Global Food Compliance
Intelligence & Solutions
Home / News / Details

India Releases Draft Infant Food Regulation 2019

This new Indian draft regulation specifies the product standards for a range of infant specific foods, including the permitted ingredients, additives, nutrient contents and labeling requirements. It is prohibited to advertise infant formula for special medical purposes.

As revealed by FSSAI announcement issued on May 14, 2019, India is proposing the separation of infant nutrition food standards from the umbrella standard for all foods ("Food Products Standards and Food Additives" )and will develop a new regulation named "Food Safety and Standards (Food for Infant Nutrition) Regulation, 2019". It specifies the product standards for infant formula, infant formula for special medical purposes, cereal-based complementary baby food and 7 other infant foods. Food additives, amino acids and permitted nutrients (and corresponding permitted concentrations) are listed in the regulation.

The regulation is open for public feedback and the consultation will end on Jun. 14, 2019.

Infant formula

  • It includes infant formula in powder or liquid form as a complete food to meet all infants nutritional requirements

  • It is not permitted to use hydrogenated vegetable oils and fats

  • It shall be free from color and flavor. Thickeners, emulsifiers, acidity regulators, antioxidants and packaging gases permitted are listed in the standard.

Follow-up formula

  • It shall contain protein at least 3g/100 kcal, and a permitted fat content ranging from 3g/100 kcal to 6g/100 kcal.

  • It shall be free from starch and coloring agents. Thickening agent, emulsifiers, pH adjusting agents, antioxidants and permitted flavors are listed in the standard

Infant Formula for Special Medical Purpose (FSMP)

  • It is classified into following 4 types:

  1. Premature infant milk substitute

  2. Lactose free

  3. Hypoallergenic infant milk substitutes

  4. Foods for Infants with Inborn Errors of Metabolism (IEM)

  • Apart from those permitted in infant formula, the following food additives are allowable in infant FSMP as well:

  • The labeling of infant formula for special medical purposes are subject to additional requirements. For example, the label requires the product is clearly labeled “FOOD FOR SPECIAL MEDICAL PURPOSE” in immediate proximity of the product name and must also include the disclaimer “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY”.

  • Advertisement of infant formula for special medical purposes is prohibited.

Please click here to see the nutrient content of each infant nutrition product and other detailed requirements.

We provide full-scale global food market entry services (including product registration, ingredient review, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by [email protected]
Copyright: unless otherwise stated all contents of this website are ©2026 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact [email protected]
User Guide