CELEX: 51985PC0192
Language: en
Date: 1985-04-29
Title: PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING THE EXAMINATION OF ANIMALS AND FRESH MEAT FOR THE PRESENCE OF RESIDUES

31. 5. 85                                   Official Journal of the European Communities                               No C 132/5
                                                                   II
                                                           (Preparatory Acts)
                                                     COMMISSION
              Proposal for a Council Directive concerning the examination of animals and fresh meat for the
                                                         presence of residues
                                                          COM(85) 192 final
                                    (Submitted by the Commission to the Council on 8 May 1985)
                                                            (85/C 132/05)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                               Whereas the adoption of Community provisions
                                                                       concerning the detailed arrangements for controls of
Having regard to the Treaty establishing the European                  animals and fresh meat for residues, for the frequency of
Economic Community, and in particular Article 43                       sampling of animals or meat, for examination for
thereof,                                                               residues, and for the establishment of maximum permitted
                                                                       limits of residues of substances having a pharmacological
Having regard to Council Directive 64/433/EEC of                       action and of the conversion products thereof and other
26 June 1964 on health problems affecting intra -                      substances transmitted to meat which are likely to be
Community trade in fresh meat ('), as last amended by                  dangerous to human health have the object of protecting
Directive 83/90/EEC (2), and in particular Article 4                   human health and of removing barriers to intra-
thereof,                                                               Community trade in animals, meat and meat products
                                                                       resulting    from     differences  between     the   health
Having regard to Council Directive 81/602/EEC of                       requirements of Member States;
31 July 1981 concerning the prohibition of certain sub-
stances having a hormonal action and of any substance                  Whereas it is necessary to adopt a general solution
having a thyrostatic action (3), and in particular Article 7           concerning controls in the Community of farm animals
thereof,                                                               and meat and meat products obtained therefrom for the
                                                                       presence of residues;
Having regard to the proposal from the Commission,
                                                                       Whereas it is appropriate to provide that sampling be
Having regard to the opinion of the European Par-                      carried out officially in the Member States in accordance
liament,                                                               with common criteria for the different groups of sub-
                                                                       stances of concern; whereas it is appropriate that samples
Having regard to the opinion of the Economic and                       are subject to examination at officially authorized labora-
Social Committee,                                                      tories ;
Whereas Article 4(2) of Directive 64/433/EEC lays                      Whereas it is appropriate that the national reference
down as regards examination of animals or meat for                     laboratories designated in accordance with Article
residues that the Council shall adopt:                                 4 (1) (b) of Directive 64/433/EEC should coordinate the
                                                                       standards and methods of analysis used in their
— the detailed arrangements for controls,                              respective territories; whereas it is appropriate that for
                                                                       each residue or group of residues of concern a
— the tolerances for the substances referred to in the
                                                                       Community laboratory should be designated for liaison
     second subparagraph of Article 4 (1) (b) of that
                                                                       with the national reference laboratories;
     Directive,
                                                                       Whereas further details of the criteria of operation of
— the frequently of sampling;
                                                                       laboratories should be established later;
Whereas Article 7 of Directive 81/602/EEC requires                     Whereas, when an examination reveals the presence of
Member States to ensure that farm animals, the meat of                 residues, it is necessary that common control measures
such animals and the meat products obtained therefrom                  are taken to ascertain and eliminate the cause of the
are subjected to controls and provides that detailed rules             residue, and which ensure that meat showing residues
for carrying out such controls be laid down by the                     which exceed the permitted level is excluded from
Council;                                                               human consumption;
                                                                       Whereas measures should be taken to facilitate
(*) OJ No 121, 29. 7. 1964, p. 2012/64.                                cooperation between Member States in the application of
O OJ No L 59, 5. 3. 1983, p. 10.                                       these controls and where necessary for the adoption of
(») OJ No L 222, 7. 8. 1981, p. 32.                                    coordinated measures in accordance with the procedure
 ---pagebreak--- No C 132/6                             Official Journal of the European Communities                                  31.5.85
of the Standing Veterinary Committee set up by Council                 64/433/EEC coordinate standards and methods of
Decision 68/361/EEC ( x );                                             analysis for each residue or group of residues
                                                                       concerned, in particular as regards the specifications
Whereas it is necessary to keep under review the details               for an approved sample and methods of analysis,
of the controls carried out in particular as a function of             including the arrangement of periodic comparative
the results which are found;                                           tests of split samples by approved laboratories, and
                                                                       the respect of the tolerances laid down.
Whereas it is necessary to provide for the amendment
and, where necessary, supplementation of technical                (c) for each residue or group of residues a Community
provisions concerning controls and frequency of                        laboratory designated pursuant to paragraph 2 liaises
sampling to take account of new knowledge and                          between the national reference laboratories referred
scientific and technical developments; whereas it is                   to in (b).
necessary to provide for the adoption of the necessary
adjustments in accordance with the procedure of the
Standing Veterinary Committee;                                    2.     The Council, acting on a proposal from the
                                                                  Commission, shall determine the criteria for the authori-
Whereas Community control arrangements should be                  zation of approved laboratories, shall designate the
introduced to ensure that the requirements of this                laboratories referred to in paragraph 1 (c), and shall
Directive are applied uniformly in all Member States,             determine the powers and conditions of operation of the
                                                                  latter.
HAS ADOPTED THIS DIRECTIVE:
                                                                  3.     The examination for residues referred to in
                          Article 1                               paragraph 1 must be carried out in accordance with
                                                                  proven methods which are scientifically recognized, in
Member States shall ensure that examination of animals            particular those laid down by Community provisions.
and fresh meat for the presence of residues is carried out
in accordance with the requirements of this Directive.
                                                                  It must be possible to assess the examination for residues
                          Article 2                               using the reference methods established in accordance
                                                                  with Article 4 (1) (b) of Directive 64/433/EEC.
For the purpose of this Directive, the definitions given in
Article 2 of Directive 64/433/EEC shall apply.
                                                                  All positive findings shall be confirmed by an official
                                                                  laboratory using the reference method referred to above.
In addition:
(a) Approved sample means a sample taken by the
    competent authority and which consists for the                                           Article 4
    examination of the residue concerned of a reference           1.     Where an examination of an approved sample
    to the species, the tissue, the amount, the method of         taken in accordance with the Annex reveals the presence
    collection, package and dispatch, and the iden-               of residues of prohibited substances or of authorized
    tification of origin;                                         substances exceeding the maximum permitted levels, or
                                                                  where the problems referred to in Article 6 (1) and (2)
(b) Approved laboratory means a laboratory approved by
                                                                  are demonstrated, the Member State shall ensure that the
    the competent authorities of a Member State to
                                                                  competent authorities are informed without delay of:
    make an examination of an approved sample for the
    presence of residues;
                                                                  (a) all information needed to identify the origin of the
(c) Residue means residue of substances having a phar-                 animals;
     macological action and of conversion products
    thereof and other substances transmitted to meat
    which are likely to be dangerous to human health.             (b) the result of the examination.
                          Article 3                               2.     The competent authorities shall thereupon ensure
 1.   Member States shall ensure that:                            that:
(a) approved samples are taken from animals and fresh
    meat for examination at approved laboratories for             (a) an investigation is made at the farm of origin to
    residues in accordance with the Annex.                             determine the reason for the presence of residues;
(b) the national reference laboratories designated in             (b) an investigation of the source or sources of the
    accordance with Article 4 (1) (b) of Directive                     substance concerned is made as necessary at the
                                                                       levels of distribution, sale, transport, handling,
C) OJ No L 255, 18. 10. 1968, p. 23.                                   storage and manufacture.
 ---pagebreak--- 31.5.85                                 Official Journal of the European Communities                              No C 132/7
3.     The competent authorities shall also ensure that:           2.     Where the findings in one Member State indicate
                                                                   the need for investigation in one or more other Member
(a) the herd or animals at the farm of origin and herds            States, the Member State concerned shall inform the
     which, as a result of the investigations referred to in       other Member States and the Commission thereof.
     paragraph 2 may be assumed to contain the residue
     in question, are provided with official marking and           3.     In accordance with the procedure of Article 10,
     subject to appropriate examinations;                          measures may be taken to ensure the coordination of the
                                                                   investigations necessary.
(b) if the examination reveals the presence of prohibited
     substances, the animals shall be confiscated or
     destroyed;                                                                               Article 7
                                                                   The Member States shall annually inform the
(c) if the examination reveals the presence of residues of
                                                                   Commission and the other Member States of the details
     authorized substances above the maximum permitted
                                                                   of the examinations made and of the results.
     levels, the slaughter of the animals concerned for
     human consumption shall be prohibited until it can
     be ensured that the amount of residue no longer                                          Article 8
     exceeds the permitted levels. This period may in no
     case be shorter than the delay period fixed for the           1.     The provisions of the Annex may be amended or
     substance. However, where it is ascertained that the          supplemented in accordance with the procedure laid
     conditions of use laid down have not been complied            down in Article 10.
     with, the animals concerned shall be confiscated or
     destroyed;                                                    2.     By way of derogation from Article 3 (1) (a) and
                                                                   Article 6 (1), in accordance with the procedure laid
(d) during the period of examination, the animals must             down in Article 9, other sampling examination fre-
     not be disposed of to other parties.                          quencies may be applied on application and presentation
                                                                   of alternative strategies for those Member States:
4.     By way of derogation from paragraph 3 (c),
animals whose slaughter is prohibited may be slaughtered           — with small animal populations, or
before the end of the prohibition period if the competent
authority is informed at least one week before the                 — with less than 10 % holdings with more than 20
proposed slaughter date, stating the place of slaughter.                animals.
The officially marked animals must be accompanied to
the place of slaughter by an official veterinary certificate                                  Article 9
containing the information required under paragraph
1(a).                                                              1.     Where the procedure laid down in this Article is to
                                                                   be used, the matter shall be referred without delay to the
The carcase of each animal whose slaughter is notified             Standing Veterinary Committee (hereinafter referred to
pursuant to the first subparagraph shall be officially             as 'the Committee'), by the chairman, either on his own
examined for the residue concerned and shall be                    initiative or at the request of a Member State.
detained until the result of the examination is known.
                                                                   2.     Within the Committee, the voters of the Member
5.     The competent authorities shall also ensure that at         States shall be weighted as provided in Article 148 (2) of
the establishment of production, or animal holdings in             the Treaty. The chairman shall not vote.
the same region or locality supplying the establishment,
additional samples are examined for the substance                  3.     The Commission representative shall submit a draft
concerned in accordance with the intensive surveillance            of the measures to be adopted. The Committee shall
system laid down in the Annex.                                     deliver its opinion on the measures within a period to be
                                                                   determined by the chairman in keeping with the urgency
                                                                   of the question submitted for examination. Opinion shall
                          Article 5
                                                                   be delivered by a majority of 45 votes.
Notwithstanding Article 4, the competent authority shall,
if information suggests the presence of residues, examine          4.     The Commission shall adopt the measures and shall
the animals or the fresh meat involved for the presence            implement them immediately, where they are in
of these residues.                                                 accordance with the opinion of the Committee. Where
                                                                   they are not in accordance with the opinion of the
                          Article 6                                Committee or if no opinion is delivered, the Commission
                                                                   shall without delay submit to the Council a proposal on
1.     Where examination in its territory demonstrates in          the measures to be adopted. The Council shall adopt the
animals of fresh meat a widespread presence of residues,           measures by a qualified majority.
the Member State concerned shall intensify the sampling
and investigation measures for the residue concerned in            If the Council has not adopted any measures within
accordance with the Annex.                                         three months from the date on which the proposal was
 ---pagebreak--- No C 132/8                                  Official Journal of the European Communities                                      31. 5. 85
submitted to it, the Commission shall adopt the proposed                    in accordance with the opinion of the Committee or if
measures and apply them immediately save where the                          no opinion is delivered, the Commission shall without
Council has decided against them by a simple majority.                      delay submit to the Council a proposal on the measures
                                                                            to be adopted. The Council shall adopt the measures by
                           Article 10                                       a qualified majority.
1.    Where the procedure laid down in this Article is to                   If the Council has not adopted any measures within 15
be used, the matter shall be referred without delay to the                  days from the date on which the proposal was submitted
Committee by the chairman, either on his own initiative                     to it, the Commission shall adopt the proposed measures
or at the request of a Member State.                                        and shall apply them immediately save where the Council
                                                                            has decided against them by a simple majority.
2.    Within the Committee, the votes of the Member
States shall be weighted as provided in Article 148 (2) of
the Treaty. The chairman shall not vote.                                                             Article 11
3.    The Commission representative shall submit a draft                    The Member States shall bring into force the laws, regu-
of the measures to be adopted. The Committee shall                          lations and administrative provisions necessary to comply
deliver its opinion on such measures within two days.                       with this Directive not later than 1 April 1986 and shall
Opinions shall be delivered by a majority of 45 votes.                      forthwith inform the Commission thereof.
4.    The Commission shall adopt the measures and shall                                              Article 12
apply them immediately where they are in accordance
with the opinion of the Committee. Where they are not                      This Directive is addressed to the Member States.
                                                                  ANNEX
                                                          RESIDUE SAMPLING
                                                                CHAPTER 1
               1. Sampling frequency will be based on the following general groups of substances, animal populations
                  and variable criteria.
                  Residue groups substances
                  Group I         (a) Stilbenes, stilbene derivatives, their salts and esters
                                  (b) Thyrostatic substances
                  Group II        Other substances with oestrogenic, androgenic or gestagenic action used for fattening
                  Group III       Chloramphenicol, antibiotics, sulphonamides and other antimicrobial substances
                  Group IV      Pesticides
                                  — Organochlorine compounds — including PCBs
                  Group V         Heavy metals
                                  — Lead                — Antimony
                                  — Cadmium             — Copper
                                  — Mercury             — Zinc
                                  — Arsenic             — Nickel
                                  — Selenium            — Chromium
                  Group VI        Endo- and ectoporasitic substances
                  Group VII       Tranquilizers and beta blockers
                  Group VIII      (a) Other veterinary medicines
                                  (b) Other substances
 ---pagebreak--- 31.5.85                               Official Journal of the European Communities                                 No C 132/9
        2. Population species groups
           Group I            Bovine animals
           Group II           Porcine animals
           Group III          Sheep and goats
           Group IV           Solipeds
        3. Sampling conditions and randomization
           (a) Member States shall ensure that official samples are taken for official examination from animals
               and meat in accordance with the appropriate sampling system, and the following variable criteria.
               Samples shall be taken in confidence and on a statistically random basis.
           (b) Variable criteria
               Account shall be taken of:
                  (i) Legislation in force regarding the use of the substances referred to in the residue groups
                      mentioned above, in particular the prohibition of use, authorization of use.
                 (ii) Factors liable to encourage fraud or misuse.
                (iii) The animal population concerned as regards:
                      — total size of population;
                      — homogeneity of population groups;
                      — age of animals in particular in respect of Group IV and V substances;
                      — sex of animals in particular as regards Group I substances.
                (iv) The environment of farms as regards:
                      — regional differences;
                      — the relation to industrial activity, in particular for Group IV and V substances;
                      — relation to arable farming in particular for Group IV substances.
                 (v) The farm production systems including:
                      — intensive farming units;
                      — fattening systems, in particular as regards Group I and II substances;
                      — husbandry systems, in particular feeding regime, and animal health care measures.
                (vi) The expectation of problems, known on account of past history and other indications of the
                      existence of problems.
               (vii) The required degree of consumer protection, according to the nature and toxicity of the
                      substance in question.
        4. Sampling system
           Member States shall apply for each group of substances, and according to the appropriate status level
           and variable criteria appropriate to their territory, a sampling and examination system in accordance
           with the provision of the following chapter.
                                                         CHAPTER II
                                                Sampling levels and frequency
        5. Group I (a) (Stilbenes, stilbene derivatives, their salts and esters)
           Member States shall at least apply the frequency of Level II during the first year following the
           adoption of this Directive.
           Level I (Survey)
           (a) Member States shall ensure that the population of bovine animals for fattening is sampled annually
               at a frequency which gives at least a 95 % assurance that there will be residue in less than 1 % of
               the bovine fattening population if no positive findings are made.
 ---pagebreak--- N o C 132/10                              Official Journal of the European Communities                                    31.5.85
                (b) If, following the sampling mentioned above, one positive finding is officially confirmed, Member
                    States shall monitor the extent of possible residues by the application of the sampling frequency of
                    Level II.
                Level II (Monitoring)
                (a) Member States shall ensure that the population of bovine animals for fattening is sampled annually
                    at a frequency which gives at least a 99,9 % assurance that there will be residue in less than 1 % of
                    the bovine fattening population if no positive findings are made.
                (b) If, following the sampling mentioned above, one positive finding is officially confirmed, Member
                    States shall measure the extent of possible residues by application of the sampling frequency of
                    Level III.
                (c) If, following the application of the sampling frequency indicated in paragraph (a), no positive
                    findings are officially confirmed during two sucessive years, Member States may apply the
                    sampling frequency of Level I.
                Level HI (Measuring)
                (a) Member States shall ensure that the population of bovine fattening animals is sampled annually at a
                    frequency which gives at least a 99,9 % assurance that there will be residues in less than 0,5 % of
                    the bovine fattening population if no positive findings are made.
                (b) Following the annual sampling mentioned above:
                    — if one positive finding is officially confirmed, Member States shall continue to sample at the
                        frequency mentioned in paragraph (a);
                    — if more than one positive finding is officially confirmed, Member States shall apply the
                        sampling frequency of Level IV;
                    — if no positive findings are officially confirmed, Member States may apply the sampling
                        frequency of Level II.
                Level IV (Intensive)
                (a) Member States shall ensure that the population of bovine fattening animals is sampled annually
                    at the frequency indicated in Level III paragraph (a). Member States shall also ensure that the
                    non-fattening bovine population is sampled annually at the frequency indicated in Level II para-
                    graph (a).
                (b) In addition for each positive finding officially confirmed during the previous sampling at Level III,
                    Member States shall ensure that in each case the population of bovine fattening animals in the
                    same area of origin is also sampled annually at a frequency which gives at least a 99,9 % assurance
                    that there will be residue in less than 1 % of the bovine fattening population of the area if no
                    positive findings are made.
                (c) When positive findings have been officially confirmed in more than one area in the same region
                    during the previous sampling at Level III, Member States shall ensure that, in addition to the
                    sampling mentioned above, the population of bovine fattening animals of the region is sampled
                    annually at the frequency referred to in paragraph (b).
                (d) The abovementioned sampling shall be continued until during one year not more than one positive
                    finding is officially confirmed. In which case Member States may continue to sample at the
                    frequency indicated in Level III.
             6. Group I (b) (Thyrostatics)
                Member States shall at least apply the sampling levels and frequency laid down for Group I (a) sub-
                stances. However, during the first year following the adoption of this Directive, the frequency of Level
                I may be applied.
             7. Group II
                (a) Trenbolone and zeranol
                    Member States shall at least apply the sampling levels and frequencies laid down for Group I (a)
                    substances.
                (b) Oestradiol 17B, testosterone and progesterone
                    Member States shall ensure that the population of bovine animals for fattening is sampled annually
                    at the sampling frequency laid down for Group III substances.
                    For each sample taken an examination shall be made at least for those substances which are
                    atypical for the sex and physiological status of the animal concerned.
 ---pagebreak--- 31.5.85                              Official Journal of the European Communities                                   N o C 132/11
        8. Group III (Chloramphenicol, antibiotics, sulphonamides and similar antimicrobial substances)
           Member States shall ensure that at least the following sampling levels and frequencies are applied:
           Level I (Monitoring)
           (a) Member States shall ensure that the populations and species of animals in their territory which
               present the greatest expectation of residue problems, taking into account the variables mentioned
               in Chapter I, in particular, past-history, age, sex and farm production systems are subject to stat-
               istically random sampling. The populations identified shall be sampled annually at a frequency
               which gives at least a 99,9 % assurance that there will be residue in less than 1 % of the population
               if no positive findings are made.
           (b) If, following the sampling mentioned above, positive findings are officially confirmed in more than
               0,5 % of the samples examined, Member States shall ensure that the frequency of sampling of the
               population concerned is increased by the application of the sampling frequency of Level II
           Level II (Measuring)
           (a) Member States shall ensure that each population concerned is sampled annually at a frequency
               which gives at least a 99,9 °/o assurance that there will be residue in less that 0,5 % of the popu-
               lation if no positive findings are made.
           (b) Following the annual sampling mentioned above:
               — if positive findings are officially confirmed in more than 0,5 % of the samples examined,
                    Member States shall apply the sampling frequency of Level III;
               — if positive findings are officially confirmed in less than 0,5 % of the samples examined in two
                    successive years, Member States may apply the sampling frequency of Level I.
           Level HI (Intensive)
           (a) Member States shall ensure that the population concerned is sampled annually at the frequency
               indicated in Level II paragraph (a).
           (b) In addition for each positive finding officially confirmed during the previous sampling at Level II,
               Member States shall ensure that in each case the population of animals concerned in the same area
               of origin is also sampled annually at a frequency which gives at least a 99,9 % assurance that there
               will be residue in less that 1 % of the population of the area if no positive findings are made.
           (c) When positive findings have been officially confirmed in more than one area of the same region
               during the previous sampling at Level II, Member States shall ensure that in addition to the
               sampling mentioned above that the population concerned in the region is sampled annually at the
               frequency referred to in paragraph (b).
           (d) The abovementioned sampling shall be continued until during one year's positive findings are
                officially confirmed in less than 0,5 % of the population concerned. In which case Member States
               may continue to sample at the frequency indicated in Level II.
           Supplementary survey
           (a) Further to the sampling provided for in the levels indicated above, in addition Member States shall
               ensure that animal species populations not covered by the sampling of those levels are also sampled
               for residues. Each population identified shall be sampled annually at a frequency which gives at
               least a 99,9 % assurance that there will be residue in less than 1 % of the population if no positive
               findings are made.
           (b) If, during the course of the sampling mentioned above, positive findings are officially confirmed in
               a population group at a proportion higher than the level found in population groups already
               identified, the former is substituted for the latter unless the latter has shown positive findings in
               more than 0,5 % of the samples examined, in which case it is added to the latter. The population
               group shall also be added if, following the sampling, positive findings are officially confirmed in
               more than 0,5 % of the samples examined.
 ---pagebreak--- No C 132/12                               Official Journal of the European Communities                                    31. 5. 85
             9. Group IV (Pesticides)
                (a) Member States shall ensure that at least samples are taken annually from each of the species groups
                    I, II and III at a frequency which gives at least 99,9 % assurance that there will be residue in less
                    than 5 % of the population if no positive findings are made.
                (b) In addition to the application of Article 4, following the application of the annual sampling
                    frequency, analysis shall be made of the laboratory findings of all the official samples examined.
                    The analysis shall determine the distribution of the total levels found so that comparison may be
                    made between at least four equal portions of the distribution area, and with levels found at
                    previous annual sampling.
                    If, following the above analysis, there is an indication of either a significant overall increase in
                    relation to previous years, or a significant shift of levels found towards the tolerance levels,
                    Member States shall ensure that all necessary action is taken to identify and reduce the levels
                    found.
            10. Group V (Heavy metals)
                (a) Member States shall ensure that at least for: lead, cadmium, mercury, for arsenic, and for selenium
                    when the latter are authorized for use in feedingstuffs samples are taken annually from the animal
                    population at a frequency which gives at least 95 % assurance that there will be residue in less than
                    1 % of the population if no positive findings are made.
                (b) Following the application of the annual sampling the provisions laid down for Group IV substances
                    under paragraph (b) shall be applied.