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
Date: 1993-07-02
Institutions: European Commission
Subjects: animal product, food inspection, health control, pharmaceutical legislation, veterinary medicinal product, veterinary medicine

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) 

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) 

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. 

^ 

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: 

A N N EX 

A N N EX 

I 

List of pharmacologically active substances for which maximum residue  limits have been fixed 

I. 
1.2 
the following heading  is added: 

Under 
Antibiotics 

1.2.3  Quinolones 

Pharmacologically 
Active Substances(s) 

Marker 
Residue 

Animal 
Species 

MILs 

Target 
Tissues 

Other provisions 

1.2.3.1 Enrofloxacin 

Sum of 
enrofloxacin 
and 
ciprofloxacin 

Bovine 
Porcine 
Poultry 

30  fig/kg 

Muscle 
Liver 
Kidney 

II. 
2.1 

Under 
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 

100 ftg/kg  Liver 
40  fig/kg  Fat 

Ovine 
Porcine 
Equidae 

15 /ug/kg  Liver 
20 Mg/kg 

Fat 

^ 

and the following heading  is added: 

2.1.2  Salicylanilides 

Pharmacologically 
Active Substances(s) 

Marker 
Residue 

Animal 
Species 

MRLs 

Target 
Tissues 

Other provisions 

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; 

B. 

ANNEX II  is  modified  as  follows: 

A N N EX 

II 

List of substances not  subject  to maximum residue  limits 

The following heading  is added: 

2. 

Organic  compounds 

Pharmacologically 
Active Substances(s) 

2.1 

Etiproston tromethamine 

Animal 
Species 

Bovine 
Porcine 

Other  provisions 

c. 

ANNEX  I II 

is  modified  as  follows: 

A N N EX 

I II 

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 

^ 

D. 

ANNEX IV is hereby replaced by the following: 

A N N EX 

IV 

List of pharmacologically active substances for Which no maximum ievels can be fixed 

1. 

Nitrofurans, except furazolidone (see Annex III). 

-^ 

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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