Additional terminology for manufacturers
European Economic Area (EEA)
The EEA came into formal existence in January 1994 and includes EC countries and all European Free Trade Association (EFTA) countries except Switzerland, viz the EC countries, Norway, Iceland and Liechtenstein. All such countries have agreed to implement single market legislation so that products that meet relevant EC legislation will be able to circulate freely within all EEA countries. Switzerland has implemented some of the Single Market directives although it remains outside the EEA.
In 1985, the EU agreed a new approach to the use of European Standards: directives would contain broad goal-setting 'essential requirements', with the technical detail in individual 'harmonised' standards. The use of such standards was and is voluntary. Non-governmental European Standards organisations CEN and CENELEC prepared a wide range of product standards, on mandates from the European Commission, in support of various Single Market directives. Compliance with the harmonised standards gave a 'presumption of conformity' with the essential requirements addressed in the standards. Only those standards cited as providing evidence of conformity for specific directives are allowable to show compliance.
Conformity assessment procedures
The processes a manufacturer has to go through to demonstrate that their product meets relevant essential safety requirements. They include some form of certification and, in some cases, type-examination and testing of the product by a notified body. Procedures vary from one product type to another: most manufacturers can certify that their own machinery meets essential safety requirements; for most simple pressure vessels, type-examination is required if vessels are not made to harmonised standards.
Technical documentation or technical file
New Approach directives require manufacturers, their agents or importers into the European Economic Area (EEA) to draw up technical documentation or files to demonstrate how their products conform to the requirements of the directives. Such files or documentation are to be available to the national enforcing authorities and do not have to be made available to users, for reasons of confidentiality.
Under the New Approach directives, verification or type-examination of a range of products is required by notified bodies - bodies notified by member states to the Commission as approved for the purpose. European Standards set criteria for accepting third party testing and examination bodies. Once notified, such organisations are deemed competent to undertake the appropriate type-examination for any manufacturer supplying within the EEA. British manufacturers can use the services of a continental notified body. In the UK, notified bodies are sometimes referred to as 'approved bodies' and are usually approved by the Department for Business, Innovation and Skills (BIS).
CE marking is not a quality mark, nor a guarantee that a product meets relevant European requirements. In most cases, it amounts to a claim by the manufacturer to have met all the requirements of relevant EC directives. The manufacturer, assembler or installer is required to affix the CE marking to the product or, in some cases, its packaging. The product user should not rely on the presence of a CE marking, but should make other checks to ensure a product is safe. A visual inspection may be enough, but sometimes the product will come with a declaration of conformity as well as instructions for safe use.
Enforcement action can still be taken against the supplier and/or user, of products with a CE marking which are unsafe, as appropriate.
Placing on the market
The Commission Guide states that 'placing on the market' means the initial action of making a product available on the Community market, for payment or free of charge, with a view to distribution and/or use in the Community: when the product first moves from manufacture to distribution and/or use. It refers only to the first time the product is made available on the Community market, so the directives apply only to new products manufactured in the EEA, and to new or used products imported for the first time from a third, ie non-EEA, country.