The “New Approach” to technical harmonisation is a flexible regulatory framework that sets essential requirements to be fulfilled in order to meet policy objectives (e.g. free movement of safe products), and allows experts to decide how the requirements can be technically achieved at product level. The conformity assessment is facilitated through the use of harmonised standards that provide a presumption of conformity to the law (module A) for many engineering products. This compliance is declared through the affixing of the CE-marking on the product or its packaging.

Since 1973, the New Approach has been successfully applied to non-food products, such as electrical goods (LVD) or machines (MD), electromagnetic compatibility (EMCD) or radio and telecommunications (RTTED). It has proved to work well and has boosted the competitiveness of the European engineering industry, thereby

constituting one of the cornerstones of the European single market.

However, the future of the New Approach is under threat for 2 main reasons:

  • Excess and unco-ordinated EU legislation increasingly affects both product design and manufacturing processes (e.g. for environment protection) and thereby jeopardises the flexible self-conformity assessment procedure of New Approach directives;
  • Customer confidence and industry competitiveness are challenged by free-riders, that tend to expand their illegal activity because of poor border controls and nationally segmented and understaffed market surveillance.

As a supporter of the New Approach, Orgalime monitors current efforts of the European Commission to harmonise common elements of existing New Approach directives very closely, especially the manufacturer/importer’s responsibility (placing on the market), the conformity assessment modules, standardisation, the affixing of the CE-marking, and market surveillance.

Orgalime is also open to the idea of examining how the New Approach can be applied to areas other than health and safety legislation regulating products, or could be used to develop equivalent co-regulatory tools. This is particularly relevant for any new policy, which would apply to engineering products that are already covered by various New Approach directives.

The New and global approach - Web pages of the Commission

Picture Courtesy of Atlas Copco