-
Sections
-
Regulation - 1. Short title and commencement.
-
Regulation - 2. Definitions.
-
Regulation - 3. General requirements.
-
Regulation - 4. Labelling.
-
Regulation - 5. Food Additives.
-
Regulation - 6. Hygiene.
-
Regulation - 7. Infant formula.
-
Regulation - 8. Milk cereal based complementary Food.
-
Regulation - 9. Processed cereal based complementary Food.
-
Regulation - 10. Follow-up Formula.
-
Regulation - 11. Food for Infants based on traditional food ingredients.
-
Regulation - 12. Food for special medical purpose intended for infants.
-
Regulation - 13. Preterm infant milk substitute.
-
Regulation - 14. Lactose free infant milk substitutes.
-
Regulation - 15. Hypoallergenic infant milk substitutes.
-
Regulation - 16. Foods for Infants with Inborn Errors of Metabolism (IEM).
FOOD
SAFETY AND STANDARDS (FOODS FOR INFANT NUTRITION) REGULATIONS, 2020
PREAMBLE
Whereas the draft of
the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2019
were published as required by section 92 of the Food Safety and
Standards Act, 2006 (34 of 2006), vide notification of the Food Safety and
Standards Authority of India number F. No. Stds/03/Notification
(IFR)/FSSAI-2017, dated the 1st May, 2019, in the Gazette of India,
Extraordinary, Part III, Section 4, inviting objections and suggestions from
the persons likely to be affected thereby, before the expiry of the period of
thirty days from the date on which the copies of the Official Gazette
containing the said notification were made available to the public;
And whereas, the
copies of the said Gazette were made available to the public on the 14th May,
2019;
And whereas the
objections and suggestions received from the public in respect of the said
draft regulations have been considered by the Food Safety and Standards
Authority of India;
Now, therefore, in
exercise of the powers conferred by clause (e) of sub-section (2) of
section 92 of the said Act and in supersession of the sub-regulation
2.1.19 of regulation 2.0 of Food Safety and Standards (Food Products Standards
and Food Additives) Regulations, 2011, except as respects things done or
omitted to be done before such supersession, the Food Safety and Standards
Authority of India hereby makes the following regulations, namely:
CHAPTER 1 PRELIMINARY
Regulation - 1. Short title and commencement.
(1) These regulations may
be called the Food Safety and Standards (Foods for Infant Nutrition)
Regulations, 2020.
(2) They shall come into
force on the date of their publication in the Official Gazette and Food
Business Operator shall comply with all the provisions of these regulations by
1st July, 2021.
Regulation - 2. Definitions.
(1) In these regulations,
unless the context otherwise requires,
(a) "Act" means
the Food Safety and Standards Act, 2006 (34 of 2006);
(b) "Food
Authority" means the Food Safety and Standards Authority of India
established under section 4 of the Act;
(c) "Food for infants
based on traditional food ingredients" are products known to be prepared
traditionally at home for feeding infants, but processed and provided in
packaged forms, after six months up to twenty-four months of age;
(d) "Food for
special medical purpose intended for infants" means a substitute for human
milk or formula that is specially manufactured to meet the special nutritional
requirements of infants from birth to twenty-four months with specific
disorders, diseases or medical conditions;
(e) "Follow-up formula"
means a food for infants after six months up to twenty four months of age,
which is intended for use as a liquid part of the complementary diet for
infants when prepared in accordance with instructions for use;
(f) "Infant
Food" shall have the meaning assigned to it in clause (x) of sub-section
(1) of Section 3 of the Act;
(g) "Infant Milk
substitute" shall have the meaning assigned to it in clause (x) of
sub-section (1) of Section 3 of the Act;
(h) "Infant
formula" means a breast milk substitute product based on milk of cow or
buffalo or other milch animals as specified under the Food Safety and Standards
(Food Products Standards and Food Additives) Regulations, 2011 or mixture
thereof and other ingredients which have been proven to be suitable for infant feeding,
to meet the nutritional requirements of infant during the first six months;
(i) "Milk cereal
based complementary food" means the food for infants after 6 months up to
24 months of age, which is based on milk, cereals and/or legumes (pulses),
millets, nuts and protein concentrates or protein isolates and/or defatted
edible oilseed extracts and so prepared as to permit dilution with water or
milk or other suitable medium;
(j) "Processed
cereal based complementary food" means food for infants after 6 months up
to 24 months of age, which is based on cereals and legumes (pulses), millets,
nuts and protein isolates or protein concentrates or de-fatted edible oil seed
extracts and so prepared as to permit dilution with water or milk or other
suitable medium;
(k) "Schedules"
means the Schedules to these regulations.
(2) Words and expression
used herein and not defined in these regulations shall have the same meaning as
assigned to them in the Act.
Regulation - 3. General requirements.
(1) An article of infant
milk substitutes or infant foods or food for special medical purpose intended
for infants, whose standards are not specified under these regulations shall be
manufactured for sale, exhibited for sale or stored for sale only after
obtaining approval of such article of food and its label from the Food
Authority.
(2) Foods for infant
nutrition shall be packed in hermetically sealed, clean and sound containers or
in flexible pack made from paper, polymer and/or metallic film as per the Food
Safety and Standards (Packaging) Regulations, 2018, so as to protect the
contents from deterioration. It shall be packed under inert atmosphere. The
packaging material used for products covered under these regulations shall be
free from Bisphenol A (BPA).
(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 the composition tables.
(4) Wherever applicable,
food for infant nutrition shall use the source compounds for minerals, vitamins
and other nutrients from Schedule-I(a), Schedule-I(b) and Schedule-I(c),
respectively provided under these regulations.
(5) Foods for infant
nutrition may contain algal and fungal oil as sources of Docosahexaenoic Acid
(DHA) and Arachidonic acid (ARA) from Crypthecodiniumcohnii, Mortierellaalpina,
Schizochytrium sp., and Ulkenia sp. or fish oil at the level of maximum 0.5 per
cent. DHA of total fatty acids and ratio of ARA: DHA as 1:1 minimum.
Provided that DHA
content shall not be less than 0.2 per cent of total fatty acids, if a claim
related to the addition of DHA is made.
Provided further that
Infant Milk substitutes for preterm infants shall comply with requirements
specified under the standards.
(6) Lactose and glucose
polymers shall be the preferred carbohydrates for food for infant nutrition.
Sucrose and/or fructose shall not be added, unless needed as a carbohydrate
source, and provided the sum of these does not exceed 20 per cent of total
carbohydrate.
(7) Food for infant
nutrition shall be free from lumps and coarse particles, and shall be uniform
in appearance. It shall be free from rancid taste and musty odour.
Provided that milk
cereal based complementary food and processed cereal based complementary food
may be in the form of small granules and flakes forms.
(8) Food for infant
nutrition shall comply with the requirements of the Infant Milk Substitutes,
Feeding Bottles and Infant Foods (Regulation of Production, Supply and
Distribution) Act, 1992(42 of 1992) as amended in 2003 including aspect related
to advertisement, marketing and promotion of Food products covered under these
regulations in accordance with the section 3, 4, 5, 7, 8, 9 and 10 of
the said Act.
(9) Food for infant
nutrition shall comply with the requirements of the Legal Metrology (Packaged
Commodities) Rules, 2011 except for the requirement of standard pack size as
per the second schedule of the aforesaid rules in case of food for special
medical purpose intended for infants.
(10) Food for infant
nutrition shall conform to the Food Safety and Standards (Contaminants, Toxins
and Residues) Regulations, 2011.
(11) Food for infant
nutrition shall conform to the Food Safety and Standards (Prohibition and
Restriction of Sales) Regulation, 2011.
(12) Food for infant
nutrition shall conform to the microbiological requirements specified under
Appendix B of Food Safety and Standards (Food Products Standards and Food
Additives) Regulations, 2011.
(13) Advertisements and
claims of products covered under these regulations shall be in accordance with
the Food Safety and standards (Advertising and Claims) Regulations, 2018.
(14) Wherever nutritional
composition has been specified in 100 gm or 100 kcal basis under specific
product categories in the composition tables, the FBO's shall comply with the
nutrition composition in either per 100 gm or per 100 kcal basis.
Regulation - 4. Labelling.
The labelling of the
food for infant nutrition shall be in accordance with the [1][Food
Safety and Standards (Labelling and Display) Regulations, 2020], and the
specific labelling requirements provided under these regulations.
(1) Without prejudice to
any other provisions relating to labelling requirements contained in these
regulations, every container of products covered under these regulations or any
label affixed thereto shall indicate in a clear, conspicuous and in an easily
readable manner, the words "IMPORTANT NOTICE" in capital letters and
indicating thereunder the following particulars, namely:
(a) a statement
"MOTHER'S MILK IS BEST FOR YOUR BABY" in capital letters. The types
of letters used shall not be less than five millimetres and the text of such
statement shall be in the front of the pack of every container of food for
infant nutrition or any label affixed thereto. The colour of the text printed
or used shall be different from that of the background of the label, container
as the case maybe. In case of infant food, a statement indicating "Infant
food shall be introduced only after the age of six months and up to the age of
two years" shall also be given.
Provided that in case
of food for special medical purpose intended for infants where breastfeeding is
contraindicated on medical grounds for the disease(s), disorders(s) or medical
condition(s) for which the product is intended, the labelling provision
"MOTHERS' MILK IS BEST FOR YOUR BABY" shall not be required.
(b) a statement that
infant milk substitute or infant food shall be used only on the advice of a
health worker as to the need for its use and the proper method of its use;
(c) a warning that Infant
milk substitute or infant food is not the sole source of nourishment of an
infant;
(d) a statement
indicating instruction for appropriate and hygienic preparation including cleaning
of utensils, bottles and teats and warning against health hazards of
inappropriate preparations, as under;
Warning/Caution-Careful
and hygienic preparation of infant foods or infant milk substitute is most
essential for health. Do not use fewer scoops than directed since diluted
feeding will not provide adequate nutrients needed by your infant. Do not use
more scoops than directed since concentrated feed will not provide the water
needed by your infant.
(e) the approximate
composition of nutrients per 100 gm or 100 ml of the product including its
energy value in kilo calories or kilo joules;
(f) the storage condition
specifically stating "Store in a cool and dry place in an air tight
container" or the like (after opening use the contents within the period mentioned
or the expiry date whichever is earlier);
(g) the feeding chart and
directions for use and instruction for discarding leftover feed;
(h) instruction for use
of measuring scoop (level or heaped) and the quantity per scoop (scoop to be
given with pack);
(i) indicating the Batch
number, Month and Year of its manufacture, Use by date or Recommended Last
Consumption date or Expiry Date;
(j) the protein
efficiency ratio (PER) which shall be minimum 2.5, if the product other than
infant milk substitute is claimed to have higher quality protein;
(k) the specific name of
the food additives and appropriate class titles, if permitted, shall also be
declared;
(2) No containers or
label of food for infant nutrition shall have a picture of infant or women or
both. It shall not have picture or other graphic materials or phrases designed
to increase the sale ability or the infant milk substitute or infant food. The
terms "Humanised" or "Maternalised" or any other similar
words shall not be used. The package and/or any other label of infant milk
substitute or infant food shall not exhibit the words, "Full Protein
Food", "Energy Food", "Completer Food" or "Health
Food" or any other similar expression.
(3) The product which
contains neither milk nor any milk derivatives shall be labelled "Contains
no milk or milk products or milk derivatives" in conspicuous manner.
(4) Declaration to be
surrounded by line: There shall be a surrounding line enclosing the declaration
where the words "unsuitable for babies" are required to be used. The
distance between any part of the word "unsuitable for babies"
surrounding the line enclosing these words shall not be less than 1.5 mm.
(5) A warning relating to
allergen if any ingredients with known allergenicity are present;
(6) A warning against
inherent contamination as under:
"Warning: Boiled
and cooled water shall be used to prepare this product and any leftover product
must be discarded to reduce the risk of infection".
Regulation - 5. Food Additives.
(1) Food for infant
nutrition shall be free from preservatives, added colours and flavours.
(2) Only the food
additives listed under these regulations shall be used in the foods covered
under these regulations. The articles of food may contain carry over food
additives subject to compliance with the provisions specified under 3.1.1 (10)
of Food Safety and standards (Food products Standards and Food Additives)
Regulations, 2011.
Regulation - 6. Hygiene.
The product covered
under these regulations shall be prepared and handled in accordance with the
requirement specified in Schedule-IV of the Food Safety and Standards
(Licensing and Registration of Food Businesses) Regulations, 2011 and Code of
Hygienic Practice for Powdered Formulae for Infants and Young Children (CAC/RCP
66-2008) specified by Codex Alimentarius Commission.
CHAPTER 2 INFANT MILK
SUBSTITUTE
Regulation - 7. Infant formula.
This standard applies
to infant formula in liquid or powdered form intended for use, where necessary,
as a substitute for human milk in meeting the normal nutritional requirements
of infants during the first six months.
(1) Composition:
(a) Infant formula is a
product based on milk of cow or buffalo or other milch animals as defined under
the Food Safety and Standards (Food Products Standards and Food Additives)
Regulations, 2011 or mixture thereof, and other nutrients and ingredients which
have been provided under these regulations.
(b) The product may be
modified by partial removal or substitution of different milk solids and
addition of carbohydrates; and salts such as phosphates and citrates. Only
precooked and/or gelatinised starches gluten-free by nature may be added to
infant formula up to 30 per cent of total carbohydrates and up to 2 gm/100ml.
(c) The infant formula
may contain vegetable oils rich in polyunsaturated fatty acids to partially
substitute milk fat. It may contain medium chain triglycerides. Hydrogenated
vegetable oils and fats shall not be used in infant formula.
(d) The infant formula
may contain fructo-oligosaccharides and/or galacto-oligosaccharides. In either
case, their content shall not exceed 0.8 gm/100ml. When used in combination the
percentage ratio shall be 90:10 of galacto-oligosaccharides and
fructo-oligosaccharides, respectively.
(e) Infant formula may
contain L(+) lactic acid producing bacteria with prior approval of the Food
Authority.
(f) Infant formula ready
for consumption in accordance with instructions of the manufacturer shall
contain not less than 60 kcal and not more than 70kcal of energy per 100 ml.
(g) The infant formula
shall also conform to the following requirements, namely:-
|
Sl. No. |
Parameters |
Requirements per 100g |
Requirements per 100 kcal |
|
1. |
Moisture, per cent by weight, Max |
4.50 |
- |
|
2. |
Total Protein (N x 6.25[2])
per cent by weight |
10.00-16.00 |
2.10-3.40 |
|
3. |
Total fat, including milk fat[3],
g Milk fat, g, Min |
18.00-25.00 12.00 |
3.80-5.30 2.50 |
|
4. |
a) Linoleic acid, mg b) α-Linolenic acid, mg, Min c) Ratio of Linoleic acid/α-Linolenic
acid, Min. |
1500.00-7000.00 250.00 6:1 |
300.00-1500.00 50.00 6:1 |
|
5. |
Carbohydrates, per cent by weight |
45.00-70.00 |
9.60-14.90 |
|
6. |
Total ash, percent by weight, Max |
8.50 |
- |
|
7. |
Ash insoluble in dilute hydrochloric
acid, per cent by weight, Max |
0.10 |
- |
|
8. |
Vitamin A (as retinol equivalent,
RE), μg |
350.00-823.00 |
75.00-175.00 |
|
9. |
Vitamin D, μg |
5.00-14.00 |
1.00-3.00 |
|
10. |
Vitamin E (as alpha tocopherol
equivalent), mg |
2.50-6.00 |
0.50-1.30 |
|
11. |
Vitamin K, μg |
7.50-19.00 |
1.60-4.00 |
|
12. |
Vitamin C, mg |
25.00-75.00 |
5.30-16.00 |
|
13. |
Thiamine, μg |
200.00-517.00 |
42.50-110.00 |
|
14. |
Riboflavin, μg |
400.00-2000.00 |
85.10-425.50 |
|
15. |
Niacin equivalent, mg |
3.80-9.90 |
0.80-2.10 |
|
16. |
Pyridoxine, μg |
100.00-400.00 |
21.30-85.10 |
|
17. |
Dietary Folate equivalent (DFE)[4],
μg |
15.00-56.90 |
3.20-12.10 |
|
18. |
Pantothenic acid, mg |
2.00-10.00 |
0.42-2.12 |
|
[5][19. |
Vitamin B12, μg |
0.25-4.0 |
0.05-0.90] |
|
20. |
Biotin, μg |
7.50-50.00 |
1.60-10.60 |
|
21. |
Choline, mg, Min |
32.00 |
6.80 |
|
22. |
Sodium, mg |
90.00-300.00 |
19.15-63.80 |
|
23. |
Potassium, mg |
300.00-900.00 |
63.82-191.48 |
|
24. |
Chloride, mg |
250.00-800.00 |
53.20-170.20 |
|
25. |
Calcium, mg |
250.00-700.00 |
53.20-148.90 |
|
26. |
Phosphorous, mg |
125.00-500.00 |
26.60-106.40 |
|
27. |
Calcium: Phosphorus ratio |
1:1-2:1 |
1:1-2:1 |
|
28. |
Magnesium, mg |
30.00-75.20 |
6.40-16.00 |
|
29. |
Iron, mg |
3.00-7.00 |
0.60-1.50 |
|
30. |
Iodine, μg |
90.00-225.60 |
19.15-48.00 |
|
31. |
Copper, μg |
160.00-470.00 |
34.00-100.00 |
|
32. |
Zinc, mg |
2.50-5.90 |
0.50-1.25 |
|
33. |
Manganese, μg |
5.00-500.00 |
1.00-106.40 |
|
34. |
Selenium, μg |
5.00-17.00 |
1.00-3.60 |
(h) Optional Ingredients:
when prepared in accordance with instructions for use infant formula may
contain other nutrients which are ordinarily found in human milk in amounts
prescribed below:
|
Sl. No. |
Nutrients |
Requirements per 100 ml of the
product ready for consumption |
|
1. |
Carotenes, mg, Min |
0.025 |
|
2. |
Amino acids (L forms), mg, Min |
0.90 |
|
3. |
Non-protein nitrogen, mg, Min |
17.00 |
|
4. |
Nucleotides, mg, Min |
1.17 |
|
5. |
L-carnitine, mg, Min |
0.72 |
|
6. |
Lactalbumin, mg, Min |
140.00 |
|
7. |
Lactoferrin, mg, Min |
27.00 |
|
8. |
Lysozyme, mg, Min |
80.00 |
|
9. |
Glucosamine, mg, Min |
70.00 |
|
10. |
Inositol, mg, Min |
2.70 |
|
11. |
Citric acid, mg, Min |
35.00 |
|
12. |
Cholesterol, mg, Min |
8.80 |
|
13. |
Fucose, mg, Min |
130.00 |
|
14. |
Lipid phosphorous, mg, Min |
0.70 |
|
15. |
Prostaglandins, mg, Min |
PGE 15.00 PGF 40.00 |
|
16. |
Taurine, mg, Max |
8.40 |
|
17. |
Molybdenum, μg |
0.90-6.50 |
|
18. |
Chromium, μg |
0.90-6.50 |
(2) Food additives:
(a) The following food
additives may be used in the preparation of infant formula ready for
consumption prepared following manufacturer's instructions, unless otherwise indicated:
|
Food Additive |
INS No. |
Recommended maximum level per 100 ml
of the product ready for consumption |
|
Thickeners |
||
|
Guar gum |
412 |
0.1 gm in liquid formulas containing
hydrolysed protein |
|
Carob bean gum (Locust bean gum) |
410 |
0.1 gm in all types of infant formula |
|
Distarch phosphate |
1412 |
0.5 gm singly or in combination in
soy based infant formula only 2.5 gm singly or in combination in
hydrolysed protein and/or amino acid based infant formula only |
|
Acetylated distarch phosphate |
1414 |
|
|
Phosphateddistarch phosphate |
1413 |
|
|
Hydroxypropyl starch |
1440 |
|
|
Carrageenan |
407 |
0.03 gm (in regular milk and soy
based liquid infant formula only) 0.1 gm in hydrolysed protein and/or
amino acid based liquid infant formula only |
|
Emulsifiers |
||
|
Lecithin |
322 |
0.5 gm in all types of infant formula[6] |
|
Mono-and diglycerides |
471 |
0.4 gm in all types of infant formula[7] |
|
Citric and fatty acid esters of
glycerol |
472c |
0.9 gm in all types of liquid infant
formula 0.75 gm in all types of powdered infant formula |
|
Acidity Regulators |
||
|
Sodium hydroxide |
524 |
0.2 gm singly or in combination and
within the limits for sodium, potassium and calcium in provision (g) of
sub-regulation 7(1) in all types of infant formula |
|
Sodium hydrogen carbonate |
500ii |
|
|
Sodium carbonate |
500i |
|
|
Potassium hydrogen carbonate |
501ii |
|
|
Potassium carbonate |
501i |
|
|
Potassium hydroxide |
525 |
|
|
Calcium hydroxide |
526 |
|
|
L(+) lactic acid |
270 |
GMP in all types of infant formula |
|
Citric acid |
330 |
|
|
Sodium dihydrogen citrate |
331i |
|
|
Trisodium citrate |
331iii |
|
|
Potassium citrate |
332 |
|
|
Sodium dihydrogen phosphate, disodium
hydrogen phosphate and trisodium phosphate |
339 i, ii and iii |
45 mg as phosphorous singly or in
combination and within limits for sodium, potassium and phosphorous in
provision (g) of sub-regulation 7(1) in all types of infant formula |
|
Potassium dihydrogen phosphate,
dipotassium hydrogen phosphate and tripotassium phosphate |
340 i, ii and iii |
|
|
Antioxidants |
||
|
Mixed tocopherol concentrate |
307b |
1 mg in all types of infant formula
singly or in combination |
|
Ascorbyl palmitate |
304i |
1 mg in all type of infant formula
singly or in combination |
|
Packaging gases |
||
|
Carbon dioxide |
290 |
GMP |
|
Nitrogen |
941 |
|
(b) Food additives shown
in Schedule I (d) for special nutrient formulations may also be used.
(3) [8][where an infant
formula in powder format is manufactured without use of any vegetable oil,
linoleate, vitamin E, starch, specified food additive and optional ingredients,
the product may be named as 'Infant Milk Food'.]
CHAPTER 3 INFANT FOOD
Regulation - 8. Milk cereal based complementary Food.
This standard applies
to milk-cereal based complementary food in powder, small granules or flakes
form intended to complement the diet of infant after six months up to twenty
four months of age.
(1) Composition:
(a) Milk cereal based
complementary food is based on milk of cow or buffalo or other milch animals as
specified under the Food Safety and Standards (Food Products Standards and Food
Additives) Regulations, 2011 or mixture thereof, and/or other nutrients or ingredients
which have been provided under these regulations.
(b) It may contain a
variety of cereals, pulses, soybean, millets, fruits and vegetables or their
products, egg or egg products, nuts and edible oil seeds after processing.
(c) It may also contain
edible vegetable oil, defatted edible oil seed extracts, protein concentrates
or protein isolates or protein hydrolysates, milk solids, various
carbohydrates, and salts such as phosphates and citrates. It shall not contain
hydrogenated vegetable fats and oils.
(d) The milk cereal based
complementary food shall conform to the following requirements, namely:
|
Sl. No. |
Parameters |
Requirements per 100 g |
Requirements per 100 kcal |
|
1. |
Moisture, per cent by weight, Max |
5.00 |
- |
|
2. |
Total protein including milk protein,
per cent by weight (N x 6.25), Min Milk protein (N x 6.38), per cent by
weight, Min |
15.00 5.00 |
3.20 1.00 |
|
3. |
Total fat (including milk fat), per
cent by weight, Min Milk fat, per cent by weight, Min |
7.50 5.00 |
1.60 1.00 |
|
4. |
Total carbohydrates, per cent by weight,
Min |
55.00 |
11.70 |
|
5. |
Total ash, per cent by weight, Max |
5.00 |
- |
|
6. |
Ash insoluble in dilute hydrochloric
acid; per cent by weight, Max |
0.10 |
- |
|
7. |
Crude fibre (on dry basis), per cent
by weight, Max |
1.00 |
- |
|
8. |
Vitamin A (as retinol equivalent,
RE), μg |
350.00-823.00 |
75.00-175.00 |
|
9. |
Vitamin D, μg |
5.00-14.00 |
1.00-3.00 |
|
10. |
Vitamin C, mg |
25.00-75.00 |
5.30-16.00 |
|
11. |
Thiamine, mg |
0.20-0.50 |
0.04-0.10 |
|
12. |
Riboflavin, mg |
0.40-2.00 |
0.08-0.40 |
|
13. |
Niacin equivalent, mg |
3.80-9.90 |
0.80-2.10 |
|
14. |
Dietary Folate equivalent (DFE)[9],
μg |
15.00-50.00 |
3.20-10.60 |
|
15. |
Iron, mg |
3.00-7.00 |
0.60-1.50 |
|
16. |
Zinc, mg |
2.50-5.90 |
0.50-1.25 |
(e) Optional Ingredient
or Nutrient: It may also contain optional ingredient or nutrient as below:
|
Sl. No. |
Nutrient |
Requirements per 100 g |
Requirements per 100 kcal |
|
1. |
Pantothenic acid, mg |
2.00-10.00 |
0.40-2.10 |
|
2. |
Vitamin B12, μg |
0.25-0.70 |
0.05-0.15 |
|
3. |
Vitamin K, μg |
7.50-19.00 |
1.60-4.00 |
|
4. |
Choline, mg, Max |
32.00 |
6.80 |
|
5. |
Inositol, mg |
20.00 200.00 |
4.25-42.55 |
|
6. |
Calcium, mg |
250.00-700.00 |
53.20-14.90 |
|
7. |
Phosphorus, mg |
125.00-500.00 |
26.60-106.40 |
|
8. |
Chloride, mg |
250.00-800.00 |
53.20-170.20 |
|
9. |
Magnesium, mg |
30.00-75.20 |
6.40-16.00 |
|
10. |
Sodium, mg |
90.00-300.00 |
19.15-63.80 |
|
11. |
Selenium, μg |
5.00-17.00 |
1.00-3.60 |
|
12. |
Taurine, mg, Max |
60.00 |
12.75 |
|
13. |
L-amino acids, mg, Min |
0.90 |
0.20 |
|
14. |
L-Carnitine, mg, Min |
5.00 |
1.00 |
|
15. |
Biotin, µg |
7.50-50.00 |
1.60-10.60 |
|
16. |
Iodine, µg |
90.00-225.60 |
19.15-48.00 |
|
17. |
Potassium, mg |
300.00-900.00 |
63.80-191.50 |
|
18. |
Pyridoxine, µg |
100.00-400.00 |
21.30-85.10 |
(2) Food Additives:
(a) Following additives
are permitted in the preparation of milk cereal based complementary food for
infants in 100 gm of the product ready for consumption prepared following
manufacturer's instructions, unless otherwise indicated.
|
Food Additive |
INS No. |
Recommended maximum Level per 100 g
of the product ready for consumption |
|
Emulsifiers |
||
|
Lecithins |
322 |
1500 mg |
|
Mono-and diglycerides |
471 |
5000 mg singly or in combination |
|
Acetic fatty acid esters of glycerol |
472a |
|
|
Lactic fatty acid esters of glycerol |
472b |
|
|
Citric acid fatty acid esters of
glycerol |
472c |
|
|
Acidity regulators |
||
|
Sodium hydrogen carbonate |
500i i |
GMP |
|
Potassium hydrogen carbonate |
501ii |
|
|
Calcium carbonate |
170i |
|
|
L(+) lactic acid |
270 |
|
|
Citric acid |
330 |
|
|
Acetic acid |
260 |
|
|
Potassium acetate |
261 |
|
|
Sodium acetate |
262i |
|
|
Calcium acetate |
263 |
|
|
Malic acid (DL)-L(+) form only |
296 |
|
|
Sodium lactate (solution)-L(+) form
only |
325 |
|
|
Potassium lactate (solution)-L(+)
form only |
326 |
|
|
Calcium lactate-L(+) form only |
327 |
|
|
Monosodium citrate |
331i |
|
|
Trisodium citrate |
331ii |
|
|
Monopotassium citrate |
332i |
|
|
Tripotassium citrate |
332ii |
|
|
Calcium citrate |
333 |
|
|
Hydrochloric acid |
507 |
|
|
Sodium hydroxide |
524 |
|
|
Potassium hydroxide |
525 |
|
|
Calcium hydroxide |
526 |
|
|
Glucono-delta-lactone |
575 |
GMP |
|
L(+) Tartaric acid |
334 |
500 mg singly or in combination |
|
Disodium tartarate |
335ii |
|
|
Potassium sodium L(+) tartrate L(+)
form only |
337 |
|
|
Ortho phosphoric acid |
338 |
Only for pH adjustment 440 mg singly or in combination as
phosphorous |
|
Mono sodium ortho phosphate |
339i |
|
|
Disodium orthophosphate |
339ii |
|
|
Trisodium orthophosphate |
339iii |
|
|
Monopotassium orthophosphate |
340i |
|
|
Dipotassium orthophosphate |
340ii |
|
|
Tripotassium orthophosphate |
340iii |
|
|
Monocalcium orthophosphate |
341i |
|
|
Dicalcium orthophosphate |
341ii |
|
|
Tricalcium orthophosphate |
341iii |
|
|
Antioxidants |
||
|
Mixed tocopherol concentrate |
306 |
300 mg/kg fat or oil singly or in
combination |
|
Alpha tocopherol |
307 |
|
|
L-ascorbylpalmitate |
304 |
200 mg/kg fat or oil |
|
L-ascorbic acid |
300 |
50 mg expressed as ascorbic acid |
|
Sodium ascorbate |
301 |
|
|
Potassium ascorbate |
303 |
|
|
Calcium ascorbate |
302 |
20 mg expressed as ascorbic acid |
|
Raising agent |
||
|
Ammonium carbonate |
503i |
GMP |
|
Ammonium hydrogen carbonate |
503ii |
|
|
Sodium carbonate |
500i |
|
|
sodium hydrogen carbonate |
500ii |
|
|
Thickeners |
||
|
Carob bean gum |
410 |
1000 mg singly or in combination 2000 mg in gluten free cereal based
foods |
|
Guar gum |
412 |
|
|
Gum Arabic |
414 |
|
|
Xanthan gum |
415 |
|
|
Pectins (amidated and non amidated) |
440 |
|
|
Oxidized starch |
1404 |
5000 mg singly or in combination |
|
Mono starch phosphate |
1410 |
|
|
Distarch phosphate |
1412 |
|
|
Phosphateddistarch phosphate |
1413 |
|
|
Acetylated distarch phosphate |
1414 |
|
|
Acetylated distarchadipate |
1422 |
|
|
Starch acetate esterified with acetic
anhydride |
1420 |
|
|
Starch sodium octenyl succinate |
1450 |
|
|
Acetylated oxidized starch |
1451 |
|
|
Anticaking agent |
||
|
Silicon dioxide |
551 |
GMP |
|
Packaging gases |
||
|
Carbon dioxide |
290 |
GMP |
|
Nitrogen |
941 |
|
|
Enzymes |
|
|
|
Alpha amylase |
- |
GMP |
(b) Food additives shown
in Schedule I (d) for special nutrient formulations may also be used.
Regulation - 9. Processed cereal based complementary Food.
This standard applies
to processed cereal based complementary food in powder, small granules or
flakes form intended to complement the diet of infant after six months up to
twenty-four months of age.
(1) Composition:
(a) Processed cereal
based complementary food is a product based on variety of cereals, pulses
including soybean, millets, nuts and edible oil seeds.
(b) It shall contain
milled cereals and legumes combined accounting for not less than 75 per cent.
(c) The Sodium content of
the product shall not exceed 100 mg per 100 kcals of the ready to eat product.
(d) It may also contain
other ingredients such as protein concentrates, protein isolates, protein
hydrolysates, essential amino acids, milk and milk products, eggs and egg
products, edible vegetable oils, defatted edible oil seed extracts, fruits and
vegetables or their products, nuts or their products, honey, corn syrup, malt
and various carbohydrates. It shall not contain hydrogenated vegetable oils and
fats.
Provided that
products containing honey or maple syrup shall be processed in such a way as to
destroy spores of Clostridium botulimum.
(e) It may also contain
other vitamins and minerals other than the listed ones. When any of these
nutrient is added, the same shall not exceed the Recommended Dietary allowances
(RDA) as specified by the Indian Council of Medical Research and in case such
standards are not specified, the standards laid down by Codex Alimentarious
Commission, shall apply.
(f) The processed cereal
based complementary food shall conform to the following requirements, namely:
|
Sl. No. |
Parameters |
Requirements per 100 g |
Requirements per 100 kcal |
|
1. |
Moisture, per cent by weight, Max |
5.00 |
- |
|
2. |
Total protein (N x 6.25)[10],
per cent by weight, Min |
15.00 |
3.20 |
|
3. |
Total fat, per cent by weight, Max |
7.50 |
1.60 |
|
4. |
Total carbohydrates, per cent by
weight, Min |
55.00 |
11.70 |
|
5. |
Total ash, per cent by weight, Max |
5.00 |
- |
|
6. |
Ash insoluble in dilute hydrochloric
acid, per cent by weight, Max |
0.10 |
- |
|
7. |
Crude fibre (on dry basis), per cent
by weight, Max |
1.00 |
- |
|
8. |
Vitamin A (as retinol equivalent), mg |
350.00-823.00 |
75.00-175.00 |
|
9. |
Vitamin D, μg |
5.00-14.00 |
1.00-3.00 |
|
10. |
Vitamin C, mg |
25.00-75.00 |
5.30-16.0 |
|
11. |
Thiamine, mg |
0.20-0.50 |
0.04-0.10 |
|
12. |
Riboflavin, mg |
0.40-2.00 |
0.08-0.40 |
|
13. |
Niacin equivalent, mg |
3.80-9.90 |
0.80-2.10 |
|
14. |
Dietary Folate equivalent (DFE)[11],
μg |
15.00-50.00 |
3.20-10.60 |
|
15. |
Iron, mg |
3.00-5.65 |
0.60-1.20 |
|
16. |
Zinc, mg |
2.50-5.90 |
0.50-1.25 |
|
17. |
Pantothenic acid, mg |
2.00-10.00 |
0.40-2.10 |
|
18. |
Pyridoxine, µg |
100.00-400.00 |
21.30-85.10 |
|
19. |
Vitamin B12, µg |
0.25-0.70 |
0.05-0.15 |
|
20. |
Biotin, µg |
7.50-50.0 |
1.60-10.60 |
|
21. |
Choline, mg, Min |
32.00 |
6.80 |
|
22. |
Inositol, mg |
20.00-200.00 |
4.25-42.55 |
|
23. |
Selenium, µg |
5.00-17.00 |
1.00-3.60 |
(2) Food Additives:
(a) Following additives
are permitted in the preparation of processed cereal based complementary food
for infants in 100 g of the product ready for consumption prepared following
manufacturer's instructions unless otherwise indicated.
|
Food Additive |
INS No. |
Recommended maximum level per 100 g
of the product ready for consumption |
|
Emulsifiers |
||
|
Lecithins |
322 |
1500 mg |
|
Mono-and diglycerides |
471 |
5000 mg singly or in combination |
|
Acetic fatty acid esters of glycerol |
472a |
|
|
Lactic fatty acid esters of glycerol |
472b |
|
|
Citric acid fatty acid esters of
glycerol |
472c |
|
|
Acidity regulators |
||
|
Sodium hydrogen carbonate |
500i i |
GMP |
|
Potassium hydrogen carbonate |
501ii |
|
|
Calcium carbonate |
170i |
|
|
L(+) lactic acid |
270 |
|
|
Citric acid |
330 |
|
|
Acetic acid |
260 |
|
|
Potassium acetate |
261 |
|
|
Sodium acetate |
262i |
|
|
Calcium acetate |
263 |
|
|
Malic acid (DL)-L(+) form only |
296 |
|
|
Sodium lactate (solution)-L(+) form
only |
325 |
|
|
Potassium lactate (solution)-L(+)
form only |
326 |
|
|
Calcium lactate-L(+) form only |
327 |
|
|
Monosodium citrate |
331i |
|
|
Trisodium citrate |
331ii |
|
|
Monopotassium citrate |
332i |
|
|
Tripotassium citrate |
332ii |
|
|
Calcium citrate |
333 |
|
|
Hydrochloric acid |
507 |
|
|
Sodium hydroxide |
524 |
|
|
Potassium hydroxide |
525 |
|
|
Calcium hydroxide |
526 |
|
|
Glucono-delta-lactone |
575 |
GMP |
|
L(+) Tartaric acid |
334 |
500 mg singly or in combination |
|
Disodium tartarate |
335ii |
|
|
Potassium sodium L(+) tartrate L(+)
form only |
337 |
|
|
Ortho phosphoric acid |
338 |
Only for pH adjustment |
|
Mono sodium ortho phosphate |
339i |
|
|
Disodium orthophosphate |
339ii |
440 mg singly or in combination as phosphorous |
|
Trisodium orthophosphate |
339iii |
|
|
Monopotassium orthophosphate |
340i |
|
|
Dipotassium orthophosphate |
340ii |
|
|
Tripotassium orthophosphate |
340iii |
|
|
Monocalcium orthophosphate |
341i |
|
|
Dicalcium orthophosphate |
341ii |
|
|
Tricalcium orthophosphate |
341iii |
|
|
Antioxidants |
||
|
Mixed tocopherol concentrate |
306 |
300 mg/kg fat or oil singly or in
combination |
|
Alpha tocopherol |
307 |
|
|
L-ascorbylpalmitate |
304 |
200 mg/kg fat or oil |
|
L-ascorbic acid |
300 |
50 mg expressed as ascorbic acid |
|
Sodium ascorbate |
301 |
|
|
Potassium ascorbate |
303 |
|
|
Calcium ascorbate |
302 |
20 mg expressed as ascorbic acid |
|
Raising agent |
||
|
Ammonium carbonate |
503i |
GMP |
|
Ammonium hydrogen carbonate |
503ii |
|
|
Sodium carbonate |
500i |
|
|
sodium hydrogen carbonate |
500ii |
|
|
Thickeners |
||
|
Carob bean gum |
410 |
1000 mg singly or in combination 2000 mg in gluten free cereal based
foods |
|
Guar gum |
412 |
|
|
Gum Arabic |
414 |
|
|
Xanthan gum |
415 |
|
|
Pectins (amidated and non amidated) |
440 |
|
|
Oxidized starch |
1404 |
5000 mg singly or in combination |
|
Mono starch phosphate |
1410 |
|
|
Distarch phosphate |
1412 |
|
|
Phosphateddistarch phosphate |
1413 |
|
|
Acetylated distarch phosphate |
1414 |
|
|
Acetylated distarchadipate |
1422 |
|
|
Starch acetate esterified with acetic
anhydride |
1420 |
|
|
Starch sodium octenyl succinate |
1450 |
|
|
Acetylated oxidized starch |
1451 |
|
|
Anticaking agent |
||
|
Silicon dioxide |
551 |
GMP |
|
Packaging gases |
||
|
Carbon dioxide |
290 |
GMP |
|
Nitrogen |
941 |
|
|
Enzymes |
|
|
|
Alpha amylase |
- |
GMP |
(b) Food additives shown
in Schedule I (d) for special nutrient formulations may also be used.
(3) The processed cereal
based complementary foods for use in specific conditions, where protein needs
to be restricted and where other cereals like wheat, soya, legumes and milk
cannot be used, such processed cereal based complementary foods shall be prepared
with single cereal like rice or ragi, which shall have the minimum protein
content of 6 to 9 per cent, such products shall be conspicuously labelled,
"mono grain based complementary foods for use in specific conditions under
medical guidance only".
Regulation - 10. Follow-up Formula.
This standard applies
to the composition of Follow-up formula in powder or liquid form for infant
after six months up to twenty four months of age. The product shall be
nutritionally adequate to contribute to normal growth and development when used
in accordance with its directions for use. Follow-up formula, in powdered form
requires water for preparation.
(1) Composition:
(a) Follow-up formula is
a product based on milk of cow or buffalo or other milch animals as specified
under the Food Safety and Standards (Food Products Standards and Food
Additives) Regulations, 2011 or mixture thereof, and other nutrients and
ingredients provided under these regulations.
(b) The follow-up formula
shall have protein content minimum of 3 g per 100 kcal derived from whole or
skimmed milk or with minor modification that does not substantially impair the
vitamin or mineral content of milk and which represents a minimum of 90 per
cent of total protein. The product may contain vegetable proteins.
(c) The quality of
protein shall not be less than 85 per cent of casein. Essential amino acids may
be added to follow-up formula to improve its nutritional value. Essential amino
acids may be added to improve protein quality only in amounts necessary for
that purpose. Only L forms of amino acids shall be used.
(d) Fat not less than 3
gm and not more than 6 gm per 100kcal. Linoleic acid in fat shall not be less
than 300 mg per 100 kcal. Partially hydrogenated oils and fats shall not be
used in follow-up formula. Lauric acid and myristic acids are constituents of
fats, but combined shall not exceed 20 per cent of total fatty acids. The
content of trans fatty acids shall not exceed 3 per cent of total fatty acids.
The erucic acid content shall not exceed 1 per cent of total fatty acids.
(e) The product shall
contain nutritionally available carbohydrates suitable for feeding in such
quantities so as to adjust the product to the energy density given below:
100 ml of
ready-to-use formula when prepared in accordance with instructions for use
shall provide 60 to 85 kcal of energy. Only precooked and/or gelatinised
starches gluten-free by nature may be added.
(f) It may also contain
other vitamins and minerals other than the listed ones. When any of these
nutrient is added, the same shall not exceed the Recommended Dietary Allowances
(RDA) as specified by the Indian council of Medical Research and in case such
standards are not specified, the standards laid down by Codex Alimentarius
Commission, shall apply.
(g) It may also contain
optional ingredients permitted under Infant Formula.
(h) The follow-up shall
conform to the following requirements, namely:
|
Sl. No. |
Parameters |
Requirements per 100 g |
Requirements per 100 kcal |
|
1. |
Moisture, percent by weight, Max |
4.50 |
- |
|
2. |
Total ash, per cent by weight, Max |
8.50 |
- |
|
3. |
Ash insoluble in dilute hydrochloric
acid, per cent by weight, Max |
0.10 |
- |
|
4. |
Vitamin A (as retinol equivalent), µg |
350.00-823.00 |
75.00-175.00 |
|
5. |
Vitamin D, µg |
5.0-14.00 |
1.00-3.00 |
|
6. |
Vitamin E (as alpha-tocopherols), mg |
2.50-6.00 |
0.50-1.30 |
|
7. |
Vitamin K, µg |
7.50-19.00 |
1.60-4.00 |
|
8. |
Vitamin C, mg |
25.0-75.00 |
5.30-16.00 |
|
9. |
Thiamine, µg |
200.00-517.00 |
42.55-110.00 |
|
10. |
Riboflavin, µg |
400.00-2000.00 |
85.10-425.50 |
|
11. |
Niacin, equivalent mg |
3.80-9.90 |
0.80-2.10 |
|
12. |
Pyridoxine, µg per 100 g |
100.00-400.00 |
21.30-85.10 |
|
13. |
Dietary Folate equivalent (DFE)[12],
mg |
15.00-50.00 |
3.20-10.60 |
|
14. |
Pantothenic acid, mg |
2.00-10.00 |
0.40-2.10 |
|
[13][15. |
Vitamin B12, µg |
0.25-4.0 |
0.05-0.90] |
|
16. |
Choline, mg, Max |
32.00 |
6.80 |
|
17. |
Biotin, µg |
7.50-19.0 |
1.60-4.00 |
|
18. |
Sodium, mg |
90.00-300.00 |
19.15-63.80 |
|
19. |
Potassium, mg |
300.00-900.00 |
63.80-191.50 |
|
20. |
Chloride, mg |
250.00-800.00 |
53.20-170.20 |
|
21. |
Calcium, mg |
405.00-800.00 |
86.20-170.20 |
|
22. |
Phosphorus, mg |
270.00-500.00 |
57.45-106.40 |
|
23. |
Magnesium, mg |
30.00-75.20 |
6.40-16.00 |
|
24. |
Iron, mg |
3.00-7.00 |
0.60-1.50 |
|
25. |
Iodine, µg |
90.00-225.60 |
19.15-48.00 |
|
26. |
Copper, µg |
160.00-470.00 |
34.00-100.00 |
|
27. |
Zinc, mg |
2.50-5.90 |
0.50-1.25 |
|
28. |
Manganese, µg |
5.00-50.00 |
1.00-10.60 |
|
29. |
Selenium, µg |
5.00-17.00 |
1.00-3.60 |
|
30. |
Inositol, per 100 ml of the product
prepared in accordance with the manufacturer's instructions, mg, Max |
40.00 |
8.50 |
|
31. |
Taurine, mg, Max |
60.00 |
12.75 |
|
32. |
Essential Amino acids, per 100 ml of
the product prepared in accordance with the manufacturer's instructions, mg,
Min |
0.90 |
0.19 |
(2) Food Additives:
(a) The following
additives may be used in the preparation of follow up formula ready for
consumption prepared following manufacturer's instructions, unless otherwise
indicated.
|
Food Additive |
INS No. |
Recommended maximum level per 100 ml
of Product Ready-for consumption |
|
Thickening agent |
||
|
Guar gum |
412 |
0.1 g |
|
Locust bean gum (carob bean gum) |
410 |
0.5 g singly or in combination |
|
Distarch phosphate |
1412 |
|
|
Acetylated distarch phosphate |
1414 |
|
|
Phosphateddistarch phosphate |
1413 |
|
|
Acetylated distarchadipate |
1422 |
2.5 g singly or in combination in
hydrolyzed protein and/or amino acid based products only |
|
Carrageenan |
407 |
0.03 g singly or in combination in
milk and soy based products only 0.1 g singly or in combination in
hydrolyzed protein and/or amino acid based liquid products only |
|
Pectins |
440 |
1 g |
|
Emulsifiers |
||
|
Lecithin |
322(i) |
0.5 g |
|
Mono-and diglycerides |
471 |
0.4 g |
|
[14][Acidity regulators] |
||
|
Sodium hydrogen carbonate |
500ii |
GMP within the limits for sodium in
clause (h) of sub-regulation (1) of regulation 10 |
|
Sodium carbonate |
500i |
|
|
Sodium citrate |
331i |
|
|
Potassium hydrogen carbonate |
501ii |
|
|
Potassium carbonate |
501i |
|
|
Potassium citrate |
332i |
|
|
Sodium hydroxide |
525 |
|
|
Potassium hydroxide |
525 |
|
|
Calcium hydroxide |
526 |
|
|
L(+) lactic acid L(+) lactic acid
producing cultures |
270 |
|
|
Citric acid |
330 |
|
|
Antioxidants |
||
|
Mixed tocopherol concentrate |
307b |
3 mg singly or in combination |
|
Alpha tocopherol |
307a&c |
|
|
L-ascorbylpalmitate |
304 |
5 mg singly or in combination
expressed as ascorbic acid |
|
L-ascorbic acid |
300 |
|
|
Sodium ascorbate |
301 |
|
|
Calcium ascorbate |
302 |
|
|
[15][Packaging gases |
|
GMP] |
|
Carbon dioxide |
290 |
|
|
Nitrogen |
941 |
|
(b) Food additives shown
in Annexure I (d) for special nutrient formulations may also be used.
Regulation - 11. Food for Infants based on traditional food ingredients.
This standard applies
to food prepared using traditional food ingredients intended for infants after
6 months up to 24 months of age.
(1) Composition:
(a) The composition of
such foods shall be based on traditional food ingredients such as rice, rice
flour, wheat flour, semolina, pulses and other cereals, spices, fruits, dry
fruits and vegetables, milk, ghee, egg and egg products.
(b) Ingredients used
shall be safe and comply with all the applicable provisions of Food safety and
Standard Regulations, 2011.
(c) Such foods shall be
either in the form "Ready to Use" or to be reconstituted with medium
such as milk, water, curd or any other medium appropriate for infant. Clear
instructions for use shall be provided on the label.
(d) These shall be
manufactured adopting necessary and appropriate technologies during the process
and packaging so that they retain their nutritional and other physical and
sensory attributes.
(2) If required, the food
additives specified for milk cereal based complementary food under these
regulations may be used.
(3) The products shall
bear prominently the term "Traditional Food for Infants" on the front
of the pack label.
(4) Explanatory note: A
non-exhaustive examples of foods for infants based on traditional foods are:
(a) Cooked lentils,
cereals, dry fruits, grains mashed to a pasty form, sweetened with sugar or
jaggery or honey;
(b) Cooked vegetables
mashed to a pasty form either sweetened or with little ghee;
(c) Ragi malt mix;
(d) Semolina or sooji
based foods with either milk or curd or ghee.
CHAPTER 4 FOOD FOR SPECIAL
MEDICAL PURPOSE INTENDED FOR INFANTS
Regulation - 12. Food for special medical purpose intended for infants.
This standard applies
to food for special medical purpose intended for infants from birth to 24
months in liquid or powdered form intended for use, where necessary, as a
substitute for human milk or formula in meeting the special nutritional
requirements arising from the disorders, diseases or medical conditions for
whose dietary management the product has been formulated.
(1) Composition:
(a) Food for special
medical purpose intended for infants is a product based on ingredients (from
known and well established sources) suitable for human consumption.
(b) The composition of
food for special medical purpose intended for infants shall be based on sound
medical and nutritional principles. The nutritional safety and adequacy of the
formula shall be scientifically demonstrated to support the growth and
development of the infants for whom it is intended as appropriate for the
specific products and indications. Their use shall be demonstrated by
scientific evidence to be beneficial in the dietary management of the infants
for whom it is intended.
(c) The energy content
and nutrient composition of the food for special medical purpose intended for
infants except preterm infant milk substitute shall be based on the
requirements for infant formula and follow-up formula, as applicable based on
intended age group, specified under these regulations except for the
compositional provisions which must be modified to meet the especial
nutritional requirements arising from disease(s), disorder(s) or medical
condition(s) for whose dietary management the product is specifically
formulated, labelled and presented.
(d) Optional ingredients:
In addition to the compositional requirements to provide substances ordinarily
found in human milk or required other ingredients, optional ingredients as
specified under infant formula may be added to ensure that the formulation is
suitable as the sole source of nutrition for the infant and for the dietary
management of the disease, disorder or medical condition of the infant.
(e) The suitability for
the intended special medical purpose, the suitability for the particular
nutritional use of infants and the safety of these substances shall be
scientifically demonstrated. The formula shall contain sufficient amounts of
these substances to achieve the intended effect.
(2) No food business
operator shall advertise the infant formula for special medical purpose
intended for infants.
(3) Food Additives: The
food for special medical purpose intended for infants shall comply with
additives provisions specified in sub-regulation (2) of regulation 7 relating
to additives for infant formula and sub-regulation (2) of regulation 10
relating to additives for follow up formula, as applicable. Food additives
shown in Schedule I (d) for special nutrient formulations may also be used.
Regulation - 13. Preterm infant milk substitute.
The preterm infant
milk substitute is required for babies born before 37 weeks only and till they
attain 40 weeks of age or as prescribed by physician.
(1) The preterm infant
milk substitutes shall meet the following requirements:
|
Sl. No. |
Nutrient |
Requirements per 100 kcal |
Requirements per kg/day |
|
1. |
Fluids |
- |
135.00-200.00 |
|
2. |
Energy, kcal |
- |
110.00-130.00 |
|
3. |
Total protein, g |
3.20-4.10 |
3.50-4.50 |
|
4. |
Total fat, g Linoleic acid, mg α-Linolenic acid, mg (Min) |
4.40-6.00 |
4.80-6.60 |
|
350.00-1400.00 |
385.00-1540.00 |
||
|
50.00 |
55.00 |
||
|
5. |
Docosahexaenoic acid (DHA), mg |
11.00-27.00 |
12.00-30.00 |
|
6. |
Eicosapentaenoic acid (EPA), mg (Max) |
18.00 |
20.00 |
|
7. |
Arachidonic acid (ARA), mg |
16.00-39.00 |
18.00-42.00 |
|
8. |
Carbohydrate, g |
10.50-12.00 |
11.60-13.20 |
|
9. |
Sodium, mg |
63.00-105.00 |
69.00-115.00 |
|
10. |
Potassium, mg |
71.00-177.00 |
78.00-195.00 |
|
11. |
Chloride, mg |
95.00-161.00 |
105.00-177.00 |
|
12. |
Calcium, mg |
109.00-182.00 |
120.00-200.00 |
|
13. |
Phosphate, mg |
55.00-127.00 |
60.00-140.00 |
|
14. |
Magnesium, mg |
7.30-13.60 |
8.00-15.00 |
|
15. |
Iron, mg |
1.80-2.70 |
2.00-3.00 |
|
16. |
Zinc, mg |
1.30-2.30 |
1.40-2.50 |
|
17. |
Copper, µg |
90.00-210.00 |
100.00-230.00 |
|
18. |
Selenium, µg |
4.50-9.00 |
5.00-10.00 |
|
19. |
Manganese, µg |
0.90-13.60 |
1.00-15.00 |
|
20. |
Iodine, µg |
9.00-50.00 |
10.00-55.00 |
|
21. |
Chromium, µg |
27.00-2045.00 |
30.00-2250.00 |
|
22. |
Molybdenum, µg |
0.27-4.50 |
0.30-5.00 |
|
23. |
Thiamin, µg |
127.00-273.00 |
140.00-300.00 |
|
24. |
Riboflavin, µg |
181.00-364.00 |
200.00-400.00 |
|
25. |
Niacin, mg |
0.90-5.00 |
1.00-5.50 |
|
26. |
Pantothenic acid, mg |
0.45-1.90 |
0.50-2.10 |
|
27. |
Pyridoxine, µg |
45.00-273.00 |
50.00-300.00 |
|
28. |
Cobalamin, µg |
0.09-0.73 |
0.10-0.80 |
|
29. |
Folic acid, µg |
32.00-91.00 |
35.00-100.00 |
|
30. |
L-Ascorbic acid, mg |
18.00-50.00 |
20.00-55.00 |
|
31. |
Biotin, µg |
1.50-15.00 |
1.70-16.50 |
|
32. |
Vitamin A, µg retinol equivalents |
365.00-1000.00 |
400.00-1100.00 |
|
33. |
Vitamin D, IU |
- |
800.00-1000.00 |
|
34. |
Vitamin E, mg alpha tocopherol
equivalents |
2.00-10.00 |
2.20-11.00 |
|
35. |
Vitamin K, mg |
4.00-25.00 |
4.40-28.00 |
|
36. |
Choline, mg |
7.30-50.00 |
8.00-55.00 |
|
37. |
Inositol, mg |
4.00-48.00 |
4.40-53.00 |
(2) The containers of
infant milk substitute meant for preterm baby or labels affixed thereto shall
indicate the following additional information, namely:
(a) the words "FOR
THE PRETERM BABY (BORN BEFORE 37 WEEKS)" in capital and bold letters along
with the product name in central panel;
(b) a statement
"RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY" in capital and
bold letters.
Regulation - 14. Lactose free infant milk substitutes.
(1) In addition to the
nutrient requirements specified for Infant formula (except milk fat) and
follow-up formula lactose free infant milk substitute shall also meet the
following requirements:
(a) Soy-protein based,
lactose free formula shall have soy protein and glucose, dextrose,
dextrin/maltodextrin, maltose and/or sucrose as carbohydrates.
(b) Lactose-free
cow/buffalo milk-based formulas shall have carbohydrate as glucose, dextrose,
dextrin/maltodextrin, maltose and sucrose. It may also contain caseinates, milk
protein concentrates, isolates and hydrolysates.
(c) Lactose content shall
not exceed 0.05 per cent by weight.
(d) The fat content
derived from vegetable oils shall not be less than 18 per cent by weight.
(2) The container of
infant milk substitute for lactose intolerant infants or label affixed thereto
shall indicate conspicuously "LACTOSE-FREE" in capital and bold
letters.
(3) An advisory warning
"RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY" shall appear on
the label in capital and bold letters. The label shall also bear the following statements,
namely:
(a) "Lactose free
infant milk substitute shall only be used in case of diarrhoea in infants due
to lactose intolerance"
(b) "The lactose
free infant milk substitute shall be withdrawn if there is no improvement in
symptoms of intolerance".
Regulation - 15. Hypoallergenic infant milk substitutes.
(1) In addition to the
nutrient requirements specified for infant formula and follow-up formula except
for milk fat and milk protein, the hypoallergenic infant milk substitutes shall
also meet the following requirement:
(a) Protein used shall be
extensively hydrolysed whey protein or casein or contain only free amino acids.
(2) The product which
contains neither milk nor any milk derivatives shall be labelled "CONTAINS
NO MILK OR MILK PRODUCTS" in conspicuous manner.
(3) The container of
infant milk substitute meant for infants with allergy to cow/buffalo/other
milch animal (as specified under the Food Safety and Standards (Food Products
Standards and Food Additives) Regulations, 2011) milk protein shall indicate
conspicuously "HYPOALLERGENIC FORMULA" and statement
"RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY" in capital and
bold letters on the label.
Regulation - 16. Foods for Infants with Inborn Errors of Metabolism (IEM).
This standard applies
to food intended for the specific dietary management of disease or a condition
of infants with specific inborn error(s) of metabolism. This food is intended
to be given under medical supervision.
(1) Description:
(a) A food for infant
with IEM is a food which is formulated or processed to be consumed orally or
administered enterally through a tube and is intended for the specific dietary
management of a disease or a condition with distinctive nutritional
requirements, based on well-established scientific principles, studies and
medical evaluation.
(b) It is specially
processed and formulated with nutrients desirable for the infant suffering from
a specific IEM. The product shall exclude the ingredients/nutrients that are harmful
to the diseased infant. The essential characteristic involves a specific
modification of the content or nature of proteins, fats or carbohydrates.
(c) It is intended for
the dietary management of an infant who, because of therapeutic or chronic
needs has restricted, limited or impaired capacity to ingest, digest, absorb or
metabolize ordinary foodstuffs or infant formula or certain nutrients or who
needs specific nutrients established by medical observations.
(d) Such foods fulfill
unique nutritional needs of the infant with IEM through specific modifications
or alterations and processing of the food components.
(e) The Food Authority
shall specify the IEM conditions as approved by it after undertaking proper
scientific evaluation. No food business operator shall manufacture, sell,
market, or import products for IEM conditions except those specified by the
Food Authority from time to time.
(2) Composition:
(a) The composition of
food for infants with IEM shall be based on sound medical and nutritional
principles. The nutritional safety and adequacy of the food shall be
scientifically demonstrated to support the growth and development of infants
with IEM. Their use shall be demonstrated by scientific evidence to be
beneficial in the dietary management of the infants for whom it is intended.
(b) Ingredients used in
such food shall be suitable and safe and shall comply with all the applicable
provisions of the Food Safety and Standards (Food Products Standards and Food
Additives) Regulations, 2011. The product may have ingredients such as milk,
carbohydrates, vegetable oils, hydrolysed proteins, amino acids, or any other
ingredients required for the infants with IEM provided they are safe, desirable
and nutritionally beneficial for infants with IEM.
(c) The product may also
have ingredients that are scientifically and medically proven to be necessary
for such foods. However, prior approval of the authority has to be taken.
(d) It may contain
vitamins and minerals stated in infant formula; provided such nutrients are
safe, desirable and not harmful for infants suffering from IEM. Vitamins,
minerals and amino acids for infants suffering from IEM may be added at levels
greater than RDA specified based on scientific or medical needs and under
strict medical supervision.
(3) Labelling:
(a) The words 'FOOD FOR
SPECIAL MEDICAL PURPOSE' shall be printed in capital and bold letters in the
immediate proximity of the name or brand name of the product.
(b) The statement
"For the nutrition management of .................... (specific IEM
disease(s), disorder(s) or medical condition(s) for which the product is
intended, and for which it has been shown to be effective) shall be appearing
on the label.
(c) An advisory warning
"RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY" shall appearing on
the label in capital and bold letters in an area separated from other written,
printed or graphic information.
(d) Information on
osmolality or osmolarity and/or acid-base balance shall be given when
appropriate.
(e) Such foods in which
essential characteristic involves a specific modification of the content or
nature of proteins, fats or carbohydrates shall bear a description of this
modification and information on the amino acid, fatty acid or carbohydrate
profile when necessary.
(f) A prominent statement
indicating whether the product is intended or not as the sole source of
nutrition shall appear on the label.
(g) Information of the
nature of animal or plant proteins or protein hydrolysates shall be provided.
(h) Feeding instructions,
including the method of administration and serving size if applicable, shall be
given on the label.
(i) A complete statement
concerning adequate precautions, known side effects, contraindications and
product-drug interaction, as applicable shall be given on the label.
(j) A statement of the
rationale for the use of the product and a description of the properties or
characteristics that make it useful shall be given on the label.
(k) If the product has
been formulated for a specific age group, it shall carry a prominent statement
to that effect.
(l) A statement specifying
the nutrient(s) which have been reduced, omitted, increased or otherwise
modified, relative to normal requirements and the rationale for the reduction,
omission, increase or other modification shall appear on the label.
(m) A warning that the
product is not for parenteral use shall appear on the label.
Advisory
list of mineral salts for use in foods for infant nutrition under the
provisions of the regulations
|
Sl. No. |
Nutrient source |
Purity requirements by |
Use in foods for infant nutrition |
|
1. |
Calcium (Ca) |
||
|
(1) |
Calcium carbonate |
JECFA (1973), FCC, USP, BP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Calcium chloride |
JECFA (1975), FCC, USP, BP, IP |
|
|
(3) |
Calcium citrate (Tricalciumdi
citrate) |
JECFA (1975), FCC, USP, IP |
|
|
(4) |
Calcium gluconate |
JECFA (1998), FCC USP, BP, IP |
|
|
(5) |
Calcium glycerophosphate |
FCC, BP, IP |
|
|
(6) |
Calcium L-lactate |
JECFA (1974), FCC, USP, BP, IP |
|
|
(7) |
Calcium hydroxide |
JECFA (1975), FCC, USP, BP, JP |
|
|
(8) |
Calcium phosphate, monobasic (Calcium
dihydrogen phosphate) |
JECFA (1996), FCC, IP |
|
|
(9) |
Calcium phosphate, dibasic (Calcium
hydrogen phosphate) |
JECFA (1975), FCC, BP, IP |
|
|
(10) |
Calcium phosphate, tribasic
(Tricalcium diphosphate) |
JECFA (1973), FCC, BP, IP |
|
|
(11) |
Calcium oxide |
JECFA (1975), FCC, IP |
MCCF, PCCF, FSMP |
|
(12) |
Calcium sulphate |
FCC, JECFA (1975), IP |
FSMP |
|
2. |
Phosphorus (P) |
||
|
(1) |
Calcium phosphate, monobasic |
FCC, JECFA (1996), IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Calcium phosphate, dibasic |
FCC, JECFA (1975), IP |
|
|
(3) |
Calcium phosphate, tribasic |
FCC, JECFA (1973), IP |
|
|
(4) |
Magnesium phosphate, dibasic |
FCC, IP |
|
|
(5) |
Magnesium phosphate, tribasic |
FCC, IP |
|
|
(6) |
Potassium phosphate, monobasic |
FCC, IP |
|
|
(7) |
Potassium phosphate, dibasic |
FCC, IP |
|
|
(8) |
Sodium phosphate, dibasic |
FCC, IP |
|
|
(9) |
Phosphoric acid |
FCC, IP |
|
|
3. |
Chloride (Cl) |
||
|
(1) |
Calcium chloride |
FCC, JECFA (1975), IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Choline chloride |
FCC, IP |
|
|
(3) |
Magnesium chloride |
FCC, IP |
|
|
(4) |
Manganese chloride |
FCC, IP |
|
|
(5) |
Potassium chloride |
FCC, IP |
|
|
(6) |
Sodium chloride |
FCC, IP |
|
|
(7) |
Hydrochloric acid (Food grade) |
IP |
|
|
4. |
Iron (Fe) |
||
|
(1) |
Ferrous carbonate, stabilized with
saccharose |
DAB, IP |
MCCF, PCCF, FSMP |
|
(2) |
Ferrous citrate |
FCC, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(3) |
Ferrous fumarate |
FCC, USP, DAB, BP, IP |
|
|
(4) |
Ferrous gluconate |
FCC, JECFA (1999), USP, DAB, BP, IP |
|
|
(5) |
Ferrous lactate |
JECFA (1989), FCC, IP |
|
|
(6) |
Ferrous succinate |
MI, IP |
|
|
(7) |
Ferrous sulphate |
FCC, JECFA (1999), USP, BP, DAB, IP |
|
|
(8) |
Ferric ammonium citrate |
JECFA (1984), FCC, IP |
|
|
(9) |
Ferric citrate |
FCC, IP |
|
|
(10) |
Ferrous bisglycinate |
JECFA (2003), IP |
|
|
(11) |
Sodium ferric pyrophosphate Ferric
diphosphate |
FCC, IP |
|
|
(12) |
Ferric orthophosphate |
FCC, IP |
|
|
(13) |
Hydrogen reduced iron |
FCC, DAB, IP |
MCCF, PCCF, FSMP |
|
(14) |
Electrolytic iron |
FCC, IP |
|
|
(15) |
Carbonyl iron |
FCC, IP |
|
|
(16) |
Ferric saccharate |
DAB, IP |
|
|
(17) |
Sodium ferric diphosphate |
FCC, IP |
|
|
5. |
Magnesium (Mg) |
||
|
(1) |
Magnesium hydroxide carbonate |
JECFA (1979), USP, BP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Magnesium chloride |
FCC, JECFA (1979), USP, BP, IP |
|
|
(3) |
Magnesium oxide |
FCC, JECFA (1973), USP, BP, IP |
|
|
(4) |
Magnesium phosphate, dibasic
(Magnesium hydrogen phosphate) |
FCC, JECFA (1982), IP |
|
|
(5) |
Magnesium phosphate, tribasic
(Trimagnesium phosphate) |
FCC, JECFA (1982), IP |
|
|
(6) |
Magnesium sulphate |
FCC, USP, BP, IP |
|
|
(7) |
Magnesium carbonate |
JECFA (1973), FCC, USP, BP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(8) |
Magnesium hydroxide |
JECFA (1975), FCC, USP, BP, IP |
|
|
(9) |
Magnesium salts of citric acid |
USP, IP |
|
|
(10) |
Magnesium gluconate |
JECFA (1998), FCC, IP |
|
|
(11) |
Magnesium lactate |
JECFA (1983), JP |
MCCF, PCCF, FSMP |
|
(12) |
Magnesium glycerol-phosphate |
PhEur, IP |
|
|
(13) |
Magnesium acetate |
PhEur, IP |
FSMP |
|
6. |
Sodium (Na) |
||
|
(1) |
Sodium bicarbonate |
FCC, JECFA (1975), USP, IP |
IF, MCCF, FUF, FSMP |
|
(2) |
Sodium carbonate |
FCC, JECFA (1975), USP, IP |
|
|
(3) |
Sodium chloride |
FCC, USP, BP, IP |
|
|
(4) |
Sodium citrate (Trisodium citrate) |
JECFA (1975), USP, BP, DAB, IP |
|
|
(5) |
Sodium gluconate |
FCC, JECFA (1995), USP, IP |
|
|
(6) |
Sodium L-lactate |
JECFA (1974), FCC, USP, BP, IP |
|
|
(7) |
Sodium phosphate, monobasic (sodium dihydrogen
phosphate |
JECFA (1963), FCC, USP, IP |
|
|
(8) |
Sodium phosphate, dibasic (Disodium
hydrogen phosphate) |
JECFA (1975), FCC, USP, BP, IP |
|
|
(9) |
Sodium phosphate, tribasic (Trisodium
phosphate) |
FCC, JECFA (1975), IP |
|
|
(10) |
Sodium sulphate |
JECFA (2000), FCC, USP, BP, IP |
|
|
(11) |
Sodium hydroxide |
JECFA (1975), FCC, USP, BP, IP |
IF, MCCF, FUF, FSMP |
|
7. |
Potassium (K) |
||
|
(1) |
Potassium bicarbonate |
FCC, JECFA (1979), USP, BP, IP |
IF, MCCF, FUF, FSMP |
|
(2) |
Potassium carbonate |
FCC, JECFA (1975), USP, BP, IP |
|
|
(3) |
Potassium chloride |
FCC, JECFA (1979), USP, BP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(4) |
Potassium citrate (Tripotassium
citrate) |
FCC, JECFA (1975), USP, BP, IP |
|
|
(5) |
Potassium glycerol phosphate |
FCC, IP |
PCCF, FSMP |
|
(6) |
Potassium gluconate |
JECFA (1978), FCC, USP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(7) |
Potassium phosphate, monobasic
(Potassium dihydrogen phosphate) |
FCC, JECFA (1982), BP, IP |
IF, FUF, FSMP |
|
(8) |
Potassium phosphate, dibasic
(Dipotassium hydrogen phosphate) |
FCC, JECFA (1982), BP, IP |
|
|
(9) |
Potassium hydroxide |
JECFA (1975), FCC, BP, IP |
IF, FUF, FSMP |
|
(10) |
Potassium phosphate tribasic |
JECFA (1982), IP |
IF, FUF, FSMP |
|
(11) |
Potassium L-Lactate |
JECFA (1974), FCC, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
8. |
Copper (Cu) |
||
|
(1) |
Copper gluconate (Cupric gluconate) |
FCC, USP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Cupric carbonate |
MI, IP |
|
|
(3) |
Cupric citrate |
FCC, USP, IP |
|
|
(4) |
Copper sulphate (Cupric sulphate) |
JECFA (1973), FCC, USP, DAB, IP |
|
|
9. |
Iodine (I) |
||
|
(1) |
Potassium iodide |
FCC, USP, BP, DAB, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Sodium iodide |
USP, BP, DAB, IP |
|
|
(3) |
Potassium iodate |
FCC, IP |
IF, MCCF, FUF, FSMP |
|
(4) |
Sodium iodate |
FCC, IP |
FSMP |
|
10. |
Zinc (Zn) |
||
|
(1) |
Zinc acetate |
USP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Zinc chloride |
USP, BP, DAB, IP |
|
|
(3) |
Zinc oxide |
FCC, USP, DAB, BP, IP |
|
|
(4) |
Zinc sulphate |
FCC, USP, BP, IP |
|
|
(5) |
Zinc gluconate |
FCC, USP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(6) |
Zinc lactate |
FCC, IP |
|
|
(7) |
Zinc carbonate |
USP, IP |
FSMP |
|
(8) |
Zinc citrate (zinc citrate dihydrate
or zinc citrate trihydrate) |
USP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
11. |
Manganese (Mn) |
||
|
(1) |
Manganese(II) carbonate |
MI, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Manganese(II) chloride |
FCC, IP |
|
|
(3) |
Manganese(II) citrate |
FCC, IP |
|
|
(4) |
Manganese sulphate |
FCC, USP, IP |
|
|
(5) |
Manganese(II) gluconate |
FCC, IP |
|
|
(6) |
Manganese(II) glycerol-phosphate |
FCC, IP |
MCCF, PCCF, FSMP |
|
12. |
Selenium |
||
|
(1) |
Sodium selenate |
MI, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Sodium selenite |
PhEur, USP, MP, MI, IP |
|
|
(3) |
Sodium hydrogen selenite |
DVFA, IP |
FSMP |
|
13. |
Chromium (Cr) |
||
|
(1) |
Chromium(III) sulphate |
USP, MI, IP |
IF, FSMP |
|
(2) |
Chromium(III) chloride |
USP, MI, IP |
IF, FSMP |
|
14. |
Molybdenum (MoVI) |
||
|
(1) |
Sodium molybdate |
PhEur, IP |
IF, FSMP |
|
(2) |
Ammonium molybdate |
FCC, USP, IP |
IF, FSMP |
Advisory
list of vitamin compounds for use in food for infant nutrition under the
provisions of the regulations
|
Sl. No. |
Nutrient source |
Purity requirements by |
Use in foods for infant nutrition |
|
1. |
Vitamin A |
||
|
(1) |
trans Retinol |
FCC, USP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Retinyl acetate |
FCC, USP, PhEur, IP |
|
|
(3) |
Retinyl palmitate |
FCC, USP, PhEur, IP |
|
|
2. |
Provitamin A |
||
|
(1) |
Beta-carotene |
JECFA (1987), FCC, USP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
3. |
Vitamin D |
||
|
(1) |
Vitamin D2 (Ergocalciferol) |
FCC, USP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Vitamin D3 (Cholecalciferol) |
FCC, USP, BP, DAB, IP |
|
|
4. |
Vitamin E |
||
|
(1) |
D-alpha-Tocopherol |
JECFA (2000), FCC, USP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
DL-alpha-Tocopherol |
JECFA (1986), FCC, USP, IP |
|
|
(3) |
D-alpha-Tocopheryl acetate |
FCC, USP, BP, PhEur, IP |
|
|
(4) |
D-alpha-Tocopheryl acetate |
FCC, USP, BP, PhEur, IP |
|
|
(5) |
D-alpha-Tocopheryl acid succinate |
FCC, USP, PhEur, IP |
FSMP |
|
(6) |
DL-alpha Tocopheryl acid succinate |
MP, MI, USP, PhEur, IP |
|
|
(7) |
DL-alpha-Tocopheryl polyethylene
glycol succinate |
FCC, USP, IP |
|
|
5. |
Vitamin C |
||
|
(1) |
L-Ascorbic acid |
JECFA (1973), FCC, USP, BP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Calcium-L-ascorbate |
JECFA (1981), FCC, USP, PhEur, IP |
|
|
(3) |
6-Palmitoyl-L-ascorbic acid (Ascorbyl
palmitate) |
JECFA (1973), FCC, USP, BP, PhEur, IP |
|
|
(4) |
Sodium-L-ascorbate |
JECFA (1973), FCC, USP, PhEur, IP |
|
|
(5) |
Potassium-L-ascorbate |
FCC, IP |
|
|
6. |
Vitamin B1 |
||
|
(1) |
Thiamin chloride hydrochloride |
FCC, USP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Thiamin mononitrate |
FCC, USP, BP, PhEur, IP |
|
|
7. |
Vitamin B2 |
||
|
(1) |
Riboflavin |
JECFA (1987), FCC, USP, BP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Riboflavin-5-phosphate sodium |
JECFA (1987), USP, BP, PhEur, IP |
|
|
8. |
Niacin |
||
|
(1) |
Nicotinic acid amide (Nicotinamide) |
FCC, USP, PhEur, BP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Nicotinic acid |
FCC, USP, BP, PhEur, IP |
|
|
9. |
Vitamin B6 |
||
|
(1) |
Pyridoxine hydrochloride |
FCC, USP, BP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Pyridoxal 5-phosphate |
MI, FCC, USP, IP |
|
|
10. |
Folic acid |
||
|
(1) |
N-Pteroyl-L-glutamic acid |
FCC, USP, PhEur, IP |
IF, FUF, MCCF, PCCF, FSMP |
|
(2) |
Calcium-L-methyl-folate |
JECFA (2005), IP |
FSMP |
|
11. |
Pantothenic acid |
||
|
(1) |
Calcium-D-pantothenate |
FCC, USP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Sodium-D-pantothenate |
DAB, IP |
|
|
(3) |
D-Panthenol |
FCC, USP, PhEur, IP |
|
|
(4) |
DL-Panthenol |
FCC, USP, PhEur, IP |
|
|
12. |
Vitamin B12 |
||
|
(1) |
Cyanocobalamin |
FCC, USP, BP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Hydroxo-cobalamin |
USP, PhEur, IP |
|
|
13. |
Vitamin K1 |
||
|
(1) |
Phytomenadione
(2-Methyl-3-phytyl-1,4-naphtho quinine/Phylloquinone/phytonadione) |
FCC, USP, PhEur, BP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
14 |
Vitamin K2 |
||
|
(1) |
Menaquinone |
USP |
IF, MCCF, PCCF, FUF, FSMP |
|
15 |
Biotin |
||
|
(1) |
D-biotin |
FCC, USP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
Advisory
list of amino acids and other nutrients for use in foods for infant nutrition
under the provisions of the regulations
|
S. No. |
Nutrient source |
Purity requirements by |
Use in foods for infant nutrition |
|
1. |
Amino acids |
||
|
(1) |
L-Arginine |
FCC, USP, PhEur, BP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
L-Arginine hydrochloride |
FCC, USP, PhEur, BP, IP |
|
|
(3) |
L-Cystine |
FCC, USP, PhEur, IP |
|
|
(4) |
L-Cystine dihydrochloride |
MI, IP |
|
|
(5) |
L-Cysteine |
DAB, IP |
|
|
(6) |
L-Cysteine hydrochloride |
FCC, PhEur, IP |
|
|
(7) |
L-Histidine |
FCC, USP, PhEur, IP |
|
|
(8) |
L-Histidine hydrochloride |
FCC, PhEur, DAB, IP |
|
|
(9) |
L-Isoleucine |
FCC, USP, PhEur, IP |
|
|
(10) |
L-Isoleucine hydrochloride |
FCC, USP, IP |
|
|
(11) |
L-Leucine |
FCC, USP, PhEur, IP |
|
|
(12) |
L-Leucine hydrochloride |
MI, FCC, USP, IP |
|
|
(13) |
L-Lysine |
USP, IP |
|
|
(14) |
L-Lysine mono hydrochloride |
FCC, USP, PhEur, IP |
|
|
(15) |
L-Methionine |
FCC, USP, PhEur, IP |
|
|
(16) |
L-Phenylalanine |
FCC, USP, PhEur, IP |
|
|
(17) |
L-Threonine |
FCC, USP, PhEur, IP |
|
|
(18) |
L-Tryptophan |
FCC, USP, PhEur, IP |
|
|
(19) |
L-Tyrosine |
FC C, USP, PhEur, IP |
|
|
(20) |
L-Valine |
FCC, USP, PhEur, IP |
|
|
(21) |
L-Alanine |
FCC, USP, PhEur, IP |
FSMP |
|
(22) |
L-Arginine-L-aspartate |
PhEur, IP |
|
|
(23) |
L-Aspartic acid |
FCC, USP, PhEur, IP |
|
|
(24) |
L-Citrulline |
USP, IP |
|
|
(25) |
L-Glutamic acid |
JECFA (1987), USP, FCC, PhEur, IP |
|
|
(26) |
L-Glutamine |
FCC, USP, PhEur, IP |
|
|
(27) |
Glycine |
FCC, USP, PhEur, IP |
|
|
(28) |
L-Ornithine |
MI, FCC, IP |
|
|
(29) |
L-Ornithine monohydrochloride |
DAB, IP |
|
|
(30) |
L-Proline |
FCC, USP, PhEur, IP |
|
|
(31) |
L-Serine |
USP, PhEur, IP |
|
|
(32) |
N-Acetyl-L-cysteine |
USP, PhEur, IP |
|
|
(33) |
N-Acetyl-L-methionine |
FCC, IP |
FSMP (Only for use in infants above
12 months) |
|
(34) |
L-Lysine acetate |
FCC, USP, MP, PhEur, IP |
FSMP |
|
(35) |
L-Lysine-L-aspartate |
Jap Food Stan, IP |
|
|
(36) |
L-Lysine-L-glutamate dihydrate |
Jap Food Stan, IP |
|
|
(37) |
Magnesium L-aspartate |
PhEur, IP |
|
|
(38) |
Calcium L-glutamate |
JEC FA, FCC, Jap Food Stan, IP |
|
|
(39) |
Potassium L-glutamate |
JEC FA, FCC, Jap Food Stan, IP |
|
|
2. |
Carnitine |
||
|
(1) |
L-Carnitine |
FCC, USP, PhEur, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
L-Carnitine hydrochloride |
FCC, IP |
|
|
(3) |
L-Carnitine tartrate |
FCC, PhEur, IP |
IF, FUF, FSMP |
|
3. |
Taurine |
||
|
(1) |
Taurine |
USP, IP, JP |
IF, FUF, FSMP |
|
4. |
Choline |
|
|
|
(1) |
Choline |
FCC, USP, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
(2) |
Choline chloride |
FCC, IP |
|
|
(3) |
Choline citrate |
USP, IP |
|
|
(4) |
Choline hydrogen tartrate |
DAB, IP |
|
|
(5) |
Choline bitartrate |
FCC, USP, DAB, IP |
|
|
5. |
Inositols |
||
|
(1) |
Myo-inositol |
FCC, IP |
IF, MCCF, PCCF, FUF, FSMP |
|
6. |
Nucleotides |
||
|
(1) |
Adenosine 5-monophosphate (AMP) |
FSANZ, IP |
IF, FUF, FSMP |
|
(2) |
Cytidine 5-mono phosphate (CMP) |
FSANZ, IP |
|
|
(3) |
Guanosine 5-mono phosphate (GMP) |
JECFA (1985), IP |
|
|
(4) |
Inosine 5-mono phosphate (IMP) |
JECFA (1974), IP |
|
|
(5) |
Disodium Uridine 5-monophosphate salt |
FSANZ, IP |
|
|
(6) |
Disodium Guanosine 5-mono phosphate
salt |
FCC, JECFA, FSANZ, IP |
|
|
(7) |
Disodium inosine 5-mono phosphate
salt |
FCC, JECFA, FSANZ, IP |
|
Free, hydrated and
anhydrous forms of amino acids and the hydrochloride, sodium and potassium
salts of amino acids may be used for Food for Special Medical Purpose.
Advisory
list of food additives for special nutrient formulations under the provisions
of the regulations
For reasons of
stability and safe handling, some vitamins and other nutrients have to be
converted into suitable preparations. For this purpose, the food additives
included in respective specific standards may be used. In addition, the
following food additives may be used as nutrient carriers.
|
Additive/Carrier |
INS No. |
Recommended maximum level in
Ready-to-Use foods for infant nutrition (mg/kg) |
|
Gum Arabic (gum acacia) |
414 |
10 |
|
Silicon dioxide |
551 |
10 |
|
Mannitol (for vitamin B12 dry
rubbing, 0.1% only) |
421 |
10 |
|
Starch sodium octenyl succinate |
1450 |
100 |
|
Sodium L-ascorbate (in coating of
nutrient preparations containing polyunsaturated fatty acids) |
301 |
75 |
Abbreviations:
BP: British
Pharmacopoeia
DAB: DeutschesArzneibuch
DVFA: Danishn
Veterinary and Food administration
FCC: Food Chemicals
Codex
FSANZ: Food Standards
Australia and New Zealand
FSMP: Foods for
Special Medical Purposes
FUF: Follow up
Formula
IF: Infant formula
IP: Indian
Pharmacopoeia
Jap Food Stan:
Japanese Food Standard
JECFA: FAO/WHO Joint
Expert Committee on Food Additives.
JP: The Pharmacopeia
of Japan
MCCF: Milk cereal
based complementary food
MI: Merck Index.
MP: Martindale
Pharmacopoeia
PCCF: Processed
cereal based complementary food
PhEur: Pharmacopeia
Europeia
USP: The United
States Pharmacopeia
[1] Substituted by Food
Safety and Standards (Foods for Infant Nutrition) First Amendment Regulations,
2022 vide Notification No. Std/SP-05/T(IFR-01) dated 30.08.2022, w.e.f.
01.10.2022, for the following:-
"Food Safety and
Standards (Labelling and Display) Regulations, 2020"
[2] Where only milk
protein is used, a factor N x 6.38 may be used
[3] Lauric acid and
myristic acids are constituents of fats, but combined shall not exceed 20 per
cent of total fatty acids. The contents of trans fatty acids shall not exceed 3
per cent of total fatty acids. The erucic acid content shall not exceed 1 per
cent of total fatty acids. The total content of phopsholipids shall not exceed
300 mg/100 kcal.
[4] 1 microgram DFE = 0.6
microgram folic acid
[5] Substituted by Food
Safety and Standards (Foods for Infant Nutrition) First Amendment Regulations,
2022 vide Notification No. Std/SP-05/T(IFR-01) dated 30.08.2022, w.e.f.
01.10.2022, for the following:-
|
"19. |
Vitamin B12, μg |
0.25-0.70 |
0.05-0.15" |
[6] If more than one of
the substances INS 322, 471 are added the maximum level for each of those
substance is lowered with the relative part as present of the other substances.
[7] If more than one of
the substances INS 322, 471 are added the maximum level for each of those
substance is lowered with the relative part as present of the other substances.
[8] Inserted by Food
Safety and Standards (Foods for Infant Nutrition) First Amendment Regulations,
2022 vide Notification No. Std/SP-05/T(IFR-01) dated 30.08.2022, w.e.f.
01.10.2022.
[9] 1 microgram DFE = 0.6
microgram folic acid
[10] Where the product is
intended to be mixed with water or milk before consumption, the minimum content
of protein shall be 15 per cent by weight. Protein Efficiency Ratio (PER) of
processed cereal based complementary food shall not be less than 70 per cent of
that of casein which is 2.5. In all cases, the addition of amino acids is
permitted solely for the purpose of improving the nutritional value of the
protein mixture and only in the proportions necessary for that purpose. Only
natural forms of L-amino acids shall be used.
[11] 1 microgram DFE = 0.6
microgram folic acid
[12] 1 microgram DFE = 0.6
microgram folic acid
[13] Substituted by Food
Safety and Standards (Foods for Infant Nutrition) First Amendment Regulations,
2022 vide Notification No. Std/SP-05/T(IFR-01) dated 30.08.2022, w.e.f.
01.10.2022, for the following:-
|
"15. |
Vitamin B12, µg |
0.25-0.70 |
0.05-0.15" |
[14] Substituted by Food
Safety and Standards (Foods for Infant Nutrition) First Amendment Regulations,
2022 vide Notification No. Std/SP-05/T(IFR-01) dated 30.08.2022, w.e.f.
01.10.2022, for the following:-
" 'pH adjusting
agents' "
[15] Inserted by Food
Safety and Standards (Foods for Infant Nutrition) First Amendment Regulations,
2022 vide Notification No. Std/SP-05/T(IFR-01) dated 30.08.2022, w.e.f.
01.10.2022.