A ‘harmonised standard’ is a standard adopted by one of the European standardisation organisations – European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunications Standards Institute (ETSI) – following a request from the European Commission.
The so-called ‘New Approach’ represents an innovative way of technical harmonisation by splitting the responsibilities between the European legislator and the European standards bodies.
The ‘New Approach’ is based on the following fundamental principles:
- European directives define the ‘essential requirements’ to ensure a high level of protection of health, safety, consumer protection, or the protection of the environment. Such directives under the new approach are based on Article 114 of the Treaty on the Functioning of the European Union (ex Article 95 TEC) which allows for the adoption of measures for the improvement of free movement of goods.
- The task of drawing up the corresponding harmonised standards meeting the essential requirements of products established by the directives is entrusted to the European standardisation organisations (CEN, CENELEC and ETSI).
- Products that comply with harmonised standards are presumed to meet the corresponding essential requirements (presumption of conformity, CE marking) and Member States must accept the free movement of such products.
- The use of these standards remains voluntary. Alternative standards are possible but manufacturers then have an obligation to prove that their products meet the essential requirements.
In-depth information on the directives adopted under the New Approach can be found in the directives section or on the following European Commission web pages:
https://ec.europa.eu/growth/index_en.htm (main page)
Links to European and international standardisation bodies
National standardisation bodies
Members of CENELEC