MINISTRY OFHEALTHAND FAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi; dated the 1s August, 2011 FNo. 2-

regulations · 2006 · State unknown

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Parent: THE FOOD SAFETY AND STANDARDS ACT, 2006 (850f1f1d4eb97f1358a8d8224b7603cd80673d56)

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MINISTRY OFHEALTHAND FAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi; dated the 1s August, 2011 FNo. 2-15015/30/2010 Whereas in exercise of the powers conferred by clause (i) of sub section (2) section 92 read with section 20 ofFood Safety and Standards Act, 2006 (34 of2006) the Food Safety and Standards Authority of India proposes to make Food Safety and Standards Regulations in so far as they relates to Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011,and; Whereas these draft Regulations were published in consolidated form at pages to 776 in the Gazette of India Extraordinary Part III _ Section 4 dated 20uh October 2010 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; And whereas the copies of the Gazette were made available to the public on the 21s October 2010; And whereas objections and suggestions received from the stakeholders within the specified period on the said draft Regulations have been considered and finalized by the Food Safety and Standards Authority of India. Now therefore, the Food Safety and Standards Authority of India hereby make the following Regulations, namely, FOOD SAFETYAND STANDARDS (CONTAMINANTS, TOXINS AND RESIDUES) REGULATIONS,2011 CHAPTER 1 GENERAL 1.1: Short title and commencement- 1.1.l: These regulations may be called the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011. 1.1.2: These regulations shall come into force on or after Suh August, 2011 1.2: Definitions- 1.2.1: In these regulations unless the context otherwise requires: 1. ~Crop contam

Rule TOC

1 · 1: Short title and commencement-

1 · 1.l: These regulations may be called the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011.

1 · 1.2: These regulations shall come into force on or after Suh August, 2011

1 · 2: Definitions-

1 · 2.1: In these regulations unless the context otherwise requires: 1. ~Crop contaminant' means any substance not intentionally added to food, but which gets added to articles of food in the process of their production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging transport or holding of articles of such food as a result of environmental contamination

2 · 1 METALCONTAMINANTS

2 · 1.1

1 · Chemicals described in monographs of the Indian Pharmacopoeia when used in foods, shall not contain metal contaminants beyond the limits specified in the appropriate monographs of the Indian Pharmacopoeia for the time being in force. 2. Notwithstanding the provisions ofregulation 2.1.1 (1), no article of food specified in Column 2 ofthe table below shall contain any metal specified in excess of the quantity specified in Column 3 of the said table:

1 · Lead

1 · 0

2 · 0

0 · 2

10 · 0

0 · 5

1 · 0

5 · 0

5 · 0 on the dry - fat free substance

5 · 0 on the dry Matter 10.0 on the dry matter

10 · 0

10 · 0 on the dry colouring matter 50.0 2.0

2 · 0

7 · 0

5 · 0

20 · 0

30 · 0

30 · 0 on dry colouring matter 30.0 50.0 on the dried total solids 60.0 on the dry matter

70 · Oon the fat free substance

100 · 0 on the dried tomato solid

150 · 0

300 · 0

5 · 0

2 · 0

5 · 0 5.0

5 · 0

15 · 0(But not less than 2.8)

20 · 30.0 0.1

3 · Arsenic

0 · 25

0 · 05

0 · 1

0 · 2

0 · 2 3.0 on dry - matter

0 · 5

2 · 0

4 · 0

5 · 0

5 · 0 on dry colouring matter 1.0

2 · 2 Crop contaminants and naturally occurring toxic substances

22 · 1 1. No article of food specified in column (2) of the Table below shall contain any crop contaminant specified in the corresponding entry in column (1) thereof in excess of quantities specified in the corresponding entry in column (3) of the said table

2 · Naturally occurring Toxic Substances_ The toxic substances specified in column (1) of the Table below; which may occur naturally in any article of food, shall not exceed the limit specified in the corresponding entry in column (2) ofthe said Table

2 · 3: Residues 2.3.1: Restriction on the use of insecticides. 1) Subject to the Provisions of regulation 2.3.1 (2), no insecticides shall be used directly on articles of food Provided that nothing in this regulation shall apply to the fumigants which are registered and recommended for use as such on articles of food by the Registration Committee, constituted under section 5 ofthe Insecticides Act; 1968 (46 0f 1968). 2) The amount of insecticide mentioned in Column 2 on the foods mentioned in column 3,shall not exceed the tolerance limit prescribed in column 4 of the Table given below

0 · 01

0 · 15 (on a fat basis) 0.1

0 · 2 0.1 (on a shell free basis) 0.2

1 · 5

10 · 0

0 · 2

5 · 0

1 · 0

2 · 50 0.50

5 · 00

0 · 02

0 · 05 (on a fat basis) 0.2

0 · 1

0 · 3 1.25 (on a fat basis) Fruits and vegetables including potato 35 Meat, poultry and fish 7.0 (on a whole product basis) Eggs 0.5 (on a shell free basis) Carbonated Water 0.001 Carbonated Water 0.001 Carbonated Water 0.001 Foodgrains 0.05 Milled foodgrains Nil Vegetables 0.5 Foodgrains 1.0 Milled foodgrains 0.25 Vegetables 0.15 Fruits 0.1 Fruits and Vegetables 5.0 Tea (dry manufactured) 5.0 Chillies 1.0 Fruits and Vegetables 2.0 Chillies 0.5

10 ·

2 · 0 05 0.2 0.20

0 · 10

0 · 20

1 · 0 1.0 0.001

0 · 001

16 ·

0 · 02 0.005

0 · 05 (on a fat basis) 0.5

0 · 3

0 · 03

17 ·

0 · 01 0.002 0.15(on a Fat basis) 0.05

37 · 5

3 · 0

19 ·

20 ·

25 · 0

30 · 0

400 · 00

21 ·

0 · 10

0 · 05

0 · 02

1 · 00

0 · 25 0.001

0 · 10

0 · 05

0 · 02

1 · 00

0 · 25 0.001

0 · 10

0 · 05

0 · 01 (onwhole basis 0.20 0.20 (on whole basis)

1 · 00

0 · 25

0 · 10 (On shell free basis) 2.00 (On Whole basis_ 0.001

0 · 10 0.05 0.02

1 · 00

0 · 25

0 · 001

4 · 0 1.0 4.0

3 · 0

8 · 0

0 · 001

23 ·

24 ·

0 · 2 1.0

25 ·

0 · 05 Nil

0 · 2

26 ·

27 ·

0 · 025

0 · 006 0_ 2 (fat basis) 0.2 (carcass fat) 0.05 0.05 (shell free basis) 0.05 1.0 0.2 (shell free basis) 0.05

29 ·

0 · 01

0 · 2

0 · 1 (carcass fat) 0.01(fat basis) 0.05

0 · 025 0.001 0.01 0.003

0 · 2

0 · 05

0 · 05 (shell free basis) 2.0

5 · 0 0.5

1 · 0

05 · 0.5 (fat basis) 0.2 (carcass Fat basis)

0 · 2 (shell free basis) 0.025 0.006

1 · 0 2.0 0.1 (shell free basis) 0.2 1.0 2.0 1.0

33 ·

0 · 025

0 · 006

0 · 2

1 · 0

0 · 05

0 · 1

0 · 2

0 · 1

0 · 05

0 · 02 0.02

0 · 02 (shell free basis)

0 · 1

0 · 2

34 ·

0 · 1 0.025

0 · 2 0.05

0 · 2

0 · 05

0 · 01

0 · 05

35 ·

2 · 0

1 · 0 5.0 0.1

1 · 0

0 · 05

36 ·

0 · 05 0.0125 0.05

0 · 1

0 · 05

0 · 1

0 · 05

37 ·

0 · 025 0.006

0 · 5

0 · 05

0 · 5

38 ·

2 · 0 2.0

39 ·

0 · 1

40 ·

05 · 0.1

41 ·

0 · 25

0 · 50 0.12

0 · 50

2 · 00

1 · 00

5 · 00

0 · 10

0 · 10 (shell free basis) 0.10 (Carcass fat basis) 0.10 (fat basis) 0.50 0.12

43 ·

0 · 50

2 · 00

1 · 00 5.00

0 · 10

0 · 10 (shell free basis)

0 · 10 (carcass fat basis) 0.10 (fat basis) 15.00 0.10

44 ·

45 ·

0 · 03 0.10

0 · 10 0.10

0 · 10 (carcass fat basis) 0.05 (fat basis) 20.00 1.00

46 ·

20 · 00 0.05

47 ·

0 · 01

0 · 20 2.00

0 · 20 0.20

0 · 20 (carcass fat basis 0.01 (fat basis) 0.10

0 · 50

0 · 20 0.05

49 ·

0 · 02 1.00

0 · 01(shell free basis) 0.02 (carcass fat basis) 0.01( fat basis) 0.10 0.03 0.10

50 ·

0 · 05

0 · 10 0.50

0 · 50

1 · 00

2 · 00

2 · 00 (carcasss fat basis) 0.05 (fat basis) 2.00

51 ·

2 · 00

0 · 20 0.10

1 · 00 (carcass fat basis) 0.01 (fat basis) 0.20 0.05 0.10

3 · 00

1 · 00 3.00

1 · 0 0.05

53 ·

0 · 01

0 · 03

0 · 01

0 · 05 (shell free basis) 0.05 (carcass fat basis)

0 · 01 (fat basis) 0.05 0.01 0.10 0.05 0.05 0.05 0.03

54 ·

0 · 05 0.05 (shell free basis) 0.05 (carcass fat basis) 0.05 (fat basis) Nil

55 ·

0 · 25 0.50

56 ·

5 · 00

1 · 00 0.05 (shell free basis) 0.05 (carcass fat basis) 0.05 (fat basis) 0.05 0.05 0.10

57 ·

0 · 10

58 · 59.

0 · 50

0 · 05

0 · 10

60 ·

5 · 00

61 ·

0 · 50 1.00

1 · 00

63 ·

0 · 10

0 · 20 5.00

65 ·

66 ·

1 · 00

0 · 10

0 · 50

1 · 00

67 ·

2 · 00

0 · 10

2 · 00

68 ·

0 · 05 0.05

69 ·

15 · 00

50 · 00 0.05 0.05

70 ·

0 · 05

0 · 10

0 · 05

0 · 05 0.03

73 ·

0 · 02 0.50

75 ·

0 · 50 0.05

1 · 00

76 ·

0 · 01

0 · 01 0.2

77 ·

5 · 00

7 · 00

0 · 2

0 · 05

0 · 1

0 · 05

5 · 0 0.1

0 · 5

10 · 0

5 · 0

10 · 0

0 · 1

0 · 5

0 · 05

85 ·

0 · 2

0 · 05

0 · 1

1 · 0 0.02

0 · 05

0 · 01

91 · 92 93 94

0 · 05

1 · 0

0 · 05 0.05

0 · 05 0.2

95 · 9 97

0 · 02

0 · 05 0.05

0 · 05

0 · 1

0 · 05

3 · 0

0 · 05 0.05 0.05

0 · 05

0 · 1

0 · 5

0 · 05 0.02

0 · 02

0 · 01

0 · 02

116 · 117

0 · 1

0 · 02

0 · 01

0 · 1

0 · 2 0.1 0.1

0 · 1

05 · 0.1 2.0

0 · 2 0.1

10 · 0

0 · 01

0 · 02

0 · 01 0.05 0.05

132 · 133

0 · 05

0 · 05 0.05

0 · 05

0 · 1

5 · 0

0 · 1

1 · 0

0 · 01

0 · 1

0 · 01

0 · 05

1 · 0

0 · 5

2 · 0

0 · 5

0 · 05

0 · 01

2 · 3.2:ANTIIOTICAND OTHER PHARMA-COLOGICALLYACTIVE SUBSTANCES

0 · 1

0 · 05

1 · 1: Short title and commencement-

1 · .1: These regulations may be called the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011.

1 · 1.2: These regulations shall come into force On Or after 5th August;, 2011. 1.2: Definitions-

1 · 2.1: In these regulations unless the context otherwise requires: 1. ~Crop contaminant" means any substance not intentionally added to food, but which gets added to articles of food in the process of their production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine) , manufacture, processing; preparation, treatment, packing, packaging transport or holding of articles of such food as a result of environmental contamination

2 · 1 METAL CONTAMINANTS

2 · 1.1 1. Chemicals described in monographs of the Indian Pharmacopoeia when used in foods, shall not contain metal contaminants beyond the limits specified in the appropriate monographs of the Indian Pharmacopoeia for the time being in force. 2. Notwithstanding the provisions of regulation 2.1.1 (1), no article of food specified in Column 2 of the table below shall contain any metal specified in excess of the quantity specified in Column 3 of the said table:

0 · 5

1 · 0

2 · 0

0 · 5

0 · 2

10 · 0

65 · 0 on the dry fat free Isubstance

5 · 0 on the dry Matter 10.0 on the dry matter 10.0

10 · 0 on the dry colouring_matter 50.0

2 · 0

2 · 5

0 · 1

0 · 2

0 · 1

0 · 3 0.1 0.1 0.1

0 · 3

0 · 2

0 · 2 0.1

1 · 55

0 · 05

0 · 2

0 · 1

0 · 5

0 · 5 0.1

0 · 3

0 · 1

0 · 02

0 · 01

0 · 02

2 · 0

0 · 2 0.5 1.0

1 · 5]

7 · 0

1 · 5

5 · 0

20 · 0

30 · 0

30 · 0 on dry colouring matter 30.0 50.0 on the dried total solids 60.0 on the dry matter 70.0 on the fat free substance 100.0 on the dried tomato solid 150.0

300 · 0

5 · 0

2 · 0

5 · 0

15 · 0 (But not less

30 · 0

0 · 1

0 · 5

0 · 25

0 · 05

0 · 1

0 · 2

3 · 0 on dry matter

0 · 5

2 · 0

4 · 0

5 · 0 5.0 on dry colouring matter 1.0

1 · 0

0 · 1

1 · 1

0 · 1

0 · 01

0 · 5

5 · 0

50 · 200]

6 · Cadmium

1 · 0

0 · 001

0 · 1

0 · 5

1 · 0]

8 · Methyl All foods Mercury (Calculated as Ithe element)

0 · 25

2 · 2 Crop contaminants and naturally occurring toxic substances

2 · 2.1

0 · 5

100 · 100

10 · 10 10 10 10]

2 · 0 ppm

0 · 5 ppm

5 · 0 ppb]

2 · 3: Residues 2.3.1: Restriction on the use of insecticides. 1) Subject to the Provisions of regulation 2.3.1 (2), no insecticides shall be used directly on articles of food Provided that nothing in this regulation shall apply to the fumigants which are registered and recommended for use as such on articles of food by the Registration Committee, constituted under section 5 of the Insecticides Act; 1968 (46 of 1968). 2) The amount of insecticide mentioned in Column 2 on the foods mentioned in column 3, shall not exceed the tolerance limit prescribed in column 4 of the Table given below

0 · 01

0 · 15 (on a fat basis) 0_

0 · 2

0 · 1 (on a shell free bbasis ,

0 · 2

1 · 5

10 · 0

0 · 2

5 · 0

1 · 0

2 · 50

0 · 50

5 · 00

0 · 02

0 · 05 (on a fat basis) 0.2

0 · 1

0 · 3

1 · 25 (on a fat basis)

0 · 001

0 · 05

0 · 5

1 · 0

0 · 25 0.15

0 · 1

10 ·

5 · 0

1 · 0

2 · 0

0 · 5

2 · 0

0 · 5 0.2

0 · 20

0 · 10

0 · 20

1 · 0

0 · 001

16 ·

0 · 02

0 · 005 0.05 (on a fat basis) 0.5

0 · 3

0 · 03

0 · 01 0.002 0.15(on a Fat basis) 0.05

37 · 5

3 · 0

19 ·

25 · 0 25.0

30 · 0

400 · 0

0 · 10 0.05

0 · 05

1 · 00

0 · 25

0 · 001

0 · 10

0 · 05

0 · 02

1 · 00

0 · 25

0 · 001

0 · 10

0 · 05

0 · 01 (on whole basis 0.20 0.20 (on whole basis) 1.00

0 · 25

0 · 10 (on shell free basis , 2.00 (on whole basis) 0.001

0 · 10

0 · 05

0 · 02

1 · 00

0 · 25

0 · 001

4 · 0

1 · 0 4.0 3.0

8 · 0

0 · 001

0 · 5

0 · 2

1 · 0

0 · 05

0 · 006

0 · 2 (fat basis)

0 · 2 (carcass fat) 0.05 0.05 (shell free basis 0.05

1 · 0

0 · 2 shell free basis , 0.05

0 · 01

0 · 5

0 · 01

0 · 1 (carcass fat) 0.01(fat basis) 0.05

0 · 025

0 · 001

130 ·

0 · 01

0 · 003

0 · 2

0 · 05

0 · 05 (shell free basis 2.0

5 · 0

0 · 5 1.0

0 · 5

0 · 5 fat basis)

0 · 2 (carcass Fat basis) 0.2 (shell free basis_ 0.025

0 · 006

1 · 0

2 · 0

0 · 1 shell free basis 0.2

132 ·

1 · 0 2.0 1.0

0 · 2

833 ·

0 · 025

0 · 006

0 · 2

1 · 0

0 · 05

0 · 1

0 · 2

0 · 1

0 · 05

0 · 02

0 · 02 (shell free basis_ 0.1

0 · 2

0 · 1 0.025 0.2

0 · 05

0 · 2

0 · 05

0 · 01

0 · 05

135 ·

2 · 0

1 · 0

5 · 0

0 · 1

1 · 0

0 · 05

0 · 0125

0 · 05

0 · 1

0 · 05

0 · 1

0 · 05

0 · 025

0 · 006

0 · 5

0 · 05

0 · 5

2 · 0

139 ·

0 · 1

0 · 5

0 · 1 Nil

41 ·

0 · 25

42 ·

0 · 50

0 · 12

0 · 50

2 · 00

1 · 00

5 · 00

0 · 10

0 · 10 (shell free basis) 0.10 Carcass fat basis) 0.10 (fat basis)

43 ·

0 · 50

0 · 12

0 · 50 2.00

1 · 00

5 · 00

0 · 10

0 · 10 (shell free basis) 0.10 (carcass fat basis , 0.10 (fat basis)

15 · 00

45 ·

0 · 10

0 · 03

0 · 10

0 · 10 (carcass fat basis , 0.05 (fat basis)

20 · 00

1 · 00

20 · 00

0 · 05

0 · 01

0 · 20

2 · 00

0 · 20

0 · 20 (carcass fat basis 0.01 (fat basis) 0.10

0 · 50

0 · 20

0 · 05

0 · 02

1 · 00

0 · 01(shell free basis 0.02 carcass fat basis) 0.01( fat basis _

650 ·

0 · 10 0.03 0.10 0.05

0 · 10

0 · 50

1 · 00

2 · 00

2 · 00 (carcasss fat basis) 0.05 (fat basis _

651 ·

2 · 00

0 · 20

0 · 10

1 · 00 carcass fat basis) 0.01 (fat basis

652 ·

0 · 20

0 · 05 0.10

3 · 00

1 · 00

3 · 00

1 · 0

653 ·

0 · 05

0 · 01

0 · 03

0 · 01

0 · 05 shell free basis_ 0.05 (carcass fat basis) 0.01 (fat basis)

0 · 05

0 · 01 0.10 0.05

0 · 05

0 · 03

0 · 05

0 · 05 shell free basis _ 0.05 carcass fat basis) 0.05 (fat basis)

655 ·

0 · 25

556 ·

0 · 50

5 · 00

1 · 00

0 · 05 shell free basis) 0.05 (carcass fat basis_

0 · 05 (fat basis) 0.05

0 · 05

0 · 10

0 · 50

0 · 05

0 · 10

5 · 00

661 ·

0 · 50

662 ·

1 · 00

663 ·

0 · 10

0 · 20

5 · 00

166 ·

1 · 00

0 · 10

0 · 50

1 · 00

2 · 00

0 · 10

2 · 00

0 · 05

15 · 00

50 · 00

70 ·

0 · 05

71 ·

0 · 10

72 ·

0 · 05

173 ·

0 · 03

74 ·

0 · 02

0 · 50

0 · 05

1 · 00

76 ·

0 · 01

0 · 2

5 · 00

7 · 00

0 · 2

0 · 05

0 · 1

0 · 05

5 · 0

0 · 1

0 · 5

10 · 0

5 · 0

10 · 0

0 · 1

0 · 05

185 ·

0 · 2

0 · 05

0 · 1

1 · 0

0 · 02

0 · 05

0 · 01

0 · 05

1 · 0

0 · 05

0 · 2

0 · 02

0 · 05

0 · 1

0 · 05

3 · 0

0 · 05

0 · 5

0 · 1

0 · 5

0 · 05

0 · 02

0 · 01

0 · 02

0 · 01

0 · 2

0 · 1

0 · 5

2 · 0

0 · 2

10 · 0

0 · 01

0 · 02

0 · 01

0 · 05

5 · 0

0 · 1

0 · 3

1 · 0

0 · 01

0 · 1

0 · 01

0 · 05

1 · 0

0 · 5

2 · 0

0 · 5

0 · 05

0 · 01

2 · 3.2: ANTIBIOTIC AND OTHER PHARMA-COLOGICALLY ACTIVE SUBSTANCES

0 · 05

0 · 3

1 · [ (3) The limit of antibiotics mentioned in column(2), in Honey on the basis of Limit of Quantification; shall not exceed the tolerance limit prescribed in column(3) when determined by the LC-MSMMS method in the table given below: Table

0 · 5*

5 · 0*

10 ·

5 · 0*

60 · ug of Okadaic acid equivalent/Kg

160 · ug of azaspiracid equivalent/Kg

2 · 5.1: The contaminant mentioned in column 2 on the foods mentioned in column 3, shall not exceed the Maximum Level prescribed in column 4 of the Table given below:

1 · 0

0 · 15

2 · 5]

1 · _

10 ·

1 · the mean value observed is < m 2. maximum of cln values observed are between m and M 3_ no values observed exceed the limit of M,

1 · Inserted by notification no. F. No. 1-12/Sci Panel/ (Notification)/FSSAI/2012, dated the 3rd December; 2014 2. Substituted by notification no: F.No. P.15025/264/13-PA/FSSAI, dated the 4th November, 2015 3. Inserted by notification no. F.No. 1-99/4/SP(Contaminants)/FSSAL/2014, dated the 4th November; 2015 4. Substituted by notification no. FNo.1-99/1/SP(contaminants)/FSSAL/2009, dated the 4th November, 2015 5. Inserted by notification no. F. No. 1-10(6)/Standards/SP(Fish and Fisheries Products)/FSSAI-2013,dated the 4th January, 2016 6. Inserted by notification no. F. No. P 15025/264/13-PA/FSSAI, dated the Sth January, 2016. 7. Inserted by notification no. F. No. P.15025/264/13-PA/FSSAI, dated the 3rd May, 2016 8. Omitted by Notification F. No.1-99/SP (Contaminants)/REG/FSSAI/201,5 dated the 10th October, 2016 9. Inserted by notification no. F No. 1-10(2)/Standards/SP(Fish and Fisheries Products)/FSSAI-2013, dated the 18th January , 2017 10. Inserted by notification no. F. No. P/15025/264/13-PA/FSSAI, dated the Z1st July, 2017.