Chapter 3:

SUBSTANCES ADDED TO FOOD

18
[3.1: Food Additives
3.1.1:

(1) Food Additives included in these Regulations

The food additives listed herein are recognised as suitable for use in foods in
conformance with the provisions of these regulations and have been
assigned an Acceptable Daily Intake (ADI) or determined, on the basis of
other criteria, to be safe and use of additives in conformance with these
regulations is considered to be technologically justified.

(2) Food in which Additives may be used

The conditions under which food additives may be used in foods, whether or
not they have previously been permitted by the Food Safety and Standards
(Food Standards and Food Additives) regulations, 2011.

(3) Foods in which Additives may not be used

Food categories or individual food items in which the use of food additives
is not allowed, or where use should be restricted, are defined by these
Regulations.

(4) Food Additive means any substance not normally consumed as a food by
itself and not normally used as a typical ingredient of the food, whether or
not it has nutritive value, the intentional addition of which to food for a
technological (including organoleptic) purpose in the manufacture,
processing, preparation, treatment, packing, packaging, transport or holding
of such food results, or may be reasonably expected to result (directly or
indirectly), in it or its by-products becoming a component of or otherwise
affecting the characteristics of such foods but does not include contaminants
or substances added to food for maintaining or improving nutritional
qualities.

(5) Acceptable Daily Intake (ADI) means the amount of a food expressed on a
body weight basis that can be ingested daily over a lifetime without
appreciable health risk andan dditive, meeting this criterion shall be used

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 within the bounds of Good Manufacturing Practice (GMP) as specified in
clause (8) of this sub-regulation.

(6) Maximum Use Level of an additive is the highest concentration of the

additive determined to be functionally effective in a food or food category
and agreed to be safe and it is generally expressed as mg/kg of food and he
maximum use level shall not usually correspond to the optimum,
recommended, or typical level of use and under Good Manufacturing
Practice (GMP), the optimum, recommended, or typical use level will
differ for each application of an additive and is dependent on the intended
technical effect and the specific food in which the additive would be used,
taking into account the type of raw material, food processing and post-
manufacture storage, transport and handling by distributors, retailers, and
consumers. 52[Unless otherwise specified, maximum use levels for
additives in Tables are set on the final product as consumed.]

(7) Justification for the use of Food Additives

The use of food additives is justified only when such use has an advantage,
does not present an appreciable health risk to consumers, does not mislead
the consumer, and serves one or more of the technological functions as
specified in these regulations and the needs set out in sub-clause (a) to (d)
below, and only where these objectives cannot be achieved by other means
that are economically and technologically practicable:

(a) to preserve the nutritional quality of the food; an intentional reduction in

the nutritional quality of a food shall be justified in the circumstances
dealt within sub-clause (b) and also in other circumstances where the
food does not constitute a significant item in a normal diet;

(b) to provide necessary ingredients or constituents for foods manufactured

for groups of consumers having special dietary needs;

(c) to enhance the keeping quality or stability of a food or to improve its

organoleptic properties, provided that it does not change the nature,
substance or quality of the food so as to deceive the consumer;

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 (d) to aid in the manufacture, processing, preparation, treatment, packing,
transport or storage of food, provided that the additive is not used to
disguise the effects of the use of faulty raw materials or of undesirable
(including unhygienic) practices or techniques during the course of any
of these activities.

(8) Good Manufacturing Practice (GMP)

All food additives subject to the provisions of these regulations shall be
used under conditions of Good Manufacturing Practice, which includes the
following, namely:-

(a) the quantity of the additive added to food shall be limited to the lowest
possible level necessary to accomplish its desired effect;

(b) the quantity of the additive that becomes a component of food as a result
of its use in the manufacturing, processing or packaging of a food and
which is not intended to accomplish any physical, or other technical
effect in the food itself, is reduced to the extent reasonably possible;
and,
(c) The additive is of appropriate food grade quality and is prepared and
handled in the same way as a food ingredient.

(9) Specifications for the Identity and Purity of Food Additives

Food additives used in accordance with these regulations shall be of
appropriate food grade quality and should at all times conform with the
applicable Specifications of Identity and Purity recommended under these
regulations and in terms of safety, food grade quality is achieved by
conformance of additives to their specifications as a whole (not merely with
individual criteria) and through their production, storage, transport, and
handling in accordance with Good Manufacturing Practice (GMP).

(10) Carry-Over of Food Additives into Foods

(a) Conditions applying to carry-over of Food Additives from

ingredients and raw materials into foods

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 Other than by direct addition, an additive may be present in a food as a
result of carry-over from a raw material or ingredient used to produce the
food, provided that,-

(i) the additive is acceptable for use in the raw materials or other
ingredients (including food additives) in accordance with the provisions
of these Regulations;

(ii) the amount of the additive in the raw materials or other ingredients
(including food additives) does not exceed the maximum use level
specified in these regulations;

(iii) the food into which the additive is carried over does not contain the
additive in a quantity greater than that shall be introduced by the use of
raw materials, or ingredients under proper technological conditions or
manufacturing practice, consistent with the provisions of these
regulations.

(b) Special conditions applying to the use of Food Additives not directly
authorised in food ingredients and raw materials

An additive may be used in or added to a raw material or other ingredient if

the raw material or ingredient is used exclusively in the preparation of a
food that is in conformity with the provisions of these regulations, including
that any maximum level applying to the food is not exceeded.

(d) Foods for which the carry-over of Food Additives is unacceptable

Carry-over of a food additive from a raw material or ingredient shall not be

permissible for foods belonging to the following food categories; unless a
food additive provision in the specified category is mentioned in these
regulations:

(i) infant formulae, follow-up formulae, and formulae for special

medical purposes for infants.

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 (ii) complementary foods for infants and young children.]

3.2: Standards of Additives

3.2.1 Food Colours: Standards of various Food Colours with

characteristics are specified in the table below:
1. Tartrazine
Common Name Tartrazine
Synonyms FD and C Yellow No.5, E.E.C. Serial No.E
102, L-Gebb 2, C.I. Food Yellow 4.
Colour of the 0.1 Per cent Yellow
(M/V) solution in distilled
water.
Colour Index Number (1975) No 19140
Class Monoazo.
Chemical Name Trisodium salt of 5-hydroxy-1-p-
sulphopheny1-4-(p- sulphophenylazo)
pyrazol-3-carboxylic acid.
Empirical formula C16 H9 N4 O9 S2 Na3
Molecular Weight 534.37
Solubility Soluble in water. Sparingly soluble in
Ethanol.

General Requirements
The material shall conform to the requirements prescribed in Table
below:—
TABLE
Sl. No. Characteristic Requirement

1. Total dye content, corrected for Sample dried at 87

o
105±1 C for 2 hours, per cent by mass, Min.
2. Loss on drying at 135oC and Chlorides and Sulphates expressed 13
as sodium salt, percent by mass, Max.
3. Water insoluble matter, percent by mass, Max. 0.2
4. Combined ether extracts, percent by mass,max 0.2
5. Subsidiary dyes, percent by mass, Max. 1.0
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6. Dye intermediates, percent by mass, Max. 0.5
7. Lead, mg/kg, Max. 10
8. Arsenic, mg/kg, Max. 3
9. Heavy metals, mg/kg, Max. 40
It shall be free from mercury, copper and chromium in any form;
aromatic amines, aromatic nitro compounds, aromatic hydrocarbons, and
cyanides.

2. SUNSET YELLOW

Common Name Sunset Yellow

Synonyms FD and C Yellow No.6, Janus Orange S,
C.l. Food Yelow 3, -Orange 2, Janune
soil, EEC Serial No.E.10
Colour of the 0.1 Percent (M/V) Orange
solution in distilled water
Colour Index Number (1975) No 15985
Class Monoazo

Empirical formula Disodium salt of 1.(4-sulphophenylazo)

2-napthol-6-sulphonic acid
Chemical Name C10H10N2O7S2Na2
Molecular Weight 452.37
Solubility Soluble in water. Sparingly soluble in
Ethanol
General Requirements
The material shall conform to the requirements prescribed in Table below:-

TABLE
Requirements for Sunset Yellow, FCF
Sl. No. Requirements for Sunset Yellow, FCF Characteristic Requirement
1. Total dye content, corrected for Sample dried at 105±1oC for 87
2 hours, per cent by mass, Min.
2 Loss on drying at 135oC, percent by mass and Chlorides 13
and Sulphates expressed as sodium salt, percent by mass,

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 Max
3. Water insoluble matter, percent by mass, Max. 0.2
4. Combined ether extracts, percent by mass. 0.2
Max.
5. Subsidiary dyes, (lower sulphonated dyes including traces of 3.0
orange II) percent by mass, Max.
6. Dye intermediates, percent by mass, Max. 0.5
7. Lead, mg/kg, Max. 10
8. Arsenic, mg/kg, Max. 3
9. Heavy metals, mg/kg, Max. 40

It shall be free from mercury, copper and chromium in any form; aromatic
amines, aromatic nitro compounds, aromatic hydrocarbons, and cyanides;

3. ERYTHROSINE

Common Name Erythrosine

FD and C red No.3, C.l. Food Red 14, LB-
Synonyms Rot-I
Colour of the 0.1 Percent (M/V) Red
solution in distilled water
Colour Index Number (1975) No 45430
Class Xanthene
Chemical Name Disodium or dipotassium salt of 2',4', 5',
7', tetraiodo- fluerescein
Empirical formula C20 H6 O5 I4 Na2
Molecular Weight 879.87 (Disodium Salt)
Solubility Soluble in water. Sparingly soluble in
Ethanol

General Requirements
The material shall conform to the requirements prescribed in Table below:—
TABLE
Sl. No. Requirements for Sunset Yellow, FCF Characteristic Requirement
1. Total dye content, corrected for Sample dried at 87
105°±1°C for 2 hours, per cent by mass, Min.
2. Loss on drying at 135oC percent by mass and Chlorides 13

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 and Sulphates expressed as sodium salt percent by
mass, Max.
3. Water insoluble matter, percent by mass, Max. 0.2
4. Ether extractable matter, (alkaline), percent by mass. 0.2
Max.
5. Inorganic Iodide, percent by mass as sodium iodide, 0.1
Max.
6. Subsidiary colouring matters except flourescein, 4
percent by mass, Max.
7. Fluorescein, mg/kg, Max. 20
8. Organic compounds other than colouring matter 0.2
(a) Tri-iodoresorcinol, percent by mass, Max. 0.2
(b) 2.(2,4-dihydroxy-3,5-di-iodobenzoyl) benzoic acid, 0.2
percent by mass, Max.
9. Lead, mg/kg, Max. 10
10. Arsenic, mg/kg, Max. 3
11. Zinc, mg/kg, Max. 50
12. Heavy metals, mg/kg, Max. 40

It shall be free from mercury, copper and chromium in any form; aromatic
amines, aromatic nitro compounds, aromatic hydrocarbons, and cyanides.

4. INDIGO CARMINE
Common Name Indigo carmine
Synonyms Indigotine, FD and C Blue No.2, Cl
Food Blue 1, EEC Serial No. E132 L-
Blue 2
Colour of the 0.1 Percent (M/V) Blue
solution in distilled water
Colour Index Number (1975) No 73015
Class Indigoid
Chemical Name Disodium Salt of indigotine-5, 5'-
Disulphonic acid
Empirical formula C16H8N2O8S2Na2
Molecular Weight 466.36
Solubility Soluble in water. Sparingly soluble in
Ethanol

General Requirements
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The material shall conform to the requirements prescribed in Table below:-

TABLE
Requirement for Indigo Carmine
Sl. Characteristic Requirement
No.
1. Total dye content, corrected for Sample dried at 105±1oC 85
for 2 hours, per cent by mass, Min.
2. Loss on drying at 135oC, percent by mass and Chlorides 15
and Sulphates expressed as sodium salt, 15 percent by
mass, Max.
3. Water insoluble matter, percent by mass, Max. 0.2
4. Combined ether extracts, percent by mass. Max. 0.2
5. Subsidiary dyes, percent by mass, Max. 1.0
6. Isatin Sulphonic acid, percent by mass, Max. 0.5
7. Lead, mg/kg, Max. 10
8. Arsenic, mg/kg, Max. 3
9. Heavy metals, mg/kg, Max. 40
It shall be free from mercury, copper and chromium in any form; aromatic
amines, aromatic nitro compounds, aromatic hydrocarbons, and cyanides.

5. β-CAROTENE.
β-Carotene is obtained as dark violet hexagonal prisms when crystallised
from benzene methanol solution; or as red rhombic, almost quardratic plates,
from petroleum ether.
Synonyms C.I. natural yellow 26
Colour Index Number (1956) No.75130
Class Carotenoids
Chemical Name all trans β-Carotene
Empirical formula C40 H56
Molecular Weight 536.89
Melting Point 183oC ± 1oC
Solubility.- Soluble in carbon disulphide, benzene and chloroform,
moderately soluble in normal hexane, cyclohexane, ether, petroleum ether and
oils; practically insoluble in methanol; insoluble in water.
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 Spectrophotometric Requirement.-The wavelengths of absorption maxima
of all trans β-Carotene in cyclohexane (0.2 mg per 100 ml. approximately) and
in-1cm cell shall be 456 mμ to 484 mμ region. There shall be no cis-peak in the
330 mμ to 355 mμ region.

A solution of β-carotene in chloroform on addition of antimony trichloride

solution shall give a dark blue colour having maximum absorption at a
wavelength of 590 mμ.
Colour Reaction- When 2ml. of concentrated sulphuric acid is added to
2ml. of 0.2 per cent solution of β-Carotene in chloroform, the acid layer shall
turn blue.
The material shall have a minimum purity of 96.0 per cent.
Maximum limit of metallic impurities shall be:—
Arsenic (as As) 3 ppm
Lead (as Pb) 10 ppm.
Heavy metal 40 ppm.

And shall also meet the following requirements:—

(i) Subsidiary colouring matter, percent by weight, Max 3
(ii) Sulphated ash, percent of total colouring matters, Max 0.1

6-CHLOROPHYLL:

Chlorophyll, the green pigment of plants, is extracted and widely used as a

colouring matter for various food items.
Synonyms C.I. Natural Green 3; Lebensmittel Green
No.1
Colour Index Number No.75810
(1956)
Colour Index Number No. 12499
(1924)
Color Green
Class Phorbin (dihydrophorphin)
Chemical Name Chlorophyll a - magnesium complex of
1,3,5,8-tetramethyl 4-ethyl-2-vinyl-9-keto-10
carbomethoxy
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 phorbinphytyl-7-propionate.
Chlorophyll b magnesium complex 1,5,8
trimethyl-3-formyl-4-ethyl-2-vinyl-9-keto-10
carbomethoxyphorbinphytyl-7-propionate
Empirical formula Chlorophyll a - C55H72O5N4Mg
Chlorophyll b- C55H70O6N4Mg
Molecular Weight Chlorophyll a- 893.54
Chlorophyll b - 907.52

General- The material shall be an intensely dark green, aqueous, ethanolic,

or oily solution of chlorophyll degradation products. It shall be soluble in
ethanol, ether, chloroform and benzene. It shall be insoluble in water.
Identification test- A solution of chlorophyll in ethanol shall be blue with deep
red flourescence.
Brown-phase Reaction-When green ether or petroleum ether solution of
chlorophyll is treated with a small quantity of a 10 percent solution of
potassium hydroxide in methanol, the colour shall become brown quickly
returning to green.
Note.- This test is applicable only when chlorophyll has not been treated with
alkalies.
Maximum limits for metallic impurities shall be:—
Arsenic (as As) 3 ppm
Lead (as Pb) 10 ppm
Copper (as Cu) 30 ppm
Zinc (as Zn) 50 ppm
The material shall also conform to the following requirements:—

CHLOROPHYLL - MAGNESIUM COMPLEX

Requiremen
Sl. No. Characteristic t
Total combined phaeophytines and their magnesium
1 complexes, percent by weight, max. 10
Residual solvents, mg/kg, Max. Acetone, methanol, ethanol,
2 propan-2-ol, hexane 50
Dichloromethane 10

7 - CARAMEL
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 Caramel shall be prepared from the food grade carbohydrates or their
combinations in the presence of food grade acids, alkalis or salts. It shall be of
four types, namely:—

Type-I- Plain Caramel-It shall be prepared by heating carbohydrates with or

without acids or alkalis, or their salts. No. ammonium or sulphite compounds
are used.
Type-II- Caustic sulphite caramel- It shall be prepared by heating
carbohydrates with or without acids or alkalis or their salt in the presence of
sulphite compounds; no ammonium compounds are used.

Type - III- Ammonia Process Caramel- It shall be prepared by heating

carbohydrates with or without acids or alkalis or their salts in the presence of
ammonium compounds; no sulphites are used.
Type-IV- Ammonia Sulphite Caramel- It shall be prepared by heating
carbohydrates with or without acids or alkalis or their salts in the presence of
both sulphite and ammonium compounds.

RAW MATERIALS
1. Carbohydrates - Caramel shall be prepared from the following carbohydrates
or their mixtures:—
Sucrose, glucose, fructose, invert sugar, lactose, malt syrup, molasses,
starch hydrolysates and fractions there of and/or polymer thereof.
2. Acids and alkalis- The acids used are sulphuric acid, phosphoric acid, acetic
acid, or citric acid and the alkalis used are sodium, potassium or calcium
hydroxide or mixture thereof.
Where the ammonium compounds are used, they are one or more of the
following:—
Ammonium hydroxide
Ammonium Carbonate and Bicarbonate
Ammonium phosphate
Ammonium sulphate

Ammonium sulphite, Bisulphite, Metasulphite

Where the sulphite compounds are used, they are one or more of the

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 following:— Sulphurous acid, Potassium, Sodium or ammonium
Sulphite or Bisulphite.
It shall be a dark brown to black liquid or solid materials having the
characteristic odour of burnt sugar and a pleasant, bitter taste. Its solution, when
spread in a thin layer on a glass plate should appear homogeneous, transparent
and have reddish-brown colour. It shall be miscible with water. It shall be free
from any other extraneous colouring matter. It may contain permitted
emulsifying and stabilising agents.

It shall conform to the requirements prescribed in Table 1 below. All

requirements shall be on solids basis, except metallic impurities.

TABLE 1 - ROUTINE TEST REQUIREMENTS FOR CARAMEL

Sl. Characteristic Type I Type II Type III Type IV

N CausticSulp AmmoniaPro
o. Plain hite cess Sulphite
Ammonia

1. Solid content, per cent by mass 62-77 65-72 53-83 40-75

0.01-
2. Colour intensity, 0.12 0.06-0.10 0.08-0.36 0.10-0.60
Ammonical nitrogen per cent
3. by mass, max. 0.01 0.01 0.4 0.5
4. 4-Methylimidazole - - Max.300 Max.1000
mg/kg & mg/kg &
Max.200 Max.250
mg/kg on mg/kg on
equivalent equivalent
colour
colour basis basis
5. Lead (as Pb), mg/kg, Max. 5 5 5 5
6. Arsenic(as AS) mg/kg. 3 3 3 3
Note: Requirement of ammoniacal nitrogen is based on a product
colour having a minimum colour intensity prescribed at Sl. No. (2)
proportionately higher values of ammoniacal nitrogen apply for products of
higher colour intensity.
Type Test
The material shall also conform to the requirements prescribed in Table
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 2 below.

TABLE 2 - TYPE TEST REQUIREMENTS FOR CARAMEL

Sl. Characteristic Type I Type II Type III Type IV

N Plain Caustic Ammonia Sulphite
o. Sulphite Process Ammonia
1. Total sulphur Percent by Max 1.3-2.5 Max.0.3 1.4-10.0
mass. 0.3
2. Sulphur dioxide (as SO2) -- Max. 0.2% -- Max.0.5%
3. Total nitrogen, Percent by Max.0. Max.0.2 1.3-6.8 0.5-7.5
mass 1
4. Heavy metals mg/kg 25 25 25 25
(Max.)
5. 2-Acetyl-4- tetra hydroxy -- -- Max.40 --
butylimidazole (THI) mg/kg &
Max. 25
mg/kg on an
equivalent
colour basis
6. Mercury (as Hg) mg/kg, 0.1 0.1 0.1 0.1
Max.
7. Copper (as Cu) mg/kg, 20 20 20 20
Max.
All requirements shall be on solid basis except metallic impurities.

The material shall be filled in amber coloured glass or high density

polythylene containers or any other well closed suitable containers with as little
air space as possible. The containers shall be such as to preclude contamination
of the contents with metals or other impurities.

8. ANNATTO
Class Carotenoids
Code Number Cl (1975) No. 75120',
Cl (1975) Natural Orange 4 EEC No.E-160 b
Chemical Name Annatto extract in oil contains several
coloured components, the major single one
being bixin which may be present in both Cis

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 and Trans forms. Thermal degradation
products of bixin may also be present.
Solubility Water soluble annatto contains norbixin, the
hydrolysis product of bixin, in the form of
sodium or potassium salt, as the major
colouring principle. Both cis and trans forms
may be present
Chemical Formula Bixin C25 H30 O4
Norbixin C24 H28 O4
Molecular Weight Bixin 394.50
Norbixin 380.48

The material shall be of the following two types:

(a) Solution in oil for use in butter and other food products, and
(b) Solution in water for use in cheese and other food products.

General
The material shall be derived only from the plant Bixa orellana L. and shall
not contain any extraneous colouring matter. It shall be processed, packed,
stored and distributed under hygienic conditions in licensed premises.
(1) Solution of Annatto Colour in Oil for Use in Butter and Other Food
Products:—
Annatto extract in oil, as solution or suspension, is prepared by extraction
of the outer coating of seeds with vegetable oils. In the preparation of the
solution of annatto colour in oil, only the edible vegetable oils shall be used,
either singly or in a mixture.
The solution of annatto colour in oils shall be clear and shall remain so on
storage in suitable containers at 15oC except for a slight deposit of stearine or
shall be in the form of a suspension. The suspension on dilution with hot oil to
bring the bixin content to 0.24 per cent shall be a clear solution.

Colour

The colour of solution in amyl acetate at a dilution of 1:1000 (m/v) when

measured in a Lovibond Tintometer with a 1 cm Cell
Spectrophotometrically/Calorimeterically shall be not less than the following:

Yellow units 5.0

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 Red units 0.4

or be not less than the colour of the following inorganic solution at a liquid
depth of one centimeter which may be employed for matching the stated
dilution in a plunger type colorimeter using incident light closely approximating
the normal day light:

Potassium Bichromate 0.320 g

Cobalt ammonium sulphate

(CoSO4 (NH4)2 SO4 6H2O) 2.02 g

Sulphuric acid, Sp-gr 1.84 2ml

Distilled water to make solution to

one litre

These reagents shall be of the analytical reagent grade. Although the

solution retains its tinctorial value for a considerable time, after prolonged
storage, its optical clarity shall be examined before use, to ensure that no
alteration has taken place.
Note 1 - Diluted solution of annatto colour in amyl acetate is not stable in
colour quality, particularly if exposed to light, and measurement shall be carried
out on the diluted solution without undue delay.

(ii) Solution of Annatto Colour in Water for use in Cheese and Other Food
Products:
Water soluble annatto colour is prepared by extraction of the outer coating
of the seeds with aqueous alkali (sodium or potassium hydroxide). In the
preparation of the solution, potable water shall be used. A little quantity (0.5 to
3 per cent) of alkali may be added.

The solution shall be clear and shall remain so on storage in suitable

containers at a temperature of 15oC. Colour
The colour of the solution in 0.1 N sodium hydroxide or potassium
hydroxide at a dilution of 1:1000 (m/v) measured in a 1-cm shall be the same as

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that specified in (i) above.

The material shall conform to the requirements prescribed in Table below:

TABLE
Requirement for Annatto
Sl. Characteristic Requirement
No.
1. Carotenoid
(a) Annatto extract in oil, expressed as bixin, percent by 0.24
mass, Min.
(b) Water-soluble annatto, expressed as norbixin, 0.24
percent by mass, Min.
2. Arsenic, mg/kg, Max. 3
3. Lead, mg/kg, Max. 10
4. Copper, mg/kg, Max. 30
5. Heavy metal, mg/kg, Max. 40

9-RIBOFLAVIN
Riboflavin is a yellow to orange-yellow crystalline powder. Melting point about
280oC with decomposition.
Solubility-slightly soluble in water, more soluble in saline solution and in a
10 per cent (w/v) solution of urea, sparingly soluble in alcohol, practically
insoluble in chloroform and in solvent ether and soluble in dilute solution of
alkali hydroxides.

Synonyms Vitamin B2, Lactoflavin and Lactroflavine

Color Yellow to orange-yellow
Class Isoalloxazine
Chemical Name 6.7-dimethyl-9-(d-1-ribityl)- isoalloxazine
Empirical formula C17H20N4O6
Molecular Weight 376.38

Identification.-A solution of 1 mg of Riboflavin in 100 ml water is pale

greenish yellow in transmitted light, and has an intense yellowish green
flourescence which disappears on the addition of sodium dithionite and mineral

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acids or alkalies.
Spectrophotometry-Absorption maxima of aqueous solution shall be at 220
to 225, 266, 371 and 444 mu.
Specific Rotation-It shall be determined in a 0.5 per cent w/v solution in a
mixture of 1.5 ml of 0.1 N alcoholic solution of potassium hydroxide (free from
carbonate) and sufficient freshly boiled and cooled water to produce 10 ml. The
specific rotation, when calculated with reference to the substance dried to
constant weight in the dark at 105oC, shall be,- 122oC.

The material shall have minimum purity of 97.0 per cent.

Maximum limit of metallic impurities shall be:—
Arsenic (as As) 5 ppm
Lead (as Pb) 20 ppm.

10 - PONCEAU 4R
Common Name Ponceau 4R
Synonyms Cl Food Red 7, L-Rot No.4, Coccine Nouvelle,
Cochineal Red A; EEC Serial No.E 124
Colour of the 0.1 Percent Red
(m/v) solution in distilled
water
Colour Index Number No. 16255
(1975)
Class Monoazo
Chemical Name Trisodium salt of 1-(4-sulpho-1-naphtylazo)
naphthol-6, 8- disulphonic acid
Empirical formula C20 H11 N2 O10 S3 Na2
Molecular Weight 604.5
Solubility Soluble in water. Sparingly soluble in Ethanol

The material shall conform to the requirements prescribed in Table below:—

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TABLE
Requirements for Ponceau 4R
Sl. Characteristic Requirement
No.
1. Total dye content, corrected for Sample dried at 105±1oC 85
for 2 hours, per cent by mass, Min.
2 Loss on drying at 135oC, percent by mass, Max. and 18
Chlorides and Sulphates
expressed as sodium salt, per cent by mass, Max
3. Water insoluble matter, percent by mass, Max. 0.2
4. Combined ether extracts, percent by mass. Max. 0.2
5. Subsidiary dyes, percent by mass, Max. 1.0
6. Dye intermediates, per cent by mass, Max. 0.5
7. Lead, mg/kg, Max. 10
8. Arsenic, mg/kg, Max. 3
9. Heavy metals, mg/kg, Max. 40
It shall be free from mercury, selenium and chromium in any form;
aromatic amines, aromatic nitro compounds, aromatic hydrocarbons, and
cyanides.;

11-CARMOISINE
Common Name Carmoisine
Synonyms Azorubine, C.I. Food Red 3, EEC. Serial No.E
122
Colour of the 0.1 Percent Red
(m/v) solution in distilled
water
Colour Index Number No.14720
(1956)
Class Monoazo
Chemical Name Disodium salt of 2-(4-sulpho-1-naphthylazo)-1-
hydroxy- naphthalene-4-sulphonic acid
Empirical formula C20H12N2O7S2Na2
Molecular Weight 502. 44
General Requirements: The material shall be free from mercury, selenium
19 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
and chromium in any form, aromatic amines, aromatic nitro compounds,
aromatic hydrocarbons and cyanides.
Carmoisine shall also comply with requirements prescribed in Table
below:—

TABLE
Requirements for Carmoisine
Sl. No. Characteristic Requirement
o
1. Total dye content, corrected for Sample dried at 105±1 C 87
for 2 hours, per cent by mass, Min.
2. Loss on drying at 135oC, percent by mass, Max. and 13
Chlorides and Sulphates
expressed as sodium salt, per cent by mass, Max.
3. Water insoluble matter, percent by mass, Max. 0.2
4. Combined ether extracts, percent by mass. Max. 0.2
5. Subsidiary dyes, percent by mass, Max. 1.0
6. Dye intermediates, per cent by mass, Max. 0.5
7. Lead, mg/kg, Max. 10
8. Arsenic, mg/kg, Max. 3
9. Heavy metals, mg/kg, Max. 40

12-SYNTHETIC FOOD COLOUR - PREPARATION AND MIXTURES.

Colour Preparation
A Preparation containing one or more of the permitted synthetic food
colours conforming to the prescribed standard alongwith diluents and/or filler
materials and meant to be used for imparting colour to food. It may contain
permitted preservatives and stabilizers.
The colour preparation would be either in the form of a liquid or powder.
Powder preparations shall be reasonably free from lumps and any visible
extraneous/foreign matter. Liquid preparations shall be free from sediments.
Only the following diluents or filler materials shall be permitted to be used
in colour preparations conforming to the prescribed standards:—

1. Potable water
2. Edible common salt
3. Sugar
20 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 4. Dextrose Monohydrate
5. Liquid glucose
6. Sodium sulphate
7. Tartaric acid
8. Glycerine
9. Propylene glycol
10. Acetic acid, dilute
11. Sorbitol
12. Citric acid
13. Sodium carbonate and sodium hydrogen carbonate
14. Lactose
15. Ammonium, sodium and potassium alginates
16. Dextrins
17. Ethyl acetate
18. Starches
19. Diethyl ether
20. Ethanol
21. Glycerol mono, di and tri acetate
22. Edible oils and fats
23. Isopropyl alcohol
24. Bees wax
25. Sodium and ammonium hydroxide
26. Lactic acid
27. Carragenan and gum arabic
28. Gelatin
29. Pectin

Colour Mixtures
A mixture of two or more permitted synthetic food colour conforming to
prescribed standards without diluents and filler material and meant to be used
for imparting colour to food.
It may contain permitted preservatives and stabilizers.

General Requirements- For Colour Preparation & Colour Mixture. The

total Synthetic dye content, per cent by mass (m/v) in the colour preparation or
in the mixture shall be declared on the label of the container. In powder

21 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
preparations the declared value shall be on moisture free basis and in case of
liquid preparations on as in basis. The total dye content shall be within the
tolerance limits given below on the declared value:
(a) Liquid preparation +15 per cent
-5 per cent
(b) Solid preparations ±7.5 per cent

The limits of impurities shall be as prescribed in Table below:—

TABLE
Limits for Impurities
1. Water insoluble matter, per cent by mass, Max. (on dry basis), 1.0
Max.
2. Lead, (as Pb), mg/kg, Max. 10
3. Arsenic, (as As) mg/kg, Max. 3.0
4. Heavy metals, mg/kg, Max. 40

It shall be free from mercury, copper and chromium in any form; aromatic
amines, aromatic nitro compounds, aromatic hydrocarbons, polycyclic aromatic
hydrocarbon, 2-naphthyl aminobenzidine, amino-4-diphenyl (xenylamine) or
their derivatives and cyanides.

The total coal tar dye content percent by mass (m/v) in colour preparation
or in mixture shall be declared on the lable of the container. In powder
preparation, the declared value shall be on moisture free basis and in case of
liquid preparation on ' as is basis' and the total dye content shall within ± 15
percent of the declared value. Colour preparation and colour mixture shall also
comply with the following requirements namely: -
Sl. No. Characteristics Requirements

1 Water insoluble matter, percent by mass Not more than 1.0

2 Arsenic as (As), parts per million Not more than 3
3 Lead as (Pb) parts per million Not more than 10

13 BRILLIANT BLUE FCF

22 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Brilliant Blue FCF is hydroscopic in nature and its shade changes with
different pH. Suitable precautions should, therefore, be taken in packing the
colour.
Colour Brilliant Blue FCF is described below, namely:—

Common Name Brilliant Blue FCF

Synonyms C.l. Food Blue FD and C Blue No.1 Blue
brilliant FCF
Colour Blue
Colour Index Number (1975) No.42900
Class Triarymethane
Chemical Name Disodium salt of alpha 4-(N- ethylbeta
ulfobenzylamino)-
phenyl] alpha [4-(N-ethyl-3
Sulfonatobenzylimino]
cyclohexa-2, 5-dienylidene] toluene-2-
sulfonate
Empirical formula C37H34N2Na2O9S3
Molecular Weight 792.86

General requirements: The material shall conform to the requirement prescribed

in Table below, namely:—

TABLE FOR BRILLIANT BLUE FCF

Sl. No. Characteristics Requirements

Total dye content, corrected for Sample dried at 105±1oC for 85
(i) 2 hours, percent by Mass, Minimum
Loss on drying at 135oC, and Chlorides and Sulphates 15
(ii) expressed as sodium salt, per cent by Mass, Maximum
(iii) Water insoluble matter, percent by Mass, Maximum 0.2
(iv) Combined ether extracts, percent by Mass. Maximum 0.2
(v) Subsidiary dyes, percent by Mass, Maximum 3
(vi) Dye intermediates, percent by Mass, Max.
(a) O, sulpho-benzaldehyde, Maximum 1.5
(b) N-N' ethyl-benzyl-aniline-3-sulphonic acid, Maximum 0.3
(c) Leuco base, percent by Mass, Maximum 5
23 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(vii) Heavy metals, (as Pb), mg/kg, Maximum 40
Lead, mg/kg, Maximum 10
Arsenic, mg/kg, Maximum 3
Chromium, mg/kg, Maximum 50

Note:- The material shall be free from aromatic amines, aromatic nitro
compounds, aromatic hydrocarbons and cyanides.

14. Fast Green FCF:

Fast Green FCF is hydroscopic in nature and its shade changes with different
pH. Suitable precautions should, therefore, be taken in packing the colour.
14. Fast Green FCF is described below, namely:—

Common Name Fast Green FCF

Synonyms C.l. Food Green 3, FD and C
Green No.3, Vert Solide FCF
Class Triary methane
Colour Green
Colour Index (1975) No.42053
Chemical Name Disodium salt of 4-[4-(N-ethyl-p-
sulfobenzylamino)-
phenyl-(4-hydroxy-2-sulphonumphenyl)-
methylene]-
(N-ethyl-N-p-sulphobenzyl 2, 5-
cyclohexadienimine).
Empirical Formula C37 H34 O10 N2 S2 Na2
Molecular Weight 808.86

Requirements: The material shall conform to the requirement prescribed in

Table below, namely:—
TABLE FOR FAST GREEN FCF
Sl. No. Characteristic Requireme
nt
(i) Total dye content, corrected for Sample dried at 105±1°C for 2 85
hours, percent by mass, Minimum
(ii) Loss on drying at 135oC, and, percent by Mass, Maximum and 13
chlorides and Sulphates expressed
24 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 as sodium salt, percent by mass, Maximum
(iii) Water insoluble matter, percent by Mass, Maximum 0.2
(iv) Combined ether extracts, percent by Mass. Max 0.2
(v) Subsidiary dyes, percent by mass, Maximum 1.0
(vi) Organic compound other than colouring matter uncombined
intermediates and products of side reactions
(a) Sum of 2-, 3-, 4-formyl benzene sulphonic acid, sodium
salts, percent by Mass, Maximum 0.5
(b) Sum of 3- and 4-[ethyl (4-sulfophenyl) amino methyl
benzene sulphonic acid, disodium salts, Percent by Mass,
Maximum 0.3
(c) 2-formyl-5-hydroxybenzene sulphonic acid sodium salt,
percent by Mass, Maximum 0.5
(d) Leuco base, percent by Mass, Maximum 5.0
(e) Unsulphonated primary aromatic amines (calculated as
aniline), percent by Mass, Maximum 0.01
(vii) Lead, mg/kg, Maximum 10
(viii) Arsenic, mg/kg, Maximum 3
(ix) Chromium, mg/kg, Maximum 50
(x) Mercury, mg/kg, Maximum Absent
(xi) Heavy metals, mg/kg, Maximum 40
Note:- The material shall be free from aromatic nitro compounds, aromatic
hydrocarbons and cyanides

15. Aluminium Lake of Sunset Yellow FCF- Food Yellow No.5 Aluminium
Lake is a fine orange yellow water soluble, odourless powder. It is prepared by
percipating Sunset Yellow FCF (conforming to specification under 10.02 of
Appendix C of these Regulations on to a substratum of Alumina.
Chemical Name - Sunset Yellow FCF Aluminium Lake -6, hydroxy-5 (4-
sulfophenlyazo)-2 Naphthalenesulphonic acid, Aluminium Lake.
Synonym - CI Pigment Yellow, 104, FD and C Yellow No. 6, Aluminium
Lake (USA), Food Yellow No. 5 Aluminium Lake (Japan).

(1) Sunset yellow dye used in preparation of lake colour shall conform to
specifications laid down under table 2 of these Regulations.
(2) Pure dye content of Aluminium Lake not less than 17 percent
weight by weight
(3) Substratum of Aluminium oxide not more than 83
25 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 percent.
(4) Aluminium content in the lake weight not more than 44 percent
by weight
(5) Sodium chlorides and sulphates (as not more than 2.0
sodium salts) percent
(6) Inorganic matter (HCl insoluble) not more than 0.5
percent
(7) Lead (as Pb) not more than 10 ppm
(8) Arsenic (as As) not more than 3 ppm

Alumina used in colour shall conform to following, namely:—

(a) Identity: Alumina (dried as aluminium hydroxide) is a white,
odourless, tasteless, amorphous powder consisting essentially of
Aluminium hydroxide (Al2O3 × H2O).
(b) Specifications: Alumina (dried aluminium hydroxide) shall conform
to the following specifications, namely:-
(i) Acidity or alkalinity Agitate 1 gm with 25ml of water and
filter.
The filtrate shall be neutral to litmus
paper
(ii) Lead (as Pb) not more than 10 parts per million
(iii) Arsenic (as As) not more than 1 parts per million
(iv) Mercury (as Hg) not more than 1 parts per million
(v) Aluminium oxide not less than 50 percent
(Al2O3)
Solubility: Lakes are insoluble in most solvents. They are also insoluble in
water in pH range from 3.5-9.0 but outside this range and lake substrate tends to
dissolve releasing the captive dye.

42
[16. Beta-apo-8’-carotenal:

(1) Beta-apo-8’-carotenal in crystal form shall be deep violet with metallic

luster, and in case of solution in oil, fat or organic solvents or water-dispersible
forms including powder, granules or capsules, it shall be orange to red in colour
and as described below, namely:-

Common Name Beta-apo-8’-carotenal

26 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
Colour Index (DFG Lebensmittel) Orange 8
INS No. 160e
C.A.S No. 1107-26-2
Chemical Name Trans-beta-apo-8’-carotenal.
Empirical Formula C30H40O
Molecular Weight 416.65
(2) Beta-apo-8’-carotenal shall conform to the requirements specified in the
table below, namely:-
Table

SI. Characteristic Requirements

No.
(1) (2) (3)
1. Purity as C30H40O per cent. by weight, Min 96
2. Sulphated ash, per cent. by weight, Max 0.1
3. Melting range, 00C 136 - 140
4. Arsenic , mg/kg, Max 3.0
5. Lead, mg/kg, Max 2.0
17. Ethylester of Beta-apo-8'-carotenoic acid:

(1) Ethyl ester of Beta-apo-8'-carotenoic acid in crystal form shall be red and in
case of solution in oil, fat or organic solvent or water-dispersible forms
including, powder, granules or capsules, it shall be yellow to orange in colour
and as described below, namely:-

Common Name Ethyl ester of beta-apo-8'-

carotenoic acid
Colour Index (DFG Lebensmittel) Orange 9
INS No. 160f
C.A.S No. 1109-11-1
Chemical Name Trans-beta-apo-8'-carotenoic acid,
ethyl ester.
Empirical Formula C22H44O8
Molecular Weight 460.70

27 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(2) Ethylester of Beta-apo-8'-carotenoic acid shall conform to the requirements
specified in the table below, namely:-
Table

SI.No. Characteristic Requirements

(1) (2) (3)
1. Purity as C22H44O8, per cent. by mass, 96
Min
2. Sulphated ash, per cent. by mass, Max 0.1
3. Melting range, 0C 134 - 138
4. Arsenic , mg/kg, Max 3.0
5. Lead, mg/kg, Max 2.0

18. Titanium dioxide:

(1) Titanium Dioxide shall be a white, tasteless, odourless, infusible powder and
as described below, namely:-

Common Name Titanium dioxide

INS No. 171
C.A.S No. 13463-67-7
Chemical Name Titanium Dioxide
Empirical Formula TiO2
Molecular Weight 79.88
(2) Titanium dioxide shall conform to the requirements specified in the table
below, namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)

28 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 1. Purity as TiO2, per cent. by mass, Min 99
2. Loss on drying at 105 0C for 3 hours, per 0.5
cent. by mass, Max
3. Loss on ignition (at 800 0C), per cent. by 0.5
mass. Max
4. Acid soluble substances, per cent. by mass, 0.35
Max
5. Water soluble substances, per cent. by 0.25
mass, Max
6. Aluminium oxide and/or silicon dioxide 2.0
(either singly or combined), per cent. by
mass, Max
7. Mercury, mg/kg, Max 1.0
8. Antimony, mg/kg, Max 2.0
9. Zinc, mg/kg, Max 50.0
10. Arsenic, mg/kg, Max 1.0
11. Lead, mg/kg, Max 2.0
12. Barium compounds, mg/kg, Max 3.0
13. Aluminium, mg/kg, Max 1.0]

10
[3.2.2 Sweetener:-

[The sweeteners (as food additives) shall be classified as “Caloric

75

sweeteners” and “Non–caloric sweeteners”, defined as follows:

(a) Caloric sweeteners: Substances having greater than 2 percent of the caloric
value of sucrose per equivalent unit of sweetening capacity. These include
Sorbitol, Sorbitol syrup, Mannitol, Isomalt, Polyglycitol syrup, Maltitol,
Maltitol syrup, Lactitol and Xylitol.

(b) Non-caloric sweeteners: Substances having less than 2 percent of the

caloric value of sucrose per equivalent unit of sweetening capacity. These
include Erythritol, Steviol glycoside, Thaumatin, Aspartame, Sucralose,
29 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
Neotame, Acesulfame potassium, Aspartame-Acesulfame potassium salt and
Saccharins.]

The standards for various sweeteners with characteristics are –

82
[(1) STEVIOL GLYCOSIDES FROM STEVIA REBAUDIANA
BERTONI

INS number 960

Definition Steviol glycosides consist of a mixture of

compounds containing a steviol backbone
conjugated to any number or combination
of the principal sugar moieties (glucose,
rhamnose, xylose, fructose, arabinose,
galactose and deoxyglucose) in any of the
orientations occurring in the leaves of
Stevia rebaudiana Bertoni. The product is
obtained from the leaves of Stevia
rebaudiana Bertoni. The leaves are
extracted with hot water and the aqueous
extract is passed through an adsorption
resin to trap and concentrate the
component steviol glycosides. The resin is
washed with a solvent alcohol to release
the glycosides and the product is
recrystallized from methanol or aqueous
ethanol. Ion exchange resins may be used
in the purification process. The final
product may be spray-dried.

Chemical name See Appendix 1

Chemical formula See Appendix 1

30 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Formula weight See Appendix 1

Assay/purity Not less than 95% of total of steviol

glycosides, on the dried basis, determined
as the sum of all compounds containing a
steviol backbone conjugated to any
number, combination or orientation of
saccharides (glucose, rhamnose, fructose,
deoxyglucose, xylose, galactose, arabinose
and xylose) occurring in the leaves of
Stevia rebaudiana Bertoni.

Description White to light yellow powder, odourless or

having a slight characteristic odour. About
200 - 300 times sweeter than sucrose.

Characteristics

(a) Identification

Solubility Freely soluble in a mixture of ethanol and

water (50:50)

HPLC The main peaks in a chromatogram

Chromatographic correspond to steviol glycosides (method
assay of assay as per JECFA monograph)

pH Between 4.5 and 7.0 (1 in 100 solution)

(b) Purity

Total ash Not more than 1%

Loss on drying Not more than 6% (105°C, 2 h)

31 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Residual solvents Not more than 200 mg/kg methanol and
not more than 5000 mg/kg ethanol

Arsenic Not more than 1 mg/kg

Lead Not more than 1 mg/kg

Microbiological Total (aerobic) plate count: Not

criteria more than 1,000 CFU/g

Yeasts and moulds: Not more than

200 CFU/g

E. coli: Negative per g

Salmonella: Negative per 25g

Analytical methods or method of assay:

As per Joint FAO/WHO Expert Committee on Food Additives (JECFA)
monograph (2017) on STEVIOL GLYCOSIDES FROM STEVIA
REBAUDIANA BERTONI
Appendix 1: Chemical Information of Some Steviol Glycoside

32 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
33 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
34 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
35 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 ]

27
[3.2.3 Baker’s Yeast
1. The Baker’s Yeast shall be of the following types:
(i) Baker’s Yeast, Compressed; and
(ii) Baker’s Yeast, Dried.
(i) Baker’s Yeast (Compressed) shall be in the form of a block having creamy
white colour, and odour characteristic of good baker’s yeast (compressed) and a
fine even texture. It shall not be slimy or mouldy and shall not show any sign of
deterioration or decomposition. It shall be free from extraneous materials.
Starch of an edible quality may, however, be added in a quantity not exceeding
7% by weight on dry basis. Permissible edible binders and fillers may be added.
It shall break sharply on bending. The yeast blocks shall be stored at
temperature between 1 to 50C.
(ii) Baker’s Yeast (Dried) shall be in the form of small powder granules,
pellets or flakes. It shall have an odour characteristic of good baker’s yeast
36 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(dried). It shall not be mouldy and shall not show any sign of deterioration or
decomposition. It shall be free from adulterants and other extraneous materials.
Starch of an edible quality may, however, be added in a quantity not exceeding
10 % by weight of the material. The yeast shall be stored in a cool and dry place
at a temperature not more than 250C.
Baker’s Yeast shall conform to the following standards namely:-
Characteristics Requirements for
Baker’s yeast Baker’s Yeast
Compressed Dried
Moisture, percent by weight, max 73 8
Dispersibility in water To satisfy the To satisfy the
test* test*
Fermenting power*, Min 1000 350
Dough-raising capacity To satisfy the To satisfy the
test* test*

* As per method prescribed in IS: 1320.

Note: These parameters shall be tested within 24 hours of production of yeast.

2. Food Additives
Only those food additives permitted under the Food Safety and Standards (Food
Products Standards and Food Additives) Regulations, 2011 shall be used.

3. Hygiene
The product shall be prepared and handled in accordance with the guidelines
provided in Schedule 4, Part-II of the Food Safety and Standards (Licensing and
Registration of Food Businesses) Regulation, 2011 and such guidance as
provided from time to time under the provisions of the Food Safety and
Standards Act, 2006.
4. Contaminants, Toxins and Residues
The product covered in this standard shall comply with the Food Safety and
Standards (Contaminants, toxins and Residues) Regulations, 2011.
The products covered in this standard shall conform to the Microbiological
Requirements given in Appendix B of the Food Safety and Standards (Food
Products Standards and Food Additives) Regulations, 2011.
37 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
5. Packaging and Labelling

The products shall comply with the packaging and labelling requirements
specified under the Food Safety and Standards (Packaging and Labelling)
Regulations, 2011.

3.2.4 Lactic Acid (Food Grade) (INS 270)

1. Lactic acid shall be yellowish to colourless syrupy liquid with an acidic taste
and no odour. It shall be obtained by lactic fermentation of sugars or prepared
synthetically. It shall be miscible in water and ethanol. It shall give positive test
for lactate. It shall conform to the following specifications:

Characteristics Requirement

Purity (C3H6O3), % by weight of the Not less than

labelled concentration 95.0%

Sulphated ash, % by weight, Max 0.1

Chlorides, % by weight, Max 0.2

Sulphates (as SO4 ), % by weight, Max 0.25

Citric, oxalic, phosphoric and tartaric Conform to test*

acids

Sugars Conform to test*

Readily carbonizable substances Conform to test*

Cyanide Conform to test*

Iron, mg/kg, Max 10

Lead mg/kg, Max 2

*As per method prescribed in IS: 9971.

2. Hygiene
The product shall be prepared and handled in accordance with the guidelines
provided in Schedule 4, Part-II of the Food Safety and Standards (Licensing and
Registration of Food Businesses) Regulations, 2011 and such guidance as
38 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
provided from time to time under the provisions of the Food Safety and
Standards Act, 2006.
3. Contaminants, Toxins and Residues
The product covered in this standard shall comply with the Food Safety and
Standards (Contaminants, Toxins and Residues) Regulations, 2011.
4. Packaging and Labelling
The products shall comply with the packaging and labelling requirements
specified under the Food Safety and Standards (Packaging and Labelling)
Regulations, 2011.

3.2.5 Ascorbic Acid (Food Grade) (INS 300)

1. Ascorbic acid shall be a white or almost white odourless crystalline solid. Its
melting range is 190◦C to 192◦C with decomposition. The material is freely
soluble in water and sparingly soluble in ethanol and insoluble in ether. It shall
conform to the following standards:

Characteristic Requirement
Purity as C6H8O6 % by weight , Min 99
Loss on drying over sulphuric acid for 24 0.4
hours, % by weight, Max
Sulphated ash, % by weight, Max 0.1
Specific rotation, when determined in a 2 % +20.50 to +21.50
(m/v) solution in water at 200C
pH of 2 % (m/v) solution 2.4 - 2.8
Lead mg/kg, Max 2

2. Hygiene
The product shall be prepared and handled in accordance with the guidelines
provided in Schedule 4, Part-II of the Food Safety and Standards (Licensing and
Registration of Food Businesses) Regulations, 2011, and such guidance as
provided from time to time under the provisions of the Food Safety and
Standards Act, 2006.
39 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
3. Contaminants, Toxins and Residues
The product covered in this standard shall comply with the Food Safety and
Standards (Contaminants, toxins and Residues) Regulations, 2011.
4. Packaging and Labelling
The products shall comply with the packaging and labelling requirements
specified under the Food Safety and Standards (Packaging and Labelling)
Regulations, 2011.

3.2.6 Calcium Propionate (Food Grade) (INS 282)

1. Calcium propionate shall be in the form of white crystals or crystalline solid

possessing a faint odour of propionic acid. The material shall be freely soluble
in water. It shall conform to the following standards:
Characteristic Requirement
Purity as C6H10O4Ca, % by weight on dry 98
basis, Min
Moisture, % by weight, Max 5.0
Matter insoluble in water, % by weight, 0.3
Max
Iron (as Fe), mg/kg, Max 50
Fluoride, mg/kg, Max 10
Lead mg/kg, Max 5
Magnesium (as MgO) To pass the test (about
0.4%)
pH of the 10 %(m/v) solution at 25 + 20C 7-9
2. Hygiene
The product shall be prepared and handled in accordance with the guideline
provided in Schedule 4, Part-II of the Food Safety and Standards (Licensing and
Registration of Food Businesses) Regulation, 2011, and such guidance as
provided from time to time under the provisions of the Food Safety and
Standards Act, 2006.
3. Contaminants, Toxins and Residues
40 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
The product covered in this standard shall comply with the Food Safety and
Standards (Contaminants, toxins and Residues) Regulations, 2011.
4. Packaging and Labelling
The products shall comply with the packaging and labelling requirements
specified under the Food Safety and Standards (Packaging and Labelling)
Regulations, 2011.

3.2.7 Sodium Metabisulphite (Food Grade) (INS 223)

1. Sodium Metabisulphite shall be colourless crystals or white to yellowish

crystalline powder having an odour of sulphur dioxide. The material is
soluble in water but insoluble in ethanol. It shall conform to the following
standards:
Characteristics Requirement
Purity
(a) As Na2S2O5 , % by weight , Min 95
(b) As SO2, % by weight, Min 64
Water insoluble matter, % by weight, 0.05
Max
Thiosulphate, % by weight, Max 0.01
Iron mg/kg, Max 5
Selenium (as Se), mg/kg, Max 5
Lead mg/kg, Max 2
pH Acidic to litmus

41 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
2.Hygiene
The product shall be prepared and handled in accordance with the guideline
provided in Schedule 4, Part-II of the Food Safety and Standards (Licensing and
Registration of Food Businesses) Regulation, 2011 and such guidance as
provided from time to time under the provisions of the Food Safety and
Standards Act, 2006.
3. Contaminants, Toxins and Residues
The product covered in this standard shall comply with the Food Safety and
Standards (Contaminants, toxins and Residues) Regulations, 2011.
4. Packaging and Labelling
The products shall comply with the packaging and labelling requirements
specified under the Food Safety and Standards (Packaging and Labelling)
Regulations, 2011.

3.2.8 Potassium Metabisulphite (Food Grade) (INS 224)

1. Potassium Metabisulphite shall be white or colourless, free flowing crystals,
crystalline powder or granules usually having an odour of sulphur dioxide. It
gradually oxidizes in air to sulphate. The material is soluble in water but
insoluble in ethanol. It shall conform to the following standards:
Characteristic Requirement
Purity, as K2S2O5, % by weight , Min 90
Water insoluble matter, %by weight, Max 0.05
Thiosulphate, % by weight, Max 0.1
Iron, mg/kg, Max 5
Selenium (as Se), mg/kg, Max 5
Lead mg/kg, Max 2
pH Acidic to
litmus

42 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
2. Hygiene
The product shall be prepared and handled in accordance with the guidelines
provided in Schedule 4, Part-II of the Food Safety and Standards (Licensing and
Registration of Food Businesses) Regulations, 2011 and such guidance provided
from time to time under the provisions of the Food Safety and Standards Act,
2006.
3. Contaminants, Toxins and Residues
The product covered in this standard shall comply with the Food Safety and
Standards (Contaminants, toxins and Residues) Regulations, 2011.
4. Packaging and Labelling
The products shall comply with the packaging and labelling requirements
specified under the Food Safety and Standards (Packaging and Labelling)
Regulations, 2011.]

42
[3.2.9. Preservatives:

1. Sodium benzoate:

(1) Sodium benzoate shall be a white, almost odourless, crystalline powder or

flakes and as described below, namely:-

Common Name Sodium benzoate

INS No. 211
C.A.S No. 532-32-1
Chemical Name Sodium salt of benzene carboxylic
acid, and sodium salt of phenyl
carboxylic acid
Empirical Formula C7H502Na
Molecular Weight 144.11
(2) Sodium benzoate shall conform to the requirements specified in the table
below, namely:-
Table
SI. Characteristic Requirements
No.
43 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 (1) (2) (3)
1. Purity, expressed as C7H502Na, per cent. by 99.0
mass, Min
2. Melting range of liberated benzoic acid 121.5°C- 123.5°C
3. Moisture, per cent. by mass, Max 1.5
4. Acidity or alkalinity shall conform to test as
per BIS standard
5. Readily carbonizable substances shall conform to test as
per BIS standard
6. Readily oxidizable substances shall conform to test as
per BIS standard
7. Chlorinated organic compounds shall conform to test as
per BIS standard
8. Arsenic, mg/kg, Max 3.0
9. Lead, mg/kg, Max 2.0
2. Benzoic acid:

(1) Benzoic acid shall be in the form of white crystals, scales or needles and as
described below, namely:-

Common Name Benzoic acid

INS No. 210
C.A.S No. 65-85-0
Chemical Name benzene carboxylic acid,
and phenyl carboxylic acid
Empirical Formula C7H602
Molecular Weight 122.12
(2) Benzoic acid shall conform to the requirements specified in the table below,
namely:-
Table

44 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
SI.No. Characteristic Requirements
(1) (2) (3)
1. Purity, as C7H602, per cent. by mass, Min 99.5
2. Melting range 121.5°C - 123.5°C
3. Sulphated ash, per cent. by mass, Max 0.05
4. Readily carbonizable substances shall conform to test as
per BIS standard
5. Readily oxidizable substances shall conform to test as
per BIS standard
6. Loss on drying (for 3 hours over sulphuric 0.5
acid or silica gel at ambient temperature in a
dessicator) per cent. by mass, Max
7. Chlorinated organic compounds shall conform to test as
per BIS standard
8. Arsenic, mg/kg, Max 3.0
9. Lead, mg/kg, Max 2.0

3. Potassium nitrate:

(1) Potassium nitrate shall be colourless, odourless and salty to taste and may be
in the form of transparent prisms or white granules or crystalline powder and as
described below, namely:-

Common Name Potassium nitrate

INS No. 252
C.A.S No. 7757-79-1
Chemical Name Potassium nitrate
Empirical Formula KNO3
Molecular Weight 101.11
(2) Potassium nitrate shall conform to the requirements specified in the table
below, namely:-
Table
45 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
SI.No. Characteristic Requirements
(1) (2) (3)
1. Purity, as KNO3, per cent. by mass, Min 99

2. Moisture per cent. by mass, Max 1

3. Matter insoluble in water Shall pass the test as per

BIS standard
4. Chlorates Shall pass the test as per
BIS standard
5. Sulphates (as K2SO4), per cent. by mass, 0.10
Max
6. Arsenic, mg/kg, Max 3.0
7. Lead, mg/kg, Max 2.0
8. Nitrite, mg/kg, Max 20.0

4. Sorbic acid:
(1) Sorbic acid shall be colourless needles or white free flowing powder, having
a slight characteristic odour and as described below, namely:-
Common Name Sorbic acid
INS No. 200
C.A.S No. 110-44-1
Chemical Name Sorbic acid; trans, all trans 2, 4-
hexadienoic acid.
Empirical Formula C6H8O2
Molecular Weight 112.13
(2) Sorbic acid shall conform to the requirements specified in the table below,
namely:-

Table
SI.No. Characteristic Requirements
(1) (2) (3)
46 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
1 Purity, as C6H8O2, per cent. by mass(on dry 99
basis), Min
2 Moisture, per cent. by mass, Max 0.5
3 Sulphated ash, per cent. by mass, Max 0.2
4 Aldehydes, per cent. by mass, Max 0.1
5 Melting range, 0C 132 - 135
6 Arsenic, mg/kg, Max 3.0
7 Lead, mg/kg, Max 2.0

5. Potassium nitrite:
(1) Potassium nitrite shall be in the form of small white or yellowish
deliquescent granules or cylindrical sticks and as described below, namely:-
Common Name Potassium nitrite
INS No. 249
C.A.S No. 7758-09-0
Chemical Name Potassium nitrite
Empirical Formula KNO2
Molecular Weight 85.11
(2) Potassium nitrite shall conform to the requirements specified in the table
below, namely:-
Table

SI.No. Characteristic Requirements

(1) (2) (3)
1. Purity, as (KNO2), on dry basis, per cent. 97
by mass, Min
2. Loss on drying when dried over silica gel 1
for four
hours, per cent. by mass, Max
3. Arsenic, mg/kg, Max 3.0
4. Lead, mg/kg, Max 2.0

47 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
6. Sodium propionate:
(1) Sodium propionate shall be colourless and in the form of transparent crystals
or granular crystalline powder and shall be odourless or with a faint acetic
butyric odour and as described below, namely:-

Common Name Sodium propionate

INS No. 281
C.A.S No. 137-40-6
Chemical Name Sodium Propionate
Empirical Formula C3H5O2Na
Molecular Weight 96.06
(2) Sodium propionate shall conform to the requirements specified in the table
below, namely:-

Table
SI.No. Characteristic Requirements
(1) (2) (3)
1. Purity as C3H5O2Na, per cent. by mass, on 99
dry basis, Min
2. Moisture, per cent. by mass, Max 1
3. Matter insoluble in water, per cent. by 0.1
mass, Max
4. Iron, mg/kg, Max 30
5. Arsenic, mg/kg, Max 3.0
6. Lead, mg/kg, Max 5.0

7. Sulphur dioxide:

(1) Sulphur dioxide shall be a colourless, non-flammable gas, with a strong,

pungent suffocating odour and as described below, namely:-

48 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
Common Name Sulphur dioxide
INS No. 220
C.A.S No. 7446-09-5
Chemical Name Sulphur dioxide, sulphurous acid
anhydrate
Empirical Formula SO2
Molecular weight 64.007
(2) Sulphur dioxide shall conform to the requirements specified in the table
below, namely:-

Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Purity (as SO2), per cent. by mass, on dry 95
basis, Min
2. Non-volatile residue shall conform to test as
per BIS Standard
3. Moisture, per cent. by mass, Max 0.05
4. Selenium, mg/kg, Max 20.0

5. Arsenic, mg/kg, Max 3.0

6. Lead, mg/kg, Max 5.0

3.2.10 Acidity regulator:

1. Ammonium hydrogen carbonate:
(1) Ammonium hydrogen carbonate shall be in the form of white crystals or fine
white crystalline powder and as described below, namely:-

Common Name Ammonium bicarbonate

INS No. 503(ii)

49 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
C.A.S No. 1066-33-7

Chemical Name Ammonium hydrogen carbonate

Empirical Formula CH5NO3

Molecular Weight 79.06

(2) Ammonium hydrogen carbonate shall conform to the requirements specified

in the table below, namely:-
Table
SI.No. Characteristic Requirements

(1) (2) (3)

1. Ammonium Hydrogen Carbonate, per cent. by 98.0

mass, Min

2. Chlorides (as Cl), per cent. by mass, Max 0.2

3. Sulphates (as SO4), per cent. by mass, Max 0.1

4. Non-volatile matter, per cent. by mass, Max 0.1

5. Iron (as Fe), per cent. by mass, Max 0.004

6. Non-volatile matter, per cent. by mass, Max 0.1

7. Arsenic, mg/kg, Max 0.6

8. Lead, mg/kg, Max 2.0

9. Copper, mg/kg, Max 5.0

2. Trisodium citrate:

(1) Trisodium citrate shall be in the form of colourless crystals or white

crystalline powder and as described below, namely:-

50 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
Common Name Trisodium citrate
INS No. 331 (iii)
C.A.S No. 68-04-2
Chemical Name Trisodium citrate
Empirical Formula C6H5Na3O7.2H2O
Molecular Weight 294.10

(2) Trisodium citrate shall conform to the requirements specified in the table
below, namely:-
Table
SI.No. Characteristic Requirements
(1) (2) (3)
1. Purity, (asC6H5Na3O7), on dry basis, per cent. 99
by mass, Min
2. Moisture, per cent. by mass, Max
a) Anhydrous 1
b) Dehydrate 13
3. Alkalinity shall pass the test as
per BIS standard
4. Arsenic, mg/kg, Max 3.0
5. Lead, mg/kg, Max 2.0

3. Fumaric acid:
(1) Fumaric acid shall be in the form of white, odourless granules or crystalline
powder with characteristic acid taste and as described below, namely:-
Common Name Fumaric acid
INS No. 297
C.A.S No. 110-17-8
Chemical Name trans-butenedioic acid, and trans-
1,2 ethylene dicarboxylic acid
51 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
Empirical Formula C4H4O4
Molecular Weight 116.07
(2) Fumaric acid shall conform to the requirements specified in the table below,
namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Purity as C4H4O4, per cent. by mass, (on 99.5
anhydrous basis), Min
2. Moisture, per cent. by mass, Max 0.5
3. Sulphated ash, per cent. by mass, Max 0.1
4. Maleic acid, per cent. by mass, Max 0.1
5. Arsenic, mg/kg, Max 3.0
6. Lead, mg/kg, Max 2.0

4. L (+) - Tartaric acid:

(1) L (+) - Tartaric acid shall be either in the form of colorless or translucent
crystals, or a white, fine to granular, crystalline powder and shall be odourless,
acidic in taste and stable in air and as described below, namely:-
Common Name L (+) - Tartaric acid
INS No. 334
C.A.S No. 87-69-4
Chemical Name Tartaric acid - 2,3-dihydroxy
succinic acid
Empirical Formula C4H6O6
Molecular Weight 150.09
(2) L(+) – Tartaric acid shall conform to the requirements specified in the table
below, namely:-
52 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Purity as (C4H6O6), per cent. by mass (on 99.5
dry basis), Min
2. Loss on drying, per cent. by mass, on 0.5
drying at 105 0C for 3 hours over
P3O4,Max
3. Sulphated ash, per cent. by mass, Max 0.1
4. Oxalate shall pass the test as per
BIS standard
5. Sulphate 0.05

6. Arsenic, mg/kg, Max 3.0

7. Lead, mg/kg, Max 2.0

5. Dicalcium phosphate:
(1) Dicalcium phosphate shall be white crystals or granules or granular powder
or powder and as described below, namely:-

Common Name Calcium hydrogen phosphate, dibasic calcium phosphate

INS No. 341 (ii)
C.A.S No. 7757-93-9
Chemical Name Secondary calcium phosphate, calcium hydrogen
orthophosphate, calcium hydrogen phosphate.
Empirical CaHP04 (Anhydrous)
Formula CaHPO4. 2H2O (Dihydrate)
Molecular 136.06 (Anhydrous)
Weight 172.09 (Dihydrate)
(2) Dicalcium phosphate shall conform to the requirements specified in the table
below, namely:-
Table

53 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Purity as (CaHP04), after drying at 200 98 to 102
0C for 3 h, per cent. by mass
2. Loss on drying, per cent. by mass, after
drying at 200 0C for 3 h

a) Anhydrous, Max 2
b) Dihydrate 18 to 22
3. Fluoride, mg/kg, Max 50.0
4. Arsenic, mg/kg, Max 3.0
5. Lead, mg/kg, Max 4.0

6. Phosphoric Acid:
(1) Phosphoric Acid shall be a clear, colourless, odourless viscous liquid and as
described below, namely:-

Common Name Phosphoric Acid

INS No. 338
C.A.S No. 7664-38-20
Chemical Name Phosphoric acid, orthophosphoric
acid
Empirical Formula H3PO4
Molecular Weight 98.0
(2) Phosphoric acid shall conform to the requirements specified in the table
below:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Purity as H3PO4, per cent. by mass, Min 85
54 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 2. Nitrates, mg/kg, Max 5
3. Volatile acids, mg/kg, Max 10
4. Chlorides, mg/kg, Max 200
5. Sulphates per cent. by mass, Max 0.15
6. Chloride, mg/kg, Max 200.0
7. Fluoride, mg/kg, Max 10.0
8. Arsenic, mg/kg, Max 2.0
9. Lead, mg/kg, Max 4.0

7. Citric Acid:

(1) Citric Acid shall be white or colourless, odourless, crystalline solid which in
monohydrate form effloresces in dry air and as described below, namely:-

Common Name Citric Acid

INS No. 330
C.A.S No. 77-92-9(anhydrous)
5949-29-1 (monohydrate)
Chemical Name 2-hydroxyl-l,2,3-
propanetricarboxylic acid; B-
hydroxytricarboxylic acid.
Empirical Formula C6H807 (anhydrous)
C6H8O7.H2O(monohydrate)
Molecular Weight 192.13 (anhydrous)
210.15 (monohydrate)
(2) Citric acid shall conform to the requirements specified in the table below,
namely:-
Table
SI. Characteristic Requirement
No.
(1) (2) (3)

1. Water insoluble matter, ppm, Max 30

55 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 2. Chloride (as Cl), ppm, Max 5
3. Calcium, ppm, Max 25

4. Tridodecylamine, ppm, Max 0.1

5. Arsenic, mg/kg, Max 3.0

6. Lead, mg/kg, Max 0.5

8. Malic acid:

(1) Malic acid shall be a white to nearly white crystalline powder or granules
having a strong acid taste and as described below, namely:-

Common Name Malic Acid

INS No. 296
C.A.S No. 6915-15-7
Chemical Name DL-malic acid and hydroxyl succinic acid
Empirical Formula C4H6O5
Molecular Weight 134.09
(2) Malic acid shall conform to the requirements specified in the table below,
namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1 Purity as C4H6O5 (on dry basis), per cent. 99.0
by mass, Min
2 Moisture, per cent. by mass, Max 0.3
3 Residue on ignition (on dry basis), per cent. 0.1
by mass, Max
4 Water insolube matter, per cent. by mass, 0.1
Max
56 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
5 Fumaric acid, per cent. by mass, Max 1.0
6 Maleic acid, per cent. by mass, Max 0.05
7 Lead, mg/kg, Max 2.0
8 Arsenic, mg/kg, Max 3.0
9. Sodium Hydroxide:
(1) Sodium Hydroxide may be in the form of white or nearly white pellets,
flakes, sticks, fused masses or in any other form and as described below,
namely:-

Common Name Caustic soda, lye, sodium hydrate

INS No. 524
C.A.S No. 1310-73-2
Chemical Name Sodium hydroxide
Empirical Formula NaOH
Molecular Weight 40.0
(2) Sodium Hydroxide shall conform to the requirements specified in the table
below, namely:-
Table
SI. No. Characteristic Requirements
(1) (2) (3)
1 Purity as NaOH, per cent. by mass, Min 95
2 Carbonate, per cent. by mass as Na2CO3, Max 3
3 Lead, mg/kg, Max 2.0
4 Mercury, mg/kg, Max 1.5

3.2.11 Gelling agent or Thickener or stabilizer:

1. Sodium alginate:

57 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(1) Sodium Alginate shall be white, yellowish or pale brown fibrous or granular
powder and as described below, namely:-
Common Name Sodium alginate
INS No. 401
C.A.S No. 9005-38-3
Chemical Name Sodium alginate
Empirical Formula (C6H7O6Na)n
Equivalent Weight (average) 222.00
(2) Sodium alginate shall conform to the requirements specified in the table
below, namely:-
Table
SI.No. Characteristic Requirements
(1) (2) (3)
1 Purity as (C6H7O6Na), per cent. by mass 91 to 106

2 Moisture, per cent. by mass, Max 15

3 Matter insoluble in water, per cent. by mass, 1

Max
4 Viscosity of a one per cent. solution (m/m), in 30
centipoise, Min
5 Ash (on dry basis), per cent. by mass, Max 18 to 27

6 Acid insoluble ash (on dry basis), per cent. by 0.5

mass, Max
7 Lead, mg/kg, Max 5.0

8 Arsenic, mg/kg, Max 3.0

2. Sodium Carboxymethyl Cellulose:

(1) Sodium Carboxymethyl Cellulose shall be a white or slightly yellowish

powder consisting of very fine particles, fine granules or fine fibers with
hygroscopic nature and as described below, namely:-

58 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
Common Name Sodium Carboxymethyl Cellulose

INS No. 466

C.A.S No. 9004-32-4

Chemical Name Sodium salt of carboxy methyl

ether of cellulose.
Empirical Formula [C6H7O2(OH) x
(OCH2COONa)y]n
x = 2.00 to 2.80

y = 0.20 to 1.00 = degree of

substitution or 3.00 - x

x + y = 3.00

Structural units with degree of

substitution of 0.20 178.14

Mono substituted structural units:

242.16

Molecular Weight 178.14

(2) Sodium Carboxymethyl Cellulose shall conform to the requirements

specified in the table below, namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)

1 Purity, as sodium carboxy methyl cellulose 99.5

per cent. by mass, Min (Purity is determined
by subtracting from
100, the per cent.age
of combined sodium
chloride and free
glycolate)

59 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
2 Degree of substitution, Max 0.20 to 1.00

3 Loss on drying, per cent. by mass, Max 10

4 Sodium chloride, on dry basis, per cent. by 0.5

mass, Max
5 Free glycolate, on dry basis, per cent. by 0.1
mass, Max
6 pH of 1 per cent. colloidal solution 6 to 8.5

7 Combined sodium chloride and free glycolate 0.5

(on dry basis), per cent. by mass, Max
(Obtained by the simple
addition of values
obtained at SI No. (4 &
5).
8 Lead, mg/kg, Max 2.0

9 Arsenic, mg/kg, Max 3.0

3. Sodium Carboxymethyl Cellulose, enzyme hydrolysed:

(1) Sodium Carboxymethyl Cellulose, Enzyme hydrolysed shall be a white or

slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous
powder and as described below, namely:-

Common Name Enzymatically hydrolyzed sodium carboxy methyl

cellulose
INS No. 469
Chemical Name Carboxymethyl cellulose, sodium, partially
enzymatically hydrolyzed
Empirical Formula [C6H7O2(OH)x(OCH2COONa)y]n
x = 1.50 to 2.80
y = 0.20 to 1.50 = degree of substitution or 3.00 - x
x + y = 3.00
Structural units with degree of substitution of 0.20

60 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 178.14
Mono substituted structural units: 242.16
Molecular Weight 178.14
(2) Sodium Carboxymethyl Cellulose, enzyme hydrolysed shall conform to the
requirements specified in the table below, namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1 Loss on drying, per cent., Max 12
2 pH 6 - 8.5
3 Sodium chloride and sodium glycolate, per 0.5
cent., Max
4 Degree of substitution 0.2 - 1.5
5 Residual enzyme activity shall pass test as per
BIS standard
6 Lead, mg/kg, Max 3.0

4. Agar
(1) Agar shall be a dried hydrophylic, colloidal polygalactoside extracted from
Gelidiella species and Gracilaria species or any other red algae species of the
class Rhodophyceae and may be in bundles consisting of thin, membranous
strips or in cut, flaked, granulated, or powdered form and shall be white to pale
yellow in colour and as described below, namely:-

Common Name Agar-agar, gelose, Japanese isinglass

INS No. 406
C.A.S No. 9002-18-0

(2) Agar shall conform to the requirements specified in the table below,
namely:-
61 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1 Water absorption shall pass the test as
per BIS standards
2 Moisture, per cent. by mass, Max 20
3 Total ash, per cent. by mass, Max 6.5
4 Acid insoluble ash, per cent. by mass, Max 0.5
5 Gelatin shall pass the test as
per BIS standards
6 Insoluble matter, per cent. by mass, Max 1
7 Starch and dextrins shall pass the test as
per BIS standards
8 Arsenic, mg/kg, Max 3.0
9 Lead, mg/kg, Max 5.0

5. Gum Arabic or Acacia Gum:

(1) Acacia gum,-

(a) shall be a dried gummy exudation obtained from the stems and branches of
Acacia senegal (L) wild or Acacia seyal (L) wild, or other related species of
Acacia (Family Leguminosae);

(b) may contain extraneous matter like pieces of bark, but which shall be
removed before use in foods;

(c) Acacia gum (A. senegal) shall be pale white to orange brown solid, which
breaks with a glassy fracture;

62 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(d) the best grades shall be in the form of whole, spheroidal tears of varying
sizes with a matt surface texture and when ground, the pieces are paler and have
a glassy appearance;

(e) shall also be available in the form of white to yellowish-white flakes,

granules, powder, roller dried or spray dried material; and

(f) as described below, namely:-

Common Name Acacia gum

INS No. 414
C.A.S No. 9000-01-5
(2) Gum Arabic shall conform to the requirements specified in the table below,
namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1 Loss on drying, per cent. by mass, Max
a) Granular material 15
b) Spray dried material 10
2 Total ash, per cent. by mass, Max 4

3 Acid insoluble ash, per cent. by mass, Max 0.5

4 Insoluble matter, per cent. by mass, Max 1

5 Starch and dextrins shall pass the test as per
BIS standard
6 Tannin-bearing gums shall pass the test as per
BIS standard
7 Salmonella per g, Max Negative

8 Escherichia coli per g, Max Negative

9 Arsenic, mg/kg, Max 2.0

10 Lead, mg/kg, Max 3.0

63 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
6. Tragacanth gum:
(1) Tragacanth gum,-

(a) in raw form, is dried gummy exudation obtained from Astragalus

strobiliferus or other species of Astragalus (Fam, Leguminosae) which is a
white to yellowish-white and nearly odourless powder;

(b) in powdered form shall be in white to yellowish-white colour;

(c) in un-ground form, is flattened or lamellated or frequently curved fragments

or straight or spirally tested linear pieces from 0.5 to 2.5 mm in thickness and
white to pale yellow in colour, translucent, horny in texture and breaks with
short fracture, odourless, insipid mucilaginous in taste and as described below,
namely:-

Common Name Tragacanth gum

INS No. 413
C.A.S No. 9000-65-1

(2) Tragacanth gum shall conform to the requirements specified in the table
below, namely:-
Table
SI. Characteristic Requirement
No.
(1) (2) (3)
1 Loss on drying, per cent. by mass, Max 10

2 Total ash, per cent. by mass, Max 4

3 Acid insoluble ash, per cent. by mass, Max 0.5

4 Starch and dextrins shall pass the test as per

BIS standard
5 Tannin-bearing gums shall pass the test as per
BIS standard

64 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
6 Viscosity of a 1 per cent. solution, Min 250
7 Karaya gum test, per cent. by mass, Min shall pass the test as per
BIS standard
8 Salmonella per g, Max Negative

9 Escherichia coli per g, Max Negative

10 Lead, mg/kg, Max 2.0

11 Arsenic, mg/kg, Max 3.0

7. Gum Ghatti:

(1) Gum Ghatti is a dried gummy exudation obtained from Anogeissus latifolia
Wall (family Combretaceae) consisting mainly of a calcium salt (which on
occasions occur as a magnesium salt) of high molecular weight polysaccharide
which on hydrolysis yields arabinose, galactose, mannose, xylose and
glucuronic acid and shall be amorphous translucent rounded tears with a glassy
texture, light brown to dark brown in colour with lighter colour giving better
grade of material and powdered material shall have grey to reddish grey colour,
and as described below, namely:-

Common Name Indian gum, ghatti gum, gum

ghati
INS No. 419

C.A.S No. 9000-28-6

(2) Gum Ghatti shall conform to the requirements specified in the table below,
namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1 Loss on drying, per cent. by mass, Max 14

2 Total ash, per cent. by mass, Max 6

65 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
3 Acid insoluble ash, per cent. by mass, Max 0.5

4 Insoluble matter, per cent. by mass, Max 10

5 Starch and dextrins shall pass the test as per

BIS standard
6 Tannin-bearing gums shall pass the test as per
BIS standard
7 Salmonella per g, Max Negative

8 Escherichia coli per g, Max Negative

9 Lead, mg/kg, Max 5.0

10 Arsenic, mg/kg, Max 3.0

8. Calcium Alginate:
(1) The calcium salt of alginic acid shall be a white to yellowish fibrous or
granular powder and as described below, namely:-
Common Name Calcium Alginate
INS No. 404
C.A.S No. 9005-35-0
Chemical Name Calcium alginate
Empirical Formula [(C6H706)2Ca]
Equivalent Weight (average) 219.00
(2) Calcium Alginate shall conform to the requirements specified in the table
below, namely:-
Table
SI. Characteristic Requirement
No.
(1) (2) (3)
1 Purity as [(C6H706)2Ca], per cent. by mass, 90
on dry basis, Min
2 Moisture, per cent. by mass, (on drying 15

at 105°C for 4 h), Max

3 Insoluble matter, per cent. by mass, Max 0.2
66 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
4 Ash, per cent. by mass, Max 18-27

5 Total plate count per g, Max 5000

6 Yeasts and moulds per g, Max 500
7 Arsenic, mg/kg, Max 3.0
8 Lead, mg/kg, Max 5.0

9. Alginic acid:
(1) Alginic acid shall be the hydrophilic colloidal carbohydrate extracted by the
use of dilute alkali from various species of brown seaweed
(Phaeophyceae),described chemically as a linear glycurono glycan consisting
mainly of B (1-4) linked D-mannuronic and L-guluronic acid units in the
pyranose ring forms and white to yellowish-white, fibrous powder and as
described below, namely:-

Common Name Alginic Acid

INS No. 400
C.A.S No. 9005-32-7
Chemical Name Alginic acid
Empirical Formula (C6H8O6)n
Equivalent Weight (average) 200.00
(2) Alginic acid shall conform to the requirements specified in the table below,
namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1 Purity as (C6H8O6)n, per cent. by mass, 91
Min
2 Moisture, per cent. by mass, on drying 15

67 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 at 105°C for 4 h, Max
3 Insoluble matter, per cent. by mass, Max 0.2

4 Ash (on dry basis), per cent. by mass, Max 4

5 Acid insoluble ash (on dry basis), per cent. 0.5

by mass, Max
6 Escherichia coli Absent (in 1 g)
7 Salmonella Absent (in 10 g)
8 Arsenic, mg/kg, Max 3.0
9 Lead, mg/kg, Max 5.0

10. Guar Gum:

(1) Guar Gum shall be a white to yellowish white powder with a characteristic
guar odour and as described below, namely:-

Common Name Guar Gum

INS No. 412
C.A.S No. 9000-30-0
Chemical Name Galactomannan
(2) Guar Gum shall conform to the requirements specified in the table below,
namely:-
Table
Requirements for Guar Gum
SI. Characteristic Requirements
No.
(1) (2) (3)
1 Purity as galactomannans, per cent. by 77.5
mass, Min
2 Acid insoluble matter, per cent. by mass, 3.0
Max
68 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
3 Total ash, per cent. by mass, Max 1.5
4 Protein (N x 5.7), per cent. by mass, Max 6.0
5 Starch shall pass the test as per
BIS standard
6 Loss on drying at 105 0C for 5 h, Max 12.0

7 Mould and yeast count per g, Max 500

8 Escherichia coli, per g, Max Absent

9 Salmonella Absent (in 10 g)

10 Total plate count per g, Max 5000

11 Arsenic, mg/kg, Max 3.0

12 Lead, mg/kg, Max 2.0

11. Gum Karaya:

(1) Gum Karaya shall be a dried gummy exudation obtained from the stems and
branches of Sterculiaurens Roxb and S. Villosa Roxb of family Sterculiaceae,
white to amber colour in the form of tears of variable size or in broken irregular
pieces and as described below, namely:-

Common Name Karaya, Gum Karaya, Sterculia,

Gum Sterculia, Kadaya, Katilo,
Kullo, Kuterra
INS No. 416
C.A.S No. 9000-36-6
(2) Gum Karaya shall conform to the requirements specified in the table below,
namely:-
Table
SI. No. Characteristic Requirement
(1) (2) (3)
1 Loss on drying, per cent. by mass, Max 16

69 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
2 Starch Nil

3 Total ash, per cent. by mass (on dry basis), 8

Max
4 Acid insoluble ash, per cent. by mass (on 1
dry basis), Max
5 Acid insoluble matter, per cent. by mass (on 3
dry basis), Max
6 Chlorides Nil
7 Sulphates Nil

8 Volatile acid (as acetic acid), per cent. by 10

mass, Min
9 Swelling property, ml, Min 200

10 Water absorption, ml, Min 75

11 Freedom from animal filth shall pass test as per BIS

Standard
12 Salmonella Negative (on 1 g)

13 E. coli Negative (on 1 g)

14 Arsenic, mg/kg, Max 3.0

15 Lead, mg/kg, Max 2.0

12. Polyglycerol esters of fatty acids

(1) Polyglycerol esters of fatty acids shall be yellowish to amber unctuous
liquids, semi-solids or waxy solids and as described below, namely:-

Common Name Polyglycerol esters of fatty acids

INS No. 475
Chemical Name polyglycerol fatty acid ester and
glyceran fatty acid esters
(2) Polyglycerol esters of fatty acids shall conform to the requirements specified
in the table below, namely:-
70 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Total fatty acid ester content, per cent. by 90
mass, Min
2. Free fatty acids (estimated as oleic acid), 6
per cent. by mass ,Max
3. Total glycerol and polyglycerol, per cent. 18-60
by mass
4. Free glycerol and polyglycerol, per cent. by 7
mass, Max
5. Sulphated ash, per cent. by mass, Max 0.5

6. Lead, mg/kg, Max 2.0

7. Copper and zinc, mg/kg, Max 50
8. Arsenic, mg/kg, Max 3.0

13. Polyglycerol Esters of Interesterified Ricinoleic Acid:

(1) Polyglycerol Esters of Interesterified Ricinoleic Acid shall be a highly
viscous liquids, yellowish to brown in colour, with a typical fat-related odour
and as described below, namely:-

Common Name glyceran ester of condensed castor oil fatty acids and
polyglycerol esters of polycondensed fatty acids from
castor oil
INS No. 476
Chemical Name Polyglycerol Esters of Interesterified Ricinoleic Acid
(2) Polyglycerol Esters of Interesterified Ricinoleic Acid shall conform to the
requirements specified in the table below, namely:-
Table

71 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Hydroxyl value 80-100

2. Refractive index 1.4630 to 1.4665

3. Acid value, Max (mg KOH per g) 6
4. Iodine value, Wijs 72-103

5. Lead, mg/kg, Max 2.0

6. Copper and zinc, mg/kg, Max 50
7. Arsenic, mg/kg, Max 3.0

14. Glycerol Esters of Wood Rosin:

(1) Glycerol Esters of Wood Rosin shall be a hard pale amber coloured resin
produced by the esterification of pale wood rosin with food grade glycerin and
as described below, namely:-

Common Name Ester Gums

INS No. 445(iii)
C.A.S No. 8050-30-4
Chemical Name Glycerol Esters of Wood Rosin

(2) Glycerol Esters of Wood Rosin shall conform to the requirements specified
in the table below, namely:-

Table
SI. Characteristic Requirement
No.
(1) (2) (3)
1. Acid value (mg KOH/g) 3- 9

72 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 2. Drop softening point, 0C 88- 96
3. Hydroxyl number 15- 45

4. Lead, mg/kg, Max 1.0

5. Arsenic, mg/kg, Max 3.0

15. Pectin:
(1) Pectin shall be white, yellowish, light greyish or light brownish powder and
as described below, namely:-
Common Name Pectin
INS No. 440
C.A.S No. 9000-69-5
Chemical Name Pectin
(2) Pectin shall conform to the requirements specified in the table below,
namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Loss on drying, per cent. by mass, Max 12

2. Sulphur dioxide, mg/kg, Max 50

3. Methanol, per cent. by mass, Max 1
4. Ethanol, per cent. by mass, Max 1
5. 2-propanol, per cent. by mass, Max 1

6. Methanol, ethanol and 2-propanol, per cent. 1

by mass, Max
7. Acid insoluble ash, per cent. by mass, Max 1

8. Total insolubles, per cent. by mass, Max 3

9. Nitrogen, per cent. by mass, Max 2.5

10. Galacturonic acid, per cent. by mass on 65

73 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 ash-free and dried basis, Min
11. Degree of amidation, per cent. by mass of 25
total
carboxyl groups of pectin, Max
12. Lead, mg/kg, Max 2.0
13. Copper, mg/kg, Max 300
14. Arsenic, mg/kg, Max 5.0

16. Carrageenan :
(1) Carrageenan shall be yellowish or tan to white, coarse to fine powder that is
practically odourless and as described below, namely:-

Common Name Carrageenan

INS No. 407
C.A.S No. 9000-07-1
(2) Carrageenan shall conform to the requirements specified in the table below,
namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Loss on drying, per cent. by mass, on 12
drying at 1O5 0C till constant weight, Max
2. pH(1 in 100 suspension) 8-11
3. Viscosity, at 750 C (1.5% solution), Min 5 cp
4. Sulfate, (as SO4) on the dried basis, per 15 to 40
cent.
5. Total ash, on the dried basis, per cent. 15 to 40

6. Acid-insoluble ash, per cent., Max 1

74 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 7. Acid-insoluble matter, per cent., Max 2

8. Residual solvents, per cent. of ethanol, 0.1

isopropanol, or methanol, singly or in
combination, Max
9. Total (aerobic) plate count, cfu/g, Max 5000

10. Salmonella spp. Negative (per test)

11. Escherichia coli Negative (in 1 g)

12. Cadmium, mg/kg, Max 1.5

13. Mercury, mg/kg, Max 1.0
14. Arsenic, mg/kg, Max 3.0
15. Lead, mg/kg, Max 5.0

3.2.12 Antioxidants:
1. Butylated hydroxyanisole
(1) Butylated hydroxy anisole shall be in the form of white or slightly yellow
waxy crystalline solid with an aromatic odour and as described below, namely:-

Common Name BHA

INS No. 320
C.A.S No. 25013-16-5
Chemical Name A mixture of 3- and 2-tertiary butyl-4-hydroxyanisole; a
mixture of 3- and 2-tertiary butyl-4-methoxyphenol.
Empirical Formula C11H16O2
Molecular Weight 180.24
(2) Butylated hydroxyanisole shall conform to the requirements specified in the
table below, namely:-
Table
SI. Characteristic Requirements
No.
75 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(1) (2) (3)
1. a) Purity as C11H16O2, per cent. by mass, Min 98.5
b) 3 tertiary butyl4-hydroxyanisole, per cent. 85
by mass, Min
2. Melting point, 0C 48 to 63
3. Sulphated ash, per cent. by mass, Max 0.05
4. Phenolic impurities, per cent. by mass, Max 0.5
5. Specific absorption E 1 per cent.
(1 cm cell) in ethanol at
a) 290 nm 190 Min 210 Max
b) 228 nm 326 Min 345 Max
6. Lead, mg/kg, Max 2.0
7. Arsenic, mg/kg, Max 3.0
8. Iron, mg/kg, Max 5.0

2. Dodecyl gallate:
(1) Dodecyl gallate shall be a creamy white waxy solid, which may have a
slightly bitter taste and as described below, namely:-

Common Name Lauryl gallate

INS No. 312
C.A.S No. 1166-52-5
Chemical Name Dodecyl gallate, n-dodecyl (or lauryl) ester of 3,4,5-
trihydroxybenzoic acid
Empirical Formula C19H30O5
Molecular Weight 338.45
(2) Dodecyl gallate shall conform to the requirements specified in the table
below, namely:-

76 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Table
SI. Characteristic Requirement
No.
(1) (2) (3)
1. Purity as C19H30O5, per cent. by mass, Min 98.5
2. Moisture, per cent. by mass, Max 0.5
3. Sulphated ash, per cent. by mass, Max 0.05
4. Chlorinated organic compounds (as 100
Cholrine) mass, mg/kg, Max
5. Free acid (as gallic acid), per cent. by mass, 0.5
Max
6. Specific absorption at 275 nm,
Min 300
Max 325
7. Lead, mg/kg, Max 2.0
Arsenic, mg/kg, Max 3.0

3. Propyl gallate:
(1) Propyl gallate shall be a white to creamy-white crystalline, odourless solid
with a slightly bitter taste and as described below, namely:-

Common Name Propyl gallate

INS No. 310
C.A.S No. 121-79-9
Chemical Name Propyl gallate, and n-propyl ester
of 3,4,5-trihydroxybenzoic acid
Empirical Formula C10H12O5
Molecular Weight 212.21
(2) Propyl gallate shall conform to the requirements specified in the table
below, namely:-

Table

77 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Purity as C10H12O5, per cent. by mass, Min 99

2. Moisture, per cent. by mass, Max 0.5

3. Sulphated ash, per cent. by mass, Max 0.05

4. Melting range, 0C 146-150

5. Chlorinated organic compounds (as 100

cholrine), mg/kg, Max
6. Free acid (as gallic acid), per cent. by mass, 0.5
Max
7. Lead, mg/kg, Max 2.0
8. Arsenic, mg/kg, Max 3.0

4. Octyl gallate:
(1) Octyl gallate shall be a white to creamy-white odourless solid which may
have a slightly bitter taste and as described below, namely:-

Common Name Octylgallate

INS No. 311
C.A.S No. 1034-01-01
Chemical Name Octyl gallate and n-octyl ester of
3, 4, 5-trihydroxybenzoic acid
Empirical Formula C15H22O5
Molecular Weight 282.34

(2) Octyl gallate shall conform to the requirements specified in the table below,
namely:-

78 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Purity as C15H22O5, per cent. by mass, Min 98.5

2. Moisture, per cent. by mass, Max 0.5

3. Sulphated ash, per cent. by mass, Max 0.05

4. Melting range, 0C 99-102

5. Chlorinated organic compounds (as 100

cholrine), mg/kg, Max
6. Free acid (as gallic acid), per cent. by mass, 0.5
Max
7. Lead, mg/kg, Max 2.0
8. Arsenic, mg/kg, Max 3.0

5. Ascorbyl palmitate
(1) Ascorbyl palmitate shall be a white or yellowish white solid, with a citrus
like odour and as described below, namely:-

Common Name Vitamin C palmitate

INS No. 304
Chemical Name L-ascorbylpalmitate, 8-palmitoyl-3-
keto-L-gulofuranolactone, 2, 3-dehydro-L threo-hexono-
1, 4-lactone-6-palmitate.
Empirical C22H38O7
Formula
Molecular 414.55
Weight

79 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(2) Ascorbyl palmitate shall conform to the requirements specified in the table
below, namely:-

Table
SI. Characteristic Requirement
No.
(1) (2) (3)
1. Purity as C22H38O7, per cent. by mass (on 95
dry basis), Min
2. Sulphated ash, per cent. by mass (on dry 0.1
basis), Max
3. Loss on drying, per cent. by mass, after 2
drying in a vacuum oven at 56-60 0C for
one hour, Max
4. Lead, mg/kg, Max 2.0
5. Arsenic, mg/kg, Max 3.0

6. Sodium ascorbate:
(1) Sodium Ascorbate shall be a white to yellowish crystalline solid and as
described below, namely:-
Common Name Sodium ascorbate
INS No. 301
C.A.S No. 134-03-2
Chemical Name Vitamin C sodium and sodium L-
ascorbate.
Empirical Formula C6H7Na06
Molecular Weight 198.11
(2) Sodium ascorbate shall conform to the requirements specified in the table
below, namely:-
Table
SI. Characteristic Requirements
80 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
No.
(1) (2) (3)
1. Assay as C6H7Na06 ( on dry basis), per cent. 99 to 101
by mass
2. Loss on drying, per cent. by mass, Max, 0.25
after
drying in vacuum over phosphorus
pentoxide
at 600C for 4 hours
3. Lead, mg/kg, Max 2.0
4. Arsenic, mg/kg, Max 3.0

3.2.13 Flavour enhancers:

1. Monosodium L-glutamate:
(1) Monosodium L-glutamate shall be in the form of white, practically
odourless crystals or crystalline powder which may have either a slightly sweet
or a slightly salty taste and as described below, namely:-
Common Name Sodium glutamate, MSG
INS No. 621
C.A.S No. 142-47-2
Chemical Name monosodium L-glutamate monohydrate, sodium
glutamate, MSG
Empirical Formula C5H804NNaH20
Molecular Weight 187.13
(2) Monosodium L-glutamate shall conform to the requirements specified in the
table below, namely:-

Table
SI. Characteristic Requirements
No.
81 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(1) (2) (3)
1. Purity as (C5H804NNaH20), per cent. by 99
mass, Min
2. Loss on drying, per cent. by mass, at 98 0C 0.5
for 5h, Max
3. Chloride, per cent. by mass, Max 0.2
4. Lead, mg/kg, Max 1.0
5. Arsenic, mg/kg, Max 2.0

3.2.14 Glazing Agent:

1. Mineral Oil (low viscosity):
(1) Mineral oil, food grade is a mixture of liquid hydrocarbons, essentially
parafinic and napthenic in nature, obtained from petroleum, refined by the use
of oleum, excluding the mineral oils produced by the hydrogenation process
unless they have been subsequently refined by the use of oleum and also
excluding other types of white mineral oils to which antioxidants may have
been added for technological purposes which shall be colourless, transparent
oily liquid, free from fluorescence, odourless, tasteless, and as described below,
namely:-

Common Name Liquid paraffin, liquid petrolatum,

food grade mineral oil, white
mineral oil
INS No. 905e
C.A.S No. 8012-95-1
(2) Mineral Oil (low viscosity) shall conform to the requirements specified in
the table below, namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
82 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 1. Acidity or alkalinity shall pass the test as per
BIS standard
2. Readily carbonizable substances shall pass the test as per
BIS standard
3. Polynuclear aromatic hydrocarbons, 0.10
absorbance
at wave lengths between 260-350 nm, Max
4. Solid paraffins shall pass the test as per
BIS standard
5. Sulphurs ( as SO4) shall pass the test as per
BIS standard
6. Lead, mg/kg, Max 1.0
7. Arsenic, mg/kg, Max 1.0

2. Mineral Oil (High viscosity):

(1) A mixture of highly refined paraffinic and naphthenic liquid hydrocarbons
with boiling point above 3500, obtained from mineral crude oils through
various refining steps including distillation, extraction and crystallization and
subsequent purification by acid or catalytic hydro treatment which may contain
antioxidants approved for food use shall be colourless, transparent oily liquid,
free from fluorescence, odourless, tasteless and as described below, namely:-

Common Name Liquid paraffin, liquid petrolatum,

food grade mineral oil, white
mineral oil
INS No. 905d
C.A.S No. 8012-95-1

(2) Oil (High viscosity) shall conform to the requirements specified in the table
below, namely:-

83 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Acidity or alkalinity shall pass the test as per
BIS standard
2. Readily carbonizable substances shall pass the test as per
BIS standard
3. Polynuclear aromatic
hydrocarbons, 0.10*
absorbance (test shall be as per BIS
at wave lengths between 260-350 nm, Max standard)
4. Solid paraffins shall pass the test as per
BIS standard
5. Sulphurs ( as SO4) shall pass the test as per
BIS standard
6. Lead, mg/kg, Max 1.0
7. Arsenic, mg/kg, Max 1.0

3.2.15 Humectant or Wetting Agent or Dispersing Agent:

1.Propylene glycol:
(1) Propylene Glycol shall be a clear, colourless, practically odourless, viscous
liquid having a slight characteristic taste and as described below, namely:-
Common Name Propylene glycol
INS No. 1520
C.A.S No. 57-55-6
Chemical Name 1, 2-propanediol, 1, 2 dihydroxypropane and methyl
glycol
Empirical Formula C6H802
Molecular Weight 76.1

84 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(2) Propylene glycol shall conform to the requirements specified in the table
below, namely:-
Table
SI. Characteristic Requirements
No.
(1) (2) (3)
1. Purity as C6H802, per cent. by mass, Min 99.5

2. Moisture, per cent. by mass, Max 0.2

3. Acidity shall pass test as per BIS
standard
4. Sulphated ash (on dry basis), per cent. by 0.007
mass, Max
5. Presence of other polyhydroxy compounds Absent
6. Ethylene glycol Absent
7. Lead, mg/kg, Max 2.0
8. Arsenic, mg/kg, Max 3.0

3.2.16 Sweetner or Humectant or Sequestrant:

1. Sorbitol:
(1) Sorbitol shall be white hygroscopic powder having a sweet taste and as
described below, namely:-
Common Name Sorbitol
INS No. 420
C.A.S No. 50-70-4
Chemical Name d-sorbitol, d-glucitol, d-sorbite, d-sorbol, and
1,2,3,4,5,6-hevanehexal
Empirical Formula C6H14O6
Molecular Weight 182.17

85 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
(2) Sorbitol shall conform to the requirements specified in the table below,
namely:-

SI. Characteristic Requirements

No.
(1) (2) (3)
1. Purity, as d sorbitol C6H14O6, per cent. by 91 or 99
mass. Min (Depending on the
method of test used for
analysis.)
2. Moisture per cent. by mass, Max 1

3. Melting range
a) Metastable 92.5 0C to 93.5 0C
b) Stable 96 0C to 97.5 0C
4. Reducing sugars, per cent. by mass, Max 0.2

5. Sulphated ash, per cent. by mass, Max 0.1

6. Sulphates (as SO4) per cent. by mass, Max 0.01

7. Chlorides (as Cl) per cent. by mass Max 0.005

8. Arsenic , mg/kg, Max 3.0

9. Lead , mg/kg, Max 1.0
10. Nickel, mg/kg, Max 2.0]

18
[3.3 Other substances for use in food products

3.3.1 Flavouring agents and related substances

1) Flavouring agents include flavour substances, flavour extracts or flavour

preparations, which are capable ofimparting flavouring properties, namely taste
or odour or both to food. The following type of Flavouring agents may be added
to food as per Good Manufacturing Practices: -

(i) Natural flavours and natural favouring substances means flavour

preparations and single substancerespectively, acceptable for human
86 | V e r s i o n 2 ( 0 4 . 1 1 . 2 0 2 4 )
 consumption, obtained exclusively by physical processes from vegetables,
for human consumption

(ii) Nature-identical flavouring substances means substances chemically

isolated from aromatic rawmaterials or obtained synthetically; they are
chemically identical to substances present in natural productsintended for
human consumption, either processed or not.

(iii) Artificial flavouring substances means those substances which have not
been identified in naturalproducts intended for human consumption either
processed or not;

2) Use of antioxidants, emulsifying and stabilising agents and food

preservatives in flavour -The flavouring agents may contain permitted
antioxidants, emulsifying and stabilising agents and foodpreservatives.

3) Use of anticaking agent in flavours - Synthetic amorphous silicon dioxide

(INS 551) may be used in powder flavouringsubstances to a maximum level of
2 percent.

4) Restriction on use of flavouring agents:-The use of the following flavouring

agents is prohibited in any article of food, namely,-

(i) Coumarin and dihydrocoumarin;

(ii) Tonkabean (Dipteryl adorat);
(iii) β-asarone and cinamyl anthracilate
(iv) Estragole
(v) Ethyl methyl ketone
(vi) Ethyl-3-phenylglycidate
(vii) Eugenyl methyl ether
(viii) Methyl β napthyl ketone
(ix) p-Propylanisole
(x) Saffrole and isosaffrole
(xi) Thujone and isothujone (α & β thujone)
69
[(xii) 4,5 epoxydec-2(trans)-enal]
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5) Solvent in flavour

Diethyleneglycol and monoethyl ether shall not be used as solvent in

flavours.

3.3.2 Lactulose syrup

1) Lactulose syrup may be used in special milk based infant food

formulations, which is to be taken under medical advice up to a maximum
level of 0.5 per cent of final food subject to label declaration.

2) Lactulose syrup may be used in bakery products up to 0.5 per cent

maximum by weight.

3.3.3 Oligofructose

Oligofructose may be added at not more than 10 per cent of the product, in the
following products, subject to label declaration under sub-regulation 43 of
regulation 2.4.5 of the Food Safety and Standards (Packaging and Labelling)
Regulations, 2011, -

Dairy products like yoghurt, mousse, spreads, dairy based drinks (milkshakes,
yoghurt drink), cheese, pudding, cream and ice-cream, frozen desserts like
nondairy ice, sorbet and fruit ice, frozen yoghurt, flakes and ready-to-eat dry
breakfast cereals, chocolate and sweets and carbohydrate based and milk
product based sweets like halwa, mysore pak, boondi laddu, jalebi, khoyaburfi,
peda, gulabjamun, rasgulla and similar milk product based sweets sold by any
name; cooked sausages, ham and meat spreads.

Amendment for substitution of highlighted provision

83
[3.3.3 Oligofructose

Oligofructose may be added as an ingredient in the following foods. The usage levels
shall not exceed maximum levels specified in the Table below, namely:-

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 S. Category Usage level
No. (Maximum)
(1) (2) (3)
1. Dairy products like yoghurt, mousse, spreads, dairy based drinks 10 per cent.
(milkshakes, yoghurt drink), cheese, pudding, cream and ice-cream,
frozen desserts like non-dairy ice, sorbet and fruit ice, frozen yoghurt,
flakes and ready-to-eat dry breakfast cereals, chocolate and sweets and
carbohydrate based and milk product based sweets like halwa, mysore
pak, boondi laddu, jalebi, khoyaburfi, peda, gulabjamun, rasgulla and
similar milk product based sweets sold by any name, cooked sausages,
ham and meat spreads.
Confectionery (cocoa and chocolate products, imitation chocolate,
chocolate substitute products, hard candy, soft candy, nougats and
marzipans, chewing gum, decorations (e.g. for fine bakery wares),
toppings (non-fruit) and sweet sauces).
Cereal and cereal products (such as cereal and starch based desserts,
pre-cooked or processed cereal or grain or legume products, soybean-
based beverages, soybean-based beverage film, soybean curd (tofu),
semi-dehydrated soybean curd, dehydrated soybean curd, Fermented
soybean curd).
2. Processed fruits (canned or bottled (pasteurized) fruit, jams, jellies, 15 per cent.
marmalades, fruit bar or toffee and fruit cheese, fruit- based spreads
(e.g. chutney), candied fruit, fruit preparations, including pulp, purees,
fruit toppings and coconut milk).
Soups and broths (ready-to-eat soups and broths, including canned,
bottled, and frozen; mixes for soups and broths).
Sauces and like products (emulsified sauces and dips; non- emulsified
sauces; mixes for sauces and gravies; clear sauces).
Fruit and vegetable nectars (fruit nectar; vegetable nectar, concentrates
of fruit nectar, concentrates of vegetable nectar).
Ready-to-eat savouries (snacks - potato, cereal, flour or starch based
(from roots and tubers, pulses and legumes), processed nuts, including
coated nuts and nut mixtures, bread and bread-type products and
biscuit.
3. Non-alcoholic ("soft") beverages (water-based flavoured drinks, 1 per cent]
including "sport," “energy,” or "electrolyte" drinks and articulated
drinks, carbonated water-based flavoured drinks, non-carbonated water-
based flavoured drinks, including punches and ades, concentrates
(liquid or solid) for water-based flavoured drinks, hot cereal and grain
beverages, excluding cocoa).

[This amendment shall come into force on 1st May, 2025]

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73
[3.3.4 Trehalose. - (1) Trehalose shall be in the form of white or almost white
crystals; soluble in water, slightly soluble in ethanol.
(2) Trehalose shall be added at the level of good manufacturing practices
(GMP) in all food categories except infant food provided that the standard
specifications of such food products as prescribed under Food Safety and
standards Regulations, 2011 are not altered with.
(3) It shall conform to the following requirements, namely: -

TABLE

S. No. Parameters Limits

1 Loss on drying (%) Not more than 1.5
2 Total ash (%) Not more than 0.05

(4) Trehalose may be added as an ingredient subject to label declaration under

the provisions 1.8 of schedule-II of the Food Safety and Standards (Labelling
and Display) Regulations, 2020, without health claims.
(5) Methods of analysis for trehalose shall be as specified in Joint FAO/WHO
Expert Committee on Food Additives (JECFA) (2000).]

3.3.5 Phyto or Plant Stanol

66
[Phyto or Plant stanol esters may be added to the following products so as to
allow users to easily restrict their consumption to maximum 3 g stanol per day
through the use of either one portion containing maximum 3 g or three portions
each containing 1 g and it shall be added subject to the table declaration under
sub-regulation 48 of regulation 2.4.5 of the Food Safety and Standards
(Packaging and Labelling) Regulations, 2011, namely:-]
(i) Fat spread, milk products, milk based fruit drink, fermented milk
products, soy and rice drink, cheese products, yoghurt products, spice
sauces, salad dressings, juices and nectars.
(ii) Products containing Phyto or Plant Stanols be sold in single portions
containing either maximum 3 g or ‘maximum 1 g of Phyto or Plant
Stanols, calculated as free Phyto or Plant Stanols, and if they do not
contain so, there should be a clear indication of what constitutes a
standard portion of the food, expressed in g or ml, and of the amount
of Phyto or Plant Stanols, calculated as free Phyto or Plant Stanols,
contained in such a portion;

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3.3.6 Phyto or Plant Sterol

(a) The Phyto or Plant sterols from Non-Genetically Modified source may be
used in the following categories of food products with their use at the level not
exceeding 3 g/day;-

Fat spread, milk products, milk based fruit drink, fermented milk products, soy
and rice drinks, cheese products, yoghurt products, spice sauces, salad
dressings, juices and nectars, edible oils, and bakery products

Products containing Phyto or Plant Sterols be sold in single portions containing

either maximum 3 g or maximum 1g of Phyto/ Plant Sterols, calculated as free
Phyto or Plant Sterols. And if they do not contain so, there should be a clear
indication of what constitutes a standard portion of the food, expressed in g or
ml, and of the amount of Phyto or Plant Sterol, calculated as free Phyto or Plant
Sterol, contained in such a portion. In all events, the composition and labelling
of the products should be such as to allow users to easily restrict their
consumption to maximum 3g/day of Phytosterols through the use of either one
portion of 3g or three portions containing minimum 1g.

(b) The products referred to in sub-clause (a) shall not exceed the Acceptable
Daily Intake (ADI) for Phytosterols and shall contain the label declarations as
provided in the clause 55 of sub-regulation 2.4.5 of the Food Safety and
Standards (Packaging and Labelling) Regulations, 2011.]

71
[3.4 PROCESSING AIDS

3.4.1: DEFINITIONS AND CONDITIONS OF USE

(1) Processing aids included in these regulations

The processing aids listed herein are recognised as suitable for use in foods in
conformance with the provisions of these regulations and have been assigned an
Acceptable Daily Intake (ADI) or determined (wherever applicable), on the
basis of other criteria, to be safe and the use of processing aids in conformance
with these regulations has to be technologically justified.

(2) Product category

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The foods or food processing procedures, in which the processing aid is utilised,
are defined by these regulations.

(3) Food in which processing aids may be used

The conditions, under which processing aids may be used in foods, are defined
by these regulations.

(4) Foods in which processing aids shall not be used

Unless expressly permitted in these regulations, processing aids shall not be
used in food processing.

(5) “Processing aid” means any substance or material, not including apparatus
or utensils, and not consumed as a food ingredient by itself, intentionally used
in the processing of raw materials, foods or its ingredients, to fulfill a certain
technological purpose during treatment or processing and which may result in
the non-intentional but unavoidable presence of residues or derivatives in the
final product.

(6) “Acceptable Daily Intake (ADI)” means the amount of a processing aid in
food expressed on a body weight basis that can be ingested daily over a lifetime
without appreciable health risk and a processing aid, meeting this criterion shall
be used within the bounds of Good Manufacturing Practice (GMP) as specified
in clause (11) of this sub-regulation.

(7) Maximum permitted Level of a processing aid, is the highest concentration

of the processing aid, determined to be functionally effective in a food or food
category and agreed to be safe and it is generally expressed as mg/kg of food.

(8) “Residual level” means the level of processing aid remaining in food after
processing. The levels should be designated with respect to those directly
measured by analysis or estimated by other means. Values are in mg/kg and
values at the detection limit of available analytical procedures are reported as
"Not more than".

(9) “EC number” (Enzyme Commission number) means the number which the
Enzyme Commission uses to classify the principal enzyme activity.

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(10) Justification for the use of processing aids
The use of a substance as a processing aid is justified when such use performs
one or more technological functions during treatment or processing of raw
materials, foods, or ingredients. Any residues of processing aids remaining in
the food after processing should not perform a technological function in the
final product.
(11) Good Manufacturing Practice (GMP)
All the processing aids subject to the provisions of these regulations shall be
used under conditions of good manufacturing practices (GMP) which includes
the following, namely: -
(a) the quantity of the substance used shall be limited to the lowest
achievable level necessary to accomplish its desired technological
function;
(b) residues or derivatives of the substance remaining in food should be
reduced to the extent reasonably achievable and should not pose any
health risk; and
(c) The substance is prepared and handled in the same way as a food
ingredient.
(12) Specifications for the identity and purity of processing aids
(a) Substances used as processing aids should be of food grade quality. This
can be demonstrated by conforming to the applicable specifications of
identity and purity recommended under these regulations, and in case
such standards are not specified, the purity criteria accepted by
international bodies such as Codex Alimentarius may be adhered to.
(b) The safety of a substance used as a processing aid shall be demonstrated
by the supplier or the user of the substance. The demonstration of safety
shall include appropriate assessment of any unintended or unavoidable
residues resulting from its use as a processing aid under conditions of
GMP.
(13) Conditions for labelling
The product covered by this Standard shall be labelled in
accordance with the Food Safety and Standards (Packaging &
Labelling) Regulation, 2011. Declaration of vegetarian or non-
vegetarian irrespective of the residue level, has to be mentioned on
the label.]

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