This article explains what the term "essential requirements" entails. This term can be found in almost all CE Marking Directives.
A fundamental principle of New Approach is to limit legislative harmonization to the essential requirements that are of public interest. These requirements deal in particular with the protection of health and safety of users (e.g. consumers and workers) and sometimes cover other fundamental requirements (e.g. protection of property or the environment).
Essential requirements are designed to provide and ensure a high level of protection. They either arise from certain hazards associated with the product (e.g. physical and mechanical resistance, flammability, chemical, electrical or biological properties, hygiene, radioactivity, accuracy), or refer to the product or its performance (e.g. provisions regarding materials, design, construction, manufacturing process, instructions drawn up by the manufacturer), or lay down the principal protection objective (e.g. by means of an illustrative list). Often they are a combination of these. The different orientations reflect to a certain extent the two regulatory approaches; i.e. New Approach directives cover a defined product type and/or a defined hazard. As a result, several directives may be applicable to a given product at the same time, since essential requirements of different directives need to be applied simultaneously in order to cover all relevant public interests.
Essential requirements must be applied as a function of the hazard inherent to a given product. Therefore, manufacturers need to carry out hazard analysis to determine the essential requirement applicable to the product. This analysis should be documented and included in the technical documentation.
Essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify or predict the technical solutions for doing so. This flexibility allows manufacturers to choose the way to meet the requirements. It allows also that, for instance, the materials and product design may be adapted to technological progress. Accordingly, New Approach directives do not necessitate regular adaptation to technical progress, since assessment of whether requirements have been met or not is based on the state of technical know-how at a given moment.
The essential requirements are set out in annexes to the directives. Although no detailed manufacturing specifications are included in the essential requirements, the degree of detailed wording differs between directives.
The wording is aimed to be precise enough to create, on transposition into national legislation, legally binding obligations that can be enforced, and to facilitate the setting up of mandates by the Commission to the European standards bodies in order to produce harmonized standards.
They are also formulated as to enable the assessment of conformity with those requirements, even in the absence of harmonized standards or in case the manufacturer chooses not to apply them.
(Source: European Commission)
