Activites

• 2004/04/30 Final act published in Official Journal
  • Directive 2004/22
  • OJ L 135 30.04.2004, p. 0001-0080
• 2004/03/31 Final act signed
• 2004/03/31 End of procedure in Parliament
• #2565
• 2004/02/26 Council Meeting
• 2003/12/17 Decision by Parliament, 2nd reading
  • T5-0580/2003 summary

    The European Parliament adopted a resolution drafted by Giles Bryan CHICHESTER (EPP-ED, United Kingdom) some of which agreed in advance with Council on legislation relating to measuring instruments. The vote in second-reading should avoid the need for conciliation. Parliament stated that Member States should, as a general rule, prescribe legal metrological control. - new recitals state that the principle of optionality introduced by the Directive, implying that Member States may exercise their right to decide whether or not to regulate any of the instruments covered by this Directive, will be applicable only to the extent that this clause will not cause unfair competition. The conformity assessment of sub-assemblies should respect the provisions of the 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; - the activity of the Measuring Instruments Committee should include proper consultations with representatives of interested parties; - a new article states Member States may prescribe the use of measuring instruments mentioned in Article 1 for measuring tasks for reasons of public interest, public health, public safety, public order, protection of the environment, levying of taxes and duties, protection of consumers and fair trading, where they consider it justified. Where Member States do not prescribe such use, they must communicate the reasons to the Commission and the other Member States; - there is a new article on technical documentation stating that the latter must render the design, manufacture and operation of the measuring instrument intelligible and enable an assessment of its conformity with the appropriate requirements of this Directive. The technical documentation must be sufficiently detailed to ensure certain matters; - a new article sets out the criteria that Member States must apply for the designation of bodies; - finally, a draft joint statement says that the Council and the European Parliament undertake to act expeditiously in accordance with their respective rules of procedure, on a proposal from the Commission, concerning a full set of coherent conformity assessment procedures (Council Decision 93/465/EEC), as indicated in the Competitiveness Council Resolution adopted on 10 November 2003. The Commission has the intention to submit the necessary proposals as foreseen in its 2004 legislative programme, after consulting the interested parties.�

• 2003/12/16 Debate in Parliament
  • Debate in Parliament
• 2003/12/02 Vote in committee, 2nd reading
  • A5-0458/2003
• 2003/09/04 Committee referral announced in Parliament, 2nd reading
• #2524
• 2003/07/22 Council Meeting
  • 09681/4/2003 summary

    The common position has been accepted in Council by unanimity. It is fully in line with the main objective of the Commission's proposal. A unified legal framework for the internal market in measuring instruments and the necessary clarification of all the metrological requirements have to be combined with the objective of consumer protection. The notion of balancing simplifications, which follow from the "new approach" and greater responsibility of the manufacturer with necessary safeguards in the interest of the common good, has been respected and- where necessary - strengthened. The Council has taken great interest in technically sound and advanced solutions in a dynamically changing environment (especially concerning the instrument-specific annexes) as well as in the administrative applicability of the provisions. The Directive maintains the flexibility for those Member States, which do not regulate a specific type of instrument at the moment, but might choose to do so in the future. The Council has been in a position to accept the greater part of the EP amendments, at least in substance, in an effort to meet Parliament's concerns and to follow good legislative practice on a number of important points. The main elements of the political agreement are suppressing Annex II and withdrawing Annex MI-010. Annex II concerned non-mandatory testing methods, which, given that they can change quickly in the light of technical innovation, are just as well treated by means of standardisation, which simplifies the document and contributes to a simpler layout and more clarity. Annex MI-010 concerns alcohol breathalysers, the results of which are used as legal evidence. Several Member States indicated that they therefore needed testing of the instruments to be performed by national authorities, which rules out conformity assessment by notified bodies anywhere in the Community, as foreseen by the proposal. If a national court disputes the results produced by an instrument, national authorities need to adapt specifications of the instruments rapidly to conform to the national jurisprudence. These issues make harmonisation of the technical product requirements impossible. It should be noted that the Commission can agree with the suppression of Annex II and the withdrawal of the proposal in Annex MI-010. As regards amendments by Parliament that have been included in the amended proposal and in the common position, these concern the following: - the clarification of public interest objectives; - the clarification of the application of optionality, the amendment clarifies that there is an option for Member States to prescribe metrological control for types of instruments in the future. However, the wording has been modified in order to prevent any misunderstandings about the scope of Member States' obligations; - the clarification of the recital concerning the definition of the manufacturer; - the affixing of markings during manufacturing process); - the list of instrument-specific annexes: the amendment has been accepted because the instrument-specific annexes contain mandatory provisions and it is useful to list those annexes in Article 1 (together with the purely consequential change ofleaving out "evidential breath analyzers"); - reasons for legal metrological control: the substance of this amendment has been inserted into the definition of "legal metrological control" in Art. 3; - object and requirements : the whole paragraph 1 has been restructured in order to make the provision legally sound. As the consequence of the treatment of amendment 7 (i.e. to introduce the text in Article 3 and not in Article 1), it has not been possible to delete the entire reference to "legal metrological control". - the definition of "sub-assembly" : the substance of the amendment has been accepted with only editorial modifications to the suggested wording; - the definition of "manufacturer" : the substance of the amendment has been taken on board, including the deletion of the term "lawfully"; - the definition of authorised representative : the amendment is a clarification; - conformity marking : while the Commission had accepted the amendment in its modified proposal, the Council went further by allowing that both types of markings described be affixed during the fabrication process. The addition "if justified" should normally preclude any misuse of this flexible provision; - the criteria for designation of bodies : the amendment is accepted, because it clarifies the retaining of the right of Member States without national legislation concerning a specific instrument to designate a notified body; - the functions of the Measuring Instruments Committee : the part of the amendment aiming at excluding the modifications of details of the specific annexes from the task of the Measuring Instruments Committee has been rejected. However, the substance of the amendment has been acknowledged by strengthening the need for consultation of interested parties concerning the mentioned details of the specific annexes. - markings - here: Identification number : the amendment for the deletion of an additional sentence is accepted, given that the conformity assessment annexes are clear on this point and that the sentence is therefore superfluous; - confidentiality : the amendment is accepted. The approach has been followed not to refer to issues of "confidentiality" in the body of the text, because such provisions might give a false impression of the scope of the Directive and lead to different interpretations in the Member States; - transitional provisions: the Commission accepted the reduced period of validity of 5 years for existing approvals of indefinite duration, but the Council has in the light of applicability preferred to treat all in a similar way and to maintain 10 years for all existing approvals, i.e. those with 10 year validity and those with indefinite duration; - specification of a time period under the heading "durability": the substance of the amendment, has been accepted which is in line with the new approach concept of enhanced responsibility of the manufacturer; - reliability : in line with the amendment the sentence can be deleted; - suitability for the intended user : the amendment was accepted as a simplification; - unambiguous indications of results: the substance of theamendment has been accepted as serving a useful clarification objective. The Council has preferred however to use the wording "metrologically controlled indications" instead of "primary indication"; - data reading : the substance of the amendment has been accepted, but the wording changed in order to clarify that the accessibility to the customer should be guaranteed in any case. Concerning the amendments that have been included in the amended proposal but rejected in the common position, these refer to: markings on main device; serious influence; prevention of non-complying instruments being placed on the market and decisions on future regulation of instruments. Other modifications in the common position have been minor and mainly concern the reshuffling of articles in order to better reflect the current practice in the New Approach legislation, without materially changing them. This also applies to the changes in the annexes.�

• #X018
• 2003/05/19 Council Meeting
• #2467
• 2002/11/26 Council Meeting
  • 2467 summary

    The Council took note of a progress report from the presidency on the draft Directive of the European Parliament and the Council on measuring instruments. It requested the Permanent Representatives Committee to oversee further work on this proposal so as to enable it to reach a political agreement in the near future. There is already broad agreement on the objectives and underlying concept of the Commission's proposal, but given the large number of technical annexes, examination of the text has been a complex task. Major adjustments have been made, including some resulting from amendment proposed by the Parliament and a number of outstanding issues has been considerably reduced in recent months. Practically all of these issues concern technical details.�

• 2002/02/06 Modified legislative proposal published
  • COM(2002)0037 summary

    The European Parliament has made two kinds of modifications to its original proposal in response to the first reading by the European Parliament. The first set serve either to remove ambiguities or else to elaborate further on a specific idea in the original proposal. The second set of changes are a rewording of the text, taking into account issues raised during preliminary discussions in Council. Where necessary editing has been done to ensure consistency between this text and other applicable Community legislation. In terms of scope some of the wording has been clarified in order to specify Member States' obligations on the prescription of legal metrological instruments which need to comply with the Directive. Concerning definitions and essential requirements, the Commission has rejected those amendments which limit the Directive to a subset of measuring instruments, namely those consisting of a set of devices and sub-assemblies. The text as it stands refers to all measuring instruments. The definition of sub-assemblies as well as of authorised representatives has been expanded. At the same time essential requirements in Annex I relating to durability, reliability, suitability and protection have been clarified. Further, the Commission proposes adding a provision concerning the conformity assessment, which allows such assessments to be done according to the degree of precision declared by the manufacturer. On the question of the "Committee for Measuring Instruments", the Commission proposes introducing a regulatory area of activities for the Committee and to shift the tasks earmarked by the European Parliament from the advisory area to the regulatory area. The Commission has also sought to expand and clarify the text. For example, on the suggestion of the European Parliament the Commission has included the option of affixing the required markings at different stages. Similarly, the Commission has clarified the right of Member States to designate notified bodies for instruments in areas covered by the Directive, for which the Member State does not require legal metrological control. Concerning CE markings, it is proposed that in future "CE conformity marking" be replaced by "CE marking" since it is both clear and reduces the amount of text. Instruments sold in batches do not need to be marked separately.�

  • DG [{'url': 'http://ec.europa.eu/enterprise/', 'title': 'Enterprise and Industry'}],
• 2001/07/03 Decision by Parliament, 1st reading/single reading
  • T5-0367/2001 summary

    The proposal was endorsed, without debate, by the European Parliament along with the amendments proposed by the committee reponsible. The rapporteur was Mrs Lisbeth GRÖNFELDT BERGMAN (EPP-ED, S). (Please refer to the previous text). �

• 2001/06/20 Vote in committee, 1st reading/single reading
  • A5-0221/2001
• 2000/10/06 Committee referral announced in Parliament, 1st reading/single reading
• 2000/09/15 Legislative proposal published
  • COM(2000)0566 summary

    PURPOSE : to present the measuring instruments directive. CONTENT : National legislation in respect of measuring instruments are in some cases incompatible with eachother and lead to barriers to trade. Consequently, the Internal Market for measuring instruments must be established by harmonisation of the national legislations. This commenced in 1971, but the existing Community legislation is deficient in many ways. The need for replacement is a direct result of its Old Approach nature and optional character. The specific directives are product directives, containing detailed technical specifications that are too restictive in the current situation of rapidly changing measurement technologies. Continuous updating of the specifications has proved to be impractical. The conformity assessment procedures are generally too restrictive and none of today's modern procedures are offered to the manufacturer. In particular, there is no possibility for the use of an approved and supervised Quality System as an alternative to third party verification of the final products. The optional character of the directives has led to parallel national legislations. The proposed Measuring Instruments Directive will remedy many of the shortcomings described. It is a New Approach Directive aimed at creating an Internal Market for measuring instruments that are subject to legal metrological control, by: - establishing essential requirements and conformity assessment requirements while maintaining the high level of consumer protection existing already, and - establishing mutual recognition among the Member States of the results of the conformity assessment. The essential requirements will be performance requirements, rather than design specifications. The evolution of technology will therefore not require frequent future adaptation of the Directive . The conformity assessment procedures are the modern procedures taken from the Global Approach to testing and certification. They reinforce the role and responsibility of the manufacturer in conformity assessment and have assimilated quality assurance principles. No parallel national regimes of legal control of measuring instruments may exist after the entry into force of this Directive. The legal base is Article 95 of the EC Treaty. The specific directives for the measuring instruments covered are repealed.�

  • DG [{'url': 'http://ec.europa.eu/enterprise/', 'title': 'Enterprise and Industry'}],

Documents

• Legislative proposal published: COM(2000)0566
• Committee report tabled for plenary, 1st reading/single reading: A5-0221/2001
• Decision by Parliament, 1st reading/single reading: T5-0367/2001
• Modified legislative proposal published: COM(2002)0037
• Debate in Council: 2467
• Council position published: 09681/4/2003
• Committee recommendation tabled for plenary, 2nd reading: A5-0458/2003
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 2nd reading: T5-0580/2003
• : Directive 2004/22
• : OJ L 135 30.04.2004, p. 0001-0080

History

(these mark the time of scraping, not the official date of the change)