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Fssai and Fda Regulations ON Infant Foods
Fssai and Fda Regulations ON Infant Foods
Fssai and Fda Regulations ON Infant Foods
ON
INFANT FOODS
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
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