New Approach and other Directives 

The relationship between standardization and legislation at European level has been developed in accordance with the so-called 'New Approach' to technical harmonization and standards, which was introduced in 1985.

According to the New Approach:

  • The European Union adopts legislation (EU Directives) that defines essential requirements - in relation to safety and other aspects of public interest - which should be satisfied by products and services being sold in the Single Market;
  • The European Commission issues standardization requests (Mandates) to the European Standardization Organizations (CEN, CENELEC and ETSI), which are responsible for preparing technical standards and specifications that facilitate compliance with these essential requirements;
  • Public authorities must recognize that all products manufactured (and services provided) in accordance with harmonized standards are presumed to conform to the essential requirements as defined by the relevant EU legislation;
  • European Standards remain voluntary and there is no legal obligation to apply them. Any producer (or service provider) who chooses not to follow a harmonized standard is obliged to prove that their products (or services) conform to the essential requirements;
  • Around 25% of European Standards published by CEN have been developed in response to standardization requests (Mandates) issued by the European Commission.

Business, consumers and other stakeholders benefit from the ongoing cooperation between the European regulatory authorities (i.e. the EU institutions and EFTA) and the European Standardization System, which can be seen as a kind of public-private partnership.

When businesses make use of harmonized standards, they benefit from a 'presumption of conformity' with the requirements set out in the relevant European legislation. This means that they can sell their products or services throughout the Single Market – reaching a potential 600 million consumers in at least 34 countries.

Meanwhile, when European Standards are correctly applied, consumers benefit from safe and environmentally-friendly products and services.