A fundamental feature of a large part of Union harmonisation legislation is to limit legislative harmonisation to the essential safety requirements (ESR) 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 EU harmonisation legislations may be applicable to a given product at the same time, since the essential requirements of different EU harmonisation legislations need to be applied simultaneously in order to cover all relevant public interests.
Essential safety 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 safety 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 safety requirements are set out in relevant sections or annexes of a given piece of Union harmonisation legislation.
Which essential safety requirements must be met by the manufacturer
The manufacturer must only fulfil the specific essential safety requirements that apply to the product or the specific application. 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 applicable to the product.
When applying harmonised standards, the manufacturer can assume that he meets the essential safety requirements (presumption of conformity)
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What are harmonised standards in accordance to EU legislation?
