Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments (Text with EEA relevance)
Modified by
Council Directive 2006/96/ECof 20 November 2006adapting certain Directives in the field of free movement of goods, by reason of the accession of Bulgaria and Romania, 306L0096, December 20, 2006
Directive 2004/22/EC of the European Parliament and of the Councilof 31 March 2004on measuring instruments(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the CommissionOJ C 62 E, 27.2.2001, p. 1, and OJ C 126 E, 28.5.2002, p. 368.,Having regard to the Opinion of the European Economic and Social CommitteeOJ C 139, 11.5.2001, p. 4.,Acting in accordance with the procedure laid down in Article 251 of the TreatyOpinion of the European Parliament of 3 July 2001 (OJ C 65 E, 14.3.2002, p. 34). Council Common Position of 22 July 2003 (OJ C 252 E, 21.10.2003, p. 1) and Position of the European Parliament of 17 December 2003 (not yet published in the Official Journal). Decision of the Council of 26 February 2004.,Whereas:(1)A number of measuring instruments are covered by specific Directives, adopted on the basis of Council Directive 71/316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to common provisions for both measuring instruments and methods of metrological controlOJ L 202, 6.9.1971, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).. Specific Directives that are technically outdated should be repealed and replaced by an independent Directive reflecting the spirit of the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standardsOJ C 136, 4.6.1985, p. 1..(2)Correct and traceable measuring instruments can be used for a variety of measurement tasks. Those responding to reasons of public interest, public health, safety and order, protection of the environment and the consumer, of levying taxes and duties and of fair trading, which directly and indirectly affect the daily life of citizens in many ways, may require the use of legally controlled measuring instruments.(3)Legal metrological control should not lead to barriers to the free movement of measuring instruments. The provisions concerned should be the same in all Member States and proof of conformity accepted throughout the Community.(4)Legal metrological control requires conformity with specified performance requirements. The performance requirements that the measuring instruments must meet should provide a high level of protection. The conformity assessment should provide a high level of confidence.(5)Member States should as a general rule prescribe legal metrological control. Where legal metrological control is prescribed, only measuring instruments complying with common performance requirements should be used.(6)The principle of optionality introduced by this Directive, whereby Member States may exercise their right to decide whether or not to regulate any of the instruments covered by this Directive, should be applicable only to the extent that this will not cause unfair competition.(7)The responsibilities of the manufacturer for compliance with the requirements of this Directive should be specifically stated.(8)The performance of measuring instruments is particularly sensitive to the environment, particular the electromagnetic environment. Immunity of measuring instruments to electromagnetic interference forms an integral part of this Directive and the immunity requirements of Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibilityOJ L 139, 23.5.1989, p. 19. Directive as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1). should therefore not apply.(9)Community legislation should specify essential requirements that do not impede technical progress, preferably performance requirements. Provisions to remove technical barriers to trade should follow the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards.(10)In order to take account of differences in climatic conditions or of different levels of consumer protection that may apply at national level, essential requirements may give rise to the establishment of environmental or accuracy classes.(11)In order to ease the task of proving conformity with the essential requirements and to enable conformity to be assessed, it is desirable to have harmonised standards. Such harmonised standards are drawn up by private-law bodies and should retain their status as non-mandatory texts. To this end, the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) and the European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines on cooperation between the Commission and the European Standardisation bodies signed on 13 November 1984.(12)The technical and performance specifications of internationally agreed normative documents may also comply, in part or in full, with the essential requirements laid down by this Directive. In those cases the use of these internationally agreed normative documents can be an alternative to the use of harmonised standards and, under specific conditions, give rise to a presumption of conformity.(13)Conformity with the essential requirements laid down by this Directive can also be provided by specifications that are not supplied by a European technical standard or an internationally agreed normative document. The use of European technical standards or internationally agreed normative documents should therefore be optional.(14)The conformity assessment of sub-assemblies should respect the provisions of this Directive. If sub-assemblies are traded separately and independently of an instrument, the exercise of conformity assessment should be undertaken independently of the instrument concerned.(15)The state of the art in measurement technology is subject to constant evolution which may lead to changes in the needs for conformity assessments. Therefore, for each category of measurement and, where appropriate, sub-assemblies, there must be an appropriate procedure or a choice between different procedures of equivalent stringency. The procedures adopted are as required by Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the "CE" marking, which are intended to be used in the technical harmonisation DirectivesOJ L 220, 30.8.1993, p. 23.. However, derogations may have to be made for these modules in order to reflect specific aspects of metrological control. Provision should be made for the "CE" marking to be affixed during the fabrication process.(16)Continued development in measurement technology as well as concerns expressed by stakeholders about certification, stress the need to ensure consistent conformity assessment procedures for industrial products, as requested by the Council Resolution adopted on 10 November 2003OJ C 282, 25.11.2003, p. 3..(17)Member States should not impede the placing on the market and/or putting into use of measuring instruments that carry the "CE" marking and supplementary metrology marking in accordance with the provisions of this Directive.(18)Member States should take appropriate action to prevent non-complying measuring instruments from being placed on the market and/or put into use. Adequate cooperation between the competent authorities of the Member States is therefore necessary to ensure a Community-wide effect of this objective.(19)Manufacturers should be informed of the grounds on which negative decisions in respect of their products were taken, and of the legal remedies available to them.(20)Manufacturers should be offered the possibility to exercise the rights obtained before the entry into force of this Directive, during a reasonable transitional period.(21)National specifications concerning the appropriate national requirements in use should not interfere with the provisions of this Directive on "putting into use".(22)The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the CommissionOJ L 184, 17.7.1999, p. 23..(23)The activity of the Measuring Instruments Commmittee should include proper consultations with representatives of interested parties.(24)Directives 71/318/EEC, 71/319/EEC, 71/348/EEC, 73/362/EEC, 75/33/EEC, as concerns the meters defined in Annex MI-001 of this Directive, 75/410/EEC, 76/891/EEC, 77/95/EEC, 77/313/EEC, 78/1031/EEC and 79/830/EEC should therefore be repealed,HAVE ADOPTED THIS DIRECTIVE: