CELEX: 51981PC0501
Language: en
Date: 1981-09-14
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON HEALTH PROBLEMS RELATING TO RESIDUES OF ANTIBIOTICS IN FRESH MEAT OF COMMUNITY ORIGIN

1. 10.81                        Official Journal of the European Communities                                       No C 251/7
                                                            ANNEX I
              CCT heading                                      Description of goods
                  No
               18.06         Chocolate and other food preparations containing cocoa
               19.03         Macaroni, spaghetti and similar products
                             A. Containing eggs
               19.08         Pastry, biscuits, cakes and other fine bakers' wares, whether or not containing
                             cocoa in any proportion
               21.07         Food preparations not elsewhere specified or included:
                             G. Other:
                                  I. containing no milkfats or containing less that 1 • 5 % by weight of such
                                     fats:
                                     (a) containing no sucrose or containing less than 5 % by weight of sucrose
                                           (including invert sugar expressed as sucrose):
                                          ex 1. containing no starch or containing less than 5 % by weight of
                                                  starch:
                                                  — Preparations known as 'long eggs', consisting in hens' eggs
                                                      cooked in the form of cylinders; the centre consists of the
                                                      egg yolks and is completely surrounded by the whites of the
                                                      eggs-
               22.09 C       Spirituous beverages:
                             ex V. Other:
                                     — Containing egg or egg yolk
               35.02 A       Albumins:
                             II. Other:
                                 ex a) Ovalbumin:
                                         1. Dried (for example, in sheets, scales, flakes, powder)
                                         2. Other
             Proposal for a Council Directive on health problems relating to residues of antibiotics in
                                               fresh meat of Community origin
                         (Submitted by the Commission to the Council on 23 September 1981)
THE COUNCIL OF THE EUROPEAN                                           Having regard       to the   opinion    of the European
COMMUNITIES,                                                          Parliament,
                                                                      Having regard to the opinion of the Economic and
Having regard to the Treaty establishing the                          Social Committee,
European Economic Community, and in particular
                                                                      Whereas, pursuant to Article 6 of Directive
Article 43 thereof,
                                                                      64/433/EEC (x), health problems relating to residues
Having regard to the proposal from the Commission,                    (*) OJ No 121, 29. 7. 1964, p. 2012/64.
 ---pagebreak--- No C 251/8                           Official Journal of the European Communities                             1. 10.81
of antibiotics arising in intra-Community trade in            HAS ADOPTED THIS DIRECTIVE:
fresh meat are subject to national law; whereas, in
order to remove any barriers to trade thereby perpe-
tuated, the Member States' provisions in this respect                                 Article 1
should be replaced by Community provisions;
                                                             In order to monitor the absence of residues of
                                                             antibiotics in or on fresh meat produced within the
                                                             Community and intended for human consumption the
Whereas a Community system of controls must be               Member States shall ensure that the provisions of this
created to cover all meat produced and put into circu-       Directive shall be applied.
lation in the Community;
Whereas for the uniform implementation of such a                                      Article 2
system of controls, the frequency of sampling, the
permissible tolerances and the measures to be taken if       The definitions contained in Directive 64/433/EEC
these tolerances are exceeded must be laid down;             shall also apply in respect of this Directive.
                                                             In addition, for the purposes of this Directive:
Whereas, for laying down the methods of analysis to
be used and amending the Annexes, a procedure                (a) 'residues of antibiotics' shall mean detectable
should be chosen which ensures close cooperation                  quantities of antibiotics and substances with a
between the Commission and the Member States;                     similar action or their metabolites in or on fresh
                                                                  meat;
                                                             (b) 'tolerance' shall mean the quantity of residues of
Whereas the purpose of all measures taken in cases of             antibiotics in or on fresh meat corresponding to
exceeding the tolerances, in particular the suspension            the limit of detection of the Community method
of slaughterings, shall be that only slaughter animals            of analysis.
free of residues of antibiotics are produced within the
Community;
                                                                                      Article 3
                                                              1.    Member States shall      ensure that fresh meat
Whereas it should be possible for owners of animals,         which has been produced         in the Community and
in respect of which the suspension of slaughtering is        which is intended for          human consumption is
ordered, to slaughter the animals before the expiry of       examined for residues of       antibiotics in accordance
the period of suspension on condition that each of the       with this Directive.
animals is inspected on slaughter to ensure that they
are free of residues of antibiotics;
                                                             2.    The examination for residues of antibiotics shall
                                                             be carried out during the slaughter procedure and in
                                                             connection with meat inspection on a random basis in
Whereas a Community system of surveillance is                accordance with the frequency of sampling laid down
necessary to monitor the application of this Directive;      in Annex I to this Directive. Care shall be taken to
                                                             ensure that the sampling is evenly distributed as
                                                             between the types of animals for slaughter and that it
Whereas provision should be made for meeting the             is carried out regularly.
cost of examinations for residues; whereas appro-
priate details of these arrangements should be decided       3.     The technical details for sampling and the
 on in accordance with a procedure which permits             methods of analysis to be applied shall be drawn up
 close cooperation between the Commission and the            in accordance with the procedure laid down in
 Member States;                                              Article 9.
                                                             4.     Notwithstanding the provisions of paragraph 2
Whereas the Member States should report to           the     the official veterinarian responsible for the exami-
Commission on their monitoring activities             in     nation of meat must, if he has information suggesting
application of the present Directive in order         to     the presence of residues of antibiotics in the carcases
provide a constant overall view of the inspections   for     presented for examination, examine each slaughtered
residues of antibiotics out in the Member States,            animal for residues of antibiotics.
 ---pagebreak--- 1. 10.81                           Official Journal of the European Communities                              No C 251/9
5.     Moreover, all slaughtered animals which are             These examinations shall not count towards the
subjected to a bacteriological examination shall be            number of random samples referred to in Article
examined for residues of antibiotics.                          3(2).
6.     Examinations under paragraphs 4 and 5 shall
not count towards the number of random samples                                          Article 5
required in accordance with paragraph 2.
                                                                1.    Any slaughtered animal which is examined for
                                                               residued of antibiotics shall be detained until the
                          Article 4                            results of the examination are available.
 1.    Where examination for residues of antibiotics           2.     If the result of the examination for antibiotics
pursuant to Article 3 shows that the tolerances have           shows that the tolerance has been exceeded, the
been exceeded the inspection office in question shall          whole slaughtered animal shall be deemed unfit for
inform the competent veterinary authorities without            human consumption and shall be safely condemned.
delay of:
(a) the species of animal, its breed, age and sex,
      together with all information needed to identify                                  Article 6
      with certainty the holding from which the animal
      came; and                                                By 31 March of the year following that under review,
                                                               the Member States shall provide the Commission with
(b) the result of the examination.                             a summary annual report on the examinations made
                                                               pursuant to this Directive, on the results of the
2.      The Member States shall thereupon ensure that:         examinations and on the measures taken, using the
                                                               form at Annex II to this Directive.
1. the competent veterinary authorities investigate the
    livestock on the farm of origin to ascertain the            The Commission shall inform the Member States of
    cause of the tolerance being exceeded;                      the results of the abovementioned communications.
2. the herd or animals which, as a result of the
    investigation referred to in subparagraph 1, may be
    assumed to contain residues of antibiotics are                                      Article 7
    provided with official markings,
                                                                The costs of analysis of samples for the detection of
3. their slaughter       for human consumption is               antibiotic residues shall be apportioned among the
    prohibited until    it may be assumed that the              total of slaughtered animals and shall be borne by the
    residues present   no longer exceed the tolerance,          persons having the power of disposition of the
    and in any case    until the end of the withdrawal          abovementioned animals. Nevertheless in the cases
    period fixed for   each residue in Annex I to this          foreseen in Article 3 (5), as well as in the case where
     Directive;                                                 analysis reveals that the tolerance level has been
                                                                exceeded, the costs of analysis of each sample shall be
4. the animals or herd whose slaughter is prohibited            fully borne by the person having the power of
     are not sold to third parties during the prohibition       disposition of animals concerned.
    period.
 3.     By way of derogation from paragraph 2, animals
                                                                                        Article 8
whose slaughter is prohibited may be slaughtered
 before the end of the suspension period if the owner
 informs the competent authority at least one week              1.     The Commission shall make regular on-the-spot
 before the proposed slaughter date, stating the place          checks to verify from a veterinary viewpoint whether
 of slaughter. The animals must be accompanied by an            the provisions of this Directive are applied.
 official veterinary certificate containing the infor-          Member States shall take the necessary steps to fa-
 mation required under paragraph 1 (a).                         cilitate these checks and shall in particular ensure that
                                                                the experts are supplied at their request with all infor-
 4.     The carcase of each animal whose slaughter is           mation and documentation needed for accessing the
 notified pursuant to paragraph 3 shall be examined             execution of the requirements of this Directive.
 for residues of antibiotics. The cost of any exami-
nation which shows that the tolerance has been                  2.     The provision for implementing this Article,
exceeded shall be borne by the owner.                           especially as regards the frequency and method of
 ---pagebreak--- No C 251/10                             Official Journal of the European Communities                               1. 10.81
carrying out the checks referred to in the first subpar-             Where they are not in accordance with the opinion of
agraph, the rules governing the appointment of                       the Committee or if no opinion is delivered, the
veterinary experts and the rules which they must                     Commission shall without delay submit to the
follow when drawing up their report, shall be laid                   Council a proposal on the measures to be adopted.
down according to the procedure laid down in                         The Council shall adopt the measures by a qualified
Article 9.                                                           majority.
                                                                     If the Council has not adopted any measures within
                          Article 9                                  three months from the date on which the proposal
                                                                     was submitted to it, the Commission shall adopt the
                                                                     proposed measures and shall apply them immediately,
1.    Where the procedure laid down in this Article is
                                                                     save in the case where the Council has decided
to be followed, the chairman shall without delay refer
                                                                     against these measures by a simple majority.
the matter, either on his own initiative or at the
request of a Member State, to the Standing
Veterinary Committee (hereinafter called 'the                                               Article 10
Committee') set up by the Council Decision of 15
October 1968.
                                                                     Such amendments to the Annexes to this Directive as
                                                                     may be required by the progress of scientific research
2.    Within the Committee, the votes of Member                      shall be made in accordance with the procedure laid
States shall be weighted as provided in Article 148 (2)              down in Article 9.
of the Treaty. The Chairman shall not vote.
3.    The Commission representative shall submit a                                          Article 11
draft of the measures to be adopted. The Committee
shall deliver its opinion on the measures within a                   The Member States shall bring into force the legal
period to be determined by the Chairman in keeping                   provisions necessary to comply with this Directive
with the urgency of the question submitted for exami-                and its Annexes on the 1 July 1982 and shall
nation. Opinions shall be delivered by a majority of                 forthwith inform the Commission thereof.
45 votes.
4.    The Commission shall adopt the measures and                                           Article 12
shall implement them immediately, where they are in
accordance with the opinion of the Committee.                        This Directive is addressed to the Member States.
                                                            ANNEX I
              For every 100 slaughter animals an examination shall be carried out on:
              — at least two samples of meat from animals other than cattle aged less than six months,
              — at least five samples of meat from cattle aged less than six months.
              In the event of a suspension on slaughter, the withdrawal period:
              — for the substance responsible for the residue, in cases of proven oral administration, shall be at
                  least one week,
              — fot the substance responsible for the residue, in cases of proven parenteral administration, shall
                  be at least one month.
 ---pagebreak--- 1. 10.81                       Official Journal of the European Communities                                       No C 251/11
                                                      ANNEX II
            Report on the examinations for residues of antibiotics in accordance with Directive . . . / . . ./EEC
         Member State:
         Year under review:
                                            Cattle        Cattle
          Number of animals slaughtered                   under           Pigs        Horses           ruminants
                                         six months    six months
         (a) Number of        samples
             examined
         (b) Number of samples
             which showed that
             tolerances were ex-
             ceeded
         in accordance with         / \
                                    y
         Article 3 (2)                '
                                    (b)
         in accordance with         / \
                                    y
         Article 3 (4)                '
                                    (b)
         in accordance with         / \
                                      w
         Article 3 (5)
                                    (b)
         in accordance with         / \
                                    K
         Article 4 (4)                '
                                    (b)