CELEX: 51974PC2173
Language: en
Date: 1974-12-20
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO CERAMIC ARTICLES INTENDED TO COME INTO CONTACT WITH FOOD

27. 2. 75                            Official Journal of the European Communities                          N o C 46/1
                                                            II
                                                   (Preparatory Acts)
                                               COMMISSION
              Proposal for a Council Directive on the approximation of the laws of the Member
              States relating to ceramic articles intended to come into contact with food (limitation of
                                     extractable quantities of lead and cadmium)
                        (Submitted to the Council by the Commission on 31 December 1974)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                        Whereas these obstacles may be eliminated if the
                                                                placing of ceramic articles on the market on a
                                                                Community-wide basis is made subject to uniform
Having regard to the Treaty establishing the                    rules; whereas it is therefore necessary to harmonize
European Economic Community, and in particular                  the limit values, the test and analysis methods and
Article 100 thereof;                                            the wording shown on the labels and markings or the
                                                                documents which accompany ceramic articles when
Having regard to the proposal from the Commission;              they are marketed;
Having regard to the Opinion of the European                    Whereas the recent demonstration of the effect of
Parliament;                                                     luminescent radiation on the extraction of cadmium
                                                                requires the development of a specific test method
Having regard to the Opinion of the Economic and                and it will consequently be necessary to provide,
Social Committee;                                               at a later stage, for revision of both the proposed
                                                                method and the limits in order to take account of the
                                                                results of the studies in progress;
Whereas the Council Directive of . . . on the
approximation of the laws of the Member States
relating to substances intended to come into contact            Whereas the same applies to the effect of temperature
with food provides, in its Article 4, that specific             in the case of vessels for baking;
Directives will state the special provisions applicable
to certain groups of substances and articles;
                                                                Whereas, irrespective of the number of articles
Whereas in most of the Member States, ceramic                   selected when official tests are carried out in the
articles intended to come into contact with food are            Member States, the limit values adopted are
subject to mandatory provisions, aimed at protecting            maximum values with which any article taken
human health, relating to the limitation of the                 individually must comply;
extractable quantities of lead and cadmium;
                                                                Whereas technical progress requires frequent
Whereas these provisions vary from one Member                   adaptation of the technical specifications laid down
State to another, thus creating obstacles to                    in the Annexes to the Directive and whereas it is
establishment and functioning of the common                     advisable in order to facilitate the implementation of
market;                                                         the measures required for this purpose, to lay down a
 ---pagebreak--- No C 46/2                            Official Journal of the European Communities                              27. 2.75
procedure establishing close cooperation between the                                   Article 3
Member States and the Commission within the
Committee for Adaptation to Technical Progress and             1.     At any marketing stage, any ceramic article
in the sector of ceramic articles;                             tested in the manner laid down in Annex II shall be
                                                               such that the quantities of lead and cadmium do not
Whereas it could happen that a ceramic article which           exceed, according to the case, the following limit
                                                               values:
is intended to come into contact with food, although
conforming to the provisions of this Directive,
 endangers public health; whereas it is, therefore,            (a) Tableware and kitchenware:
 advisable to provide a procedure intended to remove
 this danger,                                                        — flatware:
                                                                          lead              1 ± 0-05 mg/dm 2 ,
                                                                          cadmium           0-1 ± 0-005 mg/dm 2 ;
                                                                     — hollow ware articles with a capacity of up to
 HAS ADOPTED THIS DIRECTIVE:                                              five litres:
                                                                           lead              5 ± 0-25 mg/1,
                                                                           cadmium           0-5 ± 0-025 mg/1.
                           Article 1
                                                                (b) Plates specially       designed   for  very    young
  The requirements of this Directive shall apply to                   children:
  ceramic articles which are made according to the
  general principles laid down in Annex I and are                          lead              2-5 ± 0-25 mg/1,
  intended to come into contact with food; such                             cadmium          0-25 ± 0-025 mg/1.
                                               1
  articles comprise:
                                                                 (c) Cooking ware:
  — tableware and kitchenware,
                                                                      — flatware:
  — plates specially designed for very young children,
                                                                            lead             0'5 ± 0-025 mg/dm 2 ,
  — cooking ware,                                                           cadmium           0*05 ± 0-0025 mg/dm 2 ;
  — packaging and storage vessels,                                    — hollow ware articles:
                                                                            lead              2\5 ± 0-25 mg/1,
   or any other article which may be employed for these                     cadmium           0-25 ± 0-025 mg/1.
   purposes except if a direction to the contrary is duly
   stated on the article itself in a clear and perfectly          (d) Packaging and storage vessels:
   visible fashion. These articles are hereinafter called
   'ceramic articles used for food'.                                   lead                   2-5 ± 0'25 mg/1,
                                                                       cadmium                0-25 ± 0-025 mg/1.
                            Article 2                             2.     Ceramic articles used for food with a capacity
                                                                  of over five litres which normally come within the
                                                                  category 'tableware and kitchenware' shall, for the
   1.     Member States shall take all appropriate                purposes of this Directive, be deemed to be storage
    measures to ensure that ceramic articles used for food        vessels.
    are not marketed unless they satisfy the requirements
    of this Directive and its Annexes.
                                                                  3.     When a ceramic article used for food consists of
                                                                  a vessel fitted with a lid, the inner surface of the lid
   2.     They shall also take all appropriate measures to        shall be tested under the same conditions as the
    ensure that ceramic articles which have the                   vessel itself.
    appearance of the articles listed in Article 1, but
    which are not ceramic articles as meant in this               In this case the level of extraction of lead and/or
    Directive, are not marketed unless they bear                  cadmium shall be calculated by relating the total
    appropriate markings.                                         extraction obtained to the vessel alone, adding the
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extraction obtained for the lid to the extraction             requirements, Member States shall not prohibit or
obtained for the vessel alone.                                impede the placing of ceramic articles on the market
                                                              if these articles satisfy the provisions of this Directive
                                                              and its Annexes.
4.    A ceramic article used for food shall be
recognized as satisfying the requirements of this
Directive as regards limits if, after a single test, the
quantities of lead and cadmium extracted in the                                         Article 6
manner laid down in Annex II are equal to or lower
than the corresponding limit values stated in                 1.    If a Member State finds that a ceramic article-
paragraph 1.                                                  which is intended to come into contact with food,
                                                              although complying with the requirements of the
                                                              Directive, constitutes a danger to health, that State
5.    The method of analysis described in Annex III
                                                              may provisionally forbid the placing of the product
is the reference method for the quantitative
                                                              on the market in its territory. It shall forthwith inform
determination of lead and/or cadmium extracted by
                                                              the Commission and the other Member States thereof
the leaching solution during the test.
                                                              and state the reasons for its decision.
                          Article 4                           2.    The Commission shall, within six weeks,
                                                              consult the Member States concerned and then,
                                                              without delay, express its opinion and take the
1.    When marketed, ceramic articles within the              appropriate measures.
meaning of this Directive shall be labelled or marked.
Such labelling or marking may be replaced or
                                                              3.    Where the Commission is of the opinion that
supplemented by accompanying commercial literature
                                                              technical adaptations to the Directive prove
when these products are not offered for sale to the
                                                              necessary, such adaptations shall be adopted by
final consumer.
                                                              either the Commission, or by the Council under the
                                                              procedure laid down in Article 8. In this event, the
2.    The labelling 'or marking shall contain the             Member State having adopted safeguard measures
following information in readily legible and clearly          may maintain them until such adaptations enter into
visible characters:                                           force.
(a) the name or trade name and the address or,
     where appropriate, the registered trade mark of                                    Article 7
     the producer or the importer of the person
     responsible for placing the article on the market;
                                                              1.    A      committee       (hereinafter    called    the
 (b) where appropriate, the words 'for children';             'committee'), is hereby set up to adapt to technical
                                                              progress Directives which concern the elimination of
(c) where appropriate, the words 'for cooking';               technical barriers to trade in the sector of ceramic
                                                              articles. It shall consist of representatives of the
(d) where appropriate, in the case of packaging sold          Member States with a representative of the
     empty to the final consumer and with a capacity          Commission as chairman.
     of up to five litres, the word 'packaging'.
                                                              2.    The committee shall adopt its own rules of
3.    Member States may require that at the time of           procedure.
offer and sale to the final consumer in their
territories, the labelling or marking specified in this
                                                              3.    Amendments needed technically to adapt the
Article shall also, be expressed in their national
                                                              provisions of this Directive and its Annexes shall be
languages.
                                                              adopted in accordance with the procedure laid down
                                                              in Article 8.
In this case this requirement shall apply only to the
labels and packaging of ceramic articles.
                                                                                        Article 8
                          Article 5
                                                              1.    Where the procedure laid down in this Article is
                                                              followed, matters shall be referred to the Committee
For reasons concerning the extraction limits for lead         by the Chairman, either on his own initiative or at
and/or cadmium and the labelling or marking                   the request of the representative of a Member State.
 ---pagebreak--- No C 46/4                             Official Journal of the European Communities                                27. 2. 75
2.    The representative of the Commission shall                                              Article 9
submit to the committee a draft of the measures to be
adopted. The committee shall deliver its Opinion of                 1.     Member States shall adopt and publish before
the draft within a time limit set by the chairman,                  1 January 1977 the provisions needed to comply with
having regard to the urgency of the matter. Opinions                this Directive and shall forthwith inform the
shall be adopted by a majority of 41 votes, the votes               Commission thereof.
of Member States being weighted as provided in
Article 148 (2) of the Treaty.
                                                                    They shall implement these provisions as from 1 July
The chairman shall not vote.                                        1977.
3. (a) The Commission shall adopt the measures                      2.     As soon as this Directive is notified, the
        envisaged where they are in accordance with                 Member States shall also take care to inform the
        the Opinion of the committee.                               Commission, in time to enable it to make its
                                                                    observations, of any proposed provisions, to be laid
   (b) If no opinion is adopted, the Commission
                                                                    down by law, regulation or administrative action,
        shall without delay propose to the Council the
                                                                    which they propose adopting in the field governed by
        measures to be adopted.
                                                                    the Directive.
        The Council shall act by a qualified majority.
   (c) If, within three months of the proposal being
                                                                                             Article 10
        submitted to it, the Council has not acted, the
        proposed measures shall be adopted by the
        Commission.                                                 This Directive is addressed to the Member States.
                                                           ANNEX     I
                                          MANUFACTURE OF CERAMIC ARTICLES
                                                        General principles
              The ceramic articles listed in Article 1 are manufactured f r o m a mixture of inorganic substances
              normally comprising a high proportion of argillaceous or siliceous minerals. A small quantity of
              organic substance may be added to this mixture in certain cases.
              These articles are first of all shaped and the shape thus obtained is permanently fixed by firing.
              Thereafter, they may or may not be coated with coloured or uncoloured glazes and/or
              decorations.
              Ceramic articles manufactured in this way are often described by the following terms:
              faience — pottery — porcelain — bone china — whiteware — earthenware — stoneware — etc.
 ---pagebreak--- 27. 2. 75                           Official Journal of the European Communities                              N o C 46/5
                                                        ANNEX     11
                                                     TEST METHOD
          1. Simulating solvent
              (a) Nature:
                   The simulating solvent to be used in the extraction of lead and cadmium from ceramic
                   articles used as food containers is a 4 % by volume acetic acid solution.
              (b) Preparation of the solution:
                  The 4 % by volume acetic acid solution is obtained by adding 40 ml of glacial acetic acid
                   to 960 ml of distilled water or water of equivalent quality.
          2. Preparation of the samples
             The sample must be clean and free from grease or other matter likely to affect the test.
             The sample is accordingly washed at a temperature of about 40° C with a solution obtained
             from a liquid detergent.
             The sample thus washed is first of all rinsed in tapwater and then in distilled water or water
             of equivalent quality.
             It is then drained and dried either in a drying oven or by means of a new filter paper so as
             to avoid any stain.
             After being cleansed in this way, the sample must be so handled that the surface to he tested
             does not come into contact with the hands of the person carrying out the test.
          3. Filling
             To avoid loss of liquid due to accidental spillage, which could distort the test results, and
             also in order that the sample may be covered with a suitable means of protection, the level of
              the liquid must be not more than 1 mm from the overflow point. For articles with a flat rim,
              the distance between the surface of the liquid and the overflow point must not be more than
             6 mm.
          4. Flatware
             (a) Definition:
                  Ceramic articles to be classified as flatware are those of which the internal depth, as
                  measured from the lowest point to the horizontal plane passing through the upper rim,
                  does not exceed 25 mm.
             (b) Determination of the surface area:
                  In the case of ceramic flatware, the extraction limit for lead and/or cadmium is related to
                  the surface of the menisans formed by the free liquid surface obtained by complying with
                  the filling requirements set out in Section 3 above.
          5. Lighting
             After being prepared in the manner described in Section 2, the sample is placed on a flat
             horizontal surface, filled as laid down in Section 4 with a 4 % by volume acetic acid solution
             prepared as described in Section 1 (b).
             The lighting conditions during the test shall be as follows:
             (a) Lead extraction:
                  "When only the extractability of lead is tested, the article shall be covered with an
                  appropriate means of protection and exposed to the usual conditions of illumination in a
                  laboratory.
 ---pagebreak--- No C 46/6                       Official Journal of the European Communities                                  27. 2.75
             (b) Lead and!or cadmium extraction:
                 When the extractability of lead and/or cadmium is tested, the article shall be covered
                 with a watch glass of a quality normally employed in chemical analysis laboratories and
                 exposed to the following conditions of illumination:
                 — for a unit period of 24 hours the room in which the test is carried out shall be
                     illuminated for five hours, kept in darkness for 14 hours and then illuminated for the
                     remaining five hours;
                 — during the two, five-hour periods of illumination, the room shall be illuminated solely
                     with fluorescent lamps of the Philips 'Daylight MCFE.33' type or tubes with
                     equivalent characteristics. These lamps will have to be placed at a height of some
                     1-5 m above the bench so as to give uniform illumination of approximately 1 000 ±
                     10 % lux.
          6. Temperature
             An ambient temperature of 22 ± 2° C shall be maintained in the place where the test is
             being carried out.
          7. Duration
             The duration of the test will be 24 hours, in the conditions set out in Section 5 (a) or (b),
             according to the type of test carried out.
                                                      ANNEX     111
                                              METHOD OF ANALYSIS
          1. Sampling of the test solution for analysis
             Prior to sampling of the test solution to determine the lead and/or cadmium concentration,
             the contents of the ceramic article to be tested are homogenized by an appropriate method
             for obviating any loss of solution and any abrasion of the surface of the article to be tested.
          2. Method of analysis
             The quantity of the lead and/or cadmium extracted by the solvent during the test is
             determined by the atomic absorption method with the aid of a flame spectrophotometer, the
             instrument having a sensitivity of at least one-tenth of the lowest limit fixed for the elements
             to be determined. This sensitivity is defined as the concentration of elements which gives rise
             to an absorption of 1 %.
             The determinations must be carried out in correspondence with the linear part of the
             instrument's calibration curve plotted by means of reference solutions. In the case of the
             concentrations of lead and/or cadmium in the test solution which lie outside the linear part
             of the calibration curve, prior dilution with 4 % by volume acetic acid will have to be carried
              out in order to work with a concentration corresponding to the linear part of the calibration
             curve.
             In order to plot the calibration curve, the reference solutions to be employed will have to be
             prepared prior to each calibration using concentrated stock solutions (at least 1 000 ppm for
             lead and 100 ppm for Qadmium) which are diluted with freshly prepared 4 % by volume
             acetic acid.
             Prior to any calibration or analysis, a blank determination is carried out on a sample of 4 %
             by volume freshly prepared acetic acid in order to take into consideration any quantities of
             lead and/or cadmium present in the glacial acetic acid and/or the water employed.