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) 
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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) 
675/92 of 18 March 1992,2 762/92 of 27 March 1992,3 3093/92 of 27 
October 19924 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. 
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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. 
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 
amended by Commission Regulation (EEC) N" 895/93^2) 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 
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; 
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 
Council Directive 81/851/EEC<3>, 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 
A. ANNEX I is modified as follows: ANNEX 
ANNEX 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 
Active Substances(s) Marker 
Residue Animal 
Species MILs Target 
Tissues Other provisions 
1.2.3.1 Enrofloxacin Sum of Bovine 
enrofloxacin Porcine 
and Poultry 
ciprofloxacin 30 fig/kg Muscle 
Liver 
Kidney 
II. Under 
2.1 Agents acting against endoparasites 
the following modification is made to: 
2.1.1 Avermectins 
Pharmacologically 
Active Substances(s) Marker 
Residue Animal 
Species MILs Target 
Tissues Other provisions 
2.1.1.1 Ivermectin H2Bla-
metabolite Bovine 
Ovine 
Porcine 
Equidae 100 ftg/kg Liver 
40 fig/kg Fat 
15 /ug/kg Liver 
20 Mg/kg Fat 
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and the following heading is added: 
2.1.2 Salicylanilides 
Pharmacologically Marker 
Active Substances(s) Residue Animal 
Species MRLs Target 
Tissues Other provisions 
2.1.2.1 Closantel Closantel Bovine 
Ovine 1000 Atg/kg Mise le 
Liver 
3000 Mg/kg Kidney 
Fat 
1500 Mg/kg Miscle 
Liver 
5000 fig/kg Kidney 
2000 fig /kg Fat 
•X; 
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 
c. ANNEX III is modified as follows: 
ANNEX III 
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 
Active Substances(s) Marker 
Residue Animal 
Species MRLs Target 
Tissue! Other provisions 
1.1.3.1 Furazolidone All residues 
with intact 
5-nitro 
structure All food 
producing 
species 5 fig/kg Miscle 
Liver 
Kidney 
Fat Provisional MRL expires on 1.7.95 
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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). 
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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 
Office for Official Publications of the European Communities 
L-2985 Luxembourg