Harmonised European Standards

Significant element of the new approach is the involvement of European standardization bodies (CEN, CENELEC, and ETSI) in order to develop specially-formed specification based on the essential requirements for health and safety of the New Approach Directives.

Harmonized standard is not part of the legal system as directive is, but it can be characterized as a reference and guide for producers. If the producer manufactures products in accordance with the relevant harmonized standards, there is a presumption of conformity with the essential requirements of the directive (s) for health and safety. Therefore, compliance with the standard constitutes a presumption of conformity with the essential requirements laid down in the directive.

For each directive the European Commission gives an order to the appropriate body for standardization to prepare the appropriate number of standards according with the list of topics. Such standards are adopted as harmonized standards. The process of preparation and adoption of harmonized standards is the same as for other standards. The Commission does not participate directly in the standardization process but the Commission will determine experts to check if the draft proposal is in conformity with the essential requirements for health and safety directives in question. The Commission has no suffrage in the process of standard adoption. List of adopted harmonized standards that follow a specific directive shall be published in the Official Journal of the EU. Each Member State is obliged to transpose such standard in its own national standardization system, as well as to exclude existing standards that are not in accordance with the harmonized standard.