The Food Safety and Standards Authority of India (FSSAI) notified the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) First Amendment Regulations, 2022[1] (hereinafter referred to as “Amendment Regulations”) on October 11, 2022, further to amend the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.
Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) First Amendment Regulations, 2022
The Amendment Regulations seeks to amend Regulation 4 which lays down the procedure for approval for manufacture or import of any non-specified food or food ingredient from the Food Authority.
With a view to streamline the approval process, following changes have been introduced by the Amendment Regulations:
| Pre-Amendment | Post-Amendment | Comments |
| Earlier no timeline was provided which obligated the Food Authority to revert on the applications within any stipulated period of time. | The Amendment Regulation has laid down a timeline of 45 days from the date of receipt of application for approval, within which the Food Authority is required to scrutinize the application and inform the applicant of any deficiencies. | The Amendment will ensure that the applications are processed in a time-bound manner, safeguarding the interests of manufacturers/ importers. |
| Earlier no timeline was provided which obligated the Food Business Operator to submit the additional documents within any stipulated period of time. | In case the Food Authority asks for additional supporting documents, the Food Business Operator (FBO) is required to submit the same within 30 days from the date of issuance of letter by Food Authority. | The Amendment will ensure that the applications are processed in a time-bound manner, avoiding any unnecessary lapses and delays in grant of approval. |
| No provision for appointment of an expert committee. | The Food Authority may appoint an expert committee to examine the application submitted by the FBO. | The Amendment shall enable the Food Authority to take assistance of expert committee to scrutinize applications for approval. |
| Earlier, the FBO was only required to submit a certificate of analysis in respect of the chemical, physical, microbiological and nutritional parameters of the food manufactured or imported. | The FBO shall conduct and provide a post market surveillance data on safety and efficacy parameters, within one year of placing the product in the market after approval, whenever asked by the Food Authority. | The Amendment obliges the FBO to submit a comprehensive post market surveillance report, ensuring an effective analysis of the impact of the product in the market. |
| Earlier there was no provision for appeal before the Chief Executive Officer of the Food Authority. | An appeal against rejection of approval application made by the FBO may be filed before the Chief Executive Officer of the Food Authority within 30 days of the receipt of rejection letter. | By providing a mechanism for appeal before the Chief Operating Officer, the Amendment ensures there is no room for foul play and the FBO is given sufficient opportunity to defend his/ her application for approval. |
| Previously, no timeline was provided for disposing of an appeal against the decision of refusal by the Food Authority. | The Chief Executive officer is required to dispose of the appeal within a period of 30 days from receipt. | The Amendment will ensure that appeal applications are disposed of in a time-bund manner. |
| Earlier there was no provision for review before the Chief Executive Officer of the Food Authority. | A FBO aggrieved by the decision of the Chief Executive Officer may file a review petition before the Chairperson of the Food Authority, within a period of 30 days from the date of issue of appellate order. | By providing a mechanism for review, the Amendment ensures there is no room for foul play and the FBO is given sufficient opportunity to defend his/ her application for approval. |
| Previously, no timeline was provided for disposing of a review petition by the Chairperson | The Chairperson is required to dispose of the review petition within a period of 30 days from receipt. | The Amendment will ensure that review petitions are disposed of in a time-bund manner. |
The Amendment is a laudable move as it attempts to streamline and strengthen the procedure for approval for manufacture or import of any non-specified food or food ingredient from the Food Authority, by laying down strict timelines, incorporating provision for appointment of an expert panel, and providing an additional authority which can review the decision of refusal by the Food Authority and affirmed by the Chief operating Officer to grant the approval to the manufacturer or importer.
Regulations available at
[1]https://www.fssai.gov.in/upload/notifications/2022/10/6348fa8baa887Gazette_Notification_Product_14_10_2022.pdf
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