Non-Specified Food and Food Ingredient Regulation

“Non-specified food” means any food other than proprietary food or food ingredients, including additives, processing aids and enzymes for which standards have not been specified in any regulation made under the Act.

Food products/Ingredients that are neither standardized nor fall under proprietary food category as mentioned under Food Safety and Standard Regulations are called as Non-Specified Food or Food Ingredients.

There are several food products/ingredients which are still not covered in any of the regulations made under Food Safety and Standards Act, 2006. In order to regulate such products including novel food and provide the opportunity to Food Business Operators to innovate food products, FSSAI came up with this regulation.

The regulation broadly 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.
5. Any other non-specified food

Novel Food or Food Ingredients:

Novel food or Food Ingredient is a food or food ingredient that may not have a history of human consumption; or may have any ingredient used in it which or the source from which it is derived, may not have a history of human consumption; or a food or ingredient obtained by new technology with innovative engineering process, where the process may give rise to significant change in the composition or structure or size of the food or food ingredients which may after the nutritional value, metabolism or level of undesirable substances.

New Additives:

A new additive is the one , which is not listed or included in the FSSR for the specific food category, this includes the additives assessed by JECFA for safety and is included in Codex and or available in other recognized regulatory bodies.

New Processing Aid:

A new processing aid is the one, which is not listed in FSSR, but available in the inventory of Codex or in any other well recognized regulatory bodies.

Prior approval for manufacture, storage, sale, distribution, import, etc.

1. No person shall manufacture or import any non-specified food or food ingredient, as the case may be, except with the prior approval of the Food Authority.
2. The provisions of these regulations are in addition to, and not in derogation of, any other rules or regulations made under the Act.

Procedure for grant of prior approval:

1. The manufacturer or importer of non-specified food shall submit an application in FORM – I of these regulations along with necessary documents and fee to the Food Authority.
2. The Food Authority shall scrutinize the application and information provided by the applicant.
3. The Food Authority may direct the applicant to submit additional supporting documents, data or clarifications, if required.
4. 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
5. Where approval is granted, the food business operator shall submit to the Food Authority, a certificate of analysis in respect of the chemical, physical, microbiological and nutritional
   parameters of the food manufactured or imported.
6. The food business operator may file an appeal before the Chairperson, Food Authority against any decision of rejection of his application.
7. A food business operator, who is aggrieved by the decision of the Chairperson, Food Authority may file review petition to be placed for consideration in the meeting of the Food Authority.
8. The Food Authority may, for reasons to be recorded in writing, suspend or revoke any approval granted to any food business operator.
9. The Food Authority may review from time to time, the amount of fee for filing an application.
10. If a food business operator has reason to believe that the food for which the approval has been granted poses any risk to health, he shall immediately suspend the manufacture, import, sale, or distribution of such article of food and take steps to recall the same under intimation to Food Authority in accordance with the provisions of the Food Safety and Standards (Food Recall) Regulations, 2017.
11. Food Safety Officers and Designated Officers shall immediately inform the Food Authority of any complaint received regarding safety of any product approved by the Food Authority under these regulations.
12. The food business operator shall, after grant of approval apply for license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.

Download, Read & Share: Regulation, Application form (Form – I) for approval of non-specified food and food ingredient, FAQs, List of Approved and Rejected Product Ingredients, Letter & Notice etc.

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