Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011- Clause 2.5

Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011 - Clause 2.5

What is Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011?

This is a Central Food Regulation drafted by Food Authority in accordance with Section 92 (1) of Food Safety and Standards Act, 2006. The Regulation explain allowable quantity of contaminants, toxins and residues in food articles.

Purpose of the Clause

Clause 2.5-Limit on Antibiotics and veterinary drugs in Food articles

Clause 2.5 of the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, prescribes tolerance limits for antibiotics and veterinary drugs in food articles. It specifies that the substances listed in the regulation shall not exceed the permissible limits mentioned for corresponding food categories, such as edible animal tissues, animal fats, and milk.

The antibiotics and veterinary drugs specified in column (2) shall not exceed the tolerance limit specified in column (4) for the article of food in column (3) of the Table below, namely:-

S. No.	Name of the antibiotics and veterinary drugs	Food	Tolerance limit (mg/Kg)
(1)	(2)	(3)	(4)
1.	Ampicillin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
2.	Cloxacillin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
3.	Colistin	Cattle
		Fat	0.15
		Muscle	0.15
		Kidney	0.2
		Liver	0.15
		Milk	0.05
		Pig
		Muscle	0.15
		Fat	0.15
		Liver	0.15
		Kidney	0.2
		Sheep
		Liver	0.15
		Milk	0.05
		Muscle	0.15
		Kidney	0.2
		Fat	0.15
		Goat
		Kidney	0.2

S. No.	Name of the antibiotics and veterinary drugs	Food	Tolerance limit (mg/Kg)
4.	Dihydrostreptomycin Streptomycin	Cattle
		Muscle	0.6
		Liver	0.6
		Kidney	1
		Fat	0.6
		Milk	0.02
		Chicken
		Muscle	0.6
		Liver	0.6
		Kidney	1
		Fat	0.6
		Pig
		Muscle	0.6
		Liver	0.6
		Kidney	1

5.	Chlortetracycline/Oxytetracy cline/Tetracycline	Cattle
		Muscle	0.2
		Liver	0.6
		Kidney	1.2
		Milk	0.1
		Muscle	0.2
		Giant prawn(Paeneus monodon)(muscle)	0.2
		Pig
		Muscle	0.2
		Liver	0.6
		Kidney	1.2
		Poultry
		Muscle	0.2
		Liver	0.6
		Kidney	1.2
		Eggs	0.4
		Sheep
		Muscle	0.2
		Liver	0.6
		Kidney	1.2
		Milk	0.1
6.	Erythromycin	Chicken
		Muscle	0.1
		Liver	0.1
		Kidney	0.1
		Fat	0.1
		Eggs	0.05
		Turkey
		Muscle	0.1
		Liver	0.1
		Kidney	0.1

7.	Flumequine	Cattle
		Muscle	0.5
		Liver	0.5
		Kidney	3
		Fat	1
		Chicken
		Muscle	0.5
		Liver	0.5
		Kidney	3
		Fat	1
		Pig
		Muscle	0.5
		Liver	0.5
		Kidney	3
		Fat	1
		Sheep
		Muscle	0.5
		Liver	0.5
		Kidney	3
		Fat	1
		Trout(muscle)	0.5
8.	Lincomycin	Cattle
		Milk	0.15
		Chicken
		Muscle	0.2
		Liver	0.5
		Kidney	0.5
		Fat	0.1
		Pig
		Muscle	0.2
		Liver	0.5
		Kidney	1.5
		Fat	0.1
9.	Neomycin	Cattle
		Liver	0.5
		Milk	1.5
		Kidney	10
		Fat	0.5
		Muscle	0.5
		Chicken
		Liver	0.5

10.	Salinomycicin	(I) All edible animal tissues. (II) Fats derived from animal tissues (III) Milk	0.01
11.	Spectinomycin	Cattle
		Muscle	0.5
		Liver	2
		Kidney	5
		Fat	2
		Milk	0.2
		Chicken
		Muscle	0.5
		Liver	2

12.	Sulphadiazine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
13.	Sulphathiazole Sodium	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
14.	Trimethoprim	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
15.	Sulfadiazine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
16.	Sulfanilamide	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
17.	Sulfaguanidine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
18.	Zinc Bacitracin (minimum 60IU/mg dried substance)	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
19.	Amprolium		0.01

20.	Apramycin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
21.	Ceftiofur	Cattle
		Muscle	1
		Liver	2
		Kidney	6
		Fat	2
		Milk	0.1
		Pig
		Muscle	1
		Liver	2
		Kidney	6
		Fat	2
22.	Cephapirine	(I) All edible animal tissues. (II) Fats derived from animal tissues (III) Milk	0.01
23.	Clopidol	(I) All edible animal tissues. (II) Fats derived from animal tissues (III) Milk	0.01
24.	Danofloxacin	Cattle
		Muscle	0.2
		Liver	0.4
		Kidney	0.4
		Fat	0.1
		Pig
		Muscle	0.1
		Liver	0.05
		Kidney	0.2
		Fat	0.1
		Chicken
		Muscle	0.2
		Liver	0.4
		Kidney	0.4
		Fat	0.1
25.	Enrofloxacin	(I) All edible animal tissues	0.01

		(II) Fats derived from animal tissues (III) Milk
26.	Ethopabate	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
27.	Flavophospholipol (Flavomycin)	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
28.	Nicarbazin	Chicken
		Kidney	0.2
		Fat/Skin	0.2
		Liver	0.2
		Muscle	0.2
29.	Monensin	Cattle
		Muscle	0.01
		Liver	0.1
		Kidney	0.01
		Fat	0.1
		Milk	0.002
		Sheep
		Muscle	0.01
		Liver	0.02
		Kidney	0.01
		Fat	0.1
		Goat
		Muscle	0.01
		Liver	0.02
		Kidney	0.01
		Fat	0.1
		Chicken
		Muscle	0.01
		Liver	0.01
		Kidney	0.01
		Fat	0.1
		Turkey
		Muscle	0.01
		Liver	0.01
		Kidney	0.01
		Fat	0.1
		Quail

		Fat	0.1
30.	Moxidectin	Cattle
		Muscle	0.02
		Liver	0.1
		Kidney	0.05
		Fat	0.5
		Sheep
		Muscle	0.05
		Liver	0.1
		Kidney	0.05
		Fat	0.5
31.	Sulphaquinoxaline	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
32.	Sulfadimidine	Cattle
		Milk	0.025
		Not specified
		Muscle	0.1
		Fat	0.1
		Kidney	0.1
		Liver	0.1
33.	Tilmicosin	Cattle
		Muscle	0.1
		Liver	1
		Kidney	0.3
		Fat	0.1
		Pig
		Muscle	0.1
		Liver	1.5
		Kidney	1
		Fat	0.1
		Sheep
		Liver	1
		Muscle	0.1
		Kidney	0.3
		Fat	0.1
		Chicken
		Liver	2.4
		Kidney	0.6

34.	Tylosin	Cattle
		Muscle	0.1
		Liver	0.1
		Kidney	0.1
		Fat	0.1
		Pig
		Muscle	0.1
		Liver	0.1
		Kidney	0.1
		Fat	0.1
		Sheep
		Muscle	0.1
		Liver	0.1
		Kidney	0.1
		Chicken
		Muscle	0.1
		Liver	0.1
		Kidney	0.1
		Fat/Skin	0.1
		Eggs	0.3
35.	Tyvalosin Tartrate	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
36.	Virginiamycin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
37.	Acepromazine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
38.	Albendazole	Species not specified
		Muscle	0.1
		Liver	5
		Kidney	5

39.	Amitraz	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
40.	Aspirin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
41.	Buqarvaquone	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
42.	Buserelin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
43.	Butafosfane	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
44.	Butaphosphan	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
45.	Calcium Borogluconate	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
46.	Calcium Magnesium Borogluconate	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
47.	Carboprost tromethamine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
48.	Cefquinone Sulphate	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
49.	Chloral hydrate	(I) All edible animal tissues (II) Fats derived from animal tissues	0.01

50.	Closprostenol Sodium	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
51.	Closantel	Cattle
		Muscle		1
		Liver		1
		Kidney		3
		Fat		3
		Sheep
		Muscle	1.5
		Liver	1.5
		Kidney	5
		Fat	2
52.	Clenbutrol (Broncopulmin powder)	Cattle
		Muscle		0.0002
		Milk		0.00005
		Liver		0.0006
		Kidney		0.0006
		Fat		0.0002
		Horse
		Muscle		0.0002
		Fat		0.0002
		Liver		0.0006
		Kidney		0.0006
53.	Diethylcarbamazine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
54.	Dinitolmide	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
55.	Doramectin	Cattle
		Muscle		0.01
		Liver		0.1
		Kidney		0.03
		Fat		0.15
		Milk		0.015
		Pig
		Muscle		0.005
		Liver		0.1
		Kidney		0.03

56.	Dexcloprostenolum	(I) All edible animal tissues. (II) Fats derived from animal tissues (III) Milk	0.01
57.	Flunixin Meglumine	(I) All edible animal tissues. (II) Fats derived from animal tissues (III) Milk	0.01
58.	Halofuginone	(I) All edible animal tissues. (II) Fats derived from animal tissues (III) Milk	0.01
59.	Haloxon	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
60.	Ivermectin	Cattle
		Milk	0.01
		Liver	0.8
		Fat	0.4
		Muscle	0.03
		Kidney	0.1
		Pig
		Liver	0.015
		Fat	0.02
		Sheep
		Liver	0.015
		Fat	0.02
61.	Kaolin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
62.	Ketamine hydrochloride	(I) All edible animal tissues. (II) Fats derived from animal tissues (III) Milk	0.01
63.	Levamisole	Cattle
		Muscle	0.01
		Liver	0.1
		Kidney	0.01
		Fat	0.01
		Pig
		Muscle	0.01

		Liver	0.1
		Kidney	0.01
		Fat	0.01
		Sheep
		Muscle		0.01
		Liver		0.1
		Kidney		0.01
		Fat		0.01
		Poultry
		Muscle		0.01
		Liver		0.1
		Kidney		0.01
		Fat		0.01
64.	Lithium Antimony Thiomalate	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
65.	Luprostiol	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
66.	Madramicin	(I) All edible animal tissues. (II) Fats derived from animal tissues (III) Milk		0.01
67.	Magnesium Hypophosphite	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
68.	Meloxicam	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
69.	Mepyramine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
70.	Methyl Hydroxybenzoate	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
71.	Nandrolone Laurate	(I) All edible animal tissues		0.01

		(II) Fats derived from animal tissues (III) Milk
72.	Niclosamide	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
73.	Nimesulide	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
74.	Nitroscanate	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
75.	Nitroxynil	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
76.	Oxybendazole	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
77.	Febantel/Fenbendazole/Oxyf endazole	Cattle
		Muscle	0.1
		Liver	0.5
		Kidney	0.1
		Fat	0.1
		Milk	0.1
		Pig
		Muscle	0.1
		Liver	0.5
		Kidney	0.1
		Fat	0.1
		Sheep
		Muscle	0.1
		Liver	0.5
		Kidney	0.1
		Fat	0.1
		Milk	0.1
		Goat
		Muscle	0.1
		Liver	0.5
		Kidney	0.1

		Fat	0.1
78.	Oxyclozanide	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
79.	Parbendazole	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
80.	Pentobarbitone	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
81.	Praziquantel	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
82.	Pregnant Mare Serum Gonadotrophin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
83.	Proligestone	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
84.	Promazine Hydrochloride	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
85.	Propofol	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
86.	Prosolvin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
87.	Rafoxanide	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
88.	Semduramycin	(I) All edible animal tissues (II) Fats derived from animal	0.01

		tissues (III) Milk
89.	Sulpha Chloropyrazine Sodium	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
90.	Suramin	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
91.	Thiabendazole	Cattle
		Muscle		0.1
		Liver		0.1
		Kidney		0.1
		Fat		0.1
		Milk		0.1 mg/l
		Pig
		Muscle		0.1
		Liver		0.1
		Kidney		0.1
		Fat		0.1
		Sheep
		Muscle		0.1
		Liver		0.1
		Kidney		0.1
		Fat		0.1
		Goat
		Muscle		0.1
		Liver		0.1
		Kidney		0.1
		Fat		0.1
		Milk		0.1 mg/l
92.	Tiamulin Hydrogen Fumarate	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
93.	Totrazuril	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk		0.01
94.	Triclabendazole	Cattle
		Muscle	0.25
		Liver	0.85
		Kidney	0.4

S. No.	Name of the antibiotics and veterinary drugs	Food	Tolerance limit (mg/Kg)
(1)	(2)	(3)	(4)
		Fat/Skin	0.1
		Sheep
		Muscle	0.2
		Liver	0.3
		Kidney	0.2
		Fat/Skin	0.1
95.	Xylazine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
96.	Clorsulon	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
97.	Diminazene	Cattle
		Muscle	0.5
		Liver	12
		Kidney	6
		Milk	0.15 mg/l
98.	Hydrocortisone	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
99.	Phenazone	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
100.	Quinapyramine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01
101.	Cefphactril	(I) All edible animal tissues. (II) Fats derived from animal tissues (III) Milk	0.01
102.	Chlorpyridazine	(I) All edible animal tissues (II) Fats derived from animal tissues (III) Milk	0.01

S. No.

Name of the antibiotics and veterinary drugs

Food

Tolerance limit (mg/Kg)

(1)

(2)

(3)

(4)

103.

Tiaprost Trometamol

(I) All edible animal tissues

(II) Fats derived from animal tissues

(III) Milk

0.01

Note : Edible animal tissues also include that of fish

Penalty for non-compliance:

Any person who manufactures, stores, sells, distributes, or imports unsafe food for human consumption shall be liable for punishment based on the severity of the outcome: up to six months’ imprisonment and a fine up to ₹1 lakh if no injury occurs; up to one year and ₹3 lakh fine for non-grievous injury; up to six years and ₹5 lakh fine for grievous injury; and a minimum of seven years’ imprisonment (extendable to life) and a fine of at least ₹10 lakh if it results in death.

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Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011 - Clause 2.5

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