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:
- Novel food or novel food ingredients or processed with the use of novel technology
- New additives
- New processing aids including enzymes
- 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.
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