After the order of the Hon’ble Supreme Court dated 19 August 2015, it became imperative for the FSSAI to discontinue the existing advisory based product approval system. In its place, the FSSAI knew there was a requirement for a legitimate process for the use of non-standardized food products/ingredients. This regulation, therefore, lays down the rules and procedure for grant of prior approval of non-specified food and food ingredients which will replace the former product approval system, which was prevalent for food products and products containing ingredients for which there were no standards.

1. Some important steps that the FSSAI took to address the situation in the absence of a product approval system are as follows:

2. Revised the definition of proprietary foods in Food Safety and Standards (Food Product Standards and Food Additives) Ninth Amendment Regulations, 2016

3. Notified the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for special dietary uses, Foods for medical purposes, Functional foods and Novel foods) Regulations, 2016

4. Amended the Food Safety and Standards (Food Product Standards and Food Additives) Seventh Amendment Regulations, 2016 relating to harmonization of food additives

The above-mentioned regulations have covered a number of products that would have otherwise required specific approvals. However, there are still many products or ingredients that have not been covered under these regulations. In order to regulate such products, including novel foods and to provide an opportunity to FBOs to innovate food products the FSSAI has made the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. This regulation covers the following foods 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

In the new regulation, FSSAI has defined Non-specified food as “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.”

FBOs will need to take prior approval for manufacture, storage, sale, distribution, import, etc. of any non-specified food or food ingredient according to the guidelines in the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. These regulations are in addition to and not in derogation of any other rules and regulations made under the Act.

1. Procedure for grant of prior approval

2. The step by step procedure is as follows

3. The manufacturer or importer of non-specified food has to first submit an application in FORM – I the format for which has been given in the regulation.

4. Along with the Form – 1 all necessary documents and fee have to also be submitted to the Food Authority (The fee may be reviewed from time to time).

5. After scrutiny of Form – I and other documents it is possible that the Food Authority could ask for additional documents, data or clarifications if required.

6. The Food Authority may then grant approval or reject the application on FORM-II and which will be based on the safety assessment of the article of food.

If approval is granted, the next step for the FBO is to 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.

After a grant of approval, FBO must apply for a license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011

Rejection of Application

The FBO can file an appeal before the Chairperson, Food Authority against any decision of rejection of the application. If FBO is still aggrieved about the decision of the Chairperson, Food Authority then they may file a review petition to be placed for consideration at the meeting of the Food Authority. The Food Authority may suspend or revoke any approval granted to any FBO for reasons recorded in writing.

Provision for Recall

If an FBO has reason to believe that the food for which the approval has been granted poses any risk to health, he has to 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.

All Food Safety Officers and Designated Officers must immediately inform the Food Authority of any complaint received regarding the safety of any product approved by the Food Authority under these regulations.