In order to prevent technical barriers to trade, at the instigation of the Commission, the Council adopted, in a 1985 Resolution, a new approach to technical harmonisation and standards. The new approach is based on the following four fundamental principles:
· legislative harmonization is limited to the adoption, by means of Directives based on Article 100 of the EEC Treaty (Article 115 TFEU, ex Article 94 TEC), of the essential safety requirements (or other requirements in the general interest) with which products put on the market must conform, and which should therefore enjoy free movement throughout the European Community/Union;
· 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 is entrusted to organisations competent in the standardization area;
· these technical specifications are not mandatory and maintain their status of voluntary standards. (This implies that the producer has the choice of not manufacturing in conformity with the standards but that in this event he has an obligation to prove that his products conform to the essential requirements of the Directive);
· but at the same time national authorities are obliged to recognise that products manufactured in conformity with harmonised standards (or, provisionally, with national standards) are presumed to conform to the "essential requirements" established by the Directive.
The key to the implementation of the new approach to technical harmonisation is the common standardisation policy, i.e. the establishment of standards that determine the specifications for industrial production. The standards are adopted by European bodies, which have the task of elaborating technical specifications that meet the essential requirements laid down by the technical harmonisation Directives, while ensuring that those standards are the result of agreement of all parties concerned: producers, users, consumers, administrations, etc. These bodies are: the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) and the European Telecommunication Standards Institute (ETSI) [see also sections 17.3.6 and 19.2.1]. No mandatory nature is attributed to these technical specifications, which have the status of voluntary standards. Industrialists are not obliged but have an interest, if they want to market their products in all the common market, to manufacture them in accordance with the European directives and hence with European standards. On the other hand, the national authorities are obliged to recognise that products manufactured in conformity with harmonised standards are presumed to conform to the essential requirements laid down in that Directive. The EU contributes to the financing of European standardisation in view of the latter's useful role in supporting its legislation and policies, notably the functioning and strengthening of the internal market, safety and environmental and consumer protection and interoperability in fields such as transport [Decision 1673/2006].
The mutual recognition principle means the recognition by the competent authorities of importing Member States of the validity of tests carried out by approved laboratories in other Member States offering adequate guarantees of good laboratory practice (GLP) [Directive 2004/9]. According to the principle of mutual recognition, a Member State may not prohibit the sale on its territory of products which are lawfully marketed in another Member State, even where those products were manufactured in accordance with technical rules different from those to which domestic products are subject. The only exceptions to that principle are restrictions which are justified on the grounds set out in Article 30 of the EC Treaty (public morality, public policy or public security, the protection of health etc.) or on the basis of other overriding reasons of public interest and which are proportionate to the aim pursued. A Regulation lays down the rules and procedures to be followed by the competent authorities of a Member State when taking or intending to take a decision, which would hinder the free movement of a product lawfully marketed in another Member State [Regulation 764/2008]. It also transfers the burden of proof from the economic operator to the administration, thus making it more difficult for a Member State to deny the marketing of products that are already accepted in another Member State.
A complementary Regulation provides a framework for the market surveillance relating to the marketing of products produced in the EU and imported from third countries to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security [Regulation 765/2008]. It also lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities and the general principles on affixing the CE marking.
Since it is very difficult to adopt European legislation for every product which exists or which may be developed, Decision 768/2008 sets out the common framework of general principles and reference provisions for the drawing up of European legislation harmonising the conditions for the marketing of products. This Decision provides definitions and general obligations for economic operators and a range of conformity assessment procedures from which the legislator can select as appropriate. It renders economic operators responsible for the compliance of their products with all applicable legislation and for ensuring that all information they provide with regard to their products is accurate, complete and in compliance with European rules applicable. It also lays down the procedure to be followed by national authorities when trying to impose a national technical rule (i.e. in cases where mutual recognition is not applied). Finally, this Decision lays down the rules for "CE" marking, which is the visible consequence of a whole process concerning the conformity assessment of a product.
The single "CE" marking is used in order to facilitate controls on the European Community/Union market by inspectors and to clarify the obligations of economic operators in respect of marking under the various European regulations [Directive 768/2008 and Regulation 765/2008]. The aim of the CE marking is to symbolize the conformity of a product with the levels of protection of collective interests imposed by the total harmonization directives and to indicate that the economic operator has undergone all the evaluation procedures laid down by European law in respect of his product. Consumers who see the marking CE (Communitas Europaea) on a product thus have an indication (not necessarily the proof) that it has been manufactured in conformity with European standards.
According to the Court of Justice [Case C-11/92], it is acceptable for only a minimum degree of harmonisation to be brought about by a Directive based on Article 100 EEC (Article 115 TFEU, ex Article 95 TEC). In other words, the use of Article 115 as a legal basis does not necessarily entail full harmonisation of the conditions of competition. The Court, thus, acknowledges that the degree of harmonisation sought at European level may give rise to less favourable treatment of domestic products, compared to imported products which meet only the minimum requirements laid down by a European Directive.
The new approach to technical harmonisation has given rise to fresh dynamism in the removal of technical barriers to intra-European trade. Many directives were adopted under it, relating, for example, to the safety of machines [Directive 2006/42], appliances burning gaseous fuels [Directive 2009/142] and footwear [Directive 94/11].