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Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 have come into effect on September 11, 2017. This regulation lays down the rules and procedures for granting the prior approval of non-specified food and food ingredients.

The regulation covers the following articles of food or food ingredients:

  1. Novel food or novel food ingredients or processed with the use of novel technology
  2. New additives
  3. New processing aids including enzymes
  4. Articles of food and food ingredients consisting of or isolated from microorganisms, bacteria, yeast, fungi or algae

Earlier FSSAI introduced a product approval system through advisories as a means to undertake safety assessment of the food products and products containing ingredients which do not have standards.

Hon’ble Supreme Court order vide dated 19.08.2015; it was no longer possible to continue the process of product approvals for non-standardized food products/ingredients in the absence of legitimate regulations.

Procedure for grant of prior approval:

The Manufacturer and importer who wish to seek approval of non-specified foods and food ingredients will now need to

  • Submit FORM-1 along with necessary documentation and fees to the food authority.
  • The Food Authority may either grant approval or reject the application, as per FORM-II, on the basis of the safety assessment of the article of food.
  • After approval is granted, the food business operator should submit a certificate of analysis in respect to the chemical, physical, microbiological and nutritional parameters of the food manufactured or imported to FSSAI.
  • If an approval has been rejected the food business operator is permitted to file a review petition for the consideration of the Food Authority.

Read more: FSSAI, Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017

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Posted by Kanimozhi Kajamohideen on Sep 19, 2017

Regulatory and Scientific Affairs Expert

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