The FSSAI has drafted new regulations called the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2019. The FSSAI has also invited comments, objections, and suggestions from stakeholders which are to reach the FSSAI office by 14 June 2019 and can also be mailed to [email protected] on or before this date. Though Food for Infant Nutrition Regulations exits as part of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, but now the FSSAI has proposed to frame a separate regulation which when implemented will supersede the existing regulation as the new proposed regulation will be more comprehensive. This regulation will also include standards for Infant formula for special medical purpose especially food for infants inborn with Errors of Metabolism (IEM). Standards have also been drafted for Premature infant milk substitutes, Lactose-free and Lactose and sucrose free infant milk substitutes under infant formula for special medical purposes. There are also standards for food for infants based on traditional food ingredients.
Draft Regulations
These regulations may be called as the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2019.
Definitions
- “Act” means the Food Safety and Standards Act, 2006 (34 of 2006)
- “Food Authority” means the Food Safety and Standards Authority of India established under section 4 of theAct
- “Infant” means a person not more than 12 months of age
- “Infant Food” shall have the meaning assigned to it in clause (x) of sub-section (1) of Section 3 of the Act
- “Infant Milk substitute” shall have the meaning assigned to it in clause (x) of sub-section (1) of Section 3 of the Act
- “Infant milk food” means a breast-milk substitute specially manufactured to meet the nutritional requirementsof infant.
- “Infant formula” means a breast milk substitute specially manufactured product based on milk of cow orbuffalo or mixture thereof and other ingredients which have been proven to be suitable for infant feeding, tomeet the nutritional requirements of infant.
- “Milk cereal based complementary food” means the food based on milk, cereals and /or legumes (pulses),millets, nuts and protein concentrates/protein isolates and/or defatted edible oilseed extracts and so prepared asto permit dilution with water or milk or other suitable medium.
- “Processed cereal based complementary food” means food based on cereals and legumes (pulses), millets, nutsand protein isolates/protein concentrates or de-fatted edible oil seed extracts and so prepared as to permitdilution with water milk or other suitable medium.
- “Follow-up formula” means a food intended for use as a liquid part of the complementary diet for infants whenprepared in accordance with instructions for use.
- “Infant Formula for special medical purpose” means a substitute for human milk or infant formula that isspecially manufactured to meet the special nutritional requirements of infants with specific disorders, diseasesor medical conditions.
- “Foods for Infant based on traditional food ingredients” are products known to be prepared traditionally athome for feeding infants, but processed and provided in packaged forms.
- “Schedules” means the Schedules to these regulations.
General requirements:
- Foods for infant nutrition shall be packed in hermetically sealed, clean and sound containers or in flexible packmade from paper, polymer and/ or metallic film as per the Food Safety and Standards (Packaging & Labelling)Regulations, 2011, so as to protect the contents from deterioration. It shall be packed under inert atmosphere.
- The category infant formula for special medical purposes provided under these regulations shall be exemptedfrom provisions specified under the Regulation 2.4 of the Food Safety and Standards (Packaging and Labelling)Regulations, 2011. Provided further that if any ingredients with known allergenicity are present, a warning shall bedeclared on the label.
- The categories infant formula for special medical purpose and food for infant based on traditional foodingredients provided under these regulations shall conform to the microbiological standards for milk and milkproducts of category infant formula as provided under Appendix B of the Food Safety and Standards (FoodProducts Standards and Food Additives) Regulations, 2011.
- A variation of ± 5.0% of the declared values of the added ingredients due to analytical variations shall beallowed.
- Wherever applicable, food for infant nutrition shall use the source compounds for minerals, vitamins and othernutrients from Schedule I (a), Schedule I (b) and Schedule I (c), respectively provided under these regulations.
- Foods for infant nutrition may contain algal and fungal oil as sources of Docosahexaenoic Acid (DHA) andArachidonic Acid (ARA) from Crypthecodinium cohnii, Mortierella alpina, Schizochytrium sp., and Ulkeniasp. 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 theaddition of DHA is made. Provided further that Infant Milk substitutes for premature infants shall contain not less than 0.2 %DHA of total fatty acids and ratio of ARA:DHA as 1:1 minimum.
- No person shall manufacture, sell, store or exhibit for sale, an infant milk food, infant formula and milk cerealbased complementary food, processed cereal based complementary food and follow up formula except underBureau of Indian Standards Certification Mark. Provided that the category infant formula for special medical purpose provided under these regulationsshall be exempted from the above provision.
- Food for infant nutrition shall comply with the requirements of the Infant Milk Substitutes, Feeding Bottles andInfant Foods (Regulation of Production, Supply and Distribution) Act, 1992 as amended in 2003 (IMS Act).Provided that in case of infant formula for special medical purpose where breastfeeding iscontraindicated on medical grounds for the disease(s), disorder(s) or medical condition(s) for which the productis intended, the labelling provision “MOTHER’S MILK IS BEST FOR YOUR BABY” shall not be required.
- 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 rulesin case of infant formula for special medical purpose.
Infant Milk Food
Scope: This standard applies to infant milk food in powder form for meeting the normal nutritional requirements ofinfant.
Composition:
- Infant milk food is a product based on milk of cow or buffalo or mixture thereof, and othernutrients and ingredients which have been provided under these regulations.
- The product may be modified by partial removal or substitution of different milk solids and addition ofcarbohydrates such as sucrose, dextrose, maltose, lactose and maltodextrin; and salts such as phosphates andcitrates.
- The product shall be uniform and free from lumps and coarse particles. It shall be free from rancid taste andmusty odour.
- The infant milk food shall conform to the following requirements:
S. N | Parameters | Limits | Limits per 100 kcal | ||
Minimum | Maximum | Minimum | Maximum | ||
1. | Moisture, per cent by weight | 4.5 | |||
2. | Total milk protein (N x 6.38), per cent by weight | 12.0 | 2.50 | ||
3. | Milk fat, per cent by weight | 18.0 | 3.80 | ||
4. | Total ash, per cent by weight | 8.50 | |||
5. | Ash insoluble in dilute hydrochloric acid, per cent by weight | 0.10 | |||
6. | Trans fatty acids, per cent by weight of total fatty acids | 3.0 | |||
7. | Energy per 100 ml of the reconstituted product prepared in accordance with manufacturer’s instructions | 60 kcal | 70 kcal | ||
8. | Carbohydrates, g per 100 g | 45.0 | 70.0 | 9.60 | 14.90 |
9. | Vitamin A (as retinol equivalent, RE), µg per 100 g | 350.0 | 400.0 | 75.00 | 85.00 |
10. | Vitamin D (expressed as cholecalciferol or ergocalciferol), µg per 100 g | 5.0 | 10.0 | 1.00 | 2.10 |
11. | Vitamin E (alpha tocopherol equivalent), mg per 100 g | 2.50 | 6.0 | 0.50 | 1.30 |
12. | Vitamin K, µg per 100 g | 7.50 | 15.0 | 1.60 | 3.20 |
13. | Vitamin C, mg/ per 100 g (as ascorbic acid) | 25.0 | 40.0 | 5.30 | 8.30 |
14. | Thiamine, µg per 100 g | 200.0 | 300.0 | 42.60 | 63.80 |
15. | Riboflavin, µg per 100 g | 400.0 | 2000.0 | 85.10 | 425.50 |
16. | Niacin equivalent, µg per 100 g | 3800.0 | 5500.0 | 808.50 | 1170.20 |
17. | Pyridoxine, µg per 100 g | 100.0 | 400.0 | 21.30 | 85.10 |
18. | Dietary Folate equivalent (DFE) (Folic acid), µg per 100 g* | 15.0 | 50.0 | 3.20 | 10.60 |
19. | Pantothenic acid, µg per 100 g | 2000.0 | 10000.0 | 425.50 | 2127.70 |
20. | Vitamin B12, µg per 100 g | 0.25 | 0.50 | 0.050 | 0.10 |
21. | Biotin, µg per 100 g | 7.50 | 50.0 | 1.60 | 10.60 |
22. | Choline, mg per 100 g | 32.0 | 6.80 | ||
23. | Sodium, mg per 100 g | 90.0 | 300.0 | 19.10 | 63.80 |
24. | Potassium, mg per 100 g | 300.0 | 900.0 | 63.80 | 191.50 |
25. | Chloride, mg per 100 g | 250.0 | 800.0 | 53.20 | 170.20 |
26. | Calcium, mg per 100 g | 250.0 | 500.0 | 53.20 | 106.40 |
27. | Phosphorous, mg per 100 g | 125.0 | 500.0 | 26.60 | 106.40 |
28. | Calcium: Phosphorus ratio | 1:1 | 2:1 | 1:1 | 2:1 |
29. | Magnesium, mg per 100 g | 30.0 | 40.0 | 6.40 | 8.50 |
30 | Iron, mg per 100 g | 3.0 | 5.0 | 0.60 | 1.0 |
31. | Iodine, µg per 100 g | 90.0 | 120.0 | 19.10 | 25.50 |
32. | Copper, µg per 100 g | 160.0 | 470.0 | 34.0 | 100.0 |
33. | Zinc, mg per 100 g | 2.50 | 5.0 | 0.50 | 1.0 |
34. | Manganese, µg per 100 g | 5.0 | 500.0 | 1.0 | 106.40 |
35. | Selenium, µg per 100 g | 5.0 | 17.0 | 1.00 | 3.60 |
* 1 microgram DFE = 0.6 microgram folic acid
In addition, the product may also contain optional ingredients as provided in regulation on Infant formula given in the table below.
Food additives: No food additives are permitted in infant milk food. However, food additives shown in Schedule I(d) for special nutrient formulations may be used.
Infant formula
Scope: This standard applies to infant formula in powder or liquid form for meeting the normal nutritionalrequirements of infant.
(Composition:
- Infant formula is a product based on milk of cow or buffalo or mixture thereof, and other nutrientsand ingredients which have been provided under these regulations.
- The product may be modified by partial removal or substitution of different milk solids and addition ofcarbohydrates such as sucrose, dextrose, maltose, lactose and maltodextrin; and salts such as phosphates andcitrates.
- The infant formula may contain vegetable oils rich in polyunsaturated fatty acids to partially substitute milk fat.Hydrogenated vegetable oils and fats shall not be used in infant formula.
- Infant formula may contain gluten free pre-cooked and/or gelatinized starches up to 30% of total carbohydratesin powder and up to 2 g/100 ml in liquid.
- Only lactic acid producing bacteria listed under schedule VII of the Food Safety and Standards (HealthSupplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foodand Novel Food) Regulations, 2016 may be used along with other requirements laid down under the sameregulations.
- The product shall be uniform and free from lumps and coarse particles. It shall be free from rancid taste andmusty odour.
The infant formula shall conform to the following requirements
S.N | Parameters | Limits | Limits per 100 kcal | ||
Minimum | maximum | Minimum | Maximum | ||
1. | Moisture, percent by weight | 4.5 | |||
2. | Energy per 100 ml of the product prepared in accordance with the manufacturer’s instructions | 60 kcal | 70kcal | ||
3. | Total Protein (N x 6.25*), per cent by weight | 10.0 | 16.0 | 2.10 | 3.40 |
4. | Total fat, g per 100 g Milk fat, g per 100 g | 18.0 12.0 | 25.0 | 3.80 2.50 | 5.30 |
5. | a) Linoleic acid, g per 100 g b) α-Linolenic acid, mg per 100 g c) Ratio of Linoleic acid/α-Linolenic acid | 1.50 250.0 6.1 | 7.0 | 0.30 53.20 6.1 | 1.50 |
6. | Sum of lauric and myristic acids, per cent byweight of total fatty acids Erucic acid, percent by weight of total fattyacids | 20.0 1.0 | 4.25 0.20 | ||
7. | Trans fatty acids, percent by weight of totalfatty acids | 3.0 | |||
8. | Carbohydrates, per cent by weight a. Galactooligosaccharides and / or fructooligosaccharides, per cent of carbohydrates | 45.0 | 70.0 10.0 | 9.60 | 14.90 2.10 |
9. | Total ash, percent by weight | 8.50 | |||
10. | Ash insoluble in dilute hydrochloric acid, percent by weight | 0.10 | |||
11. | Vitamin A (as retinol equivalent, RE), µg per100 g | 350.0 | 400.0 | 75.0 | 85.0 |
12. | Vitamin D (expressed as cholecalciferol orergocalciferol), µg per 100 g | 5.0 | 10.0 | 1.00 | 2.10 |
13. | Vitamin E (alpha tocopherol equivalent), mgper 100 g | 2.50 | 6.0 | 0.50 | 1.30 |
14. | Vitamin K, µg per 100 g | 7.50 | 15.0 | 1.60 | 3.20 |
15. | Vitamin C, mg per 100 g (expressed as ascorbic acid) | 25.0 | 40.0 | 5.30 | 8.30 |
16. | Thiamine, µg per 100 g | 200.0 | 300.0 | 42.60 | 63.80 |
17. | Riboflavin, µg per 100 g | 400.0 | 2000.0 | 85.10 | 425.50 |
18. | Niacin equivalent, µg per 100 g | 3800.0 | 5500.0 | 808.50 | 1170.20 |
19. | Pyridoxine, µg per 100 g | 100.0 | 400.0 | 21.30 | 85.10 |
20. | Dietary Folate equivalent (DFE) (Folic acid),µg per 100 g# | 15.0 | 50.0 | 3.20 | 10.60 |
21. | Pantothenic acid, µg per 100 g | 2000.0 | 10000.0 | 425.50 | 2127.70 |
22. | Vitamin B12, µg per 100 g | 0.25 | 0.50 | 0.05 | 0.10 |
23. | Biotin, µg per 100 g | 7.50 | 50.0 | 1.60 | 10.60 |
24. | Choline, mg per 100 g | 32.0 | 6.80 | ||
25. | Sodium, mg per 100 g | 90.0 | 300.0 | 19.15 | 63.80 |
26. | Potassium, mg per 100 g | 300.0 | 900.0 | 63.82 | 191.48 |
27. | Chloride, mg per 100 g | 250.0 | 800.0 | 53.20 | 170.20 |
28. | Calcium, mg per 100 g | 250.0 | 700.0 | 53.20 | 148.90 |
29. | Phosphorous, mg per 100 g | 125.0 | 500.0 | 26.60 | 106.40 |
30 | Calcium: Phosphorus ratio | 1:1 | 2:1 | 1:1 | 2:1 |
31. | Magnesium, mg per 100 g | 30.0 | 40.0 | 6.40 | 8.50 |
32. | Iron, mg per 100 g | 3.0 | 5.0 | 0.60 | 1.0 |
33. | Iodine, µg per 100 g | 90.0 | 120.0 | 19.15 | 25.50 |
34. | Copper, µg per 100 g | 160.0 | 470.0 | 34.0 | 100.0 |
35. | Zinc, mg per 100 g | 2.50 | 5.0 | 0.50 | 1.0 |
36. | Manganese, µg per 100 g | 5.0 | 500.0 | 1.0 | 106.40 |
37. | Selenium, µg per 100 g | 5.0 | 17.0 | 1.00 | 3.60 |
* where milk protein is used, a factor N x 6.38 may be used
#1 microgram DFE = 0.6 microgram folic acid
Optional Ingredients: when prepared in accordance with instructions for use infant formulamay contain othernutrients which are ordinarily found in human milk in amounts prescribed below:
S. N | Ingredient | Limits, mg per 100 g / ml | |
Minimum | Maximum | ||
1. | Carotenes | 0.025 | – |
2. | Amino acids (L forms) | 0.90 | – |
3. | Non-protein nitrogen | 17.0 | – |
4. | Nucleotides | 1.17 | – |
5. | L-carnitine | 1.13 | – |
6. | Lactalbumin | 140.0 | – |
7. | Lactoferrin | 30.0 | – |
8. | Lysozyme | 80.0 | – |
9. | Glucosamine | 70.0 | – |
10. | Inositol | 3.0 | – |
11. | Citric acid | 35.0 | – |
12. | Cholesterol | 8.80 | – |
13. | Fucose | 130.0 | – |
14. | Lipid phosphorous | 0.70 | – |
15. | Prostaglandins | PGE 15.0 PGF 40.0 | – |
16. | Taurine | – | 60.0 |
17. | Molybdenum, µg | 7.50 | 50.0 |
18. | Chromium, µg | 7.50 | 50.0 |
Food additives:
Infant formula shall be free from added colour and flavour. The following food additives may beused in the preparation of infant formula ready for consumption prepared following manufacturer’s instructions, unlessotherwise indicated:
INS No. | Additive | Maximum Level (g per 100 ml) |
Thickeners | ||
410 | Carob bean gum | 0.1 |
407 | Carrageenan | 0.03 (in regular milk and soy based liquidinfant formula only) |
Emulsifiers | ||
322 | Lecithin | 0.5 |
471 | Mono- and diglycerides | 0.4 |
472c | Citric and fatty acid esters of glycerol | 0.9 (in all types of liquid infant formula) 0.75 (in all types of powdered infantformula) |
Acidity Regulators | ||
524 | Sodium hydroxide | 0.2 (singly or in combination and within thelimits for sodium, potassium and calcium in regulation 5(2)(vii) |
500ii | Sodium hydrogen carbonate | |
500i | Sodium carbonate | |
501iii | Potassium hydrogen carbonate | |
501i | Potassium carbonate | |
525 | Potassium hydroxide | |
526 | Calcium hydroxide | |
270 | L (+) lactic acid | GMP |
330 | Citric acid | GMP |
33li | Sodium dihydrogen citrate | GMP |
331liii | Trisodium citrate | GMP |
332 | Potassium citrate | GMP |
339 i, ii and iii | Sodium dihydrogen phosphate, disodium hydrogenphosphate and trisodium phosphate | 45 mg as phosphorous singly or incombination and within limits for sodium,potassium and phosphorous in 5. (2)(vii) |
340 i, ii and iii | Potassium dihydrogen phosphate, dipotassiumhydrogen phosphate and tripotassium phosphate | |
Antioxidants | ||
307b | Mixed tocopherol concentrate | 1 mg (singly or in combination) |
304i | Ascorbyl palmitate | 1 mg (singly or in combination) |
Packaging gases | ||
290 | Carbon dioxide | GMP |
941 | Nitrogen | GMP |
(ii) Food additives shown in Schedule I (d) for special nutrient formulations may also be used.
Milk cereal based complementary
Scope: This standard applies to milk cereal based complementary food in powder form intended to complement the diet of infant.
Composition:
- Milk cereal based complementary food is based on milk of cow or buffalo or mixture thereof,and/or other nutrients/ingredients which have been provided under these regulations.
- It may contain a variety of cereals, pulses, soybean and millets.
- It may also contain edible vegetable oil, defatted edible oil seed extracts, protein concentrates / protein isolates,milk solids, various carbohydrates such as sucrose, dextrose, maltose, lactose, and malto dextrin, and salts such asphosphates and citrates. It shall not contain hydrogenated fats.
- It may contain fruits and vegetables or their products, egg or egg products, and nuts or their products.
- The product shall be free from lumps and coarse particles, and shall be uniform in appearance. It shall be freefrom rancid taste and musty odour.
- The milk cereal based complementary food shall conform to the following requirements, namely:
S N | Parameters | Limits | Limits per 100 kcal | ||
Minimum | Maximum | Minimum | Maximum | ||
1. | Moisture, percent by weight | 5.0 | |||
2. | Total Protein, per cent by weight (N x6.25) Milk Protein, per cent by weight | 15.0 5.0 | 3.20 1.0 | ||
3. | Total fat, per cent by weight (includingmilk fat) Milk fat (alone), percent by weight | 7.50 5.0 | 1.60 1.0 | ||
4. | Total Carbohydrates, per cent by weight | 55.0 | 11.70 | ||
5. | Total ash, per cent by weight | 5.0 | |||
6. | Ash insoluble in dilute hydrochloric acid;per cent by weight | 0.10 | |||
7. | Crude fibre (on dry basis), percent byweight | 1.0 | |||
8. | Vitamin A (as retinol equivalent, RE), µg per100 g | 350.0 | 400.0 | 75.0 | 85.0 |
9. | Vitamin D (expressed as cholecalciferol orergocalciferol), µg per 100 g | 5.0 | 10.0 | 1.00 | 2.10 |
10. | Vitamin C, mg per 100 g (expressed asascorbic acid) | 25.0 | 40.0 | 5.30 | 8.30 |
11. | Thiamine, µg per 100 g | 0.20 | 0.30 | 0.04 | 0.06 |
12. | Riboflavin, µg per 100 g | 0.40 | 2.0 | 0.08 | 0.40 |
13. | Niacin equivalent, µg per 100 g | 3.80 | 5.50 | 0.80 | 1.20 |
14. | Dietary Folate equivalent (DFE) (Folicacid), µg per 100 g* | 15.0 | 50.0 | 3.20 | 10.60 |
15. | Iron, mg per 100 g | 3.0 | 5.0 | 0.60 | 1.0 |
16. | Zinc, mg per 100 g | 2.50 | 5.0 | 0.50 | 1.0 |
*1 microgram DFE = 0.6 microgram folic acid
Optional Ingredient / Nutrient: It may also contain optional ingredient / nutrient as below:
S. N | Ingredient / Nutrient | Limits per 100 g | Limits per 100 kcal | ||
Minimum | Maximum | Minimum | Maximum | ||
1. | Pantothenic acid, mg | 2.0 | 10.0 | 0.40 | 2.10 |
2. | Vitamin B 12, µg | 0.25 | 0.50 | 0.07 | 0.10 |
3. | Vitamin K, µg | 7.50 | 15.0 | 1.60 | 3.20 |
4. | Choline, mg | – | 32.0 | – | 6.80 |
5. | Inositol, mg | 20.0 | 200.0 | 4.25 | 42.55 |
6. | Calcium, mg | 250.0 | 700.0 | 53.20 | 14.90 |
7. | Phosphorus, mg | 125.0 | 500.0 | 26.60 | 106.40 |
8. | Chloride, mg | 250.0 | 800.0 | 53.20 | 170.20 |
9. | Magnesium, mg | 30.0 | 40.0 | 6.40 | 8.50 |
10. | Sodium, mg | 90.0 | 300.0 | 19.15 | 63.80 |
11. | Selenium, µg | 5.0 | 17.0 | 1.0 | 3.60 |
12. | Taurine, mg | – | 60.0 | – | 12.75 |
13. | L-amino acids, mg | 0.9 | – | 0.20 | – |
14. | L-Carnitine, mg | 5.0 | – | 1.0 | – |
15. | Biotin, µg | 7.50 | 50.0 | 1.60 | 10.60 |
16. | Iodine, µg | 90.0 | 120.0 | 19.15 | 25.50 |
17. | Potassium, mg | 300.0 | 900.0 | 63.80 | 191.50 |
18. | Pyridoxine, µg | 100.0 | 400.0 | 21.30 | 85.10 |
Food Additives:
Milk cereal based complementary food shall be free from preservatives, added colours andflavours. The following food additives may be used in preparation of Milk cereal based complementary food forconsumption prepared following manufacturer’s instructions, unless otherwise indicated.
INS Number | Additive | Maximum Level g per 100 g |
Thickeners | ||
410 | Carob bean gum | 0.1 |
1412 | Distarch phosphate | 0.5 (singly or in combination) |
1414 | Acetylated distarch phosphate | |
407 | Carrageenan | 0.03 (in regular milk and soy based liquid infant formula only) |
Emulsifiers | ||
322 | Lecithin | 0.5 |
471 | Mono- and diglycerides | 0.4 |
Acidity Regulators | ||
524 | Sodium hydroxide | 0.2 (singly or in combination and within the limits for sodium, potassium and calcium in regulation 6 (2)(vii) |
500ii | Sodium hydrogen carbonate | |
500i | Sodium carbonate | |
501iii | Potassium hydrogen carbonate | |
501i | Potassium carbonate | |
525 | Potassium hydroxide | |
526 | Calcium hydroxide | |
270 | L (+) lactic acid | GMP |
330 | Citric acid | GMP |
33li | Sodium dihydrogen citrate | GMP |
331liii | Trisodium citrate | GMP |
332 | Potassium citrate | GMP |
Antioxidants | ||
307b | Mixed tocopherol concentrate | 1 mg |
304i | Ascorbyl palmitate | 1 mg |
Packing agents | ||
290 | Carbon dioxide | GMP |
941 | Nitrogen | GMP |
Enzymes | ||
Alpha Amylase | GMP |
Food additives shown in Schedule I (d) for special nutrient formulations may also be used.
- The milk cereal based complementary food prepared in the community kitchens (freshly prepared and distributedwithout storing) shall meet all the hygiene requirements specified by the FSSAI.
Processed cereal based complementary Food
Scope: This standard applies to processed cereal based complementary food in powder form intended to complementthe diet of infant.
Composition:
- Processed cereal based complementary food is a product based on variety of cereals, pulsesincluding soybean, millets, nuts and edible oil seeds.
- It shall contain milled cereals and legumes combined accounting for not less than 75 per cent.
- Where the product is intended to be mixed with water or milk before consumption, the minimum content ofprotein shall be 15 per cent. by weight.
- Protein Efficiency Ratio (PER) of processed cereal based complementary food shall not be less than 70 percent. of that of casein.
- The Sodium content of the product shall not exceed 100 mg per 100 kcals of the ready-to-eat product.
- It may also contain other ingredients such as protein concentrates, essential amino acids, milk and milkproducts, eggs and egg products, edible vegetable oils, defatted edible oil seed extracts, fruits and vegetables ortheir products, nuts or their products, various carbohydrates such as sucrose, dextrose, lactose, maltodextrin, honey,corn syrup and malt. It shall not contain hydrogenated vegetable fats.
- The product shall be free from lumps and coarse particles, and shall be uniform in appearance. It shall be freefrom rancid taste and musty odour.
- It may also contain probiotic ingredient(s) as provided under schedule VII of the Food Safety and Standards(Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, FunctionalFood and Novel Food) Regulations, 2016.
- It shall conform to the following requirements, namely:
S. N | Parameters | Limits | Limits per 100 kcal | ||
Minimum | Maximum | Minimum | Maximum | ||
1. | Moisture, percent by weight | 5.0 | |||
2. | Protein (N x 6.25), Percent by weight | 15.0 | 3.20 | ||
3. | Total Fat, per cent by weight | 7.50 | 1.60 | ||
4. | Total Carbohydrates, per cent by weight | 55.0 | 11.70 | ||
5. | Total ash, percent by weight | 5.0 | |||
6. | Ash insoluble in diluteHydrochloric acid, percent by weight | 0.10 | |||
7. | Crude fibre (on dry basis), percent by weight | 1.0 | |||
8. | Vitamin A (as retinol equivalent, RE), µg per100 g | 350.0 | 400.0 | 75.0 | 85.0 |
9. | Vitamin D (expressed as cholecalciferol orergocalciferol), µg per 100 g | 5.0 | 10.0 | 1.00 | 2.10 |
10. | Vitamin C, mg per 100 g (expressed asascorbic acid) | 25.0 | 40.0 | 5.30 | 8.30 |
11. | Thiamine, µg per 100 g | 0.20 | 0.30 | 0.04 | 0.06 |
12. | Riboflavin, µg per 100 g | 0.40 | 2.0 | 0.08 | 0.40 |
13. | Niacin equivalent, µg per 100 g | 3.80 | 5.50 | 0.80 | 1.20 |
14. | Dietary Folate equivalent (DFE) (Folicacid), µg per 100 g* | 15.0 | 50.0 | 3.20 | 10.60 |
15. | Iron, mg per 100 g | 3.0 | 5.0 | 0.60 | 1.0 |
16. | Zinc, mg per 100 g | 2.50 | 5.0 | 0.50 | 1.0 |
17. | Pantothenic acid, mg per 100 g | 2.0 | 10.0 | 0.40 | 2.10 |
18. | Pyridoxine, µg per 100 g | 100.0 | 400.0 | 21.30 | 85.10 |
19. | Vitamin B12, µg per 100 g | 0.25 | 0.50 | 0.05 | 0.10 |
20. | Biotin, µg per 100 g | 7.50 | 50.0 | 1.60 | 10.60 |
21. | Choline, mg per 100 g | 32.0 | 6.80 | ||
22. | Inositol, mg per 100 g | 20.0 | 200.0 | 4.25 | 42.55 |
23. | Selenium, µg per 100g | 5.0 | 17.0 | 1.0 | 3.60 |
*1 microgram DFE = 0.6 microgram folic acid
Food Additives:
The Product shall be free from preservatives, added colours and flavours. Following additives arepermitted in the preparation of Grain based Complementary food for infants in 100 g of the product ready forconsumption prepared following manufacturer’s instructions unless otherwise indicated.
INS No | Additive | Maximum level |
Emulsifiers | ||
322 | Lecithin | 1500 mg |
471 | Mono- and diglycerides | 5000 mg singly or in combination |
472a | Acetic fatty acid esters of glycerol | |
472b | Lactic fatty acid esters of glycerol | |
472c | Citric acid fatty acid esters of glycerol | |
Acidity Regulators | ||
500ii | Sodium hydrogen carbonate | GMP |
501ii | Potassium hydrogen carbonate | GMP |
170i | Calcium carbonate | GMP |
270 | L(+)lactic acid | GMP |
260 | Acetic acid | GMP |
261 | Potassium acetate | GMP |
262i | Sodium acetate | GMP |
296 | Malic acid (DL)-L (+) form | GMP |
325 | Sodium lactate (solution)-L (+) form | GMP |
326 | Potassium lactate (solution)-L (+) form | GMP |
327 | Calcium lactate-L (+) form | GMP |
331i | Monosodium citrate | GMP |
331ii | Trisodium citrate | GMP |
332i | Monopotassium citrate | GMP |
32ii | Tripotassium citrate | GMP |
333 | Calcium citrate | GMP |
507 | Hydrochloric acid | GMP |
524 | Sodium hydroxide | GMP |
525 | Potassium hydroxide | GMP |
526 | Calcium hydroxide | GMP |
575 | Glucono-delta-lactone | GMP |
334 | L (+) Tartaric acid | 500 mg singly or in combination |
335i | Monosodium tartrate | |
335ii | Disodium tartrate | |
336i | Mono potassium tartrate –L (+) form | |
338 | Ortho phosphoric acid | only for pH adjustment; 440 mg singly or in combination as phosphorous |
339i | Mono sodium ortho phosphate | |
339ii | Disodium orthophosphate | |
339iii | Trisodium orthophosphate | |
340i | Monopotassium orthophosphate | |
340ii | Dipotassium orthophosphate | |
340iii | Tripotassium orthophosphate | |
341i | Monocalcium orthophosphate | |
341ii | Dicalcium orthophosphate | |
341iii | Tricalcium orthophosphate | |
Antioxidants | ||
306 | Mixed tocopherol concentrate | 300 mg/Kg fat or oil singly or incombination of tocopherol |
307 | Alpha tocopherol | |
304 | L-ascorbyl palmitate | 200 mg/kg fat or oil |
300 | L-ascorbic acid | 50 mg expressed as ascorbic acid |
301 | Sodium ascorbate | |
303 | Potassium ascorbate | |
302 | Calcium ascorbate | 20 mg expressed as ascorbic acid |
Raising Agents | ||
503i | Ammonium carbonate | GMP |
503ii | Ammonium hydrogen carbonate | GMP |
500i | Sodium carbonate | GMP |
500ii | sodium hydrogen carbonate | GMP |
Thickeners | ||
410 | Carob bean gum | 1000 mg singly or in combination |
412 | Guar gum | |
414 | Gum Arabic | |
1404 | Oxidized starch | 5000 mg singly or in combination |
1410 | Mono starch phosphate | |
1412 | Distarch phosphate | |
1413 | Phosphated distarch phosphate | |
1414 | Acetylated distarch phosphate | |
1422 | Acetylated distarch adipate | |
1420 | Starch acetate esterified with acetic anhydride | |
1450 | Starch sodium octenyl succinate | |
1451 | Acetylated oxidized starch | |
Anticaking agent | ||
551 | Silicon dioxide | GMP |
Packaging gases | ||
290 | Carbon dioxide | GMP |
941 | Nitrogen | GMP |
Enzymes | ||
Alpha amylase | GMP | |
Food additives shown in Schedule I (d) for special nutrient formulations may also be used.
- The processed cereal based complementary foods for use in specific conditions, where protein needs to be restrictedand where other cereals like wheat, soya, legumes and milk cannot be used, such processed cereal based complementaryfoods shall be prepared with single cereal like rice or ragi, which shall have the minimum protein content of 6-9 percent, such products shall be conspicuously labelled, “mono grain based complementary foods for use in specificconditions under medical guidance only”.
- Process cereal based complementary food prepared in the community kitchens shall meet all the hygienicrequirements specified by the FSSAI and freshly prepared and distributed and not stored.
Follow-up Formula
Scope: This standard applies to the composition of Follow-up formula. The product shall be nutritionally adequate tocontribute to normal growth and development when used in accordance with its directions for use. Follow-up formula,in powdered form requires water for preparation.
Composition:
- Follow-up formula is a product based on milk of cow or buffalo or mixture thereof, and othernutrients and ingredients provided under these regulations.
- The follow-up formula shall have protein content minimum of 3 g per 100 kcal derived from whole or skimmedmilk or with minor modification that does not substantially impair the vitamin or mineral content of milk and whichrepresents a minimum of 90 % of total protein.
- The quality of protein shall not be less than 85 % of that of casein.
- Fat not less than 3 g and not more than 6 g per 100 kcal. Linoleic acid in fat shall not be less than 300 mg per100 kcal.5000 mg singly or incombination
- The product shall contain nutritionally available carbohydrates suitable for feeding in such quantities so as toadjust 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 to85 kcal of energy.
- The product shall be free from lumps and coarse particles, and shall be uniform in appearance. It shall be freefrom rancid taste and musty odour.
- The product may contain vegetable proteins.
- The Product shall conform to the following requirements, namely:
S. N | Parameters | Limits | Limits per 100 kcal | ||
Minimum | Maximum | Minimum | Maximum | ||
1. | Moisture, per cent by weight | 4.50 | |||
2. | Total ash, per cent by weight | 8.50 | |||
3. | Ash insoluble in dilute hydrochloric acid, per cent by weight | 0.10 | |||
4. | Vitamin A (as retinol equivalent, RE), µg per 100 g | 350.0 | 400.0 | 75.00 | 85.00 |
5. | Vitamin D (expressed as cholecalciferol or ergocalciferol), µg per 100 g | 5.0 | 10.0 | 1.00 | 2.10 |
6. | Vitamin E (alpha tocopherol equivalent), mg per 100 g | 2.50 | 6.0 | 0.50 | 1.30 |
7. | Vitamin K, µg per 100 g | 7.50 | 15.0 | 1.60 | 3.20 |
8. | Vitamin C, mg/ per 100 g (as ascorbic acid) | 25.0 | 40.0 | 5.30 | 8.30 |
9. | Thiamine, µg per 100 g | 200.0 | 300.0 | 42.55 | 63.80 |
10. | Riboflavin, µg per 100 g | 400.0 | 2000.0 | 85.10 | 425.50 |
11. | Niacin equivalent, µg per 100 g | 3.80 | 5.50 | 0.80 | 1.20 |
12. | Pyridoxine, µg per 100 g | 100.0 | 400.0 | 21.30 | 85.10 |
13. | Dietary Folate equivalent (DFE) (Folic acid), µg per 100 g* | 15.0 | 50.0 | 3.20 | 10.60 |
14. | Pantothenic acid, µg per 100 g | 2.0 | 10.0 | 0.40 | 2.10 |
15. | Vitamin B12, µg per 100 g | 0.25 | 0.50 | 0.05 | 0.10 |
16. | Biotin, µg per 100 g | 7.50 | 15.0 | 1.60 | 3.20 |
17. | Choline, mg per 100 g | 32.0 | 6.80 | ||
18. | Sodium, mg per 100 g | 90.0 | 300.0 | 19.15 | 63.80 |
19. | Potassium, mg per 100 g | 300.0 | 900.0 | 63.80 | 191.50 |
20. | Chloride, mg per 100 g | 250.0 | 800.0 | 53.20 | 170.20 |
21. | Calcium, mg per 100 g | 405.0 | 800.0 | 86.20 | 170.20 |
22. | Phosphorous, mg per 100 g | 270.0 | 500.0 | 57.45 | 106.40 |
23. | Magnesium, mg per 100 g | 30.0 | 40.0 | 6.40 | 8.50 |
24. | Iron, mg per 100 g | 3.0 | 5.0 | 0.60 | 1.0 |
25. | Iodine, µg per 100 g | 90.0 | 120.0 | 19.15 | 25.50 |
26. | Copper, µg per 100 g | 160.0 | 470.0 | 34.0 | 100.0 |
27. | Zinc, mg per 100 g | 2.50 | 5.0 | 0.50 | 1.0 |
28. | Manganese, µg per 100 g | 5.0 | 50.0 | 1.0 | 10.60 |
29. | Selenium, µg per 100 g | 5.0 | 17.0 | 1.00 | 3.60 |
30 | Inositol | 40 | 8.50 | ||
31. | Taurine, mg per 100 g | 60.0 | 12.75 | ||
32. | Essential Amino acids, mg per 100 ml | 0.9 | 0.19 |
*1 microgram DFE = 0.6 microgram folic acid
Food Additives: It shall be free from added starch and colours. The following additives may be used in the preparation of Follow up formula ready for consumption prepared following manufacturer’s instructions, unless otherwise indicated.
INS No | Additive | Maximum level |
Thickening Agents | ||
412 | Guar gum | 0.1 |
410 | Locust bean gum (carob bean gum) | 0.5 (singly or in combination) |
1412 | Distarch phosphate | |
1414 | Acetylated distarch phosphate | |
1413 | Phosphated distarch phosphate | |
1414 | Acetylated distarch adipate | 2.5 (in hydrolyzed protein and/or Aminoacid-basedproduct) |
407 | Carrageenan | 0.03 (in milk and soy-based product) |
440 | Pectin | 1 |
Emulsifiers | ||
322 | Lecithin | 0.5 |
471 | Mono- and diglycerides | 0.4 |
pH adjusting agents | ||
500i | Sodium carbonate | limited by GMP within the limits for sodium in 8. (2)(viii) |
500ii | Sodium hydrogen carbonate | |
331i | Sodium citrate | |
501ii | Potassium hydrogen carbonate | |
501i | Potassium carbonate | |
332i | Potassium citrate | |
524 | Sodium hydroxide | |
525 | Potassium hydroxide | |
526 | Calcium hydroxide | |
270 | L (+) lactic acid L (+) lactic acid producing cultures | |
330 | Citric acid | |
Antioxidants | ||
306 | Mixed tocopherol concentrate | 3 (singly or in combination) |
307 | Alpha tocopherol | 5 mg singly or in combination expressed as ascorbic acid |
304 | L-ascorbyl palmitate | |
300 | 300 L-ascorbic acid | |
301 | Sodium ascorbate | |
302 | Calcium ascorbate | |
Flavours | ||
Natural fruit extracts | GMP | |
Vanilla extract | GMP | |
Ethyl vanilla | 5mg | |
Vanillin | 5mg |
Food additives shown in Annexure I (d) for special nutrient formulations may also be used.
- The follow-up formula prepared in the community kitchens shall meet all the hygienic requirements specified by the FSSAI and freshly prepared and distributed and not stored.
Infant Formula for Special Medical Purpose (FSMP)
Scope: This standard applies to Infant Formula for special Medical purpose in liquid or powdered form intended for use, where necessary, as a substitute for human milk or infant formula in meeting the special nutritional requirements arising from the disorder, disease or medical condition for whose dietary management the product has been formulated.
Composition:
- Infant formula for special medical purpose is a product based on ingredients (from known and well-established sources) suitable for human consumption.
- The composition of infant formula for special medical purpose 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.
- The energy content and nutrient composition of the Formula for special Medical Purpose intended for infants shall be based on the requirements for Infant Formula specified under regulation 5(2)(vii) except for the compositional provisions which must be modified to meet the especial nutritional requirements arising from disease(s) for whose dietary management the product is specifically formulated, labelled and presented.
- Optional ingredients: In addition to the compositional requirements listed under regulation 5(2)(vii)for infant formula, in order to provide substances ordinarily found in human milk or required other ingredients as specified under regulation 5(2)(viii) 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.
- 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.
- Only L (+) lactic acid producing cultures may be used in the formulas for special medical purposes for infants if shown to be safe and appropriate for use in these vulnerable populations.
No food business operator shall advertise the infant formula for special medical purpose.
(1) Premature infant milk substitute
(a) The premature infant milk substitute is required for babies born before 37 weeks only and till they attain 40 weeks of age. In addition to the requirements specified under regulation 5(2)(vii) and 5(2)(viii) for Infant formula,
the premature Infant Milk Substitutes shall also meet the following requirements:
- Protein content (N x 6.25) shall not be less than 10.6 and not more than 19.2 per cent by weight or not less than 2.25 and not more than 4.1 g per 100 kcal only till 40 weeks.
- The energy content shall not be less than 70 kcal and not more than 80 kcal.
- Mineral content: Not less than 2.35 per cent by weight or 0.5 g per 100 kcal.
- Calcium: Phosphorus ratio shall be 2:1
- The Sodium, Potassium and Chloride combined together shall not be less than 40 milli equivalents per Litre when prepared in accordance with manufacturer’s instructions.
- Whey Protein: Casein ratio shall be 60: 40
- The products may contain added essential amino acids.
The containers of infant milk substitute meant for premature baby or labels affixed thereto shall indicate the following additional information, namely: –
- the words [FOR THE PREMATURE BABY (BORN BEFORE 37 WEEKS)] in capital letters along with the product name in central panel
- a statement “RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY” in capital letters. (2) Lactose free – Lactose and sucrose free – and sucrose free – Infant milk substitutes: (a) In addition to the requirements specified under regulation 5(2)(vii) and 5(2)(viii) for Infant formula (except milk fat)
- the above Infant Milk Substitute shall also meet the following requirements:
- Soy-protein based, lactose free formula shall have soy protein and glucose, dextrose, dextrin/maltodextrin, maltose and/ or sucrose as carbohydrates.
- Lactose content in lactose free and Lactose and sucrose free infant milk substitutes shall not exceed 0.05 per cent. by weight.
- The fat content derived from vegetable oils shall not be less than 18 per cent. by weight in Lactose free and Lactose- and sucrose free Infant Milk Substitutes.
The container of infant milk substitute for lactose or lactose and sucrose intolerant infants or label affixed thereto shall indicate conspicuously “LACTOSE-FREE or SUCROSE-FREE or LACTOSE and SUCROSE-FREE” in capital letters
A statement “RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY” and shall also bear the following statements, namely: –
“Lactose free Infant Milk Substitute should only be used in case of diarrhoea in infants due to lactose intolerance”.
The lactose free/sucrose free Infant Milk Substitute should be withdrawn if there is no improvement in symptoms of intolerance”.
Hypoallergenic infant milk substitutes –
(a) In addition to the requirements specified under regulation 5(2)(vii) and 5(2)(viii) for Infant formula except for milk fat and milk protein, the hypoallergenic infant milk substitutes shall also meet the following requirement: (i) Protein used shall be hydrolysed whey protein or casein or free amino acids.
(b) The product which contains neither milk nor any milk derivatives shall be labelled “contains no milk or milk products” in conspicuous manner.
(c) The container of infant milk substitute meant for infants with allergy to cow’s / buffalo’s milk protein shall indicate conspicuously “HYPOALLERGENIC FORMULA” and statement “RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY” in capital letters on the label.
Foods for Infants with Inborn Errors of Metabolism (IEM)
Scope: This standard applies to food intended for the specific dietary management of disease of infants with specific inborn error(s) of metabolism. This food is intended to be given under medical supervision.
Description:
- 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 studies and medical evaluation.
- It is specially processed and formulated with nutrients desirable for the infant suffering from a specific IEM. The product should 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.
- 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.
- Such foods fulfil unique nutritional needs of the infant with IEM through specific modifications/alterations and processing of the food components.
Composition:
- The composition of Medical 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.
- Ingredients used in such food shall be suitable and safe and comply with all the applicable provisions of Food Safety and Standards Regulations. The product may have ingredients mentioned in regulation 5(2) of infant formula, 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.
- 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.
- It may contain vitamins and minerals stated in regulation 5(2)(vii) for 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/ medical needs and under strict medical supervision.
Food Additives: (i) In addition to the additives mentioned in regulation 5(3) for Infant formula, following food additives are permitted in the preparation of 100 ml of the product ready for consumption prepared following manufacturer’s instructions, unless otherwise indicated:
INS No | Additive | Maximum level |
Thickeners | ||
412 | Guar gum | 0.1 g in formulas containing hydrolysed protein |
1412 | Distarch phosphate | 0.5 g singly or in combination in soya-based products 2.5 g singly or in combination in hydrolysed protein and/or amino acid-based products |
1414 | Acetylated distarch phosphate | |
1413 | Phosphated distarch phosphate | |
1440 | Hydorxy propyl starch | |
415 | Gum arabic | 2000 mg in gluten free infant formulae |
440 | Pectins (amidated and non-amidated) | |
407 | Carrageenan | 0.1 g in hydrolysed protein and and/or amino acid based infant formula only |
1450 | Starch sodium octenyl succinate | 2 g in hydrolysed protein and/or amino acid based infant formula only |
(ii) Food additives shown in Schedule I (d) for special nutrient formulations may also be used.
Labelling:
- The words ‘FOOD FOR SPECIAL MEDICAL PURPOSE’ printed in the immediate proximity of the name or brand name of the product.
- The statement “For the Nutrition Management of IEM conditions (specific disease(s) , disorder(s) or medical condition(s) for which the product is intended, and for which it has been shown to be effective) such as Maple syrup urine disease; Glutaric Acidemia Type 1; Homocystinuria; Isovaleric Acidemia, 3-MethylcrotonylCoA Carboxylase deficiency, 3-Methylglutaconyl-CoA Hydratase deficiency; Methylmalonic Acidemias, Propionic Acidemia; Amino acid metabolic disorders; Phynylketonuria (PKU); Urea Cycle Disorders, Argininemia, Argininosuccinic Aciduria, Carbamoylphosphate Synthetase deficiency I, Citrullinemia; Tyrosinemia; Galactosemia; 3-Hydroxy Long Chain Acyl-CoA Dehydrogenase Deficiency; Defects in the intraluminal hydrolysis of fat; defective mucosal fat absorption defective lymphatic transport of fat; Disaccharidase deficiencies, Disorders of carbohydrate metabolism Sucrase / isomaltase deficiency, Fructose intolerance; Non-ketotic Hyperglycinemia, Lysinuric protein intolerance and Glucose transport defect (Glut 1def), Pyruvate dehydrogenase complex deficiency.
- An advisory warning “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” appearing on the label in bold letters in an area separated from other written, printed or graphic information.
- Information on osmolality or osmmolarity and/or acid-base balance shall be given when appropriate.
- 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.
- A prominent statement indicating whether the product is or is not intended as the sole source of nutrition shall appear on the label.
- Information of the nature of animal or plant proteins or protein hydrolysates should be provided.
- Feeding instructions, including the method of administration and serving size if applicable, shall be given on the label.
- A complete statement concerning adequate precautions, known side effects, contraindications and product-drug interaction, as applicable shall be given on the label.
- A statement of the rationale for the use of the product and a description of the properties or characteristics that make it useful.
- If the product has been formulated for a specific age group, it should carry a prominent statement to that effect.
- 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.
- A warning that the product is not for parenteral use.
Food for Infant based on Traditional food ingredients:
Scope: This standard applies to Food for infants prepared using traditional food ingredients. These foods are intended for infants.
Composition:
- The composition of such foods shall be based on traditional food ingredients such as rice, rice flour, wheat flour, semolina, pulses and other cereals, fruits, dry fruits and vegetables, milk, ghee, egg and egg products.
- Ingredients used shall be safe and comply with all the applicable provisions of Food safety and Standard Regulations, 2011.
- The product may contain vitamins, minerals, amino acids and other nutrients necessary for Infant.
- 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.
- 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.
Food additives: They shall be free of any preservatives and colours.
Labelling:
- Such Products shall bear prominently the term “Traditional Food for Infants”.
- A prominent statement indicating whether the product is or is not intended as the sole source of nutrition shall appear on the label.
- Feeding instructions including the method of administration and serving size, if applicable, and the nutrient values shall be given on the label.
- If the product is intended for a specific age group, it should carry a prominent statement to that effect.
Explanatory note: A non-exhaustive examples of Foods for infants based on traditional foods are:
(1) Cooked lentils, cereals, dry fruits, grains mashed to a pasty form, sweetened with sugar or jaggery or honey
(2) Cooked vegetables mashed to a pasty form either sweetened or with little ghee
(3) Cooked rice made into a gruel or served with curd
(4) Cooked ganjee (cooked rice and made into a slightly thick liquid suitable for feeding
(5) Ragi malt mix
(6) Semolina or sooji based foods with either milk or curd or ghee.
Schedule I(a)
ADVISORY LISTS OF MINERAL SALTS FOR USE IN FOODS FOR INFANT NUTRITION S
No | Salts | Purity requirements | Use in Foods for Infant Nutrition |
1. | Source of Calcium | ||
1.1 | Calcium carbonate | JECFA(1973), FCC, USP, BP, IP | IMF, IF, MCCF,FUF, FSMP |
1.2 | Calcium chloride | JECFA(1975), FCC, USP, BP, IP | IMF, IF, MCCF,FUF, FSMP |
1.3 | Calcium citrate (Tricalcium dinitrate) | JECFA (1975), FCC, USP, IP | IMF, IF, MCCF,FUF, FSMP |
1.4 | Calcium gluconate | JECFA (1998), FCC USP, BP, IP | IMF, IF, MCCF,FUF, FSMP |
1.5 | Calcium glycerophosphate | FCC, BP, IP | IMF, IF, MCCF,FUF, FSMP |
1.6 | Calcium L- lactate | JECFA (1974), FCC, USP, BP, IP | IMF, IF, MCCF,FUF, FSMP |
1.7 | Calcium phosphate, monobasic (Calcium dihydrogen phosphate) | JECFA (1996), FCC, IP | IMF, IF, MCCF,FUF, FSMP |
1.8 | Calcium phosphate, dibasic (Calcium hydrogen phosphate) | JECFA (1975), FCC, BP, IP | IMF, IF, MCCF,FUF, FSMP |
1.9 | Calcium phosphate, tribasic (Tricalcium diphosphate) | JECFA (1973), FCC, BP, IP | IMF, IF, MCCF, FUF, FSMP |
1.10 | Calcium oxide | JECFA (1975), FCC, IP | IMF, IF, MCCF, FUF, FSMP |
1.11 | Calcium sulphate | FCC, JECFA(1975), IP | FSMP |
2. | Source of Phosphorus (P) | ||
2.1 | Calcium phosphate, monobasic | FCC,JECFA(1996), IP | IMF,IF, MCCF, FUF, FSMP |
2.1 | Calcium phosphate, dibasic | FCC, JECFA(1975), IP | IMF,IF, MCCF, FUF, FSMP |
2.3 | Calcium phosphate, tribasic | FCC, JECFA(1973), IP | IMF,IF, MCCF, FUF, FSMP |
2.4 | Magnesium phosphate, dibasic | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
2.5 | Magnesium phosphate, tribasic | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
2.6 | Potassium phosphate, monobasic | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
2.7 | Potassium phosphate, dibasic | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
2.8 | Sodium phosphate, dibasic | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
2.9 | Phosphoric acid | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
3. | Source of Chloride (Cl) | IMF,IF, MCCF, FUF, FSMP | |
3.1 | Calcium chloride | FCC, JECFA(1975), IP | IMF,IF, MCCF, FUF, FSMP |
3.2 | Choline chloride | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
3.3 | Magnesium chloride | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
3.4 | Manganese chloride | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
3.5 | Potassium chloride | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
3.6 | Sodium chloride | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
3.7 | Hydrochloric acid (Food grade) | IP | IMF,IF, MCCF, FUF, FSMP |
4 | Iron (Fe) | ||
4.1 | Ferrous carbonate, stabilized with saccharose | DAB, IP | MCCF, PCCF FUF, |
4.2 | Ferrous citrate | FCC, IP | IMF,IF, MCCF, PCCF FUF, FSMP |
4.3 | Ferrous fumarate | FCC, USP, DAB, BP, IP | IMF,IF, MCCF, PCCF FUF, FSMP |
4.4 | Ferrous gluconate | FCC, JECFA (1999), USP, DAB, BP, IP | IMF,IF, MCCF,PCCF FUF, FSMP |
4.5 | Ferrous lactate | JECFA (1989), FCC, NF, IP | IMF,IF, MCCF, PCCF FUF, FSMP |
4.6 | Ferrous succinate | MI, MI, IP | IMF,IF, MCCF, PCCF FUF, FSMP |
4.7 | Ferrous sulphate | FCC, JECFA (1999), USP, BP, DAB, IP | IMF,IF, MCCF, PCCF FUF, FSMP |
4.8 | Ferric ammonium citrate | JECFA (1984), FCC, IP | IMF,IF, MCCF, PCCF FUF, FSMP |
4.9 | Ferric citrate | FCC, IP | IMF,IF, MCCF, PCCF FUF, FSMP |
4.10 | Ferrous bisglycinate | JECFA (2003), IP | IMF,IF, MCCF, PCCF FUF, FSMP |
4.11 | Sodium ferric pyrophosphate Ferric diphosphate | FCC, IP | IMF,IF, MCCF, FUF, FSMP |
4.12 | Hydrogen reduced iron | FCC, DAB, IP | IMF, IF, MCCF, FUF PCCF, FSMP |
4.13 | Electrolytic iron | FCC, IP | IF, MCCF, PCCF, FSMP |
4.14 | Carbonyl iron | FCC, IP | IF, MCCF, PCCF FSMP |
4.15 | Ferric orthophosphate | FCC, IP | MCCF, PCCF |
5 | Source of Magnesium (Mg) | ||
5.1 | Magnesium carbonate | JECFA(1979), USP, BP, IP | IMF, IF, MCCF, FUF, FSMP |
5.2 | Magnesium chloride | FCC, JECFA(1979), USP, BP, IP | IMF, IF, MCCF, FUF, FSMP |
5.3 | Magnesium oxide | FCC, JECFA(1973), USP, BP, IP | IMF, IF, MCCF, FUF, FSMP |
5.4 | Magnesium phosphate, dibasic (Magnesium hydrogen Phosphate) | FCC, JECFA(1982), IP | IF, MCCF, FUF, FSMP |
5.5 | Magnesium phosphate,tribasic(Dimagnesium phosphate) | FCC, JECFA(1982), IP | IMF, IF, MCCF, FUF, FSMP |
5.6 | Magnesium sulphate Magnesium gluconate | FCC, USP, BP, IP JECFA(1998),FCC, IP | IMF, IF, MCCF, FUF, FSMP IMF, IF, MCCF, FUF, FSMP |
6. | Source of Sodium (Na) | ||
6.1 | Sodium bicarbonate | FCC, JECFA(1975), USP, NF, IP | IMF,IF,FUF, FSMP |
6.2 | Sodium carbonate | FCC, JECFA(1975), USP, NF, IP | IMF, IF, FUF, FSMP |
6.3 | Sodium chloride | FCC, USP, BP, IP | IMF, IF, FUF, FSMP |
6.4 | Sodium citrate (Trisodium citrate) | JECFA(1975), USP, BP, DAB, IP | IMF, IF, FUF, FSMP |
6.5 | Sodium gluconate | FCC, JECFA(1995), PCC, USP, IP | IMF, IF, FSMP |
6.6 | Sodium L- lactate | FCC, JECFA (1974), USP, BP, IP | IMF, IF, FUF, FSMP |
6.7 | Sodium phosphate, monobasic (sodium dihydrogen phosphate | JECFA(1963), FCC, USP, IP | IMF, IF, FUF, FSMP |
6.8 | Sodium phosphate, dibasic (Disodium hydroghen phosphate | JECFA(1975), FCC, USP, BP, IP | IMF, IF, FUF, FSMP |
6.9 | Sodium phosphate, tribasic (Trisodium phosphate) | FCC, JECFA91975), IP | IMF, IF, FUF, FSMP |
6.10 | Sodium sulphate | JECFA(2000), FCC, USP, BP, IP | IMF, IF, FUF, FSMP |
7. | Source of Potassium (K) | ||
7.1 | Potassium bicarbonate | FCC, JECFA (1979), USP, BP, IP | IMF,IF, MCCF,FUF, FSMP |
7.2 | Potassium carbonate | FCC, JECFA (1975), USP, BP, IP | IMF, IF, MCCF, FUF, FSMP |
7.3 | Potassium chloride | FCC, JECFA (1979), USP, BP, IP | IMF, IF, MCCF, FUF, FSMP |
7.4 | Potassium citrate (dipotassium citrate) | FCC, JECFA (1975), USP, BP, IP | IMF, IF, MCCF, FUF, FSMP |
7.5 | Potassium glycerophosphate | FCC, IP | PCCF, FSMP |
7.6 | Potassium gluconate | JECFA (1978), CC, USP, IP | IMF, IF, MCCF, FUF, FSMP |
7.7 | Potassium phosphate, monobasic | FCC, JECFA (1982), FCC, BP, IP | IF, FUF, FSMP |
7.8 | Potassium phosphate, dibasic | FCC, JECFA (1982), BP, IP | IF, FUF, FSMP |
8. | Source of Copper (Cu) | ||
8.1 | Copper gluconate | FCC, USP, IP | IMF, IF, FUF, FSMP |
8.2 | Copper carbonate | MI, IP | IMF, IF, FUF, FSMP |
8.3 | Copper citrate | PCC, USP, IP | IMF,IF, FUF, FSMP |
8.4 | Copper sulphate | JECFA(1973), FCC, USP,DAB, IP | IMF,IF, FUF, FSMP |
9. | Source of Iodine (I) | ||
9.1 | Potassium iodide | FCC, USP, BP, DAB, IP | IMF,IF, MCCF, FUF, FSMP |
9.2 | Sodium iodide | USP, BP, DAB, IP | IMF,IF, MCCF, FUF, FSMP |
9.3 | Potassium iodate | FCC, IP | FSMP |
9.4 | Sodium iodate | FCC, IP | FSMP |
10 | Source of Zinc (Zn) | ||
10.1 | Zinc acetate | USP, IP | IMF,IF, MCCF,FUF,PCCF, FSMP |
10.2 | Zinc chloride | USP, BP, DAB, IP | IMF,IF, MCCF,FUF,PCCF, FSMP |
10.3 | Zinc Oxide | FCC, USP, DAB, BP, IP | IMF,IF, MCCF,FUF,PCCF, FSMP |
10.4 | Zinc sulphate | FCC, USP, BP, IP | IMF,IF, MCCF,FUF,PCCF, FSMP |
11 | Source of Manganese (Mn) | ||
11.1 | Manganese carbonate | MI, IP | IMF,IF, FUF, FSMP |
11.2 | Manganese chloride | PCC, IP | IMF,IF, FUF, FSMP |
11.3 | Manganese citrate | PCC, IP | IMF,IF, FUF, FSMP |
11.4 | Manganese sulphate | PCC, USP, IP | IMF,IF, FUF, FSMP |
11.5 | Manganese gluconate | PCC, IP | IMF,IF, FUF, FSMP |
12 | Source for Selenium | ||
12.1 | Sodium selenate | Mi IP | IMF, IF, PCCF, FUF, FSMP |
12.2 | Sodium selenite | Ph Eur, USP, MP, MI, IP | IMF, IF, PCCF, FUF, FSMP |
12.3 | Sodium hydrogen selenite | DVFA, IP | IMF, IF, PCCF, FUF, FSMP |
13 | Source for Chromium (III) | ||
13.1 | Chromium sulphate | USP, MI IP | IF, FSMP |
13.2 | Chromium chloride | USP, Mi, IP | IF, FSMP |
14 | Source for Molybdenum (VI) | ||
14.1 | Sodium molybdate | Ph Eur, IP | IF, FSMP |
14.2 | Ammonium molybdate | FCC, USP, IP | IF, FSMP |
Schedule I(b)
ADVISORY LIST OF VITAMIN COMPOUNDS FOR USE IN FOODS FOR INFANT NUTRITION
No | Vitamin | Purity Requirement | Use in foods for infant Nutrition |
1 | Vitamin A | ||
1.1 | all trans retinol Retinyl acetate Retinyll palmitate | FCC., USP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP IMF, IF, MCCF, PCCF, FUF, FSMP IMF, IF, MCCF, PCCF, FUF, FSMP |
1.2 | FCC., USP, Ph Eur, IP | ||
1.3 | FCC., USP, Ph Eur, IP | ||
2. | Provitamin A | Beta- carotene | |
2.1 | Beta- carotene | JECFA (1987), FCC, USP, Ph Eur, IP | IMF, IF, FSMP |
3 | Vitamin D | ||
3.1 | Vitamin D2(Ergocalciferol) Vitamin D3(Cholecalciferol | FCC, USP, Ph Eur, IP | IMF, IF, MCCF,PCCF,FUF, FSMP IMF, IF, MCCF,PCCF,FUF FSMP |
3.2 | FCC, USP, BP, DAB, IP | ||
4. | Vitamin E | ||
4.1 | D-alpha-Tocopherol DL-alpha-Tocopherol D-alpha-Tocopheryl acetate DL-alpha-Tocopheryl acetate D-alpha-Tocopheryl acid succinate DL-alpha Tocopheryl acidsuccinate DL-alpha-Tocopheryl polyethylene glycol succinate | JECFA (2000), FCC, USP, NF, IP | IMF, IF, FUF FSMP |
4.2 | JECFA (1986), FCC, USP, NF, IP | IMF, IF, FUF FSMP | |
4.3 | FCC, USP, NF, BP, Ph Eur, IP | IMF, IF, FUF FSMP | |
4.4 | FCC, USP, NF, BP, Ph Eur, IP | IMF, IF, FUF FSMP | |
4.5 | FCC, USP, Ph Eur, IP | IMF, IF, FSMP | |
4.6 | NF, MP, MI, USP, Ph Eur, IP | IMF, IF, FSMP | |
4.7 | FCC, USP, IP | IMF, IF, FSMP | |
5 | Vitamin C | ||
5.1 | L-Ascorbic acid | JECFA (1973), FCC, USP, Ph Eur, BP, Ph Eur, IP | IMF, IF, MCCF,PCCF,FUF FSM |
5.2 | Calcium-L-ascorbate 6-Palmitoyl-L-ascorbic acid Sodium-L-ascorbate (Ascorbyl palmitate) Potassium-L-ascorbate | JECFA (1981), FCC, USP, Ph Eur, IP | IMF, IF, MCCF,PCCF,FUF FSM |
5.3 | JECFA (1973), FCC, USP, BP, NF, Ph Eur, IP | IMF, IF, MCCF,PCCF,FUF FSM | |
5.4 | JECFA (1973), FCC, USP, Ph Eur, IP | IMF, IF, MCCF,PCCF,FUF FSM | |
5.5 | FCC, IP | IMF, IF, MCCF,PCCF,FUF FSM | |
6. | Vitamin B1 | ||
6.1 | Thiaminchloride hydrochloride Thiamin mononitrate | FCC, USP, Ph Eur, IP | IMF, IF, MCCF,PCCF,FUF FSM |
6.2 | FCC, USP, Ph Eur, IP | IMF, IF, MCCF,PCCF,FUF FSM | |
7. | Vitamin B2 | ||
7.1 | Riboflavin | JECFA(1987), FCC, USP, BP, IP | IMF, IF, MCCF,PCCF, FUF,FSMP |
7.2 | Riboflavin-5/-phosphate sodium | JECFA(1987), FCC, USP, BP Ph Eur, IP | IMF, IF, MCCF,PCCF, FUF,FSMP |
8. | Niacin | ||
8.1 | Nicotinic acid amide (Nicotinamide) Nicotinic acid | FCC, USP, BP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP |
8.2 | FCC, USP, BP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP | |
9. | Vitamin B6 | ||
9.1 | Pyridoxine hydrochloride Pyridoxal 5-phosphate | FCC, USP, BP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP |
9.2 | MI, FCC, USP, IP | IMF, IF, MCCF, PCCF, FUF, FSMP | |
10. | Folic Acid | ||
10.1 | N-Pteroyl-L-glutamic acid | FCC, USP, BP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP |
10.2 | Calcium-L-methyl folate | JECFA(2005), IP | IMF, IF, FSMP |
11 | Pantothenic acid | ||
11.1 | Calcium-D-pantothenate Sodium-D-pantothenate D-Panthenol DL-Panthenol | FCC, USP, BP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP |
11.2 | DAB, IP | IMF, IF, MCCF, PCCF, FUF, FSMP | |
11.3 | FCC, USP, BP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP | |
11.4 | FCC, USP, BP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP | |
12. | Vitamin B 12 | ||
12.1 | Cyanocobalamin Hydroxocobalamin | FCC, USP, BP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP |
12.2 | USP. NF, Ph Eur, Ip | IMF, IF, MCCF, PCCF, FUF, FSMP | |
13. | Vitamin K1 | ||
Phyto menadione (2-Methyl-3-phytyl-1,4naphthoQuinine/Phylloquinone/Phyto nadione | FCC, USP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP | |
14. | Biotin | ||
14.1 | D-biotin | FCC, USP, Ph Eur, IP | IMF, IF, MCCF, PCCF, FUF, FSMP |
Schedule I(c)
ADVISORY LIST OF AMINO ACIDS AND OTHER NUTRIENTS FOR USE IN FOODS FOR
INFANT NUTRITION UNDER THE PROVISIONS OF THE REGULATIONS
No. | Nutrient Source | Purity requirements by |
1. | Amino Acids | |
1.1 | L-Arginine | FCC, USP, Ph Eur, BP, IP |
1.2 | L-arginine hydrochloride | FCC, USP, Ph Eur, BP, IP |
1.3 | L-Cystine | FCC, USP, Ph Eur, IP |
1.4 | L-Cystine dihydrochloride | MI, IP |
1.5 | L-Cysteine | DAB, IP |
1.6 | L-Cysteine hydrochloride | FCC, Ph Eur, IP |
1.7 | L-Histidine | FCC, USP, Ph Eur, IP |
1.8 | L-Histidine hydrochloride | FCC, Ph Eur, DAB, IP |
1.9 | L-isoleucine | FCC, USP, Ph Eur, IP |
1.10 | L-Isoleucine hydrochloride | FCC, USP, IP |
1.11 | L-Leucine | FCC, USP, Ph Eur, IP |
1.12 | L-Leucine hydrochloride | MI, FCC, USP, IP |
1.13 | L-Lysine | USP, IP |
1.14 | L-Lysine hydrochloride | FCC, USP, Ph Eur, IP |
1.15 | L-Methionine | FCC, USP, Ph Eur, IP |
1.16 | L-Phenylalanine | FCC, USP, Ph Eur, IP |
1.17 | L-Threonine | FCC, USP, Ph Eur, IP |
1.18 | L-Tryptophan | FCC, USP, Ph Eur, IP |
1.19 | L-Tyrosine | FCC, USP, Ph Eur, IP |
1.20 | L-Valine | FCC, USP, Ph Eur, IP |
1.21 | L-Alanine | FCC, USP, Ph Eur, IP |
1.22 | L-Arginine L-aspartate | Ph Eur, IP |
1.23 | L-Aspartic acid | FCC, USP, Ph Eur, IP |
1.24 | L-Citruline | USP, IP |
1.25 | L-Glutamic acid | JECFA(1987), USP, FCC, Ph Eur, IP |
1.26 | L-Glutamine | FCC, USP, Ph Eur, IP |
1.27 | Glycine | FCC, USP, Ph Eur, IP |
1.28 | L-Ornithine | MI, FCC, IP |
1.29 | L-ornithine monohydrochloride | DAB, IP |
1.30 | L-Proline | FCC, USP, Ph Eur, IP |
1.31 | L-Serine | USP, Ph Eur, IP |
1.32 | N-Acetyl-L-cysteine (N-Acetyl-L-methionine) | USP, Ph Eur, IP |
1.33 | L-Lysine acetate | FCC, USP, MP, Ph Eur, IP |
1.34 | L-Lysine-L-aspartate | Jap Food Stan, IP |
1.35 | L-Lysine-L-glutamate dihydrate | Jap Food Stan, IP |
1.36 | Magnesium L-aspartate | Ph Eur, IP |
1.37 | Calcium L-glutamate | JECFA, FCC, Jap Food Stan, IP |
1.38 | Potassium L-glutamate | JECFA, FCC, Jap Food Stan, IP |
2. | Carnitine | |
2.1 | L-Carnitine | FCC, USP, Ph Eur, IP |
2.2 | L-Carnitine hydrochloride | FCC,IP |
2.3 | Carnitine tartrate | FCC, Ph Eur, IP |
3. | Taurine | |
3.1 | Taurine | USP, JP, IP |
4. | Choline | |
4.1 | Choline | FCC, USP, IP |
4.2 | Choline chloride | FCC, IP |
4.3 | Choline citrate | NF, IP |
4.4 | Choline hydrogen tartrate | DAB, IP |
4.5 | Choline bitartrate | FCC, NF, DAB, IP |
5. | Inositol | |
5.1 | Myo-inositol | FCC, IP |
6. | Nucleotides | |
6.1 | Adenosine 5-monophosphate (AMP) | FSANZ, IP |
6.2 | Cytidine 5-mono phosphate (CMP) | FSANZ, IP |
6.3 | Guanosine 5-mono phosphate (GMP) | JECFA (1985), IP |
6.4 | Inosine 5-mono phosphate (IMP) | JECFA (1974), IP |
6.5 | Disodium uridine 5-monophosphate salt | FSANZ, IP |
6.6 | Disodium guanosine 5-mono phosphate salt | FCC, JECFA, FSANZ, IP |
6.7 | Disodium ionosine 5-mono phosphate | FCC, JECFA, FSANZ, IP |
As far as applicable, also the free, hydrated and anhydrous forms of amino acids and the hydrochloride, sodium and potassium salts of amino acids may be used in FSMP.
Schedule I(d)
LIST OF FOOD ADDITIVES THAT CAN BE ADDED FOR SPECIAL NUTRIENT FORMULATIONS 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.
INS No | Additive/ Carrier | Maximum level in ready-to use food For Infant Nutrition (mg/kg) |
414 | Gum Arabic/gum acacia or Galacto oligosaccharide | 10 |
551 | Silicon dioxide | 10 |
421 | Mannitol (for vitamin B12 dry rubbing, 0.1% only) | 10 |
1450 | Starch sodium octenyl succinate | 100 |
301 | Sodium L-ascorbate (in coating of nutrient preparations containing polyunsaturated fatty acids) | 75 |
Abbreviations:
BP: British pharmacopoeia
DAB: Deutsches Arzneibuch
DVFA:DanishnVeterinary and Food administration
FCC: Food Chemicals Codex
FSANZ: Food Standards Australia and New Zealand
FSMP: Foods for Special Medical Purposes
FUF: follow up Formula
IMF: Infant Milk food
IF: Infant formula
IP: Indian Pharmacopoeia
Jap Food Stan: Japanese Food Standard
JECFA: FAO/WHO Joint Expert Committee on Food Additives.
MCCF: Milk cereal based complementary food
MI: Merck Index.
PCCF: Processed cereal based complementary food Ph Eur: Pharmacopoeia Europeia
USP: The United States Pharmacopeia
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