For filing and processing of the FSSAI license application for the products covered under
Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Purpose,
Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016
1. The products covered under the said regulation shall be listed under Food Product Category 13.3,
13.4, 13.5, 13.6
2. Identify the category of product as per above regulation.
a. Health Supplements - Food Product Category 13.6
b. Nutraceuticals - Food Product Category 13.6
c. Food for Special Dietary Uses - Food Product Category 13.4, 13.5, as per ingredients/intended
d. Food For Special Medical Purposes other than infants- Food Product Category 13.3, 13.4 as
per ingredients / intended use
e. Food with added Probiotic Ingredients - Food Product Category 13.6
f. Food with added Prebiotic Ingredients - Food Product Category 13.6
g. Specialty Food containing plant/botanical ingredients with safe history of usage - Food
Product Category 13.6
3. Mention a Common/Generic name of the product in the application in case of Health Supplements
and Nutraceuticals and mention specific name of the product in remaining categories.
4. Mention the list of the ingredients along with FSSR according to theselected category of product as
mentioned in para 2 above.
5. Re-labellers shall ensure that their third party manufacturers have valid FSSAI license for
manufacturing the same product.