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. 

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information please visit our website

For enquiries, please contact:

James Cook
Food Scientific and Regulatory Affairs Manager
t: +01 973 461 1493

© SGS Group Management SA – 2015– All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.