4.1.1 必須要件の定義

A fundamental feature of a large part of Union harmonisation legislation is to limit legislative harmonisation to the essential requirements that are of public interest. These requirements deal with the protection of health and safety of users (usually consumers and workers) but may also cover other fundamental requirements (for example protection of property, scarce resources 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 (for example physical and mechanical resistance, flammability, chemical, electrical or biological properties, hygiene, radioactivity, accuracy), or refer to the product or its performance (for example provisions regarding materials, design, construction, manufacturing process, instructions drawn up by the manufacturer), or lay down the principal protection objective (for example by means of an illustrative list). Often they are a combination of these. As a result, several Union harmonisation acts may be applicable to a given product at the same time, since the essential requirements of different Union harmonisation acts 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 have to carry out a risk analysis to first identify all possible risks that the product may pose and determine the essential requirements relevant for the product. This analysis implies that the manufacturer should assess all the different elements of the products and determine which Union harmonisation legislation applies to it, and which specific essential requirements as set out therein. This analysis has to be documented and included in the technical documentation (178). In addition, the manufacturer needs to document the assessment of how the risks identified are addressed to ensure that the product complies with the relevant essential requirements (for example, by applying harmonised standards). If only part of the harmonised standard is applied or it does not cover all relevant essential requirements, then the way relevant essential requirements not covered by it are dealt with, should be documented (179).

Essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so. The precise technical solution may be provided by a standard or by other technical specifications or be developed in accordance with general engineering or scientific knowledge laid down in engineering and scientific literature at the discretion of the manufacturer. 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, Union harmonisation legislation based on essential requirements does not necessitate regular adaptation to technical progress, since assessment of whether requirements have been met or not are based on the state of technical know-how at the moment the product is placed on the market.

The essential requirements are set out in relevant sections or annexes of a given piece of Union harmonisation legislation. Although no detailed manufacturing specifications are included in the essential requirements, the degree of detailed wording differs between different Union harmonisation acts (180). The wording is intended 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 standardisation requests by the Commission to the European standardisation organisations (ESOs) in order to produce harmonised standards. They are also formulated so to enable the assessment of conformity with those requirements, even in the absence of harmonised standards or in case the manufacturer chooses not to apply them.