Through a notification dated 27 December 2017, the FSSAI has proposed a draft related to standards of foods for infant nutrition. The FSSAI has also invited comments, views, and suggestions from stakeholders which are to reach FSSAI within 30 days from the above-mentioned date. Once notified in the Official Gazette, these regulations will be called the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2017.
FSSAI has given definitions for infant (a person not more than 12 months of age) , Infant food, Infant milk substitute, Infant milk food, Infant formula, “Milk cereal-based complementary food, Processed cereal-based complementary food, Follow-up formula, Infant Formula for special medical purpose, “Foods for Infant based on traditional food ingredients.
General requirements
- To prevent deterioration foods for infant nutrition shall be packed in hermetically sealed, clean and sound containers or in a flexible pack made from paper, polymer or metallic film as per the Food Safety and Standards (Packaging & Labelling) Regulations, 2011. It shall be packed under an inert atmosphere.
- The category infant formula for special medical purposes provided under these regulations shall be exempted from provisions specified under the Regulation 2.4 (Specific Requirements/ Restrictions on a manner of labeling) 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 be declared on the label.
- The categories infant formula for special medical purpose and food for infant based on traditional food ingredients provided under these regulations shall conform to the microbiological standards for milk and milk products of category infant formula as provided under Appendix B of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011
- A variation of ± 5.0% of the declared values of the added ingredients due to analytical variations shall be allowed.
- 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.
- Foods for infant nutrition may contain algal and fungal oil as sources of Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) from Crypthecodinium cohnii, Mortierella Alpina, Schizochytrium sp., and Ulkenia sp. at the level of maximum 0.5 percent. 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 percent of total fatty acids if a claim related to the addition 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 cereal-based complementary food, processed cereal-based complementary food and follow up formula except under Bureau of Indian Standards (BIS) Certification Mark. The category infant formula for the special medical purpose shall be exempted from this provision.
- Food for infant nutrition except in the category of food for the special medical purpose shall also comply with the requirements of the “Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply, and Distribution) Act, 1992 as amended in 2003 (IMS Act).
Infant Milk Food
This standard applies to infant milk food in powder form for meeting the normal nutritional requirements of the infant.
Composition
- Infant milk food is a product based on the milk of cow or buffalo or mixture thereof, and other nutrients 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 of carbohydrates such as sucrose, dextrose, maltose, lactose and maltodextrin and salts such as phosphates and citrates.
- The product shall be uniform and free from lumps and coarse particles. It shall be free from rancid taste and musty odor.
The standards for infant milk food have been given in tabular form where the minimum and maximum Limits and Limits for 100 kcal has been given for the following parameters
Moisture
Total milk protein
Milk fat
Total ash
Ash insoluble in dilute hydrochloric acid
Trans fatty acids
Energy per 10 ml of the reconstituted product
Carbohydrates per 100 g
Vitamins A, D, E, K, C
Thiamine, Riboflavin, Niacin equivalent, Pyridoxine, Dietary Folate Equivalent (DFE) (Folic acid), Pantothenic acid, Vitamin B12, Biotin, Choline, Sodium, Potassium, Chloride,100 g Calcium, Phosphorous, Calcium: Phosphorus ratio, Magnesium, Iron, Iodine, Copper, Zinc, Manganese, and Selenium
- In addition, the product may also contain optional ingredients as provided in regulation 5(2) (viii).
- Food additives: No food additives are permitted in infant milk food. However, food additives are shown in Schedule I (d) for special nutrient formulations may be used.
Infant formula
This standard applies to infant formula in powder or liquid form for meeting the normal nutritional requirements of an infant.
Composition
- Infant formula is a product based on the milk of cow or buffalo or mixture thereof, and other nutrients 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 of carbohydrates such as sucrose, dextrose, maltose, lactose and maltodextrin; and salts such as phosphates and citrates.
- 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 carbohydrates in 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 (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 may be used along with other requirements laid down under the same regulations.
- The product shall be uniform and free from lumps and coarse particles. It shall be free from rancid taste and musty odor.
The standards for infant formula have been given in tabular form where the minimum and maximum Limits and Limits for 100 kcal has been given for the following parameters:
Moisture
Energy per 100 ml of the product
Total protein
Total Fat per 100 g
Milk Fat per 100 g
Linoleic acid, g per 100 g
α-Linolenic acid, mg per 100 g
The ratio of Linoleic acid/ α-Linolenic acid
Sum of lauric and myristic acids
Erucic acid
Trans fatty acids
Carbohydrates
Total ash
Ash insoluble in dilute hydrochloric acid
Vitamin A, D, E, K, C
Thiamine, Riboflavin, Niacin equivalent, Pyridoxine, Dietary Folate Equivalent (DFE)
(Folic acid), Pantothenic acid, Vitamin B12, Biotin, Choline, Sodium, Potassium, Chloride, Calcium, Phosphorous, Calcium: Phosphorus ratio, Magnesium, Iron, Iodine, Copper, Zinc, Manganese, Selenium
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 in minimum and maximum limits mg per 100 g / ml
Carotenes, Amino acids, Non-protein nitrogen, Nucleotides, L-carnitine, Lactalbumin, Lactoferrin, Lysozyme, Glucosamine, Inositol, Citric acid, Cholesterol, Fucose, Lipid phosphorous, Prostaglandins, Taurine, Molybdenum, Chromium
Food additives
Infant formula shall be free of added color and flavor. The following food additives may be used in the preparation of infant formula ready for consumption prepared following manufacturer’s instructions unless otherwise indicated with Additive INS No. and Maximum Level (g per 100 ml)
Thickeners
410 Carob bean gum
407 Carrageenan
Emulsifiers
322 Lecithin
471 Mono- and diglycerides
472c Citric and fatty acid esters of glycerol
Acidity Regulators
524 Sodium hydroxide
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
331i Sodium dihydrogen citrate GMP
331iii Trisodium citrate GMP
332 Potassium citrate GMP
339 I, ii and iii Sodium dihydrogen phosphate, disodium hydrogen phosphate and trisodium phosphate
340 I, ii and iii Potassium dihydrogen phosphate, dipotassium hydrogen phosphate and tripotassium phosphate
Antioxidants
307b Mixed tocopherol concentrate
304i Ascorbyl palmitate
Packaging gases
290 Carbon dioxide
941 Nitrogen
Food additives are shown in Schedule I (d) for special nutrient formulations may also be used.
Milk cereal-based complementary Food
This standard applies to milk cereal-based complementary food in powder form intended to complement the diet of an infant.
Composition:
Milk cereal-based complementary food is based on the 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
- edible vegetable oil, defatted edible oilseed extracts, protein concentrates / protein isolates, milk solids, various carbohydrates such as sucrose, dextrose, maltose, lactose, and maltodextrin, and salts such as phosphates and citrates but must not contain hydrogenated fats
- fruits and vegetables or their products, egg or egg products, and nuts or their products.
- Must be free from lumps and coarse particles, and shall be uniform in appearance. It shall be free from rancid taste and musty odor.
The standards for the milk cereal-based complementary food is given in tabular form where the minimum and maximum Limits and Limits for 100 kcal has been given for the following parameters:
Moisture
Total Protein
Milk Protein
Total fat, percent by weight (including milk fat)
Milk fat (alone
Total Carbohydrates
Total ash
Ash insoluble in dilute hydrochloric acid
Crude fiber
Vitamins A, D, C
Thiamine (as hydrochloride, Riboflavin, Niacin equivalent, Dietary Folate equivalent, Iron, Zinc
Optional Ingredients/ nutrient are as follows
Pantothenic acid, Vitamin B 12, Vitamin K, Choline, Inositol, Calcium, Phosphorus, Chloride, Magnesium, Sodium, Selenium, Taurine, L-amino acids, L-Carnitine, Biotin, Iodine, Potassium, Pyridoxine,
Food Additives:
Milk cereal-based complementary food shall be free of preservatives, added colors, and flavors. The following food additives may be used in the preparation of Milk cereal-based complementary food that has been given below with INS No. for consumption prepared following manufacturer’s instructions unless otherwise indicated
Thickeners
410 Carob bean gum
1412 Distarch phosphate
1414 Acetylated distarch phosphate
407 Carrageenan
Emulsifiers
322 Lecithins
471 Mono- and diglycerides
Acidity Regulators
524 Sodium hydroxide
500ii Sodium hydrogen carbonate
500i Sodium carbonate
501iii Potassium hydrogen carbonate
501i Potassium carbonate
525 Potassium hydroxide
526 Calcium hydroxide
270 L(+) lactic acid
330 Citric acid
331i Sodium dihydrogen citrate
331iii Trisodium citrate
332 Potassium citrate
Antioxidants
307b Mixed tocopherol concentrate
304i Ascorbyl palmitate
Packaging gases
290 Carbon dioxide
941 Nitrogen
Enzymes
Alpha Amylase
Food additives are 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 distributed without storing) shall meet all the hygiene requirements specified by the FSSAI.
Processed cereal-based complementary Food
This standard applies to processed cereal-based complementary food in powder form intended to complement the diet of the infant.
Composition
- Processed cereal-based complementary food is a product based on the variety of cereals, pulses including soybean, millets, nuts and edible oilseeds.
- It shall contain milled cereals and legumes combined accounting for not less than 75 percent.
- Where the product is intended to be mixed with water or milk before consumption, the minimum content of protein shall be 15 percent 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 milk products, eggs and egg products, edible vegetable oils, defatted edible oilseed extracts, fruits and vegetables or their 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 free from rancid taste and musty odor.
- It may also contain the 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, Functional Food and Novel Food) Regulations, 2016.
The standards are given in tabular form where the minimum and maximum Limits and Limits for 100 kcal has been given for the following parameters
Moisture,
Protein
Total Fat, percent by weight
Total Carbohydrates,
Total ash,
Ash insoluble in dilute Hydrochloric acid
Crude fiber
Vitamin A, D, C,
Thiamine, Riboflavin, Niacin equivalent, Dietary Folate equivalent, Iron, Zinc, Pantothenic acid, Pyridoxine, Vitamin B12, Biotin, Choline, Inositol, Selenium,
Food Additives
- The Product shall be free of preservatives, added colors, and flavors. Following additives are permitted in the preparation of Grain based Complementary food for infants in 100 g of the product ready for consumption prepared following manufacturer’s instructions unless otherwise indicated. INS No and Additives with Maximum Level have been proposed for a large number of Emulsifiers, Acidity regulators, Antioxidants, Raising agent, Thickeners, Anticaking agent, Packaging gases and Enzymes
- Food additives are 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 restricted and where other cereals like wheat, soy, 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 6-9 percent, such products shall be conspicuously labelled, “mono grain-based complementary foods for use in specific conditions under medical guidance only”
- Process cereal-based complementary food prepared in the community kitchens shall meet all the hygienic requirements specified by the FSSAI and freshly prepared and distributed and not stored
Follow-up Formula
This standard applies to the composition of Follow-up formula. 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.
Composition
- Follow-up formula is a product based on the milk of cow or buffalo or mixture thereof, and other nutrients 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 skimmed milk or with the minor modification that does not substantially impair the vitamin or mineral content of milk and which represents 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 per 100 kcal.
- 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.
- The product shall be free from lumps and coarse particles, and shall be uniform in appearance. It shall be free from rancid taste and musty odor
- The product may contain vegetable proteins.
The standards are given in tabular form where the minimum and maximum Limits and Limits for 100 kcal has been given for the following parameters
Moisture
Total ash, percent by weight
Ash insoluble in dilute hydrochloric acid
Vitamin A, D, E, K, C
Thiamine, Riboflavin, Niacin, equivalent, Pyridoxine, Dietary Folate equivalent, Pantothenic acid, Vitamin B12, Choline, Biotin, Sodium, Potassium, Chloride, Calcium, Phosphorus, Magnesium, Iron, Iodine, Copper, Zinc, Manganese, Selenium, Inositol, Taurine and Essential Amino acids.
Food Additives
It shall be free of added starch and colors. Additional additives that can be used in follow-up formula have been listed as thickening agents, emulsifiers, pH adjusting agents, antioxidants, and flavors.
Infant Formula for Special Medical Purpose (FSMP)
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 the special medical purpose
- is product based on ingredients (from known and well-established sources) suitable for human consumption.
- is 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 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 special nutritional requirements arising from disease(s) for whose dietary management the product is specifically formulated, labelled and presented.
- Optional ingredients Besides compositional requirements listed under regulation 5(2)(vii) for infant formula, 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.
Premature infant milk substitute
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 percent 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 percent 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 milliequivalents 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 the central panel
- a statement “RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY” in capital letters
Lactose-free – Lactose and sucrose free – and sucrose free – Infant milk substitutes
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 percent. by weight.
- The fat content derived from vegetable oils shall not be less than 18 percent 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 diarrhea 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 – 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:
- The protein used shall be hydrolyzed whey protein or casein or free amino acids.
- The product which contains neither milk nor any milk derivatives shall be labeled “contains no milk or milk products” in a conspicuous manner.
The container of infant milk substitute meant for infants with an allergy to cow’s / buffalo’s milk protein shall indicate conspicuously in capital letters on the label
“HYPOALLERGENIC FORMULA”
“RECOMMENDED TO BE TAKEN UNDER MEDICAL ADVICE ONLY”
Foods for Infants with Inborn Errors of Metabolism (IEM)
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 an 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 deceased 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 fulfill 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, hydrolyzed 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 to 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
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. The additional additives permitted for use are listed with INS No and include thickeners,
412 Guar gum
1412 Distarch phosphate
1414 Acetylated distarch phosphate
1413 Phosphated distarch phosphate
1440 Hydroxypropyl Starch
415 Gum arabic
440 Pectins (amidated and nonamidated)
407 Carrageenan
1450 Starch sodium octenyl succinate
Food additives are shown in Schedule I (d) for special nutrient formulations may also be used.
Labeling
- 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-Methylcrotonyl-CoA 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 osmolarity 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
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 the 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 colors.
Labeling
- 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:
- Cooked lentils, cereals, dry fruits, grains mashed to a pasty form, sweetened with sugar or jaggery or honey
- Cooked vegetables mashed to a pasty form either sweetened or with little ghee
- Cooked rice made into a gruel or served with curd
- Cooked ganjee (cooked rice and made into a slightly thick liquid suitable for feeding
- Ragi malt mix
- Semolina or sooji based foods with either milk or curd or ghee.
Schedule I (a)
This schedule contains an advisory list of mineral salts that are permitted for use for Infant nutrition. The list contains the name of the salt, purity requirements and the foods for infant nutrition a particular salt can be used in.
Schedule I (b)
This schedule contains an advisory list of vitamin compounds that can be used in foods for Infant nutrition. The list contains the name of the vitamin, purity requirement and the food for infant nutrition they can be used in.
Schedule I (c)
This schedule contains an advisory list of amino acids and other nutrients for use in foods for infant nutrition under the provisions of the regulations. The list contains the nutrient source and purity requirements
Schedule I (d)
This schedule contains a list of food additives that can be added for special nutrient formulations. The list contains the INS No, name of the additive or carrier and the Maximum level in ready-to-use food For Infant Nutrition (mg/kg).
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.
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