CELEX: 51993PC0441(01)
Language: en
Date: 1993-09-22
Title: Proposal for a COUNCIL REGULATION (EEC) concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists

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                         COMMISSION OF THE EUROPEAN COMMUNITIES
                                                                                COM(93) 441 final
                                                                                Brussels, 22 September 1993
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                                                          Proposal for a
                                               COUNCIL REGULATION (EEC)
                           concerning the prohibition on the use in stockfarming of certain substances
                                   having a hormonal or thyrostatic action and of p-agonists
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                                                          Proposal for a
                                               COUNCIL REGULATION (EEC)
                                 on measures to monitor certain substances and residues thereof
                                              in live animals and animal products
                                                          Proposal for a
                                               COUNCIL REGULATION (EEC)
li^fe                         amending Regulation (EEC) No 805/68 on the common organization
                                                 of the market in beef and veal
                                                 (presented by the Commission)
           .*f^7
 ---pagebreak---                                    Explanatory Memorandum
1. In its communication (COM(93) 167 final) of 21 April 1993 to the Council and to the
   European Parliament on control of residues in meat (hormones-beta-agonists and other
   substances) the Commission announced its intention to present proposals to remedy the
   principal defects in existing control arrangements, and thereby remove the potential threat to
   human health, and the distortion of competition, that arises from the non-observance of the
   rules. That communication set out the results of an enquiry into the situation in the Member
   States, and emphasized the Community-wide dimension of the problems in relation to the
   misuse of these substances. It is clear that effective measures at the Community level are an
   essential prerequisite to attaining the objectives of established policy in this sector.
2. The following proposals are presented in conformity with the conclusions in the Commission's
   communication:
   (a)    for a Council Regulation concerning the prohibition on the use, in livestock production,
          of beta-agonists substances and of certain substances having a hormonal action, and a
          thyrostatic action, and revoking Directives 81/602/EEC, 88/146/EEC and 88/299/EEC;
   (b)    for a Council Regulation concerning the control measures in relation to certain
          substances and their residues in live animals and in animal products, and revoking
          Directives 85/358/EEC and 86/469/EEC;
   (c)    for a Council Regulation modifying Council Regulation 805/68 on the common
          organization of the market in the beefmeat sector.
3. The purpose of the measures proposed is to improve the technical controls so as to make more
   effective the existing rules designed to prevent the misuse of certain growth promoters and
   other substances in livestock production; to combat in particular the growing misuse of beta-
   agonists substances for fattening purposes; to streamline and focus control procedures in
   order to enable the campaigns conducted by the competent authorities in the Member States
   to better detect residues; and to create the conditions for more effective administrative
   sanctions by way of refusal of premiums to certain producers.
   (a)    The proposed Council Regulation on the prohibition of certain substances, clarifies and
          consolidates the requirements in the existing Directives, and prohibits the use of beta-
          agonists for all purposes other than the therapeutic treatment of horses and of pet
          animals.
 ---pagebreak--- (b)  The proposed Council Regulation on the control measures, clarifies and improves
     existing procedures for the detection of residues. It requires that controls be based
     essentially on targetted and unannounced inspections, with less emphasis on the present
     system of random sampling. Central to this approach continues to be the drawing-up by
     Member States of annual plans for the detection of residues; plans must cover a
     minimum level of sampling but a certain flexibility is provided in order to reflect local
     conditions and experience. The proposal prescribes the procedures to apply in the
     investigation and confirmation of suspected cases of fraud, including destruction of the
     batch of animals concerned where at least 10% of animals have been found to have
     residues of illegal substances. Member States would be required also to take the
     necessary measures to ensure that abattoirs cooperate in the investigation of suspected
     breaches of the regulations. This draft includes the Council decisions relating to the
     powers and the designation of the Community reference laboratories for residues, which
     designation shall be amended in the future to allow for the inclusion of substances or
     residues not yet covered.
(c)  The proposed amendment to the beefmeat market organization removes the existing
     provision - considered insufficient by the Commission - that individual animals found
     to have been treated with prohibited substances should not be eligible for the male beef
     premium. The withdrawal of this provision will enable the Commission, acting under
     its own competence (recently confirmed by the Court in Case C-240/90) to provide for
     forfeiture of aid in the product sectors concerned (beefmeat and sheepmeat) in the case
     of a producer who fails to observe the regulations or who obstructs investigations. The
     Commission would intend to propose to the Management Committee that a producer be
     initially debarred from aid for the year in which the infringement first arose; debarment
     for a longer period, for example, a total of five years would be proposed in the case of
     a subsequent infringement.
The proposals do not have any impact on the Community budget, or involve additional
burdens for SMEs.
 ---pagebreak---                                             Proposal for a
                                 COUNCIL REGULATION (EEC)
            concerning the prohibition on the use in stockfarming of certain substances
                     having a hormonal or thyrostatic action and of P-agonists
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular
Article 43 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas Council Directive 81/602/EEC(1) prohibits certain substances having a hormonal action and
any substances having a thyrostatic action and whereas Council Directive 88/146/EEC(2) prohibits
the use in stockfarming of certain substances having a hormonal action, whilst conceding
derogations;
Whereas Council Directive 88/299/EEC(3) lays down the conditions for applying the derogations
provided for in Article 7 of Directive 88/146/EEC from the prohibition on trade in certain categories
of animals and their meat;
Whereas, on account of the residues they leave in meat and other foodstuffs of animal origin, certain
substances having a thyrostatic, oestrogenic, androgenic or gestagenic action may be dangerous for
consumers and may also affect the quality of foodstuffs of animal origin;
Whereas new substances having an anabolizing action such as beta-agonists are used illegally in
livestock rearing with a view to stimulating the growth and yield of animals;
Whereas the results of an enquiry conducted by the Commission in the Member States from 1990
to 1992 show that beta-agonists are widely available in the livestock rearing sector, leading to their
illegal use; whereas the improper use of beta-agonists can be a serious risk to human health;
Whereas, in the interests of the consumer, the holding, administering to any animal and placing on
the market for that purpose of stilbenes, thyrostatics and beta-agonists should be prohibited and the
 use of the other substances should be regulated;
Whereas, however, the administering of beta-agonists for therapeutic purposes to equidae and
 carnivorous pets may be authorized;
 (1)
       OJNoL222, 7.8.1981, p. 32.
 (2)
       OJ No L 70, 16.3.1988, p. 16.
 (3)
       OJ No L 128, 21.5.1988, p. 36.
 ---pagebreak--- Whereas, moreover, it is necessary to ensure that all consumers are able to purchase meat and
foodstuffs derived therefrom under the same conditions of supply and that those products correspond
more closely to their concerns and expectations; whereas, given consumer sensitivity, this can only
bring about an increase in the consumption of the products in question;
Whereas the prohibition on the use of hormonal substances for fattening purposes should continue
to apply; whereas the use of certain substances for therapeutic or zootechnical purposes may be
authorized but must be strictly controlled in order to prevent any misuse;
Whereas current scientific knowledge does not permit the normal physiological concentrations of
endogenous hormones to be determined or the withdrawal period for products containing hormonal
substances to be defined, with the result that it has not been possible to draw up a list of products
which may be used for therapeutic or zootechnical purposes and which meet the requirements laid
down by law;
Whereas, furthermore, live animals so treated for therapeutic or zootechnical purposes and the meat
from such animals should not as a general rule be traded, since this could impair the effectiveness
of the control arrangements of the scheme as a whole; whereas, however, derogations from the
prohibition may, subject to certain conditions, be provided for in respect of intra-Community trade
and imports from third countries of animals intended for breeding and breeding animals at the end
of their reproductive life;
Whereas such derogations may be authorized where adequate guarantees are provided so as to
prevent distortion of trade; whereas such guarantees must cover the products which may be used,
the conditions governing their use and the checks to ensure that the conditions are complied with,
especially with regard to the necessary withdrawal period;
Whereas equivalent guarantees must be accepted, in accordance with a Community procedure, in
respect of imports from third countries, taking account of the guarantees given by the third countries
concerned;
Whereas provision should be made for the effective verification of application of the provisions
deriving from this Regulation;
Whereas, if the illegal use of growth and productivity promoters in stockfarming is to be combated
effectively in all Member States, action will have to be organized at Community level;
Whereas, in order to ensure the immediate and uniform application of the prohibitions and
obligations envisaged, a regulation should be adopted; whereas Directives 81/602/EEC, 88/146/EEC
and 88/299/EEC sould therefore be repealed,
 ---pagebreak--- HAS ADOPTED THIS REGULATION:
                                              Article 1
For the purposes of this Regulation, the definitions of meat and meat products given in Council
Directives 64/433/EEC(4), 71/118/EEC(5) and 77/99/EEC(6) shall apply.
In addition, the following definitions shall apply:
      "farm animals" means domestic animals of the bovine, porcine, ovine and caprine species,
      solipeds and poultry, wild animals of those species and wild ruminants which have been raised
      on a holding;
      "therapeutic treatment" means the administering to an individual farm animal of any substance
      authorized under Article 4(1) to treat a fertility problem diagnosed, on examination, by a
      veterinarian;
      "zootechnical treatment" means the administering to an individual farm animal of any
      substance authorized under Article 4(2) for synchronizing oestrus, terminating unwanted
      gestation, improving fertility and preparing donors and recipients for the implantation of
      embryos, after examination by a veterinarian.
                                              Article 2
1.    The placing on the market of stilbenes, stilbene derivatives, their salts and esters and
      thyrostatic substances for administering to animals of all species is hereby prohibited.
2.    The placing on the market of beta-agonists for administering to animals of all species, with
      the exception of equidae and domestic carnivorous animals, is hereby prohibited.
                                              Article 3
Subject to Article 4, the following are also prohibited:
(a)   the administering to a farm or aquaculture animal, by any means whatsoever, of substances
      having a thyrostatic, oestrogenic, androgenic or gestagenic action and beta-agonists;
(b)   the holding, placing on the market or slaughtering for consumption of farm animals and
      aquaculture animals which contain or have contained the substances mentioned in (a);
(c)   the placing on the market of meat of the farm animals or aquaculture products referred to in
      0>);
(4)
      OJ No 121, 29.7.1964, p. 2012/64.
(5)
      OJNoL55, 8.3.1971, p. 23.
(6)
      OJ No L 26, 31.1.1977, p. 85.
 ---pagebreak--- (d)  the processing of the meat or products referred to in (c) and the placing on the market of meat
     products prepared from or with such meat and of products processed or prepared from such
     aquaculture animals.
                                               Article 4
Notwithstanding Articles 2 and 3, the following may be allowed:
1.   The administering to farm animals, for therapeutic purposes, of oestradiol 17 B, testosterone
     and progesterone and derivatives which readily yield the parent compound on hydrolysis after
     absorption at the site of application. Products used for therapeutic treatment may be
     administered only by a veterinarian, by injection and not by implant, to farm animals which
     have been clearly identified. Treatment of identified animals must be registered by the
     veterinarian directly responsible. The latter must record at least the following details in a
     register, to be made available to the competent authority at its request:
            the type of treatment,
            the type of products authorized,
            the date of treatment,
            the identity of the animals treated.
     Therapeutic treatment of animals intended for fattening and, during the fattening period, of
     breeding animals at the end of their reproductive life shall, however, be prohibited.
2.   The administering to farm animals of substances having an oestrogenic, androgenic or
     gestagenic action other than the substances referred to in Article 2 for the purpose of
     zootechnical treatment. Such substances must be administered by a veterinarian to clearly
     identified animals, and the treatment must be recorded by the veterinarian directly responsible
     in accordance with point 1.
     However, the Member States may allow the synchronization of oestrus and the preparation of
     donors and recipients for the implantation of embryos to be effected not by the veterinarian
     but on his direct responsibility. In that event, the veterinarian shall make out a non-renewable
     prescription, specifying the treatment in question and the quantity of the product required and
      shall record the products prescribed.
     Zootechnical treatment of animals intended for fattening and, during the fattening period, of
     breeding animals at the end of their reproductive life shall, however, be prohibited.
3.   The administering to equidae within the meaning of Article 2(b) of Council
     Directive 90/426/EEC(7) of beta-agonists to treat cardio-respiratory disorders. Such
      administering must be carried out by a veterinarian or on his direct responsibility. Such
      treatment must be recorded by the veterinarian directly responsible, giving at least the details
      referred to in point 1.
 (7)
      OJ No L 224, 18.8.1990, p. 42.
 ---pagebreak---                                                    Article 5
    The Commission, acting in accordance with the procedure laid down in Article 12, may decide to
    include any new substance in the group of substances referred to in Article 4(1) having a direct or
    indirect oestrogenic, androgenic or gestagenic action. To be included therein, any new substances
    must satisfy the relevant principles and criteria laid down in Council Directives 81/851/EEC(8) and
    81/852/EEC(9).
                                                   Article 6
    Hormonal products and products having an anabolic effect, whose administration to farm animals
    is permitted in accordance with Article 4, must also meet the criteria and requirements of Directives
    81/851/EEC and 81/852/EEC.
    Furthermore, the following shall not be authorized:
    (a)   sustained-release products or salts or esters with a long half-life where the therapeutic or
          zootechnical objective can be achieved by using products with a shorter half-life which, by
          reason of their composition, do not act as a deposit;
    (b)   products the withdrawal period of which is not known and those with a withdrawal period of
          more than 15 days;
    (c)   products the conditions governing the use of which are not known;
    (d)   products for which there are no available reagents or equipment for the analytical techniques
          for detecting the presence of residues exceeding the permitted limits.
                                                   Article 7
     1.   Animals, or meat or products from animals, to which substances having a thyrostatic,
          oestrogenic, androgenic or gestagenic action or beta-agonists have been administered in any
          way whatsoever may not be despatched from the territory of one Member State to that of
          another.
    2.    Notwithstanding paragraph 1, Member States may authorize trade in animals for breeding and
          breeding animals at the end of their reproductive life which, during the latter period, have
          undergone a treatment referred to in Article 4(1) and (2), and in equidae which have
          undergone a treatment as referred to in Article 4(3) or shall authorize the affixing of the
          Community stamp to meat from such animals where the conditions laid down in Articles 4
          and 6 are complied with, particularly with regard to observance of the withdrawal period.
    (8)
          OJ No L 317, 6.11.1981, p. 1.
     (9)
          OJ No L 317, 6.11.1981, p. 16.
(2)
 ---pagebreak---      However, trade in high-value horses, and in particular racehorses, competition horses, circus
     horses or horses intended for stud purposes or for exhibitions, including horses in these
     categories to which oral preparations containing allyl trenbolone or beta-agonists have been
     administered for the purposes mentioned in Article 4, may take place before the end of the
      withdrawal period, provided that the conditions governing administration are fulfilled and that
     the type and date of treatment are mentioned on the certificate accompanying the horses.
                                              Article 8
1.    The importation from third countries of farm or aquaculture animals and of meat from animals
      to which substances having a thyrostatic, oestrogenic, androgenic or gestagenic action have
      been administered in any way whatsoever is hereby prohibited.
      However, animals intended for breeding, breeding animals at the end of their reproductive life,
      or meat therefrom, from third countries may be imported subject to their satisfying guarantees
      at least equivalent to those laid down herein which have been established in accordance with
      the procedure laid down in Article 12 for the purpose of giving effect to Article 30 of Council
      Regulation (EEC) No ..../93(10) on measures to monitor certain substances and residues thereof
      in live animals and animal products.
2.    Controls on imports from third countries shall be carried out in accordance with Article 4(2)(c)
      of Council Directive 91/496/EEC(1,) and Article 8(2) of Directive 90/675/EEC(,2).
                                               Article 9
Undertakings producing substances having a thyrostatic, oestrogenic, androgenic or gestagenic action
and beta-agonists, undertakings authorized in any capacity to market such substances and
undertakings producing pharmaceutical and veterinary medicinal products from such substances shall
be required to keep registers detailing, in chronological order, quantities produced or acquired and
those sold or used for the production of pharmaceutical products or veterinary medicines.
                                              Article 10
Farm animals, their feed, the meat of such animals, the meat products obtained therefrom and all
other products of animal origin shall be subject to checks in accordance with Regulation
(EEC) No ...793 on measures to monitor certain substances and residues thereof in live animals and
animal products.
                                              Article 11
Detailed rules for the application of this Regulation shall be adopted in accordance with the
procedure laid down in Article 12.
(10)
       OJ No L
(,,)
       OJ No L 268, 24.9.1991, p. 56.
(12)
       OJ No L 373, 31.12.1990, p. 1.
 ---pagebreak---                                              Article 12
The Commission shall be assisted by the Standing Veterinary Committee (hereinafter referred to as
"the Committee").
The representative of the Commission shall submit to the Committee a draft of the measures to be
taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman
may lay down according to the urgency of the matter.
The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case
of decisions which the Council is required to adopt on a proposal from the Commission. The votes
of the representatives of the Member States within the Committee shall be weighted in the manner
set out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of
the Committee. If the measures envisaged are not in accordance with the opinion of the Committee,
or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal
relating to the measures to be taken. The Council shall act by a qualified majority. If within three
months of the date of referral the Council has not acted, the proposed measures shall be adopted
by the Commission.
                                             Article 13
Directives 81/602/EEC, 88/146/EEC and 88/299/EEC are hereby repealed.
                                             Article 14
Member States shall inform the Commission of the national measures adopted pursuant to this
Regulation.
                                             Article 15
This Regulation shall enter into force on 1 January 1994.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,                                                  For the Council
                                                                   The President
                                                 10
 ---pagebreak---                                             Proposal for a
                                  COUNCIL REGULATION (EEC)
                   on measures to monitor certain substances and residues thereof
                                 in live animals and animal products
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular
Article 43 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas by Directive 85/358/EEC(1), as last amended by Directive 88/146/EEC(2), the Council
introduced certain rules on the detection and monitoring of substances having a hormonal or a
thyrostatic action; whereas those rules should be extended to cover other substances which are used
in stockfarming to promote growth and productivity in livestock or for therapeutic purposes and
which may prove dangerous to the consumer on account of their residues;
Whereas by Directive 86/469/EEC(3), as amended by Decision 89/187/EEC(4), the Council introduced
certain rules on the monitoring of a certain number of residues of pharmacological substances and
of environmental contaminants in farm animals and in the fresh meat obtained from such animals;
whereas such monitoring should be extended to cover other animal species and all animal products
for human consumption;
Whereas there is insufficient clarity in the Community legislation on monitoring residues in meat,
giving rise to varying interpretations in the different Member States;
Whereas there is a need to reinforce the controls carried out by and in the Member States;
Whereas producers and other actors in the stockfarming industry should take greater responsibility
in future for the quality and harmlessness of meat for human consumption;
a)     O J N o L 191, 23.7.1985, p. 46.
(2)   O J N o L 7 0 , 16.3.1988, p. 16.
(3)   OJ No L 275, 26.9.1986, p. 36.
(4)   O J N 0 L 6 6 , 10.3.1989, p. 37.
                                                   11
 ---pagebreak--- Whereas the specific penalties in respect of stockfarmers not complying with Community legislation
prohibiting the use of certain hormonal and anabolic substances in stockfarming are to be
incorporated in the separate provisions governing particular product groups;
Whereas Article 4 of Council Directive 71/118/EEC(5), as last amended by Directive 92/116/EEC(6),
requires the Member States to ensure that checks are conducted to detect residues of substances
having a pharmacological action, their derivatives and other substances which may be transmitted
to poultrymeat and which may make the consumption of fresh poultrymeat dangerous or harmful
to human health;
Whereas Council Directive 91/493/EEC(7) requires a monitoring system to be established by the
Member States to detect contaminants present in the aquatic environment;
Whereas Council Directive 92/46/EEC-(8), as amended by Directive 92/118/EEC(9), provides that by
30 June 1993 at the latest, national measures for the detection of residues in raw milk, heat-treated
milk and milk-based products shall have been submitted to the Commission by the Member States;
whereas the residues to be detected are those in Part A, group III and Part B, group II of Annex I
to Directive 86/469/EEC;
Whereas Council Directive 89/437/EEC(10), as last amended by Directive 91/684/EEC (n) , requires
the Member States to ensure that checks are conducted to detect residues of substances having a
pharmacological or hormonal action, antibiotics, pesticides, detergents and other substances harmful
or likely to alter the organoleptic characteristics of egg products or make the consumption of such
products dangerous or harmful to human health;
Whereas Council Directive 92/45/EEC(12), as amended by Directive 92/116/EEC, requires the
Member States to extend their residue detection plans in order to make wild-game meat subject,
where necessary, to sampling checks with a view to detecting the presence of contaminants from
the environment;
Whereas Council Directive 91/495/EEC(13), as last amended by the aforesaid Directive 92/116/EEC,
requires the Member States to supplement their residue detection plans to make rabbits and farmed
game subject to monitoring of residues;
(5)
       O J N o L 55, 8.3.1971, p. 23.
(6)
       O J N o L 6 2 , 15.3.1993, p. 1.
(7)
       OJ No L 268, 24.9.1991, p. 15.
(8)
       O J N o L 2 6 8 , 14.9.1992, p. 1.
(9)
       O J N o L 6 2 , 15.3.1993, p. 49.
(10)
       OJ No L 212, 22.7.1989, p. 87.
(11)   O J N o L 376, 31.12.1991, p. 38.
(12)
       O J N o L 2 6 8 , 14.9.1992, p. 35.
(13)
       O J N o L 268, 24.9.1991, p. 41.
                                                    12
 ---pagebreak--- Whereas, if the illegal use of growth and productivity promoters in stockfarming is to be combated
effectively in all Member States, action will have to be organized at Community level;
Whereas a certain number of provisions of Directives 86/469/EEC and 85/358/EEC, and of Council
Decisions 89/187/EEC(14) and 91/664/EEC(15), require clarification and amendment in the interests
of the effective application of controls and residue detection in the Community; whereas, with a
view to immediate and uniform application of the controls currently provided for, the present rules
and amendments to them should be assembled in a single text in the form of a Regulation repealing
the aforesaid instruments,
HAS ADOPTED THIS REGULATION:
                                             CHAPTER I
                                        Scope and definitions
                                              Article 1
This Directive lays down measures to monitor:
       the substances listed in Part A and group I of Part B of Annex I hereto;
       the groups of residues in Annex I hereto.
                                              Article 2
For the purposes of this Regulation:
(a)    "prohibited substances or products" means substances or products the administering of which
       to animals is prohibited under Community legislation;
(b)    "authorized substances or products, used illegally" means substances or products authorized
       under Community legislation but used for purposes other than those laid down in the existing
       legislation;
(c)    "residue" means a residue of substances having a pharmacological action, of their metabolites
       and other substances transmitted to animal products and likely to be harmful to human health;
(d)    "competent authority" means the central authority of a Member State competent in veterinary
       matters or any authority to which such central authority has delegated such competence;
(e)    "official sample" means a sample taken by the competent authority which bears, for the
       purposes of examinination of the residue in question, a reference to the species, the type, the
       quantity concerned, the method of collection and particulars identifying the origin of the
       animal or of the animal product;
(14)
       O J N o L 66, 10.3.1989, p. 37.
(15)   O J N o L 368, 31.12.1991, p. 17.
                                                  13
 ---pagebreak--- (f)    "approved laboratory" means a laboratory approved by the competent authorities of a Member
       State for the purposes of examining an official sample in order to detect the presence of
       residues;
(g)    "batch of animals" means a group of animals of the same species and age, reared on the same
       holding, at the same time and under the same conditions of rearing;
(h)    "beta-agonist" means a beta adrenoceptor agonist.
                                              CHAPTER II
                                     Monitoring of certain substances
                                                  Article 3
 1.    With a view to the correct application of the Community legislation on certain substances,
       official on-the-spot checks by samplinjg shall be conducted during manufacture on the
       substances listed in Part A and group I of Part B of Annex I and during their handling,
       storage, transport, distribution and sale. Where fraud is suspected, these checks must cover the
       entire production and distribution chain.
2.     The checks provided for in paragraph 1 must be conducted with a view in particular to
       detecting the presence of prohibited substances or products which it is intended to administer
       to animals for the purposes of fattening.
3.     The checks provided for in paragraph 1 must be conducted by the competent national
       authorities without prior notice.
                                                  Article 4
Possession of the substances listed in Part A and group I of Part B of Annex I shall be restricted
to authorized persons during importing, manufacture, storage, distribution, sale and utilization.
                                                  Article 5
Without prejudice to criminal penalties, or penalties imposed by professional bodies, suitable
penalties of an administrative nature shall be imposed where a veterinarian or a pharmacist is
responsible, as the case may be, for the transfer or administering of prohibited substances or
products or for the administering of authorized substances or products for purposes other than those
 laid down in the current legislation.
                                                  Article 6
 Where the checks provided for in this Chapter show that prohibited substances or products are
 present, such substances or products shall be placed under offical supervision until the requisite
 measures been applied.
                                                     14
 ---pagebreak---                                                Article 7
Where there are reasons for suspecting that an infringement has taken place, the competent authority
shall conduct or have conducted:
      spot checks on animals on their farms of origin, in particular with a view to detecting traces
      of implants;
      checks to detect substances the use of which is prohibited on the farms where the animals are
      being reared, kept or fattened;
      spot checks on feedingstuffs for the animals at their farms of origin and on their drinking
      water.
The checks may include the taking of an official sample.
                                               Article 8
1.    Where the results of checks conducted in a Member State show the need for an investigation
      in one or more Member States or in one or more third countries, the Member State concerned
       shall inform the other Member States and the Commission. The Commission shall take the
      measures necessary for such an investigation.
2.    The measures to implement paragraph 1 shall be adopted, where required, in accordance with
      the procedure provided for in Article 34.
                                             CHAPTER m
                                  Monitoring plans to detect residues
                                                Article 9
The examination of live animals, their excrement and body fluids and of tissue, animal products,
animal feed and drinking water for the presence of residues of the substances listed in Annex I
hereto shall be carried out in accordance with this Chapter.
                                               Article 10
1.     Member States shall assign the task of coordinating the implementation of the inspections
      provided for in this Chapter to a central department or body.
2.     The department or body referred to in paragraph 1 shall be responsible for:
       (a)    drawing up the plan provided for in Article 11 to enable the competent departments to
              carry out the required inspections;
       (b)    coordinating the activities of the central and regional departments responsible for
              monitoring the various residues. Such coordination shall extend to all departments
              working to prevent the fraudulent use of substances or products on stock farms;
                                                   15
 ---pagebreak---      (c)    collecting the results and other data to be forwarded to the Commission before 1 March
            each year.
                                              Article 11
1.   By 31 January at the latest each year, the Member States shall submit plans to the
     Commission setting out the national measures to be implemented during the current year.
2.   The plans provided for in paragraph 1 shall specify in particular the measures to detect
     residues in:
     (a)    animals of the bovine, porcine, ovine, caprine and equine species, their meat and
            feedingstuffs;
     (b)    poultry, poultrymeat and poultry feed;
     (c)    farmed fish and shellfish, aquaculture products and feed;
     (d)    milk and milk products;
     (e)    egg products;
     (f)    meat of rabbits, wild game and farmed game;
     (g)    honey.
                                               Article 12
The plans shall cover the detection of groups of residues by type of animal, feedingstuffs and
products in accordance with Annex II.
                                               Article 13
The plans must comply with the rules on sampling laid down in Annex III.
                                               Article 14
     The plans must conform to the sampling levels and frequencies laid down in Annex IV.
     However, at the request of a Member State the Commission may, in accordance with the
     procedure provided for in Article 34, adjust the minimum requirements as regards checks laid
     down in Annex IV provided it is clearly established that such adjustments increase the overall
     effectiveness of the plans in respect of the Member State concerned and in no way reduces
     their freedom in identifying residues or cases of illegal use of substances as listed in Annex I.
     The sampling levels and frequencies covering the animals and products referred to in
     Article ll(2)(c), (d), (e), (f) and (g) shall be established in accordance with the procedure
     provided for in Article 34; in doing so, account shall be taken of experience gained under
      existing national measures and information forwarded to the Commission under existing
     Community requirements making such specific product groups subject to the search for
      residues.
                                                   16
 ---pagebreak---                                               Article 15
The plans shall take into account the specific situation of each Member State and specify in
particular:
      the legislation on the use of the substances listed in Annex I, and in particular on their
      prohibition or authorization, distribution and placing on the market and the rules governing
      their administration;
      the infrastructure of the relevant departments (in particular giving details of the type and size
      of the bodies involved in implementation of the plans);
      a list of approved laboratories with details of their capacity for processing samples;
      national tolerances for authorized substances where no maximum Community residue levels
      have been set under Council Regulation (EEC) No 2377/90 laying down a Community
      procedure for the establishment of maximum residue limits of veterinary medicinal products
      in foodstuffs of animal origin(16);
      a list of the substances to be detected, the methods of analysis, standards for interpreting the
      findings and, in the case of the substances listed in group B of Annex I, the number of
      samples to be taken, giving reasons for this number;
      the number of official samples to be taken in relation to the number of animals of the species
      concerned slaughtered in preceding years in accordance with the sampling levels and
      frequency laid down in Annex IV;
      details of the rules governing the collection of official samples, and in particular the rules
      concerning the particulars to appear on such official samples;
      the type of measures laid down by the competent authorities with regard to products in
      which residues have been detected.
                                              Article 16
 1.   The Commission shall examine the plans forwarded under Article 11(1) to ascertain whether
      they conform to this Regulation.
2.    The Commission shall approve the plans in accordance with the procedure provided for in
      Article 34. Under the same procedure, the Commission may decide that a Member State must
      amend or supplement the plan which it has submitted.
3.    At the request of the Member State concerned and in order to take account of changes in the
      situation in that Member State or in a region thereof, the Commission may decide, in
      accordance with the procedure provided for in Article 33, to approve an amendment or
      addition to a plan previously approved pursuant to paragraph 2.
4.    In accordance with the procedure provided for in Article 33, the Commission may decide that
      a Member State must amend or supplement a plan previously approved pursuant to
      paragraph 2 in order to take account of changes in the situation in that Member State or of
      findings gathered under Articles 25 and 26.
(16)
      OJNoL 224, 18.8.1990, p. 1.
                                                   17
 ---pagebreak---      5.    Every six months, Member States shall inform the Commission and the other Member States
           within the Standing Veterinary Committee of their implementation of plans approved pursuant
           to paragraph 2. Where necessary, paragraph 4 shall apply. Each year before 1 March the
           Member States shall forward to the Commission the results of their residue detection plans and
           of their measures to implement controls.
     6.    At regular intervals, and at all events whenever it deems it necessary on public health grounds,
           the Commission shall inform the Member States within the Standing Veterinary Committee
           of developments in the situation in the various regions of the Community.
     7.    Each year the Commission shall inform the Member States meeting within the Standing
           Veterinary Committee about:
                 the implementation of national plans,
                 developments in the situation in the various regions of the Community.
     8.    Each year the Member States shall publish the results of their national plans for monitoring
           residues.
                                                  CHAPTER IV
                                      Rules concerning checks on residues
   |                                                Article 17
  j
.$$  As provided for in Annexes I to IV, official samples shall be taken from animals, their excrement
     and body fluids, including the contents of the slurry pit, from their tissues and drinking water, from
     products of animal origin and from animal feed for examination at approved laboratories for
     residues.
                                                    Article 18
     1.    In each Member State at least one national reference laboratory shall be designated in
           accordance with the procedure provided for in Article 34. A given residue or residue group
           may not be assigned to more than one national reference laboratory.
     2.    The laboratories referred to in paragraph 1 shall be responsible for:
                 coordinating the work of the other national laboratories responsible for residue analysis,
                 in particular by coordinating the standards and methods of analysis for each residue or
                 residue group concerned;
                 assisting the competent authority in organizing the plan for monitoring residues;
                 periodically organizing comparative tests for each residue or residue group assigned to
                 them;
                 ensuring that national laboratories observe the limits laid down;
                 disseminating information supplied by Community reference laboratories.
                                                        18
 ---pagebreak---                                                Article 19
The Community reference laboratories shall be those designated in Chapter 1 of Annex V.
The powers and working conditions of the laboratories shall be as defined in Chapter 2 of Annex V.
                                               Article 20
1.     The official samples shall be analysed in accordance with the methodological routines
       determined in accordance with the procedure provided for in Article 34.
2.     All positive findings resulting from the analyses referred to in paragraph 1 must, if challenged,
      be confirmed by the national reference laboratory designated in accordance with Article 18(1)
       for the substance or residues in question, using the reference methods laid down in accordance
       with the procedure under Article 34.
                                               Article 21
Where examination of an official sample reveals the presence of residues of prohibited substances
or of authorized substances used illegally or in quantities exceeding either the levels set by
Community legislation or, pending the adoption of such provisions, the levels fixed by national
legislation, Articles 22 to 26 shall apply.
                                               Article 22
1.     The competent authority shall obtain without delay:
       (a)   all the information required to identify the animal and farm of origin;
       (b)   full details of the examination and its result. If the controls carried out in a Member
              State demonstrate the need for an investigation or other action in one or more Member
              States or third countries, the Member State concerned shall inform the other Member
             States and the Commission. The Commission shall coordinate the appropriate measures
             taken in Member States where an investigation or other action proves necessary.
2.     The appropriate authority shall thereupon carry out:
       (a)    an investigation on the farm of origin to determine the reasons for the presence of
              residues;
       (b)    an investigation of the source or sources of the substance concerned at the stage of
              manufacture, handling, storage, transport, administration, distribution or sale, as
              appropriate;
       (c)    any other further investigations which they consider necessary.
                                                    19
 ---pagebreak--- 3.   The competent authority shall ensure that the herd or animals at the farm of origin and herds
     which, as a result of the investigations referred to in paragraph 2, may be regarded as
     containing the residues in question, are marked with an official marking and subjected to the
     collection of official samples. The samples shall be taken from all the animals present on the
     inspected farm which are likely to be suspect. In the case of poultry and fish, the samples
     shall be taken from a significant number of individuals.
                                             Article 23
1.   Where examination of the samples taken pursuant to Article 22 reveals the presence of
     prohibited substances or of authorized substances used illegally, animals which have given
     positive test results shall be slaughtered immediately, either on the spot or at the nearest
     slaughterhouse and their carcases sent to a high-risk processing plant as defined in Article 2(5)
     of Council Directive 90/667/EEC(17), without prejudice to the penalties imposed by Community
     legislation in the sector.
     If 10% or more of the animals tested prove positive, the whole batch of animals shall be
     slaughtered under the conditions provided for in the first subparagraph. For a further period
     of at least twelve months, any animal from that farm or owned by the same owner or supplied
     by the same supplier shall be systematically tested for residues.
2.   Where the samples taken pursuant to Article 22 reveal residues of authorized substances
     exceeding the levels set by Community rules or, in the absence of such rules, the levels set
     by national law, slaughter of the animals for human consumption shall be prohibited until it
     can be ensured that the residues no longer exceed the permissible levels.
     This period may under no circumstances be shorter than the withdrawal period prescribed for
     the substances in question.
     However, if the presence of residues of authorized substances proves to be due to failure to
      observe the terms and conditions for using authorized substances other than the withdrawal
     period, the animals and their meat shall be destroyed as provided for in paragraph 1.
3.   During the period of examination, the animals may be disposed of to other persons only under
     the supervision of an official veterinarian.
4.    Notwithstanding the first subparagraph of paragraph 2, animals whose slaughter is prohibited
      may be slaughtered in emergencies before the end of the prohibition period only with the
      approval of the competent authority, which must have been informed before the proposed
      slaughter date and have designated the place of slaughter. The animals, officially marked,
      must be accompanied to the place of slaughter by an official veterinary certificate containing
     the information required under Article 22(1 )(a).
      The meat of each animal whose slaughter is notified pursuant to the first subparagraph shall
     be officially sampled for the residue concerned and shall be detained until the result of the
      examination is known.
(17)
      OJ No L 363, 27.12.1990, p. 51.
                                                  20
 ---pagebreak---      Meat in which the presence of residues is confirmed shall be sent to a high-risk processing
     plant within the meaning of the aforesaid Directive 90/667/EEC.
5.   The establishment or establishments supplying the farm of origin shall be subject to further
     checks for the substance in question. All farms and establishments in the same supply chain
     of animals and animal feed as the farm of origin shall be subject to similar checks.
                                            Article 24
1.   The costs of the investigations and checks referred to in Article 22(2) shall be borne by the
     owner or person having charge of the animals.
     The costs of analyses following the collection of official samples as provided for in
     Article 22(3) shall be borne by the owner or person having charge of the animals.
2.   Without prejudice to criminal or administrative penalties, the cost of destroying animals which
     have given a positive result or animals which have been deemed positive in accordance with
     Article 23 shall be borne by the owner of the animals without any financial compensation
     being paid.
                                            Article 25
1.   The Commission's veterinary experts may, in cooperation with the competent authorities of
     the Member States, make on-the-spot checks where this is necessary to ensure uniform
     application of this Regulation.
     A Member State within whose territory a check is being carried out shall give all necessary
     assistance to the experts in carrying out their duties. The Commission shall inform the
     Member State concerned of the results of the checks carried out.
     The Member State concerned shall take any measures which may prove necessary to take
     account of the results of the check. If the Member State does not take those measures, the
     Commission shall itself take appropriate measures in accordance with the procedure provided
     for in Article 34.
2.   The general rules for implementing this Article, especially as regards the frequency and
     method of carrying out the checks referred to in the first subparagraph of paragraph 1, shall
     be laid down in accordance with the procedure provided for in Article 34.
                                             Article 26
1.   The provisions of Council Directive 89/608/EEC of 21 November 1989 on mutual assistance
     between the administrative authorities of the Member States and cooperation between the latter
     and the Commission to ensure the correct application of legislation on veterinary and
     zootechnical matters08) shall apply.
(18)
     OJNoL 351, 2.12.1989, p. 34.
                                                 21
 ---pagebreak---       Where a Member State considers that, in another Member State, the controls provided for in
      this Regulation are not being, or have ceased to be, carried out, it shall inform the competent
      central authority of that State accordingly. Following an investigation in accordance with
      Article 22(2), mat authority shall take all necessary measures and shall, at the earliest
      opportunity, notify the competent central authority of the first Member State of the decisions
      taken and the reasons for those decisions.
      If the former Member State fears that such measures are not being taken or are inadequate,
      it shall, together with the Member State which has been challenged, seek ways and means of
      remedying the situation; if appropriate, this may involve a visit on the spot.
      Member States shall inform the Commission of disputes and of solutions arrived at.
      If the Member States involved are unable to reach agreement, one of them shall bring the
      matter to the notice of the Commission within a reasonable period of time, and the latter shall
      instruct one or more experts to deliver an opinion.
      Pending those conclusions, the Member State of destination may carry out checks on products
       coming from the establishment or establishments or from one or more of the holdings
      challenged by the dispute and, if the result is positive, take measures similar to those provided
      for in Article 10(4) of Council Directive 64/433/EEC(,9).
      In the light of the experts' opinion, appropriate measures may be taken in accordance with the
      procedure provided for in Article 34.
      Those measures may be reviewed in accordance with the same procedure, in the light of a
      new expert opinion delivered within a period of 15 days.
      The general rules for the application of this Article shall be adopted in accordance with the
      procedure under Article 34.
                                               Article 27
Slaughterhouse supervisors shall require a written statement from the owner or person having charge
of the animals, certifying that he has complied with Community legislation on the prohibition on
the use of substances having a hormonal or thyrostatic effect or of beta-agonists and that he takes
full responsibility if prohibited substances are found in animals delivered to the slaughterhouse.
                                               Article 28
       Any failure to cooperate with the competent authority and any obstruction of slaughterhouse
       personnel or the slaughterhouse supervisor by the owner of the animals, or by persons having
       charge of them, during inspection and sampling as required for the implementation of national
       plans for monitoring residues and during inquiries and checks provided for in this Regulation
       shall result in criminal and/or administrative penalties.
(19)
       OJ No 121, 29.7.1964, p. 2012/64.
                                                   22
 ---pagebreak---       Member States shall make every effort to ensure, within the limits of their national law, that
      judicial decisions regarding sentences for illegally holding or using prohibited substances or
      for illegally using authorized substances are published in the specialized agricultural press.
                                                 Article 29
The fees provided for in Council Directive 85/73/EEC of 29 January 1985 on the financing of health
inspections and controls of fresh meat and poultrymeat(20) shall also be used for residue monitoring
and control measures carried out under this Regulation, with the exception of those referred to in
Article 22(1) and (2). Each year, Member States will send to the Commission the data relating to
the allocation and the use of those fees.
                                                 Article 30
 1.    Inclusion and retention on the list referred to in Article 3 of Council Directive 72/462/EEC(21)
       shall be subject to submission by the third country concerned of an annual plan setting out the
       guarantees it offers as regards the monitoring of residues. This plan must be sent to the
       Commission no later than 31 January each year.
       The guarantees must have an effect at least equivalent to those provided for in this Regulation.
       The Commission shall approve the plan in accordance with the procedure provided for in
       Article 34 of this Regulation. Under the same procedure, guarantees alternative to those
       resulting from implementing this Regulation may be accepted.
2.     Where the requirements of paragraph 1 are not complied with, inclusion of a third country on
       the list referred to in Article 3 of Directive 72/462/EEC may be suspended in accordance with
       the procedure provided for in Article 34 hereof.
3.     Compliance with the plans submitted by third countries shall be verified by means of the
       checks referred to in Article 5 of Directive 72/462/EEC.
4.     Member States shall inform the Commission each year of the results of residue controls
       carried out on animals and animal products imported from third countries.
                                                 Article 31
Annexes I to V may be amended or extended in accordance with the procedure provided for in
Article 34.
(20)
       OJNoL 32, 5.2.1985, p. 14.
(21)
       OJ No L 302, 31.12.1972, p. 28.
                                                     23
 ---pagebreak---                                              Article 32
Rules for the application of this Regulation shall be drawn up if necessary in accordance with the
procedure laid down in Article 34.
                                           CHAPTER V
                                         General provisions
                                             Article 33
The Commission shall be assisted by the Standing Veterinary Committee (hereinafter referred to
as 'the Committee').
The representative of the Commission shall submit to the Committee a draft of the measures to be
taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman
may lay down according to the urgency of the matter. The opinion shall be delivered by the
majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is
required to adopt on a proposal from the Commission. The votes of the representatives of the
Member States within the Committee shall be weighted in the manner set out in that Article. The
chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of
the Committee.
If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion
is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the
measures to be taken. The Council shall act by a qualified majority.
If, fifteen days from the date of referral to the Council, the Council has not acted, the proposed
measures shall be adopted by the Commission.
                                             Article 34
The Commission shall be assisted by the Committee.
The representative of the Commission shall submit to the Committee a draft of the measures to be
taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman
may lay down according to the urgency of the matter. The opinion shall be delivered by the
majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is
required to adopt on a proposal from the Commission. The votes of the representatives of the
Member States within the Committee shall be weighted in the manner set out in that Article. The
chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of
the Committee.
                                                 24
 ---pagebreak--- If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion
is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the
measures to be taken. The Council shall act by a qualified majority.
If, three months from the date of referral to the Council, the Council has not acted, the proposed
measures shall be adopted by the Commission.
                                             Article 35
Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC are hereby
repealed.
                                             Article 36
Member States shall inform the Commission of the measures taken at national level to implement
this Regulation.
                                             Article 37
This Regulation shall enter into force on 1 January 1994.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,                                           For the Council
                                                            The President
                                                 25
 ---pagebreak---                                            ANNEX I
                                     RESIDUE GROUPS
   GROUPS COMMON TO ALL MEMBER STATES
   Group I
   (a)  Stilbenes, stilbene derivatives, their salts and esters
   (b)  Thyrostatic substances
   (c)  Other substances with oestrogenic, androgenic or gestagenic action, with the
        exception of substances in Group II
   (d)  beta-agonists, with the exception of those in Group II (b)
   Group II
   (a)  Substances authorized in accordance with Article 4(1) and (2) of Regulation (EEC)
        No ...793 concerning the prohibition on the use in stockfarming of certain substances
        having a hormonal action or a thyrostatic action and of beta-agonists
   (b)  Substances of the beta-agonist group authorized in accordance with Article 4(3) of
        Regulation (EEC) No ..../93 concerning the prohibition on the use in stockfarming of
        certain substances having a hormonal action or a thyrostatic action and of beta-
        agonists
   Group m
   (a)  Inhibitors
        Antibiotics, sulphonamides and similar antimicrobial substances
   (b)  Chloramphenicol
B. SPECIFIC GROUPS
   Group I: Other medicines
   (a)  Endo- and ectoparasitic substances
   (b)  Tranquillizers and beta-blockers
   (c)  Other veterinary medicines
   Group II: Other residues
   (a)  Contaminants present in feedingstuffs
   (b)  Contaminants present in the environment
   (c)  Other substances
                                               26
 ---pagebreak---                                                                               ANNEX II
                                          Residue group to be detected by type of animal, their feedingstuffs and products
 Type of animal,      Bovine, ovine,         Poultry(*)poultry   Aquaculture           Mi Ik and mi Ik-based Egg products    Rabbit meat and     Honey
 feedingstuffs        caprine, porcine,      meat and             animals and          products                              the meat of wild
 or animal            equine animals,        feedingstuffs        products, and                                              and farmed game
 products             their meat and                              their feedingstuffs
 Substance            feedingstuffs
 groups
    A I a                    A I a                 A I a               A I a                                       A I a     (**) A I a
    A I b                    A i b                 A I b                                                           A I b
    A I c                    A I c                 A I c                                                           A I c     (**) A I c
    A I d                    A I d                                     A I d
    A l i a and  b       A l i a and b          A l i a and b                                                  A l i a and b
    A III a                A III a               A III a              A III a               A III a               A III a     A III a    (**)      A III a
    A III b                 A III b              A III b              A III b               A III b               A III b     A III b <**)         A III b
    B I a                    B I a                 B I a                                                           B I a           B I a    (**>    B I a
    B I b                    B I b                 B I b                                                           B I b
    B I c                    B I c                 B I c            green malachite                                B I c           B I c <**)
    B II a                  8 II a               B II a                                     B I! a                B II a          B II a <**)
    B II b                  B II b               B II b               B II b                B II b                B II b          B II b            B II b
    B II c                  B II c               B II c                                     B II c                B II c          B II c
(*) Poultry = chickens, laying and breeding hens, turkeys, guinea fowl, ducks and geese.
(**) Not applicable to wild game.
                                                                              27
 ---pagebreak---                                             ANNEX III
                                     RULES ON SAMPLING
A.  SAMPLING CONDITIONS
(a) Official samples are to be taken in accordance with the appropriate sampling system and the
    following principles:
    *     Whether on the farm, at the slaughterhouse or in any other place where samples are
          taken, sampling must be unforeseen, unexpected, and effected at no fixed time and on
          no particular day of the week. The Member States must take all the precautions
          necessary to ensure that the element of surprise in the checks is constantly maintained.
    *     In the case of the substances listed in Groups A I and A II of Annex I, sampling must
          be targeted so as to take account of the criteria set out in (b) below, especially as
          regards sex, age and fattening system, and must take account of all information in the
          Member State's possession.
    *     In the case of the other substances listed in Annex I, the official samples shall be taken
          at random.
          Furthermore, the Member States shall be authorized to carry out checks on a basket of
          substances and to concentrate checks on those regions where species likely to be
          affected by such substances are produced.
(b) Variable criteria to be taken into account when collecting targeted samples:
    (i)   Legislation in force regarding the use of the substances listed in the residue groups
    (ii)  Factors liable to encourage fraud or misuse.
    (iii) The animal population concerned as regards:
                 total size of population,
                 homogenity of population groups,
                 age of animals,
                 sex of animals.
    (iv) The environment of holdings as regards.
                 regional differences,
                 the relation to industrial activity,
                 relation to arable farming.
    (v)    Farm production systems including:
                 intensive farming units,
                 fattening systems,
                 husbandry systems, in particular feeding regimes and animal health care measures
                                                  28
 ---pagebreak---       (vi) Problems liable to arise, in the light of known precedents and other indications.
      (vii) The required degree of consumer protection, according to the nature and toxicity of the
             substance in question.
      (viii) Where the provisions of Annex IV lay down that samples must be taken on the holding,
             such samples may be taken not only from the animals but also from their feedingstuffs
             and drinking water.
B.    SAMPLING SYSTEM
Member States shall apply, for each type of substance and animal, and according to the health-
protection level, the above variable criteria and the special characteristics of their territory, a
sampling and examination system in accordance with Annexes I, II and III to this Regulation.
                                                 29
 ---pagebreak---                                        ANNEX IV
                             Sampling levels and frequency
                                      CHAPTER 1
                     Cattle, pigs, sheep, goats, horses and the like
Minimum annual requirements
A.   In the case of the residues and substances listed in Groups A I and A II of Annex I
     1.    In the case of the following bovine animals for fattening: cows, young bulls, bulls,
           heifers and calves:
                 the Member States shall ensure checks on a number of samples covering
                 0.5% of the animals slaughtered in the previous year,
                 the samples must be broken down as follows:
                 (a)   three-fifths are to be taken on the farm from live animals At least one
                       third of these samples are to be tested for beta-agonists. Supplementary
                       samples are to be taken from the animals' feedingstuffs and drinking
                       water and slurry from the holding;
                 (b)   two-fifths are be taken in the slaughterhouse.
     2.    In the case of sheep and pigs for fattening
           The Member States shall effect checks on a number of samples equal to 0.05% of
           the animals of each species slaughtered the previous year.
     3.    Other animal types
           The number of samples shall be determined by the Member States on the basis of
           the problems identified for each animal category.
B.   In the case of the residues and substances listed in Group A HI of Annex I
      1.   Group A IH(a)
           Samples equal to 0.1% of the animals slaughtered shall be tested.
     2.    Group A 111(b) (Chloramphenicol)
           Samples equal to 0.02% of the animals slaughtered shall be tested.
C.   In the case of the residues listed in Groups B I and B II of Annex I:
           Monitoring shall cover 700 samples. However, instead of taking 700 samples,
           Luxembourg is authorized to effect checks on a number of samples equal to 0.2%
           of the animals slaughtered.
                                            30
 ---pagebreak---                 The annual results concerning environmental contaminants (heavy metals in
                particular) shall include a geographical map showing the distribution of the
                contamination.
II. Follow-up
    Where an animal species or type of production of a given animal species has not tested
    positive for residues or substances of Groups A I, A II or A 111(b) of Annex I for two
    consecutive years, the Member States shall be authorized to test 300 samples a year for the
    residue group concerned and for the species or type of production of the species in question.
                                           CHAPTER 2
                          Chickens, laying and breeding hens, turkeys,
                                   guinea fowl, ducks and geese
                                  Minimum annual requirements
Samples must be taken from animals and their feedingstuffs and drinking water.
A.  In the case of the residues listed in Groups A I, A H, B I and B II, with the exception of the
    coccidiostats
    The number of samples taken must be at least 0.1% of the batches of the species in question
    slaughtered during the previous year.
B.  In the case of the residues listed in Group A III of Annex I:
    1.    GroupAIII(a)
          Monitoring shall cover a number of samples equal to 1% or more of the batches, with
          a minimum of 100 samples in the case of turkeys, guinea fowl, ducks and geese.
          Group A EH (b) (chloramphenicol)
          Monitoring shall cover a number of samples equal to 1% of the batches of the species
          in question slaughtered during the previous year.
C.  In the case of the residues listed in Group B 1(a) (coccidiostats only)
    Monitoring shall cover a number of samples equal to 1% or more of the batches, with a
    minimum of 100 samples in the case of turkeys, guinea fowl, ducks and geese.
                                                31
 ---pagebreak---                                              ANNEX V
                                              Chapter 1
The following laboratories shall be designated Community reference laboratories for the
detection of residues of certain substances:
(a)   For the residues listed in Groups A I and A II of Annex I to this Regulation, with the
      exception of beta-agonists
      Rijksinstituut voor de Volksgezondheid en Milieuhygiène
      A. van Leeuwenhoeklaan 9
      NL - 3720 BILTHOVEN
(b)   For the residues listed in Group A 111(a) of Annex I to this Regulation, with the exception
      of the sulphonamides
      Laboratoires des Médicaments vétérinaires
      (CNEVA - LMV)
      La Haute Marché, JAVENE
      F - 35133 FOUGERES
(c)   For the residues listed in Group A HI(b) of Annex I to this Regulation, plus beta-agonist
      and sulphonamide residues
      B undesgesundheitsamt
      Diedersdorfer Weg 1
      D - 12277 BERLIN 48
(d)   For the residues listed in Groups B 11(a) and B 11(b) of Annex I to this Regulation
      Istituto Superiore di Sanità
      Via Regina Elena 299
      I - 00161 ROMA
                                              Chapter 2
The powers and operating conditions of the Community reference laboratories for the detection
of residues in animals and foodstuffs of animal origin shall be as follows:
 1.   The functions of Community reference laboratories shall be:
      (a)    to coordinate the application, within the various national reference laboratories, of
             good laboratory practice in accordance with Directives 87/18/EEC(1) and
             S8/320/EEC(2);
      (b)    to provide national reference laboratories with details of analytical methods and the
             comparative tests to be conducted, and to inform them of the results of such tests;
(i)
      OJNoL 15, 17.1.1987, p. 29.
(2)
      OJNoL 145, 11.6.1988, p. 35.
                                                  32
 ---pagebreak---    (c)   to provide national reference laboratories, at their request, with technical advice on
         the analysis of the substances for which they have been designated the Community
         reference laboratory;
   (d)   to distribute calibrated blank samples with and without residues to be analysed in
         comparative tests to be carried out by national reference laboratories;
   (e)   to organize comparative tests between the various reference laboratories, the
         frequency of which shall be determined under the contracts to be concluded between
         the Commission and such laboratories and each time a new reference method is
         introduced under Community rules;
   (f)   to promote and coordinate research into new analytical methods and to inform
         national reference laboratories of advances in analytical methods and equipment;
   (g)   to identify residues and determine their concentration in cases where the results of
         analysis give rise to a disagreement between Member States;
   (h)   to conduct initial and further training courses for the benefit of analysts from national
         laboratories;
   (i)   to provide the Commission services, including the Community reference bureau, with
         technical and scientific assistance;
   (j)   to compile a report on each year's work and transmit it to the Commission;
   (k)   to liaise, in the field of analytical methods and equipment, with the national reference
         laboratories designated by third countries in the plans to be submitted in accordance
         with Article 34.
2. In order to perform the functions specified in paragraph 1, Community reference
   laboratories must satisfy the following minimum requirements:
   (a)   have suitably qualified staff who are adequately trained in analytical methods used
         for the residues for which they have been designated as the Community reference
         laboratory;
   (b)   possess the equipment and substances needed to carry out the analyses for which they
         are responsible;
   (c)   have an adequate administrative infrastructure;
   (d)   have sufficient data-processing capacity to produce statistics based on their findings
         and to enable rapid communication of those statistics and other information to
         national reference laboratories and the Commission;
   (e)   ensure that their staff respect the confidential nature of certain issues, results and
         communications;
                                                33
 ---pagebreak--- (f) have sufficient knowledge of international standards and practices;
(g) have available an up-to-date list of reference substances held by the Community
    reference bureau and an up-to-date list of manufacturers and vendors of such
    substances.
                                          34
 ---pagebreak---                                             Proposal for a
                                  COUNCIL REGULATION (EEC)
               amending Regulation (EEC) No 805/68 on the common organization
                                   of the market in beef and veal
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular
Article 43 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas the administration of substances prohibited by Community veterinary regulations and in
particular substances with a hormonal action and beta-agonists carries considerable risks to human
health; whereas experience shows that, since the use of such substances can harm the reputation
of beef and veal with consumers, it is also likely to disturb the balance on the market in beef and
veal; whereas, given their effects on meat production, the illegal use of such substances is also
likely to give the producers concerned economic advantages which could distort the market;
whereas, therefore, Article 4(j) of Council Regulation (EEC) No 805/68(1), as last amended by
Regulation (EEC) No 747/93(2>, lays down that the administration of prohibited substances renders
the animals concerned ineligible for the premiums provided for in the beef and veal sector;
whereas a thoroughgoing study of the current situation has shown that this measure is inadequate
to ensure compliance with the prohibitions in force; whereas, therefore, the penalties should be
strengthened; whereas the Commission intends to take appropriate measures as regards the detailed
rules for the application of beef and veal premiums; whereas it is therefore necessary to delete the
said Article 4(j),
HAS ADOPTED THIS REGULATION:
                                              Article 1
Article 4(j) of Regulation (EEC) No 805/68 is hereby repealed.
(1)
      OJ No L 148, 28. 6. 1968, p. 24.
(2)
      OJ No L 77, 31.3.1993, p. 15.
                                                 35
 ---pagebreak---                                               Article 2
This Regulation shall enter into force on the seventh day following that of its publication in the
Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,                                           For the Council
                                                            The President
                                                 36
 ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM (93) 441 final
                                                      DOCUMENTS
EN                                                                              03
                                 Catalogue number : CB-CO-93-485-EN-C
                                                             ISBN 92-77-59409-8
Office for Official Publications of the European Communities
L-2985 Luxembourg
                                              37