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The new approach directives declare the level of safety necessary for the protection of people and goods, and they guarantee the free movement of those goods, which comply with the directive's requirements. Technical standards, which are developed in a European consensus scheme, are available to manufacturers as a tool for demonstrating compliance. These standards, which represent technical solutions to the directives' requirements and which have been agreed upon by the EU authorities as well as the standards bodies, carry with them a "presumption of conformity", very valuable to manufacturers. Technical standards that have achieved this status are called "harmonized standards," or "European Normes (EN)", and their references are published in the Official Journal of the European Communities.

Standard elements of New Approach Directives
New Approach directives are based on the following principles:
  • Harmonization is limited to essential requirements.
  • Only products fulfilling the essential requirements may be placed on the market and put into service.
  • Harmonized standards, the reference numbers of which have been published in the Official Journal and which have been transposed into national standards, are presumed to conform to the corresponding essential requirements.
  • Application of harmonized standards or other technical specifications remains voluntary, and manufacturers are free to choose any technical solution that provides compliance with the essential requirements.
  • Manufacturers may choose between different conformity assessment procedures provided for in the applicable directive.
The scope defines the range of products covered by the directive, or the nature of hazards the directive is intended to avert. It usually covers hazards related to a product or to a phenomenon. Accordingly, several directives may apply to the same product.


Click here to browse for standards associated with each specific European Union New Approach Directive.

Keywords: CE marking, CE Mark, European business, EU regulations, EU business requirements, European trade barriers, New Approach directive, technical construction file, EN, prEN, ISO, IEC, ITU, ETSI, CEN, CENELEC, EU regulatory compliance