for information related to the CE-marking directives. Along with placing the CE mark on a product using the guidelines below, a manufacturer must also issue a Declaration of Conformity (DoC), which clearly states which directives have been applied to the product. The significance of the DoC is that it is a manufacturer's declaration that the listed product(s) are in conformance with the EU requirements. The DoC accompanies each product.
Annex B(d) of Council Decision 93/465/EC provides the following guidelines for the CE mark:
- The CE conformity marking must consist of the initials 'CE' taking the form shown above. If the CE conformity marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
- Where the directive concerned does not impose specific dimensions, the CE marking must have a height of at least 5 mm.
- The CE marking must be affixed to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents.
- The CE marking must be affixed visibly, legibly and indelibly.
Label artwork provided by the EU:
Declaration of Conformity (DoC)
What is required for a DoC is specified by each individual directive. EN 45014 is a standard provided by the EU community to provide the general criteria for a DoC, and can be used as additional guidance related to the New Approach Directives. It states that a DoC can be in the form of a document or label and should contain sufficient information to allow all products covered by it to be traced back to it. In recent years, DoC's are also found on company websites. The important point is that these documents must be maintained for ten (10) years after the cease of manufacture.
As a minimum the following information should be provided:
- the name and address of the manufacturer or the authorized representative issuing the declaration;
- the identification of the product (name, type or model number, and any relevant supplementary information, such as lot, batch or serial number, sources and numbers of items);
- all relevant provisions complied with; the referenced standards or other normative documents (such as national technical standards and specifications) in a precise, complete and clearly defined way;
- all supplementary information that may be required (for example grade, category), if applicable;
- the date of issue of the declaration; signature and title or an equivalent marking of authorized person; and
- the statement that the declaration is issued under the sole responsibility of the manufacturer and, if applicable, the authorized representative.
As stated earlier, each directive may have additional requirements for what is to be included on a DoC so each directive that the manufacturer is claiming compliance should be checked to ensure that the appropriate information is provided.