Council Regulation (EEC) No 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
Modified by
  • Commission Regulation (EEC) No 675/92of 18 March 1992amending Annexes I and III of 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, 392R0675, March 19, 1992
  • Commission Regulation (EEC) No 762/92of 27 March 1992modifying Annex V to 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, 392R0762, March 28, 1992
  • Commission Regulation (EEC) No 3093/92of 27 October 1992amending Annex III to 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, 392R3093, October 28, 1992
  • Commission Regulation (EEC) No 895/93of 16 April 1993amending Annexes I, II and III of 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, 393R0895, April 17, 1993
  • Council Regulation (EEC) No 2901/93of 18 October 1993amending Annexes I, II, III and IV to 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, 393R2901, October 23, 1993
  • Commission Regulation (EC) No 3425/93of 14 December 1993amending Annexes I and II to 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, 393R3425, December 15, 1993
  • Commission Regulation (EC) No 3426/93of 14 December 1993amending Annexes III and IV to 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, 393R3426, December 15, 1993
  • Commission Regulation (EC) No 955/94of 28 April 1994amending Annexes I and II of 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, 394R0955, April 29, 1994
  • Commission Regulation (EC) No 1430/94of 22 June 1994amending Annexes I, II, III and IV of 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(Text with EEA relevance), 394R1430, June 23, 1994
  • Commission Regulation (EC) No 2701/94of 7 November 1994amending Annexes I, II, III and IV to 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(Text with EEA relevance), 394R2701, November 8, 1994
  • Commission Regulation (EC) No 2703/94of 7 November 1994amending Annexes I, II and III to 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(Text with EEA relevance), 394R2703, November 8, 1994
  • Commission Regulation (EC) No 3059/94of 15 December 1994amending Annexes I, II, and III of 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(Text with EEA relevance), 394R3059, December 16, 1994
  • Commission Regulation (EC) No 1102/95of 16 May 1995amending Annexes I, II and III of 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(Text with EEA relevance), 395R1102, May 17, 1995
  • Commission Regulation (EC) No 1441/95of 26 June 1995amending Annexes I, II and III of 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(Text with EEA relevance), 395R1441, June 27, 1995
  • Commission Regulation (EC) No 1442/95of 26 June 1995amending Annexes I, II, III and IV of 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(Text with EEA relevance)Corrigendum to Commission Regulation (EC) No 1442/95 of 26 June 1995 amending Annexes I, II, III and IV of 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(Official Journal of the European Communities No L 143 of 27 June 1995)Corrigendum to Commission Regulation (EC) No 1442/95 of 26 June 1995 amending Annexes I, II, III and IV of 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(Official Journal of the European Communities No L 143 of 27 June 1995)Corrigendum to Commission Regulation (EC) No 1442/95 of 26 June 1995 amending Annexes I, II, III and IV of Council Regulation (EEC) No 2377/90 laying down a Com munity procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin(Official journal of the European Communities No L 143 of 27 June 1995), 395R1442395R1442R(02)395R1442R(03)395R1442R(04), June 27, 1995
  • Commission Regulation (EC) No 1798/95of 25 July 1995amending Annex IV to 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, 395R1798, July 26, 1995
  • Commission Regulation (EC) No 2796/95of 4 December 1995amending Annex II of 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(Text with EEA relevance), 395R2796, December 5, 1995
  • Commission Regulation (EC) No 2804/95of 5 December 1995amending Annex II of 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(Text with EEA relevance), 395R2804, December 6, 1995
  • Commission Regulation (EC) No 281/96of 14 February 1996amending Annexes I and III to 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(Text with EEA relevance), 396R0281, February 15, 1996
  • Commission Regulation (EC) No 282/96of 14 February 1996amending Annexes I, II and III to 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(Text with EEA relevance), 396R0282, February 15, 1996
  • Commission Regulation (EC) No 1140/96of 25 June 1996amending Annex III to 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(Text with EEA relevance), 396R1140, June 26, 1996
  • Commission Regulation (EC) No 1147/96of 25 June 1996amending Annexes II and III to 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(Text with EEA relevance), 396R1147, June 26, 1996
  • Commission Regulation (EC) No 1311/96of 8 July 1996amending Annexes I, II, III and IV of 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(Text with EEA relevance), 396R1311, July 9, 1996
  • Commission Regulation (EC) No 1312/96of 8 July 1996amending Annex III of 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, 396R1312, July 9, 1996
  • Commission Regulation (EC) No 1433/96of 23 July 1996amending Annexes II and III to 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, 396R1433, July 24, 1996
  • Commission Regulation (EC) No 1742/96of 6 September 1996amending Annexes I, II and III of 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, 396R1742, September 7, 1996
  • Commission Regulation (EC) No 1798/96of 17 September 1996amending Annex III to 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, 396R1798, September 18, 1996
  • Commission Regulation (EC) No 2010/96of 21 October 1996amending Annex II to 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, 396R2010, October 22, 1996
  • Commission Regulation (EC) No 2017/96of 22 October 1996amending Annex III of 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, 396R2017, October 23, 1996
  • Commission Regulation (EC) No 2034/96of 24 October 1996amending Annexes I, II and III of 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, 396R2034, October 25, 1996
  • Commission Regulation (EC) No 17/97of 8 January 1997amending Annexes I, II, III and IV of 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, 397R0017, January 9, 1997
  • Commission Regulation (EC) No 211/97of 4 February 1997amending Annex II of 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(Text with EEA relevance), 397R0211, February 5, 1997
  • Commission Regulation (EC) No 270/97of 14 February 1997amending Annex I, II, III and IV of 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, 397R0270, February 15, 1997
  • Council Regulation (EC) No 434/97of 3 March 1997amending 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, 397R0434, March 7, 1997
  • Commission Regulation (EC) No 716/97of 23 April 1997amending Annexes II and III to 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, 397R0716, April 24, 1997
  • Commission Regulation (EC) No 748/97of 25 April 1997amending Annex I and II of 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, 397R0748, April 26, 1997
  • Commission Regulation (EC) No 749/97of 25 April 1997amending Annexes I, II and III of 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, 397R0749, April 26, 1997
  • Commission Regulation (EC) No 1836/97of 24 September 1997amending Annexes I and III to 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(Text with EEA relevance), 397R1836, September 25, 1997
  • Commission Regulation (EC) No 1837/97of 24 September 1997amending Annexes I, II and III to 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(Text with EEA relevance), 397R1837, September 25, 1997
  • Commission Regulation (EC) No 1838/97of 24 September 1997amending Annexes I, II and III to 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(Text with EEA relevance), 397R1838, September 25, 1997
  • Commission Regulation (EC) No 1850/97of 25 September 1997amending Annex III to 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(Text with EEA relevance), 397R1850, September 26, 1997
  • Commission Regulation (EC) No 121/98of 16 January 1998amending Annexes I, II and III to 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(Text with EEA relevance), 398R0121, January 17, 1998
  • Commission Regulation (EC) No 426/98of 23 February 1998amending Annexes I, II and III of 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(Text with EEA relevance), 398R0426, February 24, 1998
  • Commission Regulation (EC) No 613/98of 18 March 1998amending Annexes II, III and IV of 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(Text with EEA relevance), 398R0613, March 19, 1998
  • Commission Regulation (EC) No 1000/98of 13 May 1998amending Annexes I and II to 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(Text with EEA relevance), 398R1000, May 14, 1998
  • Commission Regulation (EC) No 1076/98of 27 May 1998amending Annex II to 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(Text with EEA relevance), 398R1076, May 28, 1998
  • Commission Regulation (EC) No 1191/98of 9 June 1998amending Annexes I and II to 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(Text with EEA relevance), 398R1191, June 10, 1998
  • Commission Regulation (EC) No 1568/98of 17 July 1998amending Annexes I, II, III and IV of 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(Text with EEA relevance)Corrigendum to Commission Regulation (EC) No 1568/98 of 17 July 1998 amending Annexes I, II, III and IV of 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(Official Journal of the European Communities L 205 of 22 July 1998), 398R1568398R1568R(01), July 22, 1998
  • Commission Regulation (EC) No 1569/98of 17 July 1998amending Annexes II and III of 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(Text with EEA relevance), 398R1569, July 22, 1998
  • Commission Regulation (EC) No 1570/98of 17 July 1998amending Annexes I to IV to 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(Text with EEA relevance), 398R1570, July 22, 1998
  • Commission Regulation (EC) No 1916/98of 9 September 1998amending Annexes I and II to 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(Text with EEA relevance), 398R1916, September 10, 1998
  • Commission Regulation (EC) No 1917/98of 9 September 1998amending Annexes I and II to 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(Text with EEA relevance), 398R1917, September 10, 1998
  • Commission Regulation (EC) No 1958/98of 15 September 1998amending Annexes I, II and III of Council Regulation (EEC) No 2377/94 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin(Text with EEA relevance), 398R1958, September 16, 1998
  • Commission Regulation (EC) No 2560/98of 27 November 1998amending Annexes I and II to 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(Text with EEA relevance), 398R2560, November 28, 1998
  • Commission Regulation (EC) No 2686/98of 11 December 1998amending Annexes I and II of 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(Text with EEA relevance), 398R2686, December 12, 1998
  • Commission Regulation (EC) No 2692/98of 14 December 1998amending Annex II to 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(Text with EEA relevance), 398R2692, December 15, 1998
  • Commission Regulation (EC) No 2728/98 of17 December 1998amending Annexes I, II and III to 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(Text with EEA relevance), 398R2728, December 18, 1998
  • Commission Regulation (EC) No 508/1999of 4 March 1999amending Annexes I to IV to 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, 399R0508, March 9, 1999
  • Commission Regulation (EC) No 804/1999of 16 April 1999amending Annexes I, II and III to 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(Text with EEA relevance), 399R0804, April 17, 1999
  • Commission Regulation (EC) No 953/1999of 5 May 1999amending Annexes II and III of 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(Text with EEA relevance), 399R0953, May 6, 1999
  • Commission Regulation (EC) No 954/1999of 5 May 1999amending Annex III to 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(Text with EEA relevance), 399R0954, May 6, 1999
  • Commission Regulation (EC) No 997/1999of 11 May 1999amending Annexes I, II and III of 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(Text with EEA relevance), 399R0997, May 12, 1999
  • Commission Regulation (EC) No 998/1999of 11 May 1999amending Annexes I and II to 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(Text with EEA relevance), 399R0998, May 12, 1999
  • Council Regulation (EC) No 1308/1999of 15 June 1999amending Regulation (EC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal originCorrigendum to Council Regulation (EC) No 1308/1999 of 15 June 1999 amending 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(Official Journal of the European Communities L 156 of 23 June 1999), 399R1308399R1308R(01), June 23, 1999
  • Commission Regulation (EC) No 1931/1999of 9 September 1999amending Annexes I, II and III of 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(Text with EEA relevance), 399R1931, September 10, 1999
  • Commission Regulation (EC) No 1942/1999of 10 September 1999amending Annexes I, II and III of 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(Text with EEA relevance), 399R1942, September 11, 1999
  • Commission Regulation (EC) No 1943/1999of 10 September 1999amending Annexes I, II and III of 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(Text with EEA relevance), 399R1943, September 11, 1999
  • Commission Regulation (EC) No 2385/1999of 10 November 1999amending Annexes I, II and III of 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(Text with EEA relevance), 399R2385, November 11, 1999
  • Commission Regulation (EC) No 2393/1999of 11 November 1999amending Annexes I, II and III of 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(Text with EEA relevance), 399R2393, November 12, 1999
  • Commission Regulation (EC) No 2593/1999of 8 December 1999amending Annexes I, II and III of 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(Text with EEA relevance), 399R2593, December 9, 1999
  • Commission Regulation (EC) No 2728/1999of 20 December 1999amending Annexes I, II and III to 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(Text with EEA relevance), 399R2728, December 22, 1999
  • Commission Regulation (EC) No 2757/1999of 22 December 1999amending Annexes I and II of 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(Text with EEA relevance), 399R2757, December 23, 1999
  • Commission Regulation (EC) No 2758/1999of 22 December 1999amending Annex II of 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(Text with EEA relevance), 399R2758, December 23, 1999
  • Commission Regulation (EC) No 1286/2000of 19 June 2000amending Annexes I, II and III of 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(Text with EEA relevance), 300R1286, June 20, 2000
  • Commission Regulation (EC) No 1295/2000of 20 June 2000amending Annexes II and III to 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(Text with EEA relevance), 300R1295, June 21, 2000
  • Commission Regulation (EC) No 1960/2000of 15 September 2000amending Annexes I and III to 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(Text with EEA relevance), 300R1960, September 16, 2000
  • Commission Regulation (EC) No 2338/2000of 20 October 2000amending Annexes I, II and III to 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(Text with EEA relevance), 300R2338, October 21, 2000
  • Commission Regulation (EC) No 2391/2000of 27 October 2000amending Annexes I, II and III to 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(Text with EEA relevance), 300R2391, October 28, 2000
  • Commission Regulation (EC) No 2535/2000of 17 November 2000amending Annex I of 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(Text with EEA relevance), 300R2535, November 18, 2000
  • Commission Regulation (EC) No 2908/2000of 29 December 2000amending Annexes I and II to 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(Text with EEA relevance), 300R2908, December 30, 2000
  • Commission Regulation (EC) No 749/2001of 18 April 2001amending Annex II to 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(Text with EEA relevance), 301R0749, April 19, 2001
  • Commission Regulation (EC) No 750/2001of 18 April 2001amending Annex II to 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(Text with EEA relevance), 301R0750, April 19, 2001
  • Commission Regulation (EC) No 807/2001of 25 April 2001amending Annexes I, II and III to 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(Text with EEA relevance)Corrigendum to Commission Regulation (EC) No 807/2001 of 25 April 2001 amending Annexes I, II and III to 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(Official Journal of the European Communities L 118 of 27 April 2001), 301R0807301R0807R(01), April 27, 2001
  • Commission Regulation (EC) No 1274/2001of 27 June 2001amending Annex I to 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(Text with EEA relevance), 301R1274, June 28, 2001
  • Commission Regulation (EC) No 1322/2001of 29 June 2001amending Annexes I and III to 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(Text with EEA relevance), 301R1322, June 30, 2001
  • Commission Regulation (EC) No 1478/2001of 18 July 2001amending Annexes I, II and III of 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(Text with EEA relevance), 301R1478, July 19, 2001
  • Commission Regulation (EC) No 1553/2001of 30 July 2001amending Annex I to 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(Text with EEA relevance), 301R1553, July 31, 2001
  • Commission Regulation (EC) No 1680/2001of 22 August 2001amending Annexes I and II to 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(Text with EEA relevance), 301R1680, August 23, 2001
  • Commission Regulation (EC) No 1815/2001of 14 September 2001amending Annexes I, II and III to 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(Text with EEA relevance)Corrigendum to Commission Regulation (EC) No 1815/2001 of 14 September 2001 amending Annexes I, II and III to 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(Official Journal of the European Communities L 246 of 15 September 2001), 301R1815301R1815R(01), September 15, 2001
  • Commission Regulation (EC) No 1879/2001of 26 September 2001amending Annex II to 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(Text with EEA relevance), 301R1879, September 27, 2001
  • Commission Regulation (EC) No 2162/2001of 7 November 2001amending Annexes I, II and III to 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(Text with EEA relevance), 301R2162, November 8, 2001
  • Council Regulation (EC) No 2584/2001of19 December 2001amending Annexes I and III of 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(Text with EEA relevance), 301R2584, December 29, 2001
  • Commission Regulation (EC) No 77/2002of 17 January 2002amending Annexes I and III to 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(Text with EEA relevance), 302R0077, January 18, 2002
  • Commission Regulation (EC) No 868/2002of 24 May 2002amending Annexes I and II of 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(Text with EEA relevance), 302R0868, May 25, 2002
  • Commission Regulation (EC) No 869/2002of 24 May 2002amending Annexes I, II and III to 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(Text with EEA relevance), 302R0869, May 25, 2002
  • Commission Regulation (EC) No 1181/2002of 1 July 2002amending Annex I of 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(Text with EEA relevance)Corrigendum to Commission Regulation (EC) No 1181/2002 of 1 July 2002 amending Annex I of 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(Official Journal of the European Communities L 172 of 2 July 2002)Corrigendum to Commission Regulation (EC) No 1181/2002 of 1 July 2002 amending Annex I of 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(Official Journal of the European Communities L 172 of 2 July 2002)Corrigendum to Commission Regulation (EC) No 1181/2002 of 1 July 2002 amending Annex I of 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(Official Journal of the European Communities L 172 of 2 July 2002), 302R1181302R1181R(01)302R1181R(02)302R1181R(03), July 2, 2002
  • Commission Regulation (EC) No 1530/2002of 27 August 2002amending Annexes I, II and III to 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(Text with EEA relevance), 302R1530, August 28, 2002
  • Commission Regulation (EC) No 1752/2002of 1 October 2002amending Annexes I and II to 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(Text with EEA relevance), 302R1752, October 2, 2002
  • Commission Regulation (EC) No 1937/2002of 30 October 2002amending Annexes II and III to 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(Text with EEA relevance), 302R1937, October 31, 2002
  • Commission Regulation (EC) No 61/2003of 15 January 2003amending Annexes I and II to 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(Text with EEA relevance), 303R0061, January 16, 2003
  • Commission Regulation (EC) No 544/2003of 27 March 2003amending Annexes I and II to 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(Text with EEA relevance), 303R0544, March 28, 2003
  • Commission Regulation (EC) No 665/2003of 11 April 2003amending Annex III to 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(Text with EEA relevance), 303R0665, April 12, 2003
  • Commission Regulation (EC) No 739/2003of 28 April 2003amending Annex I to 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(Text with EEA relevance), 303R0739, April 29, 2003
  • Council Regulation (EC) No 806/2003of 14 April 2003adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (qualified majority), 303R0806, May 16, 2003
  • Commission Regulation (EC) No 1029/2003of 16 June 2003amending Annexes I and II to 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(Text with EEA relevance), 303R1029, June 17, 2003
  • Commission Regulation (EC) No 1490/2003of 25 August 2003amending Annex I to 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(Text with EEA relevance), 303R1490, August 26, 2003
  • Commission Regulation (EC) No 1873/2003of 24 October 2003amending Annex II to 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(Text with EEA relevance), 303R1873, October 25, 2003
  • Commission Regulation (EC) No 2011/2003of 14 November 2003amending Annexes I and III to 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(Text with EEA relevance), 303R2011, November 15, 2003
  • Commission Regulation (EC) No 2145/2003of 8 December 2003amending Annex I to 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(Text with EEA relevance), 303R2145, December 9, 2003
  • Commission Regulation (EC) No 324/2004of 25 February 2004amending Annex I to 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(Text with EEA relevance), 304R0324, February 26, 2004
  • Commission Regulation (EC) No 546/2004of 24 March 2004amending Annexes I, II and III to 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(Text with EEA relevance), 304R0546, March 25, 2004
  • Commission Regulation (EC) No 1101/2004of 10 June 2004amending Annexes I and II to 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(Text with EEA relevance)Corrigendum to Commission Regulation (EC) No 1101/2004 of 10 June 2004 amending Annexes I and II to 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(Official Journal of the European Union L 211 of 12 June 2004), 304R1101304R1101R(01), June 12, 2004
  • Commission Regulation (EC) No 1646/2004of 20 September 2004amending Annex I to 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(Text with EEA relevance)Corrigendum to Commission Regulation (EC) No 1646/2004 of 20 September 2004 amending Annex I of 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(Official Journal of the European Union L 296 of 21 September 2004), 304R1646304R1646R(02), September 21, 2004
  • Commission Regulation (EC) No 1851/2004of 25 October 2004amending Annex I to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits for veterinary medicinal products in foodstuffs of animal origin(Text with EEA relevance), 304R1851, October 26, 2004
  • Commission Regulation (EC) No 1875/2004of 28 October 2004amending Annexes II and III to 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 as regards sodium salicylate and fenvalerate(Text with EEA relevance), 304R1875, October 29, 2004
Corrected by
  • Corrigendum to Commission Regulation (EC) No 1442/95 of 26 June 1995 amending Annexes I, II, III and IV of 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, 395R1442R(02), September 20, 1995
  • Corrigendum to Commission Regulation (EC) No 1442/95 of 26 June 1995 amending Annexes I, II, III and IV of 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, 395R1442R(03), December 5, 1996
  • Corrigendum to Commission Regulation (EC) No 1442/95 of 26 June 1995 amending Annexes I, II, III and IV of Council Regulation (EEC) No 2377/90 laying down a Com munity procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, 395R1442R(04), March 18, 1997
  • Corrigendum to Commission Regulation (EC) No 1568/98 of 17 July 1998 amending Annexes I, II, III and IV of 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, 398R1568R(01), October 8, 1998
  • Corrigendum to Council Regulation (EC) No 1308/1999 of 15 June 1999 amending 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, 399R1308R(01), January 13, 2000
  • Corrigendum to Commission Regulation (EC) No 807/2001 of 25 April 2001 amending Annexes I, II and III to 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, 301R0807R(01), May 16, 2001
  • Corrigendum to Commission Regulation (EC) No 1815/2001 of 14 September 2001 amending Annexes I, II and III to 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, 301R1815R(01), October 9, 2001
  • Corrigendum to Commission Regulation (EC) No 1181/2002 of 1 July 2002 amending Annex I of 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, 302R1181R(01), September 19, 2002
  • Corrigendum to Commission Regulation (EC) No 1181/2002 of 1 July 2002 amending Annex I of 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, 302R1181R(02), February 19, 2003
  • Corrigendum to Commission Regulation (EC) No 1181/2002 of 1 July 2002 amending Annex I of 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, 302R1181R(03), March 6, 2003
  • Corrigendum to Commission Regulation (EC) No 1101/2004 of 10 June 2004 amending Annexes I and II to 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, 304R1101R(01), November 13, 2004
  • Corrigendum to Commission Regulation (EC) No 1646/2004 of 20 September 2004 amending Annex I of 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, 304R1646R(02), December 22, 2004
Council Regulation (EEC) No 2377/90of 26 June 1990laying 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, and in particular Article 43 thereof,Having regard to the proposal from the CommissionOJ No C 61, 10. 3. 1989. p. 5.,Having regard to the opinion of the European ParliamentOJ No C 96, 17. 4. 1990, p. 273.,Having regard to the opinion of the Economic and Social CommitteeOJ No C 201, 17. 8. 1989, p. 1.,Whereas the use of veterinary medicinal products in food-producing animals may result in the presence of residues of foodstuffs obtained from treated animals;Whereas as a result of scientific and technical progress it is possible to detect the presence of residues of veterinary medicines in foodstuffs at ever lower levels; whereas it is therefore necessary to establish maximum residue limits for pharmacologically active substances which are used in veterinary medicinal products in respect of all the various foodstuffs of animal origin, including meat, fish, milk, eggs and honey;Whereas in order to protect public health, maximum residue limits must be established in accordance with generally recognized principles of safety assessment, taking into account any other scientific assessment of the safety of the substances concerned which may have been undertaken by international organizations, in particular the Codex Alimentarius or, where such substances are used for other purposes, by other scientific committees established within the Community;Whereas the use of veterinary medicinal products plays an important part in agricultural production; whereas the establishment of maximum residue levels will facilitate the marketing of foodstuffs of animal origin;Whereas the establishment of different maximum residue levels by Member States may hinder the free movement of foodstuffs and of veterinary medicinal products themselves;Whereas it is therefore necessary to lay down a procedure for the establishment of maximum residue levels of veterinary medicinal products by the Community, following a single scientific assessment of the highest possible quality;Whereas the need for the establishment of maximum residue levels throughout the Community is recognized in the Community rules relating to trade in foodstuffs of animal origin;Whereas provisions must be adopted with a view to the systematic establishment of maximum residue levels for new substances capable of pharmacological action intended for administration to food-producing animals;Whereas arrangements must also be made for the establishment of maximum residue levels for substances which are currently used in veterinary medicines administered to food-producing animals; whereas, however, in view of the complexity of this matter and the large number of substances involved, long transitional arrangements are required;Whereas, after scientific assessment by the Committee for Veterinary Medicinal Products, maximum residue levels must be adopted by a rapid procedure which ensures close cooperation between the Commission and the Member States through the Committee set up under Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal productsOJ No L 317, 6. 11. 1981, p. 16., as last amended by Directive 87/20/EECOJ No L 15, 17. 1. 1987, p. 34.; whereas an urgent procedure is also required to ensure the swift review of any tolerance which might prove insufficient to protect public health;Whereas medicinally induced immunological responses are usually indistinguishable from those which arise naturally, and do not affect consumers of food of animal origin;Whereas the information necessary to assess the safety of residues should be presented in accordance with the principles laid down by Directive 81/852/EEC,HAS ADOPTED THIS REGULATION:
Article 11.For the purposes of this Regulation, the following definitions shall apply:(a)"residues of veterinary medicinal products": means all pharmacologically active substances, whether active principles, excipients or degradation products, and their metabolites which remain in foodstuffs obtained from animals to which the veterinary medicinal product in question has been administered;(b)"maximum residue limit": means the maximum concentration of residue resulting from the use of a veterinary medicinal product (expressed in mg/kg or μg/kg on a fresh weight basis) which may be accepted by the Community to be legally permitted or recognized as acceptable in or on a food.It is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the acceptable daily intake (ADI), or on the basis of a temporary ADI that utilizes an additional safety factor. It also takes into account other relevant public health risks as well as food technology aspects.When establishing a maximum residue limit (MRL), consideration is also given to residues that occur in food of plant origin and/or come from the environment. Furthermore, the MRL may be reduced to be consistent with good practices in the use of veterinary drugs and to the extent that practical analytical methods are available.2.This Regulation shall not apply to active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity used in immunological veterinary medicinal products.
Article 2The list of pharmacologically active substances used in veterinary medicinal products in respect of which maximum residue limits have been established shall be contained in Annex I, which shall be adopted in accordance with the procedure laid down in Article 8. Except as provided for in Article 9, any amendments to Annex I shall be adopted in accordance with the same procedure.
Article 3Where, following an evaluation of a pharmacologically active substance used in veterinary medicinal products, it appears that it is not necessary for the protection of public health to establish a maximum residue limit, that substance shall be included in a list in Annex II, which shall be adopted in accordance with the procedure laid down in Article 8. Except as provided for in Article 9, any amendments to Annex II shall be adopted in accordance with the same procedure.
Article 4A provisional maximum residue limit may be established for a pharmacologically active substance used in veterinary medicinal products on the date of entry into force of this Regulation, provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a hazard for the health of the consumer. A provisional maximum residue limit shall apply for a defined period of time, which shall not exceed five years. That period may be extended once only in exceptional cases for a period not in excess of two years if that proves expedient for the completion of scientific studies in progress.In exceptional circumstances, a provisional maximum residue limit may also be established for a pharmacologically active substance not previously used in veterinary medicinal products on the date of entry into force of this Regulation provided that there are no grounds for supposing that residues of the substance concerned at the limit proposed present a hazard for the health of the consumer.The list of pharmacologically active substances used in veterinary medicinal products in respect of which provisional maximum residue limits have been established shall be contained in Annex III, which shall be adopted in accordance with the procedure laid down in Article 8. Except as provided for in Article 9, any amendments to Annex III shall be adopted in accordance with the same procedure.
Article 5Where it appears that a maximum residue limit cannot be established in respect of a pharmacologically active substance used in veterinary medicinal products because residues of the substances concerned, at whatever limit, in foodstuffs of animal origin constitute a hazard to the health of the consumer, that substance shall be included in a list in Annex IV, which shall be adopted in accordance with the procedure laid down in Article 8. Except as provided for in Article 9, any amendments to Annex IV shall be adopted in accordance with the same procedure.The administration of the substances listed in Annex IV to food-producing animals shall be prohibited throughout the Community.
Article 61.In order to obtain the inclusion in Annexes I, II or III of a pharmacologically active substance which is intended for use in veterinary medicinal products for administration to food-producing animals, an application to establish a maximum residue limit shall be submitted to the European Agency for the Evaluation of Medicinal Products set up by Council Regulation (EEC) No 2309/93OJ L 214, 24.8.1993, p. 1, hereinafter referred to as "the Agency".This application shall contain the information and particulars referred to in Annex V of this Regulation and shall conform with the principles laid down in Directive 81/852/EEC.2.The application shall also be accompanied by the fee payable to the Agency.
Article 71.The Committee for Veterinary Medicinal Products referred to in Article 27 of Regulation (EC) No 2309/93 (hereinafter "the Committee") shall be responsible for formulating the Agency's opinion on the classification of substances referred to in Annexes I, II, III or IV to this Regulation.2.Articles 52 and 53 of Regulation (EEC) No 2309/93 shall be applicable for the purposes of this Regulation.3.The Agency shall ensure that the Committee's opinion is delivered within a period of 120 days following the reception of a valid application.If the information submitted by the applicant is not sufficient to enable such an opinion to be prepared, the Committee may ask the applicant to supply additional information within a specific time limit. The deadline for the opinion shall then be deferred until the additional information has been received.4.The Agency shall forward the opinion to the applicant. Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he wishes to appeal. In that case he shall forward the detailed grounds for his appeal to the Agency within 60 days of receipt of the opinion. Within 60 days of the receipt of the grounds for appeal, the Committee shall consider whether its opinion should be revised and the reasons for the conclusion reached on the appeal shall be annexed to the report referred to in paragraph 5.5.The Agency shall forward the definitive opinion of the Committee within 30 days of its adoption both to the Commission and to the applicant. The opinion shall be accompanied by a report describing the safety evaluation of the substance by the Committee, which shall give the grounds for its conclusions.6.The Commission shall prepare draft measures taking account of Community legislation and shall start the procedure provided for in Article 8. The Committee referred to in Article 8 shall adapt its rules of procedure in order to take account of the tasks conferred on it by this Regulation.
Article 81.The Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products.2.Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/ECOJ L 184, 17.7.1999, p. 23. shall apply.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3.The Standing Committee shall adopt its Rules of Procedure.
Article 91.Where a Member State, as a result of new information or a reassessment of existing information, considers that the urgent amendment of a provision contained in Annexes I to IV is necessary in order to protect human or animal health, and therefore requires swift action to be taken, that Member State may temporarily suspend the operation of the provision concerned in its own territory. In that case, it shall immediately notify the other Member States and the Commission of the measures, attaching a statement of the reasons therefor.2.The Commission shall as soon as possible examine the grounds given by the Member State concerned and, after consulting the Committee for Veterinary Medicinal Products, it shall then deliver its opinion forthwith and take appropriate measures; the person responsible for marketing may be requested to provide the Committee with oral or written explanations. The Commission shall immediately notify the Council and the Member States of any measures taken. Any Member State may refer the Commission's measures to the Council within 15 days of such notification. The Council, acting by a qualified majority, may take a different decision within 30 days of the date on which the matter was referred to it.3.If the Commission considers that it is necessary to amend the provision of Annex I to IV concerned in order to resolve the difficulties referred to in paragraph 1 and to ensure the protection of human health, it shall initiate the procedure laid down in Article 10 with a view to adopting those amendments; the Member State which has taken measures under paragraph 1 may maintain them until the Council or the Commission has taken a decision in accordance with the abovementioned procedure.
Article 101.The Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products.2.Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.
Article 11Any changes which are necessary to adapt Annex V to take account of scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 2c of Directive 81/852/EEC.
Article 12As soon as possible after the amendment of Annexes I, II, III or IV, the Commission shall publish a summary of the assessment of the safety of the substances concerned that have been examined by the Committee for Veterinary Medicinal Products. The confidential nature of any proprietary data shall be respected. The Agency shall provide the competent authorities and the Commission with appropriate methods for identifying pharmacologically active substances for which the MRL's have been determined in Annexes I and III.
Article 13Member States may not prohibit or impede the putting into circulation within their territories of foodstuffs of animal origin originating in other Member States on the grounds that they contain residues of veterinary medicinal products if the quantity of residue does not exceed the maximum residue limit provided for in Annex I or III, or if the substance concerned is listed in Annex II.
Article 14With effect from 1 January 1997, the administration to food-producing animals of veterinary medicinal products containing pharmacologically active substances which are not mentioned in Annexes I, II or III shall be prohibited within the Community, except in the case of clinical trials accepted by the competent authorities following notification or authorization in accordance with the legislation in force and which do not cause foodstuffs obtained from livestock participating in such trials to contain residues which constitute a hazard to human health.However, the date referred to in the previous subparagraph shall be deferred for substances the use of which was authorized on the date of entry into force of this Regulation and in respect of which documented applications for the establishment of maximum residue limits have been lodged with the Commission or with the European Agency for the Evaluation of Medicinal Products before 1 January 1996:until 1 January 1998 in the case of pyrazolinones (including pyrazolidinediones and phenylbutazones), nitroimidazoles and arsalinic acid, anduntil 1 January 2000 in the case of other substances.The Agency shall publish a list of these substances before 7 June 1997.
Article 15This Regulation shall in no way prejudice the application of Community legislation prohibiting the use in livestock farming of certain substances having a hormonal action.Nothing in this Regulation shall prejudice the measures taken by Member States to prevent the unauthorized use of veterinary medicinal products.
Article 16This Regulation shall enter into force on 1 January 1992.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX ILIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED1.Anti-infectious agents1.1.Chemotheurapeutics1.1.1.Sulfonamides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
All substances belonging to the sulfonamide groupParent drugAll food-producing species100 μg/kgMuscleThe combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg
100 μg/kgFat
100 μg/kgLiver
100 μg/kgKidney
Bovine, ovine, caprine100 μg/kgMilk
1.1.2.Diamino pyrimidine derivatives
For porcine and poultry species this MRL relates to "skin and fat in natural proportions".For fin fish this MRL relates to "muscle and skin in natural proportions".
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
BaquiloprimBaquiloprimBovine10 μg/kgFat
300 μg/kgLiver
150 μg/kgKidney
30 μg/kgMilk
Porcine40 μg/kgSkin and fat
50 μg/kgLiver
50 μg/kgKidney
TrimethoprimTrimethoprimAll food producing species except equidae50 μg/kgFatNot for use in animals from which eggs are produced for human consumption
50 μg/kgMuscle
50 μg/kgLiver
50 μg/kgKidney
50 μg/kgMilk
Equidae100 μg/kgMuscle
100 μg/kgFat
100 μg/kgLiver
100 μg/kgKidney
1.2.Antibiotics1.2.1.Penicillins
For intramammary use only.
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AmoxicyllinAmoxicyllinAll food-producing species50 μg/kgMuscle
50 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
4 μg/kgMilk
AmpicillinAmpicillinAll food-producing species50 μg/kgMuscle
50 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
4 μg/kgMilk
BenzylpenicillinBenzylpenicillinAll food-producing species50 μg/kgMuscle
50 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
4 μg/kgMilk
CloxacillinCloxacillinAll food-producing species300 μg/kgMuscle
300 μg/kgFat
300 μg/kgLiver
300 μg/kgKidney
30 μg/kgMilk
DicloxacillinDicloxacillinAll food-producing species300 μg/kgMuscle
300 μg/kgFat
300 μg/kgLiver
300 μg/kgKidney
30 μg/kgMilk
NafcillinNafcillinAll ruminants300 µg/kgMuscle
300 µg/kgFat
300 µg/kgLiver
300 µg/kgKidney
30 µg/kgMilk
OxacillinOxacillinAll food-producing species300 μg/kgMuscle
300 μg/kgFat
300 μg/kgLiver
300 μg/kgKidney
30 μg/kgMilk
PenethamateBenzylpenicillinBovine50 μg/kgMuscle
50 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
4 μg/kgMilk
Porcine50 μg/kgMuscle
50 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
PhenoxymethylpenicillinPhenoxymethylpenicillinPorcine25 μg/kgMuscle
25 μg/kgLiver
25 μg/kgKidney
1.2.2.Cephalosporins
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CefacetrileCefacetrileBovine125 μg/kgMilkFor intramammary use only
CefalexinCefalexinBovine200 μg/kgMuscle
200 μg/kgFat
200 μg/kgLiver
1000 μg/kgKidney
100 μg/kgMilk
CefaloniumCefaloniumBovine20 μg/kgMilk
CefapirinSum of cephapirin and desacetylcephapirinBovine50 μg/kgMuscle
50 μg/kgFat
100 μg/kgKidney
60 μg/kgMilk
CefazolinCefazolinBovine, ovine, caprine50 μg/kgMilk
CefoperazoneCefoperazoneBovine50 μg/kgMilk
CefquinomeCefquinomeBovine50 μg/kgMuscle
50 μg/kgFat
100 μg/kgLiver
200 μg/kgKidney
20 μg/kgMilk
Porcine50 μg/kgMuscle
50 μg/kgSkin + fat
100 μg/kgLiver
200 μg/kgKidney
Equidae50 μg/kgMuscle
50 μg/kgFat
100 μg/kgLiver
200 μg/kgKidney
CeftiofurSum of all residues retaining the betalactam structure expressed as desfuroylceftiofurBovine1000 μg/kgMuscle
2000 μg/kgFat
2000 μg/kgLiver
6000 μg/kgKidney
100 μg/kgMilk
Porcine1000 μg/kgMuscle
2000 μg/kgFat
2000 μg/kgLiver
6000 μg/kgKidney
1.2.3.Quinolones
For fin fish this MRL relates to "muscle and skin in natural proportions".For porcine species this MRL relates to "skin and fat in natural proportions".
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
DanofloxacinDanofloxacinAll food producing species except bovine, ovine, caprine, porcine and poultry100 μg/kgMuscle
50 μg/kgFat
200 μg/kgLiver
200 μg/kgKidney
Bovine, ovine, caprine200 μg/kgMuscle
100 μg/kgFat
400 μg/kgLiver
400 μg/kgKidney
30 μg/kgMilk
Poultry200 μg/kgMuscleNot for use in animals from which eggs are produced for human consumption
100 μg/kgSkin and fat
400 μg/kgLiver
400 μg/kgKidney
DifloxacinDifloxacinAll food producing species except bovine, ovine, caprine and poultry300 μg/kgMuscle
100 μg/kgFat
800 μg/kgLiver
600 μg/kgKidney
Bovine, ovine, caprine400 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
100 μg/kgFat
1400 μg/kgLiver
800 μg/kgKidney
Porcine400 μg/kgMuscle
100 μg/kgSkin and fat
800 μg/kgLiver
800 μg/kgKidney
Poultry300 μg/kgMuscleNot for use in animals from which eggs are produced for human consumption
400 μg/kgSkin and fat
1900 μg/kgLiver
600 μg/kgKidney
EnrofloxacinSum of enrofloxacin and ciprofloxacinAll food producing species except bovine, ovine, caprine, porcine, rabbits and poultry100 μg/kgMuscle
100 μg/kgFat
200 μg/kgLiver
200 μg/kgKidney
Bovine, ovine, caprine100 μg/kgMuscle
100 μg/kgFat
300 μg/kgLiver
200 μg/kgKidney
100 μg/kgMilk
Porcine, rabbits100 μg/kgMuscle
100 μg/kgFat
200 μg/kgLiver
300 μg/kgKidney
Poultry100 μg/kgMuscleNot for use in animals from which eggs are produced for human consumption
100 μg/kgSkin and fat
200 μg/kgLiver
300 μg/kgKidney
FlumequineFlumequineAll food producing species except bovine, ovine, caprine, porcine, poultry and fin fish200 μg/kgMuscle
250 μg/kgFat
500 μg/kgLiver
1000 μg/kgKidney
Bovine, porcine, ovine, caprine200 μg/kgMuscle
300 μg/kgFat
500 μg/kgLiver
1500 μg/kgKidney
50 μg/kgMilk
Poultry400 μg/kgMuscleNot for use in animals from which eggs are produced for human consumption
250 μg/kgSkin and fat
800 μg/kgLiver
1000 μg/kgKidney
Fin fish600 μg/kgMuscle and skin in natural proportion
MarbofloxacinMarbofloxacinBovine150 μg/kgMuscle
50 μg/kgFat
150 μg/kgLiver
150 μg/kgKidney
75 μg/kgMilk
Porcine150 μg/kgMuscle
50 μg/kgSkin and fat
150 μg/kgLiver
150 μg/kgKidney
Oxolinic acidOxolinic acidPorcine100 μg/kgMuscle
50 μg/kgSkin and fat
150 μg/kgLiver
150 μg/kgKidney
Chicken100 μg/kgMuscleNot for use in animals from which eggs are produced for human consumption
50 μg/kgSkin and fat
150 μg/kgLiver
150 μg/kgKidney
Fin fish100 μg/kgMuscle and skin in natural proportions
SarafloxacinSarafloxacinChicken10 μg/kgSkin and fat
100 μg/kgLiver
Salmonidae30 μg/kgMuscle and skin in natural proportions
1.2.4.Macrolides
For fin fish this MRL relates to a "muscle and skin in natural proportions".For procine species this MRL relates to "skin and fat in natural proportions".For porcine and poultry species this MRL relates to "skin and fat in natural proportions".Not for use in animals from which milk is produced for human consumption.
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AcetylisovaleryltylosinSum of acetyl-isovaleryltylosin and 3-O-acetyltylosinPorcine50 μg/kgMuscle
50 μg/kgSkin and fat
50 μg/kgLiver
50 μg/kgKidney
ErythromycinErythromicyin AAll food producing species200 μg/kgMuscle
200 μg/kgFat
200 μg/kgLiver
200 μg/kgKidney
40 μg/kgMilk
150 μg/kgEggs
SpiramycinSum of spiramycin and neospiramycinBovine200 μg/kgMuscle
300 μg/kgFat
300 μg/kgLiver
300 μg/kgKidney
200 μg/kgMilk
Chicken200 μg/kgMuscle
300 μg/kgSkin and fat
400 μg/kgLiver
Spiramycin 1Porcine250 μg/kgMuscle
2000 μg/kgLiver
1000 μg/kgKidney
TilmicosinTilmicosinAll food producing species except poultry50 μg/kgMuscle
50 μg/kgFat
1000 μg/kgLiver
1000 μg/kgKidney
50 μg/kgMilk
Poultry75 μg/kgMuscleNot for use in animals from which eggs are produced for human consumption
75 μg/kgSin and fat
1000 μg/kgLiver
250 μg/kgKidney
Tulathromycin(2R,3S,4R,5R,8R,10R,11R,12S, 13S,14R)-2-ethyl-3,4,10,13-tetrahydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopy-ranosyl]oxy]-1-oxa-6-azacyclopent-decan-15-one expressed as tulathromycin equivalentsBovine100 μg/kgFat
3000 μg/kgLiver
3000 μg/kgKidney
Porcine100 μg/kgSkin + fat
3000 μg/kgLiver
3000 μg/kgKidney
TylosinTylosin AAll food producing species100 μg/kgFat
100 μg/kgMuscle
100 μg/kgLiver
100 μg/kgKidney
50 μg/kgMilk
200 μg/kgEggs
1.2.5.Florfenicol and related compounds
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
FlorfenicolSum of florfenicol and its metabolites measured as florfenicol-amineAll food producing species except bovine, ovine, caprine, porcine, poultry and fin fish100 μg/kgMuscle
200 μg/kgFat
2000 μg/kgLiver
300 μg/kgKidney
Bovine, ovine, caprine200 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
3000 μg/kgLiver
300 μg/kgKidney
Porcine300 μg/kgMuscle
500 μg/kgSkin and fat
2000 μg/kgLiver
500 μg/kgKidney
Poultry100 μg/kgMuscleNot for use in animals from which eggs are produced for human consumption
200 μg/kgSkin and fat
2500 μg/kgLiver
750 μg/kgKidney
Fin fish1000 μg/kgMuscle and skin in natural proportions
ThiamphenicolThiamphenicolBovine50 μg/kgMuscle
50 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
50 μg/kgMilk
Chicken50 μg/kgMuscle
Not for use in animals from which eggs are produced for human consumption50 μg/kgSkin and fat
50 μg/kgLiver
50 μg/kgKidney
1.2.6.Tetracyclines
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ChlortetracyclineSum of parent drug and its 4- epimerAll food-producing species100 μg/kgMuscle
300 μg/kgLiver
600 μg/kgKidney
100 μg/kgMilk
200 μg/kgEggs
DoxycyclineDoxycyclineBovine100 μg/kgMuscle
Not for use in animals from which milk is produced for human consumption300 μg/kgLiver
600 μg/kgKidney
Porcine100 μg/kgMuscle
300 μg/kgSkin and fat
300 μg/kgLiver
600 μg/kgKidney
Poultry100 μg/kgMuscle
Not for use in animals from which eggs are produced for human consumption300 μg/kgSkin and fat
300 μg/kgLiver
600 μg/kgKidney
OxytetracyclineSum of parent drug and its 4-epimerAll food-producing species100 μg/kgMuscle
300 μg/kgLiver
600 μg/kgKidney
100 μg/kgMilk
200 μg/kgEggs
TetracyclineSum of parent drug and its 4-epimerAll food-producing species100 μg/kgMuscle
300 μg/kgLiver
600 μg/kgKidney
100 μg/kgMilk
200 μg/kgEggs
1.2.7.Naphtalene-ringed ansamycin
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
RifaximinRifaximinBovine60 μg/kgMilk
1.2.8.Pleuromutilines
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
TiamulinSum of metabolites that may be hydrolysed to 8-a-hydroxymutilinPorcine100 μg/kgMuscle
500 μg/kgLiver
Chicken100 μg/kgMuscle
100 μg/kgSkin and fat
1000 μg/kgLiver
Rabbits100 μg/kgMuscle
500 μg/kgLiver
Turkey100 μg/kgMuscle
100 μg/kgSkin and fat
300 μg/kgLiver
Tiamulin1000 μg/kgEggs
ValnemulinValnemulinPorcine50 μg/kgMuscle
500 μg/kgLiver
100 μg/kgKidney
1.2.9.Lincosamides
For porcine and poultry species this MRL relates to "skin and fat in natural proportions".For fin fish this MRL relates to "muscle and skin in natural proportions".
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
LincomycinLincomicynAll food producing species50 μg/kgFat
100 μg/kgMuscle
500 μg/kgLiver
1500 μg/kgKidney
150 μg/kgMilk
50 μg/kgEggs
PirlimycinPirlimycinBovine100 μg/kgMuscle
100 μg/kgFat
1000 μg/kgLiver
400 μg/kgKidney
100 μg/kgMilk
Porcine100 μg/kgMuscle
50 μg/kgSkin and fat
500 μg/kgLiver
1500 μg/kgKidney
Chicken100 μg/kgMuscle
50 μg/kgSkin and fat
500 μg/kgLiver
1500 μg/kgKidney
50 μg/kgEggs
1.2.10.Aminoglycosides
For porcine and poultry species this MRL relates to "skin and fat in natural proportions".For fin fish this MRL relates to "muscle and skin in natural proportions".Not for use in animals from which eggs are produced for human consumption.
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ApramycinApramycinBovine1000 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
1000 μg/kgFat
10000 μg/kgLiver
20000 μg/kgKidney
DihydrostreptomycinDihydrostreptomycinBovine, ovine500 μg/kgMuscle
500 μg/kgFat
500 μg/kgLiver
1000 μg/kgKidney
200 μg/kgMilk
Porcine500 μg/kgMuscle
500 μg/kgSkin and fat
500 μg/kgLiver
1000 μg/kgKidney
GentamicinSum of gentamicin C1, gentamicin C1a, gentamicin C2 and gentamicin C2aBovine50 μg/kgMuscle
50 μg/kgFat
200 μg/kgLiver
750 μg/kgKidney
100 μg/kgMilk
Porcine50 μg/kgMuscle
50 μg/kgSkin and fat
200 μg/kgLiver
750 μg/kgKidney
KanamycinKanamycin AAll food producing species except fish100 μg/kgMuscle
100 μg/kgFat
600 μg/kgLiver
2500 μg/kgKidney
150 μg/kgMilk
Neomycin (including framycetin)Neomycin BAll food producing species500 μg/kgFat
500 μg/kgMuscle
500 μg/kgLiver
5000 μg/kgKidney
1500 μg/kgMilk
500 μg/kgEggs
ParomomycinParomomycinAll food producing species500 μg/kgMuscleNot for use in animals from which milk or eggs are produced for human consumption
1500 μg/kgLiver
1500 μg/kgKidney
SpectinomycinSpectinomycinAll food producing species except ovine500 μg/kgFatNot for use in animals from which eggs are produced for human consumption
300 μg/kgMuscle
1000 μg/kgLiver
5000 μg/kgKidney
200 μg/kgMilk
Ovine300 μg/kgMuscle
500 μg/kgFat
2000 μg/kgLiver
5000 μg/kgKidney
200 μg/kgMilk
StreptomycinStreptomycinBovine, ovine500 μg/kgMuscle
500 μg/kgFat
500 μg/kgLiver
1000 μg/kgKidney
200 μg/kgMilk
Porcine500 μg/kgMuscle
500 μg/kgSkin and fat
500 μg/kgLiver
1000 μg/kgKidney
1.2.11.Other antibiotics
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
NovobiocinNovobiocinBovine50 μg/kgMilk
1.2.12.Polypeptides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
BacitracinSum of bacitracin A, bacitracin B, and bacitracin CBovine100 μg/kgMilk
Rabbits150 μg/kgMuscle
150 μg/kgFat
150 μg/kgLiver
150 μg/kgKidney
1.2.13.Beta-lactamase inhibitors
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
Clavulanic acidClavulanic acidBovine100 μg/kgMuscle
100 μg/kgFat
200 μg/kgLiver
400 μg/kgKidney
200 μg/kgMilk
Porcine100 μg/kgMuscle
100 μg/kgSkin and fat
200 μg/kgLiver
400 μg/kgKidney
1.2.14.Polymyxins
For porcine and poultry species this MRL relates to "skin and fat in natural proportions".For fin fish this MRL relates to "muscle and skin in natural proportions".
Pharmacologically active substanceMarker residueAnimal speciesMRLsTarget tissuesOther provisions
ColistinColistinAll food producing species150 μg/kgFat
150 μg/kgMuscle
150 μg/kgLiver
200 μg/kgKidney
50 μg/kgMilk
300 μg/kgEggs
2.Antiparasitic agents2.1.Agents acting against endoparasites2.1.1.Salicylanilides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ClosantelClosantelBovine1000 μg/kgMuscle
3000 μg/kgFat
1000 μg/kgLiver
3000 μg/kgKidney
Ovine1500 μg/kgMuscle
2000 μg/kgFat
1500 μg/kgLiver
5000 μg/kgKidney
RafoxanideRafoxanideBovine30 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
30 μg/kgFat
10 μg/kgLiver
40 μg/kgKidney
Ovine100 μg/kgMuscle
250 μg/kgFat
150 μg/kgLiver
150 μg/kgKidney
2.1.2.Tatra-hydro-imidazoles (imidazolthiazoles)
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
LevamisoleLevamisoleBovine, ovine, porcine, poultry10 μg/kgMuscle
10 μg/kgFat
100 μg/kgLiver
10 μg/kgKidney
2.1.3.Benzimidazoles and pro-benzimidazoles
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AlbendazoleSum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazoleAll ruminants100 μg/kgMuscle
100 μg/kgFat
1000 μg/kgLiver
500 μg/kgKidney
100 μg/kgMilk
Albendazole oxideSum of albendazole oxide, albendazole sulphone and albendazole 2-aminosulphone, expressed as albendazoleBovine, ovine100 μg/kgMuscle
100 μg/kgFat
1000 μg/kgLiver
500 μg/kgKidney
100 μg/kgMilk
FebantelSum of extractable residues which may be oxidised to oxfendazole sulphoneAll ruminants50 μg/kgMuscle
50 μg/kgFat
500 μg/kgLiver
50 μg/kgKidney
10 μg/kgMilk
FenbendazoleSum of extractable residues which may be oxidised to oxfendazole sulphoneAll ruminants50 μg/kgMuscle
50 μg/kgFat
500 μg/kgLiver
50 μg/kgKidney
10 μg/kgMilk
FlubendazoleSum of flubendazole and (2-amino 1H-benzimidazol-5-yl) (4fluorophenyl) methanonePorcine, chicken, game birds50 μg/kgMuscle
50 μg/kgSkin and fat
400 μg/kgLiver
300 μg/kgKidney
Turkey50 μg/kgMuscle
50 μg/kgSkin and fat
400 μg/kgLiver
300 μg/kgKidney
FlubendazoleChicken400 μg/kgEggs
MebendazoleSum of mebendazole methyl (5-(1-hydroxy, 1-phenyl) methyl-1H-benzimidazol-2-yl) carbamate and (2-amino-1H-benzimidazol-5-yl) phenylmethanone, expressed as mebendazole equivalentsOvine, caprine, equidae60 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
60 μg/kgFat
400 μg/kgLiver
60 μg/kgKidney
NetobiminSum of albendazole oxide, albendazole sulphone and albendazole 2-aminosulphone, expressed as albendazoleBovine, ovine100 μg/kgMuscleFor oral use only
100 μg/kgFat
1000 μg/kgLiver
500 μg/kgKidney
100 μg/kgMilk
OxfendazoleSum of extractable residues which may be oxidised to oxfendazole sulphoneAll ruminants50 μg/kgMuscle
50 μg/kgFat
500 μg/kgLiver
50 μg/kgKidney
10 μg/kgMilk
OxibendazoleOxibendazolePorcine100 μg/kgMuscle
500 μg/kgSkin and fat
200 μg/kgLiver
100 μg/kgKidney
ThiabendazoleSum of thiabendazole and 5-hydroxythiabendazoleCaprine100 μg/kgMuscle
100 μg/kgFat
100 μg/kgLiver
100 μg/kgKidney
100 μg/kgMilk
TriclabendazoleSum of extractable residues that may be oxidised to ketotriclabendazoleBovine, ovine100 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
100 μg/kgLiver
100 μg/kgKidney
2.1.4.Phenol derivatives including salicylanides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
NitroxinilNitroxinilBovine, ovine400 μg/kgMuscle
200 μg/kgFat
20 μg/kgLiver
400 μg/kgKidney
OxyclozanideOxyclozanideAll ruminants20 μg/kgMuscle
20 μg/kgFat
500 μg/kgLiver
100 μg/kgKidney
10 μg/kgMilk
2.1.5.Benzenesulphonamides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ClorsulonClorsulonBovine35 μg/kgMuscle
100 μg/kgLiver
200 μg/kgKidney
2.1.6.Piperazine derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
PiperazinePiperazinePorcine400 μg/kgMuscle
800 μg/kgSkind and fat
2000 μg/kgLiver
1000 μg/kgKidney
Chicken2000 μg/kgEggs
2.1.7.Tetrahydropyrimides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
MorantelSum of residues which may be hydrolysed to N-methyl-1,3- propanediamine and expressed as morantel equivalentsBovine, ovine100 μg/kgMuscle
100 μg/kgFat
800 μg/kgLiver
200 μg/kgKidney
50 μg/kgMilk
2.2.Agents acting against ectoparasites2.2.1.Organophosphates
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CoumafosCoumafosBees100 μg/kgHoney
DiazinonDiazinonBovine, ovine, caprine20 μg/kgMilk
Bovine, porcine, ovine, caprine20 μg/kgMuscle
700 μg/kgFat
20 μg/kgLiver
20 μg/kgKidney
PhoximPhoximOvine50 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
400 μg/kgFat
50 μg/kgKidney
Porcine20 μg/kgMuscle
700 μg/kgSkin and fat
20 μg/kgLiver
20 μg/kgKidney
2.2.2.Formamidines
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AmitrazSum of amitraz and all metabolites containing the 2,4-DMA moiety, expressed as amitrazBovine200 μg/kgFat
200 μg/kgLiver
200 μg/kgKidney
10 μg/kgMilk
Ovine400 μg/kgFat
100 μg/kgLiver
200 μg/kgKidney
10 μg/kgMilk
Porcine400 μg/kgSkin and fat
200 μg/kgLiver
200 μg/kgKidney
Bees (honey)200 μg/kgHoney
Caprine200 μg/kgFat
100 μg/kgLiver
200 μg/kgKidney
10 μg/kgMilk
2.2.3.Pyrethroids
Further provisions in Commission Directive 98/82/EC are to be observed (OJ L 290, 29.10.1998, p. 25).
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CyhalothrinCyhalothrin (sum of isomers)Bovine500 μg/kgFatFurther provisions in Council Directive 94/29/EC are to be observed
50 μg/kgKidney
50 μg/kgMilk
CyfluthrinCyfluthrin (sum of isomers)Bovine10 μg/kgMuscle
50 μg/kgFat
10 μg/kgLiver
10 μg/kgKidney
20 μg/kgMilk
DeltamethrinDeltamethrinAll ruminants10 μg/kgMuscle
50 μg/kgFat
10 μg/kgLiver
10 μg/kgKidney
20 μg/kgMilk
Fin fish10 μg/kgMuscle and skin in natural proportions
FlumethrinFlumethrin (sum of trans-Z isomers)Bovine10 μg/kgMuscle
150 μg/kgFat
20 μg/kgLiver
10 μg/kgKidney
30 μg/kgMilk
Ovine10 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
150 μg/kgFat
20 μg/kgLiver
10 μg/kgKidney
PermethrinPermethrin (sum of isomers)Bovine50 μg/kgMuscle
500 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
50 μg/kgMilk
CypermethrinCypermethrin (sum of isomers)Salmonidae50 μg/kgMuscle and skin in natural proportions
All ruminants20 μg/kgMuscle
200 μg/kgFat
20 μg/kgLiver
20 μg/kgKidney
20 μg/kgMilk
AlphacypermethrinCypermethrin (sum of isomers)Bovine, ovine20 μg/kgMuscle
200 μg/kgFat
20 μg/kgLiver
20 μg/kgKidney
20 μg/kgMilk
2.2.4.Acyl urea derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
DiflubenzuronDiflubenzuronSalmonidae1000 μg/kgMuscle and skin in natural proportions
TeflubenzuronTeflubenzuronSalmonidae500 μg/kgMuscle and skin in natural proportions
2.2.5.Pyrimidines derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
DicyclanilSum of dicyclanil and 2, 4, 6-triamino-pyrimidine-5-carbonitrileOvine200 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
150 μg/kgFat
400 μg/kgLiver
400 μg/kgKidney
2.2.6.Triazine derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CyromazineCyromazineOvine300 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
300 μg/kgFat
300 μg/kgLiver
300 μg/kgKidney
2.3.Agents acting against endo- and ectoparasites2.3.1.Avermectins
Phramacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AbamectinAvermectin B1aBovine10 μg/kgFat
20 μg/kgLiver
Ovine20 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
50 μg/kgFat
25 μg/kgLiver
20 μg/kgKidney
DoramectinDoramectinBovine10 μg/kgMuscleNot for use in bovine from which milk is produced for human consumption
150 μg/kgFat
100 μg/kgLiver
30 μg/kgKidney
Porcine, ovine20 μg/kgMuscleNot for use in ovine from which milk is produced for human consumption
100 μg/kgFat
50 μg/kgLiver
30 μg/kgKidney
Deer, including reindeer20 μg/kgMuscle
100 μg/kgFat
50 μg/kgLiver
30 μg/kgKidney
EmamectinEmamectin B1aFin fish100 μg/kgMuscle and skin in natural proportions
EprinomectinEprinomectin B1aBovine50 μg/kgMuscle
250 μg/kgFat
1500 μg/kgLiver
300 μg/kgKidney
20 μg/kgMilk
Ivermectin22, 23-Dihydro-avermectin B1aBovine40 μg/kgFat
100 μg/kgLiver
Porcine, ovine, equidae20 μg/kgFat
15 μg/kgLiver
Deer, including reindeer20 μg/kgMuscle
100 μg/kgFat
50 μg/kgLiver
20 μg/kgKidney
MoxidectinMoxidectinBovine, ovine50 μg/kgMuscle
500 μg/kgFat
100 μg/kgLiver
50 μg/kgKidney
Bovine40 μg/kgMilk
Equidae50 μg/kgMuscle
500 μg/kgFat
100 μg/kgLiver
50 μg/kgKidney
2.4.Agents acting against protozoa2.4.1.Triazinetrione derivative
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ToltrazurilToltrazuril sulfoneChicken100 μg/kgMuscleNot for use in animals from which eggs are produced for human consumption
200 μg/kgSkin and fat
600 μg/kgLiver
400 μg/kgKidney
Turkey100 μg/kgMuscle
200 μg/kgSkin and fat
600 μg/kgLiver
400 μg/kgKidney
Porcine100 μg/kgMuscle
150 μg/kgSkin and fat
500 μg/kgLiver
250 μg/kgKidney
2.4.2.Quinazolone derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
HalofuginoneHalofuginoneBovine10 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
25 μg/kgFat
30 μg/kgLiver
30 μg/kgKidney
2.4.3.Carbanilides
Not for use in ovine from which milk is produced for human consumption.
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ImidocarbImidocarbBovine300 μg/kgMuscle
50 μg/kgFat
2000 μg/kgLiver
1500 μg/kgKidney
50 μg/kgMilk
Ovine300 μg/kgMuscle
50 μg/kgFat
2000 μg/kgLiver
1500 μg/kgKidney
3.Agents acting on the nervous system3.1.Agents acting on the central nervous system3.1.1.Butyrophenone tranquillisers
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AzaperoneSum of azaperone and azaperolPorcine100 μg/kgMuscle
100 μg/kgSkin and fat
100 μg/kgLiver
100 μg/kgKidney
3.2.Agents acting on the autonomic nervous system3.2.1.Anti-adrenergics
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CarazololCarazololPorcine5 μg/kgMuscle
5 μg/kgSkin and fat
25 μg/kgLiver
25 μg/kgKidney
Bovine5 μg/kgMuscle
5 μg/kgFat
15 μg/kgLiver
15 μg/kgKidney
1 μg/kgMilk
3.2.2.β2 sympathomimetic agents
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
Clenbuterol hydrochlorideClenbuterolBovine0,1 μg/kgMuscle
0,5 μg/kgLiver
0,5 μg/kgKidney
0,05 μg/kgMilk
Equidae0,1 μg/kgMuscle
0,5 μg/kgLiver
0,5 μg/kgKidney
4.Anti-inflammatory agents4.1.Nonsteroidal anti-inflammatory agents4.1.1.Arylpropionic acid derivative
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CarprofenCarprofenBovineNot for use in animals from which milk is produced for human consumption500 μg/kgMuscle
1000 μg/kgFat
1000 μg/kgLiver
1000 μg/kgKidney
Equidae500 μg/kgMuscle
1000 μg/kgFat
1000 μg/kgLiver
1000 μg/kgKidney
VedaprofenVedaprofenEquidae50 μg/kgMuscle
20 μg/kgFat
100 μg/kgLiver
1000 μg/kgKidney
4.1.2.Fenamate group derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
FlunixinFlunixinBovine20 μg/kgMuscle
30 μg/kgFat
300 μg/kgLiver
100 μg/kgKidney
5-Hydroxyflunixin40 μg/kgMilk
FlunixinPorcine50 μg/kgMuscle
10 μg/kgSkin and fat
200 μg/kgLiver
30 μg/kgKidney
Equidae10 μg/kgMuscle
20 μg/kgFat
100 μg/kgLiver
200 μg/kgKidney
Tolfenamic acidTolfenamic acidBovine50 μg/kgMuscle
400 μg/kgLiver
100 μg/kgKidney
50 μg/kgMilk
Porcine50 μg/kgMuscle
400 μg/kgLiver
100 μg/kgKidney
4.1.3.Enolic acid derivates
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
MeloxicamMeloxicamEquidae20 μg/kgMuscle
65 μg/kgLiver
65 μg/kgKidney
4.1.4.Oxican derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
MeloxicamMeloxicamBovine20 μg/kgMuscle
65 μg/kgLiver
65 μg/kgKidney
15 μg/kgMilk
Porcine20 μg/kgMuscle
65 μg/kgLiver
65 μg/kgKidney
4.1.5.Pyrazolone derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
Metamizole4-MethylaminoantipyrinBovine100 μg/kgMuscle
100 μg/kgFat
100 μg/kgLiver
100 μg/kgKidney
50 μg/kgMilk
Porcine100 μg/kgMuscle
100 μg/kgSkin and fat
100 μg/kgLiver
100 μg/kgKidney
Equidae100 μg/kgMuscle
100 μg/kgFat
100 μg/kgLiver
100 μg/kgKidney
4.1.6.Phenyl acetic acid derivatives
Not for use in animals from which milk is produced for human consumption.
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
DiclofenacDiclofenacBovine5 μg/kgMuscle
1 μg/kgFat
5 μg/kgLiver
10 μg/kgKidney
Porcine5 μg/kgMuscle
1 μg/kgSkin + fat
5 μg/kgLiver
10 μg/kgKidney
5.Corticoides5.1.Glucocorticoides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
BetamethasoneBetamethasoneBovine0,75 μg/kgMuscle
2,0 μg/kgLiver
0,75 μg/kgKidney
0,3 μg/kgMilk
Porcine0,75 μg/kgMuscle
2,0 μg/kgLiver
0,75 μg/kgKidney
DexamethasoneDexamethasoneBovine0,3 μg/kgMilk
Bovine, porcine, equidae0,75 μg/kgMuscle
2 μg/kgLiver
0,75 μg/kgKidney
Caprine0,75 μg/kgMuscle
2 μg/kgLiver
0,75 μg/kgKidney
0,3 μg/kgMilk
MethylprednisoloneMethylprednisoloneBovine10 μg/kgMuscleNot for use in animals from which milk is produced for human consumption
10 μg/kgFat
10 μg/kgLiver
10 μg/kgKidney
PrednisolonePrednisoloneBovine4 μg/kgMuscle
4 μg/kgFat
10 μg/kgLiver
10 μg/kgKidney
6 μg/kgMilk
6.Agents acting on the reproductive system6.1.Progestogens
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ChlormadinoneChlormadinoneBovine4 μg/kgFatFor zootechnical use only
2 μg/kgLiver
2,5 μg/kgMilk
Flugestone acetateFlugetone acetateOvine1 μg/kgMilkFor intravaginal use for zootechnical purposes only
Caprine1 μg/kgMilkFor intra-vaginal use for zootechnical purposes only
ANNEX IILIST OF SUBSTANCES NOT SUBJECT TO MAXIMUM RESIDUE LIMITS1.Inorganic chemicals
Pharmacologically active substance(s)Animal speciesOther provisions
Aluminium distearateAll food-producing species
Aluminium hydroxide acetateAll food-producing species
Aluminium phosphateAll food-producing species
Aluminium salicylate, basicBovineFor oral use only; Not for use in animals from which milk is produced for human consumption
Aluminium tristearateAll food-producing species
Ammonium chlorideAll food-producing species
Barium selenateBovine, ovine
Bismuth subcarbonateAll food-producing speciesFor oral use only
Bismuth subgallateAll food-producing speciesFor oral use only
Bismuth subnitrateAll food-producing speciesFor oral use only
Bismuth subsalicylateAll food-producing speciesFor oral use only
Boric acid and boratesAll food-producing species
Bromide, potassium saltAll food producing species
Bromide, sodium saltAll mammalian food-producing speciesFor topical use only
Calcium acetateCalcium benzoateCalcium carbonateCalcium chlorideCalcium gluconateCalcium hydroxideCalcium hypophosphiteCalcium malateCalcium oxideCalcium phosphateCalcium polyphosphatesCalcium propionateCalcium silicateCalcium stearateCalcium sulphateAll food-producing species
Calcium glucoheptonateAll food-producing species
Calcium glucono glucoheptonateAll food-producing species
Calcium gluconolactateAll food-producing species
Calcium glutamateAll food-producing species
Calcium glycerophosphateAll food producing species
Cobalt carbonateAll food-producing species
Cobalt dichlorideAll food-producing species
Cobalt gluconateAll food-producing species
Cobalt oxideAll food-producing species
Cobalt sulphateAll food-producing species
Cobalt trioxideAll food-producing species
Copper chlorideAll food-producing species
Copper gluconateAll food-producing species
Copper heptanoateAll food-producing species
Copper methionateAll food-producing species
Copper oxideAll food-producing species
Copper sulphateAll food-producing species
Dicopper oxideAll food-producing species
Hydrochloric acidAll food-producing speciesFor use as excipient
Hydrogen peroxideAll food-producing species
Iodine and iodine inorganic compounds including:Sodium and potassium-iodideSodium and potassium-iodateIodophors including polyvinylpyrrolidone-iodineAll food-producing species
Iron dichlorideAll food-producing species
Iron sulphateAll food-producing species
MagnesiumMagnesium sulphateMagnesium hydroxideMagnesium stearateMagnesium glutamateMagnesium orotateMagnesium aluminium silicateMagnesium oxideMagnesium carbonateMagnesium phosphateMagnesium glycerophosphateMagnesium aspartateMagnesium citrateMagnesium acetateMagnesium trisilicateAll food-producing species
Nickel gluconateAll food-producing species
Nickel sulphateAll food-producing species
Potassium DL-aspartateAll food-producing species
Potassium glucuronateAll food-producing species
Potassium glycerophosphateAll food-producing species
Potassium nitrateAll food-producing species
Potassium selenateAll food-producing species
Sodium chloriteBovineFor topical use only
Sodium dichloroisocyanurateBovine, ovine, caprineFor topical use only
Sodium glycerophosphateAll food producing species
Sodium hypophosphiteAll food-producing species
Sodium propionateAll food producing species
Sodium selenateAll food-producing species
Sodium seleniteAll food-producing species
SulphurAll food producing species
Zinc acetateZinc chlorideZinc gluconateZinc oleateZinc stearateAll food-producing species
2.Organic compounds
Only for intravaginal therapeutic or zootechnical use and in accordance with the provisions of Directive 96/22/EC.For oral use only.For oral use; not for use in animals from which milk is produced for human consumption.
Pharmacologically active substance(s)Animal speciesOther provisions
17β-OestradiolAll mammalian food-producing speciesFor therapeutic and zootechnical uses only
2-AminoethanolAll food-producing species
2-Aminoethyl dihydrogenphosphateAll food-producing species
2-PyrrolidoneAll food-producing speciesAt parenteral doses up to 40 mg/kg bw
8-HydroxyquinolineAll mammalian food-producing speciesFor topical use in newborn animals only
Acetyl cysteineAll food-producing species
AlfacalcidolBovineFor parturient cows only
AlfaprostolRabbitsBovine, porcine, equidae
BacitracinBovineFor intramammary use in lactating cows only and for all tissues except milk
Benzalkonium chlorideAll food-producing speciesFor use as an excipient at concentrations up to 0,05 % only
BenzocaineAll food-producing speciesFor use as local anaesthetic only
BenzylalcoholAll food-producing speciesFor use as excipient
BetaineAll food-producing species
BronopolSalmonidaeFor use only on farmed fertilised eggs
BrotizolamBovineFor therapeutic uses only
BuserelinAll food-producing species
Butorphanol tartrateEquidaeFor intravenous administration only
Butyl 4-hydroxybenzoateAll food-producing species
Butylscopolaminium bromideAll food-producing species
CaffeineAll food-producing species
CarbetocinAll mammalian food-producing species
CefazolinBovineOvine, caprineFor intramammary use, except if the udder may be used as food for human consumption
Cetostearyl alcoholAll food-producing species
CetrimideAll food-producing species
ChlorhexidineAll food-producing speciesFor topical use only
ChlorocresolAll food-producing species
ClazurilPigeon
CloprostenolBovine, porcine, equidae
Coco alkyl dimethyl betainesAll food-producing speciesFor use as excipient
CorticotropinAll food-producing species
D-Phe 6 -luteinising-hormone releasing hormoneAll food-producing species
DembrexineEquidae
Denaverine hydrochlorideBovine
DetomidineBovine, equidaeFor therapeutic uses only
DiclazurilAll ruminantsPorcine
Diethyl phtalateAll food-producing species
Diethylene glycol monoethyl etherBovine, porcine
Dimanganese trioxideAll food-producing speciesFor oral use only
Dimethyl phtalateAll food-producing species
DinoprostAll mammalian food-producing species
Dinoprost tromethamineAll mammalian food-producing species
DiprophyllineAll food-producing species
Etamiphylline camsylateAll food-producing species
EthanolAll food-producing speciesFor use as excipient
Ethyl lactateAll food-producing species
Etiproston tromethamineBovine, porcine
Fertirelin acetateBovine
FlumethrinBees (honey)
Folic acidAll food-producing species
Glycerol formalAll food-producing species
Gonadotrophin releasing hormoneAll food-producing species
HeptaminolAll food-producing species
HesperidinEquidae
Hesperidin methyl chalconeEquidae
HexetidineEquidaeFor topical use only
Human chorion gonadotrophinAll food-producing species
Human menopausal urinary gonadotrophinBovine
HydrocortisoneAll food-producing speciesFor topical use only
Iodine organic compoundsIodoformAll food-producing species
IsobutaneAll food-producing species
IsofluraneEquidaeFor use as anaesthetic only
IsoxsuprineBovine, equidaeFor therapeutic use only in accordance with Council Directive 96/22/EEC (OJ L 125, 23.5.1996, p. 3)
KetamineAll food-producing species
Ketanserin tartrateEquidae
KetoprofenBovine, porcine, equidae
L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calciumAll food-producing speciesFor use as excipient
Lactic acidAll food-producing species
LecirelinBovine, equidae, rabbits
LobelineAll food-producing species
LuprostiolAll mammalian species
Malic acidAll food-producing speciesFor use as excipient
Manganese carbonateAll food-producing speciesFor oral use only
Manganese chlorideAll food-producing speciesFor oral use only
Manganese gluconateAll food-producing speciesFor oral use only
Manganese glycerophosphateAll food-producing speciesFor oral use only
Manganese oxideAll food-producing speciesFor oral use only
Manganese pidolateAll food-producing speciesFor oral use only
Manganese ribonucleateAll food-producing speciesFor oral use only
Manganese sulphateAll food-producing speciesFor oral use only
MecillinamBovineFor intrauterine use only
Medroxyprogesterone acetateOvineFor intravaginal use for zootechnical purposes only
MelatoninOvine, caprine
MenadioneAll food-producing species
MenbutoneBovine, ovine, caprine, porcine, equidae
MentholAll food-producing species
Methyl nicotinateBovine, equidaeFor topical use only
Mineral hydrocarbons, low to high viscosity including microcristalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compoundsAll food-producing speciesExcludes aromatic and unsaturated compounds
N-butaneAll food-producing species
N-butanolAll food-producing speciesFor use as excipient
NatamycinBovine, equidaeFor topical use only
NeostigmineAll food-producing species
NicoboxilEquidaeFor topical use only
NonivamideEquidaeFor topical use only
OleyloleateAll food-producing speciesFor topical use only
OxytocinAll mammalian food-producing species
PancreatinAll mammalian food-producing speciesFor topical use only
PapainAll food-producing species
PapaverineBovineNewborn calves only
Peracetic acidAll food-producing species
PhenolAll food-producing species
PhloroglucinolAll food-producing species
PhytomenadioneAll food-producing species
PolicresulenAll food-producing speciesFor topical use only
Polyethylene glycol 15 hydroxystearateAll food-producing speciesFor use as excipient
Polyethylene glycol 7 glyceryl cocoateAll food-producing speciesFor topical use only
Polyethylene glycol stearates with 8-40 oxyethylene unitsAll food-producing speciesFor use as excipient
Polysulphated glycosaminoglycanEquidae
PraziquantelOvineEquidaeFor use in non-lactating sheep only
Pregnant mare serum gonadotrophinAll food-producing species
Prethcamide (crotethamide and cropropamide)All mammalian food-producing species
ProcaineAll food-producing species
PropaneAll food-producing species
Propylene glycolAll food-producing species
QuatresinAll food-producing speciesFor use as preservative only at concentrations of up to 0,5 %
R-CloprostenolBovine, porcine, equidae
RifaximinAll mammalian food-producing speciesBovineFor topical use onlyFor intramammary use, except if the udder may be used as food for human consumption
RomifidineEquidaeFor therapeutic uses only
Sodium 2-methyl-2-phenoxy-propanoateBovine, porcine, caprine, equidae
Sodium benzyl 4-hydroxybenzoateAll food-producing species
Sodium butyl 4-hydroxybenzoateAll food-producing species
Sodium cetostearyl sulphateAll food-producing speciesFor topical use only
SomatosalmSalmon
TanninumAll food-producing species
Tau fluvalinate
Terpin hydrateBovine, porcine, ovine, caprine
TetracaineAll food-producing speciesFor use as anaesthetic only
TheobromineAll food-producing species
TheophyllineAll food-producing species
ThiomersalAll food-producing speciesFor use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 %
ThymolAll food-producing species
TimerfonateAll food-producing speciesFor use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 %
TrimethylphloroglucinolAll food-producing species
Vitamin DAll food-producing species
Wool alcoholsAll food-producing speciesFor topical use only
1-Methyl-2-pyrrolidoneEquidae
CefacetrileBovineFor intramammary use only and for all tissues except milk
EnilconazoleBovine, equidaeFor topical use only
EtamsylateAll food producing species
StrychnineBovineFor oral use only at dose to 0,1 mg/kg bw
ParconazoleGuinea fowl
BiotinAll food producing species
BromhexineBovineNot for use in animals from which milk is produced for human consumption
Porcine
PoultryNot for use in animals from which eggs are produced for human consumption
Mercaptamine hydrochlorideAll mammalian food-producing species
PraziquantelOvine
Pyrantel embonateEquidae
Vitamin B1All food-producing species
Vitamin B12All food-producing species
Vitamin B2All food-producing species
Vitamin B3All food-producing species
Vitamin B5All food-producing species
Vitamin B6All food-producing species
Vitamin EAll food-producing species
TiaprostBovine, ovine, porcine, equidae
ApramycinPorcine, rabbitsOvineNot for use in animals from which milk is produced for human consumptionChickenNot for use in animals from which eggs are produced for human consumptionFor oral use only
AzamethiphosSalmonidae
DoxapramAll mammalian food producing species
Piperonyl butoxideBovine, ovine, caprine, equidaeFor topical use only
SulfogaiacolAll food producing species
Vetrabutine hydrochloridePorcine
Fenpipramide hydrochlorideEquidaeFor intravenous use only
HydrochlorothiazideBovine
LevomethadoneEquidaeFor intravenous use only
Tricaine mesilateFin fishFor water borne use only
TrichlormethiazideAll mammalian food producing speciesNot for use in animals from which milk is produced for human consumption
VincamineBovineFor use in newborn animals only
AtropineAll food producing species
CefoperazoneBovineFor intramammary use in lactating cows only and for all tissues except milk
2-aminoethanol glucuronateAll food-producing species
Betaine glucuronateAll food-producing species
Bituminosulfonates, ammonium and sodium saltsAll mammalian food-producing speciesFor topical use onlyNot for use in animals from which milk is produced for human consumption
ChlorphenamineAll mammalian food-producing species
Humic acids and their sodium saltsAll food-producing speciesFor oral use only
ParacetamolPorcineFor oral use only
Tosylchloramide sodiumFin fishFor water-borne use only
BovineFor topical use only
1-methyl-2-pyrrolidoneAll food-producing species
Ergometrine maleateAll mammalian food-producing speciesFor use in parturient animals only
Jecoris oleumAll food-producing speciesFor topical use only
MepivacaineEquidaeFor intra-articular and epidural use as local anaesthetic only
NovobiocinBovineFor intrammary use only and for all tissues except milk
Piperazine dihydrochlorideChickenFor all tissues except eggs
Polyoxyl castor oil with 30 to 40 oxyethylene unitsAll food-producing speciesFor use as excipient
Polyoxyl hydrogenated castor oil with 40 to 60 oxyethylene unitsAll food-producing speciesFor use as excipient
Xylazine hydrochlorideBovine, equidaeNot for use in animals from which milk is produced for human consumptiom
ButafosfanBovineFor intravenous use only
CefaloniumBovineFor intramammary use and eye treatment only, and for all tissues except milk
FurosemideBovine, equidaeFor intravenous administration only
LidocaineEquidaeFor local-regional anaesthesia only
3,5-Diiodo-L-thyrosineAll mammalian food-producing species
LevothyroxineAll mammalian food-producing species
Aluminium salicylate, basicAll food producing species except fish For topical use only
Bismuth subnitrateBovineFor intramammary use only
Calcium aspartateAll food producing species
Methyl salicylateAll food producing species except fishFor topical use only
Salicylic acidAll food producing species except fishFor topical use only
Sodium salicylateBovine, porcine
Zinc aspartateAll food producing species
ToldimfosAll food producing species
DecoquinateBovine, ovineFor oral use only. Not for use in animals from which milk is produced for human consumption
Sodium boroformiateAll food producing species
ThiamylalAll mammalian food producing speciesFor intravenous administration only
Thiopental sodiumAll food-producing speciesFor intravenous administration only
Acetylsalicylic acidAll food producing species except fishNot for use in animals from which milk or eggs are produced for human consumption
Acetylsalicylic acid DL-lysineAll food producing species except fishNot for use in animals from which milk or eggs are produced for human consumption
Carbasalate calciumAll food producing species except fishNot for use in animals from which milk or eggs are produced for human consumption
Sodium acetylsalicylateAll food producing species except fishNot for use in animals from which milk or eggs are produced for human consumption
Linear alkyl benzene sulphonic acids with alkyl chain lengths ranging from C9 to C13, containing less than 2,5 % of chains longer than C13BovineFor topical use only
AmproliumPoultryFor oral use only
Tiludronic acid, disodium saltEquidaeFor intravenous use only
Sorbitan trioleateAll food-producing species
Vitamin AAll food producing species
Ammonium lauryl sulphateAll food-producing species
BronopolFin fish
Calcium pantothenateAll food-producing species
AllantoinAll food producing speciesFor topical use only
BenzocaineSalmonidae
DexpanthenolAll food producing species
Azagly-nafarelinSalmonidaeNot for use in fish from which eggs are produced for human consumption
Deslorelin acetateEquidae
HydroxyethylsalicylateAll food producing species except fishFor topical use only
Xylazine hydrochlorideBovine, equidae
OmeprazoleEquidaeFor oral use only
TrichlormethiazideAll mammalian food producing species
ProgesteroneBovine, ovine, caprine, Equidae (female)
3.Substances generally recognised as safe
Pharmacologically active substance(s)Animal speciesOther provisions
Absinthium extractAll food-producing species
AcetylmethionineAll food-producing species
Aluminium hydroxideAll food-producing species
Aluminium monostearateAll food-producing species
Ammonium sulfateAll food-producing species
Benzoyl benzoateAll food-producing species
Benzyl p-hydroxybenzoateAll food-producing species
Calcium borogluconateAll food-producing species
Calcium citrateAll food-producing species
CamphorAll food-producing speciesExternal use only
Cardamon extractAll food-producing species
Diethyl sebacateAll food-producing species
DimethiconeAll food-producing species
Dimethyl acetamideAll food-producing species
Dimethyl sulphoxideAll food-producing species
EpinephrineAll food-producing species
Ethyl oleateAll food-producing species
Ethylenediaminetetraacetic acid and saltsAll food-producing species
EucalyptolAll food-producing species
Follicle stimulating hormone (natural FSH from all species and their synthetic analogues)All food-producing species
FormaldehydeAll food-producing species
Formic acidAll food-producing species
GlutaraldehydeAll food-producing species
GuaiacolAll food-producing species
Heparin and its saltsAll food-producing species
Human chorionic gonadotropin (natural HCG and its synthetic analogues)All food-producing species
Iron ammonium citrateAll food-producing species
Iron dextranAll food-producing species
Iron glucoheptonateAll food-producing species
IsopropanolAll food-producing species
LanolinAll food-producing species
Luteinising hormone (natural LH from all species and their synthetic analogues)All food-producing species
Magnesium chlorideAll food-producing species
Magnesium gluconateAll food-producing species
Magnesium hypophosphiteAll food-producing species
MannitolAll food-producing species
MethylbenzoateAll food-producing species
MonothioglycerolAll food-producing species
MontanideAll food-producing species
MyglyolAll food-producing species
OrgoteinAll food-producing species
PoloxaleneAll food-producing species
PoloxamerAll food-producing species
Polyethylene glycols (molecular weight ranging from 200 to 10000)All food-producing species
Polysorbate 80All food-producing species
SerotoninAll food-producing species
Sodium chlorideAll food-producing species
Sodium cromoglycateAll food-producing species
Sodium dioctylsulphosuccinateAll food-producing species
Sodium formaldehydesulphoxylateAll food-producing species
Sodium lauryl sulphateAll food-producing species
Sodium pyrosulphiteAll food-producing species
Sodium stearateAll food-producing species
Sodium thiosulphateAll food-producing species
TragacanthAll food-producing species
UreaAll food-producing species
Zinc oxideAll food-producing species
Zinc sulphateAll food-producing species
Adenosine and its 5′-mono-, 5′-di- and 5′-triphosphatesAll food producing species
AlanineAll food producing species
ArginineAll food producing species
AsparagineAll food producing species
Aspartic acidAll food producing species
CarnitineAll food producing species
CholineAll food producing species
ChymotrypsinAll food producing species
CitrullineAll food producing species
CysteineAll food producing species
Cytidine and its 5′-mono-, 5′-di- and 5′-triphosphatesAll food producing species
Glutamic acidAll food producing species
GlutamineAll food producing species
GlycineAll food producing species
Guanosine and its 5′-mono-, 5′-di- and 5′-triphosphatesAll food producing species
HistidineAll food producing species
Hyaluronic acidAll food producing species
Inosine and its 5′-mono-, 5′-di- and 5′-triphosphatesAll food producing species
InositolAll food producing species
IsoleucineAll food producing species
LeucineAll food producing species
LysineAll food producing species
MethionineAll food producing species
OrnithineAll food producing species
Orotic acidAll food producing species
PepsinAll food producing species
PhenylalanineAll food producing species
ProlineAll food producing species
SerineAll food producing species
Thioctic acidAll food producing species
ThreonineAll food producing species
ThymidineAll food producing species
TrypsinAll food producing species
TryptophanAll food producing species
TyrosineAll food producing species
Uridine and its 5′-mono-, 5′-di- and 5′-triphosphatesAll food producing species
ValineAll food producing species
4.Substances used in homeopathic veterinary medicinal products
Pharmacologically active substance(s)Animal speciesOther provisions
All substances used in homeopathic veterinary medicinal products provided that their concentration in the product does not exceed one part per ten thousandAll food-producing species
Adonis vernalisAll food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only
Acqua leviciAll food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias only
Atropa belladonnaAll food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only
Convallaria majalisAll food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only
Apocynum cannabinumAll food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred onlyFor oral use only
Harunga madagascariensisAll food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only
Selenicereus grandiflorusAll food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only
Thuja occidentalisAll food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only
Virola sebiferaAll food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only
Ruta graveolensAll food-producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only.Not for use in animals from which milk is produced for human consumption
Aesculus hippocastanumAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per ten only
Agnus castusAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Ailanthus altissimaAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Allium cepaAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Arnicae radixAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only
Artemisia abrotanumAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Bellis perennisAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Calendula officinalisAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only
CamphoraAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per hundred only.
Cardiospermum halicacabumAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
CrataegusAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
EchinaceaAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof onlyFor topical use only.For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only
Eucalyptus globulusAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Euphrasia officinalisAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Ginkgo bilobaAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per thousand only.
GinsengAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Hamamelis virginianaAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per ten only
Harpagophytum procumbensAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Hypericum perforatumAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Lachnanthes tinctoriaAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per thousand only.
Lobaria pulmonariaAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Okoubaka aubrevilleiAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Prunus laurocerasusAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per thousand only.
Serenoa repensAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Silybum marianumAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Solidago virgaureaAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Syzygium cuminiAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Turnera diffusaAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Viscum albumAll-food producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only
Phytolacca americanaAll food-producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only
Urginea maritimaAll food-producing speciesFor use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred onlyFor oral use only
5.Substances used as food additives in foodstuffs for human consumption
Pharmacologically active substance(s)Animal speciesOther provisions
Substances with an E numberAll food-producing speciesOnly substances approved as additives in foodstuffs for human consumption, with the exception of preservatives listed in part C of Annex III to European Parliament and Council Directive 95/2/EC (OJ L 61, 18.3.1995, p. 1).
6.Substances of vegetable origin
Pharmacologically active substance(s)Animal speciesOther provisions
Aloe vera gel and whole leaf extract of Aloe veraAll food-producing speciesFor topical use only
Aloes, Barbados and Capae, their standardised dry extract and preparations thereofAll food-producing species
Angelicae radix aetheroleumAll food-producing species
Anisi aetheroleumAll food-producing species
Anisi stellati fructus, standardised extracts and preparations thereofAll food producing species
Arnica montana (arnicae flos and arnicae planta tota)All food-producing speciesFor topical use only
Balsamum peruvianumAll food-producing speciesFor topical use only
Boldo foliumAll food-producing species
Calendulae flosAll food-producing speciesFor topical use only
Capsici fructus acerAll food-producing species
Carlinae radixAll food-producing speciesFor topical use only
Carvi aetheroleumAll food-producing species
Caryophylli aetheroleumAll food-producing species
Centellae asiaticaer extractumAll food producing speciesFor topical use only
Chrysanthemi cinerariifolii flosAll food-producing speciesFor topical use only
Cimicifugae racemosae rhizomaAll food-producing speciesNot for use in animals from which milk is produced for human consumptiom
Cinchonae cortex, standardised extracts and preparations thereofAll food producing species
Cinnamomi cassiae aetheroleumAll food-producing species
Cinnamomi cassiae cortex, standardised extracts and preparations thereofAll food producing species
Cinnamomi ceylanici aetheroleumAll food-producing species
Cinnamomi ceylanici cortex, standardised extracts and preparations thereofAll food producing species
Citri aetheroleumAll food-producing species
Citronellae aetheroleumAll food-producing species
Condurango cortex, standardised extracts and preparations thereofAll food producing species
Coriandri aetheroleumAll food-producing species
Cupressi aetheroleumAll food-producing speciesFor topical use only
Echinacea purpureaAll food-producing speciesFor topical use only
Eucalypti aetheroleumAll food-producing species
Foeniculi aetheroleumAll food-producing species
Frangulae cortex, standardised extracts and preparations thereofAll food producing species
Gentianae radix, standardised extracts and preparations thereofAll food producing species
Hamamelis virginianaAll food-producing speciesFor topical use only
Hippocastani semenAll food-producing speciesFor topical use only
Hyperici oleumAll food-producing speciesFor topical use only
Juniperi fructusAll food-producing species
Lauri folii aetheroleumAll food-producing species
Lauri fructusAll food-producing species
Lavandulae aetheroleumAll food-producing speciesFor topical use only
Lespedeza capitataAll food-producing species
Lini oleumAll food-producing species
Majoranae herbaAll food-producing species
Matricaria recutita and preparations thereofAll food producing species
Matricariae flosAll food-producing species
Medicago sativa extractumAll food-producing speciesFor topical use only
Melissae aetheroleumAll food producing species
Melissae foliumAll food-producing species
Menthae arvensis aetheroleumAll food-producing species
Menthae piperitae aetheroleumAll food-producing species
Millefolii herbaAll food-producing species
Myristicae aetheroleumAll food-producing speciesFor use in newborn animals only
Oxidation products of Terebinthinae oleumBovine, porcine, ovine, caprine
Pyrethrum extractAll food-producing speciesFor topical use only
Quercus cortexAll food-producing species
Quillaia saponinsAll food-producing species
Rhei radix, standardised extracts and preparations thereofAll food producing species
Ricini oleumAll food-producing speciesFor use as excipient
Rosmarini aetheroleumAll food-producing species
Rosmarini foliumAll food-producing species
Ruscus aculeatusAll food-producing speciesFor topical use only
Salviae foliumAll food-producing species
Sambuci flosAll food-producing species
Sinapis nigrae semenAll food-producing species
Strychni semenBovine, ovine, caprineFor oral use only at doses up to the equivalent of 0,1 mg strychnine/kg bw
Symphyti radixAll food-producing speciesFor topical use on intact skin only
Terebinthinae aetheroleum rectificatumAll food-producing speciesFor topical use only
Terebinthinae laricinaAll food-producing speciesFor topical use only
Thymi aetheroleumAll food-producing species
Tiliae flosAll food-producing species
Urticae herbaAll food-producing species
7.Anti-infectious agents
Pharmacologically active substance(s)Animal speciesOther provisions
Oxalic acidHoney bees
ANNEX IIILIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VETERINARY MEDICINAL PRODUCTS FOR WHICH PROVISIONAL MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED1.Anti-infectious agents1.1.Chemotheurapeutics1.1.2.Benzenesulphonamides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ClorsulonClorsulonBovine50 μg/kgMuscleProvisional MRLs expire on 1 January 2000
150 μg/kgLiver
400 μg/kgKidney
1.2.Antibiotics1.2.1.Beta-lactamase inhibitors
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
Clavulanic acidClavulanic acidBovine, ovine200 μg/kgMilkProvisional MRLs expire on 1 July 2001
Bovine, ovine, porcine200 μg/kgMuscle
200 μg/kgFat
200 μg/kgLiver
200 μg/kgKidney
1.2.2.Macrolides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AcetylisovaleryltylosinSum of acetylisovaleryltylosin and 3-O-acetyltylosinPorcine100 μg/kgMuscleProvisional MRLs expire on 1.7.2001
100 μg/kgSkin and fat
100 μg/kgLiver
100 μg/kgKidney
ErythromycinMRLs apply to all microbiological active residues expressed as erythromycin equivalentBovine, ovine40 μg/kgMilkProvisional MRLs expire on 1 June 2000
Bovine, ovine, porcine, poultry400 μg/kgMuscle
400 μg/kgFat
400 μg/kgLiver
400 μg/kgKidney
Poultry200 μg/kgEggs
JosamycinJosamycinChicken200 μg/kgMuscleProvisional MRLs expire on 1.7.2002
200 μg/kgFat
200 μg/kgLiver
400 μg/kgKidney
200 μg/kgEggs
Sum of the microbiologically active metabolites, expressed as josamycinPorcine200 μg/kgMuscleProvisional MRLs expire on 1.7.2002
200 μg/kgSkin and fat
200 μg/kgLiver
400 μg/kgKidney
TilmicosinTilmicosinBovine40 μg/kgMilkProvisional MRLs expire on 1.1.2001
Tulathromycin(2R,3S,4R,5R,8R,10R,11R,12S, 13S,14R)-2- ethyl-3,4,10,13-tetrahydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa- 6-azacyclopent-decan-15-one expressed as tulathromycin equivalentsBovine100 μg/kgFatProvisional MRLs expire on 1 July 2004; not for use in animals from which milk is produced for human consumption
3000 μg/kgLiver
3000 μg/kgKidney
Porcine100 μg/kgSkin and fatProvisional MRLs expire on 1 July 2004
3000 μg/kgLiver
3000 μg/kgKidney
1.2.4.Cephalosporins
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CefacetrileCefacetrileBovine125 μg/kgMilkProvisional MRLs expire on 1.1.2002For intrammamary use only
CefaloniumCefaloniumBovine10 μg/kgMilkProvisional MRLs expire on 1.1.2003
CefoperazoneCefoperazoneBovine50 μg/kgMilkProvisional MRLs expire on 1 January 2001
CefquinomeCefquinomePorcine50 μg/kgMuscleProvisional MRLs expire on 1.1.2000
50 μg/kgSkin + fat
100 μg/kgLiver
200 μg/kgKidney
CephapirinSum of cephapirin and desacetylcephapirinBovine50 μg/kgMuscleProvisional MRLs expire on 1.1.2001
50 μg/kgFat
50 μg/kgLiver
100 μg/kgKidney
10 μg/kgMilk
1.2.5.Aminoglycosides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AminosidineAminosidineBovine, porcine, rabbits, chicken500 μg/kgMuscleProvisional MRLs expire on 1 July 2000
1500 μg/kgLiver
1500 μg/kgKidney
ApramycinApramycinBovine1000 μg/kgMuscleProvisional MRLs expire on 1 July 1999
For use in non-lactating cattle only1000 μg/kgFat
10000 μg/kgLiver
20000 μg/kgKidney
Porcine1000 μg/kgMuscle
1000 μg/kgSkin and fat
1000 μg/kgLiver
5000 μg/kgKidney
DihydrostreptomycinDihydrostreptomycinBovine, ovine500 μg/kgMuscleProvisional MRLs expire on 1.6.2002
500 μg/kgFat
500 μg/kgLiver
1000 μg/kgKidney
200 μg/kgMilk
Porcine500 μg/kgMuscle
500 μg/kgSkin and fat
500 μg/kgLiver
1000 μg/kgKidney
GentamicinGentamicinBovine100 μg/kgMilkProvisional MRLs expire on 1.6.2002
Bovine, porcine50 μg/kgMuscle
50 μg/kgFat
200 μg/kgLiver
750 μg/kgKidney
KanamycinKanamycinRabbits100 μg/kgMuscleProvisional MRLs expire on 1.1.2004
100 μg/kgFat
600 μg/kgLiver
2500 μg/kgKidney
Bovine, ovine100 μg/kgMuscle
100 μg/kgFat
600 μg/kgLiver
2500 μg/kgKidney
150 μg/kgMilk
Porcine, chicken100 μg/kgMuscle
100 μg/kgSkin + fat
600 μg/kgLiver
2500 μg/kgKidney
Neomycin (including framycetin)Neomycin BBovine, porcine, chicken500 μg/kgMuscleProvisional MRLs expire on 1.6.2002
500 μg/kgFat
500 μg/kgLiver
5000 μg/kgKidney
Bovine500 μg/kgMilk
Chicken500 μg/kgEggs
SpectinomycinSpectinomycinBovine200 μg/kgMilkProvisional MRLs expire on 1 July 2000
Bovine, porcine, poultry300 μg/kgMuscle
500 μg/kgFat
2000 μg/kgLiver
5000 μg/kgKidney
OvineNot for use in animals from which milk is produced for human consumption300 μg/kgMuscleProvisional MRLs expire on 1.1.2002
500 μg/kgFat
2000 μg/kgLiver
5000 μg/kgKidney
Chicken200 μg/kgEggs
StreptomycinStreptomycinBovine, ovine500 μg/kgMuscleProvisional MRLs expire on 1.6.2002
500 μg/kgFat
500 μg/kgLiver
1000 μg/kgKidney
200 μg/kgMilk
Porcine500 μg/kgMuscle
500 μg/kgSkin and fat
500 μg/kgLiver
1000 μg/kgKidney
1.2.6.Quinolones
Provisional MRLs expire 1 January 2006.Not for use in animals from which milk is produced for human consumption.
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
DanofloxacinDanofloxacinPorcine100 μg/kgMuscleProvisional MRLs expire on 1.1.2000
50 μg/kgSkin and fat
200 μg/kgLiver
200 μg/kgKidney
DecoquinateDecoquinateBovine, ovine500 μg/kgMuscleProvisional MRLs expire on 1 July 2000
500 μg/kgFat
500 μg/kgLiver
500 μg/kgKidney
DifloxacinDifloxacinBovineNot for use in animals from which milk is produced for human consumption400 μg/kgMuscleProvisional MRLs expire on 1.1.2001
100 μg/kgFat
1400 μg/kgLiver
800 μg/kgKidney
Porcine400 μg/kgMuscle
100 μg/kgSkin and fat
800 μg/kgLiver
800 μg/kgKidney
EnrofloxacinSum of enrofloxacin and ciprofloxacinOvine100 μg/kgMuscleProvisional MRLs expire on 1 July 1999
100 μg/kgFat
300 μg/kgLiver
200 μg/kgKidney
FlumequineFlumequineBovine, ovine, porcine, chicken50 μg/kgMuscleProvisional MRLs expire on 1 January 2000
50 μg/kgFat or skin and fat
100 μg/kgLiver
300 μg/kgKidney
Salmonidae150 μg/kgMuscle and skin
MarbofloxacinMarbofloxacinBovine150 μg/kgMuscleProvisional MRLs expire on 1 July 2000
50 μg/kgFat
150 μg/kgLiver
150 μg/kgKidney
75 μg/kgMilk
Porcine150 μg/kgMuscle
50 μg/kgSkin and fat
150 μg/kgLiver
150 μg/kgKidney
Oxolinic acidOxolinic acidBovine100 µg/kgMuscle
50 µg/kgFat
150 µg/kgLiver
150 µg/kgKidney
Porcine100 μg/kgMuscle
50 μg/kgSkin + fat
150 μg/kgLiver
150 μg/kgKidney
Chicken100 μg/kgMuscle
50 μg/kgSkin + fat
150 μg/kgLiver
150 μg/kgKidney
50 μg/kgEggs
Fin fish300 μg/kgMuscle and skin in natural proportions
1.2.9.Polymyxins
Phamarcologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ColistinColistinBovine, ovine50 μg/kgMilkProvisional MRLs expire on 1.7.2002
Bovine, ovine, porcine, chicken, rabbits150 μg/kgMuscle
150 μg/kgFat
150 μg/kgLiver
200 μg/kgKidney
Chicken300 μg/kgEggs
1.2.10.Penicillins
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
NafcillinNafcillinBovine300 μg/kgMuscleProvisional MRLs expire on 1.1.2001
300 μg/kgFat
300 μg/kgLiver
300 μg/kgKidney
30 μg/kgMilk
PenethamateBenzylpenicillinOvine50 μg/kgMuscleProvisional MRLs expire on 1 January 2000
50 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
4 μg/kgMilk
Porcine50 μg/kgMuscle
50 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
1.2.11.Florfenicol and related compounds
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
FlorfenicolSum of florfenicol and its metabolites measured as florfenicol-amineFish1000 μg/kgMuscle and skin in natural proportionsProvisional MRLs expire on 1 July 2001
ThiamphenicolThiamphenicolOvine50 μg/kgMuscleProvisional MRLs expire on 1.1.2001
50 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
Porcine50 μg/kgMuscle
50 μg/kgSkin + fat
50 μg/kgLiver
50 μg/kgKidney
Fin fish50 μg/kgMuscle and skin in natural proportions
1.2.12.Polypeptides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
BacitracinBacitracinBovine150 μg/kgMilkProvisional MRLs expire on 1.7.2001
1.2.13.Lincosamides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
LincomycinLincomycinOvine100 μg/kgMuscleProvisional MRLs expire on 1.1.2001
50 μg/kgFat
500 μg/kgLiver
1500 μg/kgKidney
150 μg/kgMilk
Porcine100 μg/kgMuscle
50 μg/kgSkin + fat
500 μg/kgLiver
1500 μg/kgKidney
Chicken100 μg/kgMuscle
50 μg/kgSkin + fat
500 μg/kgLiver
1500 μg/kgKidney
50 μg/kgEggs
PirlimycinPirlimycinBovine100 μg/kgMuscleProvisional MRLs expire on 1.7.2000
100 μg/kgFat
1000 μg/kgLiver
400 μg/kgKidney
100 μg/kgMilk
1.2.14.Pleuromutilines
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
TiamulinSum of metabolites that may be hydrolysed to 8-a-hydroxymutilinTurkey100 μg/kgMuscleProvisional MRLs expire on 1.7.2001
100 μg/kgSkin and fat
300 μg/kgLiver
2.Antiparasitic agents2.1.Agents acting against endoparasites2.1.1.Phenol derivatives including salicylanides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
OxyclozanideOxyclozanideBovine20 μg/kgMuscleProvisional MRLs expire on 1.7.2002
20 μg/kgFat
500 μg/kgLiver
100 μg/kgKidney
10 μg/kgMilk
Ovine20 μg/kgMuscle
20 μg/kgFat
500 μg/kgLiver
100 μg/kgKidney
2.1.2.Benzimidazoles and pro-benzimidazoles
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
Albendazole sulphoxideSum of albendazole, albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazoleBovine, ovine100 μg/kgMilkProvisional MRLs expire on 1 January 2000
Bovine, ovine, pheasant100 μg/kgMuscle
100 μg/kgFat
1000 μg/kgLiver
500 μg/kgKidney
MebendazoleSum of mebendazole methyl (5-(1-hidroxy, 1-phenyl) methyl-1H-benzimidazol-2-yl) carbamate and (2-amino-1H-benzimidazol-5-yl) phenylmethanone, expressed as mebendazole equivalentsOvine, caprine, equidaeNot for use in animals from which milk is produced for human consumption60 μg/kgMuscleProvisional MRLs expire on 1.1.2002
60 μg/kgFat
400 μg/kgLiver
60 μg/kgKidney
NetobiminSum of netobimin and albendazole and metabolites of albendazole measured as 2-amino- benzimidazole sulphoneBovine, ovine, caprine100 μg/kgMuscleProvisional MRLs expire on 31 July 1999
100 μg/kgFat
1000 μg/kgLiver
500 μg/kgKidney
100 μg/kgMilk
2.1.3.Tetrahydropyrimides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
MorantelSum of residues which may be hydrolysed to N-Methyl-1,3-propanediamine and expressed as morantel equivalentsBovine, ovine100 μg/kgMuscleProvisional MRLs expire on 1.7.2003
100 μg/kgFat
800 μg/kgLiver
200 μg/kgKidney
100 μg/kgMilk
Porcine100 μg/kgMuscle
100 μg/kgSkin and fat
800 μg/kgLiver
200 μg/kgKidney
2.1.5.Piperazine derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
PiperazinePiperazinePorcine400 μg/kgMuscleProvisional MRLs expire on 1.7.2003
800 μg/kgSkin and fat
2000 μg/kgLiver
1000 μg/kgKidney
Chicken2000 μg/kgEggs
2.1.6.Salicylanilides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
RafoxanideRafoxanideBovineNot for use in animals from which milk is produced for human consumption30 μg/kgMuscleProvisional MRLs expire on 1.7.2001
30 μg/kgFat
10 μg/kgLiver
40 μg/kgKidney
OvineNot for use in animals from which milk is produced for human consumption100 μg/kgMuscle
250 μg/kgFat
150 μg/kgLiver
150 μg/kgKidney
2.2.Agents acting against ectoparasites2.2.1.Formamidines
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AmitrazSum of amitraz and all metabolites containing the 2,4-DMA moeity, expressed as amitrazBees200 μg/kgHoneyProvisional MRLs expire on 1 July 1999
2.2.2.Iminophenyl thiazolidine derivative
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CymiazoleCymiazoleBees1000 μg/kgHoneyProvisional MRLs expire on 1.7.2001
2.2.3.Pyretrin and pyrethroids
Provisional MRLs expire on 1 July 2006.
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CyfluthrinCyfluthrinBovine10 μg/kgMuscleProvisional MRLs expire on 1 January 2001
50 μg/kgFat
10 μg/kgLiver
10 μg/kgKidney
20 μg/kgMilk
Further provisions in Council Directive 94/29/EC are to be observed (OJ L 189, 23.7.1994, p. 67)
AlphacypermethrinCypermethrin (sum of isomers)Bovine, ovine20 μg/kgMuscleProvisional MRLs expire on 1.7.2003Further provisions in Directive 93/57/EC are to be observed
200 μg/kgFat
20 μg/kgLiver
20 μg/kgKidney
20 μg/kgMilkFurther provisions in Council Directive 93/57/EC (OJ L 211, 23.8.1992, p. 1) are to be observed
Chicken50 μg/kgMuscle
50 μg/kgSkin + fat
50 μg/kgLiver
50 μg/kgKidney
50 μg/kgEggs
CypermethrinCypermethrin (sum of isomers)Bovine20 μg/kgMuscleProvisional MRLs expire on 1.7.2003Further provisions in Directive 93/57/EC are to be observed
200 μg/kgFat
20 μg/kgLiver
20 μg/kgKidney
20 μg/kgMilk
Cypermethrin (sum of isomers)Ovine20 μg/kgMuscleProvisional MRLs expire on 1.7.2003Not for use in animals from which milk is produced for human consumption
200 μg/kgFat
20 μg/kgLiver
20 μg/kgKidney
Porcine20 μg/kgMuscle
200 μg/kgSkin + fat
20 μg/kgLiver
20 μg/kgKidney
Chicken50 μg/kgMuscle
50 μg/kgSkin + fat
50 μg/kgLiver
50 μg/kgKidney
50 μg/kgEggs
Salmonidae50 μg/kgMuscle and skin in natural proportionsProvisional MRLs expire on 1.7.2003
DeltamethrinDeltamethrinBovine10 μg/kgMuscleProvisional MRLs expire on 1 July 2001
50 μg/kgFat
10 μg/kgLiver
10 μg/kgKidney
20 μg/kgMilk
OvineNot for use in animals from which milk is produced for human consumption10 μg/kgMuscle
50 μg/kgFat
10 μg/kgLiver
10 μg/kgKidney
Chicken10 μg/kgMuscleProvisional MRLs expire on 1.7.2003
50 μg/kgSkin + fat
10 μg/kgLiver
10 μg/kgKidney
50 μg/kgEggs
Fin fish10 μg/kgMuscle and skin in natural proportionsProvisional MRLs expire on 1.1.2002
FenvalerateFenvalerate (sum of RR, SS, RS and SR isomers)Bovine25 μg/kgMuscle
250 μg/kgFat
25 μg/kgLiver
25 μg/kgKidney
40 μg/kgMilk
PermethrinPermethrin (sum of isomers)Chicken, porcine50 μg/kgMuscleProvisional MRLs expire on 1.1.2003
500 μg/kgSkin and fat
50 μg/kgLiver
50 μg/kgKidney
Bovine, caprine50 μg/kgMuscleProvisional MRLs expire on 1.1.2003
500 μg/kgFat
50 μg/kgLiver
50 μg/kgKidney
50 μg/kgMilkFurther provisions in Commission Directive 98/82/EC are to be observed (OJ L 290, 29.10.1998, p. 25)
Chicken50 μg/kgEggsProvisional MRLs expire on 1.1.2003
2.2.4.Organophosphates
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AzamethiphosAzamethiphosSalmonidae100 μg/kgMuscle and skin in natural proportionsProvisional MRLs expire on 1 June 1999
CoumafosCoumafosBees100 μg/kgHoneyProvisional MRLs expire on 1.7.2001
PhoximPhoximPorcine20 μg/kgMuscleProvisional MRLs expire on 1 January 2001
700 μg/kgSkin and fat
20 μg/kgLiver
20 μg/kgKidney
Ovine50 μg/kgMuscleProvisional MRLs expire on 1.7.2001; not for use in animals from which milk is produced for human consumption
400 μg/kgFat
50 μg/kgKidney
Chicken50 μg/kgMuscleProvisional MRLs expire on 1.7.2005.
550 μg/kgSkin and fat
25 μg/kgLiver
50 μg/kgKidney
60 μg/kgEggs
PropetamphosSum of residues of propetamphos and desisopropyl-propetamphosOvineNot for use in animals from which milk is produced for human consumption90 μg/kgFatProvisional MRLs expire on 1.1.2001
90 μg/kgKidney
2.2.5.Acyl urea derivates
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
TeflubenzuronTeflubenzuronSalmonidae500 μg/kgMuscle and skin in natural proportionsProvisional MRLs expire on 1 July 1999
DiflubenzuronDiflubenzuronSalmonidae1000 μg/kgMuscle and skin in natural proportionsProvisional MRLs expire on 1.7.2000
2.2.6.Pyrimidines derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
DicyclanilSum of dicyclanil and 2,4,6-triamino-pyrimidine-5-carbonitrileOvine200 μg/kgMuscleProvisional MRLs expire on 1 July 2000;Not for use in animals from which milk is produced for human consumption
50 μg/kgFat
400 μg/kgLiver
400 μg/kgKidney
2.2.7.Triazine derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CyromazineCyromazineOvine300 μg/kgMuscleProvisional MRLs expire on 1.7.2001Not for use in animals from which milk is produced for human consumption
300 μg/kgFat
300 μg/kgLiver
300 μg/kgKidney
2.3.Agents acting against endo- and ectoparasites2.3.1.Avermectins
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AbamectinAvermectin B1aOvine20 μg/kgMuscleProvisional MRLs expire on 1.1.2001
50 μg/kgFat
25 μg/kgLiver
20 μg/kgKidney
DoramectinDoramectinDeer, inclusing reindeer20 μg/kgMuscleProvisional MRLs expire on 1.7.2001
100 μg/kgFat
50 μg/kgLiver
30 μg/kgKidney
MoxidectinMoxidectinEquidae50 μg/kgMuscleProvisional MRLs expire on 1 January 2000
500 μg/kgFat
100 μg/kgLiver
50 μg/kgKidney
2.4.Agents acting against protozoa2.4.1.Carbanilides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ImidocarbImidocarbBovine, ovine300 μg/kgMuscleProvisonal MRLs expire on 1.1.2002
50 μg/kgFat
2000 μg/kgLiver
1500 μg/kgKidney
50 μg/kgMilk
2.4.2.Quinazolone derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
HalofuginoneHalofuginoneBovine10 μg/kgMuscleProvisional MRL's expire on 1.1.2001
25 μg/kgFat
30 μg/kgLiver
30 μg/kgKidney
2.4.3.Triazinetrione derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
ToltrazurilToltrazuril sulfonePorcine100 μg/kgMuscleProvisional MRLs expire on 1.1.2001
150 μg/kgSkin and fat
500 μg/kgLiver
250 μg/kgKidney
2.4.4.Other anti-protozoal agents
Pharmacologically active substance(s)Marker residueAnimal speciesMRLTarget tissuesOther provisions
AmproliumAmproliumChicken, turkey200 μg/kgMuscleProvisional MRLs expire on 1.1.2002
200 μg/kgSkin and fat
200 μg/kgLiver
400 μg/kgKidney
1000 μg/kgEggs
3.Agents acting on the nervous system3.2.Agents acting on the autonomic nervous system3.2.1.β 2 sympathomimetic agents
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
Clenbuterol hydrochlorideClenbuterolBovine0,1 μg/kgMuscleProvisional MRLs expire on 1 July 2000
Indication: solely for tocolysis in parturient cows0,5 μg/kgLiver
0,5 μg/kgKidney
0,05 μg/kgMilk
Equidae0,1 μg/kgMuscle
Indications: tocolysis and the treatment of respiratory ailments0,5 μg/kgLiver
0,5 μg/kgKidney
3.2.2.Anti-adrenergics
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CarazololCarazololBovine5 μg/kgMuscleProvisional MRLs expire on 1.1.2000
5 μg/kgFat
15 μg/kgLiver
15 μg/kgKidney
1 μg/kgMilk
5.Anti-inflammatory agents5.1.Nonsteroidal anti-inflammatory agents5.1.1.Arylpropionic acid derivative
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
CarprofenCarprofenBovine500 μg/kgMuscleProvisional MRLs expire on 1 January 2000
500 μg/kgFat
1000 μg/kgLiver
1000 μg/kgKidney
Equidae50 μg/kgMuscle
100 μg/kgFat
1000 μg/kgLiver
1000 μg/kgKidney
5.1.2.Enolic acid derivates
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
MeloxicamMeloxicamBovine25 μg/kgMuscleProvisional MRLs expire on 1 January 2000
60 μg/kgLiver
35 μg/kgKidney
5.1.3.Pyrazolone derivatives
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
Metamizole4-MethylaminoantipyrinBovine, porcine, equidae200 μg/kgMuscleProvisional MRLs expire on 1.7.2003.Not for use in animals from which milk is produced for human consumption
200 μg/kgFat
200 μg/kgLiver
200 μg/kgKidney
6.Agents acting on the reproductive system6.1.Progestogens
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
AltrenogestAltrenogestPorcine3 μg/kgSkin and fatProvisional MRLs expire on 1.1.2005; for zootechnical use only
3 μg/kgLiver
3 μg/kgKidney
Equidae3 μg/kgFat
3 μg/kgLiver
3 μg/kgKidney
Flugestone acetateFlugestone acetateOvine, caprine0,5 μg/kgMuscleProvisional MRLs expire on 1.1.2008; for therapeutic or zootechnical use only
0,5 μg/kgFat
0,5 μg/kgLiver
0,5 μg/kgKidney
NorgestometNorgestometBovine0,5 μg/kgMuscleProvisional MRLs expire on 1.1.2008; for therapeutic or zootechnical use only
0,5 μg/kgFat
0,5 μg/kgLiver
0,5 μg/kgKidney
0,15 μg/kgMilk
7.Corticoids7.1.Glucocorticoids
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
MethylprednisoloneMethylprednisoloneBovine10 μg/kgMuscleProvisional MRLs expire on 1.7.2001. Not for use in animals from which milk is produced for human consumption
10 μg/kgFat
10 μg/kgLiver
10 μg/kgKidney
ANNEX IVLIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH NO MAXIMUM LEVELS CAN BE FIXED
Pharmacologically active substance(s)
Aristolochia spp. and preparations thereof
Chloramphenicol
Chloroform
Chlorpromazine
Colchicine
Dapsone
Dimetridazole
Metronidazole
Nitrofurans (including furazolidone)
Ronidazole
ANNEX VInformation and particulars to be included in an application for the establishment of a maximum residue limit for a pharmacologically active substance used in veterinary medicinal productsAdministrative particulars1Name or corporate name and permanent address of the applicant.2Name of the veterinary medicinal product.3Qualitative and quantitative composition in terms of active principles, with mention of the international non-proprietary name recommended by the World Health Organization, where such name exists.4Manufacturing authorization, if any.5Marketing authorization, if any.6Summary of the characteristics of the veterinary medicinal product(s) prepared in accordance with Article 5a of Directive 81/851/EEC.A.Safety documentationA.0.Expert reportA.1.Precise identification of the substance concerned by the application1.1International non-proprietary name (INN).1.2International Union of Pure and Applied Chemistry (IUPAC) name.1.3Chemical Abstract Service (CAS) name.1.4Classification:therapeutic;pharmacological.1.5Synonyms and abbreviations.1.6Structural formula.1.7Molecular formula.1.8Molecular weight.1.9Degree of impurity.1.10Qualitative and quantitative composition of impurities.1.11Description of physical properties:melting point;boiling point;vapour pressure;solubility in water and organic solvents, expressed in grams per litre, with indication of temperature;density;refractive index, rotation, etc.A.2.Relevant pharmacological studies2.1Pharmacodynamics.2.2Pharmacokinetics.A.3.Toxicological studies3.1Single dose toxicity.3.2Repeated dose toxicity.3.3Tolerance in the target species of animal.3.4Reproductive toxicity, including teratogenicity.3.4.1Study of the effects on reproduction.3.4.2Embryotoxicity/fetotoxicity, including teratogenicity.3.5Mutagenicity.3.6Carcinogenicity.A.4.Studies of other effects4.1Immunotoxicity.4.2Microbiological properties of residues.4.2.1On the human gut flora;4.2.2On the organisms and microorganisms used for industrial food-processing.4.3Observations in humans.B.Residue documentationB.0Expert reportB.1.Precise identification of the substance concerned by the applicationThe substance concerned should be identified in accordance with point A.1. However, where the application relates to one or more veterinary medicinal products, the product itself should be identified in detail, including:qualitative and quantitative composition;purity;identification of the manufacturer's batch used in the studies; relationship to the final product;specific activity and radio-purity of labelled substances;position of labelled atoms on the molecule.B.2.Residue studies2.1Pharmacokinetics(absorption, distribution, biotransformation, excretion).2.2Depletion of residues.2.3Elaboration of maximum residue limits (MRLS).B3.Routine analytical method for the detection of residues3.1Description of the method.3.2Validation of the method.3.2.1specificity;3.2.2accuracy, including sensitivity;3.2.3precision;3.2.4limit of detection;3.2.5limit of quantitation;3.2.6practicability and applicability under normal laboratory conditions;3.2.7susceptibility to interference.