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You are here: Home / FSSAI / FSSAI Notifies Amendments Related to Standards of Formulated Supplements for Children

November 28, 2018

FSSAI Notifies Amendments Related to Standards of Formulated Supplements for Children

FSSAI Notifies Amendments Related to Standards of Formulated Supplements for Children
FSSAI Notifies Amendments Related to Standards of Formulated Supplements for Children

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

  1. 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.

Filed Under: FSSAI Tagged With: Cereal Products, Food Additives, Formulated Supplements, FSSAI, Legumes, Pulses

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