CELEX: 51981PC0795
Language: en
Date: 1982-01-14
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE MANUFACTURE, PUTTING INTO CIRCULATION AND SUPPLY OF MEDICATED FEEDING-STUFFS IN THE COMMUNITY

16.2.82                           Official Journal of the European Communities                              N o C 41/3
                                                            II
                                                    (Preparatory Acts)
                                              COMMISSION
               Proposal for a Council Directive on the manufacture, putting into circulation and supply
                                      of medicated feedingstuffs in the Community
                            (Submitted by the Commission to the Council on 20 January 1982)
THE COUNCIL OF THE EUROPEAN                                     administrative action relating to proprietary medicinal
COMMUNITIES,                                                    products (2), Council Directive 81/851/EEC of
                                                                28 September 1981 on the approximation of the laws
                                                                of Member States relating to veterinary medicinal
Having regard to the Treaty establishing the
                                                                products (J) and Council Directive 81/852/EEC of
European Economic Community, and in particular
                                                                28 September 1981 on the approximation of the laws
Article 43 thereof,
                                                                of Member States relating to analytical, pharmaco-
                                                                toxicological and clinical standards and protocols
Having regard to the proposal from the Commission,              in respect of the testing of veterinary medicinal pro-
                                                                ducts (*), should be taken into account;
Having regard to the opinion of the European
Parliament,                                                     Whereas account must also be taken of Community
                                                                rules on feedingstuffs in the form of Council
                                                                Directive 70/524/EEC of 23 November 1970
Having regard to the opinion of the Economic and                concerning additives in feedingstuffs ( 5 ), as last
Social Committee,                                               amended by the 38th Commission Directive
                                                                81/632/EEC       C), and of Council           Directive
Whereas, to safeguard public health from any dangers            79/373/EEC of 2 April 1979 on the marketing of
arising from the use of medicated feedingstuffs for             compound feedingstuffs ( 7 );
animals intended for food production, and to prevent
distortions in competition in the keeping and rearing           Whereas medicated feedingstuffs must in principle be
of farm animals, conditions should be laid down                 manufactured under the same conditions as those
regarding the manufacture, putting into circulation             applying to veterinary medicinal products; whereas,
and supply of medicated feedingstuffs;                          however, since in the manufacture of medicated
                                                                feedingstuffs simple mixing is usually the main
                                                                process, only authorized pre-mixes may be used and
Whereas Community rules regarding medicinal                     precise instructions are given in a prescription or
products, in the form of Council Directive                      standard prescription, the person responsible for
65/65/EEC of 26 January 1965 on the approximation               manufacture required by the rules on medicinal
of provisions laid down by law, regulation or
administrative action relating to proprietary medicinal
products     ('), the second         Council    Directive
75/319/EEC of 20 May 1975 on the approximation
                                                                O   OJ No L 147, 9. 6. 1975, p. 13.
of provisions laid down by law, regulation or
                                                                O   OJNoL317, 6. 11. 1981, p. 1.
                                                                (4) OJNoL317, 6. 11. 1981, p. 16.
                                                                (s) OJ No L 270, 14. 12. 1970, p. 1.
                                                                (') OJ No L 231, 15. 8. 1981, p. 30.
(') OJ No 22, 9. 2. 1965, p. 369.                               (7) OJ No L 86, 6. 4. 1979, p. 30.
 ---pagebreak--- No C 41/4                           Official Journal of the European Communities                              16.2.82
products may be replaced by a person with adequate                81/851/EEC on the approximation of the laws of
knowledge of mixing techniques;                                   Member States relating to veterinary medicinal
                                                                  products;
Whereas the supply of medicated feedingstuffs to
stockfarmers may only be by prescription of a veteri-        (d) intermediate product: any mixture of one or more
narian, who must himself comply with particular                   pre-mixes for medicated feedingstuffs and one or
conditions when issuing the prescription;                         more feedingstuffs which is prepared in advance
                                                                  with a view to the subsequent manufacture of
                                                                  medicated feedingstuffs;
Whereas, in order for there to be effective control,
the persons concerned must be required to keep a             (e) veterinary medicinal product:       any    medicinal
register or to retain the relevant documents for a                product intended for animals;
specified period of time;
                                                             (f) putting into circulation: the holding for sale or
Whereas, for the authorization of medicated                       any other disposal, and any kind of disposal to
feedingstuffs from standard prescriptions in intra-               others, whether or not for consideration;
Community trade, a procedure should be chosen
which ensures close cooperation between the                  (g) additives: substances which, when incorporated in
Commission and the Member States,                                 feedingstuffs, are likely to affect their charac-
                                                                  teristics on livestock production;
                                                             (h) feedingstuffs: organic or inorganic substances,
                                                                  used singly or in mixtures, whether or not
HAS ADOPTED THIS DIRECTIVE:                                       containing additives, for oral animal feeding;
                                                              (i) daily ration: the average total quantity of
                       CHAPTER I                                  feedingstuffs, calculated on a moisture content of
                                                                  12 % , required daily by an animal of a given
                  Definitions and scope                           species, age category and performance to satisfy
                                                                  all its nutritional requirements;
                         Article .1                           (j) complete feedingstuffs: mixtures of feedingstuffs
                                                                  which, by reason of their composition, are
This Directive covers the manufacture and putting in              sufficient for a daily ration;
circulation of medicated feedingstuffs and their
supply to livestock farmers within the Community, as         (k) supplementary        feedingstuffs:  mixtures     of
well as intra-Community trade in these products.                  feedingstuffs which have a high content of certain
                                                                  substances and which, by reason of their
                                                                  composition, are sufficient for a daily ration only
                                                                  if they are used in combination with other
                         Article 2                                feedingstuffs;
                                                              (1) mineral feedingstuffs: supplementary feedingstuffs
For the purposes of this Directive the following
                                                                  which are composed mainly of minerals and
definitions shall apply:
                                                                  contain at least 40 % crude ash;
(a) medicated feedingstuff: any mixture of one or            (m) standard prescription: officially recognized pre-
     more veterinary medicinal products and one or                scription for the manufacture of a medicated
     more feedingstuffs which is prepared prior to                feedingstuff.
     being put into circulation and which, because of
     its prophylactic or therapeutic properties or other
     properties as referred to in Article 1 (2) of
     Directive 65/65/EEC is intended to be fed to
     animals without alteration;                                                        Article 3
 (b) pre-mix for medicated feedingstuffs: any veterinary      1.    This Directive shall be without prejudice to
     medicinal product prepared in advance with a            other Community provisions on feedingstuffs.
     view to the subsequent manufacture of medicated
     feedingstuffs;
                                                             2.     The provisions of this Directive shall not apply
 (c) authorized pre-mix: any pre-mix for medicated           to medicated feedingstuffs shown, at least by appro-
     feedingstuffs for which an authorization has been       priate markings, to be intended for export to non-
     granted in accordance with Article 4 of Directive       member countries.
 ---pagebreak---  16.2.82                            Official Journal of the European Communities                              No C 41/5
                       CHAPTER II                               5. The medicated feedingstuffs manufactured must be
                                                                   checked regularly in accordance with national
        Manufacture of medicated feedingstuffs                     provisions, especially in respect of homogeneity
                                                                   and stability of the mixture and storability.
                                                               6. Manufacturers must keep records, on the basis of
                          Article 4                                immediate entries, of the types and quantities of
                                                                   pre-mixes and feedingstuffs used and of medicated
1.    As regards the content of medicinal products,                feedingstuffs manufactured, put into storage or
medicated feedingstuffs may be manufactured only                   dispatched, the names and addresses of recipients
from pre-mixes authorized for that purpose.                        and, where delivery is direct to stockfarmers, the
                                                                   name and address of the prescribing veterinarian.
                                                                   The record must be retained for at least one year
2.    Medicated feedingstuffs may be manufactured
                                                                   after the date of the last entry and be made
only from a veterinary prescription or from a
                                                                   available at any time to the inspection authorities.
standard prescription authorized in accordance with
Article 14 (2).
                                                               7. Pre-mixes, intermediate products and medicated
3.    By way of derogation from paragraph 2,                       feedingstuffs must be stored in suitable separate
however, Member States may authorize other                         rooms or containers which are specially designed
standard prescriptions for the manufacture of                      for the purpose and which can be locked.
medicated feedingstuffs. Such standard prescriptions
shall require the approval of the competent central
authority of the Member State.
                                                                                        Article 6
                                                               By way of derogation from Article 4 (1), medicated
                          Article 5                            feedingstuffs may be manufactured without the use of
                                                               an authorized pre-mix if appropriate measures are
Member States shall take all appropriate measures to           taken to ensure that in addition to the provisions of
ensure that medicated feedingstuffs are manufactured           this Directive, in particular Article 5, the provisions of
only under the conditions set out below:                       Directive 81/851/EEC and Directive 81/852/EEC
                                                               are complied with, and that in particular the manu-
1. The manufacturer must have suitable and adequate            facturer disposes of the services of a qualified person
                                                               as defined in Article 31 of Directive 81/851/EEC.
   premises, technical equipment, storage and
   inspection facilities.
                                                               In such cases the medicated feedingstuff shall require
2. The manufacturer must have available the services
                                                               authorization under Article 4 of the abovementioned
   of proficient staff to comply with the conditions
                                                               Directive 81/851/EEC.
   regarding manufacture. In particular, staff with an
   adequate knowledge of mixing techniques must be
   present in the manufacturing plant.
3. Only complete or supplementary feedingstuffs, not
                                                                                        Article 7
   including mineral feeds, which comply with the
   Community provisions on feedingstuffs may be
   used. The feedingstuffs used must demonstrably              Member States may provide that medicated
   allow of homogeneous and stable mixing with the             feedingstuffs may be manufactured from intermediate
                                                               products and that these intermediate products may be
   veterinary medicinal product and it must be
                                                               put into circulation.
   possible to store it for an appropriate period. In
   particular, the feedingstuff used may not contain
   any additives which affect the action of the                Such intermediate products may be manufactured
   veterinary medicinal product.                               only from authorized pre-mixes with the addition of
                                                               feedingstuffs.
4. In respect of premises, staff and equipment the
   entire manufacturing process must comply with               Member States shall ensure that intermediate
   provisions of the Member State ensuring the                 products are subject to the supervision of the
   observance of recognized principles of hygiene,             competent authorities, that they may be used only for
   with a view, in particular, to avoiding contami-            the manufacture of medicated feedingstuffs and that
   nation between veterinary medicinal products or             their use is subject to the conditions governing the
   feedingstuffs.                                              putting into circulation of the pre-mix used.
 ---pagebreak--- No C 41/6                           Official Journal of the European Communities                             16.2.82
                     CHAPTER III                             2.    Except in cases of tests of medicinal products
                                                             carried out pursuant to Article 5 (10) of Directive
                Packaging and labelling                      81/851/EEC a medicated feedingstuff may not be
                                                             administered to animals unless the conditions laid
                                                             down in paragraph 1 are fulfilled.
                        Article 8
                                                             3.    Articles 5, 6 and 7 of Directive 81/851/EEC
Member States shall prescribe that medicated                 shall apply to applications for authorization to put
feedingstuffs may be supplied only in containers             into circulation a medicated feedingstuff manu-
which ensure that their condition is not impaired.           factured in accordance with Article 6 of this
                                                             Directive.
Whenever medicated feedingstuffs are put into circu-         As regards indication of the components of the
lation in road tankers or similar containers, these          medicated feedingstuff, however, it shall be sufficient
must be thoroughly cleaned before any re-use in              to indicate the main components of the feedingstuff
order to prevent contamination.                              used.
                                                             As regards examination of applications for authori-
                                                             zation, Chapter III of Directive 81/851/EEC and
                        Article 9                            Directive 81/852/EEC shall apply.
1.    Member States shall take all appropriate
measures to ensure that medicated feedingstuffs are                                   Article 11
not put into circulation unless the labelling fulfils the
requirements:                                                Member States shall ensure that               medicated
                                                             feedingstuffs are put into circulation only if the daily
— Chapter VII of Directive 81/851/EEC, in respect            dose of medicinal product is contained in a quantity
    of the medicinal products used, and                      of feedingstuff corresponding to at least half the daily
— Council Directive 70/524/EEC and               Council     feed ration of the animals treated or, in the case of
     Directive 79/373/EEC, in respect            of the      ruminants, half the daily requirements of non-mineral
    feedingstuffs used.                                      supplementary feedingstuffs.
Medicated feedingstuffs must further bear the clearly
visible words 'Medicated feedingstuff           and an
                                                                                      Article 12
indication as to what proportion of the daily ration
they are intended to represent.
                                                             1.    Member States shall prescribe that medicated
                                                             feedingstuffs may be supplied to stockfarmers only on
2.    Whenever medicated feedingstuffs are put into
                                                             presentation of a prescription from a registered
circulation in road tankers or similar containers, it
                                                             veterinarian.
shall be sufficient for the indications referred to in
paragraph 1 to be contained in the accompanying              The veterinarian's prescription shall be made out in at
documents.                                                   least triplicate, at one impression, on a form based on
                                                             the model in Annex I.
                                                             The original shall be kept by the manufacturer or
                                                             dealer; the first copy shall be kept by the stockfarmer
                                                             and when the medicated feedingstuff is supplied the
                     CHAPTER IV                              manufacturer or dealer shall enter the additional
                                                             particulars provided for on the form.
Putting into circulation and supply of medicated
                      feedingstuffs                          The second copy shall be kept by the prescribing
                                                             veterinarian.
                                                             Prescriptions shall be retained by the veterinarian,
                        Article 10                           manufacturer or merchant and stockfarmer for at
                                                             least one year from the date of issue and shall be
 1.    Member States shall take all appropriate              made available to the competent supervisory auth-
measures to ensure that a medicated feedingstuff is          orities at any time on request.
put into circulation only if it has been manufactured
in accordance with the provisions of this Directive          2.    The veterinarian may prescribe medicated
and, in cases as referred to in Article 6, the authori-      feedingstuffs only for animals treated by him, only if
zation provided for has been granted.                        their use is justified on veterinary grounds and only in
 ---pagebreak---  16.2.82                           Official Journal of the European Communities                               No C 41/7
 such quantities as are necessary for the purpose of the       veterinary prescription in accordance with Annex I
treatment.                                                     shall suffice.
 3.    Member States shall lay down that medicated
feedingstuffs may not be supplied more than once on                                   CHAPTER VI
the same prescription.
                                                                               Supervision and sanctions
4.    Member States may limit the period of validity
of the veterinary prescription.
                                                                                        Article 15
                        Article 13                             1.     Member States shall take all appropriate
                                                               measures to ensure that their competent authorities
Member States shall take all appropriate measures to           satisfy themselves through inspection visits that the
ensure that medicated feedingstuffs are supplied              provisions of this Directive are complied with.
directly by the manufacturer or merchant to the
stockfarmer.                                                   2.     Such inspections shall be carried out by
                                                               employees of the competent authorities of the
                                                               Member States, who shall be empowered as a
                                                               minimum to:
                       CHAPTER V                               (a) inspect      manufacturing        and     commercial
                                                                    establishments and, in cases where       the veteri-
                 Intra-Community trade                              narian is authorized to supply             medicated
                                                                    feedingstuffs direct, the laboratories    and work
                                                                    premises of veterinary practices;
                        Article 14
                                                               (b) inspect the stock farms            where    medicated
                                                                    feedingstuffs are used;
1.    Member States shall ensure that there are no
prohibitions, limitations or obstacles in respect of           (c) take samples;
intra-Community trade in medicated feedingstuffs
                                                               (d) examine and have at their disposal any documents
which have been manufactured:
                                                                    relevant to the object of the inspection;
— in accordance with a standard prescription auth-
                                                               (e) require all necessary         particulars  from   the
    orized by the Community,
                                                                    interested parties.
— in accordance with a prescription from a veteri-
    narian, provided that the pre-mix used had been            3.     Member States shall take all appropriate
    authorized by the Community according to                  measures to ensure that infringements of this
    Directive 81/851/EEC, or                                   Directive are penalized.
— in accordance with Article 6 provided that the
    medicated feedingstuff had been authorized by
    the Community, in accordance with the
    abovementioned Directive.
                                                                                     CHAPTER VII
2.    The Community authorizations referred to in
the first indent of paragraph 1 shall be granted by the                             Final provisions
Commission in accordance with the procedure laid
down in Article 16. The criteria for the Community                                      Article 16
authorization of standard prescriptions shall be
determined in accordance with the same procedure.
                                                              1.     Where the procedure" laid down in this Article is
A list of such standard prescriptions and all                 to be used, matters shall be referred by the chairman,
amendments thereto shall be published in the Official         either on his own initiative or at the request of a
Journal of the European Communities.                          Member State, to the Standing Veterinary Committee
                                                              (hereinafter called the 'Committee') set up by Council
3.    Each consignment of a medicated feedingstuff            Decision 68/361/EEC.
must be accompanied by a certificate issued by the
competent veterinary authority, in accordance with            2.     Within the Committee, the votes of Member
the model in Annex II. In the event of manufacture as         States shall be weighted as provided in Article 148 (2)
referred to in the second indent of paragraph 1 a             of the Treaty. The chairman shall not vote.
 ---pagebreak--- No C 41/8                         Official Journal of the European Communities                          16.2.82
3.    The representative of the Commission shall           adopted any measures, the Commission shall adopt
submit a draft of the measures to be adopted. The          the proposed measures and shall apply them
Committee shall deliver its opinion on such measures       immediately.
within two days. Opinions shall be delivered by a
majority of 45 votes.
                                                                                  Article 17
4.    The Commission shall adopt the measures and
shall apply them immediately where they are in             Member States shall bring into force the laws, regu-
accordance with the opinion of the Committee.              lations and administrative provisions necessary to
Where they are not in accordance with the opinion of       comply with this Directive not later than 31 January
the Committee or if no opinion is delivered, the           1984. They shall forthwith inform the Commission
Commission shall without delay propose to the              thereof.
Council the measures to be adopted. The Council
shall adopt the measures by a qualified majority.
                                                                                  Article 18
If, within three months from the date on which the
proposal was submitted to it, the Council has not          This Directive is addressed to the Member States.
 ---pagebreak--- 16.2.82                           Official J o u r n a l of the E u r o p e a n  Communities                                 No C 41/9
                                                             ANNEX      I
          Surname, forename and address of the prescribing veterinarian:                     Date:
                                                                                Copy intended for manufacturer or dealer (')
                                                                                 (to be retained for at least one year)
               PRESCRIPTION FOR A MEDICATED FEEDINGSTUFF                                      This prescription may not
                                                                                                        be re-used
        Name or business name and address of the manufacturer or dealer:
        Name and address of the stockfarmer:.
        Identification and number of animals: '.
        Indication ( 2 ):
        Designation or composition of the medicated feedingstuff:
        Rp
        Total quantity of medicated feedingstuff:                                                                       kg
        Special instructions for the stockfarmer:
        Percentage of medicated feedingstuff in the daily ration, frequency and duration of treatment:
        Withdrawal time before slaughtering, or waiting time before marketing products from treated
        animals:
                                                                           Personal signature of veterinarian
        T o be completed by the manufacturer or dealer:
        Date of delivery:
        T o be used before:
                                                                          Signature of manufacturer or dealer
        (') The following shall be inserted instead of 'the manufacturer or dealer':
            (a) on the first copy the words: 'the stockfarmer',
            (b) on the second copy the words: 'the veterinarian'.
        (2) To be entered only on the copy for the veterinarian.
 ---pagebreak--- N o C 41/10                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s           16.2.82
                                                             ANNEX    II
            CERTIFICATE O F MANUFACTURE O F A MEDICATED FEEDINGSTUFF FOR T H E
                                      PURPOSES O F INTRA-COMMUNITY TRADE
            (pursuant to Article 14 (3) of Directive . . . / . . ./EEC on the manufacture, putting into circulation
                                              and supply of medicated feedingstuffs)
            Name and address of manufacturer or dealer:
            Designation of the medicated feedingstuff:
            Quantity of medicated feedingstuff:
            Name and address of the recipient:
            This is to certify that the abovementioned consignment of medicated feedingstuffs was manufac-
            tured in accordance with the provisions of the abovementioned Directive.
                                                                                    Place and date
            Stamp of the competent veterinary authority
                                                                                      (Signature)
                                                                                   Name and position