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The Food Safety and Standards Authority of India (FSSAI) issued a notification on October 17, 2024, amending the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011. This amendment introduces new limits for specific contaminants in food products such as wheat, barley, rye, and coffee, effective from April 1, 2025. For instance, the maximum allowable Ochratoxin A in wheat and barley is now set at 5 µg/kg, while Deoxynivalenol in wheat and barley is limited to 1000 µg/kg. Additionally, the amendment prohibits the use of certain antimicrobials and veterinary drugs in the production of meat, milk, poultry, and aquaculture, establishing residue limits for these substances. The use of antibiotics in honey production is also regulated, with stringent residue limits for several antibiotics, including Chloramphenicol and Tetracyclines. These regulations aim to ensure safer food products for consumers by setting stricter residue and contaminant limits across a variety of food items.

FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA NOTIFICATION

New Delhi, the 17th October, 2024

F. No. 01-SP (PAR)-Notification-Pesticides/Stds-FSSAI/2017.—Whereas the draft of certain regulations, further to amend the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011, was published as required under sub-section (1) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006) vide notification of the Food Safety and Standards Authority of India number F.No.01-SP (PAR)-Notification-Pesticides /Stds-FSSAI/2017, dated the 20th August, 2020 in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections or suggestions from the persons likely to be affected thereby, before the expiry of the period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas the copies of the said Official Gazette were made available to the public on the 26th August, 2020;

And whereas the objections and suggestions received from the public in respect of the said draft regulations have been considered by the Food safety and Standards Authority of India;

Now, therefore, in exercise of the powers conferred by clause (i) and (j) of sub- section (2) of section 92 read with section 20 and section 21 of the said Act, the Food Safety and Standards Authority of India hereby makes the following regulations further to amend the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011, namely:-

1. (1) These regulations may be called the Food Safety and Standards (Contaminants, toxins and Residues) First Amendment Regulations, 2024.

(2) They shall come into force on 1st April, 2025.

2. In the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011,-

(a) in regulation 2.2 relating to crop contaminants and naturally occurring toxic substances, in sub-regulation 2.2.1, in clause 1, in the Table.-

(i) against serial number 4 relating to Ochratoxin A, for the entries in columns (3) and (4), the following shall be substituted, namely: –

Article of the food Limit µg/kg
(3) (4)
“Wheat, wheat bran, rye, barley, coffee 5”;

(2) against serial number 6 relating to Deoxynivalenol, for the entries in columns (3) and (4), the following shall be substituted, namely: –

Article of the food Limit µg/kg
(1) (1)
“Wheat, wheat bran, barley 1000”;

(b) in regulation2.3, in sub-regulation 2.3.2, for clauses (2) to (4), the following clause shall be substituted, namely:-“(2) Following antimicrobials and other drugs used in veterinary practices are not permitted to be used at any stage of production of meat and meat products, milk and milk products, poultry and eggs, aquaculture and its products; and the Extraneous Maximum Residue Limits (EMRL) of 0.001 mg/kg shall be applicable except for Chloramphenicol for which it shall be 0.0003 mg/kg (0.3 ug/kg).

1. Carbadox

2. Chloramphenicol

3. Chlorpromazine

4. Clenbuterol

5. Colistin

6. Crystal Violet (Sum of Crystal Violet and Leucocrystal Violet)

7. Glycopeptides

8. Malachite Green (Sum of Malachite green and Leucomalachite green)

9. Nitrofurans and its metabolites furazolidone (AOZ), nitrofurazone (SEM), furaltadone (AMOZ) and nitrofurantoin (AHD)

10. Streptomycin and its metabolite dihydrostreptomycin

11. Nitroimidazoles including-

(A) Dimetridazole (DMZ)

(B) Ronidazole (RNZ) and its metabolite 2-hydroxymethyl-1-methyl-3 nitroimidazole(HMMNI)

(C) Ipronidazole (IPZ) and its metabolite Hydroxyipronidazole

(D) Metronidazole (MNZ) and its metabolite 3 hydroxy metronidazole

12. Steroids

13. Stilbenes

14. Sulphamethoxazole

(3) The use of any antibiotic is not permitted during the honey production, but, in order to test the misuse of antibiotics, the antibiotics specified in column (2) shall not exceed the Minimum Required Performance Limit (MRPL) specified in column (3) of the Table below, namely: –

Table

Serial No. Name of Antibiotics Maximum Residue Performance Limit (MRPL) (ug/kg)
(1) (2) (3)
1 Chloramphenicol 0.3
2 Nitrofurans and its metabolites 1
3 Sulphonamides and its metabolites 10 either individually or collectively
4 Streptomycin 10 either individually or collectively
5 Tetracycline 10
6 (a) Oxytetracycline 10
(b) Chlortetracycline 10
7 Ampicillin 10
8 Enrofloxacin 10
9 Ciprofloxacin 10
10 Erythromycin 10
11 Tylosin 10

(4) The antimicrobials and other drugs used in veterinary practices 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:-

Table

Serial No. Antimicrobials and other drugs used in veterinary practices Food Tolerance limit (mg/Kg)
(1) (2) (3) (4)
1. Ampicillin All edible animal tissues

Fats derived from animal tissues

Milk

0.01
Finfish 0.05
2. Amprolium Cattle
Kidney, Liver, Muscle 0.5
Fat 2.0
Poultry
Kidney and Liver 1.0
Egg 7.0
Muscle 0.5
3 Apramycin All edible animal tissues except in fish Fats

derived from animal tissues

Milk

0.01
4. Albendazole Species not specified
Muscle 0.1
Liver 5.0
Kidney 5.0
Fat 0.1
Milk 0.1
Fish 0.1
5. Amoxicillin Cattle
Kidney 0.05
Liver 0.05
Muscle 0.05
Milk 0.004
Fat 0.05
Finfish
Fillet 0.05
Muscle 0.05
Pig
Liver 0.05
Fat or Skin 0.05
Muscle 0.05
Kidney 0.05
Sheep
Muscle 0.05
Kidney 0.05
Milk 0.004
Fat 0.05
Liver 0.05
Muscle 0.05
6. Cloxacillin All edible animal tissues

Fats derived from animal tissues

0.01
Milk 0.03
7. Chlortetracycline or Oxytetracycline or Tetracycline Cattle
Muscle 0.2
Liver 0.6
Kidney 1.2
Milk 0.1
Muscle 0.2
Giant prawn (Paeneusmonodon) (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
Oxytetracycline Fish 0.2
8. Ceftiofur Cattle
Muscle 1.0
Liver 2.0
Kidney 6.0
Fat 2.0
Milk 0.1 mg/l
Pig
Muscle 1.0
Liver 2.0
Kidney 6.0
Fat 2.0
Sheep
Muscle 1.0
Liver 2.0
Kidney 6.0
Fat 2.0
9. Cephapirine All edible animal tissues except in fish Fats derived from animal tissues 0.01
Milk 0.06
10. Clopidol All edible animal tissues except in fish Fats derived from animal tissues 0.01
11. Closantel Cattle
Muscle 1.0
Liver 1.0
Kidney 3.0
Fat 3.0
Sheep
Muscle 1.5
Liver 1.5
Kidney 5.0
Fat 2.0
Milk (Bovine) 0.045
12. Cefphacetrile All edible animal tissues except in fish Fats derived from animal tissues 0.01
Milk 0.125
13. Cephalexin All edible animal tissues except in fish Fats derived from animal tissues 0.01
Milk 0.1
14. 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
15.

 

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
Fat 0.15
16. Diminazene Cattle
Muscle 0.5
Liver 12.0
Kidney 6.0
Milk 0.15
17. 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
Fat 0.1
18. Flumequine Cattle
Muscle 0.5
Liver 0.5
Kidney 3.0
Fat 1.0
Chicken
Muscle 0.5
Liver 0.5
Kidney 3.0
Fat 1.0
Pig
Muscle 0.5
Liver 0.5
Kidney 3.0
Fat 1.0
Sheep
Muscle 0.5
Liver 0.5
Kidney 3.0
Fat 1.0
Trout
Muscle 0.5
19. Flunixin All edible animal tissues except in fish

Fats derived from animal tissues

Milk

0.01
20. Febantel or Fenbendazole or Oxyfendazole 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
21. Gentamicin Cattle
Milk 0.2 mg/l
Liver 2.0
Fat 0.1
Kidney 5.0
Muscle 0.1
Pig
Muscle 0.1
Kidney 5.0
Fat 0.1
Liver 2.0
22. 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
23. 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
24. 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
25. 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 0.1
26. 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
27. Meloxicam Bovines
Muscle 0.02
Kidney 0.065
Liver 0.065
Milk 0.015
28. Neomycin Cattle
Liver 0.5
Milk 1.5
Kidney 10
Fat 0.5
Muscle 0.5
Chicken
Liver 0.5
Eggs 0.5
Muscle 0.5
Kidney 10
Fat 0.5
Duck
Fat 0.5
Liver 0.5
Kidney 10
Muscle 0.5
Goat
Liver 0.5
Kidney 10
Fat 0.5
Muscle 0.5
Pig
Kidney 10
Liver 0.5
Muscle 0.5
Fat 0.5
Sheep
Kidney 10
Muscle 0.5
Fat 0.5
Liver 0.5
Turkey
Liver 0.5
Muscle 0.5
Kidney 10
Fat 0.5
29 Nicarbazin Chicken
Kidney 0.2
Fat or skin 0.2
Liver 0.2
Muscle 0.2
30. Oxybendazole All edible animal tissues except in fish Fats derived from animal tissues 0.01
31. Oxyclozanide All edible animal tissues except in fish

Fats derived from animal tissues

Milk

0.01
32. Parbendazole All edible animal tissues except in fish

Fats derived from animal tissues

Milk

0.01
33. Praziquantel All edible tissues of pig 0.01
Sheep:
All edible tissues (Muscle, Liver, Kidney, Fat)- 0.05
34. Pencillin

G/Benzylpenicillin

Pig
Liver 0.05
Muscle 0.05
Kidney 0.05
Chicken
Kidney 0.05
Liver 0.05
Muscle 0.05
Cattle
Muscle 0.05
Milk 0.004
Liver 0.05
Kidney 0.05
35. Spectinomycin Cattle
Muscle 0.5
Liver 2.0
Kidney 5.0
Fat 2.0
Milk 0.2 mg/l
Chicken
Muscle 0.5
Liver 2.0
Kidney 5.0
Fat 2.0
Eggs 2.0
Pig
Muscle 0.5
Liver 2.0
Kidney 5.0
Fat 2.0
Sheep
Muscle 0.5
Liver 2.0
Kidney 5.0
Fat 2.0
36. Sulfadiazine All edible animal tissues

Fats derived from animal tissues

Milk

0.01
37. Sulfanilamide All edible animal tissues

Fats derived from animal tissues

Milk

0.01
38 Sulfaquinoxaline All edible animal tissues except in fish

Fats derived from animal tissues

Milk

0.01
39.

 

Sulfadimidine

 

Cattle
Milk 0.025
No Specified
Muscle 0.1
Fat 0.1
Kidney 0.1
Liver 0.1
40. SulfaChloropyrazine All edible animal tissues except in fish

Fats derived from animal tissues

Milk

0.01
41. Sulfamethazine All edible animal tissues except in fish Fats derived from animal tissues 0.01
42. Sulfadimethoxine All edible animal tissues except in fish

Fats derived from animal tissues

Milk

0.01
43. Thiabendazole Cattle
Muscle 0.1
Liver 0.1
Kidney 0.1
Fat 0.1
Milk 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
Fat 0.1
Goat
Muscle 0.1
Liver 0.1
Kidney 0.1
Fat 0.1
Milk 0.1
44.

 

Triclabendazole

 

Cattle
Muscle 0.25
Liver 0.85
Kidney 0.4
Fat or skin 0.1
Sheep
Muscle 0.2
Liver 0.3
Kidney 0.2
Fat or skin 0.1
Milk (All ruminants) 0.01
45. Trimethoprim All edible animal tissues except in fish Fats derived from animal tissues 0.01
Milk 0.05
46. Tylosin Cattle
Muscle 0.1
Liver 0.1
Kidney 0.1
Fat 0.1
Milk 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 or skin 0.1
Eggs 0.3
47. Virginiamycin Poultry and egg 0.01
48. Xylazine All edible animal tissues except in fish Fats derived from animal tissues 0.01
49. Zinc Bacitracin (minimum 60IU/mg dried substance) All edible animal tissues except in fish Fats derived from animal tissues 0.01
Milk 0.1”.

G. KAMALA VARDHANA RAO, Chief Executive Officer
[ADVT.-III/4/Exty./600/2024-25]

Note. – The Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011 were published in the Gazette of India, Extraordinary part III, section 4 vide notification number F. No. 2-15015/30/2010, dated the 1st August, 2011 and last amended vide notification F. No. Stds/SP/(Contaminants)/Notification-1/FSSAI-2018, dated the 7th August, 2020.

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