Regulations governing the maximum limits for veterinary medicines and stock remedies residues that may be present in foodstuffs

(updated) REGULATIO NS GO VERNING THE MAXIMUM LIMITS FO R VETERINARY MEDICINE AND STO CK REMEDY RESIDUES THAT MAY BE PRESENT IN FO O DSTUFFS Published under Government Notice No. R. 1809 of 3 July 1992 As corrected by: Government Notice No. R.2376 of 28 August 1992 As amended by: Government Notice No. R. 1387 of 19 November 1999 The Minister of National Health has, in terms of section 15(1) of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), made the regulations contained in the Schedule hereto. SCHEDULE Definitions 1. In these regulations “the Act” shall means the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), and any expression to which a meaning has been assigned in the Act bears such meaning and, unless inconsistent with the context “Annex” means the Annex to these regulations; “contain” means the presence of a veterinary medicine or stock remedy; “maximum residue limit” means the maximum concentration of the residues of a veterinary medicine or stock remedy, (including specified metabolites, reaction or conversion products or impurities) that remain in a foodstuff referred to in these regulations, resulting from the use of any such veterinary medicine or stock remedy, expressed in milligrams of the veterinary medicine or stock remedy per kilogram of the foodstuff; “stock remedy” means a stock remedy as defined in section 1 of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947); “veterinary medicine” means a veterinary medicine as defined in section 1 of the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965). 2. For the purposes of section 2(1)(a)(ii) of the Act, in so far as it is applied and applicable to foodstuffs, no foodstuff – (a) which is not imported and is listed in column III of the Annex and contains a veterinary medicine or stock remedy listed opposite thereto in column I shall be sold or manufactured for sale if such foodstuff exceeds the maximum residue limit listed opposite thereto in column IV; (b) which is not imported and contains a veterinary medicine or stock remedy which is not listed in the Annex shall be sold or manufactures for sale if such foodstuff exceeds a maximum residue limit of 0,05 mg/kg; 2 (c) which appears in the latest list of the “Codex Maximum Limits for Veterinary Drugs” of the Codex Alimentarius Commission (Joint Food and Agricultural Organisation / World Health Organisation Food Standards Programme) or in the “Directives of the European Community” and which exceeds the maximum residue limits for any veterinary medicine or stock remedy for such foodstuff specified in either or both of the said publications shall be imported; (d) which contains a veterinary medicine or a stock remedy which is not listed in the publications referred to in paragraph (c) or in the Annex shall be imported if such foodstuff exceeds a maximum residue limit of 0,05 mg/kg. ANNEX I Substances II Species III Foodstuffs IV Maximum residue limit (“MRL”) mg/kg V Definition of residues on which MRL was set Albendazole…….. All food-producing species…..……… Fat, milk and muscle…. Kidney and liver……... 0.1 5.0 2-Aminosulphone metabolite Altrenogest……… Pigs…………….. Kidney……………….. Liver…………………. 0.01 0.02 Amoxicillin……... All food-producing species…..……… Fat, kidney, liver and muscle………………... Milk………………….. 0.05 0.004 Ampicillin………. All food-producing species………….. Fat, kidney, liver and muscle………………... Milk………………….. 0.05 0.004 Apramycin……… Poultry………….. Fat……………………. Liver…………………. Muscle……………….. Skin………………….. 0.15 0.42 0.07 0.20 Azaperone………. All food-producing species………….. Fat ,liver and muscle… Kidney………………. 0.05 0.1 Cattle and pigs….. Fat, kidney, liver and muscle……………….. 0.05 Benzylpenicillin… Cattle…………… Milk…………………. 0.004 Benzylpenicillin Carazolol……….. All food-producing species………….. Fat and muscle………. Kidney and liver…….. 0.005 0.03 Carazolol Carbadox……….. Pigs……………… Liver…………………. Muscle……………….. 0.03 0.005 Quinoxaline-2 carboxylic acid Cloramphenicol…. All food-producing species………….. Fat, kidney, liver and muscle………………. 0.01 Sheep…………… Fat…………………… Kidney………………. Liver and muscle……. 2.0 5.0 1.5 Closantel………… Cattle…………… Kidney and fat………. Muscle and liver…….. 3.0 1.0 Closantel Cloxacillin……… All food-producing species………….. Fat, kidney, liver and muscle……………….. Milk………………….. 0.3 0.03 Danofloxacin……. Poultry………….. Muscle and liver……... Skin………………….. 0.05 0.01 Donafloxacin 3 Cattle……………. Fat……………………. Kidney……………….. Liver…………………. Muscle……………….. 0.01 0.03 0.12 0.05 Dapsone…………. All food-producing species………….. Fat, kidney, liver, milk and muscle…………… 0.025 Dicloxacillin……. All food-producing species………….. Fat, kidney, liver and muscle……………….. Milk………………….. 0.3 0.03 Dimetridazole…… All food-producing species…………... Fat, kidney, liver and muscle……………….. 0.01 Diminazene…….. Cattle……………. Kidney………………. Liver…………………. Milk………………….. Muscle……………….. 6.0 12.0 0.15 0.5 Diminazene Doramectin…….. *do not use muscle from injection sites Cattle…………… Kidney………………. Liver…………………. Milk………………….. Muscle……………….. 0.15(1) 0.03 0.1 0.01(1) Doramectin Enrofloxacin……. Poultry…………… Liver and muscle……. Skin………………….. 0.05 0.12 Febantel…………. All food-producing species…………… Fat, kidney, milk and muscle………………… Liver………………….. 0.01 1.0 Febendazole…….. All food-producing species…………… Fat, kidney, milk and muscle………………… Liver………………….. 0.01 0.1 Fluazuron……….. Cattle…………….. Fat…………………….. Kidney………………… Liver…………………... Muscle………………… 2.4 0.08 0.18 7.0 Flubendazole……. Pigs……………… Liver and muscle……… 0.01 Poultry…………… Eggs…………………… Liver………………….. Muscle………………… 0.4 0.5 0.2 Flubendazole Isometamidium…. Cattle……………. Fat, milk and muscle…. Kidney………………… Liver…………………… 0.1 1.0 0.5 Isometamidium Cattle……………. Fat…………………….. Liver………………….. 0.04 0.1 Ivermectin………. Pigs and sheep….. Fat…………………….. Liver………………….. 0.02 0.015 22,23-Dihydro avermectin B1a (H2B1a) Cattle, sheep, pigs and poultry………. Fat, kidney and muscle.. Liver………………….. 0.01 0.1 Levamisole……… Cattle……………. Milk…………………… 0.1 Levamisole Monensin………. All food-producing species………….. Fat, kidney, liver and muscle………………… 0.05 Cattle…………… Fat…………………….. Liver…………………… Muscle…………………. Kidney…………………. 0.5 0.1 0.02 0.05 Moxidectin…….. Sheep……………. Fat……………………... Kidney………………… Liver…………………… Muscle………………… 0.5 0.05 0.1 0.05 Moxidectin 4 Netobimin……… All food-producing species….………. Fat, milk and muscle…. Kidney and liver……… 0.1 5.0 Albendazole and its metabolites… Nitrofurans……… (all substances belonging to the nitrofuran group) All food-producing species…………... Fat, kidney, liver and muscle………………… 0.005 The combined total residues of all substances within this group shall not exceed 0.005 Oxacillin………… All food-producing species…………… Fat, kidney, liver and muscle………………… Milk…………………… 0.3 0.03 Ofendazole……… All food-producing species………….. Fat, kidney, milk and muscle…………………. Liver…………………… 0.01 1.0 Ractopamine……. Pigs……………… Fat…………………….. Kidney………………… Liver…………………… Muscle………………… 0.021 0.655 0.424 0.024 Ronidazole……… All food-producing species………….. Fat, kidney, liver and muscle………………… 0.002 Cattle……………. Fat and kidney………… Milk…………………… Muscle………………… Liver………………….. 0.3 0.2 0.2 0.6 Pigs…………….. Kidney………………… Liver…………………… Muscle………………… 0.3 0.6 0.2 Spiramycin……… Chickens………… Fat…………………….. Kidney………………… Liver…………………… Muscle………………… 0.3 0.8 0.6 0.2 Sum of spiramycin and neospiramyin Sulphadimidine… All food-producing species………….. Fat, kidney, liver and muscle………………… Milk…………………… 0.1 0.025 Sulphadimidine Sulphonamides…. (All substances belonging to the sulphonamide group) All food-producing species………….. Fat, kidney, liver, milk and muscle……………. 0.1 The combined total residues of all substances within the sulphonamide group shall not exceed 0.1 All food-producing species………….. Fat……………………. Kidney………………… Liver………………….. Milk and muscle……… 0.01 0.6 0.3 0.1 Poultry………….. Eggs………………….. 0.2 Tetracyclines…… (All substances belonging to the sulphonamide group) Fish……………… Muscle……………….. 0.1(2) The combined total residues of all substances within the tetracycline group shall not exceed limits indicated Cattle, pigs, goats and sheep……….. Fat, kidney, liver and muscle…………………. 0.1 Thiabendazole….. Cattle and goats… Milk…………………… 0.1 Sum of thiabenda zole and 5-hydroxy thiabendazole Pigs……………… Fat…………………….. Liver…………………… Muscle………………… 0.47 0.48 0.05 Tiamulin……….. Poultry………….. Fat and muscle………… Liver…………………… 0.05 0.26 5 Tilmicosin……… All food-producing species………….. Fat and muscle………… Kidney………………… Liver…………………… 0.05 0.14 6.0 Liver………………….. 0.01 …..-Trenbolone Trenbolone acetate………….. Cattle…………… Muscle………………… 0.002 …..-Trenbolone Triclabendazole… Cattle……………. Fat…………………….. Kidney and liver………. Muscle………………… 0.1 0.3 0.2 Expressed as 5 chloro-6-(2’, 3’ dichloro-phenoxy) benzimidazole-2 one Trimethoprim….. All food-producing species………….. Fat, kidney, liver, milk and muscle……………. 0.05 Zeranol…………. Cattle……………. Liver………………….. Muscle………………… 0.01 0.002 Zeranol Zilpaterol……….. Cattle……………. Fat…………………….. Kidney………………… Liver………………….. Muscle………………… 0.0003 0.014 0.022 0.0012 (1) High concentration of residue at the injection site over a period of 35 days after subcutaneous or intramuscular administration of the drug at the recommended dose (2) For oxytetracycline only