Standards & Legislation in Europe
Free movement of goods is a fundamental objective of the single European market. The mechanisms in place to achieve this aim are based on the prevention of new barriers to trade, mutual recognition and technical harmonization.
The New Approach legislative technique approved by the Council of Ministers on 7 May 1985 in its Resolution on a new approach to technical harmonisation and standards established the following principles:
- Legislative harmonisation should be limited to the essential requirements (preferably performance or functional requirements) that products placed on the EU market must meet if they are to benefit from free movement within the EU;
- The technical specifications for products meeting the essential requirements set out in legislation should be laid down in harmonised standards which can be applied alongside the legislation;
- Products manufactured in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirements of the applicable legislation, and, in some cases, the manufacturer may benefit from a simplified conformity assessment procedure (in many instances the manufacturer’s Declaration of Conformity, made more easily acceptable to public authorities by the existence of the product liability legislation);
- The application of harmonised or other standards remains voluntary, and the manufacturer can always apply other technical specifications to meet the requirements (but will carry the burden of demonstrating that these technical specifications answer the needs of the essential requirements, more often than not, through a process involving a third party conformity assessment body);
The operation of Union harmonisation legislation under the New Approach requires harmonised standards to offer a guaranteed level of protection with regard to the essential requirements established by the legislation. This constitutes one of the major preoccupations of the Commission in pursuit of its policy for a strong European standardisation process and infrastructure. Regulation (EU) No 1025/2012 on European Standardisation gives the Commission the possibility of inviting, after consultation with the Member States, the European standardisation organisations to draw up harmonised standards and it establishes procedures to assess and to object to harmonised standards.
Since the New Approach calls for common essential requirements to be made mandatory by legislation, this approach is appropriate only where it is possible to distinguish between essential requirements and technical specifications. Further, as the scope of such legislation is risk-related, the wide range of products covered has to be sufficiently homogeneous for common essential requirements to be applicable. The product area or hazards also have to be suitable for standardisation.
The principles of the New Approach laid the foundation for European standardisation in support of Union harmonisation legislation. The role of harmonised standards and the responsibilities of the European standardisation organisations are now defined in Regulation (EU) No 1025/2012 together with relevant Union harmonisation legislation.
The principle of reliance on standards in technical regulations has also been adopted by the World Trade Organisation (WTO). In its Agreement on Technical Barriers to Trade (TBT) it promotes the use of international standards.
For more information on Standards and Legislation in Europe, see the CEN and CENELEC Guide 30 European Guide on Standards and Regulation – Better regulation through the use of voluntary standards – Guidance for policy makers and the ‘Blue Guide’ on the implementation of EU product rules, 2014.