When the European Community (EC) was first formed, each of the member states already had their own product safety legislation and Standards. Differences between the various national Standards presented a barrier to the free movement of goods, which violates a fundamental principle of the EC.
CE marking was introduced as a means to reduce trade barriers between European Community member states. This target was achieved by consolidating, or ‘harmonising’ the legislation and associated Standards. The EC has no power to change laws in any member state. Instead, committees produce a regulatory structure known as a ‘Directive’, which member states then have to implement within their own national legislation. The content of numerous performance Standards was also agreed by all member states and these became ‘Harmonised Standards’. If a product meets the requirements of a relevant Harmonised Standard, then it is deemed to comply with the specific Directive to which that Standard relates.
Applying a CE mark to a product says that it meets ALL relevant Directives currently in force. A manufacturer is legally obliged to generate a “Declaration of Conformity” for each product that is placed upon the market. The Declaration of Conformity must contain certain key pieces of information, such as the Directives and Standards that have been applied to the product. It must also be signed and dated by the person who takes responsibility for the compliance of the product. Proving that a product conforms to a Directive can be demonstrated by compliance testing. Details of minimum performance specifications and test methods are set out in the Harmonised Standards. If a product meets the specified level of performance, then it can be assumed to conform to the relevant Directive. This process of implied compliance through Harmonised Standards is known as “presumption of
conformity” in the legislation.