title: Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (Recast) (Text with EEA relevance)

text:
               28.4.2009

               EN

               Official Journal of the European Union

               L 106/7

      DIRECTIVE 2009/34/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 23 April 2009
   relating to common provisions for both measuring instruments and methods of metrological control
   (Recast)
   (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 Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               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 control (3) has been substantially amended several times (4). Since further amendments are to be made, it should be recast in the interests of clarity.

               (2)

               In each Member State, mandatory provisions determine the technical characteristics of measuring instruments and the methods of metrological control. Those requirements differ from one Member State to another. Those differences hinder trade and may create unequal conditions of competition within the Community.

               (3)

               One of the objectives of controls in each Member State is to give assurance to customers that quantities delivered correspond to the price paid. Consequently, the aim of this Directive should not be to abolish those controls but to eliminate differences between rules in so far as these constitute a hindrance to trade.

               (4)

               Those hindrances to the functioning of the internal market can be reduced and eliminated if the same requirements apply in Member States, initially complementing national provisions in force and later, when the necessary conditions exist, replacing those provisions.

               (5)

               Even during the period when they coexist with national provisions, the Community requirements will enable firms to manufacture products which have uniform technical characteristics and can therefore be marketed and used throughout the Community after they have undergone EC controls.

               (6)

               Community technical requirements for design and functioning should ensure that instruments continuously give measurements that are sufficiently accurate for their intended purpose.

               (7)

               Compliance with technical requirements is usually confirmed by Member States before measuring instruments are placed on the market or used for the first time, and where appropriate when they are in service, such confirmation being effected in particular by means of pattern approval and verification procedures. In order to achieve free movement of such instruments within the Community, it is also necessary to provide for mutual recognition of controls among Member States and to establish appropriate EC pattern approval and initial verification procedures for this purpose as well as EC methods of metrological control in accordance with this Directive and with the relevant separate Directives.

               (8)

               The presence, on a measuring instrument or a product, of signs or marks showing that it has undergone the appropriate controls indicates that such instrument or product satisfies the relevant technical requirements of the Community, and therefore that when the instrument or product is imported or put into operation it is unnecessary to repeat the controls which have already been carried out.

               (9)

               National metrological rules cover numerous categories of measuring instruments and products. This Directive lays down the general provisions dealing, in particular, with EC pattern approval and initial verification procedures, as well as EC methods of metrological control. Implementing Directives covering the various categories of instruments and products will lay down the technical requirements as to design, functioning and accuracy, the control procedures and, where appropriate, the conditions under which Community technical requirements are to replace the national provisions in force.

               (10)

               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 Commission (5).

               (11)

               In particular, the Commission should be empowered to amend Annexes I and II to this Directive and the annexes to the separate Directives. Since those measures are of general scope and are designed to amend non-essential elements of this Directive and the separate Directives, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (12)

               The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.

               (13)

               This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex III, Part B,

         HAVE ADOPTED THIS DIRECTIVE:
   CHAPTER I

      BASIC PRINCIPLES

   Article 1
   1.   This Directive shall apply to:

               (a)

               instruments as defined in paragraph 2;

               (b)

               units of measurement, the harmonisation of methods of measurement and metrological control and, where appropriate, the means required for application of such methods;

               (c)

               the prescription, methods of measurement, metrological control and marking of quantities of pre-packaged products.

         2.   For the purpose of this Directive, ‘instruments’ shall mean measuring instruments, components of measuring instruments, additional devices and measurement equipment.
   3.   No Member State may, on the basis of this Directive and the separate Directives relating to it, prevent, prohibit, or restrict the placing on the market and/or entry into service of an instrument or of a product described in paragraph 1 if that instrument or product bears EC marks and/or signs in accordance with the conditions laid down in this Directive and in the separate Directives relating to the instrument or product in question.
   4.   Member States shall attach the same value to EC pattern approval and initial verification as to the corresponding national measures.
   5.   The separate Directives concerning the matters referred to in paragraph 1 shall specify:

               —

               in particular, the measurement procedures and characteristics of, and the technical requirements for, their design and functioning, as regards the instruments referred to in paragraph 1(a),

               —

               the requirements concerning points (b) and (c) of paragraph 1.

         6.   The separate Directives may fix the date on which the existing national provisions are to be replaced by Community provisions.
   CHAPTER II

      EC PATTERN APPROVAL

   Article 2
   1.   Member States shall grant EC pattern approval in accordance with the provisions of this Directive and of the relevant separate Directives.
   2.   EC pattern approval of instruments shall constitute their admission to EC initial verification and, where the latter is not required, the authorisation to place them on the market and/or to put them into service. If the separate Directive(s) applicable to a category of instruments exempt(s) that category from EC pattern approval, the instruments in that category shall be admitted directly to EC initial verification.
   3.   If their inspection equipment so permits, Member States shall grant EC pattern approval for every instrument which satisfies the requirements laid down in this Directive and the separate Directives relating to the instrument in question.
   4.   An application for EC pattern approval may be made only by the manufacturer or his representative established within the Community. For one and the same instrument, application may be made in one Member State only.
   5.   A Member State which has granted EC pattern approval shall take the necessary steps to ensure that it is kept informed of any modification of, or addition to, the approved pattern. It shall inform the other Member States of such alterations.
   Modifications of, or additions to, an approved pattern must receive additional EC pattern approval from the Member State which granted EC pattern approval, where such changes influence or might influence measurement results or the prescribed conditions for use of the instrument.
   However, in the case of a modified pattern, a new EC pattern approval shall be granted instead of an addition to the original EC pattern approval certificate if the pattern is modified after the provisions of this Directive or of the relevant separate Directive have been amended or adapted in such a way that the modified pattern could be approved only pursuant to the new provisions.
   Article 3
   When EC pattern approval is granted for ancillary equipment, the approval shall specify:

               (a)

               the patterns of instrument to which this equipment may be attached or in which it may be incorporated;

               (b)

               the general conditions for the overall functioning of the instruments for which it is approved.

         Article 4
   When an instrument has successfully completed the EC pattern approval examination laid down in this Directive and in the separate Directives relating to that instrument, the Member State which carried out that examination shall draw up an EC pattern approval certificate.
   That Member State shall forward that certificate to the applicant.
   In the cases provided for in Article 11 of this Directive or in a separate Directive, the applicant must, and in all other cases may, affix or cause to be affixed on each instrument conforming to the approved pattern the EC approval sign shown in the certificate.
   Article 5
   1.   EC pattern approval shall be valid for 10 years. It may be extended for successive periods of 10 years. The number of instruments which may be manufactured in accordance with the approved pattern shall not be limited.
   EC pattern approvals granted on the basis of the provisions of this Directive and of a separate Directive may not be extended after the date of the entry into force of any amendment to, or adaptation of, those Community provisions, in cases where such EC pattern approvals could not have been granted on the basis of the new provisions.
   When EC pattern approval is not extended, that approval shall nevertheless continue to apply to instruments already in service.
   2.   Where use is made of new techniques not provided for in a separate Directive, EC pattern approval with limited effect may be granted, after prior consultation of the other Member States.
   It may include the following restrictions:

               (a)

               a limit on the number of instruments which may be covered by the approval;

               (b)

               an obligation to notify the competent authorities of the places of installation;

               (c)

               restrictions on use;

               (d)

               special restrictions concerning the technique used.

         However, it may not be granted unless:

               (a)

               the separate Directive for that category of instruments has come into force;

               (b)

               no derogation has been made from the maximum permissible errors laid down in the separate Directives.

         The period of validity of such approval shall not exceed two years. It may be extended by up to three years.
   3.   The Member State which has granted the limited EC pattern approval referred to in paragraph 2 shall apply for adjustment to technical progress of Annexes I and II to this Directive, where appropriate, and of the separate Directives, in accordance with the procedure referred to in Article 17(2), as soon as it considers that a new technique has proved to be satisfactory.
   Article 6
   When EC pattern approval is not required for a category of instruments which meets the requirements of a separate Directive, the manufacturer may, on his own responsibility, affix to the instruments in this category the special sign described in point 3.3 of Annex I.
   Article 7
   1.   The Member State which has granted EC pattern approval may withdraw it:

               (a)

               if instruments for which this approval was granted do not conform to the approved pattern or to the provisions of the relevant separate Directive;

               (b)

               if the metrological requirements specified in the certificate of approval or the provisions of Article 5(2) are not met;

               (c)

               if it ascertains that approval was granted in an improper manner.

         2.   The Member State which has granted EC pattern approval must withdraw it if the instruments constructed according to an approved pattern reveal in service a defect of a general nature which makes them unsuitable for their intended use.
   3.   If the Member State which granted an EC pattern approval is informed by another Member State of the occurrence of one of the cases covered by paragraphs 1 and 2, it shall also take the measures provided for in those paragraphs, after consulting with that other Member State.
   4.   The Member State which declares that the case referred to in paragraph 2 has arisen may forbid the placing on the market and putting into service of the instruments concerned until further notice.
   It shall immediately inform the other Member States and the Commission, stating the reasons on which its decision is based.
   The same procedure shall apply in the cases referred to in paragraph 1, with respect to instruments which have been exempted from EC initial verification, if the manufacturer, after due warning, does not bring the instruments into conformity with the approved pattern or with the requirements of the relevant separate Directive.
   5.   If the Member State which granted the EC pattern approval disputes that the case referred to in paragraph 2 of which it has been informed has arisen, or disputes that the measures taken pursuant to paragraph 4 are justified, the Member States concerned shall endeavour to settle the dispute.
   The Commission shall be kept informed. It shall, where necessary, hold appropriate consultations with the aim of reaching a settlement.
   CHAPTER III

      INITIAL VERIFICATION

   Article 8
   1.   EC initial verification constitutes the examination of a new or reconditioned instrument and the confirmation of its conformity to the approved pattern and/or to the requirements of this Directive and the separate Directives relating to the instrument in question. It is certified by the EC initial verification mark.
   2.   EC initial verification of instruments may be carried out by a method other than unit checking in the cases specified in the separate Directives and in accordance with the procedures adopted.
   3.   If their equipment so permits, Member States shall carry out EC initial verification of instruments submitted as having the measurement characteristics and satisfying the technical construction and functioning requirements laid down by the separate Directives relating to that category of instruments.
   4.   In the case of instruments bearing the EC initial verification mark, the obligation imposed on Member States under Article 1(3) shall last until the end of the year following that in which the EC initial verification mark was affixed, unless separate Directives provide for a longer period.
   Article 9
   1.   When an instrument is submitted for EC initial verification, the Member State carrying out the examination shall determine:

               (a)

               whether the instrument belongs to a category exempt from EC pattern approval and, if so, whether it satisfies the technical construction and functioning requirements laid down by the separate Directives relating to that instrument;

               (b)

               whether the instrument has received EC pattern approval and, if so, whether it conforms to the approved pattern, and to the separate Directives relating to that instrument, in force on the date of issue of that EC pattern approval.

         2.   The examination carried out in EC initial verification relates in particular, in accordance with the separate Directives, to:

               (a)

               the metrological characteristics;

               (b)

               the maximum permissible errors;

               (c)

               the construction, in so far as this guarantees that the measurement characteristics are not likely to deteriorate to any great extent under normal conditions of use;

               (d)

               the presence of prescribed inscriptions and stamp plates or provisions for EC initial verification marking.

         Article 10
   When an instrument has successfully undergone EC initial verification, in accordance with the requirements of this Directive and of the separate Directives, the EC partial or final verification marks described in Annex II, point 3 shall be affixed to that instrument under the responsibility of the Member State concerned in accordance with the rules laid down in that point.
   Article 11
   When EC initial verification is not required for a category of instruments which meet the requirements of a separate Directive, the manufacturer shall, on his own responsibility, affix to the instruments in that category the special symbol described in point 3.4 of Annex I.
   CHAPTER IV

      PROVISIONS COMMON TO EC PATTERN APPROVAL AND EC INITIAL VERIFICATION

   Article 12
   Member States shall take all necessary measures to prevent the use on instruments of marks or inscriptions liable to be confused with the EC signs or marks.
   Article 13
   Each Member State shall notify the other Member States and the Commission of the services, agencies and institutes which are duly authorised to carry out the examinations provided for in this Directive and in the separate Directives, to issue the EC pattern approval certificates and to affix the EC initial verification marks.
   Article 14
   Member States may require that the prescribed inscriptions be drawn up in their official language or languages.
   CHAPTER V

      CONTROL OF INSTRUMENTS IN SERVICE

   Article 15
   The separate Directives shall specify the control requirements for instruments in service which bear EC signs or marks and in particular the maximum errors permitted in service. If national provisions in respect of instruments which do not bear EC signs or marks lay down less stringent requirements, the latter may serve as criteria for the controls.
   CHAPTER VI

      ADJUSTMENT OF DIRECTIVES TO TECHNICAL PROGRESS

   Article 16
   The amendments necessary for adjusting to technical progress Annexes I and II to this Directive and the annexes to the separate Directives referred to in Article 1 shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive and the separate Directives, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 17(2).
   However, this procedure shall apply neither to the chapter relating to imperial units of measurement of the annex to the Directive on units of measurement nor to the annexes, concerning quantity ranges for pre-packed quantities of products, to the Directives on pre-packed products.
   Article 17
   1.   The Commission shall be assisted by the Committee for Adjustment to Technical Progress of the Directives referred to in Article 16.
   2.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   CHAPTER VII

      FINAL PROVISIONS

   Article 18
   All decisions taken pursuant to the provisions adopted in implementation of this Directive and of the separate Directives on the instruments in question and refusing to grant or extend EC pattern approval, withdrawing such approval, refusing to carry out EC initial verification or prohibiting placing on the market or entry into service shall state the reasons on which they are based. Such refusal, withdrawal or prohibition shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies.
   Article 19
   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 20
   Directive 71/316/EEC, as amended by the acts listed in Annex III, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex III, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.
   Article 21
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 22
   This Directive is addressed to the Member States.

      Done at Strasbourg, 23 April 2009.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         P. NEČAS

      (1)  Opinion of 22 October 2008 (not yet published in the Official Journal).

      (2)  Opinion of the European Parliament of 4 December 2008 (not yet published in the Official Journal) and Council Decision of 23 March 2009.

      (3)  OJ L 202, 6.9.1971, p. 1.

      (4)  See Annex III, Part A.

      (5)  OJ L 184, 17.7.1999, p. 23.

      ANNEX I

         EC PATTERN APPROVAL

      1.   Application for EC approval

                  1.1.

                  The application and the correspondence relating to it shall be drawn up in an official language in accordance with the laws of the Member State to which the application is made. The Member State has the right to require that the annexed documents should also be written in the same official language.
                  The applicant shall send simultaneously to all Member States a copy of his application.

                  1.2.

                  The application shall contain the following information:

                              (a)

                              the name and address of the manufacturer or the firm, or of his or its authorised representative or of the applicant;

                              (b)

                              the category of instrument;

                              (c)

                              the intended use;

                              (d)

                              the measurement characteristics;

                              (e)

                              the commercial designation, if any, or the type.

                  1.3.

                  The application shall be accompanied by the documents necessary for its evaluation, in duplicate, and in particular:

                              1.3.1.

                              a description in particular of:

                                          (a)

                                          the construction and operation of the instrument;

                                          (b)

                                          the protecting arrangements ensuring correct working;

                                          (c)

                                          the devices for regulation and adjustment;

                                          (d)

                                          the intended locations for:

                                                      —

                                                      verification marks,

                                                      —

                                                      seals (where applicable);

                              1.3.2.

                              general arrangement drawings and, where necessary, detailed drawings of important components;

                              1.3.3.

                              a schematic drawing illustrating the principles of operation and, where necessary, a photograph.

                  1.4.

                  The application shall be accompanied, where appropriate, by documents relevant to the national approvals already granted.

            2.   Examination for EC approval

                  2.1.

                  The examination shall comprise:

                              2.1.1.

                              a study of the documents and an examination of the measurement characteristics of the pattern in the laboratories of the metrological service, in approved laboratories or at the place of manufacture, delivery or installation;

                              2.1.2.

                              if the measurement characteristics of the pattern are known in detail, only an examination of the documents submitted.

                  2.2.

                  The examination shall cover the entire performance of the instrument under normal conditions of use. Under such conditions, that instrument must maintain the measurement characteristics required.

                  2.3.

                  The nature and scope of the examination mentioned in point 2.1 may be specified by separate Directives.

                  2.4.

                  The metrological service may require the applicant to put at its disposal the standards and the appropriate means in terms of material and assisting personnel for the performance of the approval tests.

            3.   EC certificate and sign of approval

                  3.1.

                  The certificate shall give the results of the examination of the pattern and shall specify the other requirements which must be complied with. It shall be accompanied by descriptions, drawings and diagrams necessary to identify the pattern and to explain its functioning. The sign of approval provided for in Article 4 shall be a stylised letter ε containing:

                              —

                              in the upper part, the distinguishing capital letter(s) of the Member State which granted the approval (B for Belgium, BG for Bulgaria, CZ for the Czech Republic, DK for Denmark, D for Germany, EST for Estonia, IRL for Ireland, EL for Greece, E for Spain, F for France, I for Italy, CY for Cyprus, LV for Latvia, LT for Lithuania, L for Luxembourg, H for Hungary, M for Malta, NL for Netherlands, A for Austria, PL for Poland, P for Portugal, RO for Romania, SI for Slovenia, SK for Slovakia, FI for Finland, S for Sweden, UK for the United Kingdom) and the last two digits of the year of approval,

                              —

                              in the lower part, a designation to be determined by the metrological service which granted approval (an identification number).

                        An example of this approval sign is shown in point 6.1.

                  3.2.

                  In the case of EC limited approval, the letter P, having the same dimensions as the stylised letter ε, shall be placed before this letter.
                  An example of this limited approval sign is shown in point 6.2.

                  3.3.

                  The sign mentioned in Article 6 is the same as the EC approval sign, except that the stylised letter ε is reversed symmetrically about a vertical axis and bears no other indication unless the separate Directives stipulate otherwise.
                  An example of this sign is shown in point 6.3.

                  3.4.

                  The sign mentioned in Article 11 is the same as the EC approval sign in a hexagon.
                  An example of this sign is shown in point 6.4.

                  3.5.

                  The signs mentioned in points 3.1 to 3.4 and affixed by the manufacturer in accordance with the provisions of this Directive must be affixed at a visible point of each instrument and all ancillary equipment submitted for verification, and must be legible and indelible. If their affixation presents technical difficulties, exceptions may be made in separate Directives or accepted after agreement among the metrological services of Member States has been reached.

            4.   Depositing of a sample instrument
      In the cases mentioned by separate Directives, the service which granted the approval may, if it considers this necessary, request the deposition of the sample instrument for which approval has been granted. Instead of that sample instrument, the service may authorise the depositing of parts of the instrument, of scale models or of drawings, and will mention this on the EC certificate of approval.
      5.   Announcement of approval

                  5.1.

                  At the same time as the party concerned is notified, copies of the EC certificate of approval shall be sent to the Commission and to the other Member States; the latter can also obtain copies of the reports of the metrological examinations if they wish.

                  5.2.

                  Withdrawal of EC pattern approval and other communications concerning the extent and validity of EC pattern approval shall also be subject to the announcement procedure mentioned in point 5.1.

                  5.3.

                  A Member State which refuses to grant EC pattern approval shall inform the other Member States and the Commission of its decision.

            6.   Signs relative to EC pattern approval

                  6.1.

                  Sign of EC pattern approval

                              Example:

                              EC pattern approval granted by the Metrological Service of Germany in 1971 (see point 3.1, first indent).
                              Identification number of the EC pattern approval (see point 3.1, second indent).

                  6.2.

                  Sign of EC limited pattern approval (see point 3.2)

                              Example:

                              EC limited pattern approval granted by the Metrological Service of Germany in 1971.
                              Identification number of the EC limited pattern approval.

                  6.3.

                  Sign of exemption from EC pattern approval (see point 3.3)

                              Example:

                  6.4.

                  Sign of EC pattern approval for instruments exempt from EC initial verification (see point 3.4)

                              Example:

                              EC pattern approval granted by the Metrological Service of Germany in 1971.
                              Identification number of the EC pattern approval.

      ANNEX II
      EC INITIAL VERIFICATION
      1.   General points

                  1.1.

                  The EC initial verification may be carried out in one or more stages (usually two).

                  1.2.

                  Subject to the provisions of the separate Directives:

                              1.2.1.

                              the EC initial verification shall be carried out in one stage on instruments which constitute a whole on leaving the factory, that is to say instruments which, theoretically, can be transferred to their place of installation without first having to be dismantled;

                              1.2.2.

                              the EC initial verification shall be carried out in two or more stages for instruments the correct functioning of which depends on the conditions in which they are installed or used;

                              1.2.3.

                              the first stage of the verification procedure must ensure, in particular, that the instrument conforms to the approved EC pattern or, in the case of instruments exempt from pattern approval, that they conform to the relevant provisions.

            2.   Place of the EC initial verification

                  2.1.

                  If the separate Directives do not specify the place where verification is to be carried out, instruments which have to be verified in only one stage shall be verified at the place chosen by the metrological service concerned.

                  2.2.

                  Instruments which have to be verified in two or more stages shall be verified by the metrological service territorially competent.

                              2.2.1.

                              The last stage of verification must be carried out at the place of installation.

                              2.2.2.

                              The other stages of verification shall be carried out as laid down in point 2.1.

                  2.3.

                  In particular, when the verification takes place outside the office of verification the metrological service carrying out the verification may require the applicant:

                              —

                              to put at its disposal the standards and the appropriate means in terms of material and assisting personnel for the performance of the verification,

                              —

                              to provide a copy of the EC certificate of approval.

            3.   EC initial verification marks
      3.1.   Description of EC initial verification marks

                  3.1.1.

                  Subject to the provisions of separate Directives, EC initial verification marks which are affixed in accordance with point 3.3 shall be as follows:

                              3.1.1.1.

                              the final EC verification mark shall be composed of two stamps:

                                          (a)

                                          the first consists of a lower-case letter ‘e’ containing:

                                                      —

                                                      in the upper half, the distinguishing capital letter(s) of the Member State where the original check is carried out (B for Belgium, BG for Bulgaria, CZ for the Czech Republic, DK for Denmark, D for Germany, EST for Estonia, IRL for Ireland, EL for Greece, E for Spain, F for France, I for Italy, CY for Cyprus, LV for Latvia, LT for Lithuania, L for Luxembourg, H for Hungary, M for Malta, NL for Netherlands, A for Austria, PL for Poland, P for Portugal, RO for Romania, SI for Slovenia, SK for Slovakia, FI for Finland, S for Sweden, UK for the United Kingdom) together, where necessary, with one or two figures identifying a territorial or administrative subdivision,

                                                      —

                                                      in the lower half, the identification number of the verifying agent or office;

                                          (b)

                                          the second stamp shall consist of the last two digits of the year of the verification, in a hexagon;

                              3.1.1.2.

                              the mark of EC partial verification shall consist solely of the first stamp. It shall also serve as a seal.

            3.2.   Shape and dimensions of marks

                  3.2.1.

                  The attached drawings show the shape, dimensions and outline of the letters and numbers for the EC initial verification marks as laid down in point 3.1; the first two drawings show the various parts of the stamp and the third is an example of a stamp. The dimensions given in the drawings are relative values; they are a function of the diameter of the circle described about the lower-case letter ‘e’ and about the field of the hexagon.
                  The actual diameters of the circles described about the marks are 1,6 mm, 3,2 mm, 6,3 mm, 12,5 mm.

                  3.2.2.

                  The metrological services of Member States shall mutually exchange the original drawings of the EC initial verification marks, conforming to the models in the annexed drawings.

            3.3.   Affixing the marks

                  3.3.1.

                  The final EC verification mark shall be affixed at the appointed location on the instrument when the latter has been completely verified and is recognised to conform to EC requirements.

                  3.3.2.

                  The partial EC verification mark shall be affixed:

                              3.3.2.1.

                              when verification is made in several stages, on the instrument or part of an instrument which fulfils the conditions laid down for operations other than those at the place of installation, at the place where the stamp-date is affixed or in any other place specified in the separate Directives;

                              3.3.2.2.

                              in all cases as a seal, in the places specified in the separate Directives.

      ANNEX III

         PART A

         Repealed Directive with list of its successive amendments

      (referred to in Article 20)

                  Council Directive 71/316/EEC
                  (OJ L 202, 6.9.1971, p. 1).

                  1972 Act of Accession, Annex I, point X.12
                  (OJ L 73, 27.3.1972, p. 118).

                  Council Directive 72/427/EEC
                  (OJ L 291, 28.12.1972, p. 156).

                  1979 Act of Accession, Annex I, point X.A
                  (OJ L 291, 19.11.1979, p. 108).

                  Council Directive 83/575/EEC
                  (OJ L 332, 28.11.1983, p. 43).

                  1985 Act of Accession, Annex I, point IX.A.7
                  (OJ L 302, 15.11.1985, p. 212).

                  Council Directive 87/354/EEC
                  (OJ L 192, 11.7.1987, p. 43).

                  Only as regards references made to Directive 71/316/EEC in Article 1 and Annex, point 4

                  Council Directive 87/355/EEC
                  (OJ L 192, 11.7.1987, p. 46).

                  Council Directive 88/665/EEC
                  (OJ L 382, 31.12.1988, p. 42).

                  Only Article 1(1)

                  1994 Act of Accession, Annex I, point XI.C.VII.1
                  (OJ C 241, 29.8.1994, p. 211).

                  Council Regulation (EC) No 807/2003
                  (OJ L 122, 16.5.2003, p. 36).

                  Only Annex III, point 5

                  2003 Act of Accession, Annex II, point I.D.1
                  (OJ L 236, 23.9.2003, p. 64).

                  Council Directive 2006/96/EC
                  (OJ L 363, 20.12.2006, p. 81).

                  Only as regards references made to Directive 71/316/EEC in Article 1 and Annex, point B.1

                  Commission Directive 2007/13/EC
                  (OJ L 73, 13.3.2007, p. 10).

         PART B

         Time limits for transposition into national law

      (referred to in Article 20)

                  Directive

                  Time limit for transposition

                  71/316/EEC

                  30 January 1973

                  83/575/EEC

                  1 January 1985

                  87/354/EEC

                  31 December 1987

                  87/355/EEC

                  31 December 1987

                  2006/96/EC

                  1 January 2007

                  2007/13/EC

                  9 March 2008

      ANNEX IV

         CORRELATION TABLE

                  Directive 71/316/EEC

                  This Directive

                  Article 1(1)(a)

                  Article 1(1), point (a) and Article 1(2)

                  Article 1(1)(b)

                  Article 1(1), point (b)

                  Article 1(1)(c)

                  Article 1(1), point (c)

                  Article 1(2)

                  Article 1(3)

                  Article 1(3)

                  Article 1(4)

                  Article 1(4), first subparagraph

                  Article 1(5)

                  Article 1(4), second subparagraph

                  Article 1(6)

                  Article 2(1)

                  Article 2(2)

                  Article 2(2)

                  Article 2(3)

                  Article 2(3)

                  Article 2(4)

                  Article 2(4)

                  Article 2(5)

                  Article 2(5)

                  Article 2(1)

                  Article 3, introductory wording

                  Article 3, introductory wording

                  Article 3, first indent

                  Article 3, point (a)

                  Article 3, second indent

                  Article 3, point (b)

                  Article 4, first sentence

                  Article 4, first and second paragraphs

                  Article 4, second sentence

                  Article 4, third paragraph

                  Article 5(1)

                  Article 5(1)

                  Article 5(2), first subparagraph

                  Article 5(2), first subparagraph

                  Article 5(2), second subparagraph, introductory wording

                  Article 5(2), second subparagraph, introductory wording

                  Article 5(2), second subparagraph, first indent

                  Article 5(2), second subparagraph, point (a)

                  Article 5(2), second subparagraph, second indent

                  Article 5(2), second subparagraph, point (b)

                  Article 5(2), second subparagraph, third indent

                  Article 5(2), second subparagraph, point (c)

                  Article 5(2), second subparagraph, fourth indent

                  Article 5(2), second subparagraph, point (d)

                  Article 5(2), third subparagraph, introductory wording

                  Article 5(2), third subparagraph, introductory wording

                  Article 5(2), third subparagraph, first indent

                  Article 5(2), third subparagraph, point (a)

                  Article 5(2), third subparagraph, second indent

                  Article 5(2), third subparagraph, point (b)

                  Article 5(2), fourth subparagraph

                  Article 5(2), fourth subparagraph

                  Article 5(3)

                  Article 5(3)

                  Article 6

                  Article 6

                  Article 7(1), (2) and (3)

                  Article 7(1), (2) and (3)

                  Article 7(4), first sentence

                  Article 7(4), first subparagraph

                  Article 7(4), second sentence

                  Article 7(4), second subparagraph

                  Article 7(4), third sentence

                  Article 7(4), third subparagraph

                  Article 7(5)

                  Article 7(5)

                  Article 8(1), point (a)

                  Article 8(1)

                  Article 8(1), point (b)

                  Article 8(2)

                  Article 8(2)

                  Article 8(3)

                  Article 8(3)

                  Article 8(4)

                  Article 9(1)

                  Article 9(1)

                  Article 9(2), introductory wording

                  Article 9(2), introductory wording

                  Article 9(2), first indent

                  Article 9(2), point (a)

                  Article 9(2), second indent

                  Article 9(2), point (b)

                  Article 9(2), third indent

                  Article 9(2), point (c)

                  Article 9(2), fourth indent

                  Article 9(2), point (d)

                  Articles 10 and 11

                  Articles 10 and 11

                  Articles 12, 13 and 14

                  Articles 12, 13 and 14

                  Article 15

                  Article 15

                  Article 16, first sentence

                  Article 16, first paragraph

                  Article 16, second sentence

                  Article 16, second paragraph

                  Article 17

                  —

                  Article 18(1)

                  Article 17(1)

                  Article 18(2), first subparagraph

                  Article 17(2)

                  Article 18(2), second subparagraph

                  —

                  Article 18(3)

                  —

                  Article 19

                  Article 18

                  Article 20(1)

                  —

                  Article 20(2)

                  Article 19

                  —

                  Articles 20 and 21

                  Article 21

                  Article 22

                  Annex I

                  Annex I

                  Points 1 and 1.1

                  Points 1 and 1.1

                  Point 1.2, introductory wording

                  Point 1.2, introductory wording

                  Point 1.2, first indent

                  Point 1.2(a)

                  Point 1.2, second indent

                  Point 1.2(b)

                  Point 1.2, third indent

                  Point 1.2(c)

                  Point 1.2, fourth indent

                  Point 1.2(d)

                  Point 1.2, fifth indent

                  Point 1.2(e)

                  Point 1.3

                  Point 1.3

                  Point 1.3.1, introductory wording

                  Point 1.3.1, introductory wording

                  Point 1.3.1, first indent

                  Point 1.3.1(a)

                  Point 1.3.1, second indent

                  Point 1.3.1(b)

                  Point 1.3.1, third indent

                  Point 1.3.1(c)

                  Point 1.3.1, fourth indent

                  Point 1.3.1(d)

                  Point 1.3.2 to Point 5

                  Point 1.3.2 to Point 5

                  Point 5.2

                  Point 5.1

                  Point 5.3

                  Point 5.2

                  Point 5.4

                  Point 5.3

                  Point 6 to Point 6.4

                  Point 6 to Point 6.4

                  Annex II

                  Annex II

                  —

                  Annex III

                  —

                  Annex IV


Avis juridique important

|

31987L0018

Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances

Official Journal L 015 , 17/01/1987 P. 0029 - 0030 Finnish special edition: Chapter 15 Volume 7 P. 0195  Swedish special edition: Chapter 15 Volume 7 P. 0195

*****COUNCIL  DIRECTIVE  of 18 December 1986  on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances  (87/18/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (3), as last amended by Directive 84/449/EEC (4), requires tests to be carried out on chemical substances in order to enable their potential risk to man and the environment to be determined;  Whereas Directive 75/318/EEC (5) as amended by Directive 87/19/EEC (6), and Directive 81/852/EEC (7) as amended by Directive 87/20/EEC (8) lay down that non-clinical tests on pharmaceutical products shall be carried out in accordance with the principles of good laboratory practice in force in the Community for chemical substances;  Whereas when the active substances in pesticides undergo tests they shall do so in accordance with the protocols provided for by Directive 67/548/EEC, and hence in accordance with good laboratory practice for chemical substances;  Whereas the methods to be used for these tests are laid down in Annex V to Directive 67/548/EEC;  Whereas it is necessary to comply with the principles of good laboratory practice in carrying out the tests laid down by Directive 67/548/EEC so as to ensure that the results are comparable and of high quality;  Whereas the Commission intends shortly to submit a proposal to the Council for a Directive aiming at verifying compliance with the principles of good laboratory practice;  Whereas the resources devoted to the tests must not be wasted by having to repeat tests owing to differences in laboratory practice from one Member State to another;  Whereas the Council of the Organization for Economic Cooperation and Development (OECD) took a Decision on 12 May 1981 on the mutual acceptance of data for the evaluation of chemical products; whereas it issued a recommendation on 26 July 1983 concerning the mutual recognition of compliance with good laboratory practice;  Whereas animal protection requires that the number of experiments conducted on animals be restricted; whereas mutual recognition of the results of tests obtained using standard and recognized methods is an essential condition for reducing the number of experiments in this area;  Whereas it is necessary to set up a procedure allowing rapid adaptation of the principles of good laboratory practice,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. Member States shall take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice specified in Annex 2 to the Decision of 12 May 1981 of the Council of the OECD on the mutual acceptance of data for the evaluation of chemical products.  2. Paragraph 1 shall apply also where other Community provisions provide for the application of the principles of good laboratory practice in respect of tests on chemical products to evaluate their safety for man and/or the environment.  Article 2  When submitting results, the laboratories referred to in Article 1 must certify that the tests have been carried out in conformity with the principles of good laboratory practice referred to in that Article.  Article 3  1. Member States shall adopt the measures necessary for verification of compliance with the principles of good laboratory practice. These measures shall include, in particular, inspections and study checks in accordance with the recommendations of the OECD in this area.  2. Member States shall notify to the Commission the name or names of the authority or authorities responsible for verifying compliance with the principles of good laboratory practice, as referred to in paragraph 1. The Commission shall inform the other Member States thereof.  Article 4  Adaptations to the principles of good laboratory practice mentioned in Article 1 may be adopted in accordance with the procedure laid down in Article 21 of Directive 67/548/EEC.  Article 5  1. Where Community provisions require application of the principles of good laboratory practice following the entry into force of this Directive for tests on chemical products, Member States may not, on grounds relating to the principles of good laboratory practice, prohibit, restrict or impede the placing on the market of chemical products if the principles applied by the laboratories concerned are in conformity with those mentioned in Article 1.  2. Should a Member State establish on the basis of detailed evidence that the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances show that, although a chemical substance has been examined in accordance with the requirements of this Directive, it presents a danger to man and the environment, the Member State may provisionally prohibit or make subject to special conditions the marketing of that substance on its territory. It shall immediately inform the Commission and the other Member States thereof and give the grounds for its decision.  The Commission shall, within six weeks, consult the Member States concerned and then give its opinion and take suitable measures without delay.  Should the Commission consider that technical adaptations to this Directive are necessary, those adaptations shall be adopted either by the Commission or by the Council in accordance with the procedure laid down in Article 4. In that case, the Member State which adopted the safeguard measures may maintain them until entry into force of those adaptations.  Article 6  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 1988. They shall forthwith inform the Commission thereof.  Article 7  This Directive is addressed to the Member States.  Done at Brussels, 18 December 1986.  For the Council  The President  M. JOPLING  (1) OJ No C 120, 20. 5. 1986, p. 177.  (2) OJ No C 354, 31. 12. 1985, p. 5.  (3) OJ No 196, 16. 8. 1967, p. 1.  (4) OJ No L 251, 19. 9. 1984, p. 1.  (5) OJ No L 147, 9. 6. 1975, p. 1.  (6) See page 31 of this Official Journal.  (7) OJ No L 317, 6. 11. 1981, p. 16.  (8) See page 34 of this Official Journal.


title: Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (codified version)   (Text with EEA relevance)

text:
               27.12.2006

               EN

               Official Journal of the European Union

               L 376/21

      DIRECTIVE 2006/114/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 12 December 2006
   concerning misleading and comparative advertising
   (codified version)
   (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 Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Council Directive 84/450/EEC of 10 September 1984 concerning misleading and comparative advertising (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Directive should be codified.

               (2)

               The laws against misleading advertising in force in the Member States differ widely. Since advertising reaches beyond the frontiers of individual Member States, it has a direct effect on the smooth functioning of the internal market.

               (3)

               Misleading and unlawful comparative advertising can lead to distortion of competition within the internal market.

               (4)

               Advertising, whether or not it induces a contract, affects the economic welfare of consumers and traders.

               (5)

               The differences between the laws of the Member States on advertising which misleads business hinder the execution of advertising campaigns beyond national boundaries and thus affect the free circulation of goods and provision of services.

               (6)

               The completion of the internal market means a wide range of choice. Given that consumers and traders can and must make the best possible use of the internal market, and that advertising is a very important means of creating genuine outlets for all goods and services throughout the Community, the basic provisions governing the form and content of comparative advertising should be uniform and the conditions of the use of comparative advertising in the Member States should be harmonised. If these conditions are met, this will help demonstrate objectively the merits of the various comparable products. Comparative advertising can also stimulate competition between suppliers of goods and services to the consumer's advantage.

               (7)

               Minimum and objective criteria for determining whether advertising is misleading should be established.

               (8)

               Comparative advertising, when it compares material, relevant, verifiable and representative features and is not misleading, may be a legitimate means of informing consumers of their advantage. It is desirable to provide a broad concept of comparative advertising to cover all modes of comparative advertising.

               (9)

               Conditions of permitted comparative advertising, as far as the comparison is concerned, should be established in order to determine which practices relating to comparative advertising may distort competition, be detrimental to competitors and have an adverse effect on consumer choice. Such conditions of permitted advertising should include criteria of objective comparison of the features of goods and services.

               (10)

               The international conventions on copyright as well as the national provisions on contractual and non-contractual liability should apply when the results of comparative tests carried out by third parties are referred to or reproduced in comparative advertising.

               (11)

               The conditions of comparative advertising should be cumulative and respected in their entirety. In accordance with the Treaty, the choice of forms and methods for the implementation of these conditions should be left to the Member States, insofar as those forms and methods are not already determined by this Directive.

               (12)

               These conditions should include, in particular, consideration of the provisions resulting from Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (5), and in particular Article 13 thereof, and of the other Community provisions adopted in the agricultural sphere.

               (13)

               Article 5 of First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks (6) confers exclusive rights on the proprietor of a registered trade mark, including the right to prevent all third parties from using, in the course of trade, any sign which is identical to, or similar to, the trade mark in relation to identical goods or services or even, where appropriate, other goods.

               (14)

               It may, however, be indispensable, in order to make comparative advertising effective, to identify the goods or services of a competitor, making reference to a trade mark or trade name of which the latter is the proprietor.

               (15)

               Such use of another's trade mark, trade name or other distinguishing marks does not breach this exclusive right in cases where it complies with the conditions laid down by this Directive, the intended target being solely to distinguish between them and thus to highlight differences objectively.

               (16)

               Persons or organisations regarded under national law as having a legitimate interest in the matter should have facilities for initiating proceedings against misleading and unlawful comparative advertising, either before a court or before an administrative authority which is competent to decide upon complaints or to initiate appropriate legal proceedings.

               (17)

               The courts or administrative authorities should have powers enabling them to order or obtain the cessation of misleading and unlawful comparative advertising. In certain cases it may be desirable to prohibit misleading and unlawful comparative advertising even before it is published. However, this in no way implies that Member States are under an obligation to introduce rules requiring the systematic prior vetting of advertising.

               (18)

               The voluntary control exercised by self-regulatory bodies to eliminate misleading or unlawful comparative advertising may avoid recourse to administrative or judicial action and ought therefore to be encouraged.

               (19)

               While it is for national law to determine the burden of proof, it is appropriate to enable courts and administrative authorities to require traders to produce evidence as to the accuracy of factual claims they have made.

               (20)

               Regulating comparative advertising is necessary for the smooth functioning of the internal market. Action at Community level is therefore required. The adoption of a Directive is the appropriate instrument because it lays down uniform general principles while allowing the Member States to choose the form and appropriate method by which to attain these objectives. It is in accordance with the principle of subsidiarity.

               (21)

               This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives as set out in Part B of Annex I,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   The purpose of this Directive is to protect traders against misleading advertising and the unfair consequences thereof and to lay down the conditions under which comparative advertising is permitted.
   Article 2
   For the purposes of this Directive:

               (a)

               ‘advertising’ means the making of a representation in any form in connection with a trade, business, craft or profession in order to promote the supply of goods or services, including immovable property, rights and obligations;

               (b)

               ‘misleading advertising’ means any advertising which in any way, including its presentation, deceives or is likely to deceive the persons to whom it is addressed or whom it reaches and which, by reason of its deceptive nature, is likely to affect their economic behaviour or which, for those reasons, injures or is likely to injure a competitor;

               (c)

               ‘comparative advertising’ means any advertising which explicitly or by implication identifies a competitor or goods or services offered by a competitor;

               (d)

               ‘trader’ means any natural or legal person who is acting for purposes relating to his trade, craft, business or profession and anyone acting in the name of or on behalf of a trader;

               (e)

               ‘code owner’ means any entity, including a trader or group of traders, which is responsible for the formulation and revision of a code of conduct and/or for monitoring compliance with the code by those who have undertaken to be bound by it.

         Article 3
   In determining whether advertising is misleading, account shall be taken of all its features, and in particular of any information it contains concerning:

               (a)

               the characteristics of goods or services, such as their availability, nature, execution, composition, method and date of manufacture or provision, fitness for purpose, uses, quantity, specification, geographical or commercial origin or the results to be expected from their use, or the results and material features of tests or checks carried out on the goods or services;

               (b)

               the price or the manner in which the price is calculated, and the conditions on which the goods are supplied or the services provided;

               (c)

               the nature, attributes and rights of the advertiser, such as his identity and assets, his qualifications and ownership of industrial, commercial or intellectual property rights or his awards and distinctions.

         Article 4
   Comparative advertising shall, as far as the comparison is concerned, be permitted when the following conditions are met:

               (a)

               it is not misleading within the meaning of Articles 2(b), 3 and 8(1) of this Directive or Articles 6 and 7 of Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (‘Unfair Commercial Practices Directive’) (7);

               (b)

               it compares goods or services meeting the same needs or intended for the same purpose;

               (c)

               it objectively compares one or more material, relevant, verifiable and representative features of those goods and services, which may include price;

               (d)

               it does not discredit or denigrate the trade marks, trade names, other distinguishing marks, goods, services, activities or circumstances of a competitor;

               (e)

               for products with designation of origin, it relates in each case to products with the same designation;

               (f)

               it does not take unfair advantage of the reputation of a trade mark, trade name or other distinguishing marks of a competitor or of the designation of origin of competing products;

               (g)

               it does not present goods or services as imitations or replicas of goods or services bearing a protected trade mark or trade name;

               (h)

               it does not create confusion among traders, between the advertiser and a competitor or between the advertiser's trade marks, trade names, other distinguishing marks, goods or services and those of a competitor.

         Article 5
   1.   Member States shall ensure that adequate and effective means exist to combat misleading advertising and enforce compliance with the provisions on comparative advertising in the interests of traders and competitors.
   Such means shall include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in combating misleading advertising or regulating comparative advertising may:

               (a)

               take legal action against such advertising;
               or

               (b)

               bring such advertising before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings.

         2.   It shall be for each Member State to decide which of the facilities referred to in the second subparagraph of paragraph 1 shall be available and whether to enable the courts or administrative authorities to require prior recourse to other established means of dealing with complaints, including those referred to in Article 6.
   It shall be for each Member State to decide:

               (a)

               whether these legal facilities may be directed separately or jointly against a number of traders from the same economic sector;
               and

               (b)

               whether these legal facilities may be directed against a code owner where the relevant code promotes non-compliance with legal requirements.

         3.   Under the provisions referred to in paragraphs 1 and 2, Member States shall confer upon the courts or administrative authorities powers enabling them, in cases where they deem such measures to be necessary taking into account all the interests involved and in particular the public interest:

               (a)

               to order the cessation of, or to institute appropriate legal proceedings for an order for the cessation of, misleading advertising or unlawful comparative advertising;
               or

               (b)

               if the misleading advertising or unlawful comparative advertising has not yet been published but publication is imminent, to order the prohibition of, or to institute appropriate legal proceedings for an order for the prohibition of, such publication.

         The first subparagraph shall apply even where there is no proof of actual loss or damage or of intention or negligence on the part of the advertiser.
   Member States shall make provision for the measures referred to in the first subparagraph to be taken under an accelerated procedure either with interim effect or with definitive effect, at the Member States' discretion.
   4.   Member States may confer upon the courts or administrative authorities powers enabling them, with a view to eliminating the continuing effects of misleading advertising or unlawful comparative advertising, the cessation of which has been ordered by a final decision:

               (a)

               to require publication of that decision in full or in part and in such form as they deem adequate;

               (b)

               to require in addition the publication of a corrective statement.

         5.   The administrative authorities referred to in point (b) of the second subparagraph of paragraph 1 must:

               (a)

               be composed so as not to cast doubt on their impartiality;

               (b)

               have adequate powers, where they decide on complaints, to monitor and enforce the observance of their decisions effectively;

               (c)

               normally give reasons for their decisions.

         6.   Where the powers referred to in paragraphs 3 and 4 are exercised exclusively by an administrative authority, reasons for its decisions shall always be given. In this case, provision must be made for procedures whereby improper or unreasonable exercise of its powers by the administrative authority or improper or unreasonable failure to exercise the said powers can be the subject of judicial review.
   Article 6
   This Directive does not exclude the voluntary control, which Member States may encourage, of misleading or comparative advertising by self-regulatory bodies and recourse to such bodies by the persons or organisations referred to in the second subparagraph of Article 5(1) on condition that proceedings before such bodies are additional to the court or administrative proceedings referred to in that Article.
   Article 7
   Member States shall confer upon the courts or administrative authorities powers enabling them in the civil or administrative proceedings referred to in Article 5:

               (a)

               to require the advertiser to furnish evidence as to the accuracy of factual claims in advertising if, taking into account the legitimate interest of the advertiser and any other party to the proceedings, such a requirement appears appropriate on the basis of the circumstances of the particular case and in the case of comparative advertising to require the advertiser to furnish such evidence in a short period of time;
               and

               (b)

               to consider factual claims as inaccurate if the evidence demanded in accordance with point (a) is not furnished or is deemed insufficient by the court or administrative authority.

         Article 8
   1.   This Directive shall not preclude Member States from retaining or adopting provisions with a view to ensuring more extensive protection, with regard to misleading advertising, for traders and competitors.
   The first subparagraph shall not apply to comparative advertising as far as the comparison is concerned.
   2.   The provisions of this Directive shall apply without prejudice to Community provisions on advertising for specific products and/or services or to restrictions or prohibitions on advertising in particular media.
   3.   The provisions of this Directive concerning comparative advertising shall not oblige Member States which, in compliance with the provisions of the Treaty, maintain or introduce advertising bans regarding certain goods or services, whether imposed directly or by a body or organisation responsible, under the law of the Member States, for regulating the exercise of a commercial, industrial, craft or professional activity, to permit comparative advertising regarding those goods or services. Where these bans are limited to particular media, this Directive shall apply to the media not covered by these bans.
   4.   Nothing in this Directive shall prevent Member States, in compliance with the provisions of the Treaty, from maintaining or introducing bans or limitations on the use of comparisons in the advertising of professional services, whether imposed directly or by a body or organisation responsible, under the law of the Member States, for regulating the exercise of a professional activity.
   Article 9
   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 10
   Directive 84/450/EEC is hereby repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives, as set out in Part B of Annex I.
   References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table set out in Annex II.
   Article 11
   This Directive shall enter into force on 12 December 2007.
   Article 12
   This Directive is addressed to the Member States.

      Done at Strasbourg, 12 December 2006.

            For the European Parliament

            The President

         J. BORRELL FONTELLES

            For the Council

            The President

         M. PEKKARINEN

      (1)  Opinion of 26 October 2006 (not yet published in the Official Journal).

      (2)  Opinion of the European Parliament of 12 October 2006 (not yet published in the Official Journal) and Council Decision of 30 November 2006.

      (3)  OJ L 250, 19.9.1984, p. 17. Directive as last amended by Directive 2005/29/EC of the European Parliament and of the Council (OJ L 149, 11.6.2005, p. 22).

      (4)  See Annex I, Part A.

      (5)  OJ L 93, 31.3.2006, p. 12.

      (6)  OJ L 40, 11.2.1989, p. 1. Directive as amended by Decision 92/10/EEC (OJ L 6, 11.1.1992, p. 35).

      (7)  OJ L 149, 11.6.2005, p. 22.

      ANNEX I
      PART A
      Repealed Directive with its successive amendments

                  Council Directive 84/450/EEC
                  (OJ L 250, 19.9.1984, p. 17)

                  Directive 97/55/EC of the European Parliament and of the Council
                  (OJ L 290, 23.10.1997, p. 18)

                  Directive 2005/29/EC of the European Parliament and of the Council
                  (OJ L 149, 11.6.2005, p. 22)

                  only Article 14

            PART B
      List of time-limits for transposition into national law and application

         (referred to in Article 10)

                  Directive

                  Time-limit for transposition

                  Date of application

                  84/450/EEC

                  1 October 1986

                  —

                  97/55/EC

                  23 April 2000

                  —

                  2005/29/EC

                  12 June 2007

                  12 December 2007

      ANNEX II
      CORRELATION TABLE

                  Directive 84/450/EEC

                  This Directive

                  Article 1

                  Article 1

                  Article 2, introductory words

                  Article 2, introductory words

                  Article 2, point 1

                  Article 2(a)

                  Article 2, point 2

                  Article 2(b)

                  Article 2, point 2a

                  Article 2(c)

                  Article 2, point 3

                  Article 2(d)

                  Article 2, point 4

                  Article 2(e)

                  Article 3

                  Article 3

                  Article 3a(1)

                  Article 4

                  Article 4(1), first subparagraph, first sentence

                  Article 5(1), first subparagraph

                  Article 4(1), first subparagraph, second sentence

                  Article 5(1), second subparagraph

                  Article 4(1), second subparagraph

                  Article 5(2), first subparagraph

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                  Article 4(2), first subparagraph, introductory words

                  Article 5(3), first subparagraph, introductory words

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                  Article 5(3), first subparagraph, point (a)

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                  Article 4(2), first subparagraph, final words

                  Article 5(3), second subparagraph

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                  Article 4(2), third subparagraph, introductory words

                  Article 5(4), introductory words

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                  Article 5(4), point (a)

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                  Article 5(4), point (b)

                  Article 4(3), first subparagraph

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                  Article 5(6)

                  Article 5

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                  Article 7(1)

                  Article 8(1), first subparagraph

                  Article 7(2)

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                  Article 7(3)

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                  Article 7(4)

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                  Annex I

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                  Annex II


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31983L0513

Council Directive 83/513/EEC of 26 September 1983 on limit values and quality objectives for cadmium discharges

Official Journal L 291 , 24/10/1983 P. 0001 - 0008 Spanish special edition: Chapter 15 Volume 4 P. 0131  Portuguese special edition Chapter 15 Volume 4 P. 0131  Finnish special edition: Chapter 15 Volume 4 P. 0140  Swedish special edition: Chapter 15 Volume 4 P. 0140

COUNCIL DIRECTIVE of 26 September 1983 on limit values and quality objectives for cadmium discharges (83/513/EEC)    THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100 and 235 thereof,  Having regard to Directive 76/464/EEC of 4 May 1976 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community (1), and in particular Articles 6 and 12 thereof,  Having regard to the proposal from the Commission (2),  Having regard to the opinion of the European Parliament (3),  Having regard to the opinion of the Economic and Social Committee (4),  Whereas, in order to protect the aquatic environment of the Community against pollution by certain dangerous substances, Article 3 of Directive 76/464/EEC introduces a system of prior authorization laying down emission standards for discharges of the substances in List I in the Annex thereto ; whereas Article 6 of the said Directive provides that limit values shall be laid down for such emission standards and also quality objectives for the aquatic environment affected by discharges of these substances;  Whereas cadmium and its compounds are included in List I;  Whereas the Member States are required to apply the limit values except in the cases where they may employ quality objectives;  Whereas, since pollution due to the discharge of cadmium into water is caused by a large number of industries, it is necessary to lay down specific limit values according to the type of industry concerned and to lay down quality objectives for the aquatic environment into which cadmium is discharged by such industries;  Whereas at the present time it is not, however, possible to establish limit values for discharges arising from the manufacture of phosphoric acid and phosphatic fertilizer from phosphatic rock;  Whereas the purpose of the quality objectives must be to eliminate cadmium pollution of the various parts of the aquatic environment which might be affected by cadmium discharges;  Whereas such quality objectives must be laid down expressly for this purpose and not with the intention of establishing rules pertaining to consumer protection or to the marketing of products from the aquatic environment;  (1) OJ No L 129, 18.5.1976, p. 23. (2) OJ No C 118, 21.5.1981, p. 3. (3) OJ No C 334, 20.12.1982, p. 138. (4) OJ No C 230, 10.9.1981, p. 22.   Whereas a specific monitoring procedure should be laid down to enable Member States to demonstrate that the quality objectives are being complied with;  Whereas provision should be made for the monitoring by Member States of the aquatic environment affected by the aforesaid cadmium discharges with a view to effective implementation of this Directive ; whereas Article 6 of Directive 76/464/EEC does not provide for the powers to introduce such monitoring ; whereas, since the specific powers have not been provided for in the Treaty, Article 235 thereof should be invoked;  Whereas it is important that the Commission forward to the Council, every five years, a comparative assessment of the implementation of this Directive by Member States;  Whereas, since groundwater is the subject of Directive 80/68/EEC (1), it is excluded from the scope of this Directive;  Whereas the level of industrialization is very low in Greenland because of the overall situation of the island, and in particular the fact that it is sparsely populated, its considerable size and its special geographical position ; whereas, therefore, this Directive should not apply to Greenland,  HAS ADOPTED THIS DIRECTIVE:     Article 1 1. This Directive:    - in pursuance of Article 6 (1) of Directive 76/464/EEC, lays down limit values for emission standards for cadmium in discharges from industrial plants as defined in Article 2 (e) hereof,       - in pursuance of Article 6 (2) of Directive 76/464/EEC, lays down quality objectives for cadmium in the aquatic environment,       - in pursuance of Article 6 (4) of Directive 76/464/EEC, lays down the time limits for compliance with the conditions specified in the authorizations granted by the competent authorities of Member States in respect of existing discharges,       - in pursuance of Article 12 (1) of Directive 76/464/EEC, lays down the reference methods of measurement enabling the cadmium content in discharges and in the aquatic environment to be determined,       - in pursuance of Article 6 (3) of Directive 76/464/EEC, establishes a monitoring procedure,       - requires Member States to cooperate with one another in the case of discharges affecting the waters of more than one Member State.         2. This Directive applies to the waters referred to in Article 1 of Directive 76/464/EEC with the exception of groundwater.    Article 2 For the purposes of this Directive:    (a) "cadmium" means:      - the chemical element cadmium,           - the cadmium contained in any of its compounds;                  (b) "limit values" means the values specified in Annex I;       (c) "quality objectives" means the requirements specified in Annex II;       (d) "handling of cadmium" means any industrial process involving the use or production of cadmium, or any other process in which the presence of cadmium is inherent;       (e) "industrial plant" means any plant at which cadmium or any substance containing cadmium is handled;       (f) "existing plant" means an industrial plant which is operational on the date of notification of this Directive;       (g) "new plant" means:      - an industrial plant which has become operational after the date of notification of this Directive,           - an existing industrial plant whose cadmium-processing capacity has been substantially increased after the date of notification of this Directive.                      Article 3 1. The limit values, the time limits by which they must be complied with and the (1) OJ No L 20, 26.1.1980, p. 43.   monitoring procedure for discharges are laid down in Annex I.  2. The limit values shall normally apply at the point where waste waters containing cadmium leave the industrial plant.  When waste waters containing cadmium are treated outside the industrial plant at a treatment plant intended for the removal of cadmium, the Member State may permit the limit values to be applied at the point where the waste waters leave the treatment plant.  3. The authorizations referred to in Article 3 of Directive 76/464/EEC must contain provisions at least as stringent as those in Annex I to this Directive, except where a Member State is complying with Article 6 (3) of Directive 76/464/EEC on the basis of Annexes II and IV to this Directive.  Authorizations shall be reviewed at least every four years.  4. Without prejudice to their obligations arising from paragraphs 1, 2 and 3 and to the provisions of Directive 76/464/EEC, Member States may grant authorizations for new plants only if those plants apply the standards corresponding to the best technical means available when that is necessary for the elimination of pollution in accordance with Article 2 of the said Directive or for the prevention of distortion of competition.  Whatever method it adopts, the Member State shall, where for technical reasons the intended measures do not correspond to the best technical means available, provide the Commission, before any authorization, with evidence in support of these reasons.  The Commission shall forward this evidence to the other Member States immediately and shall send all Member States a report as soon as possible giving its opinion on the derogation referred to in the second subparagraph. If necessary, it shall at the same time submit appropriate proposals to the Council.  5. The reference method of analysis to be used in determining the presence of cadmium is given in Annex III (1). Other methods may be used provided that the limits of detection, precision and accuracy of such methods are at least as good as those laid down in Annex III (1). The accuracy required in the measurement of effluent flow is given in Annex III (2).    Article 4 The Member States concerned shall be responsible for monitoring the aquatic environment affected by industrial discharges.  In the case of discharges affecting the waters of more than one Member State, the Member States concerned shall cooperate with a view to harmonizing monitoring procedures.    Article 5 1. The Commission shall make a comparative assessment of the implementation of this Directive by Member States on the basis of information supplied to it by them pursuant to Article 13 of Directive 76/464/EEC at its request, which it must submit case by case. The information concerned shall, in particular, comprise:    - details of authorizations laying down emission standards for discharges of cadmium,       - the results of the inventory of cadmium discharged into the waters referred to in Article 1 (2),       - the results of measurements made by the national network set up to determine concentrations of cadmium.         2. The Commission shall forward the comparative assessment referred to in paragraph 1 to the Council every five years, and for the first time four years after notification of this Directive.  3. In the event of a change in scientific knowledge relating principally to the toxicity, persistence and accumulation of cadmium in living organisms and sediments, or in the event of an improvement in the best technical means available, the Commission shall submit appropriate proposals to the Council with the aim of reinforcing, if necessary, the limit values and the quality objectives or of establishing new limit values and new quality objectives.    Article 6 1. Member States shall bring into force the measures necessary to comply with this Directive within two years following its notification. They shall forthwith inform the Commission thereof.   2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive.    Article 7 This Directive shall not apply to Greenland.    Article 8 This Directive is addressed to the Member States.     Done at Brussels, 26 September 1983.  For the Council  The President  C. SIMITIS     ANNEX I Limit values, time limits fixed for compliance with these values and monitoring procedures to be applied to discharges     1. Limit values and time limits >PIC FILE= "T0024692">         2. Limit values expressed as concentrations which in principle must not be exceeded are given in the above table for the industrial sectors in sections 2, 3, 4, 5 and 6. In no instance may limit values expressed as maximum concentrations be greater than those expressed as maximum quantities divided by water requirements per kilogram of cadmium handled. However, because the concentration of cadmium in effluents depends on the volume of water involved, which differs for different processes and plants, the limit values, expressed in terms of the quantity of cadmium discharged in relation to the quantity of cadmium handled, given in the above table must be complied with in all cases.       3. The daily average limit values are twice the corresponding monthly average limit values given in the above table.       4. A monitoring procedure must be instituted to check whether the discharges comply with the emission standards which have been fixed in accordance with the limit values laid down in this Annex.  This procedure must provide for the taking and analysis of samples and for measurement of the flow of the discharge and the quantity of cadmium handled.  Should the quantity of cadmium handled be impossible to determine, the monitoring procedure may be based on the quantity of cadmium that may be used in the light of the production capacity on which the authorization was based.       5. A sample representative of the discharge over a period of 24 hours will be taken. The quantity of cadmium discharged over a month must be calculated on the basis of the daily quantities of cadmium discharged.  However, a simplified monitoring procedure may be instituted in the case of industrial plants which do not discharge more than 10 kg of cadmium per annum. In the case of industrial electroplating plants, a simplified monitoring procedure may only be instituted if the total volume of the electroplating tanks is less than 1,5 m3.           ANNEX II Quality objectives  For those Member States which apply the exception referred to in Article 6 (3) of Directive 76/464/EEC, the emission standards which Member States must establish and ensure are applied, pursuant to Article 5 of that Directive, will be fixed so that the appropriate quality objective or objectives from among those listed below is or are complied with in the area affected by discharges of cadmium. The competent authority shall determine the area affected in each case and shall select from among the quality objectives listed in paragraph 1 the objective or objectives that it deems appropriate having regard to the intended use of the area affected, while taking account of the fact that the purpose of this Directive is to eliminate all pollution.    1. The following quality objectives (1), which will be measured sufficiently close to the point of discharge, are fixed, with the object of eliminating pollution within the meaning of Directive 76/464/EEC and pursuant to Article 2 of that Directive (2):      1.1. The total cadmium concentration in inland surface waters affected by discharges must not exceed 5 ¶g/litre.  1.2. The concentration of dissolved cadmium in estuary waters affected by discharges must not exceed 5 ¶g/litre.  1.3. The concentration of dissolved cadmium in territorial waters and in internal coastal waters other than estuary waters affected by discharges must not exceed 2,5 ¶g/litre.  1.4. In the case of waters used for the abstraction of drinking water, the cadmium content must conform to the requirements of Directive 75/440/EEC (3).                  2. In addition to the above requirements, cadmium concentrations must be determined by the national network referred to in Article 5 and the results compared with the following concentrations (2):      2.1. In the case of inland surface waters, a total cadmium concentration of 1 ¶g/litre.  2.2. In the case of estuary waters, a dissolved cadmium concentration of 1 ¶g/litre.  2.3. In the case of territorial and internal coastal waters, other than estuary waters, a dissolved cadmium concentration of 0,5 ¶g/litre.  If these concentrations are not complied with at any one of the points on the national network, the reasons must be reported to the Commission.                  3. The concentration of cadmium in sediments and/or shellfish, if possible of the species Mytilus edulis, must not increase significantly with time.       4. Where several quality objectives are supplied to waters in an area, the quality of the waters must be sufficient to comply with each of those objectives.  (1) The cadmium concentrations indicated in 1.1, 1.2 and 1.3 are the minimum requirements necessary to protect aquatic life. (2) With the exception of quality objective 1.4, all concentrations relate to the arithmetic mean of the results obtained over one year. (3) Directive 75/440/EEC concerns the quality required of surface water intended for the abstraction of drinking water in the Member States (OJ No L 194, 25.7.1975, p. 26). It provides for a mandatory cadmium value of 5 ¶g/litre on the basis of 95 % of the samples taken.            ANNEX III Reference methods of measurement     1. The reference method of analysis used for determining the cadmium content of waters, sediments and shellfish is atomic absorption spectrophotometry after preservation and suitable treatment of the sample.  The limits of detection (1) must be such that the cadmium concentration can be measured to an accuracy (1) of ± 30 % and a precision (1) of ± 30 % at the following concentrations:      - in the case of discharges, one-tenth of the maximum permitted concentration of cadmium specified in the authorization,           - in the case of surface water, 0,1 ¶g/litre or one-tenth of the cadmium concentration specified in the quality objective, whichever is the greater,           - in the case of shellfish, 0,1 mg/kg, wet weight,           - in the case of sediments, one-tenth of the cadmium concentration in the sample or 0,1 mg/kg, dry weight, with drying being carried out between 105 and 110 °C at constant weight, whichever value is the greater.                  2. Flow measurement must be carried out to an accurancy of ± 20 %.          ANNEX IV Monitoring procedure for quality objectives     1. For each authorization granted in pursuance of this Directive, the competent authority will specify the restrictions, monitoring procedure and time limits for ensuring compliance with the quality objective(s) concerned.       2. In accordance with Article 6 (3) of Directive 76/464/EEC, the Member State will, for each quality objective chosen and applied, report to the Commission, on:      - the points of discharge and the means of dispersal,           - the area in which the quality objective is applied,           - the location of sampling points,           - the frequency of sampling,           - the methods of sampling and measurement,           - the results obtained.                  3. Samples must be sufficiently representative of the quality of the aquatic environment in the area affected by the discharges, and the frequency of sampling must be sufficient to show any changes in the aquatic environment, taking into account, in particular, natural variations in the hydrological regime.  (1) The definitions of these terms are given in Council Directive 79/869/EEC of 9 October 1979 concerning the methods of measurement and frequencies of sampling and analysis of surface water intended for the abstraction of drinking water in the Member States (OJ No L 271, 29.10.1979, p. 44).