title: Directive 2009/23/EC of the European Parliament and of the Council of 23 April 2009 on non-automatic weighing instruments (Codified version) (Text with EEA relevance )

text:
               16.5.2009

               EN

               Official Journal of the European Union

               L 122/6

      DIRECTIVE 2009/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 23 April 2009
   on non-automatic weighing instruments
   (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 90/384/EEC of 20 June 1990 on the harmonisation of the laws of the Member States relating to non-automatic weighing instruments (3) has been substantially amended (4). In the interests of clarity and rationality the said Directive should be codified.

               (2)

               Member States have the responsibility of protecting the public against incorrect results of weighing operations by means of non-automatic weighing instruments when used for certain categories of applications.

               (3)

               In each Member State, mandatory provisions fix in particular the necessary performance requirements of non-automatic weighing instruments by specifying metrological and technical requirements, together with inspection procedures before and after going into service. These mandatory provisions do not necessarily lead to different levels of protection from one Member State to another but do, by their disparity, impede trade within the Community.

               (4)

               This Directive should set out mandatory and essential requirements as regards metrology and performance in relation to non-automatic weighing instruments. To facilitate proof of conformity with the essential requirements, it is necessary to have harmonised standards at European level, in particular as to the metrological, design and construction characteristics, so that instruments complying with those harmonised standards may be assumed to conform to the essential requirements. These standards, harmonised at European level, are drawn up by private bodies and must remain non-mandatory texts. For that purpose the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (Cenelec) and the European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines (5) for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies, signed on 28 March 2003.

               (5)

               A series of Directives designed to remove technical barriers to trade in accordance with the principles established in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards (6) has been adopted; each of those Directives provides for the affixing of the ‘CE’ conformity marking. In its communication of 15 June 1989 (7) on a global approach to certification and testing, the Commission proposed that common rules be drawn up concerning a ‘CE’ conformity marking with a single design. In its Resolution of 21 December 1989 on a global approach to conformity assessment (8), the Council approved as a guiding principle the adoption of a consistent approach such as this with regard to the use of the ‘CE’ conformity marking. The two basic elements of the new approach which should be applied are the essential requirements and the conformity assessment procedures.

               (6)

               Assessment of conformity with the relevant metrological and technical provisions is necessary to provide effective protection for users and third parties. The existing conformity assessment procedures differ from one Member State to another. To avoid multiple assessments of conformity, which are in effect barriers to the free movement of the instruments, arrangements should be made for the mutual recognition of conformity assessment procedures by the Member States. To facilitate the mutual recognition of conformity assessment procedures, Community procedures should be set up, together with criteria for the designation of the bodies responsible for carrying out tasks pertaining to the conformity assessment procedures.

               (7)

               It is therefore essential to ensure that such designated bodies ensure a high level of quality throughout the Community.

               (8)

               The presence on a non-automatic weighing instrument of the ‘CE’ conformity marking or of the sticker bearing the letter ‘M’ should indicate that there is a presumption that it satisfies the provisions of this Directive and therefore make it unnecessary to repeat the assessments of conformity already carried out.

               (9)

               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 set out in Annex VII, Part B,

         HAVE ADOPTED THIS DIRECTIVE:
   CHAPTER 1

      SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT

   Article 1
   1.   This Directive shall apply to all non-automatic weighing instruments.
   2.   For the purposes of this Directive, the following categories of use of non-automatic weighing instruments shall be distinguished:

               (a)

                           (i)

                           determination of mass for commercial transactions;

                           (ii)

                           determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;

                           (iii)

                           determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;

                           (iv)

                           determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;

                           (v)

                           determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;

                           (vi)

                           determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages;

               (b)

               all applications other than those listed in point (a).

         Article 2
   For the purposes of this Directive, the following definitions shall apply:
   1.   ‘weighing instrument’: a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics;
   2.   ‘non-automatic weighing instrument’ or ‘instrument’: a weighing instrument requiring the intervention of an operator during weighing;
   3.   ‘harmonised standard’: a technical specification (European standard or harmonised document) adopted by the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (Cenelec), or the European Telecommunications Standards Institute (ETSI), or by two or three of those bodies, upon a remit from the Commission in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (9) and the general guidelines for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies, signed on 28 March 2003.
   Article 3
   1.   Member States shall take all steps to ensure that only instruments that meet the requirements of this Directive may be placed on the market.
   2.   Member States shall take all steps to ensure that instruments may not be brought into service for the uses referred to in point (a) of Article 1(2) unless they meet the requirements of this Directive and accordingly bear the ‘CE’ conformity marking provided for in Article 11.
   Article 4
   Instruments used for the applications listed in point (a) of Article 1(2) must satisfy the essential requirements set out in Annex I.
   In cases where the instrument includes, or is connected to, devices which are not used for the applications listed in point (a) of Article 1(2), such devices shall not be subject to those essential requirements.
   Article 5
   1.   Member States shall not impede the placing on the market of instruments which meet the requirements of this Directive.
   2.   Member States shall not impede the putting into service, for the uses referred to in point (a) of Article 1(2), of instruments which meet the requirements of this Directive.
   Article 6
   1.   Member States shall presume conformity with the essential requirements set out in Annex I in respect of instruments which comply with the relevant national standards implementing the harmonised standards that meet those requirements.
   2.   The Commission shall publish the references of the harmonised standards referred to in paragraph 1 in the Official Journal of the European Union.
   Member States shall publish the references of the national standards referred to in paragraph 1.
   Article 7
   Where a Member State or the Commission considers that the harmonised standards referred to in Article 6(1) do not fully meet the essential requirements set out in Annex I, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC, hereinafter referred to as ‘the Committee’, giving its reasons for doing so.
   The Committee shall deliver an opinion without delay.
   In the light of the Committee’s opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 6(2).
   Article 8
   1.   Where a Member State considers that instruments bearing the ‘CE’ conformity marking referred to in Annex II, points 2, 3 and 4, do not meet the requirements of this Directive when properly installed and used for the purposes for which they are intended, it shall take all appropriate measures to withdraw those instruments from the market or to prohibit or restrict their being put into service and/or placed on the market.
   The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision, and in particular whether non-compliance is due to:

               (a)

               failure to meet the essential requirements set out in Annex I, where instruments do not meet the harmonised standards referred to in Article 6(1);

               (b)

               incorrect application of the harmonised standards referred to in Article 6(1);

               (c)

               shortcomings in the harmonised standards referred to in Article 6(1) themselves.

         2.   The Commission shall enter into consultation with the parties concerned as soon as possible.
   After such consultation the Commission shall immediately inform the Member State which took the action of the result. Should it find that the measure is justified it shall immediately inform the other Member States.
   If the decision is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends to maintain them, and shall subsequently initiate the procedures referred to in Article 7.
   3.   Where an instrument which does not comply bears the ‘CE’ conformity marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking and shall inform the Commission and the other Member States thereof.
   4.   The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
   CHAPTER 2

      CONFORMITY ASSESSMENT

   Article 9
   1.   The conformity of instruments to the essential requirements set out in Annex I may be certified by either of the following procedures as selected by the applicant:

               (a)

               EC type examination as referred to in Annex II, point 1, followed either by the EC declaration of type conformity (guarantee of production quality) as referred to in Annex II, point 2, or by the EC verification as referred to in Annex II, point 3.
               However, EC type examination shall not be compulsory for instruments which do not use electronic devices and the load-measuring device of which does not use a spring to balance the load;

               (b)

               EC unit verification as referred to in Annex II, point 4.

         2.   The documents and correspondence relating to the procedures referred to in paragraph 1 shall be drafted in an official language of the Member State where the said procedures are carried out, or in a language accepted by the body notified in accordance with Article 10(1).
   3.   Where the instruments are subject to other Directives covering other aspects and which also provide for the affixing of the ‘CE’ conformity marking, that marking shall indicate that the instruments in question are also presumed to conform to the provisions of those other Directives.
   However, where one or more of the Directives which apply to the instruments allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ conformity marking shall indicate conformity only to the Directives applied by the manufacturer. In this case, particulars of publication in the Official Journal of the European Union of the Directives applied must be given in the documents, notices or instructions required by the Directives and accompanying such instruments.
   Article 10
   1.   Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 9 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.
   The Commission shall publish in the Official Journal of the European Union a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.
   2.   Member States shall apply the minimum criteria set out in Annex V for the designation of bodies. Bodies which satisfy the criteria fixed by the relevant harmonised standards shall be presumed to satisfy the criteria set out in that Annex.
   3.   A Member State which has designated a body shall cancel the designation if the body no longer meets the criteria for designation referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof and withdraw the notification.
   CHAPTER 3

      ‘CE’ CONFORMITY MARKING AND INSCRIPTIONS

   Article 11
   1.   The ‘CE’ conformity marking and the required supplementary data as described in Annex IV, point 1, shall be affixed in a clearly visible, easily legible and indelible form to instruments for which EC conformity has been established.
   2.   The inscriptions referred to in Annex IV, point 2, shall be affixed in a clearly visible, easily legible and indelible form to all other instruments.
   3.   The affixing on the instruments of markings which are likely to deceive third parties as to the meaning and form of the ‘CE’ conformity marking shall be prohibited. Any other marking may be affixed to the instruments provided that the visibility and legibility of the ‘CE’ conformity marking is not thereby reduced.
   Article 12
   Without prejudice to Article 8:

               (a)

               where a Member State establishes that the ‘CE’ conformity marking has been affixed unduly, the manufacturer or his authorised representative established within the Community shall be obliged to make the instrument conform as regards the provisions concerning the ‘CE’ conformity marking and to end the infringement under the conditions imposed by the Member State;

               (b)

               where non-conformity continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the instrument in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 8.

         Article 13
   Where an instrument which is used for any of the applications referred to in point (a) of Article 1(2) includes, or is connected to, devices that have not been subject to conformity assessment as referred to in Article 9, each of those devices shall bear the symbol restricting its use as defined by Annex IV, point 3. That symbol shall be affixed to the devices in a clearly visible and indelible form.
   CHAPTER 4

      FINAL PROVISIONS

   Article 14
   Member States shall take all steps to ensure that instruments bearing the ‘CE’ conformity marking attesting conformity with the requirements of this Directive continue to conform to those requirements.
   Article 15
   Any decision taken pursuant to this Directive and resulting in restrictions on the putting into service of an instrument shall state the exact grounds on which it is based.
   Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the judicial remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.
   Article 16
   Member States shall communicate to the Commission the texts of the main provisions of internal law which they adopt in the field covered by this Directive.
   Article 17
   Directive 90/384/EEC, as amended by the Directive listed in Annex VII, Part A, is 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 set out in Annex VII, 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 VIII.
   Article 18
   This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
   Article 19
   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)  OJ C 44, 16.2.2008, p. 33.

      (2)  Opinion of the European Parliament of 11 December 2007 (OJ C 323 E, 18.12.2008, p. 57) and Council Decision of 23 March 2009.

      (3)  OJ L 189, 20.7.1990, p. 1.

      (4)  See Annex VII, Part A.

      (5)  OJ C 91, 16.4.2003, p. 7.

      (6)  OJ C 136, 4.6.1985, p. 1.

      (7)  OJ C 267, 19.10.1989, p. 3.

      (8)  OJ C 10, 16.1.1990, p. 1.

      (9)  OJ L 204, 21.7.1998, p. 37.

      ANNEX I

         ESSENTIAL REQUIREMENTS

      The terminology used is that of the International Organisation of Legal Metrology.

         Preliminary observation

      Where an instrument includes, or is connected to, more than one indicating or printing device used for the applications listed in point (a) of Article 1(2), those devices which repeat the results of the weighing operation and which cannot influence the correct functioning of the instrument shall not be subject to the essential requirements if the weighing results are printed or recorded correctly and indelibly by a part of the instrument which meets the essential requirements and the results are accessible to both parties concerned by the measurement. However, in the case of instruments used for direct sales to the public, display and printing devices for the vendor and the customer must fulfil the essential requirements.

         METROLOGICAL REQUIREMENTS

      1.   Units of mass
      The units of mass used shall be the legal units within the meaning of Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement (1).
      Subject to compliance with this condition, the following units are permitted:

                  —

                  SI units: kilogram, microgram, milligram, gram, tonne,

                  —

                  imperial unit: troy ounce, if weighing precious metals,

                  —

                  other non-SI unit: metric carat, if weighing precious stones.

            For instruments that make use of the imperial unit of mass referred to above, the relevant essential requirements specified below shall be converted to that unit, using simple interpolation.
      2.   Accuracy classes
      2.1.   The following accuracy classes have been defined:

                  I

                  special

                  II

                  high

                  III

                  medium

                  IIII

                  ordinary

            The specifications of these classes are given in Table 1.

         Table 1

         Accuracy classes

                  Class

                  Verification scale interval (e)

                  Minimum capacity (Min)

                  Number of verification scale intervalsFOR-L_2009122EN.01001101.notes.0001.xml.jpg

                  minimum value

                  minimum value

                  maximum value

                  I

                  0,001

                  g ≤ e

                  100 e

                  50 000

                  —

                  II

                  0,001

                  g ≤ e ≤ 0,05 g

                  20 e

                  100

                  100 000

                  0,1

                  g ≤ e

                  50 e

                  5 000

                  100 000

                  III

                  0,1

                  g ≤ e ≤ 2 g

                  20 e

                  100

                  10 000

                  5

                  g ≤ e

                  20 e

                  500

                  10 000

                  IIII

                  5

                  g ≤ e

                  10 e

                  100

                  1 000

            The minimum capacity is reduced to 5 e for instruments in classes II and III for determining a conveying tariff.
      2.2.   Scale intervals

                  2.2.1.

                  The actual scale interval (d) and the verification scale interval (e) shall be in the form:
                  1 × 10k, 2 × 10k, or 5 × 10k mass units,
                  k being any integer or zero.

                  2.2.2.

                  For all instruments other than those with auxiliary indicating devices:
                  d = e.

                  2.2.3.

                  For instruments with auxiliary indicating devices the following conditions apply:
                  e = 1 × 10k g,
                  d < e ≤ 10 d,
                  except for instruments of class I with d < 10–4 g, for which e = 10–3 g.

            3.   Classification
      3.1.   Instruments with one weighing range
      Instruments equipped with an auxiliary indicating device shall belong to class I or class II. For these instruments the minimum capacity lower limits for these two classes are obtained from Table 1 by replacement in column 3 of the verification scale interval (e) by the actual scale interval (d).
      If d < 10–4 g, the maximum capacity of class I may be less than 50 000 e.
      3.2.   Instruments with multiple weighing ranges
      Multiple weighing ranges are permitted, provided they are clearly indicated on the instrument. Each individual weighing range is classified according to point 3.1. If the weighing ranges fall into different accuracy classes the instrument shall comply with the severest of the requirements that apply for the accuracy classes in which the weighing ranges fall.
      3.3.   Multi-interval instruments

                  3.3.1.

                  Instruments with one weighing range may have several partial weighing ranges (multi-interval instruments).
                  Multi-interval instruments shall not be equipped with an auxiliary indicating device.

                  3.3.2.

                  Each partial weighing range i of multi-interval instruments is defined by:

                                          —

                                          its verification scale interval ei

                              with e(i + 1) > ei

                                          —

                                          its maximum capacity Maxi

                              with Maxr = Max

                                          —

                                          its minimum capacity Mini

                              with Mini = Max (i – 1)

                              and Min1 = Min

                        where:

                              i

                              =

                              1, 2, … r,

                              i

                              =

                              partial weighing range number,

                              r

                              =

                              the total number of partial weighing ranges.

                        All capacities are capacities of net load, irrespective of the value of any tare used.

                  3.3.3.

                  The partial weighing ranges are classified according to Table 2. All partial weighing ranges shall fall into the same accuracy class, that class being the instrument’s accuracy class.

                     Table 2

                     Multi-interval instruments

                              i

                              =

                              1, 2, … r

                              i

                              =

                              partial weighing range number

                              r

                              =

                              total number of partial weighing ranges

                              Class

                              Verification scale interval (e)

                              Minimum capacity (Min)

                              Number of verification scale intervals

                              Minimum value

                              Minimum value (2)
                              FOR-L_2009122EN.01001101.notes.0002.xml.jpg

                              Maximum valueFOR-L_2009122EN.01001101.notes.0003.xml.jpg

                              I

                              0,001

                              g ≤ ei

                              100 e1

                              50 000

                              —

                              II

                              0,001

                              g ≤ ei ≤ 0,05 g

                              20 e1

                              5 000

                              100 000

                              0,1

                              g ≤ ei

                              50 e1

                              5 000

                              100 000

                              III

                              0,1

                              g ≤ ei

                              20 e1

                              500

                              10 000

                              IIII

                              5

                              g ≤ ei

                              10 e1

                              50

                              1 000

            4.   Accuracy
      4.1.   On implementation of the procedures laid down in Article 9, the error of indication shall not exceed the maximum permissible error of indication as shown in Table 3. In case of digital indication the error of indication shall be corrected for the rounding error.
      The maximum permissible errors apply to the net value and tare value for all possible loads, excluding preset tare values.

         Table 3

         Maximum permissible errors

                  Load

                  Maximum permissible error

                  Class I

                  Class II

                  Class III

                  Class IIII

                  0 ≤ m ≤ 50 000 e

                  0 ≤ m ≤ 5 000 e

                  0 ≤ m ≤ 500 e

                  0 ≤ m ≤ 50 e

                  ±0,5 e

                  50 000 e < m ≤ 200 000 e

                  5 000 e < m ≤ 20 000 e

                  500 e < m ≤ 2 000 e

                  50 e < m ≤ 200 e

                  ±1,0 e

                  200 000 e < m

                  20 000 e < m ≤ 100 000 e

                  2 000 e < m ≤ 10 000 e

                  200 e < m ≤ 1 000 e

                  ±1,5 e

            4.2.   The maximum permissible errors in service are twice the maximum permissible errors fixed in Section 4.1.
      5.   Weighing results of an instrument shall be repeatable, and shall be reproducible by the other indicating devices used and in accordance with other methods of balancing used.
      The weighing results shall be sufficiently insensitive to changes in the position of the load on the load receptor.
      6.   The instrument shall react to small variations in the load.
      7.   Influence quantities and time
      7.1.   Instruments of classes II, III and IIII, liable to be used in a tilted position, shall be sufficiently insensitive to the degree of tilting that can occur in normal use.
      7.2.   The instruments shall meet the metrological requirements within the temperature range specified by the manufacturer. The value of this range shall be at least equal to:

                  —

                  5 °C for an instrument in class I,

                  —

                  15 °C for an instrument in class II,

                  —

                  30 °C for an instrument in class III or IIII.

            In the absence of a manufacturer’s specification, the temperature range of – 10 °C to + 40 °C applies.
      7.3.   Instruments operated from a mains power supply shall meet the metrological requirements under conditions of power supply within the limits of normal fluctuation.
      Instruments operated from battery power shall indicate whenever the voltage drops below the minimum required value and shall under those circumstances either continue to function correctly or be automatically put out of service.
      7.4.   Electronic instruments, except those in class I and in class II if e is less than 1 g, shall meet the metrological requirements under conditions of high relative humidity at the upper limit of their temperature range.
      7.5.   Loading an instrument in class II, III or IIII for a prolonged period of time shall have a negligible influence on the indication at load or on the zero indication immediately after removal of the load.
      7.6.   Under other conditions the instruments shall either continue to function correctly or be automatically put out of service.

         Design and construction

      8.   General requirements
      8.1.   Design and construction of the instruments shall be such that the instruments will preserve their metrological qualities when properly used and installed and when used in an environment for which they are intended. The value of the mass must be indicated.
      8.2.   When exposed to disturbances, electronic instruments shall not display the effects of significant faults, or shall automatically detect and indicate them.
      Upon automatic detection of a significant fault, electronic instruments shall provide a visual or audible alarm that shall continue until the user takes corrective action or the fault disappears.
      8.3.   The requirements of points 8.1 and 8.2 shall be met on a lasting basis during a period of time that is normal in view of the intended use of such instruments.
      Digital electronic devices shall always exercise adequate control of the correct operation of the measuring process, of the indicating device, and of all data storage and data transfer.
      Upon automatic detection of a significant durability error, electronic instruments shall provide a visual or audible alarm that shall continue until the user takes corrective action or the error disappears.
      8.4.   When external equipment is connected to an electronic instrument through an appropriate interface the metrological qualities of the instrument shall not be adversely influenced.
      8.5.   The instruments shall have no characteristics likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal. Components that may not be dismantled or adjusted by the user shall be secured against such actions.
      8.6.   Instruments shall be designed to permit ready execution of the statutory controls laid down by this Directive.
      9.   Indication of weighing results and other weight values
      The indication of the weighing results and other weight values shall be accurate, unambiguous and non-misleading and the indicating device shall permit easy reading of the indication under normal conditions of use.
      The names and symbols of the units referred to in point 1 of this Annex shall comply with the provisions of Directive 80/181/EEC with the addition of the symbol for the metric carat which shall be the symbol ‘ct’.
      Indication shall be impossible above the maximum capacity (Max), increased by 9 e.
      An auxiliary indicating device is permitted only to the right of the decimal mark. An extended indicating device may be used only temporarily, and printing shall be inhibited during its functioning.
      Secondary indications may be shown, provided that they cannot be mistaken for primary indications.
      10.   Printing of weighing results and other weight values
      Printed results shall be correct, suitably identified and unambiguous. The printing shall be clear, legible, non-erasable and durable.
      11.   Levelling
      When appropriate, instruments shall be fitted with a levelling device and a level indicator, sufficiently sensitive to allow proper installation.
      12.   Zeroing
      Instruments may be equipped with zeroing devices. The operation of these devices shall result in accurate zeroing and shall not cause incorrect measuring results.
      13.   Tare devices and preset tare devices
      The instruments may have one or more tare devices and a preset tare device. The operation of the tare devices shall result in accurate zeroing and shall ensure correct net weighing. The operation of the preset tare device shall ensure correct determination of the calculated net value.
      14.   Instruments for direct sales to the public, with a maximum capacity not greater than 100 kg: additional requirements
      Instruments for direct sale to the public shall show all essential information about the weighing operation and, in the case of price-indicating instruments, shall clearly show the customer the price calculation of the product to be purchased.
      The price to pay, if indicated, shall be accurate.
      Price-computing instruments shall display the essential indications long enough for the customer to read them properly.
      Price-computing instruments may perform functions other than per-article weighing and price computation only if all indications related to all transactions are printed clearly and unambiguously and are conveniently arranged on a ticket or label for the customer.
      Instruments shall bear no characteristics that can cause, directly or indirectly, indications the interpretation of which is not easy or straightforward.
      Instruments shall safeguard customers against incorrect sales transactions due to their malfunctioning.
      Auxiliary indicating devices and extended indicating devices are not permitted.
      Supplementary devices are permitted only if they cannot lead to fraudulent use.
      Instruments similar to those normally used for direct sales to the public which do not satisfy the requirements of this Section must carry near to the display the indelible marking ‘Not to be used for direct sale to the public’.
      15.   Price labelling instruments
      Price labelling instruments shall meet the requirements of price indicating instruments for direct sale to the public, as far as applicable to the instrument in question. The printing of a price label shall be impossible below a minimum capacity.

         (1)  OJ L 39, 15.2.1980, p. 40.

         (2)  For i = r, the corresponding column of Table 1 applies, with e replaced by er.

      ANNEX II

         CONFORMITY ASSESSMENT PROCEDURES

      1.   EC type-examination
      1.1.   EC type-examination is the procedure whereby a notified body verifies and certifies that an instrument, representative of the production envisaged, meets the requirements of this Directive.
      1.2.   The application for EC type-examination shall be lodged with a single notified body by the manufacturer or his authorised representative established within the Community.
      The application shall include:

                  —

                  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition,

                  —

                  a written declaration that the application has not been lodged with any other notified body,

                  —

                  the design documentation, as described in Annex III.

            The applicant shall place at the disposal of the notified body an instrument, representative of the production envisaged, hereinafter the ‘type’.
      1.3.   The notified body shall:

                  1.3.1.

                  examine the design documentation and verify that the type has been manufactured in accordance with that documentation;

                  1.3.2.

                  agree with the applicant on the location where the examinations and/or tests shall be carried out;

                  1.3.3.

                  perform or have performed the appropriate examinations and/or tests to check whether the solutions adopted by the manufacturer meet the essential requirements where the harmonised standards referred to in Article 6(1) have not been applied;

                  1.3.4.

                  perform or have performed the appropriate examinations and/or tests to check whether, where the manufacturer has chosen to apply the relevant standards, these standards have been applied effectively, thereby assuring conformity with the essential requirements.

            1.4.   Where the type complies with the provisions of this Directive, the notified body shall issue an EC type-approval certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions (if any) for its validity, the necessary data for identification of the approved instrument and, if relevant, a description of its functioning. All the relevant technical elements such as drawings and layouts shall be annexed to the EC type-approval certificate.
      The certificate shall have a validity period of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.
      In the event of fundamental changes to the design of the instrument, e.g. as a result of the application of new techniques, the validity of the certificate may be limited to two years and extended by three years.
      1.5.   Each notified body shall periodically make available to all Member States the list of:

                  —

                  applications received for EC type-examination,

                  —

                  EC type-approval certificates issued,

                  —

                  applications for type-certificates refused,

                  —

                  additions and amendments relating to documents already issued.

            Each notified body shall moreover inform all the Member States forthwith of withdrawals of EC type-approval certificates.
      Each Member State shall make this information available to the bodies which it has notified.
      1.6.   The other notified bodies may receive a copy of the certificates together with the annexes to them.
      1.7.   The applicant shall keep the notified body that has issued the EC type-approval certificate informed of any modification to the approved type.
      Modifications to the approved type must receive additional approval from the notified body that issued the EC type-approval certificate where such changes influence conformity with the essential requirements of this Directive or the prescribed conditions for use of the instrument. This additional approval is given in the form of an addition to the original EC type-approval certificate.
      2.   EC declaration of type conformity (guarantee of production quality)
      2.1.   The EC declaration of type conformity (guarantee of production quality) is the procedure whereby the manufacturer who satisfies the obligations of point 2.2 declares that the instruments concerned are, where applicable, in conformity with the type as described in the EC type-approval certificate and that they satisfy the requirements of this Directive.
      The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ conformity marking to each instrument and the inscriptions provided for in Annex IV and shall draw up a written declaration of conformity.
      The ‘CE’ conformity marking shall be accompanied by the identification number of the notified body responsible for the EC surveillance referred to in point 2.4.
      2.2.   The manufacturer shall have adequately implemented a quality system as specified in point 2.3 and shall be subject to EC surveillance as specified in point 2.4.
      2.3.   Quality system

                  2.3.1.

                  The manufacturer shall lodge an application for approval of his quality system with a notified body.
                  The application shall include:

                              —

                              an undertaking to carry out the obligations arising from the approved quality system,

                              —

                              an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.

                        The manufacturer shall make available to the notified body all relevant information, in particular the quality system’s documentation and the design documentation of the instrument.

                  2.3.2.

                  The quality system shall ensure conformity of the instruments with the type as described in the EC type-approval certificate and with the requirement(s) of this Directive.
                  All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written rules, procedures and instructions. This quality system documentation shall ensure a proper understanding of the quality programmes, plans, manuals and records.
                  It shall contain in particular an adequate description of:

                              —

                              the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

                              —

                              the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used,

                              —

                              the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

                              —

                              the means to monitor the achievement of the required product quality and the effective operation of the quality system.

                  2.3.3.

                  The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in point 2.3.2. It shall presume conformity with these requirements in respect of quality systems that implement the corresponding harmonised standard.
                  It shall notify its decision to the manufacturer and inform the other notified bodies thereof. The notification to the manufacturer shall contain the conclusions of the examination and, in the event of refusal, the justification for the decision.

                  2.3.4.

                  The manufacturer or his authorised representative shall keep the notified body that has approved the quality system informed of any updating of the quality assurance system in relation to changes brought about by, e.g. new technologies and new quality concepts.

                  2.3.5.

                  Any notified body that withdraws approval of a quality system shall so inform the other notified bodies.

            2.4.   EC surveillance

                  2.4.1.

                  The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

                  2.4.2.

                  The manufacturer shall grant the notified body access for inspection purposes to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular:

                              —

                              the quality system documentation,

                              —

                              the design documentation,

                              —

                              the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.

                        The notified body shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report.
                  In addition, the notified body may carry out unscheduled visits to the manufacturer. During such visits, the notified body may carry out full or partial audits. It shall provide the manufacturer with a report on the visit, and, where appropriate, an audit report.

                  2.4.3.

                  The notified body shall ensure that the manufacturer maintains and applies the approved quality system.

            3.   EC verification
      3.1.   EC verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the instruments which have been checked in accordance with point 3.3 are, where applicable, in conformity with the type described in the EC type-examination certificate and that they satisfy the requirements of this Directive.
      3.2.   The manufacturer shall take all necessary measures in order that the manufacturing process ensures conformity of the instruments, where applicable, with the type as described in the EC type-examination certificate and with the requirements of this Directive which apply to them. The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ conformity marking to each instrument and draw up a written declaration of conformity.
      3.3.   The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of every instrument, as specified in point 3.5.
      3.4.   For instruments not subject to EC type-approval, the documents relating to the design of the instrument, as set out in Annex III, must be accessible to the notified body should the latter so request.
      3.5.   Verification by checking and testing of each instrument

                  3.5.1.

                  All instruments shall be individually examined and appropriate tests, as set out in the relevant harmonised standards referred to in Article 6(1), or equivalent tests, shall be carried out in order to verify their conformity, where applicable, with the type as described in the EC type-examination certificate and the requirements of this Directive.

                  3.5.2.

                  The notified body shall affix, or cause to be affixed, its identification number on each instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity relating to the tests carried out.

                  3.5.3.

                  The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.

            4.   EC unit verification
      4.1.   EC unit verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the instrument, generally designed for a specific application, which has been issued with the certificate referred to in point 4.2 conforms to the requirements of this Directive that apply to it. The manufacturer or his authorised representative shall affix the ‘CE’ conformity marking to the instrument and shall draw up a written declaration of conformity.
      4.2.   The notified body shall examine the instrument and carry out the appropriate tests, as set out in the relevant harmonised standard(s) referred to in Article 6(1), or equivalent tests, in order to ensure its conformity with the relevant requirements of this Directive.
      The notified body shall affix, or cause to be affixed, its identification number to the instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity concerning the tests carried out.
      4.3.   The aim of the technical documentation relating to the design of the instrument, as referred to in Annex III, is to enable conformity with the requirements of this Directive to be assessed and the design, manufacture and operation of the instrument to be understood. It must be accessible to the notified body.
      4.4.   The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
      5.   Common provisions
      5.1.   The EC declaration of type conformity (guarantee of production quality), the EC verification, and the EC unit verification may be carried out at the manufacturer’s works or any other location if transport to the place of use does not require dismantling of the instrument, if the putting into service at the place of use does not require assembly of the instrument or other technical installation work likely to affect the instrument’s performance, and if the gravity value at the place of putting into service is taken into consideration or if the instrument’s performance is insensitive to gravity variations. In all other cases, they shall be carried out at the place of use of the instrument.
      5.2.   If the instrument’s performance is sensitive to gravity variations the procedures referred to in point 5.1 may be carried out in two stages, with the second stage comprising all examinations and tests of which the outcome is gravity-dependent, and the first stage all other examinations and tests. The second stage shall be carried out at the place of use of the instrument. If a Member State has established gravity zones on its territory the expression ‘at the place of use of the instrument’ may be read as ‘in the gravity zone of use of the instrument’.
      5.2.1.   Where a manufacturer has opted for execution in two stages of one of the procedures mentioned in point 5.1, and where these two stages will be carried out by different parties, an instrument which has undergone the first stage of the procedure shall bear the identification number of the notified body involved in that stage.
      5.2.2.   The party which has carried out the first stage of the procedure shall issue for each of the instruments a certificate containing the data necessary for identification of the instrument and specifying the examinations and tests that have been carried out.
      The party which carries out the second stage of the procedure shall carry out those examinations and tests that have not yet been carried out.
      The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
      5.2.3.   A manufacturer who has opted for the EC declaration of type conformity (guarantee of production quality) in the first stage may either use this same procedure in the second stage or decide to continue in the second stage with EC verification.
      5.2.4.   The ‘CE’ conformity marking shall be affixed to the instrument on completion of the second stage, along with the identification number of the notified body which took part in the second stage.

      ANNEX III

         DESIGN TECHNICAL DOCUMENTATION

      The technical documentation must render the design, manufacture and operation of the product intelligible and enable an assessment to be made of its conformity with the requirements of this Directive.
      The documentation shall include in so far as relevant for assessment:

                  —

                  a general description of the type,

                  —

                  conceptual designs and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.,

                  —

                  descriptions and explanations necessary for the understanding of the above, including the operation of the instrument,

                  —

                  a list of the harmonised standards referred to in Article 6(1), applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the harmonised standards referred to in Article 6(1) have not been applied,

                  —

                  results of design calculations made and of examinations, etc.,

                  —

                  test reports,

                  —

                  the EC type-approval certificates and the results of relevant tests on instruments containing parts identical to those in the design.

      ANNEX IV

         ‘CE’ CONFORMITY MARKING AND INSCRIPTIONS

      1.   Instruments subject to the EC conformity assessment procedure

                  1.1.

                  These instruments must bear:

                              (a)

                                          —

                                          the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,

                                          —

                                          the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.

                                    The abovementioned marking and inscriptions shall be affixed to the instrument and distinctly grouped together;

                              (b)

                              a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ printed in black;

                              (c)

                              the following inscriptions:

                                          —

                                          the number of the EC type-approval certificate, where appropriate,

                                          —

                                          the manufacturer’s mark or name,

                                          —

                                          the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,

                                          —

                                          maximum capacity, in the form Max …,

                                          —

                                          minimum capacity, in the form Min …,

                                          —

                                          verification scale interval, in the form e = …,

                                          —

                                          the last two digits of the year in which the ‘CE’ conformity marking was affixed,

                                    plus, when applicable:

                                          —

                                          serial number,

                                          —

                                          for instruments consisting of separate but associated units: identification mark on each unit,

                                          —

                                          scale interval if it is different from e, in the form d = …,

                                          —

                                          maximum additive tare effect, in the form T = + …,

                                          —

                                          maximum subtractive tare effect if it is different from Max, in the form T = – …,

                                          —

                                          tare interval if it is different from d, in the form dT
                                              = …,

                                          —

                                          maximum safe load if it is different from Max, in the form Lim …,

                                          —

                                          the special temperature limits, in the form … °C/… °C,

                                          —

                                          ratio between load receptor and load.

                  1.2.

                  The instruments shall have adequate facilities for the affixing of the ‘CE’ conformity marking and/or inscriptions. These shall be such that it shall be impossible to remove the marking and inscriptions without damaging them, and that the marking and inscriptions shall be visible when the instrument is in its regular operating position.

                  1.3.

                  Where a data plate is used it shall be possible to seal the plate unless it cannot be removed without being destroyed. If the data plate is sealable it shall be possible to apply a control mark to it.

                  1.4.

                  The inscriptions Max, Min, e, and d, shall also be shown near the display of the result if they are not already located there.

                  1.5.

                  Each load measuring device which is connected or can be connected to one or more load receptors shall bear the relevant inscriptions relating to the said load receptors.

            2.   Other instruments
      The other instruments must bear:

                  —

                  the manufacturer’s mark or name,

                  —

                  maximum capacity, in the form Max ….

            Those instruments may not bear the stickers provided for in point 1.1(b).
      3.   Restrictive use symbol specified in Article 13
      That symbol shall be constituted by a capital letter ‘M’ printed in black on a red background at least 25 mm × 25 mm square with two intersecting diagonals forming a cross.

      ANNEX V

         The minimum criteria to be applied by member states when designating bodies for the carrying-out of tasks pertaining to the procedures referred to in article 9

                  1.

                  The bodies shall have at their disposal the necessary personnel, means and equipment.

                  2.

                  The personnel of the bodies shall have technical competence and professional integrity.

                  3.

                  The bodies shall work independently of all circles, groups or persons having a direct or indirect interest in non-automatic weighing instruments as regards the carrying-out of the tests, the preparation of the reports, the issuing of the certificates and the surveillance required by this Directive.

                  4.

                  The personnel of the bodies shall respect professional confidentiality.

                  5.

                  The bodies shall take out a civil liability insurance if their civil liability is not covered by the State under national law.

            The fulfilment of the conditions under points 1 and 2 shall be periodically verified by the Member States.

      ANNEX VI

         ‘CE’ CONFORMITY MARKING

                  —

                  The ‘CE’ conformity marking shall consist of the initials ‘CE’ taking the following form:

                  —

                  If the ‘CE’ conformity marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

                  —

                  The various components of the ‘CE’ conformity marking must have substantially the same vertical dimension, which may not be less than 5 mm.

      ANNEX VII

         PART A

         Repealed Directive with its amendment

      (referred to in Article 17)

                  Council Directive 90/384/EEC
                  (OJ L 189, 20.7.1990, p. 1)

                  Council Directive 93/68/EEC
                  (OJ L 220, 30.8.1993, p. 1)

                  Article 1, point 7, and Article 8 only

         PART B

         List of time limits for transposition into national law and application

      (referred to in Article 17)

                  Directive

                  Time limit for transposition

                  Date of application

                  90/384/EEC

                  30 June 1992

                  1 January 1993 (1)

                  93/68/EEC

                  30 June 1994

                  1 January 1995 (2)

         (1)  In accordance with Article 15(3) of Directive 90/384/EEC Member States shall permit, during a period of 10 years from the date on which they apply the laws, regulations and administrative provisions adopted by the Member States in order to transpose that Directive into national law, the placing on the market and/or putting into service of instruments which conform to the rules in force before 1 January 1993.

         (2)  In accordance with Article 14(2) of Directive 93/68/EEC: ‘Until 1 January 1997, Member States shall allow the placing on the market and the bringing into service of products which comply with the marking arrangements in force before 1 January 1995’.

      ANNEX VIII

         CORRELATION TABLE

                  Directive 90/384/EEC

                  This Directive

                  Recital 5, last sentence

                  Article 2, point (3)

                  Article 1(1), first subparagraph

                  Article 2, point (1)

                  Article 1(1), second subparagraph

                  Article 2, point (2)

                  Article 1(1), third subparagraph

                  Article 1(1)

                  Article 1(2), introductory wording

                  Article 1(2), introductory wording

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

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

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

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

                  Article 1(2), point (a)(3)

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

                  Article 1(2), point (a)(4)

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

                  Article 1(2), point (a)(5)

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

                  Article 1(2), point (a)(6)

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

                  Article 1(2), point (b)

                  Article 1(2), point (b)

                  Article 2

                  Article 3

                  Article 3

                  Article 4

                  Article 4

                  Article 5

                  Article 5

                  Article 6

                  Article 6, first paragraph, first sentence

                  Article 7, first paragraph

                  Article 6, first paragraph, second sentence

                  Article 7, second paragraph

                  Article 6, second paragraph

                  Article 7, third paragraph

                  Article 7

                  Article 8

                  Article 8(1) and (2)

                  Article 9(1) and (2)

                  Article 8(3), point (a)

                  Article 9(3), first subparagraph

                  Article 8(3), point (b)

                  Article 9(3), second subparagraph

                  Article 9

                  Article 10

                  Article 10

                  Article 11

                  Article 11

                  Article 12

                  Article 12

                  Article 13

                  Article 13

                  Article 14

                  Article 14, first sentence

                  Article 15, first paragraph

                  Article 14, second sentence

                  Article 15, second paragraph

                  Article 15(1) to (3)

                  —

                  Article 15(4)

                  Article 16

                  Article 15(5)

                  —

                  —

                  Article 17

                  —

                  Article 18

                  Article 16

                  Article 19

                  Annexes I to VI

                  Annexes I to VI

                  —

                  Annex VII

                  —

                  Annex VIII


Avis juridique important

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31988L0610

Council Directive 88/610/EEC of 24 November 1988 amending Directive 82/501/EEC on the major-accident hazards of certain industrial activities

Official Journal L 336 , 07/12/1988 P. 0014 - 0018 Finnish special edition: Chapter 15 Volume 9 P. 0039  Swedish special edition: Chapter 15 Volume 9 P. 0039

COUNCIL DIRECTIVE of 24 November 1988 amending Directive 82/501/EEC on the major-accident hazards of certain industrial activities (88/610/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 130s thereof,  Having regard to the proposal from the Commission(1),  Having regard to the opinion of the European Parliament(2),  Having regard to the opinion of the Economic and Social Comittee(3),  Whereas the protection of man and the environment calls for the provisions of Directive 82/501/EEC(4), as last amended by Directive 87/216/EEC(5), to be strengthened with regard to the storage of dangerous substances or preparations;  Whereas the present amendment to Directive 82/501/EEC extends and strengthens Annex II of that Directive concerning the storage of dangerous substances or preparations, whether in bulk or in packaged form;  Whereas the storage of dangerous substances or preparations may present a major-accident hazard both when the storage is associated with an industrial operation and when the storage is isolated or located within an installation, without being associated  with an industrial operation;  Whereas the storage of dangerous substances or preparations to which Directive 82/501/EEC must be applied can be identified by a list of chemical names or by a list of categories of danger according to the classification and labelling requirements laid  down in other relevant Community Directives, together with their respective threshold quantities; whereas such categories of substances or preparations should be the ones classified as ´very toxic', ´toxic', ´explosive', ´oxidizing', ´extremely  flammable' and ´highly flammable';  Whereas the provisions with regard to information to the public laid down in Article 8 of Directive 82/501/EEC need to be strengthened and better defined in order to ensure that any person liable to be affected by a major accident originating in a  notified industrial activity within the meaning of Article 5 of that Directive is appropriately and effectively informed, in a harmonized way throughout the whole Community, on all matters relating to safety; whereas area and persons liable to be  affected are defined by reference to the nature, extent and likely effects of possible major accidents occuring in the industrial activities;  Whereas it is necessary that the content of the information referred to in Article 8 of Directive 82/501/EEC shall be clearly specified; whereas, in order to mitigate the consequences of a major accident, the persons concerned need to know the potential  hazards and the measures to be taken; whereas it is necessary that such information has to be communicated on an active basis to the persons concerned, without a request being made, through some kind of public information media, such as leaflets or  information boards;  Whereas, in its Resolution adopted on 24 November 1986, the Council invited the Commission to review the Community measures for the prevention of major accidents and the limitation of their consequences and, if necessary, to present appropriate  proposals;  Whereas the Commission will present a proposal for a complete and systematic revision of the Annexes of Directive 82/501/EEC once further experience has been obtained;  Whereas the Advisory Committee on Safety, Hygiene and Health Protection at Work, set up by Decision 74/325/EEC(6), has been consulted,   HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 82/501/EEC is hereby amended as follows:  1.Article 8 (1) shall be replaced by the following:  ´1.  Member States shall ensure that information on safety measures and on the correct behaviour to adopt in the case of an accident is supplied in an appropriate manner, and without their having to request it, to persons liable to be affected by a major accident originating in a notified industrial activity within the meaning of Article 5. The information  shall be repeated and updated at appropriate intervals. It shall also be made publicly available.  Such information shall contain that laid down in Annex VII.' 2.Annex II shall be replaced by that in Annex A to this Directive.  3.The following shall be added to Annex IV:  ´e)Oxidizing substances:  Substances which give rise to highly exothermic reaction when in contact with other substances, particularly flammable substances'.  4.Annex VII, which appears in Annex B to this Directive, shall be added.  Article 2  1.  In the case of existing industrial activities which will be subject to the provisions of Directive 82/501/EEC for the first time following adoption of this Directive, this Directive shall apply at the latest on 1 June 1991.  2.  In the case provided for in paragraph 1, the declaration provided for in Article 9 (3) of Directive 82/501/EEC shall be submitted to the competent authority at the latest on 1 June 1991 and the supplementary declaration provided for in Article 9 (4) of the said Directive shall be submitted to the competent authority at the latest on 1 June 1994.  Article 3  1.  Member States shall take the measures necessary to comply with this Directive at the latest on 1 June 1990. They shall forthwith inform the Commission thereof.  2.  Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.  Article 4  This Directive is addressed to the Member States.   Done at Brussels, 24 November 1988.  For the CouncilThe PresidentV. KEDIKOGLOU  (1)OJ No. C 119, 6. 5. 1988, p. 2.  (2)OJ No C 290, 14. 11. 1988.  (3)OJ No C 208, 8. 8. 1988, p. 5.  (4)OJ No L 230, 5. 8. 1982, p. 1.  (5)OJ No L 85, 28. 3. 1987, p. 36.  (6)OJ No L 185, 9. 7. 1974, p. 15.    ANNEX A  ANNEX II  STORAGE OTHER THAN OF SUBSTANCES LISTED IN ANNEX III ASSOCIATED WITH AN INSTALLATION REFERRED TO IN ANNEX I This Annex applies to storage of dangerous substances and/or preparations at any place, installation, premises, building or area of land, isolated or within an establishment, being a site used for the purpose of storage, except where that storage is  associated with an installation covered by Annex I and where the substances in question appear in Annex III.  The quantities set out below in Parts I and II relate to each store or group of stores belonging to the same manufacturer where the distance between the stores is not sufficient to avoid, in foreseeable circumstances, any aggravation of major-accident  hazards. These quantities apply in any case to each group of stores belonging to the same manufacturer where the distance between the stores is less than 500 m.  The quantities to be considered are the maximum quantities which are, or are liable to be, in storage at any one time.  PART I Named substances Where a substance (or a group of substances) listed in Part I also falls within a category of Part II, the quantities set out in Part I must be used.   1.Acrylonitrile   20   200  2.Ammonia   50   500  3.Chlorine   10    75  4.Sulphur dioxide   25   250  5.Ammonium nitrate (¹)  350 2 500  6.Ammonium nitrate in the form of fertilizers (²)1 25010 000  7.Sodium chlorate   25   250  8.Oxygen  200 2 000  9.Sulphur trioxide   15   100 10.Carbonyl chloride (Phosgene)    0,750     0,750 11.Hydrogen sulphide    5    50 12.Hydrogen fluoride    5    50 13.Hydrogen cyanide    5    20 14.Carbon disulphide   20   200 15.Bromine   50   500 16.Acetylene    5    50 17.Hydrogen    5    50 18.Ethylene oxide    5    50 19.Propylene oxide    5    50 20.2-Propenal (Acrolein)   20   200 21.Formaldehyde (concentration 8 90 %)    5    50 22.Bromomethane (Methyl bromide)   20   200 23.Methyl isocyanate    0,150     0,150 24.Tetraethyl lead or tetramethyl lead    5    50 25.1,2 Dibromoethane (Ethylene dibromide)    5    50 26.Hydrogen chloride (liquefied gas)   25   250 27.Diphenyl methane di-isocyanate (MDI)   20   200 28.Toluene di-isocyanate (TDI)   10   100 (¹)This applies to ammonium nitrate and mixtures of ammonium nitrate where the nitrogen content derived from the ammonium nitrate is greater than 28 % by weight and aqueous solutions of ammonium nitrate where the concentration of ammonium nitrate is  greater than 90 % by weight.  (²)This applies to straight ammonium nitrate fertilizers which comply with Directive 80/876/EEC and to compound fertilizers where the nitrogen content derived from the ammonium nitrate is greater than 28 % by weight (a compound fertilizer contains  ammonium nitrate together with phosphate and/or potash).   7. 12. 88No L 336/Categories of substances and preparations (2)Quantity (tonnes) 8 for application of Articles 3 und 4 for application of Article 5 (3) PART II Categories of substances and preparations not specifically named in part I The quantities of different substances and preparations (1) of the same category are cumulative. Where there is more than one category specified in the same entry, the quantities of all substances and preparations of the specified categories in that  entry must be summed up.  1.Substances and preparations that are classified as ´very toxic'520 2.Substances and preparations that are classified as ´very toxic', ´toxic' (4), ´oxydizing' or ´explosive'10200 3.Gaseous substances and preparations including those in liquefied form, which are gaseous at normal pressure and which are classified as ´highly flammable' (5)50200 4.Substances and preparations (excluding gaseous substances and preparations covered under item 3 above) which are classified as ´highly flammable' or ´extremely flammable' (6)5 00050 000 1Preparations are mixtures or solutions consisting of two or more substances (Directive 79/831/EEC).  2The categories of substances and preparations are as defined in the following Directives and their amendments:  -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,  -Council Directive 73/173/EEC of 4 June 1973 on the approximation of Member States' laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (solvents),  -Council Directive 77/728/EEC of 7 November 1977 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of paints, varnishes, printing inks, adhesives and  similar products,  -Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides),  -Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations.  3Articles 5 (1) (a) and 5 (1) (b), third indent, apply where appropriate.  4Where the substances and preparations are in a state which gives them properties capable of creating a major-accident hazard.  5This includes flammable gases as defined in Annex IV (c) (i).  6This includes highly flammable liquids as defined in Annex IV (c) (ii).      ANNEX B  ANNEX VII  ITEMS OF INFORMATION TO BE COMMUNICATED TO THE PUBLIC IN APPLICATION OF ARTICLE 8 (1) (a)Name of company and address of site.  (b)Identification, by position held, of the person giving the information.  (c)Confirmation that the site is subject to the regulations and/or administrative provisions implementing the Directive and that the notification referred to in Article 5 or at least the declaration provided for in Article 9 (3) has been submitted to  the competent authority.  (d)An explanation in simple terms of the activity undertaken on the site.  (e)The common names or, in the case of storage covered by Part II of Annex II, the generic names or the general danger classification of the substances and preparations involved on site which could give rise to a major accident, with an indication of  their principal dangerous characteristics.  (f)General information relating to the nature of the major-accident hazards, including their potential effects on the population and the environment.  (g)Adequate information on how the population concerned will be warned and kept informed in the event of an accident.  (h)Adequate information on the actions the population concerned should take, and on the behaviour they should adopt, in the event of an accident.  (i)Confirmation that the company is required to make adequate arrangements on site, including liaison with the emergency services, to deal with accidents and to minimize their effects.  (j)A reference to the off-site emergency plan drawn up to cope with any off-site effects from an accident. This should include advice to cooperate with any instructions or requests from the emergency services at the time of an accident.  (k)Details of where further relevant information can be obtained, subject to the requirements of confidentiality laid down in national legislation.'   ANNEX I   CEILINGS AND REDUCTION TARGETS FOR EMISSIONS OF SO2 FROM EXISTING PLANTS (¹) (²)  0123456789Member StateSO2 emissions by large combustion plants 1980 ktonnesEmission ceiling (ktonnes/year)% reduction over 1980 emissions % reduction over adjusted 1980 emissions Phase 1Phase 2Phase 3Phase 1Phase 2Phase 3Phase 1Phase 2Phase 3199319982003199319982003199319982003Belgium530318  212  159  - 40- 60-70-40-60-70 Denmark323213  141  106  - 34- 56-67-40-60-70 Germany2 2251 335  890  668  - 40- 60-70-40-60-70 Greece303320  320  320  +  6+  6+ 6-45-45-45 Spain2 2902 290  1 730  1 440     0- 24-37-21-40-50 France1 9101 146  764  573  - 40- 60-70-40-60-70 Ireland99124  124  124  + 25+ 25+25-29-29-29 Italy2 4501 800  1 500  900  - 27- 39-63-40-50-70 Luxembourg31,81,51,5- 40- 50-60-40-50-50 Netherlands299180  120  90  - 40- 60-70-40-60-70 Portugal115232  270  206  +102+135+79-25-13-34 United Kingdom3 8833 106  2 330  1 553  - 20- 40-60-20-40-60 ;Additional emissions may arise from capacity authorized on or after 1 July 1987.  $Emissions coming from combustion plants authorized before 1 July 1987 but not yet in operation before that date and which have not been taken into account in establishing the emission ceilings fixed by this Annex shall either comply with the  requirements established by this Directive for new plants or be accounted for in the overall emissions from existing plants that must not exceed the ceilings fixed in this Annex.      ANNEX II    CEILINGS AND REDUCTION TARGETS FOR EMISSIONS OF NOx FROM EXISTING PLANTS (¹) (²)  0123456Member StateNOx emissions (as NO2 by large combustion plants 1980 (ktonnes) NOx emission ceilings (ktonnes/year)% reduction over 1980 emissions % reduction over adjusted 1980 emissions Phase 1Phase 2Phase 1Phase 2Phase 1Phase 21993 (³)19981993 (³)19981993 (³)1998Belgium11088  66  - 20- 40-20-40 Denmark124121  81  -  3- 35-10-40 Germany870696  522  - 20- 40-20-40 Greece3670  70  + 94+ 9400 Spain366368  277  +  1- 24-20-40 France400320  240  - 20- 40-20-40 Ireland2850  50  + 79+ 7900 Italy580570  428  -  2- 26-20-40 Luxembourg32,41,8- 20- 40-20-40 Netherlands12298  73  - 20- 40-20-40 Portugal2359  64  +157+178- 80 United Kingdom1 016864  711  - 15- 30-15-30 ;Additional emissions may arise from capacity on or after 1 July 1987.  $Emissions coming from combustion plants authorized before 1 July 1987 but not yet in operation before that date and which have not been taken into account in establishing the emission ceilings fixed by this Annex shall either comply with the  requirements established by this Directive for new plants or be accounted for in the overall emissions from existing plants that must not exceed the ceilings fixed in this Annex.  =Member States may for technical reasons delay for up to two years the phase 1 date for reduction in NOx emissions by notifying the Commission within one month of the notification of this Directive.      ANNEX III      ANNEX IV      ANNEX V    EMISSION LIMIT VALUES FOR SO2 FOR NEW PLANTS Gaseous fuels  Type of fuelLimit values (mg/Nm³)Gaseous fuels in general 35 Liquefied gas  5 Low calorific gases from gasification of refinery residues, coke oven gas, blast-furnace gas800 Gas from gasification of coal(¹) ;The Council will fix the emission limit values applicable to such gas at a later stage on the basis of proposals from the Commission to be made in the light of further technical experience.      ANNEX VI    EMISSION LIMIT VALUES FOR NOx FOR NEW PLANTS  Type of fuelLimit values (mg/Nm³)Solid in general  650 Solid with less than 10 % volatile compounds 1 300 Liquid  450 Gaseous  350     ANNEX VII    EMISSION LIMIT VALUES FOR DUST FOR NEW PLANTS  Type of fuelThermal capacity (MW)Emission limit values (mg/Nm³) Solid 8 500 < 500  50 100 Liquid (¹)all plants 50 Gaseousall plants  5as a rule 10for blast furnace gas 50for gases produced by the steel industry which can be used elsewhere ;A limit value of 100 mg/Nm³ may be applied to plants with a capacity of less than 500 MWth burning liquid fuel with an ash content of more than 0,06 %.      ANNEX VIII


title: Commission Directive 2008/70/EC of 11 July 2008 amending Council Directive 91/414/EEC to include tritosulfuron as an active substance (Text with EEA relevance)

text:
               12.7.2008

               EN

               Official Journal of the European Union

               L 185/40

      COMMISSION DIRECTIVE 2008/70/EC
   of 11 July 2008
   amending Council Directive 91/414/EEC to include tritosulfuron as an active substance
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               In accordance with Article 6 (2) of Directive 91/414/EEC Germany received on 8 June 2001 an application from BASF AG for the inclusion of the active substance tritosulfuron in Annex I to Directive 91/414/EEC. Commission Decision 2002/268/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (2)

               For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 5 September 2002.

               (3)

               For tritosulfuron the draft assessment reports were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 20 May 2008 in the format of the Commission review report for tritosulfuron.

               (4)

               The documents and information on tritosulfuron were also submitted to the European Food Safety Authority (EFSA) for separate consultation. The EFSA was invited to prepare a scientific opinion on the toxicological relevance of the soil and groundwater metabolite TBSA of tritosulfuron in the context of the human risk assessment. The EFSA was asked whether, on the basis of the data available, the metabolite TBSA shows a genotoxic potential or an indication of impaired fertility and what are the implications for toxicological reference values for humans.

               (5)

               In its opinion of 11 December 2007 (3), the EFSA concluded that TBSA did not show any clastogenic or other genotoxic potential and has no direct effect on fertility and that therefore there is no requirement for any adjustment of the default safety factor for potential effect on fertility. That opinion was taken into account.

               (6)

               It has appeared from the various examinations made that plant protection products containing the active substance concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include tritosulfuron in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive.

               (7)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing tritosulfuron to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (8)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (9)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish by 31 May 2009 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 June 2009.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   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 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing tritosulfuron as active substance by 31 May 2009. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to tritosulfuron, are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing tritosulfuron as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 November 2008 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning tritosulfuron. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing tritosulfuron as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2010 at the latest; or

               (b)

               in the case of a product containing tritosulfuron as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 December 2008.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 11 July 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2008/45/EC (OJ L 94, 5.4.2008, p. 21).

      (2)  OJ L 92, 9.4.2002, p. 34.

      (3)  Scientific Opinion of the Panel on Plant Protection Products and their Residues (PPR Panel) on a request from the European Commission on the toxicological relevance of the soil and groundwater metabolite TBSA of tritosulfuron in the context of the human risk assessment. The EFSA Journal (2007) 621, pp. 1-33.

      ANNEX
      In Annex I to Directive 91/414/EEC the following rows are added at the end of the table:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘192

                     Tritosulfuron
                     CAS No 142469-14-5
                     CIPAC No 735

                     1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea

                     ≥ 960 g/kg
                     The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material:
                     2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg

                     1 December 2008

                     30 November 2018

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

                                 —

                                 the protection of aquatic organisms,

                                 —

                                 the protection of small mammals.

                           Conditions of use shall include risk mitigation measures, where appropriate.’

         (1)  Further details on identity and specification of active substances are provided in the review report.