On November 01 2022, FSSAI issued a notification concerning the fee refund policy for applications under FSS (Approval for Non-Specified Food & Food Ingredients) Regulations, 2017. In this blog, we will discuss the notification issued by FSSAI regarding the fee refund policy for applications under NSF Regulations.
A Brief on the Notification Regarding Fee Refund Policy for Applications
FSSAI notified the Food Safety & Standards (Approval for Non-specified Food & Food Ingredients) Regulations, 2017 (hereafter referred to as NSF Regulations) on September 15, 2017 for approval of non-specified food & food ingredients comprising novel food. So, on November 01, 2022, FSSAI issued a notification regarding fee refund policy for applications under FSS (Approval for Non-specified Food & Food Ingredients) Regulations, 2017. The applicants seeking approval of non-specified food & food ingredients must submit an application in Form-1 of these regulations along with crucial documents and a fee of Rs. 50,000/- plus 18% GST.
Further, the Food Safety & Standards Authority of India issued a notice on August 31 2022, stating that applications & requisite fees under NSF Regulations shall be submitted via ePAAS (electronic Product & Claim Approval Application System) only and applications submitted through email or post shall be instantly rejected with effect from October 01, 2022. The Authority decided that since it takes a lot of time & effort for the scrutiny officers to perform initial scrutiny of applications, the fee, once paid under NSF Regulations, shall not be refunded to the applicant in any instance.
An Overview of FSS (Approval for Non-specified Food & Food Ingredients) Regulations, 2017
On September 11 2017, the FSSAI notified the FSS (Approval for Non-specified Food & Food Ingredients) Regulations, 2017. These regulations have been finalised after consideration of the comments getting from stakeholders. After the order of the Hon’ble Supreme Court (SC) dated August 19 2015, it became important for the FSSAI to discontinue the existing advisory-based Product Approval System. This regulation lays down the rules & procedure for the grant of prior approval of non-specified food & food ingredients which will replace the earlier Product Approval Ingredients, which was prevalent for food items & items containing ingredients for which there were no standards.
Some vital steps that the FSSAI took to address the situation or condition in the absence of a Product Approval System (PAS) are as follows:
- Notified the FSS (Food or Health Supplements, Nutraceuticals, Foods for Medical purposes, Foods for special dietary uses, Functional Foods & Novel Foods) Regulations, 2016.
- Revised the definition of Proprietary Foods in FSS (Food Product Standards & Food Additives) 9th Amendment Regulations, 2016.
- Amended the FSS (Food Product Standards & Food Additives) 7th Amendment Regulations, 2016, concerning the harmonisation of food additives.
All the above-mentioned regulations have covered a number of products or items that would have otherwise required specific approvals. However, there are still many products/ingredients that haven’t been covered under these regulations. To regulate such products comprising novel foods & to provide an opportunity for Food Business Operators to innovate food items, the FSSAI has made the FSS (Approval for Non-Specified Food & Food Ingredients) Regulations, 2017. This regulation covers the following food/food ingredients:
- New additives;
- Novel food or novel food ingredients/processed with the use of novel technology;
- New processing aid including enzymes;
- Articles of food & food ingredients consisting of/isolated from bacteria, yeast, microorganisms, fungi, or algae.
In the regulation, the FSSAI has defined non-specified food as any food other than proprietary food/food ingredients, including additives, processing aids & enzymes for which standards haven’t been specified in any regulation made under the Act.
Food Business Operators will need to take prior approval for storage, sale, manufacture, import, distribution, etc., of any non-specified food or food ingredient as per the guidelines in the FSS (Approval for Non-Specified Food & Food Ingredients) Regulations, 2017. These regulations are in addition to & not in derogation of any other Rules & Regulations made under the Act.
Procedure for Grant of Prior Approval
Following is the step-by-step procedure for grant of Prior Approval:
- The manufacturer/importer of non-specified food has to 1st submit the application form (Form-1);
- Along with the application form, all vital documents & fees have to be submitted to the FSSAI;
- After examination of the application form and other documents, it is possible that the concerned Authority could ask for additional documents, data/clarifications if required;
- The Food Authority may grant approval/reject the application on Form-II & which will be based on the Safety Assessment of the food product;
- If approval or consent is granted, the next step for the Food Business Operator is to submit to the Food Authority a Certificate of Analysis concerning physical, chemical, nutritional, and microbiological parameters of the food manufactured or imported;
- After a grant of approval, Food Business must apply for a License in accordance with the process specified in the FSS (Licensing & Registration of Food Businesses) Regulations, 2011.
Conclusion
FSSAI notified the Food Safety & Standards (Approval for Non-specified Food & Food Ingredients) Regulations, 2017 (hereafter referred to as NSF Regulations) on September 15, 2017, for approval of non-specified food[1] & food ingredients comprising novel food. The applicants seeking approval of non-specified food & food ingredients must submit an application in Form-1 of these regulations along with crucial documents and fees.
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