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FSSAI

Re-operationalisation of FSS Regulations for Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food


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Importer & Manufacturer   |   FSSAI
11 April, 2023
Enforcement Date: 01 April, 2023
Re-operationalisation of FSS Regulations for Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food

The Food Safety and Standards Authority of India (FSSAI) has decided to re-operationalize the FSS Regulations for Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Pre-biotic and Probiotic Food for the 2nd time as specified in the direction under Section 18(2)(d) read with Section 16(5) of Food Safety and Standards Act, 2006 effective from the 1st of April, 2023.


Under Section 92 of the Food Safety and Standards Act, 2006, the Food Safety and Standards Authority of India (FSSAI) has framed the draft FSS Regulations 2022 with respect to the standards of Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food. • The above was operationalized with the help of direction under Section 18(2)(d) read with Section 16(5) of Food Safety and Standards Act, 2006 dated 29th of March, 2022. This regulation has replaced the FSS Regulations 2016 with respect to the standards of the same products. • This regulations’ was further revised on 10th of May, 2022 to permit additional food additives and enzyme/proteins for Health Supplements. The provisions of the above regulations’ under both the directions were re-operationalized effective from the 1st of October, 2022 (with the help of direction dated 18th of October, 2022). • However, the above regulations will further take time for finalization. Hence, in the interim, FSSAI has re-operationalized the provisions of the above draft FSS Regulations for the 2nd time. • This re-operationalize is issued by the approval of the Competent Authority under Section 18(2)(d) and Section 16(5) of Food Safety and Standards Act, 2006.

Applicable For: Importer & Manufacturer
Reference Number: Std/SP-05/T(Nutraceutical-2022)(part-1)-(Part-1) Notification Link

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