Through a notification dated 12 October, 2017 the FSSAI proposes standards related to Complementary Foods for Older Infants and Young Children in the Food Safety and Standards (Food products Standards and Food Additives) Regulations, 2011. FSSAI has invited comments and suggestions from stakeholders to reach the FSSAI office by 17 November 2017. Complementary foods are suitable for use during and beyond complementary feeding period. The revised standards will be notified for implementation within a period of six months.
Once published in the Official Gazette, these regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives)….Amendment Regulations, 2017. Standards for COMPLEMENTARY FOODS FOR OLDER INFANTS AND YOUNG CHILDREN have been added to the category of foods called “Malt extract” in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.
Complementary food for older infants and young children means foods which are suitable for use during and beyond complementary feeding period. These foods are specially formulated with appropriate nutritional quality to provide additional energy and nutrients to complement foods derived from the local diet by providing those nutrients that are either non-existent or present in insufficient quantities.
Complementary feeding period means the period when the older infants transit from exclusive feeding of breast milk and/or breast milk substitutes to eating the family diet.
- Older infants mean infants of age between eighteen months and twenty four months.
- Young children mean children of age between twenty four months and five years.
These foods may be prepared using cereals, legumes and pulses, oilseeds, fruits and vegetables, milk and milk products etc. It contains digestible carbohydrates, proteins and other essential micronutrients like vitamins and minerals at a definite level to replenish the local diet to a balanced diet for older infants and young children.
Raw materials and ingredients
- All milled cereals suitable for human consumption shall be used in such a way so as to reduce the fibre content, when necessary.
- Cereals shall be processed in a way so as to decrease, and, if possible to eliminate the anti-nutrients such as phytates, tannins and other phenolic materials, lectins, trypsins and chymo-trypsin inhibitors which can lower the protein quality and digestibility, amino acid bioavailability and mineral absorption shall be
- Appropriate Enzymes for decreasing the fibre content and anti-nutrients may be used during such
- Cereals as a source should mainly contain carbohydrates and significant quantity (8-12%) of protein.
Legumes and Pulses
- such as chick peas, cow peas, lentils, peas, green gram, kidney beans, soya beans containing at least 20% protein on dry basis
- provide lysine that is deficient in cereals but deficient in L-methionine which may be added
- must be appropriately processed to reduce, as much as possible, the anti-nutritional factors normally present such as phytates, lectins (haemagglutenins), trypsin and chemo-trypsin inhibitors
Soya when used, must be ensured that it contains low levels of phytoerstroges [lectins may be reduced by moist heat treatment; tryspsin 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 should 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 may be used.
Following oil seeds depending on local conditions and requirements may be used
- Soya bean – defatted flour, (full fat and defatted) protein concentrate, protein isolate
- Ground nut – paste, protein isolate
- Sesame seeds – whole ground and defatted flour
- Sunflower seed – defatted flour
- Low erucic acid rape seed – full fat flour
- Defatted oil seed flours and protein isolates, if produced and appropriately processed for human consumption, can be used as a food source of protein (50-95%).
Animal source foods
Meat, fish, poultry and eggs are nutrient dense and source of high quality protein and nutrients and may be used.
Fats and oils
- Fats and oils which are energy dense may be added in adequate quantities.
- Use of partially hydrogenated fats is prohibited.
Fruits and vegetables may be added as a source of micronutrients.
Milk and milk products
Ingredients including those listed below, may be used to improve the nutritional quality
- digestible carbohydrates to increase energy density of foods
- Vitamins, minerals and other nutrients may be added to improve the micronutrient levels of the product at the levels (calculated at minimum 50% RDA and maximum 1 RDA)
Vitamins ingredients and their level are given in the Table below
|1.||Vitamin A (as retinol), µg per 100 g||Not less than 200
Not more than 400
|2.||Vitamin D (expressed as cholecalciferol or
ergocalciferol),µg per 100 g
|Not less than 5
Not more than 10
|3.||Vitamin C, mg per 100||Not less than 20
Not more than 40
|4.||Thiamine, µg per 100 g||Not less than 250
Not more than 500
|5.||Riboflavin, µg per 100 g||Not less than 300
Not more than 600
|6.||Niacin, µg per 100 g||Not less than 4,000
Not more than 8,000
|7.||Pyridoxine, µg per 100 g||Not less than 450
Not more than 900
|8.||Folic Acid, µg per 100 g||Not less than 20
Not more than 40
|9.||Pantothenic acid, mg per 100 g||Not less than1.0
Not more than 2.0
|10.||Vitamin B12, µg per 100 g||Not less than 0.25
Not more than 0.5
|11.||Choline, mg per 100 g||Not less than 32|
|12.||Vitamin K, µg per 100 g||Not less than 7.50
Not more than 15
|13.||Biotin, µg per 100 g||Not less than 7.5
Not more than 50.0
|14.||Vitamin E (as L- tocopherols), mg per 100 g||Not less than 2.5
Not more than 5
|15.||Sodium, mg per 100 g||Not less than 90
Not more than 300
|16.||Potassium, mg per 100 g||Not less than 300
Not more than 900
|17.||Chloride, mg per 100 g||Not less than 250
Not more than 800
|18.||Calcium, mg per 100 g||Not less than 300
Not more than 600
|19.||Phosphorus, mg per 100 g||Not less than 225
Not more than 450
|20.||Magnesium, mg per 100g||Not less than 25
Not more than 50
|21.||Iron, mg per 100 g||Not less than 4.5 **
Not more than 9 *
|22.||Iodine, µ g per 100 g||Not less than 45
Not more than 90
|23.||Copper, µg per 100 g||Not less than170
Not more than 340
|24.||Zinc, mg per 100g||Not less than 2.5 ***
Not more than 5.0 ***
|25.||Manganese, µg per 100 g||Not less than 0.6
Not more than 1.2
|26.||Selenium, µg per 100 g||Not less than 0.85
Not more than 17
|27.||Inositol, g per litre*||Not more than 0.40|
|28.||a. Docosa hexaenoic acid per 100 g
b Arachidonic acid
c. Eicosapentaenoic acid
|Not less than 50
Not more than 100
|29.||Taurine, mg per 100 g||Not more than 60|
|30.||Essential amino acids, mg per litre*||Not less than 9|
NOTE * When prepared in accordance with instructions for use.
(±5.0% of the values due to analytical variations from the quantities of these ingredients declared on the label of the product shall be permitted). Vitamins, minerals, amino acids and other compounds may be chosen from sub-regulation
2.1.9 related to ‘Foods for Infant Nutrition’ of these regulations.
1For converting folic acid to dietary folate equivalent (DFE) use the conversion factor of 1DEF µg = 0.5 µg folic acid
** With a iron bioavailability factor of 5%
*** With a zinc bioavailability factor of 25%
- energy density should be at least 4 kilo calories per gram on dry basis;
- protein digestibility corrected amino acid score (PDCAAS) should not be less than 70% of the WHO amino acid pattern for children between two and five years. Protein shall be minimum 15% with Protein Efficiency Ratio (PER) of 2.0 or minimum 20% with PER of 1.75
- moisture % by weight maximum 8.0
- fat % by weight maximum 7.5
- total ash % by weight maximum 7.5
- bacterial count, per g not more than 10,000 colonies (TPC)
- coliform count absent in 0.1 g
- coli count absent in 0.1 g
- yeast and mould count absent in 0.1 g
- staphylococcus aureus absent in 0.1 g
- bacillus cereus absent in 0.1 g
- salmonella and shigella absent in 0.1 g.
The following food additives may be used in the preparation of Complimentary Foods for older Infants and young children in 100 g of the product ready for consumption prepared following Manufacturer’s instruction, unless otherwise indicated.
|INS No.||Additive||Maximum Level|
|410||Locust bean gum (carob bean gum)||
0.5 g singly or in combination
|1414||Acetylated distarch phosphate|
|1414||Acetylated distarchadipate||2.5 g in hydrolyzed protein and /or amino acid based product|
|407||Carrageenan||0.03 g in milk and soy based product|
|471||Mono- and diglycerides||0.4 g|
|pH adjusting agents|
|500ii||Sodium hydrogen carbonate||
|501ii||Potassium hydrogen carbonate||
|270||L(+) lactic acid
L(+) lactic acid producing cultures
|306||Mixed tocopherol concentrate||3 g singly or in combination|
|304||L-ascorbyl palmitate||5 mg singly or in combination expressed as ascorbic acid|
|Natural fruit extracts||GMP|
|Ethyl vanillin||5 mg|
|* Total sodium content in the food shall not exceed the limit specified in sub-clause 2 (ii) (b).|
Contaminants, Toxins and Residues
The product shall conform to the limits of contaminants as specified in the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011.
Packaging and Labelling
- The food shall be packed in hermetically sealed, clean and sound containers or in flexible pack made from film or combination of any other substrate made of board, paper, polyethylene, polyester, metallized film or in such a way to protect from deterioration. It may be packed with nitrogen or mixture of nitrogen and carbon dioxide flushing and filling during packing to remove atmosphere of oxygen within the pack.
- The product shall be labelled in accordance with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011.
- Products under these regulations shall also comply with the labelling requirements under the “Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (41 of 1992).