CELEX: 51993PC0287
Language: en
Date: 1993-07-02
Title: Proposal for a COUNCIL REGULATION (EEC) amending Annexes I, II, III and IV of Council Regulation (EEC) N° 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin

COMMISSION OF THE EUROPEAN COMMUNITIES
                                             C0M(93) 287 final
                                             Brussels, 2 July 1993
                              Proposal for a
                         COUNCIL REGULATION (EEC)
   amending Annexes I, II, III and IV of Council Regulation (EEC) N' 2377/90
                      laying down a Community procedure for
      the establishment of maximum residue limits of veterinary medicinal
                    products In foodstuffs of animal origin
                      (presented by the Commission)
 ---pagebreak---                                                                                            ï
                                    Explanatory note
Pursuant   to Council      Regulation     (EEC) 2377/90 of       26 June 19901      laying
down  a Community       procedure    for   the establishment       of maximum     residue
limits of veterinary medicinal products In foodstuffs of animal origin,
the Commission      must   adopt    legally binding maximum        residue    limits for
residues of     veterinary     medicinal     products     In such   foodstuffs.      These
maximum residue limits are established             in accordance with the procedure
of  the   regulatory      Committee,     following    scientific    assessment     by  the
Committee for Veterinary Medicinal Products.
Since   1 January     1992, when      the Regulation       entered    Into   force,   four
implementing regulations have been adopted by the Commission                     via this
procedure    without     any   major    problems:     Commission     regulations     (EEC)
                                2                                     3
675/92   of   18 March 1992,        762/92    of   27 March     1992,    3093/92    of  27
October 1992 4 and 895/93 of 16 April 1993. 5
On  27 May     1993   the Commission        submitted    a  draft   regulation     to  the
Committee for adaptation to technical progress of directives designed to
remove   technical     barriers    to trade      in veterinary    medicinal     products.
While there were no problems regarding the substances listed In Annexes
 I and   II, there      was   disagreement      over   substances     belonging    to  the
nitrofuran group and the Committee was unable to deliver an opinion.
Nitrofurans     are   a   category    of   existing    medicinal    product    for   which
provisional     maximum     residue     limits    were    established     in   regulation
675/92,    pending    further     information.     These    limits are valid unti\       1
July 1993.
1  OJ L 224, 18.08.1990, p. 1.
2  0J L 73, 19.03.1992, p. 8.
3  0J L 83, 28.03.1992, p. 14.
4  OJ L 311, 28.10.1992, p. 18.
5  0J L 93, 17.04.1993, p. 10.
 ---pagebreak---                                                                                       ^
A number   of  substances     belonging     to  the nitrofuran    group   have   been
examined   by   the   JEFCA    (an    FAO/WHO   committee   of   experts    on   food
additives).   The Committee       for   veterinary   medicinal   products    and  its
working group took another        look at these dossiers at the beginning of
the year.
Under  the   terms   of  Article     4 of    Regulation   2377/90   the   period   of
validity   of  maximum     residue     limits  may   be  extended    only   once   In
exceptional   cases    for   a   period    not   exceeding   two   years,   so   that
scientific studies in progress may be completed.
In the Commission's       view,    these   conditions   have  been   fulfilled    for
furazolidone,    since   the   data    should  be   available  within   two years.
However, as regards all the other substances belonging to the nitrofuran
group, the Commission has not received sufficient Information within the
meaning of Article 4 and therefore believes that they should be included
In Annex IV.
 ---pagebreak---                          PROPOSAL FOR A COUNCIL REGULATION
   amending Annexes I, II, III and IV of Council Regulation (EEC) N' 2377/90
   laying down a Community procedure for the establishment of maximum residue
     limits of veterinary medicinal products In foodstuffs of animal origin
THE COUNCIL OF THE EUROPEAN COMMUNITIES
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Regulation (EEC) N* 2377/90 of 26 June 1990 laying
down a Community procedure for the establishment of maximum residue limits of
veterinary   medicinal   products    In  foodstuffs     of  animal  origin^ 1 ),  as  last
                                                                 2
amended   by   Commission   Regulation     (EEC)   N"    895/93^ )   and   In  particular
Articles 6, 7 and 8 thereof;
Having regard to the proposal from the Commission ;
Whereas,   in accordance    with   Regulation    (EEC) N"     2377/90, maximum     residue
 limits must   be established     progressively     for   all  pharmacologically    active
substances    which  are   used   within    the  Community     In  veterinary    medicinal
products intended for administration to food-producing animals;
Whereas   maximum    residue    limits    should    be   established    only   after   the
examination within the Committee for Veterinary Medicinal Products of 'II the
relevant    information  concerning     the   safety   of   residues   of  ïh    substance
concerned for the consumer of foodstuffs of animal origin and i .3 impact of
residues on the industrial processing of foodstuffs;
Whereas,   In establishing maximum      residue    limits for    residues of    veterinary
medicinal products in foodstuffs of animal origin, it is necessary to specify
the animal species in which residues may be present, the levels which may be
present In each of the relevant meat tissues obtained from the treated animal
(1) OJ N* L 224, 18.08.1990, p 1
(2) 0J N* L 93, 17.04.1993, p 10
 ---pagebreak---                                                                                           s
(target   tissue) and   the nature   of   the   residue   which   is relevant    for  the
monitoring of residues (marker residue) ;
Whereas, for the control of residues, as provided for in appropriate Community
legislation, maximum     residue  limits should     usually   be established     for  the
target tissues of liver or kidney; whereas, however, the liver and kidney are
frequently removed from carcasses moving        in international trade, and maximum
residue limits should therefore also always be established for muscle or fat
t issues;
Whereas,    In the case of veterinary medicinal        products    Intended  for use In
laying birds,    lactatlng animals or honey bees, maximum          residue   limits must
also be established for eggs, milk or honey;
Whereas    enrofloxacin   and  closantel    should   be   inserted    into  Annex    I to
Regulation (EEC) N* 2377/90; whereas, In the same Annex, as a result of new
scientific    information, maximum    residue    limits set    for   ivermectin   In the
bovine species should be modified;
Whereas etlproston tromethamlne should be Inserted Into Annex II to Regulation
(EEC) N" 2377/90;
Whereas,    In order  to allow   for  the completion     of  scientific    studies,   the
duration of the provisional maximum residue limits previously defined in Annex
 III of   Regulation  (EEC) N" 2377/90     should   be extended     for one   nitrofuran
compound, namely furazolidone;
Whereas all substances belonging to the nitrofuran group, except furazolidone
referred    to above, should   be  Inserted    in Annex    IV of   Regulation   (EEC) N*
2377/90;
 ---pagebreak--- Whereas a period of 60 days should be allowed before the entry        into force of
this Regulation    in order to allow Member States to make any adjustment which
may  be   necessary   to  the authorizations  to place  the  veterinary   medicinal
products concerned on the market which have been granted        in accordance with
                                  3
Council    Directive  81/851/EEC< >,  as  amended  by Directive   90/676/EEC<4) to
take account of the provisions of this Regulation;
Whereas, in accordance with the procedure of Article 8 of Council Regulation
(EEC) N' 2377/90, this text was submitted to the Committee for Adaptation to
Technical Progress of the Directives on Veterinary Medicinal Products, which
was unable to express an opinion and, whereas under the same procedure, the
Commission shall submit to the Council a proposal relating to the measures to
be taken,
HAS ADOPTED THE FOLLOWING REGULATION :
                                      Article 1
Annexes I, II,     III and IV of Regulation (EEC) N'2377/90 are hereby amended as
set out In the Annex hereto.
                                      Article 2
This   Regulation   shall  enter  into force on   the sixtieth  day  following   its
publication in the Official Journal of the European Communities;
This Regulation shall be binding      in its entirety and directly applicable in
a I I Member States.
Done at Brussels,
(3)   OJ N* L 317, 06.11.1981, p 1
(4)   OJ N* L 373, 31.12.1990, p 15
 ---pagebreak---                                                            A N N E X
A.     ANNEX I is modified as follows:
                                                        A N N E X     I
                 List of pharmacologically active substances for which maximum residue limits have been fixed
I.     Under
1.2    Antibiotics
the following heading is added:
1.2.3  Quinolones
       Pharmacologically           Marker          Animal         MILs        Target     Other provisions
       Active Substances(s)        Residue         Species                    Tissues
1.2.3.1 Enrofloxacin               Sum of          Bovine           30 fig/kg Muscle
                                    enrofloxacin   Porcine                    Liver
                                    and            Poultry                    Kidney
                                    ciprofloxacin
II.    Under
2.1    Agents acting against endoparasites
       the following modification is made to:
2.1.1  Avermectins
       Pharmacologically           Marker          Animal         MILs        Target     Other provisions
       Active Substances(s)        Residue         Species                    Tissues
2.1.1.1 Ivermectin                 H2Bla-          Bovine          100 ftg/kg Liver
                                   metabolite                       40 fig/kg Fat
                                                   Ovine            15 /ug/kg Liver
                                                   Porcine          20 Mg/kg  Fat
                                                   Equidae
                                                                                                              ^
 ---pagebreak--- and the following heading is added:
2.1.2  Salicylanilides
       Pharmacologically           Marker    Animal  MRLs         Target  Other provisions
       Active Substances(s)        Residue   Species              Tissues
2.1.2.1 Closantel                  Closantel Bovine  1000 Atg/kg Mise le
                                                                  Liver
                                                     3000 Mg/kg Kidney
                                                                  Fat
                                             Ovine   1500 Mg/kg   Miscle
                                                                  Liver
                                                     5000 fig/kg  Kidney
                                                     2000 fig /kg Fat
                                                                                           •X;
 ---pagebreak--- B.  ANNEX II is modified as follows:
                                                     ANNEX       II
                                List of substances not subject to maximum residue limits
    The following heading is added:
2.  Organic compounds
    Pharmacologically                           Animal                                Other provisions
    Active Substances(s)                         Species
2.1 Etiproston tromethamine                      Bovine
                                                 Porcine
 ---pagebreak--- c.     ANNEX I I I is modified as follows:
                                                         ANNEX        I I I
                   List of pharmacologically active substances used in veterinary medicinal products for which
                                        provisional maximum residue limits have been fixed
Under
1.1.3 Nitrofurans
the following modification is made:
       Pharmacologically             Marker           Animal       MRLs        Target      Other provisions
       Active Substances(s)          Residue          Species                  Tissue!
1.1.3.1 Furazolidone                 All residues     All food      5 fig/kg   Miscle      Provisional MRL expires on 1.7.95
                                     with intact      producing                Liver
                                     5-nitro          species                  Kidney
                                     structure                                  Fat
                                                                                                                             ^
 ---pagebreak--- D. ANNEX IV is hereby replaced by the following:
                                                   ANNEX       IV
                List of pharmacologically active substances for Which no maximum ievels can be fixed
1. Nitrofurans, except furazolidone (see Annex III).
                                                                                                     -^
 ---pagebreak---                                                                                     ÀI
                                                                     ISSN 0254-1475
                                                              COM(93) 287 final
                                                     DOCUMENTS
EN                                                                         10 03
                                Catalogue number : CB-CO-93-321-EN-C
                                                             ISBN 92-77-56968-9
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