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Which product groups are covered by the EU's New Approach Directives?
There are New Approach Directives for electronic and electrical products, machinery, medical devices, radio and telecommunications terminal equipment, recreational craft, pressure equipment, equipment for use in potentially explosive atmospheres, personal protective equipment, toys, simple pressure vessels, and others. New Approach Directives indicate a product has met certain health and safety requirements. A company affixes the CE mark to its product once it has met the requirements of the applicable New Approach Directive(s). These directives came about as a way of eliminating trade barriers and facilitating the EU Single Internal Market. Not all products fall under the New Approach Directives. There are essentially three levels of regulatory control: Old Approach - The Old Approach Directives apply to the foodstuff, motor vehicle, chemical, cosmetic, and pharmaceutical sectors. These regulations have technical specifications written into the annexes. New Approach - These directives make references to harmonized standards and apply to broad product sectors such as machinery, electrical and electronic products, medical devices, and radio and telecommunications equipment. The directives usually set down general health and safety requirements, and the specifications for meeting these general requirements are found in the standards applicable to the manufacturer's product. Conformity assessment procedures (the system and responsibilities for testing and certification which should lie with the manufacturer and, where applicable, the notified bodies) are also contained in the these directives. The General Product Safety Directive (GPSD) covers all products not specifically covered by the CE mark directives but which do require some level of safety regulation. These products may also be regulated at the national level by member states. There is a vast body of European standards not mandated by the European Commission. These standards are not directed toward either the Old Approach or New Approach Directives. While the use of these standards is in theory voluntary, they can support claims of a product's quality either for marketing or legal purposes. These standards cover such products as furniture, household appliances (non-electrical), sports equipment, carpeting, footwear, and small hand-held tools. The standards define characteristics such as durability, appearance, quality, and even cultural preferences. Products meeting the applicable technical standards developed by the three standards organizations are presumed to conform to the requirements of EU directives and are allowed to circulate freely within the European Union. Use of European standards is seen as a 'fast track' for gaining CE mark compliance for a product. For many products, though, a manufacturer can choose not to comply with the CEN, CENELEC, or ETSI standards, if the company can demonstrate that its product satisfies the essential safety and performance requirements of the directives.
European Commission (EC)
http://ec.europa.eu/index_en.htm
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