This page explains the rationale of the 'New Approach' and clarifies some specific aspects of the 'New Approach Directives' such as Essential Requirements, Harmonized Standards. All explained mechanisms apply throughout the whole European Economic Area.
1 BASIC PRINCIPLES OF THE 'NEW APPROACH'
1.1 The so-called 'New Approach' was conceived in the early eighties and laid down in a 'Council Resolution of 7 May 1985 on a New Approach to technical harmonisation and standards'.
1.2 It is based on four fundamental principles:
- legislative harmonization is limited to the adoption, by means of Directives based on Article 100 of the EC Treaty (Rome Treaty, now Art. 95 of the Amsterdam Treaty), of the essential safety requirements (or other requirements on the general interest) with which products put on the market must conform, and which will therefore enjoy free movement throughout the territory of the European Union (EU);
- the task of drawing up the technical specifications needed for the production and placing on the market of products conforming to the Essential Requirements established by the Directives, while taking into account the current stage of technology, is entrusted to organizations competent in the standardization area (e.g. CEN);
- these technical specifications are not mandatory and maintain their status of voluntary standards;
- but at the same time national authorities are obliged to recognize that products manufactured in conformity with Harmonized Standards are presumed to conform to the Essential Requirements established by the Directive. This means that the producer has the choice of not manufacturing in conformity with the Harmonized Standards but that in this case he has an obligation to prove that his products conform to the Essential Requirements of the Directive.
In order that this system may operate, the resolution also specifies that it is necessary that:
- on the one hand, the standards offer a guarantee of quality with regard to the Essential Requirements established by the Directives;
- on the other hand, the public authorities keep intact their responsibility for the protection of safety (or other requirements envisaged) on their territory.
There is thus a clear distinction between the methods adopted under the New Approach and those used prior to its adoption. It should be noted that the 'Old Approach' is still used in some areas of EU technical legislation such as cars, food and cosmetics.
1.3 The differences may briefly be summarized as follows:
- The New Approach deals with large families of products (e.g. machinery, construction products, toys), or horizontal risks (such as electromagnetic compatibility), as opposed to the product-based approach used under the Old Approach;
- The New Approach establishes close cooperation between public authorities and market operators: an important role exists for standards, and the bodies responsible for the assessment of conformity with the requirements of the Directive (the so-called 'Notified Bodies') can be private entities, notified by Member States. Under the Old Approach, technical specifications are adopted by authorities and the functions of 'Notified Bodies' are carried out by national authorities;
- The New Approach Directives define the Essential Requirements that products must meet when they are put on the market but, in contrast to the Old Approach Directives, technical specifications on how to meet them are not included;
- New Approach Directives, since they do not contain technical specifications, do not necessitate regular adaptation to technical progress, in contrast to Old Approach Directives;
- New Approach Directives allow manufacturers a significant degree of flexibility. They can choose and adapt technology to meet the Essential Requirements. In regard to conformity assessment, normally a New Approach Directive gives various options;
- Old Approach Directives are often based on optional harmonization, i.e. leaving a choice to manufacturers to follow the harmonized Community rules, assuring free movement, or to follow national legislation, without a guarantee of free movement. New Approach Directives are based on total harmonization, since they replace diverging national legislation.
The New Approach is currently the method of harmonization used for most industrial products.
2 SOME SPECIFIC ASPECTS OF THE NEW APPROACH
2.1.1 New Approach Directives deal with large families of products (e.g. gas appliances, toys, machinery, pressure equipment). Product-related Directives define, for groups of products, the risks that have to be dealt with before such products can be put on the market. New Approach Directives can, however, also address horizontal risks such as electromagnetic compatibility (EMC).
2.1.2 It is quite possible that products may be governed by more than one Directive. This is not a legislative error ('overlap'), but a consequence of the fact that different risks may be dealt with under various Directives. For instance, one can easily imagine the simultaneous application of the Electromagnetic Compatibility (EMC) Directive and the Machinery Directive: the EMC aspects of a machine will be covered by the EMC Directive while mechanical risks may be covered by the Machinery Directive.
2.2 Essential Requirements
Essential Requirements are the requirements that products must meet to be put on the market. They are mandatory.
These requirements define the results to be attained, or the risks to be dealt with, but do not specify the technical solutions for doing so; suppliers are free to choose how the requirements are to be met.
Essential Requirements are therefore written in such a way that they remain valid over time, and do not become obsolete with technical progress. Assessment of whether requirements have been met should be based on the state of technical know-how at a given moment.
This does not mean that Essential Requirements are vague. They have to be drafted in such a way as to give sufficient information to enable assessment of whether products meet them.
2.3 Harmonized Standards
2.3.1 New Approach Directives foresee that the European Standardization Organizations (e.g. CEN), following a standardization request given by the European Commission, will elaborate European Standards (EN), or identify existing ENs, which will offer technical solutions to meet the Essential Requirements.
The references and titles of these standards – called ‘Harmonized Standards’ – are published by the European Commission in the Official Journal of the European Union. After being transposed into identical national standards by the National Standards Bodies (NSB) in the Member States, they will give manufacturers and service providers a presumption of conformity with respect to the Essential Requirements that they deal with.
The process of transposition by all the NSBs does not need to have taken place for such presumption of conformity to be valid, though of course the national bodies are obliged to transpose all new or revised ENs.
2.3.2 Standards remain voluntary. Therefore, under the New Approach, there is no obligation to use ENs.
Where another specification is used to meet the Essential Requirements, or in the absence of standards, the burden of proof that the product meets the Essential Requirements will rest on the person affixing the CE marking (i.e. the producer, his Authorized Representative in the Community or the importer of the product).
The European Commission publishes references of Harmonized Standards as they are presented to the European Commission by the European Standardization Organizations.