Question 1          What is product approval?

Answer:               Product approval is the process by which a product gets approved by FSSAI in which the ingredient and  additives are not as per prescribed standards in the act & regulations.

Question 2          Does every product with minor changes in composition or ingredients or additives require product approval?

Answer                Yes every product which has different ingredients/ additives/ composition needs to go for product approval (except any numbers of flavors or color can be accommodated in one application)

Question 3          Is there any need for product approval for product having same composition but different nomenclature?

Answer                No, except case where different claims are made on label.

Question 4          Whether traditional/ ethnic food {FSSR 3.1.1 (2)} required to go for product approval?

Answer                No, provided it contains food additive permitted in Table 2 of Appendix A of Food safety & standards regulation- 2011.

Question 5          Do intermediary product not meant for consumer require product approval?

Answer                If product contains ingredients or additives which are not specified or do not have FSS regulation these product will have to go for product approval.

Question 6          List of documents Required?

Answer:               Below mentioned list of documents are required for product approval:

  • Duly typed product approval application form in prescribed format as uploaded in website.
  • Certificate of analysis from NABL Laboratory.
  • Shelf life stability report of product.
  • Copy of original Label (if product is already in the market)
  • Copy of prototype label (if product is new in the market)
  • Separate dully signed approval application form for each product having difference in composition.
  • Copy of notarized affidavit on Rs. 100 stamp paper.
  • Detailed composition of the product with quantity of Ingredients & additives added in the product (as per serving size)
  • Health Certificate / Nutrient profile studies/ risk assessment reports/ toxicological studies/ clinical trial report of the products in human being.
  • Safety evaluation data on proposed product & ingredients from US-FDA, CODEX, EU, any national & international agencies responsible for food safety.
  • Differential amount for product as per advisory dated 11.05.2013.
  • Proof of Import like custom invoice, bill of entry etc.
  • Copy of agreement between marketer & manufacturer.
  • Copy of previous license (if any)

Question 7          I am food manufacturer of a food product in which all ingredients approved or listed     under FSS regulation -2011 but final product is not standardized do we need to go for product approval.

Answer                Yes, product approval is required.