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SAFEGUARDS | Food NO. 112/15

SafeGuardS baby with milk bottle

On 22 June 2015 the United States Food and Drug Administration (US FDA) published a measure which will add selenium to the required list for nutrients in infant formulas. This rule is to be effective 23 July 2016.

Selenium added as a required nutrient in the list for infant formula [1]

US FDA [2] has modified 21 Code of Federal Regulations (CFR) 107.10 which provides the nutrient information required for infant formula. This change requires a minimum of 2 micrograms per kilocalories and a maximum of 7 micrograms per 100 kilocalories of selenium in infant formula. Additionally the US FDA has modified 21 CFR 107.100 the nutrient specifications for infant formula which will require the labeling of the amount of selenium per 100 kilocalories in infant formula.

Selenium which is found in breast milk is an essential nutrient for infants. Selenium helps the infant’s body defend against oxidative stress and aids in the regulation of the thyroid.

In 1989, the Institute of Medicine recognized selenium to be an essential nutrient for infants. The US manufactures have been adding selenium to infant formula since then. US FDA is establishing a safe range for the use of selenium. 

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