Regulations No. R 1543 of 2002

REGULATIONS GOVERNING THE MAXIMUM LIMITS FOR VETERINARY MEDICINE AND STOCK REMEDY RESIDUES THAT MAY BE PRESENT IN FOODSTUFFS: AMENDMENT

The Minister of Health intends, in terms of section 15(1) of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), to make the regulations in the Schedule.

Interested persons are invited to submit any comments on the proposed regulations or any representations they wish to make in regard thereto to the Director-General: Health, Private Bag X828, Pretoria, 0001 (for the attention of the Director: Food Control), within three months of the date of publication of this notice.

I	II	III	IV	V
Substance	Species	Foodstuff	Maximum Residue Limit MRL (mg/kg)	Definition of residues on which MRL was set
Abamectin……..…	Cattle………………	Fat and liver……...….… Kidney………………..… Meat……………….....… Milk………………...……	0.1 0.05 0.01 0.005	Avermectin B1a
Abamectin……..…	Goats………………	Meat………………..….. Milk…………………...… Edible offal………….....	0.01 0.005 0.1	Avermectin B1a
Albendazole…….…	All food producing species……..……...	Fat, milk and muscle…. Kidney and liver…….....	0.1 5.0	MRLs analysed as 2-aminobenzimidazole and expressed as parent drug equivalents
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 and muscle……..… Kidney and liver……....	0.06 0.1	Sum of concentrations of azaperone and azaperol
Benzylpenicillin/ Procaine benzylpenicillin…..	Cattle and pigs……	Kidney, liver and muscle………………….	0.05	Benzylpenicillin
	Cattle………………	Milk……………………..	0.004
	Chickens…………. (Applies only to procaine benzylpenicillin)	Kidney, liver and muscle………………….	0.05
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
Cefquinome…….	Cattle and pigs……	Fat, muscle and skin… Kidney………………….. Liver………………….	0.05 0.2 0.1	Cefquinome
	Cattle and pigs……	Fat and liver………… Kidney………………….. Muscle………………….	2.0 6.0 1.0
	Cattle………………	Milk……………………..	0.1
Cephalexin……….	Cattle………………	Fat, liver and muscle…. Kidney………………….. Milk………………….	0.2 1.0 0.1	Cephalexin
Chloramphenicol...	All food producing species……………	Fat, kidney, liver and muscle………………….	0.01
Closantel…….……	Sheep…………….	Fat …………………..…. Kidney…………….…… Liver and muscle………	2.0 5.0 1.5	Closantel
Closantel…….……	Cattle………………	Fat and kidney……….. Liver and muscle……..	3.0 1.0	Closantel
Cloxacillin………...	All food producing species……………	Fat, kidney, liver and muscle…………………. Milk……………………..	0.3 0.03
Danofloxacin……	Chickens………….	Kidney and liver…..…... Fat……………………… Muscle……………..…..	0.4 0.1 0.2	Danofloxacin
	Cattle………………	Fat……………………… Kidney and liver………. Muscle………………….	0.1 0.4 0.2
	Pigs………………..	Fat and muscle……….. Kidney…………………. Liver…………………….	0.1 0.2 0.05
Dapsone………….	All food producing species……………	Fat, kidney, liver, milk, and muscle…………….	0.025
Dexamethasone…	Cattle and pigs…… Cattle………………	Kidney and muscle.…... Liver……………………. Milk………………..…….	0.00075 0.002 0.0003
Diclazuril………….	Sheep ……..….…	Fat……………………… Kidney…………………. Liver…………………… Muscle…………………	1.0 2.0 3.0 0.5	Diclazuril
Diclazuril………….	Poultry..…………..	Fat/Skin……………….. Kidney…………………. Liver………………..….. Muscle………………….	1.0 2.0 3.0 0.5	Diclazuril
Dicloxacillin………	All food producing species……………	Fat, kidney, liver and muscle……………..…... Milk………………..…….	0.3 0.03
Dihydrostrepto-mycin/ Streptomycin….....	Cattle, chickens, pigs and sheep……	Fat, liver and muscle…. Kidney…………..………	0.6 1.0	Sum of concentrations of dihydrostrepto mycin and streptomycin
Dihydrostrepto-mycin/ Streptomycin….....	Cattle………………	Milk……………..……….	0.2
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………………	Fat……………………… Kidney………….………. Liver……………………. Muscle………………….	0.15· 0.03 0.1 0.01·	Doramectin
Enrofloxacin……...	Cattle…………….. Poultry……………..	Fat and muscle……….. Kidney………….………. Liver……………………. Milk…………………….. Liver and muscle….….. Skin………………...…..	0.1 0.2 0.3 0.1 0.05 0.12	Enrofloxacin and ciprofloxacin
Estradiol-17b ……..	Cattle………………	Fat, kidney, liver and muscle…………..……..	Not specified · ·
Febantel…………..	All food producing animals…………….	Fat, kidney and muscle. Liver……………………. Milk……………………..	0.1 0.5 0.1	Sum of fendazole, oxfendazole and oxfendazole sulfone, expressed as oxfendazole sulfone equivalents
Fenbendazole……	All food producing animals…………….	Fat, kidney and muscle. Liver……………………. Milk……………………	0.1 0.5 0.1	Sum of fendazole, oxfendazole and oxfendazole sulfone, expressed as oxfendazole sulfone equivalents
Florfenicol………..	Cattle………………	Kidney…………………. Liver……………………. Muscle………………….	0.3 3 0.2
Fluazuron…………	Cattle………………	Fat……………………… Kidney and liver………. Muscle………………….	7.0 0.5 0.2	Fluazuron
Flubendazole ……	Pigs………………..	Liver and muscle………	0.01	Flubendazole ……
	Poultry……….……	Eggs……………………. Liver……………………. Muscle………………….	0.4 0.5 0.2
Gentamycin………	Cattle and pigs……	Fat and muscle……….. Kidney…………………. Liver…………………….	0.1 5.0 2.0	Gentamycin………
Gentamycin………	Cattle………………	Milk……………………..	0.2	Gentamycin………
Imidocarb………..	Cattle………………	Fat and milk…………… Kidney…………………. Liver……………………. Muscle………………….	0.05 1.5 2.0 0.3	Imidocarb
Isometamidium….	Cattle………………	Fat, milk and muscle… Kidney…………………. Liver…………………….	0.1 1.0 0.5	Isometamidium
Ivermectin………..	Cattle………………	Fat……………………… Liver…………….……..	0.04 0.1	22, 23-Dihydro-avermectin B1a (H2B1a)
Ivermectin………..	Pigs and sheep…	Fat……………………… Liver…………….……..	0.02 0.015	22, 23-Dihydro-avermectin B1a (H2B1a)
Levamisole……….	Cattle, sheep, pigs and poultry………..	Fat, kidney and muscle Liver…………………….	0.01 0.1	Levamisole……….
Levamisole……….	Cattle………………	Milk……………………...	0.01	Levamisole……….
Monensin…..…….	All food producing species…………….	Fat, kidney, liver and muscle………..………..	0.05
Moxidectin ……… (Very high concentration and great variation in the level of residues at the injection site in cattle over a 49 day period after dosing)	Cattle………………	Fat……………………… Kidney…………………. Liver……………..…….. Muscle………….………	0.5 0.05 0.1 0.02	Moxidectin
	Sheep……………...	Fat……………………… Kidney and muscle…… Liver………………..…..	0.5 0.05 0.1	Moxidectin
Neomycin..………	Cattle, goats, pigs, poultry and sheep...	Fat, liver and muscle…. Kidney……….…………	0.5 10	Neomycin..………
	Cattle………………	Milk……………………..	0.5
	Chickens…………..	Eggs………….………..	0.5
Netobimin…...……	All food producing species…………….	Fat, milk and muscle…. Kidney and liver.………	0.1 5.0	Albendazole and its metabilites
Nicarbazin…….....	Chickens (broilers)…………..	Fat, kidney, liver and muscle…………….…..	0.2	N, N’-bis-(4-nitrophenyl)urea
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 the group shall not exceed 0.005
Oxacillin…………..	All food producing species…………….	Fat, kidney, liver and muscle……………..….. Milk……………………..	0.3 0.03
Oxfendazole……..	All food producing animals…………….	Fat, kidney and muscle Liver……………………. Milk……………………..	0.1 0.5 0.1	Sum of fendazole, oxfendazole and oxfendazole sulfone, expressed as oxfendazole sulfone equivalents
Progesterone…….	Cattle………………	Fat, kidney, liver and muscle…………..……..	Not specified · ·
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
Sarafloxacin……...	Poultry……………..	Fat………………….….. Kidney and liver………. Muscle………………….	0.02 0.08 0.01	Sarafloxacin
Spectinomycin…...	Cattle, chickens, pigs and sheep …..	Fat and liver……….…. Kidney………….……… Muscle………………….	2.0 5.0 0.5	Spectinomycin
	Cattle…..….……….	Milk……………………..	0.2
	Chickens…………..	Eggs…………………….	2.0
Spiramycin……….	Cattle………………	Fat and kidney……….. Milk…………………….. Muscle………..……….. Liver……………………	0.3 0.2 0.2 0.6	Sum of spiramycin and neospiramycin
	Pigs……………….	Kidney………………….. Liver…………..……… Muscle…………………..	0.3 0.6 0.2
	Chickens…….…….	Fat …………………….. Kidney………………….. Liver……………………. Muscle…………..…….	0.3 0.8 0.6 0.2
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
Testosterone……..	Cattle………………	Fat, kidney, liver and muscle…………..……	Not specified · ·
Tetracyclines…….. (Group: oxytetracycline, chlortetracycline and tetracycline)	All food producing species…………… Cattle………………	Kidney………………….. Liver……………………. Muscle………………… Milk……………………..	1.2· · · 0.6· · · 0.2· · · 0.1· · ·	The combined total residues of all substances within the tetracycline group shall not exceed the limits indicated
	Chickens………….	Eggs…………………….	0.4· · ·
	Fish (applies only to oxytetracyclin)….	Muscle………………….	0.1· · ·
Thiabendazole…... The MRL also covers residues derived from feed containing the residues resulted from agricultural use	Cattle, goats, pigs and sheep…………	Fat, kidney, liver and muscle………………….	0.1	Sum of thiabendazole and 5-hydroxy-thiabendazole
	Cattle and goats….	Milk……………………..	0.1	Sum of thiabendazole and 5-hydroxy-thiabendazole
Tiamulin………….	Pigs………………..	Fat……………………… Liver……………………. Muscle………………….	0.47 0.48 0.05
Tiamulin………….	Poultry…..………..	Fat and muscle……….. Liver……………………	0.05 0.26
Tilmicosin…………	Cattle, pigs and sheep………………	Fat and muscle………..	0.1	Tilmicosin…….
	Cattle and sheep…	Kidney………….……… Liver…………….………	0.3 1.0
	Pigs………………...	Kidney………….………. Liver…………….………	1.0 1.5
Trenbalone acetate……………	Cattle………………	Liver…………………….	0.01	a -Trenbelone
	Cattle………………	Muscle………………….	0.002	b -Trenbelone
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)
Triclabendazole….	Sheep……………...	Fat, kidney, liver and muscle…………………	0.1
Trimethoprim…....	All food producing species……….……	Fat, kidney, liver, milk, and muscle………….…	0.05
Valnemulin……….	Pigs………………..	Kidney…………..……… Liver……………..…….. Muscle……………..…..	0.1 0.5 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

· High concentration of residue at injection site over a period of 35 days after subcutaneous or intramuscular administration of the drug at the recommended dose

· · MRL "not specified" means that available data on the identity and concentration of residues of the veterinary drug in animal tissues indicate a wide margin of safety for consumption of residues in food when the drug is used according to good practice in the use of veterinary drugs. For that reason , and for the reasons stated in the individual evaluation, the Joint Expert Committee for Food Additives of the World Health Organization (WHO) and the Food and Agricultural Organization of the United Nations (FAO) concluded that the presence of drug residues in the named animal product does not present a health concern and that there is no need to specify a numerical MRL

GOVERNMENT NOTICE

DEPARTMENT OF HEALTH