FSSAI issues guidelines for fortification ingredients in children's supplements

By Cheryl Tay contact

- Last updated on GMT

The FSSAI has updated its standards for supplements formulated for children. ©Getty Images
The FSSAI has updated its standards for supplements formulated for children. ©Getty Images

Related tags: Fssai, Children, Supplements, Fortification

Indian regulator FSSAI has issued a gazette notification of its amendments to the standards for children's supplements in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.

The new amendments, referred to as the Eleventh Amendment Regulations, 2018, will be implemented from the date of their Official Gazette publication; they are currently available on the regulatory body's website.

Under the regulation for cereals and cereal products, the category for malted and malt-based foods has a new sub-regulation on formulated supplements for children between two and three years old.

In the notification, the FSSAI states: “Formulated supplements for children shall be of appropriate nutritional quality to provide additional energy and nutrients to complement the family foods derived from 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.”

Seeing to better cereals

The notification then elaborates on suitable raw materials and ingredients permitted for usage in such foods, starting with cereals.

The FSSAI recommends that all milled cereals be processed with the purpose of lowering fibre content when needed, in order to eliminate ‘anti-nutrients’ such as phytates, tannins (and other phenolic materials), lectins, trypsin and chemo-trypsin inhibitors, as these can compromise protein quality and digestibility, amino acid bio-availability and mineral absorption.

“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,” ​states the notification.

Giving peas a chance

When it comes to legumes and pulses (such as chickpeas, cowpeas, lentils, peas, green gram, kidney beans, soya beans) that contain a minimum of 20% protein on a dry basis, the FSSAI recommends fortification with L-methionine, an essential amino acid.

As with cereals, the FSSAI recommends processing methods that will reduce ‘anti-nutritional factors’ like phyates, lectins, as well as trypsin and chemo-trypsin inhibitors.

The notification adds: “Soya, when used, must contain 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 fava beans shall not be used due to favism.”

Favism is a haemolytic response to consuming fava beans, and indicates possible glucose-6-phosphate dehydrogenase (G6PD) deficiency, an inborn error of metabolism (IEM).

Oil be watching you

In addition to the aforementioned ‘anti-nutrients’, the FSSAI recommends that gossypol and urease activity be reduced when processing flours, protein concentrates and protein isolates of oil seeds.

The regulator also lists its preferred forms of flour for different seed, bean and nut types (for instance, whole ground and defatted flour should be made from sunflower seeds), saying, “Defatted oilseed flours and protein isolates, if produced and appropriately processed for human consumption, can be used as a good source of protein (47% to 95%).”

Also detailed are recommendations for fats and oils, which “may be added in adequate quantities for the purpose of increasing the energy density of the product”​, but should not contain partially hydrogenated fats.

Further fortifications

The FSSAI also lists other ingredients that are permitted for fortification purposes in supplements for children, such as digestible carbohydrates, protein isolates, concentrates and hydrolysates.

The regulator adds: “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.”

At the same time, algal and fungal oil as sources of DHA and ARA and related claims are permitted, so long as DHA makes up a maximum of 0.5% of total fatty acid content. The ratio of DHA to ARA should also be a minimum of 1:1, provided that DHA content does not fall below 0.2% of total fatty acids.

The notification also includes recommendations for carbohydrates: “Carbohydrates such as sucrose, dextrose and dextrins or maltodextrin, maltose and lactose (are permitted) provided that the energy from added sugar per 100g of the product shall not exceed 10 percent of the energy of the product.”

Formulating rules for formula

Beyond supplements for children aged two to three, the notification includes essential requirements for infant nutrition.

These requirements dictate that the energy density of infant foods must be at least 4kcal per gram on a dry basis, while the maximum moisture-by-weight should be a 8% and the maximum fat by weight should be 7.5%.

It adds: 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.”

It then lists the food additives permitted for use in the preparation of formulated supplements for children in 100g of product that is, according to the manufacturer’s instructions, ready for consumption.

These additives include emulsifiers like lecithins and diglycerides, acidity regulators like citric acid, and antioxidants like alpha-tocopherols, in addition to thickeners, and anti-caking and raising agents.

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