This article explains what the term "European harmonized standards" entails, and why European harmonized standards play an important role in the CE Marking of products.

Directive 98/34/EC defines European standards as technical specifications adopted by European standards organizations for repeated or continuous application with which compliance is not compulsory. According to the internal rules of these organizations, European standards must be transposed at national level. This transposition means that the European standards in question must be made available as national standards in an identical way, and that all conflicting national standards must be withdrawn in a given period.

Harmonized standards are not a specific category amongst European standards. The terminology used in New Approach directives is a legal qualification of technical specifications existing as European standards, but to which a special meaning has been given by these directives. Harmonized standards maintain their status of voluntary application in the field of New Approach directives.

The Commission formally requests the European standards organizations to present European standards by issuing a mandate. Prior to this the Commission consults the Committee established under the directive 98/34/EC, and, in some cases, the sectoral Committee set up under the directive in question. Reaching consensus within the Committee under directive 98/34/EC implies wide consultation of sectoral authorities at national level. Thus, the mandate provides a strong indication of the expectations of public authorities.

The European standards organizations will formally take a position on a mandate from the Commission in conformity with their internal regulations. Acceptance of the mandate and the subsequent working programme of these organizations initiate the standstill as provided for in their internal regulations and in directive 98/34/EC. The elaboration and adoption of harmonized standards is based on the General Guidelines for cooperation between the European standards organizations and the Commission signed on 13 November 1984. These orientations contain series of principles and commitments concerning standardization, such as the participation of all interested parties (e.g. manufacturers, consumer associations, and trade unions), the role of public authorities, the quality of standards and a uniform application of standards throughout the Community.

The European standards organizations are responsible for identifying and elaborating harmonized standards in the meaning of New Approach, and for presenting a list of adopted harmonized standards to the Commission. The technical contents of such standards are under the entire responsibility of the European standards organizations. Once public authorities have agreed on a mandate, the search for technical solutions should in principle be left to the interested parties. In certain areas such as environment, health and safety, the participation of public authorities on a technical level is important in the standardization process. However, New Approach directives do not foresee a procedure under which public authorities would verify or approve either at Community or national level the contents of harmonized standards, which have been adopted with the procedural guarantees of the standardization process. The dialogue between standards bodies and authorities, and when appropriate their participation in the standardization process should, nevertheless, help to ensure that the terms of the mandate are correctly understood and public concerns are properly taken into account in the process.

The European standards organizations are not obliged to present newly developed standards as harmonized standards. They may also identify existing standards, which they judge, after examination and possible revision, to meet the terms of the mandate or modify existing standards in order to meet those terms. In the same way, they may identify international or national standards and adopt them as European standards, and present them to the Commission as harmonized standards.

A harmonized standard must match the essential requirements of the relevant directive. A European standard may contain provisions relating not only to essential requirements but also to other provisions. In such a case, these provisions should be clearly distinguished from those covering the essential requirements. Furthermore, a harmonized standard does not necessarily cover all essential requirements. In such a case, it is up to the manufacturer to use other relevant technical specification in order to meet all the essential requirements of the directive.

Standardization procedure under the New Approach.

1. A mandate is drawn up, following consultation of the Member States.
2. The mandate is transmitted to European standards organizations.
3. European standards organizations accept the mandate.
4. European standards organizations elaborate a (joint) programme.
5. Technical Committee elaborates draft standard.
6. European standards organizations and national standards bodies organize public enquiry.
7. Technical Committee considers comments.
8. National standards bodies vote/ European standards organizations ratify.
9. European standards organizations transmit references to the Commission.
10. Commission publishes the references.
11. National standards bodies transpose the European standard.
12. National authorities publish references of national standards.