This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL REGULATION (EEC) No 2377/90
of 26 June 1990
laying down a Community procedure for the establishment of maximum residue limits ofveterinary medicinal products in foodstuffs of animal origin
(OJ L 224, 18.8.1990, p. 1)
Amended by:
Official Journal
No page date
►M1 Commission Regulation (EEC) No 675/92 of 18 March 1992 L 73 8 19.3.1992
►M2 Commission Regulation (EEC) No 762/92 of 27 March 1992 L 83 14 28.3.1992
►M3 Commission Regulation (EEC) No 3093/92 of 27 October 1992 L 311 18 28.10.1992
►M4 Commission Regulation (EEC) No 895/93 of 16 April 1993 L 93 10 17.4.1993
►M5 Council Regulation (EEC) No 2901/93 of 18 October 1993 L 264 1 23.10.1993
►M6 Commission Regulation (EC) No 3425/93 of 14 December 1993 L 312 12 15.12.1993
►M7 Commission Regulation (EC) No 3426/93 of 14 December 1993 L 312 15 15.12.1993
►M8 Commission Regulation (EC) No 955/94 of 28 April 1994 L 108 8 29.4.1994
►M9 Commission Regulation (EC) No 1430/94 of 22 June 1994 L 156 6 23.6.1994
►M10 Commission Regulation (EC) No 2701/94 of 7 November 1994 L 287 7 8.11.1994
►M11 Commission Regulation (EC) No 2703/94 of 7 November 1994 L 287 19 8.11.1994
►M12 Commission Regulation (EC) No 3059/94 of 15 December 1994 L 323 15 16.12.1994
►M13 Commission Regulation (EC) No 1102/95 of 16 May 1995 L 110 9 17.5.1995
►M14 Commission Regulation (EC) No 1441/95 of 26 June 1995 L 143 22 27.6.1995
►M15 Commission Regulation (EC) No 1442/95 of 26 June 1995 L 143 26 27.6.1995
►M16 Commission Regulation (EC) No 1798/95 of 25 July 1995 L 174 20 26.7.1995
►M17 Commission Regulation (EC) No 2796/95 of 4 December 1995 L 290 1 5.12.1995
►M18 Commission Regulation (EC) No 2804/95 of 5 December 1995 L 291 8 6.12.1995
►M19 Commission Regulation (EC) No 281/96 of 14 February 1996 L 37 9 15.2.1996
►M20 Commission Regulation (EC) No 282/96 of 14 February 1996 L 37 12 15.2.1996
►M21 Commission Regulation (EC) No 1140/96 of 25 June 1996 L 151 6 26.6.1996
►M22 Commission Regulation (EC) No 1147/96 of 25 June 1996 L 151 26 26.6.1996
►M23 Commission Regulation (EC) No 1311/96 of 8 July 1996 L 170 4 9.7.1996
►M24 Commission Regulation (EC) No 1312/96 of 8 July 1996 L 170 8 9.7.1996
►M25 Commission Regulation (EC) No 1433/96 of 23 July 1996 L 184 21 24.7.1996
►M26 Commission Regulation (EC) No 1742/96 of 6 September 1996 L 226 5 7.9.1996
►M27 Commission Regulation (EC) No 1798/96 of 17 September 1996 L 236 23 18.9.1996
►M28 Commission Regulation (EC) No 2010/96 of 21 October 1996 L 269 5 22.10.1996
►M29 Commission Regulation (EC) No 2017/96 of 22 October 1996 L 270 2 23.10.1996
►M30 Commission Regulation (EC) No 2034/96 of 24 October 1996 L 272 2 25.10.1996
►M31 Commission Regulation (EC) No 17/97 of 8 January 1997 L 5 12 9.1.1997
►M32 Commission Regulation (EC) No 211/97 of 4 February 1997 L 35 1 5.2.1997
►M33 Commission Regulation (EC) No 270/97 of 14 February 1997 L 45 8 15.2.1997
1990R2377— EN— 16.08.2008 — 058.002— 1
►M34 Council Regulation (EC) No 434/97 of 3 March 1997 L 67 1 7.3.1997
►M35 Commission Regulation (EC) No 716/97 of 23 April 1997 L 106 10 24.4.1997
►M36 Commission Regulation (EC) No 748/97 of 25 April 1997 L 110 21 26.4.1997
►M37 Commission Regulation (EC) No 749/97 of 25 April 1997 L 110 24 26.4.1997
►M38 Commission Regulation (EC) No 1836/97 of 24 September 1997 L 263 6 25.9.1997
►M39 Commission Regulation (EC) No 1837/97 of 24 September 1997 L 263 9 25.9.1997
►M40 Commission Regulation (EC) No 1838/97 of 24 September 1997 L 263 14 25.9.1997
►M41 Commission Regulation (EC) No 1850/97 of 25 September 1997 L 264 12 26.9.1997
►M42 Commission Regulation (EC) No 121/98 of 16 January 1998 L 11 11 17.1.1998
►M43 Commission Regulation (EC) No 426/98 of 23 February 1998 L 53 3 24.2.1998
►M44 Commission Regulation (EC) No 613/98 of 18 March 1998 L 82 14 19.3.1998
►M45 Commission Regulation (EC) No 1000/98 of 13 May 1998 L 142 18 14.5.1998
►M46 Commission Regulation (EC) No 1076/98 of 27 May 1998 L 154 14 28.5.1998
►M47 Commission Regulation (EC) No 1191/98 of 9 June 1998 L 165 6 10.6.1998
►M48 Commission Regulation (EC) No 1568/98 of 17 July 1998 L 205 1 22.7.1998
►M49 Commission Regulation (EC) No 1569/98 of 17 July 1998 L 205 7 22.7.1998
►M50 Commission Regulation (EC) No 1570/98 of 17 July 1998 L 205 10 22.7.1998
►M51 Commission Regulation (EC) No 1916/98 of 9 September 1998 L 250 8 10.9.1998
►M52 Commission Regulation (EC) No 1917/98 of 9 September 1998 L 250 13 10.9.1998
►M53 Commission Regulation (EC) No 1958/98 of 15 September 1998 L 254 7 16.9.1998
►M54 Commission Regulation (EC) No 2560/98 of 27 November 1998 L 320 28 28.11.1998
►M55 Commission Regulation (EC) No 2686/98 of 11 December 1998 L 337 20 12.12.1998
►M56 Commission Regulation (EC) No 2692/98 of 14 December 1998 L 338 5 15.12.1998
►M57 Commission Regulation (EC) No 2728/98 of 17 December 1998 L 343 8 18.12.1998
►M58 Commission Regulation (EC) No 508/1999 of 4 March 1999 L 60 16 9.3.1999
►M59 Commission Regulation (EC) No 804/1999 of 16 April 1999 L 102 58 17.4.1999
►M60 Commission Regulation (EC) No 953/1999 of 5 May 1999 L 118 23 6.5.1999
►M61 Commission Regulation (EC) No 954/1999 of 5 May 1999 L 118 28 6.5.1999
►M62 Commission Regulation (EC) No 997/1999 of 11 May 1999 L 122 24 12.5.1999
►M63 Commission Regulation (EC) No 998/1999 of 11 May 1999 L 122 30 12.5.1999
►M64 Council Regulation (EC) No 1308/1999 of 15 June 1999 L 156 1 23.6.1999
►M65 Commission Regulation (EC) No 1931/1999 of 9 September 1999 L 240 3 10.9.1999
►M66 Commission Regulation (EC) No 1942/1999 of 10 September 1999 L 241 4 11.9.1999
►M67 Commission Regulation (EC) No 1943/1999 of 10 September 1999 L 241 9 11.9.1999
►M68 Commission Regulation (EC) No 2385/1999 of 10 November 1999 L 288 14 11.11.1999
►M69 Commission Regulation (EC) No 2393/1999 of 11 November 1999 L 290 5 12.11.1999
►M70 Commission Regulation (EC) No 2593/1999 of 8 December 1999 L 315 26 9.12.1999
►M71 Commission Regulation (EC) No 2728/1999 of 20 December 1999 L 328 23 22.12.1999
►M72 Commission Regulation (EC) No 2757/1999 of 22 December 1999 L 331 45 23.12.1999
►M73 Commission Regulation (EC) No 2758/1999 of 22 December 1999 L 331 49 23.12.1999
►M74 Commission Regulation (EC) No 1286/2000 of 19 June 2000 L 145 15 20.6.2000
►M75 Commission Regulation (EC) No 1295/2000 of 20 June 2000 L 146 11 21.6.2000
►M76 Commission Regulation (EC) No 1960/2000 of 15 September 2000 L 234 5 16.9.2000
►M77 Commission Regulation (EC) No 2338/2000 of 20 October 2000 L 269 21 21.10.2000
►M78 Commission Regulation (EC) No 2391/2000 of 27 October 2000 L 276 5 28.10.2000
►M79 Commission Regulation (EC) No 2535/2000 of 17 November 2000 L 291 9 18.11.2000
►M80 Commission Regulation (EC) No 2908/2000 of 29 December 2000 L 336 72 30.12.2000
►M81 Commission Regulation (EC) No 749/2001 of 18 April 2001 L 109 32 19.4.2001
►M82 Commission Regulation (EC) No 750/2001 of 18 April 2001 L 109 35 19.4.2001
►M83 Commission Regulation (EC) No 807/2001 of 25 April 2001 L 118 6 27.4.2001
►M84 Commission Regulation (EC) No 1274/2001 of 27 June 2001 L 175 14 28.6.2001
1990R2377— EN— 16.08.2008 — 058.002— 2
►M85 Commission Regulation (EC) No 1322/2001 of 29 June 2001 L 177 52 30.6.2001
►M86 Commission Regulation (EC) No 1478/2001 of 18 July 2001 L 195 32 19.7.2001
►M87 Commission Regulation (EC) No 1553/2001 of 30 July 2001 L 205 16 31.7.2001
►M88 Commission Regulation (EC) No 1680/2001 of 22 August 2001 L 227 33 23.8.2001
►M89 Commission Regulation (EC) No 1815/2001 of 14 September 2001 L 246 11 15.9.2001
►M90 Commission Regulation (EC) No 1879/2001 of 26 September 2001 L 258 11 27.9.2001
►M91 Commission Regulation (EC) No 2162/2001 of 7 November 2001 L 291 9 8.11.2001
►M92 Council Regulation (EC) No 2584/2001 of 19 December 2001 L 345 7 29.12.2001
►M93 Commission Regulation (EC) No 77/2002 of 17 January 2002 L 16 9 18.1.2002
►M94 Commission Regulation (EC) No 868/2002 of 24 May 2002 L 137 6 25.5.2002
►M95 Commission Regulation (EC) No 869/2002 of 24 May 2002 L 137 10 25.5.2002
►M96 Commission Regulation (EC) No 1181/2002 of 1 July 2002 L 172 13 2.7.2002
►M97 Commission Regulation (EC) No 1530/2002 of 27 August 2002 L 230 3 28.8.2002
►M98 Commission Regulation (EC) No 1752/2002 of 1 October 2002 L 264 18 2.10.2002
►M99 Commission Regulation (EC) No 1937/2002 of 30 October 2002 L 297 3 31.10.2002
►M100 Commission Regulation (EC) No 61/2003 of 15 January 2003 L 11 12 16.1.2003
►M101 Commission Regulation (EC) No 544/2003 of 27 March 2003 L 81 7 28.3.2003
►M102 Commission Regulation (EC) No 665/2003 of 11 April 2003 L 96 7 12.4.2003
►M103 Commission Regulation (EC) No 739/2003 of 28 April 2003 L 106 9 29.4.2003
►M104 Council Regulation (EC) No 806/2003 of 14 April 2003 L 122 1 16.5.2003
►M105 Commission Regulation (EC) No 1029/2003 of 16 June 2003 L 149 15 17.6.2003
►M106 Commission Regulation (EC) No 1490/2003 of 25 August 2003 L 214 3 26.8.2003
►M107 Commission Regulation (EC) No 1873/2003 of 24 October 2003 L 275 9 25.10.2003
►M108 Commission Regulation (EC) No 2011/2003 of 14 November 2003 L 297 15 15.11.2003
►M109 Commission Regulation (EC) No 2145/2003 of 8 December 2003 L 322 5 9.12.2003
►M110 Commission Regulation (EC) No 324/2004 of 25 February 2004 L 58 16 26.2.2004
►M111 Commission Regulation (EC) No 546/2004 of 24 March 2004 L 87 13 25.3.2004
►M112 Commission Regulation (EC) No 1101/2004 of 10 June 2004 L 211 3 12.6.2004
►M113 Commission Regulation (EC) No 1646/2004 of 20 September 2004 L 296 5 21.9.2004
►M114 Commission Regulation (EC) No 1851/2004 of25 October 2004 L 323 6 26.10.2004
►M115 Commission Regulation (EC) No 1875/2004 of 28 October 2004 L 326 19 29.10.2004
►M116 Commission Regulation (EC) No 2232/2004 of 23 December 2004 L 379 71 24.12.2004
►M117 Commission Regulation (EC) No 75/2005 of 18 January 2005 L 15 3 19.1.2005
►M118 Commission Regulation (EC) No 712/2005 of 11 May 2005 L 120 3 12.5.2005
►M119 Commission Regulation (EC) No 869/2005 of 8 June 2005 L 145 19 9.6.2005
►M120 Commission Regulation (EC) No 1148/2005 of 15 July 2005 L 185 20 16.7.2005
►M121 Commission Regulation (EC) No 1299/2005 of 8 August 2005 L 206 4 9.8.2005
►M122 Commission Regulation (EC) No 1356/2005 of 18 August 2005 L 214 3 19.8.2005
►M123 Commission Regulation (EC) No 1518/2005 of 19 September 2005 L 244 11 20.9.2005
►M124 Commission Regulation (EC) No 1911/2005 of 23 November 2005 L 305 30 24.11.2005
►M125 Commission Regulation (EC) No 6/2006 of 5 January 2006 L 3 3 6.1.2006
►M126 Commission Regulation (EC) No 205/2006 of 6 February 2006 L 34 21 7.2.2006
►M127 Commission Regulation (EC) No 1055/2006 of 12 July 2006 L 192 3 13.7.2006
►M128 Commission Regulation (EC) No 1231/2006 of 16 August 2006 L 225 3 17.8.2006
►M129 Commission Regulation (EC) No 1451/2006 of 29 September 2006 L 271 37 30.9.2006
►M130 Commission Regulation (EC) No 1729/2006 of 23 November 2006 L 325 6 24.11.2006
►M131 Commission Regulation (EC) No 1805/2006 of 7 December 2006 L 343 66 8.12.2006
►M132 Commission Regulation (EC) No 1831/2006 of 13 December 2006 L 354 5 14.12.2006
►M133 Commission Regulation (EC) No 287/2007 of 16 March 2007 L 78 13 17.3.2007
►M134 Commission Regulation (EC) No 703/2007 of 21 June 2007 L 161 28 22.6.2007
►M135 Commission Regulation (EC) No 1064/2007 of 17 September 2007 L 243 3 18.9.2007
1990R2377— EN— 16.08.2008 — 058.002— 3
►M136 Commission Regulation (EC) No 1323/2007 of 12 November 2007 L 294 11 13.11.2007
►M137 Commission Regulation (EC) No 1353/2007 of 20 November 2007 L 303 6 21.11.2007
►M138 Commission Regulation (EC) No 61/2008 of 24 January 2008 L 22 8 25.1.2008
►M139 Commission Regulation (EC) No 203/2008 of 4 March 2008 L 60 18 5.3.2008
►M140 Commission Regulation (EC) No 542/2008 of 16 June 2008 L 157 43 17.6.2008
Corrected by:
►C1 Corrigendum, OJ L 222, 20.9.1995, p. 17 (1442/95)
►C2 Corrigendum, OJ L 316, 5.12.1996, p. 37 (1442/95)
►C3 Corrigendum, OJ L 76, 18.3.1997, p. 34 (1442/95)
►C4 Corrigendum, OJ L 310, 28.11.2007, p. 22 (2796/95)
►C5 Corrigendum, OJ L 271, 8.10.1998, p. 42 (1568/98)
►C6 Corrigendum, OJ L 116, 30.4.2008, p. 86 (508/1999)
►C7 Corrigendum, OJ L 9, 13.1.2000, p. 30 (1308/1999)
►C8 Corrigendum, OJ L 133, 16.5.2001, p. 17 (807/2001)
►C9 Corrigendum, OJ L 307, 18.11.2008, p. 21 (807/2001)
►C10 Corrigendum, OJ L 268, 9.10.2001, p. 50 (1815/2001)
►C11 Corrigendum, OJ L 251, 19.9.2002, p. 20 (1181/2002)
►C12 Corrigendum, OJ L 45, 19.2.2003, p. 27 (1181/2002)
►C13 Corrigendum, OJ L 62, 6.3.2003, p. 27 (1181/2002)
►C14 Corrigendum, OJ L 337, 13.11.2004, p. 73 (1101/2004)
1990R2377— EN— 16.08.2008 — 058.002— 4
COUNCIL REGULATION (EEC) No 2377/90
of 26 June 1990
laying down a Community procedure for the establishment ofmaximum 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 EconomicCommunity, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the use of veterinary medicinal products in food-producinganimals may result in the presence of residues of foodstuffs obtainedfrom treated animals;
Whereas as a result of scientific and technical progress it is possible todetect the presence of residues of veterinary medicines in foodstuffs atever lower levels; whereas it is therefore necessary to establishmaximum residue limits for pharmacologically active substanceswhich are used in veterinary medicinal products in respect of all thevarious foodstuffs of animal origin, including meat, fish, milk, eggs andhoney;
Whereas in order to protect public health, maximum residue limits mustbe established in accordance with generally recognized principles ofsafety assessment, taking into account any other scientific assessmentof the safety of the substances concerned which may have beenundertaken by international organizations, in particular the CodexAlimentarius 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 importantpart in agricultural production; whereas the establishment of maximumresidue levels will facilitate the marketing of foodstuffs of animal origin;
Whereas the establishment of different maximum residue levels byMember States may hinder the free movement of foodstuffs and ofveterinary medicinal products themselves;
Whereas it is therefore necessary to lay down a procedure for theestablishment of maximum residue levels of veterinary medicinalproducts by the Community, following a single scientific assessmentof the highest possible quality;
Whereas the need for the establishment of maximum residue levelsthroughout the Community is recognized in the Community rulesrelating to trade in foodstuffs of animal origin;
Whereas provisions must be adopted with a view to the systematicestablishment of maximum residue levels for new substances capableof pharmacological action intended for administration to food-producinganimals;
Whereas arrangements must also be made for the establishment ofmaximum residue levels for substances which are currently used in
▼B
1990R2377— EN— 16.08.2008 — 058.002— 5
(1) OJ No C 61, 10. 3. 1989. p. 5.(2) OJ No C 96, 17. 4. 1990, p. 273.(3) OJ No C 201, 17. 8. 1989, p. 1.
veterinary medicines administered to food-producing animals; whereas,however, in view of the complexity of this matter and the large numberof substances involved, long transitional arrangements are required;
Whereas, after scientific assessment by the Committee for VeterinaryMedicinal Products, maximum residue levels must be adopted by arapid procedure which ensures close cooperation between theCommission and the Member States through the Committee set upunder Council Directive 81/852/EEC of 28 September 1981 on theapproximation of the laws of the Member States relating to analytical,pharmaco-toxicological and clinical standards and protocols in respectof the testing of veterinary medicinal products (1), as last amended byDirective 87/20/EEC (2); whereas an urgent procedure is also required toensure the swift review of any tolerance which might prove insufficientto protect public health;
Whereas medicinally induced immunological responses are usuallyindistinguishable from those which arise naturally, and do not affectconsumers of food of animal origin;
Whereas the information necessary to assess the safety of residuesshould be presented in accordance with the principles laid down byDirective 81/852/EEC,
HAS ADOPTED THIS REGULATION:
Article 1
1. For the purposes of this Regulation, the following definitions shallapply:
(a) ‘residues of veterinary medicinal products’: means all pharmacolo-gically active substances, whether active principles, excipients ordegradation products, and their metabolites which remain in food-stuffs obtained from animals to which the veterinary medicinalproduct in question has been administered;
(b) ‘maximum residue limit’: means the maximum concentration ofresidue resulting from the use of a veterinary medicinal product(expressed in mg/kg or μg/kg on a fresh weight basis) which maybe accepted by the Community to be legally permitted orrecognized as acceptable in or on a food.
It is based on the type and amount of residue considered to bewithout any toxicological hazard for human health as expressedby the acceptable daily intake (ADI), or on the basis of atemporary ADI that utilizes an additional safety factor. It alsotakes into account other relevant public health risks as well asfood technology aspects.
When establishing a maximum residue limit (MRL), considerationis also given to residues that occur in food of plant origin and/orcome from the environment. Furthermore, the MRL may be reducedto be consistent with good practices in the use of veterinary drugsand to the extent that practical analytical methods are available.
2. This Regulation shall not apply to active principles of biologicalorigin intended to produce active or passive immunity or to diagnose astate of immunity used in immunological veterinary medicinal products.
Article 2
The list of pharmacologically active substances used in veterinarymedicinal products in respect of which maximum residue limits have
▼B
1990R2377— EN— 16.08.2008 — 058.002— 6
(1) OJ No L 317, 6. 11. 1981, p. 16.(2) OJ No L 15, 17. 1. 1987, p. 34.
been established shall be contained in Annex I, which shall be adoptedin accordance with the procedure laid down in Article 8. Except asprovided for in Article 9, any amendments to Annex I shall beadopted in accordance with the same procedure.
Article 3
Where, following an evaluation of a pharmacologically active substanceused in veterinary medicinal products, it appears that it is not necessaryfor the protection of public health to establish a maximum residue limit,that substance shall be included in a list in Annex II, which shall beadopted in accordance with the procedure laid down in Article 8. Exceptas provided for in Article 9, any amendments to Annex II shall beadopted in accordance with the same procedure.
Article 4
A provisional maximum residue limit may be established for a pharma-cologically active substance used in veterinary medicinal products onthe date of entry into force of this Regulation, provided that there are nogrounds for supposing that residues of the substance concerned at thelevel proposed present a hazard for the health of the consumer. Aprovisional maximum residue limit shall apply for a defined period oftime, which shall not exceed five years. That period may be extendedonce only in exceptional cases for a period not in excess of two years ifthat proves expedient for the completion of scientific studies inprogress.
In exceptional circumstances, a provisional maximum residue limit mayalso be established for a pharmacologically active substance notpreviously used in veterinary medicinal products on the date of entryinto force of this Regulation provided that there are no grounds forsupposing that residues of the substance concerned at the limitproposed present a hazard for the health of the consumer.
The list of pharmacologically active substances used in veterinarymedicinal products in respect of which provisional maximum residuelimits have been established shall be contained in Annex III, which shallbe adopted in accordance with the procedure laid down in Article 8.Except as provided for in Article 9, any amendments to Annex III shallbe adopted in accordance with the same procedure.
Article 5
Where it appears that a maximum residue limit cannot be established inrespect of a pharmacologically active substance used in veterinarymedicinal products because residues of the substances concerned, atwhatever limit, in foodstuffs of animal origin constitute a hazard tothe health of the consumer, that substance shall be included in a listin Annex IV, which shall be adopted in accordance with the procedurelaid down in Article 8. Except as provided for in Article 9, anyamendments to Annex IV shall be adopted in accordance with thesame procedure.
The administration of the substances listed in Annex IV to food-producing animals shall be prohibited throughout the Community.
▼M64
Article 6
1. In order to obtain the inclusion in Annexes I, II or III of a phar-macologically active substance which is intended for use in veterinarymedicinal products for administration to food-producing animals, anapplication to establish a maximum residue limit shall be submitted to
▼B
1990R2377— EN— 16.08.2008 — 058.002— 7
the European Agency for the Evaluation of Medicinal Products set upby Council Regulation (EEC) No 2309/93 (1), hereinafter referred to as‘the Agency’.
This application shall contain the information and particulars referred toin Annex V of this Regulation and shall conform with the principleslaid down in Directive 81/852/EEC.
2. The application shall also be accompanied by the fee payable tothe Agency.
Article 7
1. The Committee for Veterinary Medicinal Products referred to inArticle 27 of Regulation (EC) No 2309/93 (hereinafter ‘the Committee’)shall be responsible for formulating the Agency's opinion on the classi-fication of substances referred to in Annexes I, II, III or IV to thisRegulation.
2. Articles 52 and 53 of Regulation (EEC) No 2309/93 shall beapplicable for the purposes of this Regulation.
3. The Agency shall ensure that the Committee's opinion is deliveredwithin a period of 120 days following the reception of a valid appli-cation.
If the information submitted by the applicant is not sufficient to enablesuch an opinion to be prepared, the Committee may ask the applicant tosupply additional information within a specific time limit. The deadlinefor the opinion shall then be deferred until the additional informationhas been received.
4. The Agency shall forward the opinion to the applicant. Within 15days of receipt of the opinion, the applicant may provide written noticeto the Agency that he wishes to appeal. In that case he shall forward thedetailed grounds for his appeal to the Agency within 60 days of receiptof the opinion. Within 60 days of the receipt of the grounds for appeal,the Committee shall consider whether its opinion should be revised andthe reasons for the conclusion reached on the appeal shall be annexed tothe report referred to in paragraph 5.
5. The Agency shall forward the definitive opinion of the Committeewithin 30 days of its adoption both to the Commission and to theapplicant. The opinion shall be accompanied by a report describingthe safety evaluation of the substance by the Committee, which shallgive the grounds for its conclusions.
6. The Commission shall prepare draft measures taking account ofCommunity legislation and shall start the procedure provided for inArticle 8. The Committee referred to in Article 8 shall adapt its rulesof procedure in order to take account of the tasks conferred on it by thisRegulation.
▼M104
Article 8
1. The Commission shall be assisted by the Standing Committee onVeterinary Medicinal Products.
2. Where reference is made to this Article, Articles 5 and 7 ofDecision 1999/468/EC (2) shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall beset at three months.
3. The Standing Committee shall adopt its Rules of Procedure.
▼M64
1990R2377— EN— 16.08.2008 — 058.002— 8
(1) OJ L 214, 24.8.1993, p. 1(2) OJ L 184, 17.7.1999, p. 23.
Article 9
1. Where a Member State, as a result of new information or a reas-sessment of existing information, considers that the urgent amendmentof a provision contained in Annexes I to IV is necessary in order toprotect human or animal health, and therefore requires swift action to betaken, that Member State may temporarily suspend the operation of theprovision concerned in its own territory. In that case, it shall imme-diately notify the other Member States and the Commission of themeasures, attaching a statement of the reasons therefor.
2. ►M64 The Commission shall as soon as possible examine thegrounds given by the Member State concerned and, after consulting theCommittee for Veterinary Medicinal Products, it shall then deliver itsopinion forthwith and take appropriate measures; the person responsiblefor marketing may be requested to provide the Committee with oral orwritten explanations ◄. The Commission shall immediately notify theCouncil and the Member States of any measures taken. Any MemberState may refer the Commission's measures to the Council within 15days of such notification. The Council, acting by a qualified majority,may take a different decision within 30 days of the date on which thematter was referred to it.
3. If the Commission considers that it is necessary to amend theprovision of Annex I to IV concerned in order to resolve the difficultiesreferred 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 toadopting those amendments; the Member State which has takenmeasures under paragraph 1 may maintain them until the Council orthe Commission has taken a decision in accordance with the above-mentioned procedure.
▼M104
Article 10
1. The Commission shall be assisted by the Standing Committee onVeterinary Medicinal Products.
2. Where reference is made to this Article, Articles 5 and 7 ofDecision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall beset at 15 days.
▼B
Article 11
Any changes which are necessary to adapt Annex V to take account ofscientific and technical progress shall be adopted in accordance with theprocedure laid down in Article 2c of Directive 81/852/EEC.
▼M64
Article 12
As soon as possible after the amendment of Annexes I, II, III or IV, theCommission shall publish a summary of the assessment of the safety ofthe substances concerned that have been examined by the Committeefor Veterinary Medicinal Products. The confidential nature of anyproprietary data shall be respected. The Agency shall provide thecompetent authorities and the Commission with appropriate methodsfor identifying pharmacologically active substances for which theMRL's have been determined in ►C7 Annexes I and III. ◄
▼B
1990R2377— EN— 16.08.2008 — 058.002— 9
Article 13
Member States may not prohibit or impede the putting into circulationwithin their territories of foodstuffs of animal origin originating in otherMember States on the grounds that they contain residues of veterinarymedicinal products if the quantity of residue does not exceed themaximum residue limit provided for in Annex I or III, or if thesubstance concerned is listed in Annex II.
Article 14
With effect from 1 January 1997, the administration to food-producinganimals of veterinary medicinal products containing pharmacologicallyactive substances which are not mentioned in Annexes I, II or III shallbe prohibited within the Community, except in the case of clinical trialsaccepted by the competent authorities following notification or author-ization in accordance with the legislation in force and which do notcause foodstuffs obtained from livestock participating in such trials tocontain residues which constitute a hazard to human health.
▼M34However, the date referred to in the previous subparagraph shall bedeferred for substances the use of which was authorized on the dateof entry into force of this Regulation and in respect of which docu-mented applications for the establishment of maximum residue limitshave been lodged with the Commission or with the European Agencyfor the Evaluation of Medicinal Products before 1 January 1996:
▼M64— until 1 January 1998 in the case of pyrazolinones (including pyra-
zolidinediones and phenylbutazones), nitroimidazoles and arsalinicacid, and
▼M34— until 1 January 2000 in the case of other substances.
The Agency shall publish a list of these substances before 7 June 1997.
▼B
Article 15
This Regulation shall in no way prejudice the application of Communitylegislation prohibiting the use in livestock farming of certain substanceshaving a hormonal action.
Nothing in this Regulation shall prejudice the measures taken byMember States to prevent the unauthorized use of veterinarymedicinal products.
Article 16
This Regulation shall enter into force on 1 January 1992.
This Regulation shall be binding in its entirety and directly applicable inall Member States.
▼B
1990R2377— EN — 16.08.2008 — 058.002— 10
1990R2377— EN— 16.08.2008 — 058.002 — 11
ANNEX
I
LIST
OF
PHARMACOLOGIC
ALLY
ACTIV
ESUBSTANCESFOR
WHIC
HMAXIM
UM
RESID
UE
LIM
ITSHAVE
BEEN
FIX
ED
1.Anti-infectious
agents
1.1.
Chemotheurapeutics
1.1.1.
Sulfonamides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
All
substances
belong
ing
tothe
sulfo-
namidegroup
Parentdrug
All
food
-produ
cing
species
100μg
/kg
Muscle
The
combined
totalresidu
esof
all
substances
with
inthe
sulfon
amide
grou
pshou
ldno
texceed
100μg
/kg
100μg
/kg
Fat
100μg
/kg
Liver
100μg
/kg
Kidney
Bov
ine,
ovine,
caprine
100μg
/kg
Milk
1.1.2.
Diaminopy
rimidinederivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Baquiloprim
Baquiloprim
Bov
ine
10μg
/kg
Fat
300μg
/kg
Liver
150μg
/kg
Kidney
30μg
/kg
Milk
Porcine
40μg
/kg
Skinandfat
50μg
/kg
Liver
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 12
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
50μg
/kg
Kidney
▼M96
Trimetho
prim
Trimetho
prim
All
food
prod
ucing
speciesexcept
equidae
50μg
/kg
Fat(1)
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
for
human
consum
ption
50μg
/kg
Muscle
(2)
50μg
/kg
Liver
50μg
/kg
Kidney
50μg
/kg
Milk
Equ
idae
100μg
/kg
Muscle
100μg
/kg
Fat
100μg
/kg
Liver
100μg
/kg
Kidney
(1)For
porcineandpo
ultryspeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
(2)For
finfish
this
MRL
relatesto
‘muscleandskin
innaturalprop
ortio
ns’.
▼M58
1.2.
Antibiotics
1.2.1.
Penicillins
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Amox
icyllin
Amox
icyllin
All
food
-produ
cing
species
50μg
/kg
Muscle
50μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
4μg
/kg
Milk
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 13
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Ampicillin
Ampicillin
All
food
-produ
cing
species
50μg
/kg
Muscle
50μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
4μg
/kg
Milk
Benzylpenicillin
Benzylpenicillin
All
food
-produ
cing
species
50μg
/kg
Muscle
50μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
4μg
/kg
Milk
Cloxacillin
Cloxacillin
All
food
-produ
cing
species
300μg
/kg
Muscle
300μg
/kg
Fat
300μg
/kg
Liver
300μg
/kg
Kidney
30μg
/kg
Milk
Dicloxacillin
Dicloxacillin
All
food
-produ
cing
species
300μg
/kg
Muscle
300μg
/kg
Fat
300μg
/kg
Liver
300μg
/kg
Kidney
30μg
/kg
Milk
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 14
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Nafcillin
Nafcillin
Allruminants(1)
300μg
/kg
Muscle
300μg
/kg
Fat
300μg
/kg
Liver
300μg
/kg
Kidney
30μg
/kg
Milk
▼M58
Oxacillin
Oxacillin
All
food
-produ
cing
species
300μg
/kg
Muscle
300μg
/kg
Fat
300μg
/kg
Liver
300μg
/kg
Kidney
30μg
/kg
Milk
Penethamate
Benzylpenicillin
Bov
ine
50μg
/kg
Muscle
50μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
4μg
/kg
Milk
▼M72
Porcine
50μg
/kg
Muscle
50μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
▼M120
All
mam
malian-food
prod
ucingspecies
50μg
/kg
Muscle
50μg
/kg
Fat
▼M111
1990R2377— EN — 16.08.2008 — 058.002— 15
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
50μg
/kg
Liver
50μg
/kg
Kidney
4μg
/kg
Milk
▼M74
Phenoxymethylpenicillin
Phenoxymethylpeni-
cillin
Porcine
25μg
/kg
Muscle
25μg
/kg
Liver
25μg
/kg
Kidney
▼M121
Pou
ltry(2)
25μg
/kg
Muscle
25μg
/kg
Skin+fat
25μg
/kg
Liver
25μg
/kg
Kidney
▼M111
(1)For
intram
ammaryuseon
ly.
►M12
1(2)Not
forusein
anim
alsfrom
which
eggs
areprod
uced
forhu
man
consum
ption.
◄
▼M58
1.2.2.
Cephalosporins
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M91
Cefacetrile
Cefacetrile
Bov
ine
125μg
/kg
Milk
For
intram
ammaryuseon
ly
▼M71
Cefalexin
Cefalexin
Bov
ine
200μg
/kg
Muscle
200μg
/kg
Fat
200μg
/kg
Liver
▼M120
1990R2377— EN — 16.08.2008 — 058.002— 16
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
100
0μg
/kg
Kidney
100μg
/kg
Milk
▼M100
Cefalon
ium
Cefalon
ium
Bov
ine
20μg
/kg
Milk
▼M87
Cefapirin
Sum
ofceph
apirin
and
desacetylcephapirin
Bov
ine
50μg
/kg
Muscle
50μg
/kg
Fat
100μg
/kg
Kidney
60μg
/kg
Milk
▼M58
Cefazolin
Cefazolin
Bov
ine,
ovine,
caprine
50μg
/kg
Milk
▼M83
Cefop
erazon
eCefop
erazon
eBov
ine
50μg
/kg
Milk
▼M58
Cefqu
inom
eCefqu
inom
eBov
ine
50μg
/kg
Muscle
50μg
/kg
Fat
100μg
/kg
Liver
200μg
/kg
Kidney
20μg
/kg
Milk
▼M65
Porcine
50μg
/kg
Muscle
50μg
/kg
Skin+fat
100μg
/kg
Liver
200μg
/kg
Kidney
▼M71
1990R2377— EN — 16.08.2008 — 058.002— 17
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M109
Equ
idae
50μg
/kg
Muscle
50μg
/kg
Fat
100μg
/kg
Liver
200μg
/kg
Kidney
▼M128
Ceftio
fur
Sum
ofall
residu
esretainingthebetalactam
structure
expressed
asdesfuroy
lceftio
fur
All
mam
malian
food-
prod
ucingspecies
100
0μg
/kg
Muscle
200
0μg
/kg
Fat(1)
200
0μg
/kg
Liver
600
0μg
/kg
Kidney
100μg
/kg
Milk
(1)For
porcinespeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
▼M58
1.2.3.
Quino
lones
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M96
Danofloxacin
Danofloxacin
►C11
All
food
prod
ucing
species
except
bovine,
ovine,
caprine,
porcine
and
poultry◄
100μg
/kg
Muscle(2)
50μg
/kg
Fat(1)
200μg
/kg
Liver
200μg
/kg
Kidney
▼M65
1990R2377— EN — 16.08.2008 — 058.002— 18
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Bov
ine,
ovine,
caprine
200μg
/kg
Muscle
100μg
/kg
Fat
400μg
/kg
Liver
400μg
/kg
Kidney
30μg
/kg
Milk
Pou
ltry
200μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
for
human
consum
ption
100μg
/kg
Skinandfat
400μg
/kg
Liver
400μg
/kg
Kidney
Difloxacin
Difloxacin
All
food
prod
ucing
speciesexcept
bovine,
ovine,
caprine
and
poultry
300μg
/kg
Muscle(2)
100μg
/kg
Fat
800μg
/kg
Liver
600μg
/kg
Kidney
Bov
ine,
ovine,
caprine
400μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
100μg
/kg
Fat
140
0μg
/kg
Liver
800μg
/kg
Kidney
Porcine
400μg
/kg
Muscle
100μg
/kg
Skinandfat
800μg
/kg
Liver
800μg
/kg
Kidney
Pou
ltry
300μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
for
human
consum
ption
400μg
/kg
Skinandfat
190
0μg
/kg
Liver
600μg
/kg
Kidney
Enrofloxacin
Sum
ofenroflox
acin
andciprofloxacin
All
food
prod
ucing
speciesexcept
bovine,
ovine,
caprine,
porcine,
rabb
itsand
poultry
100μg
/kg
Muscle(2)
100μg
/kg
Fat
200μg
/kg
Liver
200μg
/kg
Kidney
▼M96
1990R2377— EN — 16.08.2008 — 058.002— 19
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Bov
ine,
ovine,
caprine
100μg
/kg
Muscle
100μg
/kg
Fat
300μg
/kg
Liver
200μg
/kg
Kidney
100μg
/kg
Milk
Porcine,rabb
its10
0μg
/kg
Muscle
100μg
/kg
Fat(1)
200μg
/kg
Liver
300μg
/kg
Kidney
Pou
ltry
100μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
for
human
consum
ption
100μg
/kg
Skinandfat
200μg
/kg
Liver
300μg
/kg
Kidney
Flumequine
Flumequine
All
food
prod
ucing
speciesexcept
bovine,
ovine,
caprine,
porcine,
poultry
and
finfish
200μg
/kg
Muscle
250μg
/kg
Fat
500μg
/kg
Liver
100
0μg
/kg
Kidney
Bov
ine,
porcine,
ovine,
caprine
200μg
/kg
Muscle
300μg
/kg
Fat(1)
500μg
/kg
Liver
150
0μg
/kg
Kidney
50μg
/kg
Milk
Pou
ltry
400μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
for
human
consum
ption
250μg
/kg
Skinandfat
800μg
/kg
Liver
100
0μg
/kg
Kidney
Fin
fish
600μg
/kg
Muscle
and
skin
innaturalprop
ortio
n
▼M96
1990R2377— EN — 16.08.2008 — 058.002— 20
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M77
Marbo
flox
acin
Marbo
flox
acin
Bov
ine
150μg
/kg
Muscle
50μg
/kg
Fat
150μg
/kg
Liver
150μg
/kg
Kidney
75μg
/kg
Milk
Porcine
150μg
/kg
Muscle
50μg
/kg
Skinandfat
150μg
/kg
Liver
150μg
/kg
Kidney
▼M103
Oxo
linic
acid
Oxo
linic
acid
Porcine
100μg
/kg
Muscle
50μg
/kg
Skinandfat
150μg
/kg
Liver
150μg
/kg
Kidney
Chicken
100μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
for
human
consum
ption
50μg
/kg
Skinandfat
150μg
/kg
Liver
150μg
/kg
Kidney
Fin
fish
100μg
/kg
Muscle
and
skin
innaturalprop
ortio
ns
▼M122
All
food
-produ
cing
species(3)
100μg
/kg
Muscle(1)
50μg
/kg
Fat(4)
150μg
/kg
Liver
150μg
/kg
Kidney
▼M96
1990R2377— EN — 16.08.2008 — 058.002— 21
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M58
Sarafloxacin
Sarafloxacin
Chicken
10μg
/kg
Skinandfat
100μg
/kg
Liver
Salmonidae
30μg
/kg
Muscle
and
skin
innaturalprop
ortio
ns
▼M96
(1)For
finfish
this
MRL
relatesto
‘muscleandskin
innaturalprop
ortio
ns’.
(2)For
porcinespeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
►M12
2(3)Not
forusein
anim
alsfrom
which
milk
oreggs
areprod
uced
forhu
man
consum
ption;
MRLsforfat,liv
erandkidn
eydo
notapplyto
finfish.
(4)For
porcineandpo
ultryspeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.◄
▼M58
1.2.4.
Macrolid
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M137
____
____
__
▼M96
Erythromycin
ErythromicyinA
All
food
prod
ucing
species
200μg
/kg
Muscle
(1)
200μg
/kg
Fat
(2)
200μg
/kg
Liver
200μg
/kg
Kidney
40μg
/kg
Milk
150μg
/kg
Egg
s
▼M122
1990R2377— EN — 16.08.2008 — 058.002— 22
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M58
Spiramycin
Sum
ofspiram
ycin
and
neospiramycin
Bov
ine
200μg
/kg
Muscle
300μg
/kg
Fat
300μg
/kg
Liver
300μg
/kg
Kidney
200μg
/kg
Milk
Chicken
200μg
/kg
Muscle
300μg
/kg
Skinandfat
400μg
/kg
Liver
▼M70
Spiramycin
1Porcine
250μg
/kg
Muscle
200
0μg
/kg
Liver
100
0μg
/kg
Kidney
▼M96
1990R2377— EN — 16.08.2008 — 058.002— 23
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M96
Tilm
icosin
Tilm
icosin
All
food
prod
ucing
speciesexcept
poultry
50μg
/kg
Muscle
(1)
50μg
/kg
Fat
(2)
100
0μg
/kg
Liver
100
0μg
/kg
Kidney
50μg
/kg
Milk
Pou
ltry
75μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
for
human
consum
ption
75μg
/kg
Sin
andfat
100
0μg
/kg
Liver
250μg
/kg
Kidney
▼M112
▼C14
Tulathrom
ycin
(2R,3S,4R,5R,8R,10-
R,11R
,12S
,13
S,14R
)-2-ethy
l-3,4,10
,13-tetra-
hydrox
y-3,5,8,10
,12,14
-hexamethy
l-11
-[[3,4,6-
trideoxy
-3-(dimethy
-lamino)-ß-D
-xylo-
hexo
py-ranosyl]oxy
]-1-
oxa-6-azacyclopent-
decan-15
-one
expressed
astulathromycin
equivalents
Bov
ine(4)
100μg
/kg
Fat
300
0μg
/kg
Liver
300
0μg
/kg
Kidney
Porcine
100μg
/kg
Skin+fat
300
0μg
/kg
Liver
300
0μg
/kg
Kidney
▼M70
1990R2377— EN — 16.08.2008 — 058.002— 24
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M96
Tylosin
Tylosin
AAll
food
prod
ucing
species
100μg
/kg
Fat
(3)
100μg
/kg
Muscle
(1)
100μg
/kg
Liver
100μg
/kg
Kidney
50μg
/kg
Milk
200μg
/kg
Egg
s
▼M137
Tylva
losin
Sum
oftylvalosin
and
3-O-acetylty
losin
Porcine
50μg
/kg
Muscle
50μg
/kg
Fat(18 )
50μg
/kg
Liver
50μg
/kg
Kidney
Pou
ltry(6)
50μg
/kg
Fat(7)
50μg
/kg
Liver
▼M96
(1)For
finfish
this
MRL
relatesto
a‘m
uscleandskin
innaturalprop
ortio
ns’.
(2)For
porcinespeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
(3)For
porcineandpo
ultryspeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
►M11
2►C14
(4)N
otforusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
◄◄
►M12
3(5)
Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
◄►M13
7(6)
Not
forusein
anim
alsfrom
which
eggs
areprod
uced
forhu
man
consum
ption.
(7)For
poultryspecies,
this
MRL
relatesto
“skinandfatin
naturalprop
ortio
ns”.◄
▼C14
1990R2377— EN — 16.08.2008 — 058.002— 25
1.2.5.Florfenicol
andrelatedcompo
unds
Pharm
acolog
ically
activ
eSub
stance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Thiamphenicol
Thiam
phenicol
Allfood
prod
ucingspecies(1)
50μg
/kg
Muscle(2)
50μg
/kg
Fat(3)
50μg
/kg
Liver
50μg
/kg
Kidney
50μg
/kg
Milk
(1)
Not
forusein
anim
alsfrom
which
eggs
areprod
uced
forhu
man
consum
ption,
MRLsforfat,liv
erandkidn
eydo
notapplyto
finfish.
(2)
For
finfish
musclerelatesto
‘muscleandskin
innaturalprop
ortio
ns’.
(3)
For
porcineandpo
ultryspeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
▼M58
1.2.6.Tetracyclines
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Chlortetracyclin
eSum
ofparent
drug
and
its4-
epim
erAll
food
-produ
cing
species
100μg
/kg
Muscle
300μg
/kg
Liver
600μg
/kg
Kidney
100μg
/kg
Milk
200μg
/kg
Egg
s
Dox
ycyclin
eDox
ycyclin
eBov
ine
100μg
/kg
Muscle
Not
forusein
anim
als
from
which
milk
isprod
uced
for
human
consum
ption
300μg
/kg
Liver
600μg
/kg
Kidney
Porcine
100μg
/kg
Muscle
300μg
/kg
Skinandfat
300μg
/kg
Liver
600μg
/kg
Kidney
▼M131
1990R2377— EN — 16.08.2008 — 058.002— 26
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Pou
ltry
100μg
/kg
Muscle
Not
forusein
anim
als
from
which
eggs
are
prod
uced
for
human
consum
ption
300μg
/kg
Skinandfat
300μg
/kg
Liver
600μg
/kg
Kidney
Oxy
tetracyclin
eSum
ofparent
drug
and
its4-epim
erAll
food
-produ
cing
species
100μg
/kg
Muscle
300μg
/kg
Liver
600μg
/kg
Kidney
100μg
/kg
Milk
200μg
/kg
Egg
s
Tetracycline
Sum
ofparent
drug
and
its4-epim
erAll
food
-produ
cing
species
100μg
/kg
Muscle
300μg
/kg
Liver
600μg
/kg
Kidney
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 27
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
100μg
/kg
Milk
200μg
/kg
Egg
s
1.2.7.Naphtalene-ring
edansamycin
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Rifaxim
inRifaxim
inBovine
60μg
/kg
Milk
1.2.8.Pleurom
utilines
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M71
Tiamulin
Sum
ofmetabolitesthat
may
behy
drolysed
to8-a-hy
drox
ymutilin
Porcine
100μg
/kg
Muscle
500μg
/kg
Liver
Chicken
100μg
/kg
Muscle
100μg
/kg
Skinandfat
100
0μg
/kg
Liver
▼M77
Rabbits
100μg
/kg
Muscle
500μg
/kg
Liver
▼M83
Turkey
100μg
/kg
Muscle
100μg
/kg
Skinandfat
300μg
/kg
Liver
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 28
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M71
Tiamulin
100
0μg
/kg
Egg
s
▼M58
Valnemulin
Valnemulin
Porcine
50μg
/kg
Muscle
500μg
/kg
Liver
100μg
/kg
Kidney
▼M59
1.2.9.Lincosamides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M96
Lincomycin
Lincomicyn
All
food
prod
ucing
species
50μg
/kg
Fat
(1)
100μg
/kg
Muscle
(2)
500μg
/kg
Liver
150
0μg
/kg
Kidney
150μg
/kg
Milk
50μg
/kg
Egg
s
▼M77
Pirlim
ycin
Pirlim
ycin
Bov
ine
100μg
/kg
Muscle
100μg
/kg
Fat
100
0μg
/kg
Liver
400μg
/kg
Kidney
▼M83
1990R2377— EN — 16.08.2008 — 058.002— 29
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
100μg
/kg
Milk
Porcine
100μg
/kg
Muscle
50μg
/kg
Skinandfat
500μg
/kg
Liver
150
0μg
/kg
Kidney
Chicken
100μg
/kg
Muscle
50μg
/kg
Skinandfat
500μg
/kg
Liver
150
0μg
/kg
Kidney
50μg
/kg
Egg
s
▼M96
(1)For
porcineandpo
ultryspeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
(2)For
finfish
this
MRL
relatesto
‘muscleandskin
innaturalprop
ortio
ns’.
▼M65
1.2.10
.Aminog
lycosides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Apram
ycin
Apram
ycin
Bov
ine
100
0μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
100
0μg
/kg
Fat
1000
0μg
/kg
Liver
2000
0μg
/kg
Kidney
▼M77
1990R2377— EN — 16.08.2008 — 058.002— 30
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M134
Dihyd
rostreptom
ycin
Dihyd
rostreptom
ycin
Allruminants
500μg
/kg
Muscle
500μg
/kg
Fat
500μg
/kg
Liver
100
0μg
/kg
Kidney
200μg
/kg
Milk
Porcine
500μg
/kg
Muscle
500μg
/kg
Skin+fat
500μg
/kg
Liver
100
0μg
/kg
Kidney
Rabbits
500μg
/kg
Muscle
500μg
/kg
Fat
500μg
/kg
Liver
100
0μg
/kg
Kidney
▼M94
Gentamicin
Sum
ofgentam
icin
C1,
gentam
icin
C1a,
gentam
icin
C2and
gentam
icin
C2a
Bov
ine
50μg
/kg
Muscle
50μg
/kg
Fat
200μg
/kg
Liver
750μg
/kg
Kidney
100μg
/kg
Milk
▼M65
1990R2377— EN — 16.08.2008 — 058.002— 31
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Porcine
50μg
/kg
Muscle
50μg
/kg
Skinandfat
200μg
/kg
Liver
750μg
/kg
Kidney
▼M110
Kanam
ycin
Kanam
ycin
AAll
food
prod
ucing
speciesexcept
fish
(3)
100μg
/kg
Muscle
100μg
/kg
Fat(1)
600μg
/kg
Liver
250
0μg
/kg
Kidney
150μg
/kg
Milk
▼M96
Neomycin
(including
fram
ycetin)
Neomycin
BAll
food
prod
ucing
species
500μg
/kg
Fat
(1)
500μg
/kg
Muscle
(2)
500μg
/kg
Liver
500
0μg
/kg
Kidney
150
0μg
/kg
Milk
500μg
/kg
Egg
s
Parom
omycin
Parom
omycin
All
food
prod
ucing
species
500μg
/kg
Muscle(2)
Not
forusein
anim
alsfrom
which
milk
oreggs
areprod
uced
forhu
man
consum
ption
150
0μg
/kg
Liver
150
0μg
/kg
Kidney
▼M94
1990R2377— EN — 16.08.2008 — 058.002— 32
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Spectinom
ycin
Spectinom
ycin
All
food
producing
speciesexcept
ovine
500μg
/kg
Fat(1)
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
for
human
consum
ption
300μg
/kg
Muscle
(2)
100
0μg
/kg
Liver
500
0μg
/kg
Kidney
200μg
/kg
Milk
Ovine
300μg
/kg
Muscle
500μg
/kg
Fat
200
0μg
/kg
Liver
500
0μg
/kg
Kidney
200μg
/kg
Milk
▼M134
Streptomycin
Streptomycin
Allruminants
500μg
/kg
Muscle
500μg
/kg
Fat
500μg
/kg
Liver
100
0μg
/kg
Kidney
200μg
/kg
Milk
Porcine
500μg
/kg
Muscle
500μg
/kg
Skin+fat
500μg
/kg
Liver
100
0μg
/kg
Kidney
Rabbits
500μg
/kg
Muscle
500μg
/kg
Fat
500μg
/kg
Liver
▼M96
1990R2377— EN — 16.08.2008 — 058.002— 33
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
100
0μg
/kg
Kidney
▼M96
(1)
For
porcineandpo
ultryspeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
(2)
For
finfish
this
MRL
relatesto
‘muscleandskin
innaturalprop
ortio
ns’.
►M11
0(3)
Not
forusein
anim
alsfrom
which
eggs
areprod
uced
forhu
man
consum
ption.
◄
▼M70
1.2.11
.Other
antib
iotics
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Nov
obiocin
Nov
obiocin
Bov
ine
50μg
/kg
Milk
▼M86
1.2.12
.Polyp
eptid
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Bacitracin
Sum
ofbacitracin
A,
bacitracin
B,andbaci-
tracin
C
Bov
ine
100μg
/kg
Milk
▼M101
Rabbits
150μg
/kg
Muscle
150μg
/kg
Fat
150μg
/kg
Liver
150μg
/kg
Kidney
▼M134
1990R2377— EN — 16.08.2008 — 058.002— 34
1.2.13
.Beta-lactam
aseinhibitors
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Clavu
lanicacid
Clavu
lanicacid
Bov
ine
100μg
/kg
Muscle
100μg
/kg
Fat
200μg
/kg
Liver
400μg
/kg
Kidney
200μg
/kg
Milk
Porcine
100μg
/kg
Muscle
100μg
/kg
Skinandfat
200μg
/kg
Liver
400μg
/kg
Kidney
▼M96
1.2.14
.Polym
yxins
Pharm
acolog
ically
activ
esubstance
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Colistin
Colistin
All
food
prod
ucing
species
150μg
/kg
Fat
(1)
150μg
/kg
Muscle
(2)
150μg
/kg
Liver
200μg
/kg
Kidney
50μg
/kg
Milk
300μg
/kg
Egg
s
(1)
For
porcineandpo
ultryspeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
(2)
For
finfish
this
MRL
relatesto
‘muscleandskin
innaturalprop
ortio
ns’.
▼M87
1990R2377— EN — 16.08.2008 — 058.002— 35
1.2.15
.Ortho
somycins
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Avilamycin
Dichloroisoeverninic
acid
Porcine
50μg
/kg
Muscle
100μg
/kg
Fat(1)
300μg
/kg
Liver
200μg
/kg
Kidney
Rabbit
50μg
/kg
Muscle
100μg
/kg
Fat
300μg
/kg
Liver
200μg
/kg
Kidney
Pou
ltry(2)
50μg
/kg
Muscle
100μg
/kg
Fat(1)
300μg
/kg
Liver
200μg
/kg
Kidney
(1)
For
porcineandpo
ultryspecies,
this
MRL
relatesto
skin
andfatin
naturalprop
ortio
ns.
(2)
Not
forusein
anim
alsfrom
which
eggs
areprod
uced
forhu
man
consum
ption.
▼M137
1.2.16
.Ion
opho
res
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Mon
ensin
Mon
ensinA
Bov
ine
2μg
/kg
Muscle
10μg
/kg
Fat
30μg
/kg
Liver
2μg
/kg
Kidney
2μg
/kg
Milk
▼M135
1990R2377— EN — 16.08.2008 — 058.002— 36
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Lasalocid
Lasalocid
APou
ltry
20μg
/kg
Muscle
100μg
/kg
Fat(1)
100μg
/kg
Liver
50μg
/kg
Kidney
150μg
/kg
Egg
s
(1)
For
poultryspecies,
this
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
▼M137
1990R2377— EN — 16.08.2008 — 058.002— 37
2.Antiparasiticagents
2.1.
Agentsactin
gagainstendo
parasites
2.1.1.
Salicylanilides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Closantel
Closantel
Bov
ine
100
0μg
/kg
Muscle
300
0μg
/kg
Fat
100
0μg
/kg
Liver
300
0μg
/kg
Kidney
Ovine
150
0μg
/kg
Muscle
200
0μg
/kg
Fat
150
0μg
/kg
Liver
500
0μg
/kg
Kidney
▼M86
Rafox
anide
Rafox
anide
Bov
ine
30μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
30μg
/kg
Fat
10μg
/kg
Liver
40μg
/kg
Kidney
Ovine
100μg
/kg
Muscle
250μg
/kg
Fat
150μg
/kg
Liver
150μg
/kg
Kidney
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 38
2.1.2.
Tatra-hyd
ro-imidazoles
(imidazolthiazoles)
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Levam
isole
Levam
isole
Bov
ine,
ovine,
porcine,
poultry
10μg
/kg
Muscle
10μg
/kg
Fat
100μg
/kg
Liver
10μg
/kg
Kidney
2.1.3.
Benzimidazoles
andpro-benzim
idazoles
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M113
Albendazole
Sum
ofalbend
azole
sulpho
xide,albend
azole
sulpho
ne,
and
alben-
dazole
2-am
ino
sulpho
ne,expressed
asalbend
azole
Allruminants
100μg
/kg
Muscle
100μg
/kg
Fat
100
0μg
/kg
Liver
500μg
/kg
Kidney
100μg
/kg
Milk
▼M69
Albendazole
oxide
Sum
ofalbend
azole
oxide,
albend
azole
sulpho
neand
alben-
dazole
2-am
ino-
sulpho
ne,expressed
asalbend
azole
Bov
ine,
ovine
100μg
/kg
Muscle
100μg
/kg
Fat
100
0μg
/kg
Liver
500μg
/kg
Kidney
100μg
/kg
Milk
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 39
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M113
Febantel
Sum
ofextractable
residu
eswhich
may
beox
idised
toox
fend
azole
sulpho
ne
Allruminants
50μg
/kg
Muscle
50μg
/kg
Fat
500μg
/kg
Liver
50μg
/kg
Kidney
10μg
/kg
Milk
Fenbend
azole
Sum
ofextractable
residu
eswhich
may
beox
idised
toox
fend
azole
sulpho
ne
Allruminants
50μg
/kg
Muscle
50μg
/kg
Fat
500μg
/kg
Liver
50μg
/kg
Kidney
10μg
/kg
Milk
▼M127
Flubendazole
Sum
offlubendazole
and(2-amino1H
-benzi-
midazol-5-yl)
(4fluo
ro-
phenyl)methano
ne
Pou
ltry,
porcine
50μg
/kg
Muscle
50μg
/kg
Skin+fat
400μg
/kg
Liver
300μg
/kg
Kidney
Flubend
azole
Flubend
azole
Pou
ltry
400μg
/kg
Egg
s
▼M88
Mebendazole
Sum
ofmebendazole
methy
l(5-(1-hy
drox
y,1-ph
enyl)
methy
l-1H
-benzim
idazol-2-yl)
carbam
ate
and
(2-
amino-1H
-benzi-
midazol-5-yl)
phenyl-
methano
ne,
expressed
asmebendazole
equivalents
Ovine,caprine,
equidae
60μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
60μg
/kg
Fat
400μg
/kg
Liver
60μg
/kg
Kidney
▼M69
1990R2377— EN — 16.08.2008 — 058.002— 40
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M83
Netob
imin
Sum
ofalbend
azole
oxide,
albend
azole
sulpho
neand
alben-
dazole
2-am
ino-
sulpho
ne,expressed
asalbend
azole
►C8
Bov
ine,
ovine◄
100μg
/kg
Muscle
For
oral
useon
ly
100μg
/kg
Fat
100
0μg
/kg
Liver
500μg
/kg
Kidney
100μg
/kg
Milk
▼M113
Oxfendazole
Sum
ofextractable
residu
eswhich
may
beox
idised
toox
fend
azole
sulpho
ne
Allruminants
50μg
/kg
Muscle
50μg
/kg
Fat
500μg
/kg
Liver
50μg
/kg
Kidney
10μg
/kg
Milk
▼M58
Oxibend
azole
Oxibend
azole
Porcine
100μg
/kg
Muscle
500μg
/kg
Skinandfat
200μg
/kg
Liver
100μg
/kg
Kidney
▼M113
Thiabendazole
Sum
ofthiabendazole
and
5-hy
drox
ythiaben-
dazole
Caprine
100μg
/kg
Muscle
100μg
/kg
Fat
100μg
/kg
Liver
100μg
/kg
Kidney
100μg
/kg
Milk
▼M88
1990R2377— EN — 16.08.2008 — 058.002— 41
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M58
Triclabendazole
Sum
ofextractable
residu
esthat
may
beox
idised
toketotricla-
bend
azole
Allruminants(1)
225μg
/kg
Muscle
100μg
/kg
Fat
250μg
/kg
Liver
150μg
/kg
Kidney
▼M130
(1)Not
forusein
anim
alsprod
ucingmilk
forhu
man
consum
ption.
▼M62
2.1.4.
Pheno
lderivativ
esinclud
ingsalicylanides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Nitrox
inil
Nitrox
inil
Bov
ine,
ovine
400μg
/kg
Muscle
200μg
/kg
Fat
20μg
/kg
Liver
400μg
/kg
Kidney
▼M113
Oxy
clozanide
Oxy
clozanide
Allruminants
20μg
/kg
Muscle
20μg
/kg
Fat
500μg
/kg
Liver
100μg
/kg
Kidney
▼M113
1990R2377— EN — 16.08.2008 — 058.002— 42
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
10μg
/kg
Milk
▼M66
2.1.5.
Benzenesulpho
namides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Clorsulon
Clorsulon
Bov
ine
35μg
/kg
Muscle
100μg
/kg
Liver
200μg
/kg
Kidney
▼M94
2.1.6.
Piperazinederivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Piperazine
Piperazine
Porcine
400μg
/kg
Muscle
800μg
/kg
Skind
andfat
200
0μg
/kg
Liver
100
0μg
/kg
Kidney
Chicken
200
0μg
/kg
Egg
s
▼M114
2.1.7.
Tetrahydropyrim
ides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Morantel
Sum
ofresidu
eswhich
may
behy
drolysed
toN-m
ethy
l-1,3-
prop
ane-
diam
ine
and
expressed
asmorantelequivalents
Bov
ine,
ovine
100μg
/kg
Muscle
100μg
/kg
Fat
800μg
/kg
Liver
200μg
/kg
Kidney
50μg
/kg
Milk
▼M113
1990R2377— EN — 16.08.2008 — 058.002— 43
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M122
Allruminants
100μg
/kg
Muscle
100μg
/kg
Fat
800μg
/kg
Liver
200μg
/kg
Kidney
50μg
/kg
Milk
▼M58
2.2.
Agentsactin
gagainstectoparasites
2.2.1.
Organophosphates
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M86
Cou
mafos
Cou
mafos
Bees
100μg
/kg
Hon
ey
▼M58
Diazino
nDiazino
nBov
ine,
ovine,
caprine
20μg
/kg
Milk
Bov
ine,
porcine,
ovine,
caprine
20μg
/kg
Muscle
700μg
/kg
Fat
20μg
/kg
Liver
20μg
/kg
Kidney
▼M83
Pho
xim
Pho
xim
Ovine
50μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
400μg
/kg
Fat
50μg
/kg
Kidney
▼M114
1990R2377— EN — 16.08.2008 — 058.002— 44
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Porcine
20μg
/kg
Muscle
700μg
/kg
Skinandfat
20μg
/kg
Liver
20μg
/kg
Kidney
▼M121
Chicken
25μg
/kg
Muscle
550μg
/kg
Skin+fat
50μg
/kg
Liver
30μg
/kg
Kidney
60μg
/kg
Egg
s
▼M58
2.2.2.
Formam
idines
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Amitraz
Sum
ofam
itraz
andall
metabolites
containing
the
2,4-DMA
moiety,
expressedas
amitraz
Bov
ine
200μg
/kg
Fat
200μg
/kg
Liver
200μg
/kg
Kidney
10μg
/kg
Milk
▼M83
1990R2377— EN — 16.08.2008 — 058.002— 45
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Ovine
400μg
/kg
Fat
100μg
/kg
Liver
200μg
/kg
Kidney
10μg
/kg
Milk
Porcine
400μg
/kg
Skinandfat
200μg
/kg
Liver
200μg
/kg
Kidney
▼M69
Bees(hon
ey)
200μg
/kg
Hon
ey
▼M113
Caprine
200μg
/kg
Fat
100μg
/kg
Liver
200μg
/kg
Kidney
10μg
/kg
Milk
▼M58
2.2.3.
Pyrethroids
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M83
▼C8
Cyh
alothrin
Cyh
alothrin
(sum
ofisom
ers)
Bov
ine
500μg
/kg
Fat
Further
prov
isions
inCou
ncil
Directiv
e94
/29/EC
are
tobe
observed
50μg
/kg
Kidney
50μg
/kg
Milk
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 46
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼C9
Cyfluthrin
Cyfluthrin
(sum
ofisom
ers)
Bov
ine,
caprine
50μg
/kg
Fat
10μg
/kg
Liver
10μg
/kg
Kidney
20μg
/kg
Milk
Further
prov
isions
inCou
ncil
Directiv
e94
/29/EC
are
tobe
observed
▼M113
Deltamethrin
Deltamethrin
Allruminants
10μg
/kg
Muscle
50μg
/kg
Fat
10μg
/kg
Liver
10μg
/kg
Kidney
20μg
/kg
Milk
▼M91
Fin
fish
10μg
/kg
Muscle
and
skin
innaturalprop
ortio
ns
▼M131
Fenvalerate
Fenvalerate
(sum
ofRR,SS,RS
and
SR
isom
ers)
Bov
ine
25μg
/kg
Muscle
250μg
/kg
Fat
25μg
/kg
Liver
25μg
/kg
Kidney
40μg
/kg
Milk
▼M58
Flumethrin
Flumethrin
(sum
oftrans-Z
isom
ers)
Bov
ine
10μg
/kg
Muscle
150μg
/kg
Fat
20μg
/kg
Liver
10μg
/kg
Kidney
▼C8
1990R2377— EN — 16.08.2008 — 058.002— 47
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
30μg
/kg
Milk
▼M78
Ovine
10μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
150μg
/kg
Fat
20μg
/kg
Liver
10μg
/kg
Kidney
▼M100
Permethrin
Permethrin
(sum
ofisom
ers)
Bov
ine
50μg
/kg
Muscle
500μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
50μg
/kg
Milk
(*)
▼M105
Cyp
ermethrin
Cyp
ermethrin
(sum
ofisom
ers)
Salmonidae
50μg
/kg
Muscle
and
skin
innaturalprop
ortio
ns
▼M113
Allruminants
20μg
/kg
Muscle
200μg
/kg
Fat
20μg
/kg
Liver
20μg
/kg
Kidney
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 48
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
20μg
/kg
Milk
(*)
Alphacyperm
ethrin
Cyp
ermethrin
(sum
ofisom
ers)
Bov
ine,
ovine
20μg
/kg
Muscle
200μg
/kg
Fat
20μg
/kg
Liver
20μg
/kg
Kidney
20μg
/kg
Milk
(*)
▼M100
(*)F
urther
prov
isions
inCom
mission
Directiv
e98
/82/EC
areto
beob
served
(OJL
290,
29.10.19
98,p.
25).
▼M65
2.2.4.
Acylurea
derivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M70
Diflubenzuron
Diflubenzuron
Salmonidae
1000μg
/kg
Muscle
and
skin
innaturalprop
ortio
ns
▼M129
Fluazuron
Fluazuron
Bov
ine(1)
200μg
/kg
Muscle
700
0μg
/kg
Fat
500μg
/kg
Liver
500μg
/kg
Kidney
▼M65
Teflubenzuron
Teflubenzuron
Salmonidae
500μg
/kg
Muscle
and
skin
innaturalprop
ortio
ns
▼M129
(1)Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
▼M113
1990R2377— EN — 16.08.2008 — 058.002— 49
2.2.5.
Pyrim
idines
derivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Dicyclanil
Sum
ofdicyclanil
and
2,4,
6-triamino-py
ri-
midine-5-carbon
itrile
Ovine
200μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
►M78
150μg
/kg
◄Fat
400μg
/kg
Liver
400μg
/kg
Kidney
▼M86
2.2.6.
Triazinederivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Cyrom
azine
Cyrom
azine
Ovine
300μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
300μg
/kg
Fat
300μg
/kg
Liver
300μg
/kg
Kidney
▼M58
2.3.
Agentsactin
gagainstendo
-andectoparasites
2.3.1.
Averm
ectin
s
Phram
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Abamectin
Averm
ectin
B1a
Bov
ine
10μg
/kg
Fat
▼M76
1990R2377— EN — 16.08.2008 — 058.002— 50
Phram
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
20μg
/kg
Liver
▼M94
Ovine
20μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
50μg
/kg
Fat
25μg
/kg
Liver
20μg
/kg
Kidney
▼M132
Doram
ectin
Doram
ectin
All
mam
malian
food
prod
ucingspecies(1)
40μg
/kg
Muscle
150μg
/kg
Fat
100μg
/kg
Liver
60μg
/kg
Kidney
▼M106
Emam
ectin
Emam
ectin
B1a
Fin
fish
100μg
/kg
Muscle
and
skin
innaturalprop
ortio
ns
▼M58
Eprinom
ectin
Eprinom
ectin
B1a
Bov
ine
►M67
50μg
/kg
◄Muscle
►M67
250μg
/kg
◄Fat
►M67
150
0μg
/kg◄
Liver
►M67
300μg
/kg
◄Kidney
►M67
20μg
/kg
◄Milk
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 51
Phram
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Ivermectin
22,
23-D
ihyd
ro-aver-
mectin
B1a
Bov
ine
40μg
/kg
Fat
100μg
/kg
Liver
Porcine,ov
ine,
equidae
20μg
/kg
Fat
15μg
/kg
Liver
Deer,
includ
ing
reindeer
20μg
/kg
Muscle
100μg
/kg
Fat
50μg
/kg
Liver
20μg
/kg
Kidney
▼M119
All
mam
malian
food-
prod
ucingspecies(1)
100μg
/kg
Fat
100μg
/kg
Liver
30μg
/kg
Kidney
▼M58
Mox
idectin
Mox
idectin
Bov
ine,
ovine
50μg
/kg
Muscle
500μg
/kg
Fat
100μg
/kg
Liver
50μg
/kg
Kidney
▼M87
Bov
ine
40μg
/kg
Milk
▼M66
Equ
idae
50μg
/kg
Muscle
500μg
/kg
Fat
100μg
/kg
Liver
50μg
/kg
Kidney
▼M117
Ovine
40μg
/kg
Milk
▼M119
(1)Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 52
2.4.
Agentsactin
gagainstprotozoa
2.4.1.
Triazinetrionederivativ
e
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Toltrazuril
Toltrazurilsulfon
eChicken
100μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
for
human
consum
ption
200μg
/kg
Skinandfat
600μg
/kg
Liver
400μg
/kg
Kidney
Turkey
100μg
/kg
Muscle
200μg
/kg
Skinandfat
600μg
/kg
Liver
400μg
/kg
Kidney
▼M80
Porcine
100μg
/kg
Muscle
150μg
/kg
Skinandfat
500μg
/kg
Liver
250μg
/kg
Kidney
▼M126
All
mam
malian
food
prod
ucingspecies(1)
100μg
/kg
Muscle
150μg
/kg
Fat(2)
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 53
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
500μg
/kg
Liver
250μg
/kg
Kidney
Pou
ltry(3)
100μg
/kg
Muscle
200μg
/kg
Skin+fat
600μg
/kg
Liver
400μg
/kg
Kidney
(1)Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
(2)For
porcinespeciesthis
MRL
relatesto
‘skinandfatin
naturalprop
ortio
ns’.
(3)Not
forusein
anim
alsfrom
which
eggs
areprod
uced
forhu
man
consum
ption.
▼M80
2.4.2.
Quinazolone
derivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Halofug
inon
eHalofug
inon
eBov
ine
10μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
25μg
/kg
Fat
30μg
/kg
Liver
30μg
/kg
Kidney
▼M91
2.4.3.
Carbanilid
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Imidocarb
Imidocarb
Bov
ine
300μg
/kg
Muscle
50μg
/kg
Fat
▼M126
1990R2377— EN — 16.08.2008 — 058.002— 54
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
200
0μg
/kg
Liver
150
0μg
/kg
Kidney
50μg
/kg
Milk
▼M109
Ovine
(1)
300μg
/kg
Muscle
50μg
/kg
Fat
200
0μg
/kg
Liver
150
0μg
/kg
Kidney
(1)Not
forusein
ovinefrom
which
milk
isprod
uced
forhu
man
consum
ption.
▼M118
2.4.4.
Iono
phores
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M137
____
____
__
▼M91
1990R2377— EN — 16.08.2008 — 058.002— 55
3.Agentsactin
gon
thenervou
ssystem
3.1.
Agentsactin
gon
thecentralnervou
ssystem
3.1.1.
Butyrophenone
tranquillisers
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Azaperone
Sum
ofazaperon
eand
azaperol
Porcine
100μg
/kg
Muscle
100μg
/kg
Skinandfat
100μg
/kg
Liver
100μg
/kg
Kidney
3.2.
Agentsactin
gon
theautono
mic
nervou
ssystem
3.2.1.
Anti-adrenergics
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Carazolol
Carazolol
Porcine
5μg
/kg
Muscle
5μg
/kg
Skinandfat
25μg
/kg
Liver
25μg
/kg
Kidney
▼M72
Bov
ine
5μg
/kg
Muscle
5μg
/kg
Fat
15μg
/kg
Liver
15μg
/kg
Kidney
1μg
/kg
Milk
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 56
3.2.2.
β2sympathom
imetic
agents
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Clenb
uterol
hydrochloride
Clenb
uterol
Bov
ine
0,1μg
/kg
Muscle
0,5μg
/kg
Liver
0,5μg
/kg
Kidney
0,05
μg/kg
Milk
Equ
idae
0,1μg
/kg
Muscle
0,5μg
/kg
Liver
0,5μg
/kg
Kidney
▼M58
4.Anti-inflam
matoryagents
4.1.
Non
steroidalanti-inflam
matoryagents
4.1.1.
Arylpropion
icacid
derivativ
e
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M65
Carprofen
Carprofen
Bov
ine
Not
forusein
anim
als
from
which
milk
isprod
uced
for
human
consum
ption
500μg
/kg
Muscle
100
0μg
/kg
Fat
100
0μg
/kg
Liver
100
0μg
/kg
Kidney
Equ
idae
500μg
/kg
Muscle
100
0μg
/kg
Fat
100
0μg
/kg
Liver
100
0μg
/kg
Kidney
▼M78
1990R2377— EN — 16.08.2008 — 058.002— 57
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M58
Vedaprofen
Vedaprofen
Equ
idae
50μg
/kg
Muscle
20μg
/kg
Fat
100μg
/kg
Liver
100
0μg
/kg
Kidney
▼M119
Carprofen
Sum
ofcarprofen
and
carprofen
glucuron
ide
conjug
ate
Bov
ine,
equidae
500μg
/kg
Muscle
100
0μg
/kg
Fat
100
0μg
/kg
Liver
100
0μg
/kg
Kidney
▼M58
4.1.2.
Fenam
ategrou
pderivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M71
Flunixin
Flunixin
Bov
ine
20μg
/kg
Muscle
30μg
/kg
Fat
300μg
/kg
Liver
100μg
/kg
Kidney
5-Hyd
roxy
flun
ixin
40μg
/kg
Milk
Flunixin
Porcine
50μg
/kg
Muscle
10μg
/kg
Skinandfat
200μg
/kg
Liver
30μg
/kg
Kidney
▼M65
1990R2377— EN — 16.08.2008 — 058.002— 58
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M80
Equ
idae
10μg
/kg
Muscle
20μg
/kg
Fat
100μg
/kg
Liver
200μg
/kg
Kidney
▼M58
Tolfenamic
acid
Tolfenamic
acid
Bov
ine
50μg
/kg
Muscle
400μg
/kg
Liver
100μg
/kg
Kidney
50μg
/kg
Milk
Porcine
50μg
/kg
Muscle
400μg
/kg
Liver
100μg
/kg
Kidney
▼M71
1990R2377— EN — 16.08.2008 — 058.002— 59
4.1.3.
Eno
licacid
derivates
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Melox
icam
Melox
icam
Equ
idae
20μg
/kg
Muscle
65μg
/kg
Liver
65μg
/kg
Kidney
▼M69
4.1.4.
Oxicanderivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M131
Melox
icam
Melox
icam
Porcine,equidae,
rabb
it20
μg/kg
Muscle
65μg
/kg
Liver
65μg
/kg
Kidney
Bov
ine,
caprine
20μg
/kg
Muscle
65μg
/kg
Liver
65μg
/kg
Kidney
15μg
/kg
Milk
▼M97
1990R2377— EN — 16.08.2008 — 058.002— 60
4.1.5.
Pyrazolon
ederivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Metam
izole
4-Methy
laminoan-
tipyrin
Bov
ine
100μg
/kg
Muscle
100μg
/kg
Fat
100μg
/kg
Liver
100μg
/kg
Kidney
50μg
/kg
Milk
Porcine
100μg
/kg
Muscle
100μg
/kg
Skinandfat
100μg
/kg
Liver
100μg
/kg
Kidney
Equ
idae
100μg
/kg
Muscle
100μg
/kg
Fat
100μg
/kg
Liver
100μg
/kg
Kidney
▼M110
4.1.6.
Phenylacetic
acid
derivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Diclofenac
Diclofenac
Bov
ine(1)
5μg
/kg
Muscle
1μg
/kg
Fat
5μg
/kg
Liver
10μg
/kg
Kidney
Porcine
5μg
/kg
Muscle
1μg
/kg
Skin+fat
5μg
/kg
Liver
10μg
/kg
Kidney
(1)Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
▼M108
1990R2377— EN — 16.08.2008 — 058.002— 61
4.1.7.
Sulph
onated
feny
llacton
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Firocox
ibFirocox
ibEqu
idae
10μg
/kg
Muscle
15μg
/kg
Fat
60μg
/kg
Liver
10μg
/kg
Kidney
▼M58
5.Corticoides
5.1.
Glucocorticoides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M70
Betam
ethasone
Betam
ethasone
Bov
ine
0,75
μg/kg
Muscle
2,0μg
/kg
Liver
0,75
μg/kg
Kidney
0,3μg
/kg
Milk
Porcine
0,75
μg/kg
Muscle
2,0μg
/kg
Liver
0,75
μg/kg
Kidney
▼M58
Dexam
ethasone
Dexam
ethasone
Bovine
0,3μg
/kg
Milk
Bov
ine,
porcine,
equidae
0,75
μg/kg
Muscle
2μg
/kg
Liver
0,75
μg/kg
Kidney
Caprine
0,75
μg/kg
Muscle
2μg
/kg
Liver
0,75
μg/kg
Kidney
0,3μg
/kg
Milk
▼M136
1990R2377— EN — 16.08.2008 — 058.002— 62
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M93
Methylprednisolone
Methylprednisolone
Bovine
10μg
/kg
Muscle
Not
forusein
anim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
10μg
/kg
Fat
10μg
/kg
Liver
10μg
/kg
Kidney
▼M79
Predn
isolon
ePredn
isolon
eBov
ine
4μg
/kg
Muscle
4μg
/kg
Fat
10μg
/kg
Liver
10μg
/kg
Kidney
6μg
/kg
Milk
▼M92
6.Agentsactin
gon
thereprod
uctiv
esystem
6.1.
Progestog
ens
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Chlormadinone
Chlormadinone
Bovine
4μg
/kg
Fat
For
zootechn
ical
useon
ly
2μg
/kg
Liver
2,5μg
/kg
Milk
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 63
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Flugeston
eacetate
Flugetone
acetate
Ovine
1μg
/kg
Milk
For
intravaginal
useforzootechn
ical
purposes
only
▼M103
Caprine
1μg
/kg
Milk
For
intra-vaginal
use
for
zootechn
ical
purposes
only
▼M124
Ovine,caprine
0,5μg
/kg
Muscle
For
therapeutic
and
zootechn
ical
purposes
only
0,5μg
/kg
Fat
0,5μg
/kg
Liver
0,5μg
/kg
Kidney
▼M116
Altrenog
est(
1 )Altrenog
est
Porcine
1μg
/kg
Skinandfat
0,4μg
/kg
Liver
Equ
idae
1μg
/kg
Fat
0,9μg
/kg
Liver
▼M121
Norgestom
et(2)
Norgestom
etBov
ine
0,2μg
/kg
Muscle
0,2μg
/kg
Fat
0,2μg
/kg
Liver
0,2μg
/kg
Kidney
0,12
μg/kg
Milk
▼M116
(1)Onlyforzootechn
ical
useandin
accordance
with
theprov
isions
ofDirectiv
e96
/22/EC.
►M12
1(2)
For
therapeutic
andzootechn
ical
purposes
only.◄
▼M92
1990R2377— EN — 16.08.2008 — 058.002— 64
ANNEX
II
LIST
OF
SUBSTANCESNOT
SUBJE
CT
TO
MAXIM
UM
RESID
UE
LIM
ITS
1.Inorganicchem
icals
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Aluminium
distearate
Allfood-produ
cing
species
Aluminium
hydrox
ideacetate
Allfood-produ
cing
species
Aluminium
phosph
ate
Allfood-produ
cing
species
▼M99
Aluminium
salicylate,
basic
Bov
ine
For
oral
useon
ly;Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption
▼M58
Aluminium
tristearate
Allfood-produ
cing
species
Ammon
ium
chloride
Allfood-produ
cing
species
▼M72
Barium
selenate
Bov
ine,
ovine
▼M58
Bismuthsubcarbo
nate
Allfood-produ
cing
species
For
oral
useon
ly
Bismuthsubg
allate
Allfood-produ
cing
species
For
oral
useon
ly
Bismuthsubn
itrate
Allfood-produ
cing
species
For
oral
useon
ly
Bismuthsubsalicylate
Allfood-produ
cing
species
For
oral
useon
ly
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 65
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Boric
acid
andbo
rates
Allfood-produ
cing
species
▼M65
Bromide,
potassium
salt
Allfood
prod
ucingspecies
▼M58
Bromide,
sodium
salt
Allmam
malianfood
-produ
cing
species
For
topicaluseon
ly
Calcium
acetate
Calcium
benzoate
Calcium
carbon
ate
Calcium
chloride
Calcium
gluconate
Calcium
hydrox
ide
Calcium
hypo
phosphite
Calcium
malate
Calcium
oxide
Calcium
phosph
ate
Calcium
polyph
osph
ates
Calcium
propionate
Calcium
silicate
Calcium
stearate
Calcium
sulphate
Allfood-produ
cing
species
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 66
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Calcium
glucoheptonate
Allfood-producing
species
Calcium
glucon
oglucoh
eptonate
Allfood-produ
cing
species
Calcium
gluconolactate
Allfood-producing
species
Calcium
glutam
ate
Allfood-produ
cing
species
▼M80
Calcium
glycerophosphate
Allfood
producingspecies
▼M58
Cob
altcarbon
ate
Allfood-produ
cing
species
Cob
altdichloride
Allfood-produ
cing
species
Cob
altglucon
ate
Allfood-produ
cing
species
Cob
altox
ide
Allfood-produ
cing
species
Cob
altsulphate
Allfood-produ
cing
species
Cob
alttrioxide
Allfood-produ
cing
species
Cop
perchloride
Allfood-produ
cing
species
Cop
perglucon
ate
Allfood-produ
cing
species
Cop
perheptanoate
Allfood-produ
cing
species
Cop
permethion
ate
Allfood-produ
cing
species
Cop
perox
ide
Allfood-produ
cing
species
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 67
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Cop
persulphate
Allfood-produ
cing
species
Dicop
perox
ide
Allfood-produ
cing
species
Hyd
rochloricacid
Allfood-produ
cing
species
For
useas
excipient
Hydrogenperoxide
Allfood-producing
species
Iodine
andiodine
inorganiccompo
unds
includ
ing:
—Sod
ium
andpo
tassium-iod
ide
—Sod
ium
andpo
tassium-iod
ate
—Iodophorsincludingpolyvinylpyrrolid
one-iodine
Allfood-produ
cing
species
Iron
dichloride
Allfood-produ
cing
species
Iron
sulphate
Allfood-produ
cing
species
Magnesium
Magnesium
sulphate
Magnesium
hydrox
ide
Magnesium
stearate
Magnesium
glutam
ate
Magnesium
orotate
Magnesium
alum
inium
silicate
Magnesium
oxide
Magnesium
carbon
ate
Magnesium
phosph
ate
Allfood-produ
cing
species
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 68
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Magnesium
glycerop
hosphate
Magnesium
aspartate
Magnesium
citrate
Magnesium
acetate
Magnesium
trisilicate
Nickelglucon
ate
Allfood-produ
cing
species
Nickelsulphate
Allfood-produ
cing
species
Potassium
DL-aspartate
Allfood-producing
species
Potassium
glucuron
ate
Allfood-produ
cing
species
Potassium
glycerop
hosphate
Allfood-produ
cing
species
Potassium
nitrate
Allfood-produ
cing
species
Potassium
selenate
Allfood-produ
cing
species
Sod
ium
chlorite
Bov
ine
For
topicaluseon
ly
Sod
ium
dichloroisocyanu
rate
Bov
ine,
ovine,
caprine
For
topicaluseon
ly
▼M62
Sod
ium
glycerop
hosphate
Allfood
prod
ucingspecies
▼M58
Sod
ium
hypo
phosph
iteAllfood-produ
cing
species
▼M129
Sod
ium
nitrite
Bov
ine
For
topicaluseon
ly
▼M77
Sod
ium
prop
ionate
Allfood
prod
ucingspecies
▼M58
Sod
ium
selenate
Allfood-produ
cing
species
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 69
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Sod
ium
selenite
Allfood-produ
cing
species
Sulph
ur►M10
1Allfood
prod
ucingspecies◄
Zincacetate
Zincchloride
Zincglucon
ate
Zincoleate
Zincstearate
Allfood-produ
cing
species
2.Organic
compo
unds Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
17β-Oestradiol
Allmam
malianfood
-produ
cing
species
For
therapeutic
andzootechn
ical
uses
only
2-Aminoethanol
Allfood-produ
cing
species
2-Aminoethyl
dihy
drog
enphosph
ate
Allfood-produ
cing
species
2-Pyrrolid
one
Allfood-produ
cing
species
Atparenteral
dosesup
to40
mg/kg
bw
8-Hyd
roxy
quinoline
Allmam
malianfood
-produ
cing
species
For
topicalusein
newbo
rnanim
alson
ly
Acetylcysteine
Allfood-produ
cing
species
Alfacalcido
lBov
ine
For
parturient
cowson
ly
Alfaprostol
Rabbits
Bov
ine,
porcine,
equidae
Bacitracin
Bov
ine
For
intram
ammaryusein
lactatingcowson
lyandforalltissues
except
milk
Benzalkon
ium
chloride
Allfood-produ
cing
species
For
useas
anexcipientat
concentrations
upto
0,05
%on
ly
Benzocaine
Allfood-produ
cing
species
For
useas
localanaesthetic
only
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 70
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Benzylalcoh
olAllfood-produ
cing
species
For
useas
excipient
Betaine
Allfood-produ
cing
species
Brono
pol
Salmon
idae
For
useon
lyon
farm
edfertilisedeggs
Brotizolam
Bov
ine
For
therapeutic
uses
only
Buserelin
Allfood-produ
cing
species
Butorph
anol
tartrate
Equ
idae
For
intravenou
sadministrationon
ly
Butyl
4-hy
drox
ybenzoate
Allfood-produ
cing
species
Butylscop
olam
inium
brom
ide
Allfood-produ
cing
species
Caffeine
Allfood-produ
cing
species
Carbetocin
Allmam
malianfood
-produ
cing
species
Cefazolin
Bov
ine
Ovine,caprine
For
intram
ammaryuse,
except
iftheud
dermay
beused
asfood
for
human
consum
ption
Cetostearyl
alcoho
lAllfood-produ
cing
species
Cetrimide
Allfood-produ
cing
species
Chlorhexidine
Allfood-produ
cing
species
For
topicaluseon
ly
Chlorocresol
Allfood-produ
cing
species
Clazuril
Pigeon
Cloprosteno
lBov
ine,
porcine,
equidae
Cocoalky
ldimethy
lbetaines
Allfood-produ
cing
species
For
useas
excipient
Corticotropin
Allfood-produ
cing
species
D-Phe
6-luteinising
-hormon
ereleasingho
rmon
eAllfood-produ
cing
species
Dem
brexine
Equ
idae
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 71
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Denaverinehy
drochloride
Bov
ine
Detom
idine
Bov
ine,
equidae
For
therapeutic
uses
only
▼M112
Diclazuril
Allruminants(1)
Porcine
(1)
▼M58
Diethyl
phtalate
Allfood-produ
cing
species
Diethyleneglycol
mon
oethyl
ether
Bov
ine,
porcine
Dim
anganese
trioxide
Allfood-produ
cing
species
For
oral
useon
ly
Dim
ethy
lph
talate
Allfood-produ
cing
species
Dinop
rost
Allmam
malianfood
-produ
cing
species
Dinop
rost
trom
ethamine
Allmam
malianfood
-produ
cing
species
Diproph
yllin
eAllfood-produ
cing
species
Etamiphy
lline
camsylate
Allfood-produ
cing
species
Ethanol
Allfood-produ
cing
species
For
useas
excipient
Ethyl
lactate
Allfood-produ
cing
species
Etip
roston
trom
ethamine
Bovine,
porcine
Fertirelin
acetate
Bov
ine
Flumethrin
Bees(hon
ey)
Folic
acid
Allfood-produ
cing
species
Glycerolform
alAllfood-produ
cing
species
Gon
adotroph
inreleasingho
rmon
eAllfood-produ
cing
species
Heptaminol
Allfood-produ
cing
species
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 72
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Hesperidin
Equ
idae
Hesperidinmethy
lchalcone
Equ
idae
Hexetidine
Equ
idae
For
topicaluseon
ly
Hum
anchoriongo
nado
trop
hin
Allfood-produ
cing
species
Hum
anmenop
ausalurinarygo
nado
trop
hin
Bov
ine
Hyd
rocortison
eAllfood-produ
cing
species
For
topicaluseon
ly
Iodine
organiccompo
unds
—Iodo
form
Allfood-produ
cing
species
Isob
utane
Allfood-produ
cing
species
Isoflurane
Equ
idae
For
useas
anaesthetic
only
Isox
suprine
Bov
ine,
equidae
For
therapeutic
useon
lyin
accordance
with
Cou
ncilDirectiv
e96
/22
/EEC
(OJL
125,
23.5.199
6,p.
3)
Ketam
ine
Allfood-produ
cing
species
Ketanserintartrate
Equ
idae
Ketop
rofen
Bov
ine,
porcine,
equidae
L-tartaricacid
andits
mon
o-anddi-basic
saltof
sodium
,po
tassium
andcalcium
Allfood-produ
cing
species
For
useas
excipient
Lactic
acid
Allfood-produ
cing
species
Lecirelin
Bov
ine,
equidae,
rabb
its
Lob
eline
Allfood-produ
cing
species
Luprostiol
Allmam
malianspecies
Malic
acid
Allfood-produ
cing
species
For
useas
excipient
Manganese
carbon
ate
Allfood-produ
cing
species
For
oral
useon
ly
Manganese
chloride
Allfood-produ
cing
species
For
oral
useon
ly
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 73
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Manganese
glucon
ate
Allfood-produ
cing
species
For
oral
useon
ly
Manganese
glycerop
hosphate
Allfood-produ
cing
species
For
oral
useon
ly
Manganese
oxide
Allfood-produ
cing
species
For
oral
useon
ly
Manganese
pido
late
Allfood-produ
cing
species
For
oral
useon
ly
Manganese
ribo
nucleate
Allfood-produ
cing
species
For
oral
useon
ly
Manganese
sulphate
Allfood-produ
cing
species
For
oral
useon
ly
Mecillinam
Bov
ine
For
intrauterine
useon
ly
Medroxyprogesterone
acetate
Ovine
For
intravaginal
useforzootechnical
purposes
only
Melaton
inOvine,caprine
Menadione
Allfood-produ
cing
species
Menbu
tone
Bov
ine,
ovine,
caprine,
porcine,
equidae
Menthol
Allfood-produ
cing
species
Methy
lnicotin
ate
Bov
ine,
equidae
For
topicaluseon
ly
Mineral
hydrocarbo
ns,low
tohigh
viscosity
includ
ingmicrocris-
talline
waxes,
approxim
ately
C10-C60;
aliphatic,
branched
aliphatic
andalicyclic
compo
unds
Allfood-producing
species
Excludesarom
atic
andunsaturatedcompounds
N-butane
Allfood-produ
cing
species
N-butanol
Allfood-produ
cing
species
For
useas
excipient
Natam
ycin
Bov
ine,
equidae
For
topicaluseon
ly
Neostigmine
Allfood-produ
cing
species
Nicob
oxil
Equ
idae
For
topicaluseon
ly
Non
ivam
ide
Equ
idae
For
topicaluseon
ly
Oleyloleate
Allfood-produ
cing
species
For
topicaluseon
ly
Oxy
tocin
Allmam
malianfood
-produ
cing
species
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 74
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Pancreatin
Allmam
malianfood
-produ
cing
species
For
topicaluseon
ly
Papain
Allfood-produ
cing
species
Papaverine
Bov
ine
New
born
calves
only
Peracetic
acid
Allfood-produ
cing
species
Pheno
lAllfood-produ
cing
species
Phlorog
lucino
lAllfood-produ
cing
species
Phy
tomenadione
Allfood-produ
cing
species
Policresulen
Allfood-produ
cing
species
For
topicaluseon
ly
Polyethyleneglycol
15hy
drox
ystearate
Allfood-produ
cing
species
For
useas
excipient
Polyethyleneglycol
7glyceryl
cocoate
Allfood-produ
cing
species
For
topicaluseon
ly
Polyethyleneglycol
stearateswith
8-40
oxyethyleneun
itsAllfood-produ
cing
species
For
useas
excipient
Polysulph
ated
glycosam
inog
lycan
Equ
idae
Praziqu
antel
Ovine
Equ
idae
For
usein
non-lactatingsheepon
ly
Pregn
antmareserum
gonado
trop
hin
Allfood-produ
cing
species
Prethcamide(crotetham
ideandcrop
ropamide)
Allmam
malianfood
-produ
cing
species
Procaine
Allfood-produ
cing
species
Propane
Allfood-produ
cing
species
Propy
lene
glycol
Allfood-produ
cing
species
Quatresin
Allfood-produ
cing
species
For
useas
preservativ
eon
lyat
concentrations
ofup
to0,5%
R-Cloprosteno
lBov
ine,
porcine,
equidae
Rifaxim
inAllmam
malianfood
-produ
cing
species
Bov
ine
For
topicaluseon
lyFor
intram
ammaryuse,
except
iftheud
dermay
beused
asfood
for
human
consum
ption
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 75
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Rom
ifidine
Equ
idae
For
therapeutic
uses
only
Sod
ium
2-methy
l-2-ph
enox
y-prop
anoate
Bov
ine,
porcine,
caprine,
equidae
Sod
ium
benzyl
4-hydrox
ybenzoate
Allfood-produ
cing
species
Sodium
butyl4-hydroxybenzoate
Allfood-producing
species
Sod
ium
cetostearylsulphate
Allfood-produ
cing
species
For
topicaluseon
ly
Som
atosalm
Salmon
Tanninu
mAllfood-produ
cing
species
Tau
fluv
alinate
Terpinhy
drate
Bov
ine,
porcine,
ovine,
caprine
Tetracaine
Allfood-produ
cing
species
For
useas
anaesthetic
only
Theob
romine
Allfood-produ
cing
species
Theop
hylline
Allfood-produ
cing
species
Thiom
ersal
Allfood-produ
cing
species
For
useon
lyas
preservativ
esin
multid
osevaccines
ataconcen-
trationno
texceeding0,02
%
Thy
mol
Allfood-produ
cing
species
Tim
erfonate
Allfood-produ
cing
species
For
useon
lyas
preservativ
esin
multid
osevaccines
ataconcen-
trationno
texceeding0,02
%
Trimethy
lphlorog
lucino
lAllfood-produ
cing
species
Vitamin
DAllfood-produ
cing
species
Woo
lalcoho
lsAllfood-produ
cing
species
For
topicaluseon
ly
▼M59
1-Methy
l-2-py
rrolidon
eEqu
idae
Cefacetrile
Bov
ine
For
intram
ammaryuseon
lyandforalltissues
except
milk
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 76
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Enilcon
azole
Bov
ine,
equidae
For
topicaluseon
ly
Etamsylate
Allfood
prod
ucingspecies
Strychn
ine
Bov
ine
For
oral
useon
lyat
dose
to0,1mg/kg
bw
▼M60
Parconazole
Guineafowl
▼M62
Biotin
Allfood
prod
ucingspecies
Bromhexine
Bov
ine
Not
foruse
inanim
als
from
which
milk
isprod
uced
forhu
man
consum
ption
Porcine
Pou
ltry
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
forhu
man
consum
ption
Mercaptam
inehydrochloride
Allmam
malianfood-producing
species
Praziqu
antel
Ovine
Pyrantelem
bonate
Equ
idae
Vitamin
B1
Allfood-produ
cing
species
Vitamin
B12
Allfood-produ
cing
species
Vitamin
B2
Allfood-produ
cing
species
Vitamin
B3
Allfood-produ
cing
species
Vitamin
B5
Allfood-produ
cing
species
Vitamin
B6
Allfood-produ
cing
species
▼M59
1990R2377— EN — 16.08.2008 — 058.002— 77
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Vitamin
EAllfood-produ
cing
species
▼M63
Tiaprost
Bov
ine,
ovine,
porcine,
equidae
▼M65
Apram
ycin
Porcine,rabb
its
Ovine
Not
foruse
inanim
als
from
which
milk
isprod
uced
forhu
man
consum
ption
Chicken
Not
forusein
anim
alsfrom
which
eggs
are
prod
uced
forhu
man
consum
ption
For
oral
useon
ly
Azamethiph
osSalmon
idae
Dox
apram
Allmam
malianfood
prod
ucingspecies
Piperon
ylbu
toxide
Bov
ine,
ovine,
caprine,
equidae
For
topicaluseon
ly
Sulfogaiacol
Allfood
prod
ucingspecies
Vetrabu
tinehy
drochloride
Porcine
▼M66
Fenpipram
idehy
drochloride
Equ
idae
For
intravenou
suseon
ly
Hyd
rochlorothiazide
Bov
ine
Levom
ethado
neEqu
idae
For
intravenou
suseon
ly
Tricainemesilate
Fin
fish
For
water
borneuseon
ly
Trichlorm
ethiazide
Allmam
malianfood
prod
ucingspecies
Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption
▼M62
1990R2377— EN — 16.08.2008 — 058.002— 78
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Vincamine
Bov
ine
For
usein
newbo
rnanim
alson
ly
▼M67
Atrop
ine
Allfood
prod
ucingspecies
Cefop
erazon
eBov
ine
For
intram
ammaryusein
lactatingcowson
lyandforalltissues
except
milk
▼M69
2-am
inoethanol
glucuron
ate
Allfood-produ
cing
species
Betaine
glucuron
ate
Allfood-produ
cing
species
▼M118
Bitu
minosulfonates,
ammon
ium
andsodium
salts
Allmam
malianfood
prod
ucingspecies
For
topicaluseon
ly
▼M69
Chlorph
enam
ine
Allmam
malianfood
-produ
cing
species
Hum
icacidsandtheirsodium
salts
Allfood-produ
cing
species
For
oral
useon
ly
Paracetam
olPorcine
For
oral
useon
ly
Tosylchloramidesodium
Fin
fish
For
water-borne
useon
ly
▼M88
Bov
ine
For
topicaluseon
ly
▼M125
Equ
idae
For
topicaluseon
ly
▼M70
1-methy
l-2-py
rrolidon
eAllfood-produ
cing
species
Ergom
etrine
maleate
Allmam
malianfood
-produ
cing
species
For
usein
parturient
anim
alson
ly
Jecorisoleum
Allfood-produ
cing
species
For
topicaluseon
ly
▼M66
1990R2377— EN — 16.08.2008 — 058.002— 79
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Mepivacaine
Equ
idae
For
intra-articular
andepidural
useas
localanaesthetic
only
Nov
obiocin
Bov
ine
For
intram
maryuseon
lyandforalltissues
except
milk
Piperazinedihydrochloride
Chicken
For
alltissues
except
eggs
Polyo
xylcastor
oilwith
30to
40ox
yethyleneun
itsAllfood-produ
cing
species
For
useas
excipient
Polyo
xylhy
drog
enated
castor
oilwith
40to
60ox
yethyleneun
itsAllfood-produ
cing
species
For
useas
excipient
Xylazinehy
drochloride
Bov
ine,
equidae
Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ptiom
▼M71
Butafosfan
Bov
ine
►M78
For
intravenou
suseon
ly◄
Cefalon
ium
Bov
ine
For
intram
ammaryuseandeyetreatm
enton
ly,andforalltissues
except
milk
Furosem
ide
Bov
ine,
equidae
For
intravenou
sadministrationon
ly
Lidocaine
Equ
idae
For
local-region
alanaesthesiaon
ly
▼M72
3,5-Diio
do-L-thy
rosine
Allmam
malianfood
-produ
cing
species
Levothy
roxine
Allmam
malianfood
-produ
cing
species
▼M74
Aluminium
salicylate,
basic
All
food
prod
ucing
species
except
fish
For
topicaluseon
ly
Bismuthsubn
itrate
Bov
ine
For
intram
ammaryuseon
ly
Calcium
aspartate
Allfood
producingspecies
Methy
lsalicylate
Allfood
prod
ucingspeciesexcept
fish
For
topicaluseon
ly
▼M70
1990R2377— EN — 16.08.2008 — 058.002— 80
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Salicylic
acid
Allfood
prod
ucingspeciesexcept
fish
For
topicaluseon
ly
▼M115
Sod
ium
salicylate
Bov
ine,
porcine(2)
▼M74
Zincaspartate
Allfood
prod
ucingspecies
▼M75
Toldimfos
Allfood
prod
ucingspecies
▼M77
Decoq
uinate
Bov
ine,
ovine
For
oral
use
only.Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption
Sod
ium
boroform
iate
Allfood
prod
ucingspecies
▼M81
Thiam
ylal
Allmam
malianfood
prod
ucingspecies
For
intravenou
sadministrationon
ly
Thiop
entalsodium
Allfood-produ
cing
species
For
intravenou
sadministrationon
ly
▼M105
Acetylsalicylic
acid
Allfood
prod
ucingspeciesexcept
fish
Not
forusein
anim
alsfrom
which
milk
oreggs
areprod
uced
for
human
consum
ption
Acetylsalicylic
acid
DL-lysine
Allfood
prod
ucingspeciesexcept
fish
Not
forusein
anim
alsfrom
which
milk
oreggs
areprod
uced
for
human
consum
ption
Carbasalate
calcium
Allfood
prod
ucingspeciesexcept
fish
Not
forusein
anim
alsfrom
which
milk
oreggs
areprod
uced
for
human
consum
ption
▼M74
1990R2377— EN — 16.08.2008 — 058.002— 81
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Sod
ium
acetylsalicylate
Allfood
prod
ucingspeciesexcept
fish
Not
forusein
anim
alsfrom
which
milk
oreggs
areprod
uced
for
human
consum
ption
▼M83
Linearalkylbenzene
sulpho
nic
acidswith
alky
lchain
leng
ths
rang
ing
from
C9to
C13,containing
less
than
2,5
%of
chains
long
erthan
C13
Bov
ine
For
topicaluseon
ly
▼M117
Ovine
(4)
▼M86
Amprolium
Pou
ltry
For
oral
useon
ly
Tilu
dron
icacid,disodium
salt
Equ
idae
For
intravenou
suseon
ly
▼M89
Sorbitantrioleate
Allfood-produ
cing
species
▼M90
Vitamin
AAllfood
prod
ucingspecies
▼M91
Ammon
ium
lauryl
sulphate
Allfood-produ
cing
species
Brono
pol
Fin
fish
Calcium
pantothenate
Allfood-producing
species
▼M94
Allantoin
Allfood
prod
ucingspecies
For
topicaluseon
ly
Benzocaine
Salmon
idae
▼M95
Dexpantheno
lAllfood
prod
ucingspecies
▼M105
1990R2377— EN — 16.08.2008 — 058.002— 82
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
▼M97
Azagly-nafarelin
Salmon
idae
Not
foruse
infish
from
which
eggs
are
prod
uced
forhu
man
consum
ption
Deslorelin
acetate
Equ
idae
▼M98
Hyd
roxy
ethy
lsalicylate
Allfood
prod
ucingspeciesexcept
fish
For
topicaluseon
ly
Xylazinehydrochloride
Bovine,
equidae
▼M99
Omeprazole
Equ
idae
For
oral
useon
ly
▼M100
Trichlorm
ethiazide
Allmam
malianfood
prod
ucingspecies
▼M107
Progesteron
e(*)
Bov
ine,
ovine,
caprine,
Equ
idae
(fem
ale)
▼M116
Beclomethasone
dipropionate
Equidae
(3)
Cloprosteno
lCaprine
R-cloprosteno
lCaprine
Sorbitansesquioleate
Allfood
prod
ucingspecies
▼M126
Diethyleneglycol
mon
oethyl
ether
Allruminants
andpo
rcine
▼M129
Peforelin
Porcine
▼M94
1990R2377— EN — 16.08.2008 — 058.002— 83
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
▼M138
Dinop
roston
eAllmam
malianspecies
▼M107
(*)O
nlyforintravaginal
therapeutic
orzootechn
ical
useandin
accordance
with
theprov
isions
ofDirectiv
e96
/22/EC.
►M11
2(1)For
oral
useon
ly.◄
►M11
5(2)For
oral
use;
notforusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
◄►M11
6(3)For
inhalatio
nuseon
ly.◄
►M11
7(4)For
topicaluseon
ly.◄
▼M129
1990R2377— EN — 16.08.2008 — 058.002— 84
3.Sub
stancesgenerally
recogn
ised
assafe
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Absinthium
extract
Allfood-produ
cing
species
Acetylm
ethion
ine
Allfood-produ
cing
species
Aluminium
hydrox
ide
Allfood-produ
cing
species
Aluminium
mon
ostearate
Allfood-produ
cing
species
Ammon
ium
sulfate
Allfood-produ
cing
species
►C6
Benzylbenzoate◄
Allfood-produ
cing
species
Benzylp-hy
drox
ybenzoate
Allfood-produ
cing
species
Calcium
boroglucon
ate
Allfood-produ
cing
species
Calcium
citrate
Allfood-produ
cing
species
Cam
phor
Allfood-produ
cing
species
Externaluseon
ly
Cardamon
extract
Allfood-produ
cing
species
Diethyl
sebacate
Allfood-produ
cing
species
Dim
ethicone
Allfood-produ
cing
species
Dim
ethylacetam
ide
Allfood-producing
species
Dim
ethy
lsulpho
xide
Allfood-produ
cing
species
Epineph
rine
Allfood-produ
cing
species
Ethyl
oleate
Allfood-produ
cing
species
Ethylenediaminetetraacetic
acid
andsalts
Allfood-produ
cing
species
Eucalyp
tol
Allfood-produ
cing
species
Follicle
stim
ulating
horm
one(natural
FSH
from
allspeciesand
theirsynthetic
analogues)
Allfood-produ
cing
species
Formaldehy
deAllfood-produ
cing
species
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 85
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Formic
acid
Allfood-produ
cing
species
Glutaraldehyd
eAllfood-produ
cing
species
Guaiacol
Allfood-produ
cing
species
Heparin
andits
salts
Allfood-produ
cing
species
Hum
anchorionic
gonado
trop
in(natural
HCG
and
itssynthetic
analog
ues)
Allfood-produ
cing
species
Iron
ammon
ium
citrate
Allfood-produ
cing
species
Iron
dextran
Allfood-produ
cing
species
Iron
glucoh
eptonate
Allfood-produ
cing
species
Isop
ropano
lAllfood-produ
cing
species
Lanolin
Allfood-produ
cing
species
Luteinising
horm
one
(natural
LH
from
all
species
and
their
synthetic
analogues)
Allfood-produ
cing
species
Magnesium
chloride
Allfood-produ
cing
species
Magnesium
glucon
ate
Allfood-produ
cing
species
Magnesium
hypo
phosph
iteAllfood-produ
cing
species
Mannitol
Allfood-produ
cing
species
Methy
lbenzoate
Allfood-produ
cing
species
Mon
othiog
lycerol
Allfood-produ
cing
species
Mon
tanide
Allfood-produ
cing
species
Myg
lyol
Allfood-produ
cing
species
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 86
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Orgotein
Allfood-produ
cing
species
Polox
alene
Allfood-produ
cing
species
Polox
amer
Allfood-produ
cing
species
Polyethylene
glycols
(molecular
weightranging
from
200
to10
000)
Allfood-produ
cing
species
Polysorbate
80Allfood-produ
cing
species
Seroton
inAllfood-produ
cing
species
Sod
ium
chloride
Allfood-produ
cing
species
Sod
ium
crom
oglycate
Allfood-produ
cing
species
Sod
ium
dioctylsulph
osuccinate
Allfood-produ
cing
species
Sod
ium
form
aldehy
desulpho
xylate
Allfood-produ
cing
species
Sod
ium
lauryl
sulphate
Allfood-produ
cing
species
Sod
ium
pyrosulphite
Allfood-produ
cing
species
Sod
ium
stearate
Allfood-produ
cing
species
Sod
ium
thiosulphate
Allfood-produ
cing
species
Tragacanth
Allfood-produ
cing
species
Urea
Allfood-produ
cing
species
Zincox
ide
Allfood-produ
cing
species
Zincsulphate
Allfood-produ
cing
species
▼M65
Adeno
sine
andits
5′-m
ono-,5′-di-and5′-triph
osph
ates
Allfood
prod
ucingspecies
Alanine
Allfood
prod
ucingspecies
Arginine
Allfood
prod
ucingspecies
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 87
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Asparagine
Allfood
prod
ucingspecies
Aspartic
acid
Allfood
prod
ucingspecies
Carnitin
eAllfood
prod
ucingspecies
Cho
line
Allfood
prod
ucingspecies
Chy
motrypsin
Allfood
prod
ucingspecies
Citrullin
eAllfood
prod
ucingspecies
Cysteine
Allfood
prod
ucingspecies
Cytidineandits
5′-m
ono-,5′-di-and5′-triph
osph
ates
Allfood
prod
ucingspecies
Glutamic
acid
Allfood
prod
ucingspecies
Glutamine
Allfood
prod
ucingspecies
Glycine
Allfood
prod
ucingspecies
Guano
sine
andits
5′-m
ono-,5′-di-and5′-triph
osph
ates
Allfood
prod
ucingspecies
Histid
ine
Allfood
prod
ucingspecies
Hyaluronicacid
Allfood
prod
ucingspecies
Inosineandits
5′-m
ono-,5′-di-and5′-triph
osph
ates
Allfood
prod
ucingspecies
Inosito
lAllfood
prod
ucingspecies
Isoleucine
Allfood
prod
ucingspecies
Leucine
Allfood
prod
ucingspecies
Lysine
Allfood
prod
ucingspecies
Methion
ine
Allfood
prod
ucingspecies
Ornith
ine
Allfood
prod
ucingspecies
Orotic
acid
Allfood
prod
ucingspecies
Pepsin
Allfood
prod
ucingspecies
▼M65
1990R2377— EN — 16.08.2008 — 058.002— 88
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Pheny
lalanine
Allfood
prod
ucingspecies
Prolin
eAllfood
prod
ucingspecies
Serine
Allfood
prod
ucingspecies
Thioctic
acid
Allfood
prod
ucingspecies
Threonine
Allfood
prod
ucingspecies
Thy
midine
Allfood
prod
ucingspecies
Trypsin
Allfood
prod
ucingspecies
Tryptop
han
Allfood
prod
ucingspecies
Tyrosine
Allfood
prod
ucingspecies
Uridine
andits
5′-m
ono-,5′-di-and5′-triphosphates
Allfood
producingspecies
Valine
Allfood
prod
ucingspecies
▼M126
Polyoxyethylene
sorbitanmonooleate
Allfood
producingspecies
▼M128
Polyo
xyethy
lene
sorbitanmon
ooleateandtrioleate
Allfood-produ
cing
species
▼M65
1990R2377— EN — 16.08.2008 — 058.002— 89
4.Sub
stancesused
inho
meopathic
veterinary
medicinal
prod
ucts
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Allsubstances
used
inho
meopathic
veterinary
medicinal
prod
ucts
prov
ided
that
theirconcentrationin
theprod
uctdo
esno
texceed
onepartpertenthou
sand
Allfood-produ
cing
species
▼M63
Adonisvernalis
Allfood
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperhu
ndredon
ly
Acqua
levici
Allfood
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiason
ly
Atrop
abellado
nna
Allfood
prod
ucingspecies
For
use
inho
meopathic
veterinary
medicinal
prod
ucts
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperhu
ndredon
ly
Con
vallariamajalis
Allfood
prod
ucingspecies
For
use
inho
meopathic
veterinary
medicinal
prod
ucts
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperthou
sand
only
▼M66
Apo
cynu
mcann
abinum
Allfood
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperhu
ndredon
lyFor
oral
useon
ly
Harun
gamad
agascariensis
Allfood
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperhu
ndredon
ly
Selenicereus
gran
diflo
rus
Allfood
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperhu
ndredon
ly
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 90
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Thu
jaoccidentalis
Allfood
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperhu
ndredon
ly
Virolasebifera
Allfood
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperthou
sand
only
▼M68
Rutagraveolens
Allfood-producing
species
For
use
inhomeopathic
veterinary
medicinal
products
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperthou
sand
only.
Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption
▼M71
Aesculushippocastanum
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
inthe
prod
ucts
notexceedingon
epartpertenon
ly
Agnus
castus
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Aila
nthu
saltissima
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Allium
cepa
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
▼M66
1990R2377— EN — 16.08.2008 — 058.002— 91
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Arnicae
radix
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
intheprod
ucts
notexceedingon
epartpertenon
ly
Artem
isia
abrotanu
mAll-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Bellis
perenn
isAll-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Calendu
laofficinalis
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
intheprod
ucts
notexceedingon
epartpertenon
ly
Cam
phora
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
inthe
prod
ucts
notexceedingon
epartperhu
ndredon
ly.
Cardiosperm
umha
licacab
umAll-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Crataegus
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Echinacea
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
lyFor
topicaluseon
ly.
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
intheprod
ucts
notexceedingon
epartpertenon
ly
▼M71
1990R2377— EN — 16.08.2008 — 058.002— 92
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Eucalyptusglob
ulus
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Eup
hrasia
officinalis
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Ginkgobiloba
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
inthe
prod
ucts
notexceedingon
epartperthou
sand
only.
Ginseng
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Ham
amelis
virginiana
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
inthe
prod
ucts
notexceedingon
epartpertenon
ly
Harpa
goph
ytum
procum
bens
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Hypericum
perforatum
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Lachn
anthes
tinctoria
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
inthe
prod
ucts
notexceedingon
epartperthou
sand
only.
Lobaria
pulmonaria
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
▼M71
1990R2377— EN — 16.08.2008 — 058.002— 93
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Okoub
akaau
brevillei
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Prunuslaurocerasus
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
inthe
prod
ucts
notexceedingon
epartperthou
sand
only.
Sereno
arepens
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Silybu
mmarianu
mAll-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Solid
agovirgau
rea
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Syzygium
cumini
All-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Turnera
diffu
saAll-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
Viscum
albu
mAll-food
producingspecies
For
use
inhomeopathic
veterinary
medicinal
products
prepared
accordingto
homeopathic
pharmacop
oeiasat
concentrations
corre-
spon
ding
tothemothertin
ctureanddilutio
nsthereofon
ly
▼M71
1990R2377— EN — 16.08.2008 — 058.002— 94
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
▼M72
Phytolaccaam
erican
aAllfood-producing
species
For
use
inhomeopathic
veterinary
medicinal
products
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperthou
sand
only
Urginea
maritima
Allfood-producing
species
For
use
inhomeopathic
veterinary
medicinal
products
prepared
according
toho
meopathic
pharmacop
oeias,
atconcentrations
intheprod
ucts
notexceedingon
epartperhu
ndredon
lyFor
oral
useon
ly
▼M58
5.Sub
stancesused
asfood
additiv
esin
food
stuffs
forhu
man
consum
ption
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Sub
stanceswith
anE
number
Allfood-produ
cing
species
Only
substances
approved
asadditiv
esin
food
stuffs
forhu
man
consum
ption,
with
theexceptionof
preservativ
eslistedin
part
Cof
Ann
exIIIto
Europ
eanParliamentandCou
ncilDirectiv
e95
/2/EC
(OJL
61,18
.3.199
5,p.
1).
6.Sub
stancesof
vegetableorigin
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
▼M73
Aloevera
gelandwho
leleaf
extractof
Aloevera
Allfood-produ
cing
species
For
topicaluseon
ly
▼M71
Aloes,Barba
dosan
dCap
ae,theirstan
dardised
dryextractan
dpreparations
thereof
Allfood-produ
cing
species
▼M71
1990R2377— EN — 16.08.2008 — 058.002— 95
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
▼M58
Ang
elicae
radixaetheroleum
Allfood-produ
cing
species
Anisi
aetheroleum
Allfood-produ
cing
species
▼M77
Anisi
stellatifructus,standardised
extracts
andpreparations
thereof
Allfood
prod
ucingspecies
▼M71
Arnicamon
tana
(arnicae
flosan
darnicaeplan
tatota)
Allfood-produ
cing
species
For
topicaluseon
ly
▼M58
Balsamum
peruvian
umAllfood-produ
cing
species
For
topicaluseon
ly
▼M71
Boldo
foliu
mAllfood-produ
cing
species
▼M70
Calendu
laeflo
sAllfood-produ
cing
species
For
topicaluseon
ly
▼M68
Cap
sici
fructusacer
Allfood-produ
cing
species
▼M71
Carlin
aeradix
Allfood-produ
cing
species
For
topicaluseon
ly
▼M58
Carvi
aetheroleum
Allfood-produ
cing
species
Caryoph
ylliaetheroleum
Allfood-produ
cing
species
▼M59
Centella
easiaticaerextractum
Allfood
prod
ucingspecies
For
topicaluseon
ly
▼M58
Chrysan
them
icinerariifo
liiflo
sAllfood-produ
cing
species
For
topicaluseon
ly
▼M71
1990R2377— EN — 16.08.2008 — 058.002— 96
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
▼M70
Cimicifu
gaeracemosae
rhizom
aAllfood-produ
cing
species
Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ptiom
▼M77
Cinchon
aecortex,standardised
extracts
and
preparations
thereof
Allfood
producingspecies
▼M58
Cinnamom
icassiaeaetheroleum
Allfood-produ
cing
species
▼M77
Cinna
mom
icassiaecortex,standardised
extracts
andpreparations
thereof
Allfood
prod
ucingspecies
▼M58
Cinna
mom
iceylan
iciaetheroleum
Allfood-produ
cing
species
▼M77
Cinna
mom
iceylan
icicortex,standardised
extractsandpreparations
thereof
Allfood
prod
ucingspecies
▼M58
Citriaetheroleum
Allfood-produ
cing
species
Citron
ellaeaetheroleum
Allfood-produ
cing
species
▼M77
Con
durang
ocortex,standardised
extracts
andpreparations
thereof
Allfood
prod
ucingspecies
▼M58
Coriandri
aetheroleum
Allfood-produ
cing
species
▼M71
Cup
ressiaetheroleum
Allfood-produ
cing
species
For
topicaluseon
ly
▼M58
1990R2377— EN — 16.08.2008 — 058.002— 97
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
▼M58
Echinacea
purpurea
Allfood-produ
cing
species
For
topicaluseon
ly
Eucalyptiaetheroleum
Allfood-produ
cing
species
Foeniculiaetheroleum
Allfood-produ
cing
species
▼M77
Frang
ulae
cortex,standardised
extracts
andpreparations
thereof
Allfood
producingspecies
Gentia
naeradix,
standardised
extracts
andpreparations
thereof
Allfood
prod
ucingspecies
▼M133
Ginseng
,standardised
extracts
andpreparations
thereof
Allfood-produ
cing
species
▼M58
Ham
amelis
virginiana
Allfood-produ
cing
species
For
topicaluseon
ly
▼M68
Hippo
castan
isemen
Allfood-produ
cing
species
For
topicaluseon
ly
▼M58
Hypericiol0eum
Allfood-produ
cing
species
For
topicaluseon
ly
▼M68
Juniperi
fructus
Allfood-produ
cing
species
Lauri
folii
aetheroleum
Allfood-produ
cing
species
Lau
rifructus
Allfood-produ
cing
species
▼M71
Lavan
dulaeaetheroleum
Allfood-produ
cing
species
For
topicaluseon
ly
▼M58
Lespedeza
capitata
Allfood-produ
cing
species
Linioleum
Allfood-produ
cing
species
Majoran
aeherba
Allfood-produ
cing
species
▼M74
Matricariarecutitaandpreparations
thereof
Allfood
prod
ucingspecies
▼M71
1990R2377— EN — 16.08.2008 — 058.002— 98
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
▼M58
Matricariae
flos
Allfood-produ
cing
species
Medicag
osativaextractum
Allfood-produ
cing
species
For
topicaluseon
ly
▼M59
Melissaeaetheroleum
Allfood
prod
ucingspecies
▼M58
Melissaefoliu
mAllfood-produ
cing
species
▼M91
Menthae
arvensis
aetheroleum
Allfood-produ
cing
species
▼M58
Menthae
piperitaeaetheroleum
Allfood-produ
cing
species
Millefoliiherba
Allfood-produ
cing
species
Myristicae
aetheroleum
Allfood-produ
cing
species
For
usein
newbo
rnanim
alson
ly
▼M140
Lectin
extractedfrom
redkidn
eybeansPha
seolus
vulgaris
Porcine
For
oral
useon
ly
▼M125
Piceaeturion
esrecentes
extractum
Allfood
prod
ucingspecies
For
oral
useon
ly
▼M58
Oxidatio
nprod
ucts
ofTerebinthinae
oleum
Bov
ine,
porcine,
ovine,
caprine
Pyrethrum
extract
Allfood-produ
cing
species
For
topicaluseon
ly
Quercus
cortex
Allfood-produ
cing
species
Quilla
iasapo
nins
Allfood-produ
cing
species
▼M74
Rheiradix,
standardised
extracts
andpreparations
thereof
Allfood
producingspecies
▼M58
Ricinioleum
Allfood-produ
cing
species
For
useas
excipient
Rosmariniaetheroleum
Allfood-produ
cing
species
▼M74
1990R2377— EN — 16.08.2008 — 058.002— 99
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Rosmarinifoliu
mAllfood-produ
cing
species
▼M68
Ruscusaculeatus
Allfood-produ
cing
species
For
topicaluseon
ly
▼M58
Salviaefoliu
mAllfood-produ
cing
species
Sambu
ciflo
sAllfood-produ
cing
species
Sina
pisnigrae
semen
Allfood-produ
cing
species
▼M68
Strychni
semen
Bov
ine,
ovine,
caprine
For
oral
use
only
atdo
ses
upto
the
equivalent
of0,1
mg
strychnine/kgbw
▼M71
Symph
ytiradix
Allfood-produ
cing
species
For
topicaluseon
intact
skin
only
▼M58
Terebinthinae
aetheroleum
rectificatum
Allfood-produ
cing
species
For
topicaluseon
ly
Terebinthinae
laricina
Allfood-produ
cing
species
For
topicaluseon
ly
Thymiaetheroleum
Allfood-produ
cing
species
Tiliae
flos
Allfood-produ
cing
species
Urticae
herba
Allfood-produ
cing
species
▼M1117.
Anti-infectious
agents
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Oxalic
acid
Hon
eybees
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 100
8.Anti-inflam
matoryagents
Pharm
acolog
ically
activ
esubstance(s)
Animal
species
Other
prov
isions
Carprofen
Bov
ine(1)
(1)For
bovine
milk
only.
▼M119
1990R2377— EN— 16.08.2008 — 058.002 — 101
ANNEX
III
LIST
OF
PHARMACOLOGIC
ALLY
ACTIV
ESUBSTANCES
USED
INVETERIN
ARY
MEDIC
INAL
PRODUCTS
FOR
WHIC
HPROVISIO
NAL
MAXIM
UM
RESID
UE
LIM
ITSHAVE
BEEN
FIX
ED
1.Anti-infectious
agents
1.1.
Chemotheurapeutics
1.1.2.
Benzenesulphonamides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Clorsulon
Clorsulon
Bov
ine
50μg
/kg
Muscle
Provision
alMRLsexpire
on1Janu
ary
2000
150μg
/kg
Liver
400μg
/kg
Kidney
1.2.
Antibiotics
1.2.1.
Beta-lactam
aseinhibitors
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Clavu
lanicacid
Clavu
lanicacid
Bov
ine,
ovine
200μg
/kg
Milk
►M67
Provision
alMRLsexpire
on1July
2001
◄
Bov
ine,
ovine,
porcine
200μg
/kg
Muscle
200μg
/kg
Fat
200μg
/kg
Liver
200μg
/kg
Kidney
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 102
1.2.2.
Macrolid
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M74
Acetylisov
aleryltylosin
Sum
ofacetylisov
aler-
yltylosinand3-O-acet-
yltylosin
Porcine
100μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
01
100μg
/kg
Skinandfat
100μg
/kg
Liver
100μg
/kg
Kidney
▼M117
Acetylisov
aleryltylosin(1)
Sum
ofacetyl-isovaler-
yltylosinand3-O-acet-
yltylosin
Pou
ltry(2)
50μg
/kg
Skinandfat
50μg
/kg
Liver
▼M58
Erythromycin
MRLs
apply
toall
microbiolog
ical
activ
eresidu
esexpressed
aserythrom
ycin
equivalent
Bov
ine,
ovine
40μg
/kg
Milk
Provision
alMRLsexpire
on1
June
2000
Bov
ine,
ovine,
porcine,
poultry
400μg
/kg
Muscle
400μg
/kg
Fat
400μg
/kg
Liver
400μg
/kg
Kidney
Pou
ltry
200μg
/kg
Egg
s
Josamycin
Josamycin
Chicken
200μg
/kg
Muscle
►M77
Provision
alMRLsexpire
on1.7.20
02◄
200μg
/kg
Fat
200μg
/kg
Liver
400μg
/kg
Kidney
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 103
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
200μg
/kg
Egg
s
▼M60
Sum
ofthemicrobiolo-
gically
activ
emeta-
bolites,
expressed
asjosamycin
Porcine
200μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
02
200μg
/kg
Skinandfat
200μg
/kg
Liver
400μg
/kg
Kidney
▼M70
Tilm
icosin
Tilm
icosin
Bov
ine
40μg
/kg
Milk
Provision
alMRLsexpire
on1.1.20
01
▼M99
Tulathrom
ycin
(2R,3S,4R,5R,8R,10-
R,11R
,12S
,13
S,14R
)-2-
ethy
l-3,4,10
,13-tetra-
hydrox
y-3,5,8,10
,12,14
-hexamethy
l-11
-[[3,4,6-
trideoxy
-3-(dimethy
-lamino)-β-D
-xylo-
hexo
pyrano
syl]ox
y]-1-
oxa-
6-azacyclopent-
decan-15
-one
expressed
astula-
thromycin
equivalents
Bov
ine
100μg
/kg
Fat
Provision
alMRLsexpire
on1
July
2004
;no
tforuse
inanim
als
from
which
milk
isproduced
forhu
man
consum
ption
300
0μg
/kg
Liver
300
0μg
/kg
Kidney
Porcine
100μg
/kg
Skinandfat
Provision
alMRLsexpire
on1
July
2004
300
0μg
/kg
Liver
300
0μg
/kg
Kidney
▼M139
Gam
ithromycin
Gam
ithromycin
Bov
ine
20μg
/kg
Fat
Provision
alMRLs
will
expire
on1July
2009
.Not
forusein
anim
alsprod
ucingmilk
forhu
man
consum
ption
200μg
/kg
Liver
100μg
/kg
Kidney
▼M117
(1)Provision
alMRLsexpire
on1July
2006
.(2)Not
forusein
anim
alsfrom
which
eggs
areprod
uced
forhu
man
consum
ption.
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 104
1.2.4.
Cephalosporins
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Cefacetrile
Cefacetrile
Bov
ine
125μg
/kg
Milk
►M83
Provision
alMRLsexpire
on1.1.20
02◄
For
intram
mam
aryuseon
ly
▼M71
Cefalon
ium
Cefalon
ium
Bov
ine
10μg
/kg
Milk
►M85
Provision
alMRLsexpire
on1.1.20
03◄
▼M67
Cefop
erazon
eCefop
erazon
eBov
ine
50μg
/kg
Milk
Provision
alMRLsexpire
on1Janu
ary
2001
▼M61
Cefqu
inom
eCefqu
inom
ePorcine
50μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
00
50μg
/kg
Skin+fat
100μg
/kg
Liver
200μg
/kg
Kidney
▼M59
Cephapirin
Sum
ofceph
apirin
and
desacetylcephapirin
Bov
ine
50μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
01
50μg
/kg
Fat
50μg
/kg
Liver
100μg
/kg
Kidney
10μg
/kg
Milk
▼M59
1990R2377— EN— 16.08.2008 — 058.002 — 105
1.2.5.
Aminoglycosides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Aminosidine
Aminosidine
Bov
ine,
porcine,
rabb
its,chicken
500μg
/kg
Muscle
Provision
alMRLsexpire
on1
July
2000
150
0μg
/kg
Liver
150
0μg
/kg
Kidney
Apram
ycin
Apram
ycin
Bov
ine
100
0μg
/kg
Muscle
Provision
alMRLsexpire
on1
July
1999
For
use
inno
n-lactatingcattleon
ly100
0μg
/kg
Fat
1000
0μg
/kg
Liver
2000
0μg
/kg
Kidney
Porcine
100
0μg
/kg
Muscle
100
0μg
/kg
Skinandfat
100
0μg
/kg
Liver
500
0μg
/kg
Kidney
▼M76
Dihyd
rostreptom
ycin
Dihyd
rostreptom
ycin
Bov
ine,
ovine
500μg
/kg
Muscle
Provision
alMRLsexpire
on1.6.20
02
500μg
/kg
Fat
500μg
/kg
Liver
100
0μg
/kg
Kidney
200μg
/kg
Milk
Porcine
500μg
/kg
Muscle
500μg
/kg
Skinandfat
500μg
/kg
Liver
100
0μg
/kg
Kidney
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 106
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Gentamicin
Gentamicin
Bov
ine
100μg
/kg
Milk
Provision
alMRLsexpire
on1.6.20
02
Bov
ine,
porcine
50μg
/kg
Muscle
50μg
/kg
Fat
200μg
/kg
Liver
750μg
/kg
Kidney
▼M65
Kanam
ycin
Kanam
ycin
Rabbits
100μg
/kg
Muscle
►M91
Provision
alMRLsexpire
on1.1.20
04◄
100μg
/kg
Fat
600μg
/kg
Liver
250
0μg
/kg
Kidney
Bov
ine,
ovine
100μg
/kg
Muscle
100μg
/kg
Fat
▼M76
1990R2377— EN— 16.08.2008 — 058.002 — 107
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
600μg
/kg
Liver
250
0μg
/kg
Kidney
150μg
/kg
Milk
Porcine,chicken
100μg
/kg
Muscle
100μg
/kg
Skin+fat
600μg
/kg
Liver
250
0μg
/kg
Kidney
▼M76
Neomycin
(including
fram
ycetin)
Neomycin
BBovine,
porcine,
chicken
500μg
/kg
Muscle
Provision
alMRLsexpire
on1.6.20
02
500μg
/kg
Fat
500μg
/kg
Liver
500
0μg
/kg
Kidney
Bov
ine
500μg
/kg
Milk
Chicken
500μg
/kg
Egg
s
▼M58
Spectinom
ycin
Spectinom
ycin
Bov
ine
200μg
/kg
Milk
Provision
alMRLsexpire
on1
July
2000
Bov
ine,
porcine,
poultry
300μg
/kg
Muscle
500μg
/kg
Fat
200
0μg
/kg
Liver
500
0μg
/kg
Kidney
▼M65
1990R2377— EN— 16.08.2008 — 058.002 — 108
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M71
Ovine
Not
forusein
anim
als
from
which
milk
isprod
uced
for
human
consum
ption
300μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
02
500μg
/kg
Fat
200
0μg
/kg
Liver
500
0μg
/kg
Kidney
Chicken
200μg
/kg
Egg
s
▼M76
Streptomycin
Streptomycin
Bov
ine,
ovine
500μg
/kg
Muscle
Provision
alMRLsexpire
on1.6.20
02
500μg
/kg
Fat
500μg
/kg
Liver
100
0μg
/kg
Kidney
200μg
/kg
Milk
Porcine
500μg
/kg
Muscle
500μg
/kg
Skinandfat
500μg
/kg
Liver
100
0μg
/kg
Kidney
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 109
1.2.6.
Quino
lones
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M60
Danofloxacin
Danofloxacin
Porcine
100μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
00
50μg
/kg
Skinandfat
200μg
/kg
Liver
200μg
/kg
Kidney
▼M58
Decoq
uinate
Decoq
uinate
Bov
ine,
ovine
500μg
/kg
Muscle
Provision
alMRLsexpire
on1
July
2000
500μg
/kg
Fat
500μg
/kg
Liver
500μg
/kg
Kidney
▼M62
Difloxacin
Difloxacin
Bov
ine
Not
forusein
anim
als
from
which
milk
isprod
uced
for
human
consum
ption
400μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
01
100μg
/kg
Fat
140
0μg
/kg
Liver
800μg
/kg
Kidney
Porcine
400μg
/kg
Muscle
100μg
/kg
Skinandfat
800μg
/kg
Liver
800μg
/kg
Kidney
▼M58
1990R2377— EN— 16.08.2008 — 058.002— 110
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M58
Enrofloxacin
Sum
ofenroflox
acin
andciprofloxacin
Ovine
100μg
/kg
Muscle
Provision
alMRLsexpire
on1
July
1999
100μg
/kg
Fat
300μg
/kg
Liver
200μg
/kg
Kidney
Flumequine
Flumequine
Bov
ine,
ovine,
porcine,
chicken
50μg
/kg
Muscle
Provision
alMRLsexpire
on1Janu
ary
2000
50μg
/kg
Fat
orskin
andfat
100μg
/kg
Liver
300μg
/kg
Kidney
Salmonidae
150μg
/kg
Muscleandskin
Marbo
flox
acin
Marbo
flox
acin
Bov
ine
150μg
/kg
Muscle
Provision
alMRLsexpire
on1
July
2000
50μg
/kg
Fat
150μg
/kg
Liver
150μg
/kg
Kidney
▼M62
1990R2377— EN — 16.08.2008 — 058.002— 111
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
75μg
/kg
Milk
Porcine
150μg
/kg
Muscle
50μg
/kg
Skinandfat
150μg
/kg
Liver
150μg
/kg
Kidney
▼M111
Oxo
linic
acid
(1)
Oxo
linic
acid
Bov
ine(2)
100μg
/kg
Muscle
50μg
/kg
Fat
150μg
/kg
Liver
150μg
/kg
Kidney
▼M59
Porcine
100μg
/kg
Muscle
50μg
/kg
Skin+fat
150μg
/kg
Liver
150μg
/kg
Kidney
Chicken
100μg
/kg
Muscle
50μg
/kg
Skin+fat
150μg
/kg
Liver
150μg
/kg
Kidney
50μg
/kg
Egg
s
Fin
fish
300μg
/kg
Muscle
and
skin
innaturalproportio
ns
▼M111
(1)Provision
alMRLsexpire
1Janu
ary20
06.
(2)Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
▼M58
1990R2377— EN— 16.08.2008 — 058.002— 112
1.2.9.
Polym
yxins
Phamarcologicallyactiv
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Colistin
Colistin
Bov
ine,
ovine
50μg
/kg
Milk
►M77
Provision
alMRLsexpire
on1.7.20
02◄
Bov
ine,
ovine,
porcine,
chicken,
rabb
its15
0μg
/kg
Muscle
150μg
/kg
Fat
150μg
/kg
Liver
200μg
/kg
Kidney
Chicken
300μg
/kg
Egg
s
1.2.10.Penicillins
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M59
Nafcillin
Nafcillin
Bov
ine
300μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
01
300μg
/kg
Fat
300μg
/kg
Liver
300μg
/kg
Kidney
30μg
/kg
Milk
▼M58
Penethamate
Benzylpenicillin
Ovine
50μg
/kg
Muscle
Provision
alMRLsexpire
on1Janu
ary
2000
50μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
4μg
/kg
Milk
▼M58
1990R2377— EN— 16.08.2008 — 058.002— 113
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Porcine
50μg
/kg
Muscle
50μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
1.2.11
.Florfenicol
andrelatedcompo
unds
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Florfenicol
Sum
offlorfenicoland
itsmetabolites
measured
asflor-
fenicol-am
ine
Fish
100
0μg
/kg
Muscle
and
skin
innaturalproportio
nsProvision
alMRLsexpire
on1
July
2001
▼M59
Thiam
phenicol
Thiam
phenicol
Ovine
50μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
01
50μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
Porcine
50μg
/kg
Muscle
50μg
/kg
Skin+fat
50μg
/kg
Liver
50μg
/kg
Kidney
Fin
fish
50μg
/kg
Muscle
and
skin
innaturalproportio
ns
▼M58
1990R2377— EN— 16.08.2008 — 058.002— 114
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M121
Thiam
phenicol
(1)
Thiam
phenicol
Porcine
50μg
/kg
Muscle
50μg
/kg
Skin+fat
50μg
/kg
Liver
50μg
/kg
Kidney
(1)Provision
alMRLsexpire
on1Janu
ary20
07.
▼M60
1.2.12
.Polyp
eptid
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Bacitracin
Bacitracin
Bov
ine
150μg
/kg
Milk
Provision
alMRLsexpire
on1.7.20
01
▼M59
1.2.13
.Lincosamides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Lincomycin
Lincomycin
Ovine
100μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
01
50μg
/kg
Fat
500μg
/kg
Liver
150
0μg
/kg
Kidney
150μg
/kg
Milk
Porcine
100μg
/kg
Muscle
50μg
/kg
Skin+fat
500μg
/kg
Liver
150
0μg
/kg
Kidney
▼M59
1990R2377— EN— 16.08.2008 — 058.002— 115
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Chicken
100μg
/kg
Muscle
50μg
/kg
Skin+fat
500μg
/kg
Liver
150
0μg
/kg
Kidney
50μg
/kg
Egg
s
▼M60
Pirlim
ycin
Pirlim
ycin
Bov
ine
100μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
00
100μg
/kg
Fat
100
0μg
/kg
Liver
400μg
/kg
Kidney
100μg
/kg
Milk
▼M59
1990R2377— EN— 16.08.2008 — 058.002— 116
1.2.14.Pleurom
utilines
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Tiamulin
Sum
ofmetabolitesthat
may
behy
drolysed
to8-a-hy
drox
ymutilin
Turkey
100μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
01
100μg
/kg
Skinandfat
300μg
/kg
Liver
▼M58
2.Antiparasiticagents
2.1.
Agentsactin
gagainstendo
parasites
▼M62
2.1.1.
Pheno
lderivativ
esinclud
ingsalicylanides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Oxy
clozanide
Oxy
clozanide
Bov
ine
20μg
/kg
Muscle
►M77
Provision
alMRLsexpire
on1.7.20
02◄
20μg
/kg
Fat
500μg
/kg
Liver
100μg
/kg
Kidney
10μg
/kg
Milk
Ovine
20μg
/kg
Muscle
20μg
/kg
Fat
500μg
/kg
Liver
100μg
/kg
Kidney
▼M71
1990R2377— EN— 16.08.2008 — 058.002— 117
2.1.2.
Benzimidazoles
andpro-benzim
idazoles
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Albendazole
sulpho
xide
Sum
ofalbend
azole,
albend
azole
sulpho
xide,
alben-
dazole
sulpho
ne,
and
albend
azole
2-am
ino
sulpho
ne,expressed
asalbend
azole
Bov
ine,
ovine
100μg
/kg
Milk
Provision
alMRLsexpire
on1Janu
ary
2000
Bov
ine,
ovine,
pheasant
100μg
/kg
Muscle
100μg
/kg
Fat
100
0μg
/kg
Liver
500μg
/kg
Kidney
▼M71
Mebendazole
Sum
ofmebendazole
methy
l(5-(1-hidrox
y,1-ph
enyl)
methy
l-1H
-benzim
idazol-2-yl)
carbam
ate
and
(2-
amino-1H
-benzi-
midazol-5-yl)
phenyl-
methano
ne,
expressed
asmebendazole
equivalents
Ovine,caprine,
equidae
Not
forusein
anim
als
from
which
milk
isprod
uced
for
human
consum
ption
60μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
02
60μg
/kg
Fat
400μg
/kg
Liver
60μg
/kg
Kidney
▼M58
Netob
imin
Sum
ofnetobimin
and
albend
azole
and
meta-
bolites
ofalbendazole
measured
as2-am
ino-
benzim
idazole
sulpho
ne
Bov
ine,
ovine,
caprine
100μg
/kg
Muscle
Provision
alMRLsexpire
on31
July
1999
100μg
/kg
Fat
100
0μg
/kg
Liver
500μg
/kg
Kidney
▼M58
1990R2377— EN— 16.08.2008 — 058.002— 118
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
100μg
/kg
Milk
▼M62
2.1.3.
Tetrahydropyrim
ides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Morantel
Sum
ofresidu
eswhich
may
behy
drolysed
toN-M
ethy
l-1,3-prop
ane-
diam
ineand
expressed
asmorantelequivalents
Bov
ine,
ovine
100μg
/kg
Muscle
►M85
Provision
alMRLsexpire
on1.7.20
03◄
100μg
/kg
Fat
800μg
/kg
Liver
200μg
/kg
Kidney
100μg
/kg
Milk
Porcine
100μg
/kg
Muscle
100μg
/kg
Skinandfat
800μg
/kg
Liver
200μg
/kg
Kidney
▼M70
2.1.5.
Piperazinederivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Piperazine
Piperazine
Porcine
400μg
/kg
Muscle
►M86
Provision
alMRLsexpire
on1.7.20
03◄
800μg
/kg
Skinandfat
200
0μg
/kg
Liver
100
0μg
/kg
Kidney
Chicken
200
0μg
/kg
Egg
s
▼M58
1990R2377— EN— 16.08.2008 — 058.002— 119
2.1.6.
Salicylanilides
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Rafox
anide
Rafox
anide
Bov
ine
Not
forusein
anim
als
from
which
milk
isprod
uced
for
human
consum
ption
30μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
01
30μg
/kg
Fat
10μg
/kg
Liver
40μg
/kg
Kidney
Ovine
Not
forusein
anim
als
from
which
milk
isprod
uced
for
human
consum
ption
100μg
/kg
Muscle
250μg
/kg
Fat
150μg
/kg
Liver
150μg
/kg
Kidney
▼M58
2.2.
Agentsactin
gagainstectoparasites
2.2.1.
Formam
idines
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Amitraz
Sum
ofam
itraz
andall
metabolites
containing
the
2,4-DMA
moeity
,expressedas
amitraz
Bees
200μg
/kg
Hon
eyProvision
alMRLsexpire
on1
July
1999
2.2.2.
Iminophenylthiazolid
inederivativ
e
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Cym
iazole
Cym
iazole
Bees
100
0μg
/kg
Hon
ey►M65
Provision
alMRLsexpire
on1.7.20
01◄
▼M71
1990R2377— EN— 16.08.2008 — 058.002 — 120
2.2.3.
Pyretrinandpyrethroids
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Cyfluthrin
Cyfluthrin
Bov
ine
10μg
/kg
Muscle
Provision
alMRLsexpire
on1Janu
ary
2001
50μg
/kg
Fat
10μg
/kg
Liver
10μg
/kg
Kidney
20μg
/kg
Milk
Further
provisions
inCou
ncilDirectiv
e94
/29/
EC
are
tobe
observed
(OJ
L18
9,23
.7.199
4,p.
67)
▼M61
Alphacyperm
ethrin
Cyp
ermethrin
(sum
ofisom
ers)
Bov
ine,
ovine
20μg
/kg
Muscle
►M95
Provision
alMRLsexpire
on1.7.20
03Further
prov
isions
inDirectiv
e93
/57/
EC
areto
beob
served
◄20
0μg
/kg
Fat
20μg
/kg
Liver
20μg
/kg
Kidney
20μg
/kg
Milk
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 121
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Chicken
50μg
/kg
Muscle
50μg
/kg
Skin+fat
50μg
/kg
Liver
50μg
/kg
Kidney
50μg
/kg
Egg
s
▼M95
Cyp
ermethrin
Cyp
ermethrin
(sum
ofisom
ers)
Bov
ine
20μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
03Further
prov
isions
inDirectiv
e93
/57/
EC
areto
beob
served
200μg
/kg
Fat
20μg
/kg
Liver
20μg
/kg
Kidney
20μg
/kg
Milk
Cyp
ermethrin
(sum
ofisom
ers)
Ovine
20μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
03Not
foruse
inanim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
200μg
/kg
Fat
20μg
/kg
Liver
20μg
/kg
Kidney
▼M61
Porcine
20μg
/kg
Muscle
200μg
/kg
Skin+fat
20μg
/kg
Liver
20μg
/kg
Kidney
▼M61
1990R2377— EN— 16.08.2008 — 058.002 — 122
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Chicken
50μg
/kg
Muscle
50μg
/kg
Skin+fat
50μg
/kg
Liver
50μg
/kg
Kidney
50μg
/kg
Egg
s
Salmonidae
50μg
/kg
Muscle
and
skin
innaturalproportio
ns►M93
Provision
alMRLsexpire
on1.7.20
03◄
▼M66
Deltamethrin
Deltamethrin
Bov
ine
10μg
/kg
Muscle
Provision
alMRLsexpire
on1
July
2001
50μg
/kg
Fat
10μg
/kg
Liver
10μg
/kg
Kidney
20μg
/kg
Milk
Ovine
Not
forusein
anim
als
from
which
milk
isprod
uced
for
human
consum
ption
10μg
/kg
Muscle
50μg
/kg
Fat
10μg
/kg
Liver
10μg
/kg
Kidney
▼M61
1990R2377— EN— 16.08.2008 — 058.002 — 123
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Chicken
10μg
/kg
Muscle
►M89
Provision
alMRLsexpire
on1.7.20
03◄
50μg
/kg
Skin+fat
10μg
/kg
Liver
10μg
/kg
Kidney
50μg
/kg
Egg
s
▼M76
Fin
fish
10μg
/kg
Muscle
and
skin
innaturalproportio
nsProvision
alMRLsexpire
on1.1.20
02
▼M115
Fenvalerate(1)
Fenvalerate
(sum
ofRR,SS,RS
and
SR
isom
ers)
Bov
ine
25μg
/kg
Muscle
250μg
/kg
Fat
25μg
/kg
Liver
25μg
/kg
Kidney
40μg
/kg
Milk
▼M83
Permethrin
Permethrin
(sum
ofisom
ers)
Chicken,po
rcine
50μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
03
500μg
/kg
Skinandfat
50μg
/kg
Liver
50μg
/kg
Kidney
▼M66
1990R2377— EN— 16.08.2008 — 058.002 — 124
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Bov
ine,
caprine
50μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
03
500μg
/kg
Fat
50μg
/kg
Liver
50μg
/kg
Kidney
50μg
/kg
Milk
Further
prov
isions
inCom
mission
Directiv
e98
/82/EC
are
tobe
observed
(OJ
L29
0,29
.10.19
98,
p.25
)
Chicken
50μg
/kg
Egg
sProvision
alMRLsexpire
on1.1.20
03
▼M115
(1)Provision
alMRLsexpire
on1July
2006
.
▼M58
2.2.4.
Organophosphates
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Azamethiphos
Azamethiphos
Salmonidae
100μg
/kg
Muscle
and
skin
innaturalproportio
nsProvision
alMRLsexpire
on1
June
1999
▼M83
1990R2377— EN— 16.08.2008 — 058.002 — 125
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M65
Cou
mafos
Cou
mafos
Bees
100μg
/kg
Hon
eyProvision
alMRLsexpire
on1.7.20
01
▼M68
Pho
xim
Pho
xim
Porcine
20μg
/kg
Muscle
Provision
alMRLsexpire
on1Janu
ary
2001
700μg
/kg
Skinandfat
20μg
/kg
Liver
20μg
/kg
Kidney
▼M78
Ovine
50μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
01;
notforuse
inanim
als
from
which
milk
isprod
uced
for
human
consum
ption
400μg
/kg
Fat
50μg
/kg
Kidney
▼M108
Chicken
50μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
05.
550μg
/kg
Skinandfat
25μg
/kg
Liver
50μg
/kg
Kidney
60μg
/kg
Egg
s
▼M71
Propetamph
osSum
ofresidu
esof
prop
etam
phos
anddesi-
soprop
yl-propetamph
os
Ovine
Not
forusein
anim
als
from
which
milk
isprod
uced
for
human
consum
ption
90μg
/kg
Fat
Provision
alMRLsexpire
on1.1.20
01
90μg
/kg
Kidney
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 126
2.2.5.
Acylurea
derivates
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Teflubenzuron
Teflubenzuron
Salmonidae
500μg
/kg
Muscle
and
skin
innaturalproportio
nsProvision
alMRLsexpire
on1
July
1999
▼M62
Diflubenzuron
Diflubenzuron
Salmonidae
1000μg
/kg
Muscle
and
skin
innaturalproportio
nsProvision
alMRLsexpire
on1.7.20
00
▼M123
Fluazuron
(1)
Fluazuron
Bov
ine(2)
200μg
/kg
Muscle
700
0μg
/kg
Fat
500μg
/kg
Liver
500μg
/kg
Kidney
(1)Provision
alMRLsexpire
on1.1.20
07.
(2)Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
▼M69
2.2.6.
Pyrim
idines
derivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Dicyclanil
Sum
ofdicyclanil
and
2,4,6-triamino-py
ri-
midine-5-carbon
itrile
Ovine
200μg
/kg
Muscle
Provision
alMRLsexpire
on1
July
2000
;Not
foruse
inanim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
50μg
/kg
Fat
400μg
/kg
Liver
400μg
/kg
Kidney
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 127
2.2.7.
Triazinederivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Cyrom
azine
Cyrom
azine
Ovine
300μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
01Not
foruse
inanim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
300μg
/kg
Fat
300μg
/kg
Liver
300μg
/kg
Kidney
▼M58
2.3.
Agentsactin
gagainstendo
-andectoparasites
2.3.1.
Averm
ectin
s
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M71
Abamectin
Averm
ectin
B1a
Ovine
20μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
01
50μg
/kg
Fat
25μg
/kg
Liver
20μg
/kg
Kidney
Doram
ectin
Doram
ectin
Deer,
inclusing
reindeer
20μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
01
100μg
/kg
Fat
50μg
/kg
Liver
30μg
/kg
Kidney
▼M70
1990R2377— EN— 16.08.2008 — 058.002 — 128
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M58
Mox
idectin
Mox
idectin
Equ
idae
50μg
/kg
Muscle
Provision
alMRLsexpire
on1Janu
ary
2000
500μg
/kg
Fat
100μg
/kg
Liver
50μg
/kg
Kidney
▼M60
2.4.
Agentsactin
gagainstprotozoa
2.4.1.
Carbanilid
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Imidocarb
Imidocarb
Bov
ine,
ovine
300μg
/kg
Muscle
ProvisonalMRLsexpire
on1.1.20
02
50μg
/kg
Fat
200
0μg
/kg
Liver
150
0μg
/kg
Kidney
50μg
/kg
Milk
▼M62
2.4.2.
Quinazolone
derivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Halofug
inon
eHalofug
inon
eBov
ine
10μg
/kg
Muscle
Provision
alMRL'sexpire
on1.1.20
01
25μg
/kg
Fat
30μg
/kg
Liver
▼M71
1990R2377— EN— 16.08.2008 — 058.002 — 129
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
30μg
/kg
Kidney
▼M70
2.4.3.
Triazinetrionederivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Toltrazuril
Toltrazurilsulfon
ePorcine
100μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
01
150μg
/kg
Skinandfat
500μg
/kg
Liver
250μg
/kg
Kidney
▼M116
Toltrazuril(1)
Toltrazurilsulfon
eBov
ine
100μg
/kg
Muscle
150μg
/kg
Fat
500μg
/kg
Liver
250μg
/kg
Kidney
(1)Provision
alMRLsexpire
on1July
2006
.Not
forusein
anim
alsfrom
which
milk
isprod
uced
forhu
man
consum
ption.
▼M75
2.4.4.
Other
anti-protozoalagents
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRL
Targettissues
Other
prov
isions
Amprolium
Amprolium
Chicken,turkey
200μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
02
200μg
/kg
Skinandfat
200μg
/kg
Liver
400μg
/kg
Kidney
100
0μg
/kg
Egg
s
▼M62
1990R2377— EN— 16.08.2008 — 058.002 — 130
2.4.5.
Ionoph
ores
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Lasalocid
Lasalocid
APou
ltry
150μg
/kg
Egg
s(1)
(1)Provision
alMRLsexpire
on1Janu
ary20
08.
▼M58
3.Agentsactin
gon
thenervou
ssystem
3.2.
Agentsactin
gon
theautono
mic
nervou
ssystem
3.2.1.
β2sympathom
imetic
agents
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Clenb
uterol
hydrochloride
Clenb
uterol
Bov
ine
0,1μg
/kg
Muscle
Provision
alMRLsexpire
on1
July
2000
Indicatio
n:solely
for
tocolysis
inparturient
cows
0,5μg
/kg
Liver
0,5μg
/kg
Kidney
0,05
μg/kg
Milk
Equ
idae
0,1μg
/kg
Muscle
Indicatio
ns:
tocolysis
and
the
treatm
ent
ofrespiratoryailm
ents
0,5μg
/kg
Liver
0,5μg
/kg
Kidney
▼M127
1990R2377— EN— 16.08.2008 — 058.002 — 131
3.2.2.
Anti-adrenergics
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Carazolol
Carazolol
Bov
ine
5μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
00
5μg
/kg
Fat
15μg
/kg
Liver
15μg
/kg
Kidney
1μg
/kg
Milk
▼M58
5.Anti-inflam
matoryagents
5.1.
Nonsteroidalanti-inflam
matoryagents
5.1.1.
Arylpropionic
acid
derivativ
e
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Carprofen
Carprofen
Bov
ine
500μg
/kg
Muscle
Provision
alMRLsexpire
on1Janu
ary
2000
500μg
/kg
Fat
100
0μg
/kg
Liver
100
0μg
/kg
Kidney
Equ
idae
50μg
/kg
Muscle
100μg
/kg
Fat
100
0μg
/kg
Liver
100
0μg
/kg
Kidney
▼M60
1990R2377— EN— 16.08.2008 — 058.002 — 132
5.1.2.
Eno
licacid
derivates
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Melox
icam
Melox
icam
Bov
ine
25μg
/kg
Muscle
Provision
alMRLsexpire
on1Janu
ary
2000
60μg
/kg
Liver
35μg
/kg
Kidney
▼M71
5.1.3.
Pyrazolon
ederivativ
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
▼M85
Metam
izole
4-Methy
laminoan-
tipyrin
Bov
ine,
porcine,
equidae
200μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
03.
Not
foruse
inanim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
200μg
/kg
Fat
200μg
/kg
Liver
200μg
/kg
Kidney
▼M130
5.1.4.
Sulfonatedph
enyl
lacton
es
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Firocox
ibFirocox
ibEqu
idae
10μg
/kg
Muscle
Provision
alMRLsexpire
on1
July
2007
15μg
/kg
Fat
60μg
/kg
Liver
10μg
/kg
Kidney
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 133
6.Agentsactin
gon
thereprod
uctiv
esystem
6.1.
Progestog
ens
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Altrenog
est
Altrenog
est
Porcine
3μg
/kg
►M97
Skinandfat◄
►M97
Provision
alMRLsexpire
on1.1.20
05;forzootechn
ical
useon
ly◄
3μg
/kg
Liver
3μg
/kg
Kidney
Equ
idae
3μg
/kg
Fat
3μg
/kg
Liver
3μg
/kg
Kidney
▼M102
Flugeston
eacetate
Flugeston
eacetate
Ovine,caprine
0,5μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
08;
for
therapeutic
orzootechn
ical
use
only
0,5μg
/kg
Fat
0,5μg
/kg
Liver
0,5μg
/kg
Kidney
Norgestom
etNorgestom
etBov
ine
0,5μg
/kg
Muscle
Provision
alMRLsexpire
on1.1.20
08;
for
therapeutic
orzootechn
ical
use
only
0,5μg
/kg
Fat
0,5μg
/kg
Liver
0,5μg
/kg
Kidney
0,15
μg/kg
Milk
▼M74
7.Corticoids
7.1.
Glucocorticoids
Pharm
acolog
ically
activ
esubstance(s)
Markerresidu
eAnimal
species
MRLs
Targettissues
Other
prov
isions
Methy
lpredn
isolon
eMethy
lpredn
isolon
eBov
ine
10μg
/kg
Muscle
Provision
alMRLsexpire
on1.7.20
01.
Not
foruse
inanim
alsfrom
which
milk
isprod
uced
for
human
consum
ption
10μg
/kg
Fat
10μg
/kg
Liver
10μg
/kg
Kidney
▼M92
ANNEX IV
LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FORWHICH 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
▼M58
1990R2377— EN— 16.08.2008 — 058.002 — 134
ANNEX V
Information and particulars to be included in an application for theestablishment of a maximum residue limit for a pharmacologically active
substance used in veterinary medicinal products
Administrative particulars
1 Name or corporate name and permanent address of the applicant.
2 Name of the veterinary medicinal product.
3 Qualitative and quantitative composition in terms of active principles,with mention of the international non-proprietary name recommendedby the World Health Organization, where such name exists.
4 Manufacturing authorization, if any.
5 Marketing authorization, if any.
6 Summary of the characteristics of the veterinary medicinal product(s)prepared in accordance with Article 5a of Directive 81/851/EEC.
A. Safety documentation
A.0. Expert report
A.1. Precise identification of the substance concerned by the application
1.1 International non-proprietary name (INN).
1.2 International Union of Pure and Applied Chemistry (IUPAC)name.
1.3 Chemical Abstract Service (CAS) name.
1.4 Classification:
— therapeutic;
— pharmacological.
1.5 Synonyms and abbreviations.
1.6 Structural formula.
1.7 Molecular formula.
1.8 Molecular weight.
1.9 Degree of impurity.
1.10 Qualitative and quantitative composition of impurities.
1.11 Description of physical properties:
— melting point;
— boiling point;
— vapour pressure;
— solubility in water and organic solvents, expressed in gramsper litre, with indication of temperature;
— density;
— refractive index, rotation, etc.
A.2. Relevant pharmacological studies
2.1 Pharmacodynamics.
2.2 Pharmacokinetics.
A.3. Toxicological studies
3.1 Single dose toxicity.
3.2 Repeated dose toxicity.
3.3 Tolerance in the target species of animal.
3.4 Reproductive toxicity, including teratogenicity.
▼M2
1990R2377— EN— 16.08.2008 — 058.002 — 135
3.4.1 Study of the effects on reproduction.
3.4.2 Embryotoxicity/fetotoxicity, including teratogenicity.
3.5 Mutagenicity.
3.6 Carcinogenicity.
A.4. Studies of other effects
4.1 Immunotoxicity.
4.2 Microbiological properties of residues.
4.2.1 On the human gut flora;
4.2.2 On the organisms and microorganisms used for industrial food-processing.
4.3 Observations in humans.
B. Residue documentation
B.0 Expert report
B.1. Precise identification of the substance concerned by the application
The substance concerned should be identified in accordance with pointA.1. However, where the application relates to one or more veterinarymedicinal 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 studies
2.1 Pharmacokinetics
(absorption, distribution, biotransformation, excretion).
2.2 Depletion of residues.
2.3 Elaboration of maximum residue limits (MRLS).
B3. Routine analytical method for the detection of residues
3.1 Description of the method.
3.2 Validation of the method.
3.2.1 specificity;
3.2.2 accuracy, including sensitivity;
3.2.3 precision;
3.2.4 limit of detection;
3.2.5 limit of quantitation;
3.2.6 practicability and applicability under normal laboratoryconditions;
3.2.7 susceptibility to interference.
▼M2
1990R2377— EN— 16.08.2008 — 058.002 — 136