New Approach directives (directives providing for CE marking)
Standards are shaped by consensus among enterprises, public authorities, consumers, and trade unions, through a consultation process organised by independent, recognised standardisation bodies at national, European and international level.
A harmonised standard is elaborated on the basis of a request from the European Commission to a recognised European Standards Organisation to develop a European standard that provides solutions for compliance with a legal provision.
Such a request provides guidelines which standards must respect to meet the essential requirements or other provisions of harmonisation legislation.
Compliance with harmonised standards provides a presumption of conformity with the corresponding requirements of harmonisation legislation.
Manufacturers, other economic operators or conformity assessment bodies can use harmonised standards to demonstrate that products, services or processes comply with relevant EU legislation.
To create the capacity to confer this presumption of conformity, the references of harmonised standards must be published in the Official Journal of the European Union.
The use of these standards remains voluntary.
Manufacturers, other economic operators or conformity assessment bodies are free to choose any other technical solution that provides compliance with the mandatory legal requirements.
Within the context of some directives or regulations voluntary European standards supporting implementation of relevant legal requirements are not called "harmonised standards".
Such legislation and related European standards are also included in this information service, if relevant legislation foresees a need for a Commission standardisation request to European Standards Organisations and if publication of references in the Official Journal of the European Union is foreseen as a precondition for presumption of conformity or for other legal effect.