The completion of the internal market by 31 December 1992 as contemplated under the Single European Act amendments to the treaties required a new method of technical harmonisation of standards.\u00a0 Prior to that, technical standards had been spelled out in detail, which resulted in very slow progress in the harmonisation of standards.<\/p>\n
Under the new approach, general rules were established for particular sectors or types of product or risk.\u00a0 This avoided lengthy decision-making process which had involved harmonisation to detailed technical product by product directives.<\/p>\n
A Council resolution adopted a new approach on standardisation in the mid-1980s.\u00a0 The following fundamental principles apply.<\/p>\n
The new approach involves a number of key principles.\u00a0 Legislation on harmonisation is limited to the essential safety requirements or other requirements necessary in the general interest.\u00a0 Products must at least conform to these requirements before enjoying free movement to the EU.<\/p>\n
The task of preparing technical specifications is entrusted to organisations which undertake industrial standardisation.\u00a0 Standards are not generally mandatory and are voluntary.\u00a0 Authorities are obliged to recognise products manufactured in accordance with harmonised standards which are presumed to conform with the essential requirements under the directive.\u00a0 If the producer manufactures other than in conformity with those standards, he must prove that the products conform with the essential safety requirements.<\/p>\n
Standards must guarantee the quality of the product.\u00a0 Authorities must ensure protection of safety within their jurisdiction.<\/p>\n
The Commission issues standardisation mandates to the EU Standardisation Organisation.\u00a0 In the absence of European standards, national standards are verified by a procedure at community level managed by the Commission assisted by a standing committee comprised of individuals from national authorities.\u00a0 There are safeguards to allow authorities the possibility of contesting conformity of a product or quality of a standard.<\/p>\n
States are responsible for ensuring the safety of persons and goods in their own territory.\u00a0 The European committee for standardisation (CEN and the European Committee for Electoral Technical Standards) (CEN, ELEC) are the competent bodies to adopt European standards with the scope of directives.\u00a0 In other sectors, other competent bodies may be involved.<\/p>\n
Products covered by a directive may only be placed on the market if they do not endanger the safety of persons, animals or goods.\u00a0 The general rule is that only products which conform with the harmonisation requirements of the directive may be placed on the market.<\/p>\n
The directive should contain a description of the safety requirements with which all products covered must conform.\u00a0 This should be precise enough so that legally binding obligations can be enforced through national law.<\/p>\n
Free movement of products is usually permitted without recourse to prior verification of compliance with essential requirements.<\/p>\n
States may presume the conformity of products \u00a0which are accompanied by one of a number of means of attestation set out in the directive declaring that they conform either with the harmonised standards, or in their absence national standards.<\/p>\n
States must communicate to the commission details of the national standards which they consider meet the general requirements for placing on the market and the essential requirements.<\/p>\n
The commission ensures that other states are informed of the standards and that they are published in the official journal.\u00a0 National standards are selected on a transitional basis.\u00a0 The decision is to be accompanied by instructions to the competent European organisations to draft a corresponding EU standard.<\/p>\n
States accept that a product for which a manufacturer has not applied any standard because of the absence of an existing standard or innovation is considered to be in conformity with the essential requirements when accompanied by an attestation delivered by an independent body.<\/p>\n
When states consider the harmonised standards do not satisfy essential requirements, the commission is to bring this to the attention of the committee on standards and technical regulations for its opinion.\u00a0 In light of its opinion, the standard may be withdrawn, revised or maintained.<\/p>\n
If a state finds a product might adversely affect the safety of individuals, animals or property, it may take all measures appropriate to withdraw and prohibit the placing on the market of that product.\u00a0 Free movement can be restricted even if products are accompanied by attestation of conformity.\u00a0 In this case, states inform the Commission of the measure, setting out reasons.<\/p>\n
The Commission enters into consultation with the states and the standing committee.\u00a0 If the action is justified, the Commission informs states, who are then obliged to prevents the product being placed on the market.<\/p>\n
The methods of attestation include<\/p>\n
The national authorities authorise marks \/ \u00a0certificates of conformity which are notified by the states to the Commission and other states.\u00a0 They must work in accordance with the International Standards Organisation principles and practice.<\/p>\n
National authorities have the right to request the manufacturer to provide them with data relating to safety tests when there is any doubt about conformity with safety requirements.\u00a0 Manufacturers may prove in any manner they see fit within the framework of a dispute or court proceedings the conformity of the product.<\/p>\n
Directives distinguish between the essential requirements which are to be harmonised and other manufacturing specifications.<\/p>\n
An EU communication in 2003 sought to give fresh impetus to the technical harmonisation system.\u00a0 The communication calls for greater transparency in the operation of the national standards bodies.<\/p>\n
It calls for national legislative requirements to be implemented to ensure consistence in accreditation and accreditation services.\u00a0 States must ensure that standards bodies continue to have the technical qualifications required by the directive.<\/p>\n
Approved standard bodies may pursue activities in the internal market under the principles of mutual recognition.\u00a0 The commission supports information exchange procedures between agencies and accreditation bodies in the host state and the designating authority in the home authority for the relevant body.<\/p>\n
The system of conformity approval may be used in both areas subject to formal regulation and those not so subject.\u00a0 The standard body should adopt the same principles.\u00a0 The Commission introduced provisions to provide for exchange of information on products which are found non-compliant.<\/p>\n
Although market surveillance is a matter for the national authority, the commission has endeavoured to achieve a common level of market surveillance based on common criteria, including<\/p>\n
Market surveillance must be accompanied by effective cross-border administrative cooperation including reinforced mutual assistance between the national authorities in undertaking market surveillance, cleaner operational framework for administrative cooperation, faster exchange of information on noncompliant products, public access to information on dangerous products.<\/p>\n
States are obliged to take measures against products which are unsafe.\u00a0 The absence of CE marking on a product which should carry it allows the national authority to deem the product noncompliant.\u00a0 Safeguard clause procedure in the directives allows the commission to verify the grounds for national measures which aim to restrict free movement of goods.<\/p>\n
The Commission has taken steps to amend the safeguard procedure by revising the legal framework to guarantee a more uniform approach under the directives.<\/p>\n
The general product safety directive is relevant to goods and products covered under the new approach directive.<\/p>\n