FSSAI AND FDA REGULATIONS

ON
INFANT FOODS

Submitted by: Ishita chaudhary

Priyanka arora
Sajal gupta
Gagandeep singh khera
FSSAI
 The FSSAI has drafted new regulations called the Food Safety and Standards
(Foods for Infant Nutrition) Regulations, 2019. The FSSAI has also invited
comments, objections, and suggestions from stakeholders which are to reach the
FSSAI office by 14 June 2019 and can also be mailed
to regulation@fssai.gov.in on or before this date.  Though Food for Infant Nutrition
Regulations exits as part of the Food Safety and Standards (Food Products
Standards and Food Additives) Regulations, 2011, but now the FSSAI has
proposed to frame a separate regulation which when implemented will supersede
the existing regulation as the new proposed regulation will be more
comprehensive. This regulation will also include standards for Infant formula for
special medical purpose especially food for infants inborn with Errors of Metabolism
(IEM). Standards have also been drafted for Premature infant milk substitutes,
Lactose-free and Lactose and sucrose free infant milk substitutes under infant
formula for special medical purposes.  There are also standards for food for infants
based on traditional food ingredients.
GENERAL REQUIREMENTS
 For the purpose of the Draft Regulations, infant will be considered as a person of
not more than 12 months of age.
 The Draft Regulation specifies the composition, parameters, limits and permitted

food additives for the following categories of infant food-

-  Infant Milk Food
 - Infant formula
 - Milk cereal based complementary Food
 - Processed cereal based complementary Food
 - Follow-up Formula
 - Infant Formula for Special Medical Purpose
 - Food for Infant based on Traditional food ingredients
 Food for infant nutrition shall be packed in hermetically sealed, clean and sound

containers or in flexible pack made from paper, polymer and/ or metallic film as per
requirements under the Food Safety and Standards (Packaging & Labelling)
Regulations, 2011. This excludes infant formula for special medical purpose and
food for infant based on traditional food
 ingredients, which will be required to conform to the microbiological standards for
milk and milk products of category infant formula as provided under Appendix B of
the Food Safety and Standards (Food Products Standards and Food Additives)
Regulations, 2011.
 Food for infant nutrition will be required to comply with the requirements of the
Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of
Production, Supply and Distribution) Act, 1992. 
 Compliance with the Legal Metrology (Packaged Commodities) Rules, 2011 is
mandatory for all food for infant nutrition. However, the requirement of standard
pack size under this shall not apply to infant formula for special medical
purpose. For the categories Infant Formula for Special Medical Purpose and Food
for Infant based on Traditional food ingredients, specific labelling requirements
have also been laid down under the Draft Regulation.
 Manufacturing, selling, storing or exhibiting for sale, an infant milk food, infant
formula and milk cereal based complementary food, processed cereal based
complementary food and follow up formula, excluding infant formula for special
medical purpose, shall be under Bureau of Indian Standards Certification Mark.
FDA
 The Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a
food which purports to be or is represented for special dietary use solely as a food
for infants by reason of its simulation of human milk or its suitability as a complete
or partial substitute for human milk"FDA regulations define infants as persons not
more than 12 months old.
 The centre for Food Safety and Applied Nutrition is responsible for regulation of
infant formula. The Office of Nutritional Products, Labeling, and Dietary
Supplements (ONPLDS) has program responsibility for INFANT FORMULA. The
Office of Food Additive Safety (OFAS) has program responsibility for Food
ingredients and packaging.

 Substances used in food, including infant formula, must be safe and lawful.
Substances that may be used in infant formulas are food ingredients that are
generally recognized as safe (GRAS) for use in infant formula and those that are
used in accordance with the FDA's food additive regulations.
 REGULATION ON INFANT FORMULA

  The infant formula manufacturer must provide assurance that the

formula will provide adequate nutrition for infants to thrive, that the
formula will be manufactured under current good manufacturing
practices including quality control procedures, and that every batch of
the formula will meet all of the nutrient requirements under the FFDCA
and its implementing regulations in 21 CFR. These regulations include:
1) 21 CFR Part 106 - Infant formula quality control procedures
2) 21 CFR Part 107 - Infant formula
3) 21 CFR Part 110 - Current good manufacturing practice in
manufacturing, packing, or holding human food
4) 21 CFR Part 113 - Thermally processed low-acid foods packaged in
hermetically sealed containers.
  An infant formula shall contain the following nutrients at a level not less than the
minimum level specified and not more than the maximum level specified for each
100 kilocalories of the infant formula in the form prepared for consumption as
directed on the container:

NUTRIENTS UNIT OF MINIMUM MAXIMUM LEVEL

MEASUREMENT LEVEL

Protein Grams 1.8 4.5

Fat Percent calories 30 54
Vitamin A International Units 250 750
Vitamin K Micrograms 4
Sodium Milligrams 20 60
Manganese Micrograms 5
Vitamin C
Milligrams 8
(Ascorbic acid)
 Vitamin E shall be present at a level of at least 0.7 International Unit of vitamin E
per gram of linoleic acid.
 Any vitamin K added shall be in the form of phylloquinone.
 Vitamin B6 shall be present at a level of at least 15 micrograms of vitamin B6 for
each gram of protein in excess of 1.8 grams of protein per 100 kilocalories of infant
formula in the form prepared for consumption as directed on the container.
 The ratio of calcium to phosphorus in infant formula in the form prepared for
consumption as directed on the container shall be no less than 1.1 and not more
than 2.0.
 Protein shall be present in an amount not to exceed 4.5 grams per 100
kilocalories regardless of quality, and not less than 1.8 grams per 100 kilocalories
of infant formula in the form prepared for consumption as directed on the container
when its biological quality is equivalent to or better than that of casein. If the
biological quality of the protein is less than that of casein, the minimum amount of
protein shall be increased proportionately to compensate for its lower biological
quality. For example, an infant formula containing protein with a biological quality
of 75 percent of casein shall contain at least 2.4 grams of protein (1.8/0.75). No
protein with a biological quality less than 70 percent of casein shall be used.
THANK
YOU