Frequently Asked Questions

The New Approach Directives are listed on the website: www.newapproach.org. 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. A company affixes CE marking to its product once the essential health and safety requirements of the applicable New Approach Directive(s) have been met.

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, detergents, biocides, 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, accredited test laboratories) are also contained in these directives.

The General Product Safety Directive (GPSD) covers all products not specifically covered by CE marking directives but which do require some level of safety regulation. These products may also be regulated at the national level by member states.

The role of standards in New Approach, Old Approach and GPSD:

There is a vast body of European standards. Voluntary industry standards are known as European harmonized standards whenever they are linked to European new approach legislation. European harmonized standards are developed by one of three European standards organizations based on a mandate from the European Commission. Products meeting the applicable technical standards developed by the European standards organizations are presumed to conform to the requirements of EU new approach directives and are allowed to circulate freely within the European Union. Use of the European harmonized standards is seen as a "fast track" for gaining CE marking 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.

Old approach legislation may refer to existing standards in the text or annexes, thus becoming mandatory. Technical annexes often are standards in their own right.
As for the general product safety directive, safety of products can be demonstrated by using existing standards which have been referenced in the Official Journal, the EU equivalent of the U.S. Federal Register. These standards cover products such as furniture, household appliances (non-electrical), sports equipment, childcare articles, and small hand-held tools. The standards define characteristics such as durability, appearance, and quality.