Previous Page Table of Contents


LIST OF APPENDICES


APPENDIX I: LIST OF PARTICIPANTS/LISTE DES PARTICIANTS/LISTA DE PARTICIPATES
APPENDIX II: DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Advanced to Step 8)
APPENDIX III: DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Retained at Step 7)
APPENDIX IV: PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Advanced to Steps 5/8)
APPENDIX V: PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Advanced to Step 5)
APPENDIX VI: PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Retained at Step 4)
APPENDIX VII: PRIORITY LIST OF VETERINARY DRUGS REQUIRING EVALUATION OR REEVALUATION
APPENDIX VIII: AMENDMENTS TO METHODS OF ANALYSIS FOR PREVIOUSLY ADOPTED CODEX MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Recommendations from the 10th Session)

APPENDIX I: LIST OF PARTICIPANTS/LISTE DES PARTICIANTS/LISTA DE PARTICIPATES

Chairman
Président
Presidente

Dr. Stephen Sundlof
Director
Center for Veterinary Medicine
Food and Drug Administration
HFV-1, MPN-2, 7500 Standish Place
Rockville, MD 20855
United States of America
Tel: (301) 594-1798
Fax: (301) 594-1830

ARGENTINA
ARGENTINE

Dr. Eduardo A. Butler
Gerente de Aprobación de Productos
Alimenticios y Farmacológicos
Servicio Nacional de Sanidad Animal
Paseo Colón 367, 3o. Piso P. Frente
(1063) Buenos Aires
Tel: 054 1 345-4110/4112 Int. 1301
Fax: 054 1 334-3207

AUSTRALIA
AUSTRALIE

Dr. Peter Miller (Head of Delegation)
Veterinary Counsellor
Australian Embassy Washington
1601 Massachusetts Ave, N. W.
Washington, D.C. 20036
U.S.A.
Tel: 202 797-3319
Fax: 202 797-3037
E-mail: [email protected]

Mr. Kerryn McDougall
NSW Agriculture
P.O. Box 285 Lismore
NSW Australia 2480
Tel: 61-66-212-632
Fax: 61-66-214-319
E-mail: [email protected]

Dr. John Owusu
National Registration Authority
P.O. Box E240
Kingston ACT 2604
Barton ACT 2600
Tel: 61-6 271-6375
Fax: 61-6 272-4753

Dr. Jonathan Webber
Manager Animal Programs
National Residue Survey
Bureau of Resource Sciences
P.O. Box E11
Kingston ACT 2604
Tel: 61-6 272-3762
Fax: 61-6 272-4023
E-mail: [email protected]

Dr. Terry Spencer
Australian Government Analytical Laboratories
GPO Box 1844
Canberra ACT 2601
Tel: 61-6-275-8714
Fax: 61-6-275-3565
E-mail: [email protected]

Mr. Claude Gauchat
Executive Director
Avcare Limited
Level 11, 53 Walker Street
North Sydney NSW 2060
Locked Bag 916
NSW 2059
Tel: 61-2 992-22199
Fax: 61-2 995-40588

Mr. Ian Coleman
Director
Agricultural and Veterinary Chemicals
Policy Section
DPIEPO Box 858
Canberra ACT 2601
Tel: 61-6271-6371
Fax: 61-6272-5899
E-mail: [email protected]

BELGIUM
BELGIQUE
BELGICA

Prof. Dr. Lic. Marc Cornelis
Inspecteur-expert
Institut d 'expertise vétérinaire
Ministère de la Santé Publique
Rue de la Loi, 56
1040 Bruxelles
Tel: 32-2-287-0253
Fax: 32-2-287-0200

BRAZIL
BRESIL
BRASIL

Dr. Francisco Bezerra da Silva
(Head of Delegation)
Coordenador-Geral/PNCRB
Ministerio da Agricultura
Secretaría de Defesa Agropecuária
Anexo B 4 Andar/406
70043-900 Brasilia, D.F.
Tel. 55-61-2269771/224-6182
Fax. 55-61-2243995/218-2316

Prof. Dr. Joao Palermo-Neto
Professor
School of Veterinary Medicine
University of Sao Paulo
Av. Corifeu Azevedo Marques No. 2720
CEP 05340-901
Tel: 55-11-8187693
Fax: 55-11-8187829
E-mail: [email protected]

Dr. Marta Palma de Freitas Severo
Food Residues Analyst - Laboratory
Regional Laboratory of Animal Supply
"LARA-RS"
Ponta Grossa Estrada No. 3036
Porto Alegre
Rio Grande do Sul - 90.000
Tel: 55-51-2482133 R.(ext) 109
Fax: 55-51-2481926

Dr. Maria Angélica Ribeiro de Oliveira
Head Coordinator of Veterinary Products
Ministerio da Agricultura e do Abastecimento
Esplanada dos Ministérios
Anexo A, Bloco D
Room 314 - Andar 3o.
70043-900 Brasilia D. F.
Tel. 55-61 223-7073
Fax. 55-61 323-5936

CANADA

Dr. Man Sen Yong (Head of Delegation)
Chief Human Safety Division and
Acting Director
Bureau of Veterinary Drugs
Food Directorate
Health Protection Branch, Health Canada
Main Statistics Building
Tunney's Pasture, Locator # 0302H3
Ottawa, Ontario KIA OL2
Tel: 613-957-3857
Fax: 613-957-3861

Dr. Arnost Vilim
Human Safety Division
Bureau of Veterinary Drugs
Food Directorate
Health Protection Branch
2605-C, 2nd Floor
Main Statistics Canada Building
Tunney's Pasture
Ottawa, Ontario K1A OL2
Tel: 613 957-3880
Fax: 613 957-3861

Dr. J.D. MacNeil
Head, Center for Veterinary Drug Residues
Health of Animals Laboratory
Agriculture and Agri-Food Canada
116 Veterinary Road
Saskatoon, Saskatchewan S7N 2R3
Tel: 306 975-5347
Fax: 306 975-5711
E-mail: [email protected]

Dr. Paul Dick
Manager, Research & Development
Elanco Animal Health
Division Eli Lilly Canada Inc.
150 Research Lane, Suite 120
Guelph, Ontario NIG 4T2
Tel: 519 821-0277
Fax: 519 821-7831

Ms. Jean Szkotnicki
Executive Director
Canadian Animal Health Institute
27 Cork St. W.
Guelph, Ontario, NIH 2W9
Tel: 519 763-7777
Fax: 519 763-7407

COLOMBIA
COLOMBIE

Dr. Salomon Marín Lasso
División de Insumos Pecuarios
Instituto Colombiano Agropecuario
Calle 37, No. 8-43, Oficina 411
Santafé de Bogotá, D. C.
Tel: 232-4715
Fax: 288-1753

Mr. Hernan Cifuentes Sguerra
Presidente Ejecutivo - APPROVET
Ave. El Dorado No. 84A-55 Oficina 240
Apartado Aéreo 4193 (1)
Santafé de Bogotá, DC
Tel: 2956225/2951708
Fax: 4100513

COSTA RICA

Dr. Rigoberto Blanco Sáenz
División de Saneamiento Ambiental
Ministerio de Salud
Apartado 1510, Guadalupe 2100
San Jos6
Tel: 223-8925
Fax: 223-7411

Lic. Jenniffer Lee
Departmento Control de Alimentos
Ministerio de Salud
Apartado 10123-1000
San Jos6
Tel: 233-8159/255-4426/223-0333, ext. 215
Fax: 255-4426

Dr. Sergio Vindas
PFIZER Zona Franca, S.A.
División de Salud Animal
Apartado 10202-1000
San José
Tel: 293-2345
Fax: 293-2346

Licda. Cristina Vargas Chacón
Microbióloga
Ministerio de Agricultura y Ganadería
Laboratorio Nacional de Servicios Veterinarios
San José
Tel: 260-8300
Fax: 260-5483

Dr. Jose Luis Rojas Martínez
Jefe de la Sección de Toxicología y
Residuos en Alimentos de Origen Animal
Laboratorio Nacional de Servicios Veterinarios
Apartado Postal 1610-4050
San Jos6
Tel: 442-8873
Fax: 441-1359

Dr. José Luis Rojas Piedra
Coordinador
Departamento de Sanidad Animal
TRISAN S.A.
Apartado 4102-1000
San Jos6
Tel: 232-0690
Fax: 231-7956

Dr. Alfredo Gómez B.
Dos Pinos
Residencial Los Dorados, Casa 40-C
Tels: 259-1635/257-1311, ext. 2021

Dr. David Mora Villegas
Laboratorios ALCAMES S.A.
Tel: 26-2735
Fax: 227-1098

Dra. Myriam Jiménez Mata
Jefe, Registro Medicamentos
Veterinarios de Costa Rica
Ministerio de Agricultura y Ganadería
Apartado 10094-1000
San Jos6
Tel: 260-8300
Fax: 260-8291

Dr. Arturo Méndez Salinas
Departamento de Salud Animal
Grupo ZARAGOZA
Apartado 168-4300
Palmares
Tel: 452-0116
Fax: 453-1155
E-mail: [email protected]

María Eugenia Chacón Morux
Directora Técnica
Proyecto Pequeñas y Medianas Empresas
Centroamérica, Panamá y Belice
Apartado 4135-1000
San José
Tel: 231-6910
Fax: 231-6910

Dr. Jorge Villalobos Salazar
Escuela de Medicina Veterinaria
Universidad Nacional
Apartado 86
Heredia
Tel: 261-0025
Fax: 238-1298

Lic. Marco A. Aguilar Bogantes
Cámara de Productores de
Leche de Costa Rica
Apartado Postal 605
1000 San Jos6
Tel: 257-8111
Fax: 221-4489

DENMARK
DANEMARK
DINAMARCA

Dr. Kaj Andreasen (Head of Delegation)
Senior Veterinary Officer
Danish Veterinary Service
Rolighedsvej 25
DK-1958 Fredriksberg C
Tel: 45 31 35 81 00
Fax: 45 35 36 19 12
Direct fax: 45 35 36 06 07

Dr. Gitte Rasmussen
Scientific Adviser, M.Sc.
National Food Agency of Denmark
Morkhoj Bygade 19
DK-2860 Soeborg
Tel: 45 39 69 66 00
Fax: 45 39 66 01 00

Dr. Martin Vahl
Senior Chemist
National Food Agency of Denmark
Morkhoj Bygade 19
DK-2860 Soeborg
Tel: 45 39 69 66 00
Fax 45 39 66 01 00:

Dr. Torben Westfahl
Master of Sciences
Ministry of Agriculture and Fisheries
Danish Veterinary Service
Food Control Laboratory
Odinsvej 4
Postbox 93
DK-4100 Ringsted
Tel: 45 53 61 80 61
Fax: 45 53 61 90 48

ECUADOR
EQUATEUR

Sr. Eduardo Andrade Martínez
Adjunto Comercial
Embajada del Ecuador
Apartado 1374-1000
San José
Tel: 232-1503
Fax: 232-2086

FINLAND
FINLANDE
FINLANDIA

Dr. Timo Hirvi (Head of Delegation)
National Veterinary and
Food Research Institute
P.O. Box 368
FIN-00231 Helsinki
Tel: 358-9 393-1912
Fax: 358-9393-1811
E-mail: [email protected]

Ms. Liisa Kaartinen
Senior Researcher
Natonal Agency for Medicines
P. O. Box 55
FIN-00301 Helsinki
Tel: 358 9 3967-2610
Fax: 358 9 3967-2600
E-mail: [email protected]

FRANCE
FRANCIA

Mr. Jacques Boisseau (Head of Delegation)
Agence Nationale du Médicament Vétérinaire
CNEVA
La Haute Marche
35133 - Javène
Tel: 33-2-99-94-78-72
Fax: 33-2-99-94-78-99

Mr. Jean-Pierre Doussin
Ministère de l'Economie et des Finances
Direction Générale de la Concurrence, de la
Consommation et de la Répression des Fraudes
59 boulevard Vincent Auriol
75703 Paris
Tel: 01-44 973470
Fax: 01-44973037

Dr. Gilles Le Lard
Ministère de l'Agriculture, de la Pêche et de
l'Alimentation
Direction Générale de l'Alimentation
175 rue du Chevaleret
75013 Paris
Tel: 01-49-55-84-66
Fax: 01-49-55-43-58

Dr. Georges Monsallier
President SIMV
Rhone Merieux
6, rue de La Trémoille
75008 Paris
Tel: 1 47239420
Fax: 1 40700013

GERMANY
ALLEMAGNE
ALEMANIA

Dr. Gerhard J. Kothmann
(Head of Delegation)
Ministerialdirigent
Ministry of Health
Bundesministerium für Gesundheit
Am Propsthof 87a
53108 Bonn
Tel: 49-228 941-4200
Fax: 49-228 941-4942

Prof. Dr. Reinhard Kroker
Federal Institute for Health Protection
of Consumers and Veterinary Medicine
Diedersdorfer Weg1
D- 12277 Berlin
Tel: 49-30 8412-2364
Fax: 49-30 8412-2965

Dr. Martin Schneidereit
Federal Association for Animal Health
Bundesverband für Tiergesundheit e.V.
Aennchen Platz 6
D-53173 Bonn
Tel: 49-228318296
Fax: 49-228 318298

Dr. Jochen Wieda
Director Regulatory Affairs
Hoechst Roussel Vet
Rheingaustr. 190
D-65203 Wiesbaden
Tel: 49 611 962-7985
Fax: 49 611 962-7854

Prof. Dr. H. Schmidt
Bavarian Animal Health Service
Tiergesundheitsdienst Bayern e.V.
Senator-Gerauer-StraBe 23
D-85586 Poing
Tel: 49 89 9091241
Fax: 49 89 9091202

Dr. Roestel-Peters
Federal Institute for Health Protection
of Consumers and Veterinary Medicine
Postfach 33 00 13
Diedersdorfer Weg 1
D-12277 Berlin
Tel: 49-30-8412-2331
Fax: 49-30-8412-2955

HUNGARY
HONGRIE
HUNGRIA

Dr. Barnabas Sas
Executive Director
National Food Investigations Institute
Budapest, 94
PF 1740, H-1465
Tel: 3612 156851
Fax: 3612 156858

IRELAND
IRLANDE
IRLANDA

Dr. Frank Kenny (Head of Delegation)
Senior Supt. Veterinary Inspector
Department of Agriculture, Food and Forestry
Kildare Street
Dublin 2
Tel: 353-1 607-2119
Fax: 353-1 661-6263

Dr. J. Gabriel Beechinor
Veterinary Assessor
Irish Medicines Board
Earlsfort Centre, Earlsfort Terrace
Dublin 2
Tel: 353-1 676-4971
Fax: 353-1 676-7836

ISRAEL

Dr. Stefan Soback
Head, National Residue Control Laboratory
Ministry of Agriculture
Kimron Veterinary Institute
P.O. Box 12
Beit Dagan
Tel: 972-3-968-1713
Fax: 972-30968-1692

ITALY
ITALIE
ITALIA

Dr. Agostino Macri
Instituto Superiore della Sanità
Viale Regina Elena 299,
00161 Rome
Tel: 00396 49902330
Fax: 00396 49387077

Dr. Brunella Lo Turco
Secretario Generale
Comitato Nazionale Codex
Ministero Risorse Agricole e Alimentari
Via Sallustiana 10
Roma 00100
Tel: 4880273
Fax: 4880273

Dr. Vittorio Maria Moretti
Universitá di Milano
Facoltá di Medicina Veterinaria
Via Trentacoste 2
20134 Milano
Tel: 39 2 2154686/2154506
Fax: 3922154671

JAPAN
JAPON

Dr. Toshihiko Yunokawa
Senior Veterinary Officer
Veterinary Sanitation Division
Environmental Health Bureau
Ministry of Health and Welfare
1-2-2, Kasumigaseki
Chiyoda-ku, Tokyo
Tel: 03-3503-1711, ext. 2474
Fax: 03-3503-7964

Dr. Yoshihito Ishihara
Assistant Director
Office of Veterinary Drug Administration
Animal Health Division
Livestock Industry Bureau
Ministry of Agriculture, Forestry and Fisheries
1-2-2, Kasumigaseki
Chiyoda-ku, Tokyo
Tel: 03 3503-8111, ext. 4625
Fax: 03 3508-2546

KOREA, REPUBLIC OF
COREE, REPUBLIQUE DE
COREA, REPUBLICA DE

Mr. Dong-Kyun Shin
Director, Division of Food Sanitation
Bureau of Food Policy
No. 2 Government Bldg.
Kwachun-Si, Kyounggi-Do Seoul
Tel: 02 503-3074
Fax: 02 504-1100

Dr. In-Sang Song
Department Head
Department of Food Hygiene Research
Korea Institute of Food Hygiene
57-1, Noryangjin-Dong, Dongjak-Ku
Seoul 156-050
Tel: 02 824-8092
Fax: 02 824-1762

Dr. Seong Wan Son
Chief of Drug Residue Analysis Lab.
480 Anyang 6 Dong, Anyang
Aniyang City. Kyunggi-Do
Seoul
Tel: 0343 671839
Fax: 41-6597

Dr. Tae Yung Kim
Senior Veterinary Officer
Animal Health Division
Livestock Bureau
Ministry of Agriculture & Forestry
Kwachun-sz, Kyounggi-Do
Seoul
Tel: 02-504-9438-9/500-2693-4
Fax: 02-507-3966

Dr. Jee-Woo Lee
Veterinary Officer
National Animal Quarantine Service
M.A.F. San 23-4 Deunghon-Dong
Kangseo-Gu, Seoul
Tel: 02 6500-670
Fax: 02 6500-655

NETHERLANDS
PAYS BAS
PAISES BAJOS

Dr. Carla A, Rutgers (Head of Delegation)
Ministry of Agriculture
Nature Management and Fisheries
P.O. Box 20401
2500 EK The Hague
Tel: 31-70-379-3071
Fax: 31-70-347-7552

Dr. Willem F. Droppers
Coordinator Veterinary Policy
Ministry of Welfare, Health and Sport
Section Nutrition and Veterinary Policy
P.O. Box 5406
2280 HK Rijswijk
Tel: 31-70 340-6999
Fax: 31-70 340-5177

Dr. Jos H. Goebbels
Ministry of Welfare, Health and Sport
Veterinary Inspectorate
P.O. Box 5406
2280 HK Rijswijk
Tel: 31-70-340-7063
Fax: 31-70-340-7080

Dr. Rainer W. Stephany
National Institute of Public Health
and the Environment
Head, Laboratory for Residue Analysis
P.O. Box 1
3720 BA Bilthoven
Tel: 31-30-274-3612
Fax: 31-30-274-4403
E-mail: [email protected]

NEW ZEALAND
NOUVELLE ZELANDE
NUEVA ZELANDIA

Dr. William T. Jolly (Head of Delegation)
National Manager, Residues
MAF Regulatory Authority
Ministry of Agriculture
P.O. Box 2526
Wellington
Tel: 64-4 474-4156
Fax: 64-4 474-4239
E-mail: [email protected]

Dr. Barry L. Marshall
Counsellor (Veterinary Services)
New Zealand Embassy
37 Observatory Circle, NW.
Washington, DC 20008
U.S.A.
Tel: 202 328-4861
Fax: 202 332-4309

NORWAY
NORVEGE
NORUEGA

Dr. John Race (Head of Delegation)
Special Advisor, International Liaison
Norwegian Food Control Authority
P.O. Box 8187 DEP
N-0034 Oslo
Tel: 47 22246268
Fax: 47 22246699
E-mail: [email protected]

Dr. Sverre O. Roald
Regional Chief Officer
Norwegian Government Fish Inspection
Quality Control Service
Directorate of Fisheries
(Kontrollverk, Royseg 15)
P.O. Box 168
N-6001 Alesund
Tel: 701-27636
Fax: 701-29647

Prof. Magne Yndestad
Dept. of Pharmacology, Microbiology
and Food Hygiene
Norwegian College of Veterinary Medicine
P.O. Box 8146 Dep.
N-0033 Oslo
Tel: 47-22-964830/964829
Fax: 47-22-964850

POLAND
POLOGNE
POLONIA

Prof. Jan Zmudzki
Head, Department of Pharmacology and
Toxicology
National Veterinary Research Institute
Al. Partyzantow 57
24-100 Pulawy
Tel: 48-81 863-051
Fax: 48-81 862-595

PORTUGAL

Dr. Maria Helena Silvares Teodoro Ponte
Ministry of Agriculture
Direcçao Geral de Veterinaria
Largo da Academia Nacional
de Belas Artes No. 2
1200 Lisboa
Tel: 351-1 346-5165
Fax: 351-1 346-3518

SOUTH AFRICA
AFRIQUE DU SUD
AFRICA DEL SUR

Dr. Naeem G. H. Bham
Assistant Director Food Control
Private Bag X828
(0001) Pretoria
Tel: +27 12 3120515
Fax: +27 12 3120811
E-mail: [email protected]

SPAIN
ESPAGNE
ESPAÑA

Dr. José A. Garrido-Pérez
Head, Service General Directorate
of Public Health
Ministry of Health and Consumer Affairs
Paseo del Prado 18-20
28071 Madrid
Tel: 596 2095
Fax: 596 4409

Dr. Odon J. Sobrino
Head, Section of Veterinary Medicinal
Products Registration
General Subdirectorate of Animal Health
Ministry of Agriculture, Fisheries and Food
c/Velazquez, 147
28002 Madrid
Tel: 347-8339
Fax: 347-8299

SWEDEN
SUEDE
SUECIA

Dr. Hakan Johnsson
Head of Chemistry Division 3
National Food Administration
Box 622
S-751 26 Uppsala
Tel: 46-18-175-737
Fax: 46-18-105-848

SWITZERLAND
SUISSE
SUIZA

Dr. Herbert Koch (Head of Delegation)
Swiss Veterinary Office
Schwarzenburgstrasse 161
CH-3003 Bern
Tel: 41-31 323-8539
Fax: 41-31 323-8522
E-mail: [email protected]

Dr. Josef Schlatter
Federal Office of Public Health
c/o Institute of Veterinary Pharmacology
and Toxicology
University of Zurich
Winterthurerstrasse 260
CH-8057 Zurich
Tel: 41-1 257-6105
Fax: 41-1 257-6107
E-mail: [email protected]

THAILAND
THAILANDE
TAILANDIA

Dr. Assoc. Prof. Danis Davitiyananda
Department of Veterinary Pharmacology
Faculty of Veterinary Science
Chulalongkorn University
Ministry of University Affairs
Henridunang Street, Bangkok 10330
Tel: 662 251-8939
Fax: 662251-8939

Dr. Assoc. Prof. Palarp Tantiyasawasdikul
Sinhaseni Department of Pharmacology
Faculty of Pharmaceutical Science
Chulalongkorn University
Ministry of University Affairs
Phrayathai Street, Bangkok 10330
Tel: 662 251-1900-2, ext. 164
Fax: 662 255-8227
E-mail: [email protected]

Dr. Yuantar Pruksaraj
Director
Feed Quality Control Division
Department of Livestock Development
Phayathai Rd. Bangkok 10400
Tel: 662251-8206
Fax: 662251-1942

Dr. Mali Boonyaratpalin
Director of Feed Quality Control and
Development Division
Department of Fisheries
Ministry of Agriculture and Cooperatives
Jatujak, Bangkok 10900
Tel: 662 579-9525
Fax: 662562-0513

Ms. Ranee Kumton
Chief, Commodity Standards Subdivision
Office of National Codex Alimentarius
Committee
Thai Industrial Standards Institute
Rama 6 Street, Bangkok 10400
Tel: 662 202-3438
Fax: 662 248-7987

Dr. Boonpeng Santiwattanatam
Federation of Thai Industries
C.P. Tower, 27th Floor
313 Silom Road
Bangkok 10500
Tel: 662 231 0550
Fax: 662 631-0944/631 0725

UNITED KINGDOM
ROYAUME-UNI
REINO UNIDO

Dr. J. Michael Rutter
Director of Veterinary Medicines
Veterinary Medicines Directorate
Woodham Lane, New Haw
Addlestone, Surrey, KT15 3NB
Tel: 44 1932 336911
Fax: 44 1932 336618
E-mail: [email protected]

Dr. George Shearer
Head Veterinary Drug Residues Section
Central Science Laboratory
Norwich Research Park
Colney Lane
Norwich, NR4 7UQ
Tel: 44-1603 259-350 ext. 275
Fax: 44-1603 501-123
E-mail: [email protected].

Dr. Anthony J. Mudd
Roche Products Ltd.
Heanor Gate
Heanor, Derbyshire DE75 7SG
Tel: 00-44-1773-536610
Fax: 00-44-1773-536585

Mr. Raj Patel
Head, Analytical Chemistry Unit
Central Veterinary Laboratories
New Haw, Addlestone
Surrey, KT15 3NB
Tel: 01932341111
Fax: 01932 347046

UNITED STATES OF AMERICA
ETATS-UNIS D'AMERIQUE
ESTADOS UNIDOS DE AMERICA

Dr. Robert C. Livingston
U.S. Delegate
Director, Office of New Animal
Drug Evaluation, HFV-100
FDA, Center for Veterinary Medicine
7500 Standish Place, Room 389
Rockville, MD 20855
Tel: (301) 594-1620
Fax: (301) 594-2297

Dr. Richard Ellis
Director, Scientific Research Oversight
USDA Department of Agriculture
Office of Public Health and Science
300 12th Street, SW, Room 603-Annex
Washington, DC 20250
Tel: 202 205-0623
Fax: 202205-0145
E-mail: [email protected]

Dr. Richard Mikita
USDA, FSIS
Import/Export Special Assistant
Room 341-E, Jamie L. Whitten Bldg.
Washington, DC 20250-3700
Tel: (202) 720-0290
Fax: (202) 690-0766

Dr. John O'Rangers
Technical Program Manager
Office of New Animal Drug Evaluation
Center for Veterinary Medicine
US Food and Drug Administration
7500 Standish Place, Room 389
Rockville, MD 20855
Tel: 301 594-1645
Fax: 301 594-2297
E-mail: [email protected]

Dr. Richard Carnevale
Vice-President Regulatory Scientific
International Affairs
Animal Health Institute
501 Wyeth St.
Alexandria, VA. 22314-1917
Tel: 703 684-0011
Fax: 703 684-0125
E-mail: [email protected]

Dr. Raúl Guerrero
Elanco Animal Health
Division of Eli Lilly & Company
2001 West Main Street
Greenfield, IN 46140
Tel: (317) 277-4434
Fax: (317) 277-4755
E-mail: [email protected]

Dr. Gordon Kemp
Director of Science Policy Affairs
Animal Health Group
Pfizer, Inc.
Eastern Point Road
Groton, CT 06340-5146
Tel: 860 441-4958
Fax: 860441-4101

Dr. David F. Kowalczyk
Director, Regulatory Affairs
PROTIVA
800 N. Lindbergh Blvd.
St. Louis, MO 63167
Tel: 314694-5348
Fax: 314694-5271
E-mail: [email protected]

Dr. Stephen F. Sutherland
Director
Animal Health Regulatory Affairs
Pharmacia & Upjohn Company
7000 Portage Road
Kalamazoo, Michigan 49001-0199
Tel: 616 833-2426
Fax: 616 833-2707
E-mail: [email protected]

Dr. Michael Wehr
Novigen Sciences, Inc.
1730 Rhode Island Avenue, NW
Ste. 1100
Washington, D.C. 20036
Tel: 202293-5374
Fax: 202 293-5377
E-mail: [email protected]

URUGUAY

Dr. Délvey Anchieri
Departamento de Higiene de Alimentos
Ministerio de Salud Pública
18 de julio 1892, 4to. Piso
Montevideo
Tel: 598 2 49-83-02
Fax: 598 2 48-85-78

INTERNATIONAL ORGANIZATIONS
CONSULTATION MONDIALE DE
L'INDUSTRIE DE LA SANTE ANIMALE
(COMISA)

Dr. Christian Verschueren
Secretary General
COMISA
Rue Defacqz 1
1000 Brussels
Belgique
Tel: 32-2 543-7567
Fax: 32-2 537-0049

Dr. Peter Altreuther (President)
COMISA
c/o Bayer
GB Animal Health
D-51368 Leverkusen
Germany

Dr. Diana M. Galer
Director, Safety and Metabolism
Animal Health, Product Development
PFIZER Inc
Central Research
Eastern Point Road
Groton, CT 06340
U.S.A.
Tel: 860441-6078
Fax: 860441-5779
E-mail: [email protected]

Dr. Michael J. McGowan
Director, Regulatory Affairs
Animal Health, Product Development
PFIZER
Eastern Point Road
Groton, CT 06340
U.S.A.
Tel: 860441-4947
Fax: 860441-5779

Mr. Brower A. Merriam
PFIZER
235 East 42nd Street 10017-5755
New York
U.S.A.

Dr. Ricardo J. Wyse
CAPROVE
H. Yrigoyen 850, p. 1 of 124/132
1377 Buenos Aires
Argentina

CONSUMERS INTERNATIONAL

Ms. Lisa Y. Lefferts
Consultant
6719 Chillum Manor Road
Hyattsville, MD 20783
U.S.A.
Tel: 301 559-3630
Fax: 301 853-3272
E-mail: [email protected]

Head Office:
24 Highbury Crescent
London N5, 1RX
United Kingdom
Tel: 44 171 226-6663
Fax: 44 171 354-0607
E-mail: [email protected]

COUNCIL OF THE EUROPEAN UNION

Mr. Luciano Robotti
Principal Administrator
Council of the E. U.
175, rue de la Loi
B-1048 Brussels
Belgium
Tel: 322285-7312
Fax: 32 2 285-7928

EUROPEAN COMMISSION

Ms. Geraldine Fages
Administrator
Directorate General Industry
Pharmacie (III E.3)
Rond Point Schuman 11
B-1049 Brussels
Belgium
Tel: 32-2-296 19 78
Fax: 32-2-296 15 20

Dr. Claire Gaudot
Principal Administrator
Directorate General Agriculture
Rue de la Loi, 200
B-1049 Brussels
Belgium
Tel: 32-2-295 62 16

Peter Jones
Head of Unit Veterinary Medicines
European Agency for the evaluation
of Medicinal Products
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom

INTER-AMERICAN INSTITUTE FOR
COOPERATION ON AGRICULTURE (IICA)

Dr. Theresa Bernardo
Acting Director, Agricultural Health
Apdo. 55-2200 Coronado
Costa Rica
Tel: 506 229-2718
Fax: 506 229-4741
E-mail: [email protected]

Ing. Pilar Fernández
Assistant to the Director
IICA Agricultural Health Area
Apdo. 55-2200 Coronado
Costa Rica
Tel: 506 229-2718
Fax: 506 229-4741
E-mail: [email protected]

INTERNATIONAL CO-OPERATIVE
ALLIANCE (ICA)

Hiroshi Suzuki
Laboratory
Japanese Consumers' Co-operative Union
(JCCU)
1-17.18 Nishikicho
Warabi, Saitama
Japan
Tel: 81-48 433-8300
Fax: 81-48 433-8309

INTERNATIONAL DAIRY FEDERATION
(IDF)

Prof. Dr. Walther H. Heeschen
Director
Federal Dairy Rearch Center
Institute fur Hygiene
Hermann- Weigmann-Str. 1
D-24103 Kiel
Germany
Tel: 49-431 609-392
Fax: 49-431 609-222

OFFICE INTERNATIONAL DES EPIZOOTIES
(OIE)

Dr. J. Boisseau
Director of the OIE Collaborating
Centre for Veterinary Drugs
La Haute Marche
35133 Javène
France
Tel: 33-99-94-7872
Fax: 33-99-94-7899

PAN AMERICAN HEALTH ORGANIZATION
(PAHO)

Dr. Claudio R. Almeida
Regional Advisor, Veterinary
Public Health Program
525 Twenty-third Streeet, N.W.
Washington, D.C. 20037-2895
U.S.A.
Tel: 202 974-3193
Fax: 202 223-5971
E-mail: [email protected]

FOOD AND AGRICULTURE
ORGANIZATION
OF THE UNITED NATIONS (FAO)

Dr. J. Paakkanen
FAO Joint Secretary to JECFA
Food Quality Liaison Group
Food Policy and Nutrition Division
FAO
Via delle Terme di Caracalla
00100 Rome
Italy
Tel: 39-6-52253523
Fax: 39-6-52254593

Constantino Tapias
FAO Representative in Costa Rica
P. O. Box 8198-1000
San José
Costa Rica
Tel: 220 0511/1290
Fax: 232 8848
E-mail: [email protected]

INTERNATIONAL REGIONAL
ORGANIZATION FOR PLANT AND ANIMAL
HEALTH (OIRSA)

Ernesto Calderón
Director Técnico de Salud Animal
Pje. Isolde
Colonia Escalón
San Salvador
Tel: 503 223-9391
Fax: 503 2983-2119
E-mail: [email protected]

WORLD HEALTH ORGANIZATION (WHO)

Dr. John L. Herrman
International Programme on Chemical Safety
World Health Organization
1211 Geneva 27
Switzerland
Tel: 41-22-791-3569
Fax: 41-22-791-4848

CODEX SECRETARIAT

Dr. Alan Randell
Senior Officer
Joint FAO/WHO Food Standards Programme
FAO
Via delle Terme di Caracalla
00100 Rome
Italy
Tel: 39-6-5225-4390
Fax: 39-6-5225-4593

Mr. David H. Byron
Food Standards Officer
Joint FAO/WHO Food Standards Programme
FAO
Via delle Terme di Caracalla
00100 Rome
Italy
Tel: 39-6-5225-4419
Fax: 39-6-5225-4593

UNITED STATES SECRETARIAT

Ms. Rhonda S. Nally
Executive Officer for Codex Alimentarius
FSIS, Am. 311, West-end Court
U.S. Department of Agriculture
1255 22nd St.
Washington, DC 20250 - 3700
U.S.A.
Tel: (202) 418-8852
E-mail: [email protected]

Ms. Edith E. Kennard
Codex Officer
Food Safety and Inspection Service
U.S. Department of Agriculture
Washington, D.C. 20250
U.S.A.
Tel: (202) 418-8852

Ms. Margaret Klock
Office of the Director
Center for Veterinary Medicine (HFV-1)
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
U.S.A.

Ms. Maureen Obando
IICA Support Staff
P.O. Box 55-2200
Coronado
Costa Rica

SPECIAL

Ms. Joan Murphy
World Food Chemical News
1101 Pennsylvania Ave., SE
Washington, D.C. 20005
U.S.A.
Tel: 202544-1980
Fax: 202 546-3890

APPENDIX II: DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Advanced to Step 8)

NOTE: Section 5 - Reference to JECFA Reports - contains references to the reports of meetings of the Joint FAO/WHO Expert Committee on Food Additives, as published in the WHO Technical Report Series (TRS). Relevant toxicological monographs are published in the WHO Food Additives Series (FAS) and residue monographs of the substances concerned are published in the FAO Food and Nutrition Paper (FNP) Series.

1. Substance: Carazolol


2. Acceptable Daily Intake (ADI) as established by JECFA

0-0.1 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle and fat/skin (pigs)

(b) MRL:

(b) 5 µg/kg (The concentration at the injection site may exceed the ADI)

(c) Definition of residue on which MRL was set:

(c) Carazolol

3.2. (a) Commodity:

(a) Liver and kidney (pigs)

(b) MRL:

(b) 25 µg/kg

(c) Definition of residue on which MRL was set:

(c) Carazolol

4. Reference to recommended method(s) of analysis

Keuken, H.J. and Aerts, M.M.L. "Determination of Residues of Keuken, H.J. and Aerts, M.M.L. analysis "Determination of Residues of Carazololand a Number of Tranquilizers in Swine Kidney by High Performance Liquid Chromatography with Ultraviolet and Fluorescence Detection" (1989) J. Chromatography, 464, 149-161 (kidney /pigs) (provisional)


Keuken, H.J. and Aerts, M.M.L. analysis "Determination of Residues of Carazolol and a Number of Tranquilizers in Swine Kidney by High-Performance Liquid Chromatography with Ultraviolet and Fluorescence Detection" (1989) J. Chromatography, 464, 149-161 (kidney/pigs) (provisional)


Carazolol and a Number of Tranquilizers in Swine Kidney by High-Performance Liquid Chromatography with Ultraviolet and Fluorescence Detection" (1989) J. Chromatography, 464, 149-161 (kidney /pigs) (provisional)


Vogelgesang, J. "Determination of Carazolol in Tissues of Pigs by High-Performance Liquid Chromatography" (1989) Dtsch. Lebensmittel Runfsch.,85, 251-258 (liver /pigs) (provisional)


Rudolph, M. & Steinhart, H. "Determination of Carazolol in Tissues of Pigs by High Performance Liquid Chromatography" (1987) J. Chromatography, 392, 371-378 (liver, kidney /pigs) (provisional)


Rose, M.D. and Shearer, G., "Determination of Tranquilizers and Carazolol Residues in Animal Tissue Using High-Performance Liquid Chromatography with Electrochemical Detection (1992) J. Chromatography, 624, 471-477 (liver, kidney /pigs) (provisional)

5. Reference to JECFA Reports:

WHO TRS 815 (38th-1991)


WHO FAS 29 (38th-1991)


FAO FNP 41/4 (38th-1991)


WHO TRS 855 (43rd-1995)


WHO FAS 34 (43rd-1995)


FAO FNP 41/7 (43rd-1995)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 93/31A


Appendix V, ALINORM 95/31


Appendix IV, ALINORM 97/31


1. Substance: Diminazene


2. Acceptable Daily Intake (ADI) as established by JECFA

0-100 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle)

(b) MRL:

(b) 500 µg/kg

(c) Definition of residue on which MRL was set:

(c) Diminazene

3.2 (a) Commodity:

(a) Liver (cattle)

(b) MRL:

(b) 12000 µg/kg

(c) Definition of residue on which MRL was set:

(c) Diminazene

3.3 (a) Commodity:

(a) Kidney (cattle)

(b) MRL:

(b) 6000 µg/kg

(c) Definition of residue on which MRL was set:

(c) Diminazene

3.4 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 150 µg/l (Quantitation limit of the analytical method)

(c) Definition of residue on which MRL was set:

(c) Diminazene

4. Reference to recommended method(s) of analysis

Bottner, A., Hoechst Veterinary GmbH, Wiesbaden, Germany, Hoechst Report 01-L423-0636-92 (D. Schmidt and A. Albrecht) (cattle milk)

5. Reference to JECFA Reports:

WHO TRS 788 (34th-1989)


WHO FAS 25 (34th-1989)


FAO FNP 41/2 (34th-1989)


WHO TRS 851 (42nd-1994)


WHO FAS 33 (42nd-1994)


FAO FNP 41/6 (42nd-1994)

6. Reference to previous Codex Reports:

Appendix IV, ALINORM 95/31


Appendix III, ALINORM 97/31


1. Substance: Doramectin


2. Acceptable Daily Intake (ADI) as established by JECFA

0-0.5 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle)

(b) MRL:

(b) 10 µg/kg (High concentration of residues at the injection site over a 35 day period after subcutaneous or intramuscular administration of the drug at the recommended dose)

(c) Definition of residues on which MRL was set:

(c) Doramectin

3.2 (a) Commodity:

(a) Liver (cattle)

(b) MRL:

(b) 100 µg/kg

(c) Definition of residue on which MRL was set:

(c) Doramectin

3.3 (a) Commodity:

(a) Kidney (cattle)

(b) MRL:

(b) 30 µg/kg

(c) Definition of residue on which MRL was set:

(c) Doramectin

3.4 (a) Commodity:

(a) Fat (cattle)

(b) MRL:

(b) 150 µg/kg (High concentration of residues at the injection site over a 35 day period after subcutaneous or intramuscular administration of the drug at the recommended dose.)

(c) Definition of residue on which MRL was set:

(c) Doramectin

4. Reference to recommended method(s)

Galer, D.M., Pfizer Central Research, Groton, of analysis Connecticut. Internal Report (publication, in press)


See also


Sklavounos, C., et al., "Photoisomerism of Aromatic Doramectin Derivatives. " (1994), J. Agric. and Food Chem., 42, 1228-1231. (cattle fat and liver)

5. Reference to JECFA Reports:

WHO TRS 864 (45th- 1995)


WHO FAS 36 (45th-1995


FAO FNP 41/8 (45th-1995)

6. Reference to previous Codex Reports:

Appendix IV, ALINORM 97/31


1. Substance: Levamisole


2. Acceptable Daily Intake (ADI) as established by JECFA

(b) MRL:

3.1 (a) Commodity:

(c) Definition of residue on which MRL was set:

(b) MRL:

(b) 10 µg/kg

(c) Definition of residue on which MRL was set:

(c) Levamisole

3.2 (a) Commodity:

(a) Liver (poultry)

(b) MRL:

(b) 100 µg/kg

(c) Definition of residue on which MRL was set:

(c) Levamisole

4. Reference to recommended method(s) of

Lauridsen, M. Danish National Food Agency, Method F40251 (pig liver) Note: A similar method has been reported for levamisole residues in cattle milk in Method F40261.


Ellis, R.L., et al. USDA Food Safety and Inspection Service, Analytical Chemistry Laboratory Guidebook -Residue Chemistry Supplement, 1995. (cattle, pig & sheep liver)

5. Reference to JECFA Reports:

WHO TRS 799 (36th-1990)


WHO FAS 27 (36th-1990)


FAO FNP 41/3 (36th-1990)


WHO TRS 851 (42nd-1994)


WHO FAS 33 (42nd-1994)


FAO FNP 41/6 (42nd-1994)

6. Reference to previous Codex Reports

Appendix II, ALINORM 91/31 A


Appendix V, ALINORM 93/31 A


Appendix II, ALINORM 95/31


Appendix III, ALINORM 97/31


1. Substance: Moxidectin


2. Acceptable Daily Intake (ADI) as established by JECFA

0-2 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle)

(b) MRL:

(b) 20 µg/kg[23] (Very high concentrations and great variation in the level of residues at the injection site in cattle over a 49-day period after dosing)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.2 (a) Commodity:

(a) muscle (sheep)

(b) MRL:

(b) 50 µg/kg

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.3 (a) Commodity:

(a) Liver (cattle, sheep)

(b) MRL:

(b) 100 µg/kg

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.4 (a) Commodity:

(a) Kidney (cattle, sheep)

(b) MRL:

(b) SO µg/kg

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.5 (a) Commodity:

(a) Fat (cattle, sheep)

(b) MRL:

(b) 500 µg/kg (Very high concentrations and great variation in the level of residues at the injection site in cattle over a 49-day period after dosing)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

4. Reference to recommended methods(s)

Khunachak, A., Dacunla, A.R. and of analysis Stout, S.J. "Liquid Chromatographic Determination of Moxidectin Residues in Cattle Tissue and Confirmation in Cattle Fat by Liquid Chromatography - Mass Spectrometry" (1993) J. AOAC International 76 (Part 6), 1230-1235. (muscle, liver, kidneys, fat/Cattle and Sheep)

5. Reference to JECFA Reports:

WHO TRS 864 (45th-1995)


WHO FAS 36 (45th-1995)


FAO FNP 41/8 (45th-1995)


WHO TRS in preparation


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th 1996)

6. Reference to previous Codex Reports:

Appendix IV, ALINORM 97/31


1. Substance: Spiramycin


2. Acceptable Daily Intake (ADI) as established by JECFA

0-50 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle/chickens)

(b) MRL:

(b) 200 µg/kg

(c) Definition of residue on which MRL was set:

(c) Sum of spiramycin and neospiramycin

3.2 (a) Commodity:

(a) Muscle (pigs)

(b) MRL:

(b) 200 µg/kg

(c) Definition of residue on which MRL was set:

(c) Expressed as spiramycin equivalents (antimicrobially active residues)

3.3 (a) Commodity:

(a) Liver (cattle/chickens)

(b) MRL:

(b) 600 µg/kg

(c) Definition of residue on which MRL was set:

(c) Sum of spiramycin and neospiramycin

3.4 (a) Commodity:

(a) Liver (pigs)

(b) MRL:

(b) 600 µg/kg

(c) Definition of residue on which MRL was set:

(c) Expressed as spiramycin equivalents (antimicrobially active residues)

3.5 (a) Commodity:

(a) Kidney (cattle)

(b) MRL:

(b) 300 µg/kg

(c) Definition of residue on which MRL was set:

(c) Sum of spiramycin and neospiramycin

3.6 (a) Commodity:

(a) Kidney (chickens)

(b) MRL:

(b) 800 µg/kg

(c) Definition of residue on which MRL was set:

(c) Sum of spiramycin and neospiramycin

3.7 (a) Commodity:

(a) Fat (cattle, chickens)

(b) MRL:

(b) 300 µg/kg

(c) Definition of residue on which MRL was set:

(c) Sum of spiramycin and neospiramycin

3.8 (a) Commodity:

(a) Fat and Kidney (pigs)

(b) MRL:

(b) 300 µg/kg

(c) Definition of residue on which MRL was set:

(c) Expressed as spiramycin equivalents (antimicrobially active residues)

3.9 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 100 µg/l[24]

(c) Definition of residue on which MRL was set:

(c) Sum of spiramycin and neospiramycin

4. Reference to recommended methods(s) of analysis

Weil, A., Rhone Merieux Toulouse, France (muscle, liver, kidney, fat/cattle, poultry)
Weil, A., Rhone Merieux Tolouse, France (muscle/pig)

5. Reference to JECFA Reports:

WHO TRS 815 (38th-1991)


WHO FAS 29 (38th-1991)


FAO FNP 41/4 (38th-1991)


WHO TRS 855 (43rd-1994)


WHO FAS 34 (43rd-1994)


FAO FNP 41/7 (43rd-1994)


WHO TRS in preparation


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 93/31


Appendix V, ALINORM 93/31 A


Appendix V, ALINORM 95/31


Appendix IV, ALINORM 97/31


1. Substance: Triclabendazole


2. Accepetable Daily Intake (ADI) as established by JECFA

0-3 µg/kg body weight

3.1 (a) Commodity:

(a) Fat (cattle, sheep)

(b) MRL:

(b) 100 µg/kg

(c) Definition of residue on which MRL was set:

(c) 5-Chloro-6-(2',3'-dichlorophenoxy)-benzimidazole-2-one

4. Reference to recommended method(s) of

Marti, A.M., Mooser, A.E. and Koch, H. "Determination of Benzimidazole Anthelmintics in Meat Samples", J. Chromatogr., 1990, 498:145-157 (muscle, liver & kidney)

5. Reference to JECFA Reports:

WHO TRS 832 (40th-1992)


WHO FAS 31 (40th-1992)


FAO FNP 41/5 (40th-1992)

6. Reference to previous Codex Reports:

Appendix IV, ALINORM 93/31 A


Appendix III, ALINORM 95/31


Appendix III, ALINORM 97/31

APPENDIX III: DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Retained at Step 7)

NOTE: Section 5 - Reference to JECFA Reports - contains references to the reports of meetings of the Joint FAO/WHO Expert Committee on Food Additives, as published in the WHO Technical Report Series (TRS). Relevant toxicological monographs are published in the WHO Food Additives Series (FAS) and residue monographs of the substances concerned are published in the FAO Food and Nutrition Paper (FNP) Series.

1. Substance: Ceftiofur


2. Acceptable Daily Intake (ADI) as established by JECFA:

0-50 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle &pigs)

(b) MRL:

(b) 200 µg/kg

(c) Definition of residue on which MRL was set:

(c) Desfuroylceftiofur

3.2 (a) Commodity:

(a) Liver (cattle & pigs)

(b) MRL

(b) 2000 µg/kg

(c) Definition of residue on which MRL was set:

(c) Desfuroylceftiofur

3.3 (a) Commodity:

(a) Kidney (cattle & pigs)

(b) MRL:

(b) 4000 µg/kg

(c) Definition of residue on which MRL was set:

(c) Desfuroylceftiofur

3.4 (a) Commodity:

(a) Fat (cattle & pigs)

(b) MRL:

(b) 600 µg/kg

(c) Definition of residue on which MRL was set:

(c) Desfuroylceftiofur

3.5 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 100 µg/l

(c) Definition of residue on which MRL was set:

(c) Desfuroylceftiofur

4. Reference to recommended method(s) of analysis

Beconi-Barker, M.G. et. al. "Determination of Ceftiofur and its Desfuroylceftiofur- Related Metabolites in Swine Tissues by High Performance Liquid Chromatography," (1995), J. Chromatography, 673, 231-244. (Muscle, liver and kidney /Pig)

5. Reference to JECFA Reports:

WHO TRS 864 (45th-1995)


WHO FAS 36 (45th-1995)


FAO FNP 41/8 (45th-1995)

6. Reference to previous Codex Reports:

Appendix IV, ALINORM 97/31

APPENDIX IV: PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Advanced to Steps 5/8)

NOTE: Section 5 - Reference to JECFA Reports - contains references to the reports of meetings of the Joint FAO/WHO Expert Committee on Food Additives, as published in the WHO Technical Report Series (TRS). Relevant toxicological monographs are published in the WHO Food Additives Series (FAS) and residue monographs of the substances concerned are published in the FAO Food and Nutrition Paper (FNP) Series.

1. Substance: Moxidectin[25]


2. Acceptable Daily Intake (ADI) asestablished by JECFA

0-2 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (deer)

(b) MRL:

(b) 20 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.2 (a) Commodity:

(a) Liver (deer)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.3 (a) Commodity:

(a) Kidney (deer)

(b) MRL:

(b) 50 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.4 (a) Commodity:

(a) Fat (deer)

(b) MRL:

(b) 500 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

4. Reference to recommended method(s) of analysis

Khunachak, A., Dacunla, A.R. and Stout, S.J. "Liquid Chromatographic Determination of Moxidectin Residues in Cattle Tissue and Confirmation in Cattle Fat by Liquid Chromatography -Mass Spectrometry" (1993). J. AOAC International, 76 (Part 6), 1230-1225.

5. Reference to JECFA Reports:

WHO TRS 864 (45th-1995)


WHO FAS 36 (45th-1995)


FAO FNP 41/8 (45th-1995)


WHO TRS (in preparation)


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

ALINORM 97/31, Appendix V


1. Substance: Oxytetracycline (only)


2. Acceptable Daily Intake (ADI) as established by JECFA

0-3 µg/kg body weight (Group ADI for chlortetracycline, oxytetracycline and tetracycline)

3.1 (a) Commodity:

(a) Giant prawn (Penaeus monodon)

(b) MRL:

(b) 100 µg/kg

(c) Definition of residue on which MRL was set:

(c) Oxytetracycline

4. Reference to recommended method(s) of analysis:

AOAC International, Official Methods of Analysis, 16th Edition, 1995,
Method 995.09. (cattle, poultry & pig muscle & kidney)

5. Reference to JECFA Reports:

WHO TRS 864 (45th-1995)


WHO FAS 36 (45th-1995)


FAO FNP 41/8 (45th-1995)


WHO TRS (in preparation)


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

ALINORM 97/31, Appendix V


1. Substance: Spiramycin


2. Acceptable Daily Intake as established by JECFA

0-50 µg/kg body weight

3.1 (a) Commodity:

(a) Liver (pigs)

(b) MRL:

(b) 600 µg/kg

(c) Definition of residue on which MRL was set:

(c) Expressed as spiramycin equivalents (antimicrobially-active residues)

3.2 (a) Commodity:

(a) Kidney and fat (pigs)

(b) MRL

(b) 300 µg/kg

(c) Definition of residue on which MRL was set:

(c) Expressed as spiramycin equivalents (antimicrobially-active residues)

4. Reference to recommended method(s) of analysis

Weil, A., Rhone Merieux Toulouse, France (Liver, kidney, fat/Pig)

5. Reference to JECFA Reports:

WHO TRS 815 (38th-1991)


WHO FAS 29 (38th-1991)


FAO FNP 41/4 (38th-1991)


WHO TRS 855 (43rd-1994)


WHO FAS 34 (43rd-1994)


FAO FNP 41/7 (43rd-1994)


WHO TRS (in preparation)


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 93/31


Appendix V, ALINORM 93/31A


Appendix V, ALINORM 95/31


Appendix V, ALINORM 97/31

APPENDIX V: PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Advanced to Step 5)

NOTE: Section 5 - Reference to JECFA Reports - contains references to the reports of meetings of the Joint FAO/WHO Expert Committee on Food Additives, as published in the WHO Technical Report Series (TRS). Relevant toxicological monographs are published in the WHO Food Additives Series (FAS) and residue monographs of the substances concerned are published in the FAO Food and Nutrition Paper (FNP) Series.

1. Substance: Abamectin


2. Acceptable Daily Intake (ADI) as established by JECFA

0-1 µg/kg body weight

3.1 (a) Commodity:

(a) Liver and fat (cattle)

(b) MRL:

(b) 100 µg/kg

(c) Definition of residue on which MRL was set:

(c) Avermectin B1a

3.2 (a) Commodity:

(a) Kidney (cattle)

(b) MRL:

(b) 50 µg/kg

(c) Definition of residue on which MRL was set:

(c) Avermectin B1a

4. Reference to recommended method(s) of analysis:

None

5. Reference to JECFA Reports:

WHO TRS (in preparation)


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports

None


1. Substance: Azaperone


2. Acceptable Daily Intake (ADI) as established by JECFA

0-3 µg/kg body weight (Temporary)

3.1 (a) Commodity:

(a) Muscle and fat (pigs)

(b) MRL:

(b) 60 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of azaperone and azaperol

3.2 (a) Commodity:

(a) Liver and kidney (pigs)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of azaperone and azaperol

4. Reference to recommended method(s) of analysis

Keukens, H.J. and Aerts, M.M.L.,7. Chromatography, 484, 144 (1989) (kidney/pigs) (provisional; 1995) Rose, M.D., Shearer, G., J. Chromatography, 624, 471 (1992) (kidney, liver/pigs) (provisional; 1995) Haagsma, N., Bathelt, E.R. Engelsma, J.W., J. Chromatography, 436, 73 (1988)(muscle, kidney, liver/pigs) (provisional; 1995) van Ginkel L.A., Schuillens, P.L.W.J., Gilling, N., Anal. Chim. Acta, 225, 137 (1989) (muscle, kidney, liver /pigs) (provisional; 1995)

5. Reference to JECFA Reports:

WHO TRS 815 (38th-1991)


WHO FAS 29 (38th-1991)


FAO FNP 41/4 (38th-1991)


WHO TRS 855 (43rd-1994)


WHO FAS 34 (43rd-1994)


FAO FNP 41/7 (43rd-1994)

6. Reference to previous Codex Reports

ALINORM 97/31, Appendix V


1. Substance: Chlortetracycline, oxytetracycline and tetracycline

2. Acceptable Daily Intake (ADI) as established by JECFA

0-3 µg/kg body weight (Group ADI for Chlortetracycline, oxytetracycline and tetracycline)

3.1 (a) Commodity:

(a) Muscle (cattle, pigs, sheep & poultry)

(b) MRL:

(b) 100 µg/kg

(c) Definition of residue on which MRL was set:

(c) parent drug, singly or in combination

3.2 (a) Commodity:

(a) Liver (cattle, pigs, sheep & poultry)

(b) MRL:

(b) 300 µg/kg

(c) Definition of residue on which MRL was set:

(c) parent drug, singly or in combination

3.3 (a) Commodity:

(a) Kidney (cattle, pigs, sheep & poultry)

(b) MRL:

(b) 600 µg/kg

(c) Definition of residue on which MRL was set:

(c) parent drug, singly or in combination

3.4 (a) Commodity:

(a) Milk (cattle and sheep)

(b) MRL:

(b) 100 µg/l

(c) Definition of residue on which MRL was set:

(c) parent drug, singly or in combination

3.5 (a) Commodity:

(a) Eggs (poultry)

(b) MRL:

(b) 200 µg/kg

(c) Definition of residue on which MRL was set:

(c) parent drug, singly or in combination

4. Reference to recommended method(s) of analysis

AOAC 995.04 (milk/cattle)


AOAC 995.09 (muscle, kidney /cattle, pigs, poultry)


MacNeil, J.D., et al. "Chlortetracycline, Oxytetracycline, and Tetracycline in Edible Animal Tissues, Liquid Chromato-graphic Method: Collaborative Study." (1996) J. AOAC International, 79, 405-417. (pig and cattle, muscle and kidney)


Carson, M.C. and Breslyn, W., "Simultaneous Determination of Multiple Tetracycline Residues in Milk by Metal Chelate Affinity Chromatography: Collaborative Study", (1996) J. AOAC International, 79, 29-42.

5. Reference to JECFA Reports:

WHO TRS 864 (45th-1995)


WHO FAS 36 (45th-1995)


FAO FNP 41/8 (45th-1995)


WHO TRS (in preparation)


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)


WHO FAS 85 (1996)


FAO FNP 41/8 (1996)

6. Reference to previous Codex Reports:

ALINORM 97/31 Appendix V


1. Substance: Cypermethrim


2. Acceptable Daily Intake (ADI) as established by JECFA

0-50 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle, liver and kidney (cattle, sheep & chickens)

(b) MRL:

(b) 200 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Cypermethrin

3.2 (a) Commodity:

(a) Fat (cattle, sheep & chicken)

(b) MRL:

(b) 1000 µg/kg (temporary)

(c) Definition of residue on which MRL was set:

(c) Cypermethrin

3.3 (a) Commodity:

(a) Eggs (chicken)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Cypermethrin

3.4 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 50 µg/l (temporary)

(c) Definition of residue on which MRL was set:

(c) Cypermethrin

4. Reference to recommended method(s)

None

5. Reference to JECFA Reports

WHO TRS (in preparation) WHO FAS 38 (47th-1996) FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

None


1. Substance: a-Cypermethrin


2. Acceptable Daily Intake (ADI)

0-20 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle, liver and kidney (cattle, sheep, & chicken)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) a-Cypermethrin

3.2 (a) Commodity:

(a) Fat (cattle, sheep & chicken)

(b) MRL:

(b) 500 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) a- -cypermethrin

3.3 (a) Commodity:

(a) Eggs (chicken)

(b) MRL:

(b) 50 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) a-cypermethrin

3.4 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 25 µg/l (Temporary)

(c) Definition of residues on which MRL was set:

(c) a-Cypermethrin

4. Reference to recommended method(s) of analysis:

None

5. Reference to JECFA reports:

WHO TRS (in preparation) WHO FAS 38 (47th-1996) FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

None


1. Substance: Dexamethasone


2. Acceptable Daily Intake (ADI) as by JECFA

0-0.015 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle and kidney (cattle, horses and pigs)

(b) MRL:

(b) 0.5 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Dexamethasone

3.2 (a) Commodity:

(a) Liver (cattle, horses and pigs)

(b) MRL:

(b) 2.5 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Dexamethasone

3.3 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 0.3 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Dexamethasone

4. Reference to recommended method(s) of analysis

None

5. Reference to JECFA Reports:

WHO TRS 851 (42nd-1994)


WHO FAS 33 (42nd-1994)


FAO FNP 41/6 (42nd-1994)


WHO TRS 855 (43rd-1994)


WHO FAS 34 (43rd-1994)


FAO FNP 41/7 (43rd-1994)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 95/31


Appendix V, ALINORM 97/31


1. Substance: Diclazuril


2. Acceptable Daily Intake (ADI) as established by JECFA (Temporary)

0-20 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (sheep, rabbits & poultry)

(b) MRL:

(b) 500 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Diclazuril

3.2 (a) Commodity:

(a) Liver (sheep rabbits & poultry)

(b) MRL:

(b) 3000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Diclazuril

3.3 (a) Commodity:

(a) Kidney (sheep, rabbits & poultry

(b) MRL:

(b) 2000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Diclazuril

3.4 (a) Commodity:

(a) Fat (sheep, rabbits) and skin/fat (poultry)

(b) MRL:

(b) 1000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Diclazuril

4. Reference to recommended method(s)

Woestenborghs, R., Lorreyne, W., and Heykants, J. "Determination of Diclazuril in Plasma and Animal Tissues by High Performance Liquid Chromatography," Janssen Research Foundation Report V6851, 1988. (Muscle, liver & kidney /chicken & rabbit) (provisional; 1996)


Corbin, T.S. "Determination of Diclazuril in Tissue by Gas Chromatographic Analysis," Pitman-Moore R&D Division for Janssen Pharmaceuticals, Report V7467, 1990. (liver/chicken) (provisional; 1996)


Corbin, T.S. "Capillary Gas Chromato- graphic Analysis of Diclazuril in Tissue," Pitman-Moore R&D Division for Janssen Pharmaceuticals, Report V7468, 1990. (liver/chicken) (provisional; 1996)

5. Reference to JECFA Reports:

WHO TRS 864 (45th- 1995) WHO


FAS 36 (45th-1995) FAO FNP 41/8 (45th-1995)

6. Reference to previous Codex Reports:

ALINORM 97/31, Appendix V


1. Substance: Dihydrostreptomycin and streptomycin


2 Acceptable Daily Intake (ADI) as established by JECFA:

0-30 µg/kg body weight (Temporary)

3.1 (a) Commodity:

(a) Muscle, liver and fat (cattle, pigs, chickens & sheep)

(b) MRL:

(b) 500 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of dihydrosreptomycin and streptomycin

3.2 (a) Commodity:

(a) Kidney (cattle, pigs, chickens and sheep)

(b) MRL:

(b) 1000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of dihydrostreptomycin and streptommycin

3.3 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 200 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of dihydrostreptomycin and streptomycin

4. Reference to recommended method(s) of analysis

None

5. Reference to JECFA Reports:

WHO TRS 855 (43rd-1994) WHO FAS 34 (43rd-1994) FAO FNP 41/7 (43rd-1994)

6. Reference to previous Codex Reports:

ALINORM 97/31 Appendix V


1. Substance: Febantel/Fenbendazole/Oxfendazole


2. Acceptable Daily Intake (ADI) as established by JECFA (Temporary)

0-4 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle, kidney and fat (cattle, pigs & sheep)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of fenbendazole, oxfendazole and oxfendazole sulfone, expressed as oxfendazole sulfone equivalents

3.2 (a) Commodity:

(a) Liver (cattle, pigs & sheep)

(b) MRL:

(b) 500 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of fenbendazole, oxfendazole and oxfendazole sulfone, expressed as oxfendazole sulfone equivalents

3.3 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 100 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of fenbendazole, oxfendazole and oxfendazole sulfone, expressed as oxfendazole sulfone equivalents



4. Reference to recommended method(s) of analysis

Ellis, R.L., et al., USDA Food Safety and Inspection Service, Analytical Chemistry Laboratory Guidebook - Residue Chemistry, 1991, Method BNZ (muscle and liver)

5. Reference to JECFA Reports:

WHO TRS 815 (38th-1991)


WHO FAS 29 (38th-1991)


FAO FNP 41/4 (38th-1991)


WHO TRS 864 (45th-1995)


WHO FAS 36 (45th-1995)


FAO FNP 41/8 (45th-1995)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 93/31


Appendix V, ALINORM 93/31 A


Appendix V, ALINORM 95/31


Appendix V, ALINORM 97/31


1. Substance: Gentamicin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-4 µg/kg body weight (Temporary)

3.1 (a) Commodity:

(a) Muscle & fat (cattle & pigs)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Gentamicin

3.2 (a) Commodity:

(a) Liver (cattle & pigs)

(b) MRL:

(b) 200 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Gentamicin

3.3 (a) Commodity;

(a) Kidney (cattle & pigs)

(b) MRL:

(b) 1000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Gentamicin

3.4 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 100 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Gentamicin

4. Reference to recommended method(s)

Gugginsberg, D., Koch, H., Mitt. Gebiete Lebensm. Hyg. 1995 86, 14-28 (cattle, pig, liver & kidney /muscle) (provisional; 1995)

5. Reference to JECFA Reports:

WHO TRS 855 (43rd-1994)


WHO FAS 34 (43rd-1994)


FAO FNP 41/7 (43rd-1994)

6. Reference to previous Codex Reports:

ALINORM 97/31, Appendix V


1. Substance: Neomycin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-60 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle, liver & fat (cattle, chickens, ducks, goats, pigs, sheep & turkeys)

(b) MRL:

(b) 500 µg/kg

(c) Definition of residue on which MRL was set:

(c) Neomycin

3.2 (a) Commodity:

(a) Kidney (cattle, chickens, ducks, goats, pigs, sheep & turkeys)

(b) MRL:

(b) 10000 µg/kg

(c) Definition of residue on which MRL was set:

(c) Neomycin

3.3 (a) Commodity:

(a) Eggs (chickens)

(b) MRL:

(b) 500 µg/kg

(c) Definition of residue on which MRL was set:

(c) Neomycin

3.4 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 500 µg/l

(c) Definition of residue on which MRL was set:

(c) Neomycin

4. Reference to recommended method(s)

Gugginsberg, D., Koch, H., Mitt. Gebiete Lebensm. Hyg. 1995 (liver & kidney /cattle & pig) (provisional; 1995)

5. Reference to JECFA Reports:

WHO TRS 855 (43rd-1994)


WHO FAS 34 (43rd-1994)


FAO FNP 41/7 (43rd-1994)


WHO TRS (in preparation)


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

ALINORM 97/31, Appendix V


1. Substance: Spectinomycin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-40 µg/kg body weight

3.1 (a) Commodity;

(a) Muscle (cattle, pigs & chickens)

(b) MRL:

(b) 300 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

3.2 (a) Commodity:

(a) Liver (cattle, pigs & chickens)

(b) MRL:

(b) 2000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

3.3 (a) Commodity:

(a) Kidney (cattle, pigs & chickens)

(b) MRL:

(b) 5000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

3.4 (a) Commodity:

(a) Fat (cattle, pigs & chickens)

(b) MRL:

(b) 500 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

3.5 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 200 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

4. Reference to recommended method(s) of analysis

None

5. Reference to JECFA Reports:

WHO TRS 851 (42nd-1994)


WHO FAS 33 (42nd-1994)


FAO FNP 41/6 (42nd-1994)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 95/31


Appendix V, ALINORM 97/31


1. Substance: Thiamphenicol


2 Acceptable Daily Intake (ADI) as established by JECFA

0-6 µg/kg body weight (Temporary)

3.1 (a) Commodity;

(a) Muscle, liver, kidney and fat (cattle & chickens)

(b) MRL:

(b) 40 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Thiamphenicol

4. Reference to recommended method(s) of analysis

None

5. Reference to JECFA Reports:

WHO TRS (in preparation)


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 95/31


Appendix V, ALINORM 97/31


1. Substance: Tilmicosin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-40 µg/kg body weight

3.1 (a) Commodity;

(a) Muscle and fat (cattle, pigs & sheep)

(b) MRL:

(b) 100 µg/kg

(c) Definition of residue on which MRL was set:

(c) Tilmicosin

3.2 (a) Commodity:

(a) Liver (cattle & sheep)

(b) MRL:

(b) 1000 µg/kg

(c) Definition of residue on which MRL was set:

(c) Tilmicosin

3.3 (a) Commodity:

(a) Liver (pig)

(b) MRL:

(b) 1500 µg/kg

(c) Definition of residue on which MRL was set:

(c) Tilmicosin

3.4 (a) Commodity:

(a) Kidney (cattle & sheep)

(b) MRL:

(b) 300 µg/kg

(c) Definition of residue on which MRL was set:

(c) Tilmicosin

3.5 (a) Commodity:

(a) Kidney (pigs)

(b) MRL:

(b) 1000 µg/kg

(c) Definition of residue on which MRL was set:

(c) Tilmicosin

3.6 (a) Commodity:

(a) Milk (sheep)

(b) MRL:

(b) 50 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Tilmicosin

4. Reference to recommended method(s) of analysis

None

5. Reference to JECFA Reports:

WHO TRS (in preparation)


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

None

APPENDIX VI: PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Retained at Step 4)

NOTE: Section 5 - Reference to JECFA Reports - contains references to the reports of meetings of the Joint FAO/WHO Expert Committee on Food Additives, as published in the WHO Technical Report Series (TRS). Relevant toxicological monographs are published in the WHO Food Additives Series (FAS) and residue monographs of the substances concerned are published in the FAO Food and Nutrition Paper (FNP) Series.

1. Substance: Clenbuterol


2. Acceptable Daily Intake (ADI) as established by JECFA

0-0.004 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle and fat (cattle and horses)

(b) MRL:

(b) 0.2 µg/kg

(c) Definition of residues on which MRL was set:

(c) Clenbuterol

3.2 (a) Commodity;

(a) Liver and kidney (cattle and horses)

(b) MRL:

(b) 0.6 µg/kg

(c) Definition of residues on which MRL was set:

(c) Clenbuterol

3.3 (a) Commodity

(a) Milk (cattle)

(b) MRL:

(b) 0.05 µg/l

(c) Definition of residue on which MRL was set:

(c) Clenbuterol

4. Reference to recommended method(s) of analysis

None

5. Reference to JECFA Reports:

WHO TRS (in preparation)


WHO FAS 38 (47th-1996)


FAO FNP 41/9 (47th-1996)

6. Reference to previous Codex Reports:

None

APPENDIX VII: PRIORITY LIST OF VETERINARY DRUGS REQUIRING EVALUATION OR REEVALUATION

1. Substances scheduled for evaluation at the forty-eighth meeting of JECFA in February 1997:

Ceftiofur (residues)*
Cyfluthrin
Danofloxacin
Dexamethasone (monitoring methodology)*
Dihydrostreptomycin*
Enrofloxacin*
Fluazuron
Flumequine*
Gentamicin*
Moxidectin (residues in cattle muscle following single doses and in cattle fat following multiple doses)*
Spiramycin (residues in cattle milk)*
Streptomycin*
Thiabendazole (toxicology)*

2. Substances provisionally scheduled for evaluation at the fiftieth meeting of JECFA in February 1998:

Azaperone*
Cyhalothrin
Diclazuril*
Eprinomectin
Febantel*
Fenbendazole*
Imidocarb
Moxidectin (residues in deer)*
Nicarbazin
Olaquindox (residues)*
Oxfendazole*
Porcine somatotropin
Procaine penicillin
Sarafloxacin
Spectinomycin (residues)*

3. Substances provisionally scheduled for evaluation at the fifty-second meeting of JECFA in February 1999:

Deltamethrin
Doramectin (residues in pigs and sheep)
Metrifonate
Permethrin
Phoxim
Temephos (subject to the availability of data)
Thiamphenicol*
Tilmicosin (residues)*

4. Substances provisionally scheduled for evaluation at the fifty-fourth meeting of JECFA in February 2000:

Cypermethrin (residues)*
alpha-Cypermethrin (residues)*

* Reevaluation

APPENDIX VIII: AMENDMENTS TO METHODS OF ANALYSIS FOR PREVIOUSLY ADOPTED CODEX MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (Recommendations from the 10th Session)

1. New methods provisionally recommended

Trenbolone acetate:

Degand, G., Schmitz, P., and Maghuin-Rogister, G. (1989), J. Chromatography, 489. 235-243.


Van Vyncht, G., Gaspar, P., DePauw, E., and Maghuin-Rogister, G. (1994), J. Chromatography, 683. 66-74.


See also:


Maghuin-Rogister, G., et al., "Validation of Two Enzyme Immunoassay Kits for the Quantitative Analysis of 8-Trenbolone and Trenbolone in Muscle and Liver in the Framework of MRLs", (1996) in press. (muscle, liver/cattle).

Flubendazole:

Woestenborghs, R., Jannsen Research Foundation, Beerse, Belgium, Non-clinical Pharmacokinetics Report R017889/FK1926, Jannsen Accession No. V8979. (muscle, liver/pig, poultry) and (eggs/poultry)

Carbadox:

To be provided to Secretariat (muscle, liver/pig)



[23] See para. 27 of this report.
[24] See para. 30 of this report.
[25] Proposed time frame validity is 1997-1999 (see para. 47 of this report).

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