The FSSAI has invited suggestions, views and comments from stakeholders on the recently drafted Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2018 relating to standards of formulated supplements for children. The draft has been notified as complementary foods for older infants and young children.
In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, in regulation CEREALS AND CEREAL PRODUCTS (2.4) in the category, MALTED AND MALT BASED FOODS (2.4.11) the FSSAI has proposed to add the following new clause to the regulation
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 are shall be of appropriate nutritional quality to provide additional energy and nutrients to complement the family foods derived from the local diet 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 that are permitted to be used are as follows:
Cereals: All milled cereals suitable for human consumption processed in such a way as to reduce the fiber 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 fiber 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 L-methionine which 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.
Oilseed flours and oilseed protein products: Flours, protein concentrates and protein isolates of oilseeds with reduced anti-nutritional factors and undesirable toxic substances such as trypsins and chymotrypsin inhibitors, gossypol and urease activity. Following oil seeds depending on local conditions and requirements may be used;
- Soybeans: 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: such as meat, fish, poultry, and eggs are nutrient dense and source of high-quality protein and micronutrients. It may also contain protein concentrates derived from these sources.
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: 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: 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
- Vitamins, minerals and other nutrients. In tabular form, FSSAI has provided the names of the vitamins, minerals and other nutrients that may be added to improve the micronutrient levels of the product and the levels in which they are permitted. There are 32 minerals and vitamins named in the table and their minimum and maximum levels have been given against the names of each in a Table.
- 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 minimum 15% with Protein Efficiency Ratio (PER) of 2.0 or minimum 20% with PER of 1.75.
- Moisture (percent by weight): Max 8.0
- Fat (percent by weight): Max 7.5
- Total ash (percent by weight): Max 7.5
- 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 food additives may be used in the preparation of formulated supplements for children in 100g 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 a clause on Food Additives (3.1.1) (10) of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.
FSSAI has also listed the names of the food additives along with their INS No. and the maximum levels at which they can be used. These additives include
- Acidity Regulators
- Raising agents
- Anticaking agents
- Packaging gases
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 and Standards (Contaminants, Toxins, and Residues) Regulations, 2011.
- 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.
- 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 & Labelling) Regulations, 2011 so as to protect the contents from deterioration. It shall be packed under an 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’. The 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 an allergen.
Instructions for use:
- Directions as to the preparation and use of the food shall be given; preferably accompanied by graphical presentations. Vanillin 7mg
- 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/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.
(This article contains only a summary of the draft amendments and not the full details)