Harmonised Standards and Legislation
The "New Approach", defined in a Council Resolution of May 1985
European Commission directives define the "essential requirements", e.g., protection of health and safety that goods must meet when they are placed on the market.
The European standards bodies have the task of drawing up the corresponding technical specifications meeting the essential requirements of the directives, compliance with which will provide a presumption of conformity with the essential requirements. Such specifications are referred to as "harmonised standards".
The establishment of an internal market based upon the free movement of goods critically depends upon an adequate level of technical harmonization. Since 1985, the "new approach to harmonisation and standardisation" has represented a major change in dealing with the drafting of directives which are proposed in application of Art. 100A of the Treaty.
Such a new approach is based on a few key principles:
- there is a clear separation between the European Economic Community (EEC) legislation and European standardisation;
- EEC legislative harmonisation (e.g. EEC Directives) is limited to the essential requirements (safety requirements of general interest) needed to ensure the free movement of products throughout the Community;
- the task of drawing up the corresponding technical specifications is entrusted to the standardisation bodies;
- products manufactured in conformity with harmonised standards are presumed to be conformant to the essential requirements;
- standards are not mandatory, they remain voluntary Alternate paths are possible but the producer has an obligation to prove his products are conformant to the essential requirements;
- standards must offer a guarantee of quality with regard to the essential requirements of the directives;
- public authorities are still responsible for the protection requirements on their territory (e.g. market surveillance);
- safety clauses require the Member States to take all appropriate measures to withdraw unsafe products from the market.
In comparison with the former directives, some improvements have to be noted since the new approach:
- deals with large families of products (e.g. machinery, toys, etc.);
- covers horizontal risks (e.g. EMC) and not specific products;
- establishes a close co-operation between public authorities and market operators;
- is based on total harmonisation (replacing diverging national legislation) as compared to optional harmonisation (dual regime).
A summary of the key features of the "New Approach" would not be complete without mentioning the degree of flexibility which is allowed in most of the directives. The flexibility of the "New Approach" is linked to the following features:
- it indicates what has to be achieved but not the details of the corresponding technical solutions;
- it presents different options for conformity assessment (see the "global approach");
- it does not necessitate regular adaptation to technical progress.
The "New Approach" directives are supported by "harmonised standards" which play a significant role in ensuring their application. Such standards have first the characteristics inherent to European standards:
- the standards (typically EN, ETSs) are drafted by one of three European Standards Organisations (CEN, CENELEC, ETSI);
- the work is based on consensus;
- standards are adopted after a public inquiry with the national votes based on corresponding weighting features;
- standards remain voluntary but their transposition into national standards and the withdrawal of diverging national standards is mandatory according to the internal rules of the European Standards Organisations.
Within the context of the "New Approach" additional conditions are superposed to the European standards to cover the specific role of harmonised standards:
- the Commission issues a standardisation mandate according to the procedure of Directive 98/34/EC (consolidating Directive 83/189/EEC);
- the standards are developed in taking due account of the essential requirements;
- the reference of the standard is published in the Official Journal with the indication of the Directive for which the presumption of conformity should apply.
It should be noted that the European Standards Organisations are introducing internal assessment procedures to ensure the essential requirements have been effectively taken into account and directives might include specific procedures which can be applied whenever a standard has been found inadequate to fulfil the role it had been assigned under the EC legislation (e.g. use of a safeguard clause).
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 standard that provides solutions for compliance with a legal provision. Such a request provides guidelines which standards must respect to meet the essential requirements of a 'New Approach' or another relevant directive.
Compliance with harmonised standards provides a presumption of conformity with the corresponding requirements of the 'New Approach' directives and other relevant directives. Manufacturers can use harmonised standards to demonstrate that products comply with EU legislation.
To create the capacity to confer this presumption of conformity, the references of harmonised standards must be published in the EU Official Journal.
The use of these standards remains voluntary. Manufacturers are free to choose any other technical solution that provides compliance with the essential requirements.