FSSAI has issued a Gazette Notification related to amendments in the standards of formulated supplements for children in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Eleventh Amendment Regulations, 2018. They shall come into force from the date of their publication in the Official Gazette.
In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, in regulation CEREALS AND CEREAL PRODUCTS (2.4) under the category MALTED AND MALT BASED FOODS a new sub-regulation has been added called
- Formulated supplements for children
- Scope: This standard specifies requirements of formulated supplements for children of age above 24 months till 36 months.
- Description: Formulated supplements for children shall be of appropriate nutritional quality to provide additional energy and nutrients to complement the family foods derived from the local produce by providing those nutrients that are either lacking or are present in insufficient quantities. These foods may be presented in any other age suitable food format.
Suitable raw materials and ingredients
Basic raw materials and ingredients permitted to be used include
Cereals: All milled cereals suitable for human consumption processed in such a way as to reduce the fibre content, when necessary. Such cereals processed in a way to decrease, and, if possible to eliminate the anti-nutrients such as phytates, tannins and other phenolic materials, lectins, trypsins and chymotrypsin inhibitors which can lower the protein quality and digestibility, amino acid bioavailability and mineral absorption shall be permitted. Appropriate enzymes for decreasing the fibre content and anti-nutrients may be used during such processing. Cereals as a source should mainly contain carbohydrates and significant quantity (8-12%) of protein.
Legumes and pulses: Legumes and pulses such as chickpeas, cowpeas, lentils, peas, green gram, kidney beans, soya beans containing at least 20% protein on a dry basis. Legumes and pulses provide lysine that is deficient in cereals but deficient in Lmethioninewhich may be added. Legumes and pulses must be appropriately processed to reduce, as much as possible, the anti-nutritional factors normally present such as phytates, lectins (haemagglutinins), trypsin and chemo-trypsin inhibitors. Soya, when used, must be ensured that it contains low levels of phytoestrogens. [lectins may be reduced by moist heat treatment; trypsin inhibitor activity by heating to high temperature or prolonged boiling; phytates may be reduced enzymatically or by soaking; phytoestrogens by fermentation].Field beans and faba beans shall not be used due to favism.
Oil seed flours and oil seed protein products: Flours, protein concentrates and protein isolates of oil seeds with reduced anti-nutritional factors and undesirable toxic substances such as trypsins and chymotrypsin inhibitors, gossypol and urease activity. The following oil seeds depending on local conditions and requirements may be used
- Soyabeans: dehulled flour, (full fat and defatted) protein concentrate, protein isolate
- Groundnut: paste, protein isolate
- Sesame seeds: whole ground and defatted flour
- Sunflower seed: defatted flour
- Low erucic acid rapeseed: full-fat flour
- Defatted oilseed flours and protein isolates, if produced and appropriately processed for human Consumption, can be used as a good source of protein (47-95%).
Animal source foods: Animal source foods such as meat, fish, poultry and eggs and their primary processed products are nutrient dense and source of high-quality protein and micronutrients. It may also contain protein concentrates derived from these sources.
Fats and oils: Fats and oils may be added in adequate quantities for the purpose of increasing the energy density of the product. It shall not contain partially hydrogenated fats.
Fruits and vegetables: Fruits and vegetables and their primary processed products as a good source of micronutrients, when technologically feasible.
Milk and milk products: Foods such as milk and milk products are nutrient dense and source of high-quality protein and micronutrients. It may also contain protein concentrates derived from these sources.
Other Ingredients: Other ingredients including those listed below may be used to improve the nutritional quality
- Digestible carbohydrates to increase the energy density of foods
- Protein isolates, concentrates, and hydrolysates
- Probiotic ingredient(s) and prebiotic ingredient(s) as provided under schedule VII and schedule VIII, respectively, 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 along with other requirements laid down under the said regulations
- Algal and fungal oil as sources of Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) from Crypthecodiniumcohnii, Morterella alpine, Schizochytrium sp., and Ulkenia sp. at the level of maximum 0.5 per cent Docosahexaenoic acid (DHA) of total fatty acids and ratio of arachidonic acid (ARA): docosahexaenoic acid (DHA) as 1:1 minimum provided that docosahexaenoic acid (DHA) content shall not be less than 0.2 percent of total fatty acids, if a claim related to the addition of docosahexaenoic acid (DHA) is made.
- Carbohydrates such as sucrose, dextrose and dextrins or maltodextrin, maltose and lactose. Provided that the energy from added sugar per 100 g of the product shall not exceed 10 percent of the energy of the product.
- Vitamins, minerals and other nutrients: Following vitamins, minerals and other nutrients may be added to improve the micronutrient level of the product at the level as shown in the table
| 1. | Vitamin A (as retinol), µg per 100 g | Not less than 120.0
Not more than 400.0 |
| 2. | Vitamin D (expressed as cholecalciferol or ergocalciferol), µg per 100 g | Not less than 3.0
Not more than 10.0 |
| 3. | Vitamin C, mg per 100 g | Not less than 12.0
Not more than 40.0 |
| 4. | Thiamine, µg per 100 g | Not less than 150.0
Not more than 500.0 |
| 5. | Riboflavin, µg per 100 g | Not less than 180.0
Not more than 600.0 |
| 6. | Niacin, mg per 100 g | Not less than 2.50
Not more than 8.0 |
| 7. | Pyridoxine, µg per 100 g | Not less than 270.0
Not more than 900.0 |
| 8. | Folic Acid, µg per 100 g1 | Not less than 14.50
Not more than 48.0 |
| 9. | Pantothenic acid, mg per 100 g | Not less than 0.60
Not more than 2.0 |
| 10. | Vitamin B12, µg per 100 g | Not less than 0.15
Not more than 0.50 |
| 11. | Choline, mg per 100 g | Not less than 32.0 |
| 12. | Vitamin K, µg per 100 g | Not less than 4.50
Not more than 15.0 |
| 13. | Biotin, µg per 100 g | Not less than 2.50
Not more than 8.0 |
| 14. | Vitamin E (as L- tocopherols), mg per 100 g | Not less than 1.50
Not more than 5.0 |
| 15. | Sodium, mg per 100 g | Not less than 90.0
Not more than 300 |
| 16. | Potassium, mg per 100 g | Not less than 270.0
Not more than 900.0 |
| 17. | Chloride, mg per 100 g | Not less than 240.0
Not more than 800.0 |
| 18. | Calcium, mg per 100 g | Not less than 180.0
Not more than 600.0 |
| 19. | Phosphorus, mg per 100 g | Not less than 135.0
Not more than 450.0 |
| 20. | Magnesium, mg per 100 g | Not less than 15.0
Not more than 50.0 |
| 21. | Iron, mg per 100 g | Not less than 2.50
Not more than 9.0 |
| 22. | Iodine, µg per 100 g | Not less than 27.0
Not more than 90.0 |
| 23. | Copper, µg per 100 g | Not less than 102.0
Not more than 340.0 |
| 24. | Zinc, mg per 100 g | Not less than 1.50
Not more than 5.0 |
| 25. | Manganese, mg per 100 g | Not less than 0.30
Not more than 1.20 |
| 26. | Selenium, µg per 100 g | Not less than 5.0
Not more than 17.0 |
| 27. | Inositol, g per litre* | Not more than 0.40 |
| 28. | Taurine, mg per 100 g | Not more than 60.0 |
| 29. | Essential amino acids, mg per litre* | Not less than 9.0 |
(* When prepared in accordance with instructions for use; 11 microgram DFE = 0.6 micrograms folic acid.)
Formulated supplements for children shall use the source compounds for vitamins, minerals and other nutrients from sub-regulation
2.1.19 Foods for Infant Nutrition
Essential requirements
- Energy density shall be at least 4 kilocalories per gram on a dry basis
- Protein digestibility corrected amino acid score (PDCAAS) shall not be less than 70% of the WHO amino acid pattern for the children from 2 to 5 years. Protein shall be min 15% with Protein Efficiency Ratio (PER) of 2.0 or minimum 20% withPER of 1.75.
- Moisture (percent by weight): Max 8.0
- Fat (percent by weight): Min 7.50
- Total ash (percent by weight): Max 7.50
- The product shall conform to the microbiological requirements of ‘Follow up formula’ given in Appendix B of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.
Food additives
- The following food additives may be used in the preparation of formulated supplements for children in 100 g of the product ready for consumption prepared following Manufacturer’s instruction unless otherwise indicated.
- Carry-over of food Additives into foods shall be in accordance with clause 3.1.1.(10) of the Food Safety and Standards (FoodProducts Standards and Food Additives) Regulations, 2011.
| INS No | Additive | Maximum level |
| Emulsifiers | ||
| 322 | Lecithins | 1500mg |
| 471 | Mono- and diglycerides | 500mg
Singly or in combination |
| 472a | Acetic and fatty acid esters of glycerol | |
| 472b | Lactic and fatty acid esters of glycerol | |
| 472c | Citric and fatty acid esters of glycerol | |
| Acidity Regulators | ||
| 500 ii | Sodium hydrogen carbonate |
GMP |
| 501 ii | Potassium hydrogen carbonate | |
| 170 i | Calcium carbonate | |
| 270 | L(+) Lactic acid | |
| 330 | Citric acid | |
| 260 | Acetic acid | |
| 261 | Potassium acetates | |
| 262 i | Sodium acetate | |
| 263 | Calcium acetate | |
| 296 | Malic acid (DL) – L(+)-form only | |
| 325 | Sodium lactate (solution) – L(+)-form only | |
| 326 | Potassium lactate (solution) – L(+)-form only | |
| 327 | Calcium lactate – L(+)-form only | |
| 331 i | Monosodium citrate | |
| 331 ii | Trisodium citrate | |
| 332 i | Monopotassium citrate | |
| 332 ii | Tripotassium citrate | |
| 333 | Calcium citrate | |
| 507 | Hydrochloric acid | |
| 524 | Sodium hydroxide | |
| 525 | Potassium hydroxide | |
| 526 | Calcium hydroxide | |
| 575 | Glucono delta-lactone | |
| 334 | L(+)-Tartaric acid – L(+)form only | 500 mg
Singly and in combination |
| 335 i | Monosodium tartrate | |
| 336 i | Disodium tartrate | |
| 336 i | Monopotassium tartrate –L(+)form only | Tartrates as residue in biscuits and rusks |
| 336 ii | Dipotassium tartrate – L(+)form only | |
| 337 | Potassium sodium L(+)tartrate L(+)form only | |
| 338 | Orthophosphoric acid | Only for pH adjustment
440 mg Singly or in combination as phosphorous |
| 339 i | Monosodium orthophosphate | |
| 339 ii | Disodium orthophosphate | |
| 339 iii | Trisodium orthophosphate | |
| 340 i | Monopotassium orthophosphate | |
| 340 ii | Dipotassium orthophosphate | |
| 340 iii | Tripotassium orthophosphate | |
| 341 i | Monocalcium orthophosphate | |
| 341 ii | Dicalcium orthophosphate | |
| 341 iii | Tricalcium orthophosphate | |
| Antioxidants | ||
| 306 | Mixed tocopherols concentrate | 300 mg/kg fat or oil basis,
Singly or in combination |
| 307 | Alpha-tocopherol | |
| 304 | L-Ascorbylpalmitate | 200 mg/kg fat |
| 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 | ||
| 503 i | Ammonium carbonate | Limited by GMP |
| 503 ii | Ammonium hydrogen carbonate | |
| 500 i | Sodium carbonate | |
| 500 ii | Sodium hydrogen carbonate | |
| Thickeners | ||
| 410 | Carob bean gum | 1000 mg singly or in combination
2000 mg in gluten-free cereal-basedfoods |
| 412 | Gaur gum | |
| 414 | Gum arabic | |
| 415 | Xanthan gum | |
| 440 | Pectins (Amidated and Non- Amidated) | |
| 1404 | Oxidized starch | 5000 mg
Singly or in combination |
| 1410 | Monostarch phosphate | |
| 1412 | Distarch phosphate | |
| 1413 | Phosphateddistarch phosphate | |
| 1414 | Acetylated distarch phosphate | |
| 1422 | Acetylated distarchadipate | |
| 1420 | Starch acetate esterified with acetic anhydride | |
| 1450 | Starch sodium octenyl succinate | |
| 1451 | Acetylated oxidized starch | |
| Anticaking Agents | ||
| 551 | Silicon dioxide (amorphous) | 200 mg for dry cereals only |
| Packaging Gases | ||
| 290 | Carbon dioxide | GMP |
| 941 | Nitrogen | GMP |
| Flavours | ||
| Natural fruit extract | GMP | |
| Vanilla extract | GMP | |
| Ethyl vanillin | 7 mg | |
| Vanillin | 7 mg | |
The product and its components shall not have been treated by ionizing radiation.
Contaminants, Toxins, and Residues
- The product shall conform to the limits of contaminants as Specified in Food Safety andStandards (Contaminants, Toxins, and Residues) Regulations, 2011.
- The products shall be prepared with special care under good manufacturing practices so that residues of those pesticides which may be required in the production, storage or processing of the raw materials or the finished food ingredients do not remain, or, if technically unavoidable, are reduced to the maximum extent possible.
- The product shall be free from residues of hormones, antibiotics as determined by means of agreed methods of analysis and practically free from other contaminants, especially pharmacologically active substances.
Food Hygiene
The product shall be prepared and handled in accordance with Schedule 4 of the Food Safety and Standards(Licensing and Registration of Food Businesses) Regulations, 2011.
Packaging and Labelling
- The food shall be packed in hermetically sealed, clean and sound containers or in the flexible pack made from paper, polymer and/ or metallic film as per the Food Safety and Standards (Packaging and Labelling) Regulations, 2011 so as to protect the contents from deterioration. It shall be packed under the inert atmosphere.
- The product shall be labeled in accordance with the Food Safety and Standards (Packaging and Labelling) Regulations,2011 and the specific labeling requirements provided in these regulations.
- The name of the food to be declared on the label shall indicate that the food is a formulated supplement for children. Provided that these products shall not be presented as ‘Energy food’ or ‘Health food’.
- Label of this food shall not refer to malnourished children.
- The label should clearly indicate the major sources of protein and product is recommended for children age above 24 months till 36 months.
- The label shall also declare information relating to the allergen.
- Instructions for use:
(a) Directions as to the preparation and use of the food shall be given; preferably accompanied by graphical presentations.
(b) In the case that addition of water is needed, the directions for the preparation shall include a precise statement that:
- where the food contains non-heat-processed basic ingredients, the food must be adequately boiled in a prescribed amount of water
- where the food contains heat-processed basic ingredients:
(a) the food requires boiling, or
(b) can be mixed with boiled water that has been cooled.
- Formulated supplements for Children foods to which fats, sugars or other digestible carbohydrates shall be added during preparation, the instructions for use shall identify appropriate sources and indicate the amounts of the ingredients to be added. In such situations, fats and oils with an appropriate essential fatty acid ratio shall be recommended.
- Directions for use shall include a statement that only an amount of food sufficient for one feeding occasion shall be prepared at one time. Foods not consumed during the feeding occasion shall be discarded unless consumed within a period as recommended by the manufacturer under the instructions for use.
- The label shall also include a statement that ‘formulated supplements for children are to be consumed to complement family foods and breast milk or breast milk substitutes’.
Method of sampling and analysis
- Method of sampling and analysis shall be as per the Food Safety and Standards(Laboratory and Sample Analysis) Regulations, 2011 and manuals published by the Food Authority.
The tolerance limit for variation in case of formulated supplements for children during analysis of samples of finished products shall not be more than ±10.0 percent from the declared value of the nutrients or nutritional ingredients on the label.