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Infant Food - Milk-Cereal Based Complementary Foods - : Specification

The document outlines the Indian Standard IS 1656:2022 for milk-cereal based complementary foods intended for infants aged six months to two years. It details the specifications, requirements, and permissible ingredients for these foods, emphasizing their nutritional role in an infant's diet. The fifth revision harmonizes these standards with recent regulations and updates various requirements including product description, permitted ingredients, and labeling clauses.

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0% found this document useful (0 votes)
102 views20 pages

Infant Food - Milk-Cereal Based Complementary Foods - : Specification

The document outlines the Indian Standard IS 1656:2022 for milk-cereal based complementary foods intended for infants aged six months to two years. It details the specifications, requirements, and permissible ingredients for these foods, emphasizing their nutritional role in an infant's diet. The fifth revision harmonizes these standards with recent regulations and updates various requirements including product description, permitted ingredients, and labeling clauses.

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Shanmuga Selvan
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com)
103.210.141.140 [for non-commercial use only].

भारतीय मानक IS 1656 : 2022


Indian Standard

शिशु आहार — दुग्ध-अनाज आधारित


अनुपूरक आहार — विशिष्टि
( पांचवा पनु रीक्षण )

Infant Food — Milk-Cereal Based


Complementary Foods —
Specification
( Fifth Revision )

ICS 67.100.99

© BIS 2022

भारतीय मानक ब्रयू ो


B U R E A U O F I N D I A N S TA N D A R D S
मानक भवन, 9 बहादरु शाह ज़फर मार्ग, नई िदल्ली – 110002
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI-110002
         www.bis.gov.in  
www.standardsbis.in

April 2022  Price Group 7


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Dairy Products and Equipment Sectional Committee, FAD 19

FOREWORD
This Indian Standard (Fifth Revision) was adopted by the Bureau of Indian Standards, after the draft finalized
by the Dairy Products and Equipment Sectional Committee had been approved by the Food and Agriculture
Division Council.
Milk-cereal based complementary foods are mainly intended to accustom the infant’s digestive tract to solid foods.
Nutritionally, this category of foods serves as an important source of calories to meet the energy requirements
due to increased physical activity of infant. Beginning with the introduction of cereals after six months of age,
the intake is slowly increased so that by 8 months of age and onwards, nearly half of the total intake is from milk
and remaining from cereals and a variety of other foods. With such a feeding practice, milk almost completely
meets the protein requirements, while cereals and/or other foods meet the energy and satiety requirements of the
infant.
Under the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and
Distribution) Act, 1992, various types of foods for infants being marketed in our country have been placed under
the following two categories:
a) Infant milk substitutes, and
b) Infant foods.
‘Infant milk substitute’ means any food being marketed or otherwise represented as partial or total replacement for
mother’s milk, whereas ‘Infant Food’ means any food being marketed or otherwise represented as a complement
to mother’s milk to meet the growing nutritional needs of the infant after the age of six months and up to the age
of two years.
This standard covers the requirements for milk-cereal based complementary foods and a separate standard,
namely, IS 11536 : 2022 ‘Processed cereal based complementary foods for infants — Specification (third revision)’
exists which covers the requirements for processed cereal based complementary foods.
This standard was first published in 1960 and subsequesntly revised in 1969, 1985, 1997 and then in 2007 to
update the chemical and microbiological requirements and recommendatory list of sources of vitamin compounds
and minerals salts; and to include list of permitted food additives.
A scheme for labelling environment friendly products known as ECO-Mark was also introduced in the fourth
revision at the instance of the Ministry of Environment and Forests, Government of India. The ECO-Mark shall be
administered by the Bureau of Indian Standards (BIS) under the BIS Act, 2016 as per the Resolution No. 71 dated
20 February 1991 and No. 425 dated 28 October 1992 published in the Gazette of the Government of India. For
a product to be eligible for marking with the ECO-Mark, it shall also carry the Standard Mark of BIS for quality
besides meeting additional environment friendly (EF) requirements given in the standard, which are based on the
Gazette Notification No. GSR 624 (E) dated 6 September 1995 for labelling beverages, infant foods and processed
fruits and vegetable products as Environment Friendly Products, published in the Gazette of the Government of
India.
Amendments were later issued to IS 1656 : 2007 in November 2012 and November 2014.
This fifth revision has been brought out to harmonize the requirements of milk-cereal based complementary foods
with the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. Major changes include:
a) Product description has been updated;
b) List of permitted optional ingredients has been updated;
c) List of permitted food additives as well as their levels have been updated;
d) Referred test methods have been updated;
e) Chemical and microbiological requirements have been updated; and
f) Labelling clause has been modified.

(Continued on third cover)


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IS 1656 : 2022

Indian Standard
INFANT FOOD — MILK-CEREAL BASED
COMPLEMENTARY FOODS — SPECIFICATION
( Fifth Revision )

1 SCOPE 4 REQUIREMENTS
This standard prescribes the requirements, methods of 4.1 Description
test and sampling for milk-cereal based complementary
foods intended to complement the diet of infants after The milk-cereal based complementary food shall be in
six months up to twenty four months of age. the form of powder, small granules or flakes, free from
lumps and shall be uniform in appearance. It shall also
2 REFERENCES be free from dirt, and extraneous matter, preservatives,
The standards listed in Annex A contain provisions added colour and flavour and from any material which
which, through reference in this text, constitute are harmful to infant’s health. The flavour and odour
provisions of this standard. At the time of publication, of the milk-cereal based complementary food in the
the editions indicated were valid. All standards are powder form or when reconstituted with water shall be
subject to revision, and parties to agreements based fresh and sweet (see IS 10641). It shall be free from
on this standard are encouraged to investigate the rancid taste and musty odour (see IS 10641).
possibility of applying the most recent editions of these 4.2 The product shall be reasonably free from scorched
standards. particles.
3 TERMINOLOGY 4.3 Lactose and glucose polymers shall be the preferred
For the purpose of this standard, the following carbohydrates for milk-cereal based complementary
definitions shall apply. food. Sucrose and/or fructose shall not be added,
unless needed as a carbohydrate source, and provided
3.1 Milk-Cereal Based Complementary Food — the sum of these does not exceed 20 per cent of total
Milk-cereal based complementary foods commonly carbohydrate.
called as weaning foods or supplementary foods means NOTE — For the purpose of the above clause, record of
the food for infants after 6 months up to 24 months of the addition may be maintained by the manufacturer since
age, which is based on milk (see 4 of IS 13688), cereals analytical methods have not been established for these.
and/or legumes (pulses), millets, nuts and defatted 4.4 The milk-cereal based complementary food shall
edible oilseed extracts and so prepared as to permit not contain hydrogenated vegetable fats and oils.
dilution with water or milk or other suitable medium. It
may also contain soybean, fruits and vegetables or their 4.5 Optional Ingredients
products, egg or egg products, protein concentrates or
The milk-cereal based complementary food may
protein isolates or protein hydrolysates, milk solids,
contain in addition to the vitamin and minerals listed
various carbohydrates, and salts such as phosphates
under Table 2, other nutrients ordinarily found in
and citrates.
human milk in amounts prescribed in Table 1 (either
3.2 Routine Tests — The tests carried out on each lot per 100 g or 100 kcal basis).
to check the essential requirements which are likely to
4.5.1 The product may also contain algal and fungal
vary during production.
oil as sources of docosahexaenoic acid (DHA) and
3.3 Type Test — The tests to prove conformity to arachidonic acid (ARA) from Crypthecodiniumcohnii,
the requirements of this standard. These are intended Mortierellaalpina, Schizochytrium sp., and Ulkenia sp.
to approve the formulation and quality of the product or fish oil at the level of maximum 0.5 percent DHA
at least in the beginning of marketing or certification of total fatty acids and ratio of ARA : DHA as 1 : 1
or both. These tests are also conducted periodically minimum.
to supplement the routine tests or whenever the basic NOTE — DHA content shall not be less than 0.2 per cent of
formula or method is changed. total fatty acids, if a claim related to the addition of DHA is
made.

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IS 1656 : 2022

Table 1 Optional Ingredients


( Clause 4.5 )

Sl No. Nutrient Requirements per 100 g Requirements per 100 kcal Method of Test, Ref to
(1) (2) (3) (4) (5)
i) Pantothenic acid, mg 2.00 - 10.00 0.40 - 2.10 IS 16642
ii) Vitamin B12, µg 0.25 - 0.70 0.05 - 0.15 IS 16640* or AOAC 2014.02
iii) Vitamin K, µg 7.50 - 19.00 1.60 - 4.00 IS 21446
iv) Choline, mg, Max 32.00 6.80 IS 17668
v) Inositol, mg 20.00 - 200.00 4.25 - 42.55 IS 16649* or any other validated
international method
vi) Calcium, mg 250.00 - 700.00 53.20 - 148.90 IS 12760 or
ISO 15151 or
ISO 21424*
vii) Phosphorus, mg 125.00 - 500.00 26.60 - 106.40 IS 12756 or
ISO 15151 or
ISO 21424*
viii) Chloride, mg 250.00 - 800.00 53.20 - 170.20 IS 11763 or
AOAC 2016.03*
ix) Magnesium, mg 30.00 - 75.20 6.40 - 16.00 IS 12760 or
ISO 15151 or
ISO 21424*
x) Sodium, mg 90.00 - 300.00 19.15 - 63.80 IS 12760 or
ISO 15151 or
ISO 21424*
xi) Selenium, µg 5.00 - 40.00 1.00 - 9.0 IS 15303 or
ISO 15151 or
ISO 20649*
xii) Taurine, mg, Max 60.00 12.75 AOAC 2018.06* or
AOAC 997.05
xiii) L-amino acids, mg, Min 0.90 0.20 AOAC 2018.06
xiv) L-Carnitine, mg, Min 5.00 1.00 IS 17668
xv) Biotin, μg 7.50 - 50.00 1.60 - 10.60 IS 17670
xvi) Iodine, μg 90.00 - 225.60 19.15 - 48.00 IS 17379
xvii) Potassium, mg 300.00 - 900.00 63.80 - 191.50 IS 12760 or
ISO 15151 or
ISO 21424*
xviii) Pyridoxine, μg 100.00 - 400.00 21.30 - 85.10 IS 17669*

NOTES:
1 When any of the nutrients listed in this table are added, the amount of these added nutrients shall be declared on the label.
A variation of minus 10.0 per cent from the declared value of the nutrients or nutritional ingredients on the label shall be allowed.
2 In case of dispute, the method indicated by ‘*’ shall be the referee method.

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IS 1656 : 2022

4.6 Food Additives for infants ready for consumption prepared following
manufacturer’s instructions, unless otherwise
4.6.1 Following additives may be used in the indicated:
preparation of milk-cereal based complementary food

Food Additives Recommended Maximum Level per 100 g of the


Product Ready for Consumption
Emulsifiers
Lecithins 1 500 mg
Mono- and diglycerides
Acetic fatty acid esters of glycerol
5 000 mg singly or in combination1
Lactic fatty acid esters of glycerol
Citric acid fatty acid esters of glycerol
Acidity regulators
Sodium hydrogen carbonate
Calcium carbonate
Potassium hydrogen carbonate
L(+)lactic acid
Citric acid
Acetic acid
Potassium acetate
Sodium acetate
Calcium acetate
Malic acid (DL)-L(+) form only
Sodium lactate (solution)-L(+) form only
Potassium lactate (solution)-L(+) form only GMP
Calcium lactate-L(+) form only
Monosodium citrate
Trisodium citrate
Monopotassium citrate
Tripotassium citrate
Calcium citrate
Hydrochloric acid (food grade)
Sodium hydroxide
Potassium hydroxide
Calcium hydroxide
Glucono-delta-lactone
L(+)Tartaric acid
Disodium tartarate 500 mg singly or in combination
Potassium sodium L(+) tartrate L(+) form only
Ortho phosphoric acid
Mono sodium ortho phosphate
Disodium orthophosphate
Trisodium orthophosphate
Monopotassium orthophosphate Only for pH adjustment, 440 mg singly or in
Dipotassium orthophosphate combination as phosphorous
Tripotassium orthophosphate
Monocalcium orthophosphate
Dicalcium orthophosphate
Tricalcium orthophosphate

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IS 1656 : 2022

Food Additives Recommended Maximum Level per 100 g of the


Product Ready for Consumption
Antioxidants
Mixed tocopherols concentrate
300 mg/kg fat or oil, singly or in combination
Alpha tocopherol
L-Ascorbyl palmitate 200 mg/kg fat or oil
L-ascorbic acid
Sodium ascorbate 50 mg expressed as ascorbic acid
Potassium ascorbate
Calcium ascorbate 20 mg expressed as ascorbic acid
Raising Agents
Ammonium carbonate
Ammonium hydrogen carbonate
GMP
Sodium carbonate
Sodium hydrogen carbonate
Thickeners
Carob bean gum
Guar gum
1 000 mg singly or in combination;
Gum Arabic
2 000 mg in gluten free cereal based foods
Xanthan gum
Pectins (amidated and non-amidated)
Oxidized starch
Mono starch phosphate
Distarch phosphate
Phosphated distarch phosphate
Acetylated distarch phosphate 5 000 mg singly or in combination
Acetylated distarch adipate
Starch acetate esterified with acetic anhydride
Starch sodium octenyl succinate
Acetylated oxidized starch
Anticaking Agent
Silicon dioxide GMP
Packaging gases
Carbon dioxide
GMP
Nitrogen
Enzymes
Alpha amylase GMP

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IS 1656 : 2022

4.6.2 For reasons of stability and safe handling, some fumarate, ferrous gluconate, ferrous succinate,
vitamins and other nutrients have to be converted into ferrous lactate, ferric ammonium citrate,
suitable preparations. For this purpose, the following ferric citrate, ferrous bisglycinate, sodium
food additives may be used as nutrient carriers in milk- ferric pyrophosphate ferric diphosphate, ferric
cereal based complementary food: orthophosphate, ferrous sulphate, hydrogen
reduced iron, electrolytic iron, carbonyl iron,
Additive/Carrier Recommended ferric saccharate, sodium ferric diphosphate;
Maximum Level in 5) Magnesium (Mg) — Magnesium hydroxide
Ready-to-Use foods carbonate, magnesium chloride, magnesium
for Infant Nutrition oxide, magnesium phosphate dibasic
(mg/kg) (magnesium hydrogen phosphate), magnesium
Gum arabic (gum acacia) 10 phosphate tribasic (trimagnesium phosphate),
magnesium carbonate, magnesium sulphate,
Silicon dioxide 10
magnesium hydroxide, magnesium salts of
Mannitol (for vitamin B12 10 citric acid, magnesium gluconate, magnesium
dry rubbing, 0.1 percent lactate, magnesium glycerol-phosphate,
only) magnesium acetate;
Starch sodium octenyl 100 6) Sodium (Na) — Sodium bicarbonate, sodium
succinate carbonate, sodium chloride, trisodium citrate,
Sodium L-ascorbate 75 sodium gluconate, sodium L-lactate, sodium
(in coating of nutrient phosphate monobasic (sodium dihydrogen
preparations containing phosphate), sodium phosphate dibasic
polyunsaturated fatty acids) (disodium hydrogen phosphate), sodium
phosphate tribasic (trisodium phosphate),
4.7 Quality of Ingredients sodium sulphate, sodium hydroxide;
7) Potassium (K) — Potassium bicarbonate,
4.7.1 All ingredients used shall be clean, of good potassium carbonate, potassium chloride,
quality, safe and suitable for ingestion by infants. potassium citrate (tripotassium citrate),
potassium gluconate, potassium L-lactate;
4.7.2 The vitamins, minerals and other nutrients shall be
of food grade. Wherever applicable, milk-cereal based 8) Copper (Cu) — Copper gluconate (cupric
complementary foods shall use the source compounds gluconate), cupric carbonate, cupric citrate,
for minerals, vitamins and other nutrients as follows: copper sulphate (cupric sulphate);
a) Minerals 9) Iodine (I) — Potassium iodide, sodium iodide,
potassium iodate;
1) Calcium (Ca) — Calcium carbonate, calcium
chloride, calcium citrate (tricalciumdi citrate), 10) Zinc (Zn) — Zinc acetate, zinc chloride, zinc
calcium gluconate, calcium glycerophosphate, oxide, zinc sulphate, zinc gluconate, zinc
calcium L-lactate, calcium hydroxide, calcium lactate, zinc citrate (zinc citrate dihydrate or
phosphate monobasic (calcium dihydrogen zinc citrate trihydrate);
phosphate), calcium phosphate dibasic 11) Manganese (Mn) — Manganese(II) carbonate,
(calcium hydrogen phosphate), calcium manganese(II) chloride, manganese(II)
phosphate tribasic (tricalcium diphosphate), citrate, manganese sulphate, manganese (II)
calcium oxide; gluconate, manganese (II) glycerol-phosphate;
2) Phosphorous (P) — Calcium phosphate and
monobasic, calcium phosphate dibasic, calcium 12) Selenium — Sodium selenate, sodium selenite,
phosphate tribasic, magnesium phosphate sodium hydrogen selenite.
dibasic, magnesium phosphate tribasic, b) Vitamins
potassium phosphate monobasic, potassium
1) Vitamin A — Retinyl acetate, retinyl palmitate,
phosphate dibasic, sodium phosphate dibasic,
trans retinol;
Phosphoric acid;
2) Provitamin A — Beta-carotene;
3) Chloride (Cl) — Calcium chloride, choline
chloride, magnesium chloride, manganese 3) Vitamin D — Vitamin D2 (ergocalciferol),
chloride, potassium chloride, sodium chloride, vitamin D3 (cholecalciferol);
hydrochloric acid (food grade); 4) Vitamin E — D-alpha-tocopherol, DL-alpha-
4) Iron (Fe) — Ferrous carbonate (stabilized tocopherol, D-alpha-tocopheryl acetate, DL-
with saccharose), ferrous citrate, ferrous alpha-tocopheryl acetate;

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IS 1656 : 2022

5) Vitamin K1 — Phytomenadione (2-Methyl- 9) L-Isoleucine;


3-phytyl-1,4-naphthoquinine/Phylloquinone/ 10) L-Isoleucine hydrochloride;
phytonadione);
11) L-Leucine;
6) Vitamin K2 — Menaquinone;
12) L-Leucine hydrochloride;
7) Thiamin (Vitamin B1) — Thiamin chloride
13) L-Lysine;
hydrochloride, thiamin mononitrate;
14) L-Lysine mono hydrochloride;
8) Riboflavin (Vitamin B2) — Riboflavin,
riboflavin-5-phosphate sodium; 15) L-Methionine;
9) Niacin — Nicotinamide, nicotinic acid; 16) L-Phenylalanine;
10) Pantothenic Acid — Calcium -D- pantothenate, 17) L-Threonine;
D-panthenol, sodium-D-pantothenate, DL- 18) L-Tryptophan;
panthenol; 19) L-Tyrosine; and
11) Vitamin B6 — Pyridoxine hydrochloride; 20) L-Valine.
Pyridoxal-5-phosphate;
d) Carnitine
12) Folic Acid — N-Pteroyl-L-glutamic acid;
1) L-Carnitine; and
13) Biotin (Vitamin H) — D-biotin;
2) L-Carnitine hydrochloride.
14) Vitamin B12 — Cyanocobalamin, hydroxo-
cobalamin; and e) Choline
15) Vitamin C — L-ascorbic acid, sodium-L- 1) Choline;
ascorbate, calcium-L-ascorbate, potassium- 2) Choline chloride;
L-ascorbate, 6-palmitoyl-L-ascorbic acid 3) Choline citrate;
(ascorbyl palmitate). 4) Choline hydrogen tartrate; and
c) Amino Acids 5) Choline bitartrate.
1) L-Arginine; f) Inositols
2) L-Arginine hydrochloride; 1) Myo-inositol.
3) L-Cystine;
4.8 The product shall also conform to the requirements
4) L-Cystine dihydrochloride;
given in Table 2 (either per 100 g or 100 kcal basis)
5) L-Cysteine; and Table 3.
6) L-Cysteine hydrochloride;
4.9 If the product claims to have higher quality protein,
7) L-Histidine; the protein efficiency ratio (PER), when tested as per
8) L-Histidine hydrochloride; IS 7481 shall be minimum 2.5.

Table 2 Requirements for Milk-Cereal Based Complementary Foods


( Clause 4.8 )

Sl Characteristic Requirement per Requirements Method of Test, Ref to


No. 100 g per 100 kcal
(1) (2) (3) (4) (5)
i) Moisture, percent by mass, Max 5.00 – IS 11623 for reference purpose
IS 16072 for routine purpose
ii) Protein, percent by mass IS 11917
a) Total Protein including milk protein, (N × 6.25), 15.0 3.20
Min
b) Milk protein (N × 6.38), Min 5.0 1.00
iii) Fat, percent by mass Annex B
a) Total fat, including milk fat, Min 7.5 1.60
b) Milk fat1), Min 5.0 1.00
iv) Total carbohydrates, per cent by weight, Min 55.0 11.70 Annex C
v) Total ash, per cent by weight, Max 5.0 – Annex C of IS 14433
vi) Acid insoluble ash in dilute hydrochloric acid, per 0.10 – Annex D of IS 14433
cent by weight, Max

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IS 1656 : 2022

Table 2 ( Concluded )

Sl Characteristic Requirement per Requirements Method of Test, Ref to


No. 100 g per 100 kcal
(1) (2) (3) (4) (5)
vii) Vitamin A (as retinol equivalent RE), µg 350.00 - 823.00 75.00 - 175.00 IS 16639
viii) Vitamin C, mg 25.00 - 75.00 5.30 - 16.00 IS 5838 or IS 17176*
ix) Iron, mg 3.00 - 7.00 0.60 - 1.50 AOAC 985.35 or ISO 15151
or ISO 21424*
x) Crude fibre (on dry basis), percent by mass, Max 1.00 – IS 10226 (Part 1)
xi) Vitamin D, µg 5.00 - 14.00 1.00 - 3.00 IS 17177
xii) Thiamine, mg 0.20 - 0.50 0.04 - 0.10 IS 17669
xiii) Riboflavin mg 0.40 - 2.00 0.08 - 0.40 IS 17669
xiv) Niacin equivalent, mg 3.80 - 9.90 0.80 - 2.10 IS 17669
xv) Dietary Folate equivalent (DFE)2), μg 15.00 - 50.00 3.20 - 10.60 AOAC 2013.13
xvi) Zinc, mg 2.50 - 5.90 0.50 - 1.25 15 of IS 1699 or ISO 15151 or
ISO 21424*

NOTES:
1 In case of dispute, the method indicated by ‘*’shall be the referee method.
2 For the purpose of Type tests, all tests mentioned above are to be carried out and for the purpose of Routine tests, the tests given
from Sl. No. (i) to (ix) are to be carried out.
3 A variation of minus 10.0 per cent from the declared value of the nutrients or nutritional ingredients on the label shall be allowed.
The nutrient levels shall not exceed maximum limits as specified in Table 2.
—————————————
1)
 Since there is no reliable methods at present for the estimation of separate contents of milk fat and vegetable fat in the total fat, records of their
addition shall be maintained by the manufacturer. However, the product shall not have less than 7.5 percent total fat when tested as per Annex B.
2)
1 microgram DFE = 0.6 microgram folic acid.

Table 3 Microbiological Requirements for Milk-Cereal based Complementary Food


( Clause 4.8 )

Sl No. Characteristic Requirement Method of Test, Ref to

Sampling Plan Limit (cfu)


n c m M
(1) (2) (3) (4) (5) (6) (7)
(i) Aerobic plate count 5 2 1 × 103/g 1 × 104/g IS 5402 (Part 1)
(ii) Coliform count 10 0 < 10/g – IS 5401 (Part 1)
(iii) Staphylococcus aureus 5 0 < 10/g – IS 5887 (Part 8/Sec 1* or 2)
(Coagulase positive)
(iv) Yeast and mould count 5 0 < 10/g – IS 5403 or
IS 16069-2*
(v) Salmonella sp. 15 0 Absent/25 g – IS 5887 (Part 3/Sec 1)
(vi) Listeria monocytogenes 10 0 Absent/25 g – IS 14988 (Part 1)
(vii) Bacillus cereus 5 2 1 × 10 /g 2
5 × 10 /g 2
IS 5887 (Part 6)
(viii) Sulphite reducing clostridia 5 2 10/g 1 × 102/g ISO 15213
(ix) E. coli 10 0 Absent/g – IS 5887 (Part 1) or IS 16424*

NOTES:
1 For sampling plan, see Annex D.
2 In case of dispute, the method indicated by ‘*’ shall be the referee method.
3 The requirement for Salmonella shall be tested in a laboratory situated away from the production area.

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IS 1656 : 2022

4.10 The pesticide residues, antibiotic and veterinary 4.13.1.3 The product/packaging may also display in
drug residues, naturally occurring toxins and other brief the criteria based on which the product has been
contaminants, if any, in the raw materials used in labelled environment friendly.
the manufacture of the product shall not exceed the
limits as prescribed in the Food Safety and Standards 4.13.1.4 The material used for product packing shall be
(Contaminants, Toxins and Residues) Regulations, recyclable or biodegradable.
2011. 4.13.1.5 The product shall be microbiologically safe
4.11 Heavy metals and other contaminants or toxic when tested as per IS 5887 (Part 5) and should be free
substances (melamine), if any, in the product shall not from bacterial and fungal toxins.
exceed the limits specified in Table 4. 4.13.1.6 The product package or leaflet accompanying
Table 4 Limits of Heavy Metals and Other it may display instruction of proper use, storage
contaminants or Toxic Substances and transport (including refrigeration temperature
( Clause 4.11 ) compliance) so as to maximize the product performance,
safety and minimize wastage.
Sl Contaminant/Toxin Limit Method of
No. Test,Ref to
4.13.2 Specific Requirements
(1) (2) (3) (4) 4.13.2.1 The material used inside tile metal cap of the
i) Lead, ppm, Max 0.2 IS 12074 or product shall conform to the relevant Indian Standards
AOAC 2015.01* of food grade plastics as permitted under the Food
ii) Copper, ppm 2.8 to 15.0 15 of IS 1699 or
Safety and Standards Act, 2006 and the Rules and
Regulations made there under. Caps and closures shall
ISO 15151 or
not be treated as labels.
ISO 21424*
ii) Arsenic, ppm, Max 0.05 IS 11124 or 4.13.2.2 No synthetic food colour and artificial
AOAC 2015.01 sweetener shall be added or used in the product.
iii) Tin, ppm, Max 5.0 ISO 14377 4.13.2.3 The percentage of fruit juice/pulp, if any added
iv) Cadmium, ppm, Max 0.1 15 of IS 1699 or shall be mentioned on the product package.
AOAC 2015.01*
v) Melamine, ppm, Max 2.5 IS 16195 5 PACKING AND MARKING

NOTE — In case of dispute, the method indicated by ‘*’ 5.1 Packing
shall be the referee method.
5.1.1 The milk-cereal based complementary foods
4.12 Hygienic Conditions shall be packed in hermetically sealed, clean and
sound metal containers (see IS 11078) or in a flexible
The product shall be processed, packed, stored
pack so as to protect it from deterioration. In case
and distributed under strict hygienic conditions as
plastic material is used for flexible packaging, only
prescribed in IS 2491.
food grade plastic shall be used (see IS 10171). The
4.13 Optional Requirements for Eco-Mark packaging material used for product shall be free
from Bisphenol A (BPA).
4.13.1 General Requirements
5.1.2 The product shall be packed in quantities
4.13.1.1 The product shall conform to the requirements as stipulated under Legal Metrology (Packaged
prescribed under 4.1 to 4.12. Commodities) Rules, 2011 as well as in accordance
with requirements under the Food Safety and Standards
4.13.1.2 The manufacturers shall produce the consent
(Packaging) Regulations, 2018.
clearance as per the provisions of Water (PCP) Act,
1974, Water (PCP) Cess Act, 1977 and Air (PCP) Act, 5.2 Marking
1981 along with the authorization if required under
Environment (Protection) Act, 1986 and the Rules made 5.2.1 The containers shall bear legibly and indelibly
thereunder to the Bureau of Indian Standards, while with the following information:
applying for the ECO-Mark and the product shall also a) Name of the product, and brand name, if any;
be in accordance with the Food Safety and Standards
b) Name and address of the manufacturer;
Act, 2006 and the Rules made thereunder. Additionally,
the Legal Metrology (Packaged Commodities) Rules, c) Batch or lot or code number;
2011 have to be complied with. d) Month and year of manufacturing or packing;
e) Net quantity;

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f) Date before which the contents should be Regulations, 2020; Infant Milk Substitutes,
consumed be indicated by marking the words ‘Use Feeding Bottles and Infant Foods Act, 1992 and
by date/recommended last consumption date/ Rules 1993; and Legal Metrology (Packaged
Expiry date ……….(month and year)’; Commodities) Rules, 2011.
g) Directions for storage; 5.2.1.1 In case of flexible packs, a cautionary notice to
h) Composition — Indicating the approximate the following effect shall be printed on the container:
composition of nutrients per 100 g or per 100 ml ‘On opening, transfer the contents of the pack to a clean
of the product as well as the energy value in air tight container. After each use, replace the lid tightly
kilocalories or kilojoules; and store in a cool dry place.’
j) In case fish oil is used, it shall be mentioned on the
5.2.2 BIS Certification Marking
label;
k) Statement in bold letters: “IMPORTANT The product(s) conforming to the requirements of
NOTICE : MOTHER’S MILK IS BEST FOR this standard may be certified as per the conformity
YOUR BABY”; assessment schemes under the provisions of the Bureau
m) A statement that infant food shall be used only on of Indian Standards Act, 2016 and the Rules and
the advice of a health worker as to the need for its Regulations framed thereunder, and the products may
use and the proper method of its use; be marked with the Standard Mark.
n) A warning that infant food is not the sole source of 5.2.3 ECO-Mark
nourishment of an infant;
p) A statement indicating instruction for appropriate The Product may also be marked with the ECO-Mark,
and hygienic preparation including cleaning of the details of which may be obtained from the Bureau
utensils, bottles and teats and warning against of Indian Standards.
health hazards of inappropriate preparations; 6 SAMPLING
q) Feed chart and directions for use;
Representative samples of the material shall be drawn
r) Instructions for discarding leftover feed;
and tested for conformity to this standard as prescribed
s) Instructions for use of measuring scoop (level or in Annex F of IS 14433.
heaped) and the quantity per scoop (scoop to be NOTE — The crude fibre content [Table 2, SI No. (x)] shall be
given with pack); and tested on the composite sample.
t) Any other requirements as stipulated under Food
Safety and Standards (Labelling and Display)

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ANNEX A
( Clause 2 )

LIST OF REFERRED STANDARDS

IS No. Title IS No. Title

1070 : 1992 Reagent grade water — (Part 6) : 2012/ Horizontal method for
Specification (third ISO 7932 : 2004 the enumeration of
revision) presumptive Bacillus
cereus — Colony count
1699 : 1995 Methods of sampling technique at 30°C (first
and test for food colours revision)
(second revision)
(Part 8/ Sec 1) : 2002/ Horizontal method for
2491 : 2013 Food hygiene — General ISO 6888-1:1999 enumeration of coagulase-
principles — Code of positive Staphylococci
practice (third revision) (Staphylococcus aureus
5401 (Part 1) : 2012/ Microbiology of food and and other species),
ISO 4832 : 2006 animal feeding stuffs — Section 1 Technique using
Horizontal method for the Baird-Parker agar medium
detection and enumeration (Part 8/ Sec 2) : 2002/ Horizontal method for
of coliforms: Part 1 Colony ISO 6888-2 : 1999 enumeration of coagulase-
count technique (second positive Staphylococci
revision) (Staphylococcus aureus
5402 (Part 1) : 2021 Microbiology of the and other species),
food chain — Horizontal Section 2 Technique using
method for the enumeration rabbit plasma fibrinogen
of microorganisms: Part 1 agar medium
Colony count at 30 C by 7481 : 1974 Method for determination
the pour plate technique of protein efficiency ratio
5403 : 1999 Method for yeast and (PER)
mould count of foodstuffs 10171 : 1999 Guide on suitability of
and animal feeds (first plastics for food packaging
revision) (second revision)
5838 : 1970 Methods for estimation of 10226 (Part 1) : 1982/ Method for determination
vitamin C in foodstuffs ISO 5498 : 1981 of crude fibre content
5887 Methods for detection of in food products: Part 1
bacteria responsible for General method
food poisoning 10641 : 1983 Recommended methods
(Part 1) : 1976 Isolation, identification for determination of aroma
and enumeration of and taste thresholds
Escherichia coli (first 11078 : 2012 Round open top sanitary
revision) cans for milk powder —
(Part 3/Sec 1) : 2020/ Horizontal method for the Specification (second
ISO 6579-1 : 2017 detection, enumeration and revision)
serotyping of Salmonella, 11124 : 1984 Method for
Section 1 Detection of atomic absorption
Salmonella spp. (third spectrophotometric deter­
revision) mination of arsenic
(Part 5) : 1976 Isolation, identification 11623 : 2008/ Dried milk —
and enumeration of Vibrio ISO 5537 : 2004 Determination of moisture
cholerae and Vibrio content (Reference
parahaemolyticus (first Method) (first revision)
revision)

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IS No. Title IS No. Title


11721 : 2013/ Dried milk and dried milk 14988 (Part 1) : 2020/ Microbiology of the
ISO 1736 : 2008 products — Determination ISO 11290-1: 2017 food chain — Horizontal
of fat content — method for detection and
Gravimetric method enumeration of Listeria
(Reference method) monocytogenes and of
(second revision) Listeria spp.: Part 1
11763 : 2011/ Cheese and processed Detection method (first
ISO 5943 : 2006 cheese products — revision)
Determination of chloride 15303 : 2003 Determination of antimony,
content — Potentiometric iron and selenium in water
titration method (third by electrothermal atomic
revision) absorption spectrometric
11917 : 2018/ Milk and milk products — method
ISO 8968-1 : 2014 Determination of nitrogen 16069 (Part 2) : 2013/ Microbiology of food and
content — Kjeldahl ISO 21527-2 : 2008 animal feeding stuffs —
principle and crude Horizontal method for the
protein calculation (first enumeration of yeasts and
revision) moulds: Part 2 Colony
12074 : 1987 Method for determination count technique in products
of lead by atomic with water activity less
absorption spectro­ than or equal to 0.95
photometer 16072 : 2012 Determination of moisture
12756 : 2019/ Cheese and processed content in milk powder and
ISO 2962:2010 cheese products — similar products (Routine
Determination of total method)
phosphorus content — 16195 : 2014/ Milk, milk products
Molecular absorption ISO/TS 15495 : 2010 and infant formulae —
spectrometric method (first Guidelines for the
revision) quantitative determination
12759 : 2019/ Dried milk and dried milk of melamine and cyanuric
ISO 8156 : 2005 products — Determination acid by LC-MS/MS
of insolubility index (first 16424 : 2016/ Microbiology of food and
revision) ISO 7251 : 2005 animal feeding stuffs —
12760 : 2012/ Milk and milk products — Horizontal method for the
ISO 8070 : 2007 Determination of calcium, detection and enumeration
sodium, potassium and of presumptive Escherichia
magnesium contents — coli — Most probable
Atomic absorption number technique
spectrometric method (first 16639 : 2018/ Infant formula and
revision) ISO 20633 : 2015 adult nutritionals —
13500 : 1992 Spray dried milk powders Determination of vitamin E
scorched particles — and vitamin A by normal
Determination phase high performance
liquid chromatography
13688 : 2020 Packaged pasteurized
milk — Specification 16640 : 2018/ Infant formula and
(second revision) ISO 20634 : 2015 adult nutritionals —
Determination of vitamin
14433 : 2022 Infant milk substitutes — B12 by reversed phase
Specification (second high performance liquid
revision) chromatography (RP-
HPLC)

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IS No. Title IS No. Title


16642 : 2018/ Infant formula and 17670 : 2021/ Fortified milk powders,
ISO 20639 : 2015 adult nutritionals — ISO 23305 : 2020 infant formula and
Determination of adult nutritionals —
pantothenic acid by ultra Determination of
high performance liquid total biotin by liquid
chromatography and chromatography coupled
tandem mass spectrometry with immunoaffinity
method (UHPLC-MS/MS) column clean-up extraction
16649 : 2018/ Infant formula and IS/ISO 21446 : 2019 Infant formula and
ISO 20637 : 2015 adult nutritionals — adult nutritionals —
Determination of Myo — Determination of trans and
Inositol by liquid total cis trans Vitamin K1
chromatography and content — Normal phase
pulsed amperometry HPLC
17176 : 2019/ Infant formula and ISO 14377 : 2002 Canned evaporated milk
ISO 20635 : 2018 adult nutritionals — — Determination of tin
Determination of content — Method using
vitamin C by (Ultra) graphite furnace atomic
high performance liquid absorption spectrometry
chromatography with ISO 15151 : 2018 Milk, milk products,
ultraviolet detection ((U) infant formula and
HPLC-UV) adult nutritionals —
17177 : 2019/ Infant formula and Determination of minerals
ISO 20636 : 2018 adult nutritionals — and trace elements —
Determination of Inductively coupled
vitamin D by liquid plasma atomic emission
chromatography mass spectrometry (ICP-AES)
spectrometry method
17379 : 2020/ Infant formula and ISO 15213 : 2003 Microbiology of food and
ISO 20647 : 2015 adult nutritionals — animal feeding stuffs —
Determination of total Horizontal method for the
iodine - Inductively enumeration of sulfite-
coupled plasma mass reducing bacteria growing
spectrometry (ICP-MS) under anaerobic conditions
17668 : 2021/ Infant formula and ISO 20649 : 2015 Infant formula and
ISO 21468 : 2020 adult nutritionals — adult nutritionals —
Determination of free and Determination of
total choline and free and chromium, selenium
total carnitine — Liquid and molybdenum —
chromatography tandem Inductively coupled
mass spectrometry (HPLC- plasma mass spectrometry
MSMS) (ICP-MS)
17669 : 2021/ Infant formula and ISO 21424 : 2018 Milk, milk products,
ISO 21470 : 2020 adult nutritionals — infant formula and
Simultaneous determina­ adult nutritionals —
tion of total vitamins B1, Determination of minerals
B2, B3 and B6 Enzymatic and trace elements —
digestion and LC-MSMS Inductively coupled
plasma mass spectrometry
(ICP-MS) method

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ANNEX B
[ Table 2, SI No. (iii) ]

DETERMINATION OF FAT

B-1 APPARATUS the sample into the flask, add approximately 0.5 g
diastase or amylase. Then add 8 to 10 ml distilled water
As prescribed in 6 of IS 11721.
(see IS 1070) at 45°C to facilitate suspension.
B-2 REAGENTS B-3.2 Place the stoppered extraction flask in the
As prescribed in 5 of IS 11721 and the reagents given water-bath for 2 hours, shaking it from time to time
in B-2.1 and B-2.2. taking care that the product does not stick to the
walls of the flask. Check if the starch is digested. Add
B-2.1 Iodine Solution, 0.1 N. 2 drops of iodine solution. No blue colouration should
appear. If required, place the flask again in water-bath
B-2.2 Diastase or Amylase till the digestion of the starch is complete. Proceed
further as prescribed in 9.2 to 10.1 of IS 11721,
B-3 PROCEDURE
excluding 9.4.1.
B-3.1 Weigh accurately about 1 g of the sample in
a Mojonnier fat extraction flask. After introducing

ANNEX C
[ Table 2, SI No. (iv) ]

DETERMINATION OF TOTAL CARBOHYDRATES

C-1 Total carbohydrates are calculated as follows, after where


determining the percentage of moisture, total protein, A= percent by mass of moisture;
fat and total ash:
B= percent by mass of total protein;
Total carbohydrates, including sucrose, dextrose and
C= percent by mass of fat; and
dextrins, maltose or lactose, percent by mass =
D= Total ash, percent by mass.
100 – (A + B + C + D)

ANNEX D
[ Table 3 ]

SAMPLING PLAN FOR MICROBIOLOGICAL REQUIREMENTS

D-1 SAMPLING PLAN FOR m = Microbiological limit that separates


MICROBIOLOGICAL REQUIREMENTS unsatisfactory from satisfactory in a 2-class
sampling plan or acceptable from satisfactory
The terms n, c, m and M used in this standard have the
in a 3-class sampling plan; and
following meaning:
M = Microbiological limit that separates
n = Number of units comprising a sample; unsatisfactory from satisfactory in a 3-class
c = Maximum allowable number of units having sampling plan.
microbiological counts above m for 2-class
sampling plan and between m and M for
3-class sampling plan;

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D-2 INTERPRETATION OF RESULTS

2-Class Sampling Plan (where n, c and m are 3-Class Sampling Plan (where n, c, m and M are
specified) specified)
1. Satisfactory, if all the values observed are < m 1. Satisfactory, if all the values observed are < m
2. Unsatisfactory, if one or more of the values observed 2. Acceptable, if a maximum of c values are between
are > m or more than c values are > m m and M and the rest of the values are observed as < m
3. Unsatisfactory, if one or more of the values observed
are > M or more than c values are > m

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ANNEX E
( Foreword )

COMMITTEE COMPOSITION
Dairy Products and Equipment Sectional Committee, FAD 19

Organization Representative(s)

National Dairy Research Institute, Karnal Dr Manmohan Singh Chauhan (Chairman)


All India Food Processors Association, New Delhi Dr K. L. Gaba
Mr Vijay Gaur (Alternate)
Bihar State Cooperative Milk Producers’ Federation Mr Sushil Kumar
Ltd, (COMPFED), Patna Mr Rupesh Raj (Alternate)
Confederation of Indian Food Trade and Industry, Ms Varsha Yadav
New Delhi Dr Anirudha Chhonkar (Alternate)
Confederation of Indian Industry, New Delhi Ms Neha Aggarwal
Ms Arti Gupta (Alternate)
Centre for Analysis and Learning in Livestock and Dr Rajesh Nair
Food (CALF), Anand Dr Rajeev Chawla (Alternate)
Directorate of Marketing and Inspection, Faridabad Dr D. M. Govind Reddy
Shri Rahul Singh (Alternate)
Export Inspection Council of India, New Delhi Dr J. S. Reddy
Mr Kumar Narender (Alternate)
Envirocare Labs Pvt Ltd, Thane Dr Nilesh Amritkar
Dr Priti Amritkar (Alternate)
Food Safety and Standards Authority of India, Dr Monica Puniya
New Delhi Ms Tripti Tayal (Alternate)
Gujarat Cooperative Milk Marketing Federation Ltd, Mr Sameer Saxena
Anand Mr Sayan Banerjee (Alternate)
IDMC Ltd, Anand Mr Devender Gupta
Mr Prakash Maheshwari (Alternate)
Indian Dairy Association, New Delhi Dr G. S. Rajorhia
Dr Satish Kulkarni (Alternate)
Indian Stainless Steel Development Association, Mr Rohit Kumar
Gurugram Mr Rajat Aggarwal (Alternate)
Jupitor Glass Works, New Delhi Mr Karan Nangia
Mr Amreek Singh Puri (Alternate)
Ministry of Fisheries, Animal Husbandry and Shri Goutam Kumar Deb
Dairying, Department of Animal Husbandry Shri Ajit Kumar K. (Alternate)
and Dairying, New Delhi
Mother Dairy Fruit and Vegetable Ltd, Delhi Ms Nita Sen
Mr Shailender Kumar (Alternate)
National Dairy Development Board, Anand Mr S. D. Jaisinghani
Mr Suresh Pahadia (Alternate)
National Dairy Research Institute, Karnal Dr Vivek Sharma
Dr Rajesh Kumar Bajaj (Alternate)
National Institute of Food Technology Dr P. K. Nema
Entrepreneurship and Management (NIFTEM),
Sonipat

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Organization Representative(s)

National Institute of Nutrition, Hyderabad Dr B. Santosh Kumar


Dr Sylvia Fernandez Rao (Alternate)
Punjab State Coop Milk Producers’ Federation Dr Sanjeev Kumar Sharma
Limited
Rajasthan Co-op Dairy Federation (RCDF) Ltd, Mr J. D. Singh
Jaipur
Tamil Nadu Co-op Milk Producers’ Federation Mr S. R. Sankar
Limited, Chennai Mr S. Jeyachandran (Alternate)
Tetra Pak India Pvt Ltd, Pune Mr Shashikant Ramnath Suruse
Mr Sameer Singh Suhail (Alternate)
Vimta Labs Limited, Hyderabad Dr Jagadeesh Kodali
Dr Muni Nagendra Prasad Poola (Alternate)
BIS Directorate General Shrimati Suneeti Toteja, Scientist ‘E’ and Head (FAD)
[Representing Director General ( Ex-officio ) ]

Member Secretary
Dr Bhawana
Scientist ‘D’ (FAD), BIS

Panel for Revision of Indian Standards on Infant Foods, FAD 19-FAD 24 Joint Panel 10

Organization Representative(s)

National Dairy Research Institute, Karnal Dr A. K. Singh (Convenor)


Abbott India Ltd, Mumbai Ms Arti G. Shankar
Central Institute of Agricultural Engineering, Bhopal Dr Manoj Tripathi
Danone India Limited, Delhi Mr Vijay Gaur
Food Safety and Standards Authority of India, Mr Sunil Bakshi
New Delhi
Gujarat Cooperative Milk Marketing Federation Mr Sameer Saxena
Ltd, Anand
National Dairy Research Institute, Karnal Dr Naresh Goyal
National Institute of Nutrition, Hyderabad Dr B. Santosh Kumar
National Institute of Technology, Rourkela Dr Mohd Khalid Gul
Nestle India Limited, Gurugram Dr Anirudha Chhonkar

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(Continued from second cover)

In the formulation of this standard, due consideration has been given to the provisions of the Food Safety and
Standards Act, 2006 and the Rules and Regulations framed thereunder; Infant Milk Substitutes, Feeding Bottles
and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 and Rules 1993 and the Legal
Metrology (Packaged Commodities) Rules, 2011. However, this standard is subject to the restrictions imposed
under these, wherever applicable.
The composition of the Committee responsible for formulation of the standard is given in Annex E.
For the purpose of deciding whether a particular requirement of this standard is complied with the final value,
observed or calculated, expressing the result of a test or analysis shall be rounded off in accordance with
IS 2 : 2022 ‘Rules for rounding off numerical values ( second revision )’. The number of significant places retained
in the rounded off value should be the same as that of the specified value in this standard.
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Bureau of Indian Standards

BIS is a statutory institution established under the Bureau of Indian Standards Act, 2016 to promote harmonious
development of the activities of standardization, marking and quality certification of goods and attending to
connected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of these publications may be reproduced in any form without
the prior permission in writing of BIS. This does not preclude the free use, in the course of implementing the
standard, of necessary details, such as symbols and sizes, type or grade designations. Enquiries relating to
copyright be addressed to the Head (Publication & Sales), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are also reviewed
periodically; a standard along with amendments is reaffirmed when such review indicates that no changes are
needed; if the review indicates that changes are needed, it is taken up for revision. Users of Indian Standards
should ascertain that they are in possession of the latest amendments or edition by referring to the website-
www.bis.gov.in or www.standardsbis.in.
This Indian Standard has been developed from Doc No.: FAD 19 (18815).

Amendments Issued Since Publication


Amend No. Date of Issue Text Affected

BUREAU OF INDIAN STANDARDS


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Published by BIS, New Delhi

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