A new approach to technical harmonisation
This Resolution aims to recast technical harmonisation within the European Union (EU) on a new basis by only harmonising the essential requirements of products and by applying the "general reference to standards" formula and the principle of mutual recognition in order to eliminate technical obstacles to the free movement of goods.
Council Resolution 85/C 136/01 of 7 May 1985 on a new approach to technical harmonization and standards.
The main aim of this Resolution is to develop an approach establishing general rules which are applicable to sectors or families of products as well as types of hazard.
This Resolution establishes a number of fundamental principles for a European standardisation policy:
- the Member States undertake to keep a constant check on the technical regulations which are applied so as to withdraw those which are deemed obsolete or superfluous;
- the Member States ensure the mutual recognition of the results of tests and establish harmonised rules on the operation of certification bodies (the mutual recognition principle);
- the Member States agree to early Community consultation where national regulatory proposals or procedures might pose a threat to the smooth operation of the internal market;
- there is a need to extend the "general reference to standards", preferably to European but if necessary national standards, and to define the task of standardisation as the formulation of technical characteristics of products (particularly as regards health protection and safety);
- there is a need to rapidly strengthen the capacity to standardise, preferably at European level;
- the adoption of European standards should be submitted to the European standardisation bodies for approval.
General guidelines for the new approach
The Council establishes four fundamental principles:
- legislative harmonisation is limited to essential safety requirements (or other requirements in the general interest) with which products put on the market must conform and can therefore enjoy free movement throughout the European Union;
- the task of drawing up technical production specifications is entrusted to organisations competent in industrial standardisation, which take the current stage of technology into account when doing so;
- these technical specifications are not mandatory and maintain their status of voluntary standards;
- the authorities are obliged to recognise that products manufactured in conformity with harmonised standards are presumed to conform to the essential requirements established by the Directive. If the producer does not manufacture in conformity with these standards, he has an obligation to prove that his products conform to the essential requirements.
Two conditions have to be met in order that this system may operate:
- the standards must guarantee the quality of the product;
- the public authorities must ensure the protection of safety (or other requirements envisaged) on their territory. This is a necessary condition to establish mutual trust between Member States.
The Commission issues standardisation mandates to the European standardisation organisations. Agreements between the Commission and these organisations ensure that they are carried out in accordance with the general guidelines. In the absence of European standards, national standards are verified by a procedure at European level managed by the Commission, which is assisted by a standing committee composed of officials from national administrations. Safeguard procedures are provided for in order to allow the national authorities the possibility of contesting the conformity of a product or the quality of a standard.
The scope of a directive is defined by the wide product categories and/or types of risk it encompasses.
Outline of a "new approach" directive
Member States have the responsibility of ensuring the safety on their territory of persons, domestic animals and goods. The provisions ensuring such protection must be harmonised in order to ensure the free movement of goods, without lowering existing levels of protection in the Member States.
The European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC) are the competent bodies to adopt European harmonised standards within the scope of the Directive. For specific sectors of industrial activity, other competent European bodies for the drawing up of technical specifications could be involved.
The definition of the range of products covered, as well as the nature of the hazards it is intended to avert, should ensure a consistent approach. This does not preclude the possibility of several Directives being adopted for the various types of hazard associated with the same category of product.
The products covered by a Directive may be placed on the market only if they do not endanger the safety of persons, domestic animals or goods. The Directives provide for total harmonisation as a general rule - i.e. that only products which conform can be placed on the market.
The directive should contain a description of the safety requirements with which all products covered by the Directive must conform. It should be worded precisely enough in order to create, on transposition into national law, legally binding obligations which can be enforced.
Free movement of the product in question is ensured, without recourse to prior verification of compliance with the essential requirements.
The Member States presume conformity for products which are accompanied by one of the means of attestation described in the directive declaring that they are in conformity either with the harmonised standards or, in the absence of harmonised standards, with national standards. Where a Member State considers that a harmonised standard does not satisfy the essential requirements, the Commission shall bring this to the attention of the Committee on Standards and Technical Regulations which gives an opinion as a matter of urgency. In the light of this opinion, the standard can be maintained, withdrawn or revised.
Should a Member State find that a product might compromise the safety of individuals, domestic animals or property, it takes all appropriate measures to withdraw or prohibit the placing on the market of the product in question. The free movement of the product can be restricted, even if it is accompanied by an attestation of conformity. If this is the case, the Member State informs the Commission of such a measure, indicating the reasons for its decision. The Commission enters into consultation with the Member States and the standing committee. If the action is felt to have been justified, the Commission informs the Member States who are obliged to prevent the product in question from being placed on the market.
The means of attestation which the trade may use are:
- certificates and marks of conformity issued by a third party;
- the results of tests carried out by a third party;
- the declaration of conformity issued by the manufacturer, which may be coupled with a surveillance system;
- other means of attestation which could possibly be determined in the Directive.
The national bodies authorised to issue marks or certificates of conformity are notified by the Member State to the Commission and to the other Member States. They must carry out their duties in accordance with International Standardisation Organisation (ISO) principles and practices. The Member States are responsible for controlling the operation of these bodies. The national authorities have the right to ask the manufacturer to provide them with the data relating to the safety tests carried out when they have doubts about its conformity with safety requirements. Any manufacturer may prove, by any means he sees fit within the framework of a dispute or court proceedings, the conformity of the product.
The sectoral directives standing committee is made up of representatives appointed by the Member States who may avail themselves of the help of experts or advisers. The tasks of the committee are concerned with the implementation of the Directive. The Committee constitutes a forum for discussing any possible objections, but is not intended to carry out a systematic examination of the entire contents of the standards.
Criteria for selecting the areas in which the "general reference to standards" could be applied:
- since it is only the essential requirements which are to be harmonised, it should be possible to distinguish between essential requirements and manufacturing specifications;
- the area concerned must be covered by standardisation (or the need for regulations is felt unanimously throughout the Community);
- most of the Directives adopted concern the three areas of motor vehicles, metrology and electrical equipment. The new approach should thus initially concentrate on other areas;
- the possibility of settling, with the adoption of a single Directive, all the problems concerning regulations for a large number of products, without the need for frequent amendments or adaptations to that Directive (based mainly on practical and labour-saving considerations). Consequently, the selected areas should be characterised by a wide range of products which are sufficiently homogeneous to allow common "essential requirements" to be defined.