The FSSAI has drafted amendment regulations related to the tolerance limit of antibiotics and pharmacologically active substances in food products. The FSSAI has invited suggestions and comments from stakeholders on the proposed amendments which must reach the FSSAI office by 12 December 2017.
Since there were no regulations that specified the measures for control of antibiotic residues in food so the FSSAI has drafted the tolerance limit of antibiotics and pharmacologically active substances in foods of animal origin. While the use of antibiotics and other pharmacological substances are required to control diseases in animals, yet there is also a need to limit residues in food of animal origin, like Fish and fishery products.
Globally, the presence of antibiotics and pharmacologically active substances are prohibited in foods of animal origin. Also, there is evidence that the human pathogens are becoming antibiotic resistant. Therefore the need was felt to ensure that residues of antibiotics in foods from animals do not pose a threat to human health. FSSAI has, therefore, drafted the Food Safety and Standards (Contaminants, Toxins, and Residues) Amendment Regulation 2017 which specifies the tolerance limit of antibiotics and pharmacology active substances in the food of animal origin.
In the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011, under regulation “Residues” in category ANTIBIOTIC AND OTHER PHARMACOLOGICALLY ACTIVE SUBSTANCES (2.3.2) the following clause will replace the existing clause.
(2) No person shall use any of the following antibiotics and other pharmacologically active substances in any unit which processes seafood including shrimps, prawns or any variety of fish and fishery products. (Earlier it was only prohibited)
- Nitrofurans
- Furaltadone
- Furazolidone
- Nitrofurantoin
- Nitrofurazone
- Chloramphenicol.
- Sulphamethoxazole.
- Aristolochia spp and preparations thereof.
- Chloroform.
- Chlorpromazine.
- Colchicine.
- Dapsone.
- Dimetridazole.
- Metronidazole.
- Ronidazole.
- Ipronidazole and other nitroimidazoles.
- Clenbuterol.
- Diethylstilbestrol.
- Glycopeptides.
- Stilbenes and other steroids.
- Crystal Violet.
- Malachite Green
Table 1 contains the tolerance limits of Antibiotics (used in human beings and animals) as explained below
The tolerance limit for all the antibiotics named below, used in human beings and animals will be 0.01mg/kg for the following types of foods namely:
(i) All edible animal tissue
(ii) Fats derived from animal tissues
(iii) Milk
Names of antibiotics are as follows
- Ampicillin
- Cloxacillin
- Chloramphenicol
- Dihydrostreptomycin Sulphate (Dihydrostreptomycin)/ Streptomycin
- Chlortetracycline Hydrochloride
- Erythromycin Thiocyanate
- Flumequine
- Furazolidone
- Lincomycin
- Oxytetracycline
- Salinomycin
- Spectinomycin Hydrochloride (Spectinomycin)
- Sulphadiazine
- Sulphathiazole Sodium
- Trimethoprim
- Cloxacillin
- Dicloxacillin
- Sulfadiazine
- Sulfanilamide
- Sulfaguanidine
- Zinc Bacitracin (minimum 60IU/mg dried substance)
Table 2 Antibiotics (for exclusive use in animals)
Sl.
No. |
Name | Food | Tolerance limit mg/kg |
1. | Amprolium Hydrochloride | (i) All edible animal tissue
(ii) Fats derived from animal tissues (iii) Milk |
0.01 |
2. | Apramycin Sulphate | Cattle Kidney | 0.01 |
Sheep Kidney | 0.01 | ||
3. | Ceftiofur Sodium (Ceftiofur) | Cattle | |
Muscle | 1 | ||
Liver 2 | 2 | ||
Kidney 6 | 6 | ||
Fat 2 | 2 | ||
Milk 0.1 | 0.1 | ||
Pig | |||
Muscle 1 | 1 | ||
Liver | 2 | ||
Kidney | 6 | ||
Fat | 2 | ||
4. | Carbadox | (I) All edible animal tissue
(II) Fats derived from animal tissues (III)Milk |
0.01 |
5. | CeftiofurHCl (Ceftiofur) | Cattle | |
Muscle 1 | 1 | ||
Liver 2 | 2 | ||
Kidney 6 | 6 | ||
Fat 2 | 2 | ||
Milk 0.1 | 0.1 | ||
Pig | |||
Muscle 1 | 1 | ||
Liver 2 | 2 | ||
Kidney 6 | 6 | ||
Fat | 2 | ||
6. | Cephapirin Benzathine
intrauterine |
(i) All edible animal tissue
(ii) Fats derived from animal tissues (iii) Milk |
0.01 |
7. | Clopidol | (I) All edible animal tissue
(II) Fats derived from animal tissues (III) Milk |
0.01 |
8. | Cloxacillin Benzathine | (I) All edible animal tissue
(II) Fats derived from animal tissues (III) Milk |
0.01 |
9. | Colistin Sulphate | Cattle
Fat Muscle Kidney Liver Milk |
0.15 0.15 0.2 0.05 0.15 |
Pig
Muscle Fat Liver 0.15 Kidney 0.2 Sheep Liver Milk Muscle Kidney Fat Goat Kidney Muscle Liver Fat Rabbit Fat Muscle Liver Kidney Chicken Kidney Liver Eggs Fat Turkey Muscle Liver Kidney Fat |
0.15 0.15 0.15 0.2
0.15 0.05 0.15 0.2 0.15
0.2 0.15 0.15 0.15
0.15 0.15 0.15 0.2
0.2 0.15 0.3 0.15
0.15 0.15 0.2 0.15 |
||
10. | Danofloxacin | Cattle
Muscle Liver Kidney Fat Pig Muscle Liver Kidney Fat Chicken Muscle Liver Kidney Fat |
0.2 0.4 0.4 0.1
0.1 0.05 0.2 0.1
0.2 0.4 0.4 0.1 |
11. | Enrofloxacin | (I) All edible animal tissue
(II) Fats derived from animal tissues (III) Milk |
0.01 |
12. | Ethopabate | (I) All edible animal tissue
(II) Fats derived from animal tissues (III) Milk |
0.01 |
13. | Flavophospholipol (Flavomycin) | (I) All edible animal tissue
(II) Fats derived from animal tissues (III) Milk |
0.01 |
14. | Monensin Sodium (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 Liver 0.01 Kidney 0.01 Muscle 0.01 Fat |
0.01 0.1 0.01 0.1 0.002
0.01 0.02 0.01 0.1
0.01 0.02 0.01 0.1
0.01 0.01 0.01 0.1
0.01 0.01 0.01 0.1
0.01 0.01 0.01 0.1 |
15. | 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 |
0.02 0.1 0.05 0.5
0.05 0.1 0.05 0.5 |
16. | Sulphaquinoxaline | (I) All edible animal tissue
(II) Fats derived from animal tissues (III) Milk |
0.01 |
17. | Sulfadimidine Sodium | Cattle
Milk Not specified Muscle Fat Kidney Liver |
0.02
0.1 0.1 0.1 0.1 |
18. | Tilmicosin | Cattle
Muscle Liver Kidney Fat Pig Muscle Liver Kidney Fat Sheep Liver Kidney Fat Chicken Liver Kidney Muscle Fat/Skin Turkey Liver Kidney Muscle Fat |
0.1 1 0.3 0.1
0.1 1.5 1 0.1
1 0.3 0.1
2.4 0.6 0.15 0.1
1.4 1.2 0.1 0.25 |
19. | Tylosin | Cattle
Muscle Liver Kidney Fat Pig Muscle Liver Kidney Fat Sheep Muscle Liver Kidney Chicken Muscle Liver Kidney Fat/Skin Eggs |
0.1 0.1 0.1 0.1
0.1 0.1 0.1 0.1
0.1 0.1 0.1
0.1 0.1 0.1 0.1 0.3 |
20. | Tyvalosin Tartrate | (I) All edible animal tissue
(II) Fats derived from animal tissues (III) Milk |
0.01 |
21. | Virginiamycin | (I) All edible animal tissue
(II) Fats derived from animal tissues (III) Milk |
0.01 |
Table 3 consists of a list of 77 other veterinary drugs and their maximum residue limits defined as mg/kg in
- All edible animal tissue
- Fats derived from animal tissues
- Milk
And includes maximum residue limits in muscle, kidneys, liver, fat, and milk of unspecified species and specified species like cattle, sheep, goat, horse, pig, and poultry.
This article contains only a summary of the amendment regulation
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