Operationalization of FSS (Health supplements, Nutraceuticals, Dietary use products, Prebiotic and Probiotic.

30th March, 2022
Operationalization of FSS (Health supplements, Nutraceuticals, Dietary use products, Prebiotic and Probiotic.
Regulatory BodyFSSAI Product CategoryFood for Importer & Manufacturer
India's Food Safety and Standards Authority released a Direction under section 16 (5) of the Food Safety and Standards Act, 2006. The Direction discussed the operationalization of the Food products under FSS, which included Health supplements, Nutraceuticals, Food for Dietary Use, and Food for medical purposes like Prebiotic and probiotics. The previous Gazette was amended from FSS Regulation 2016 to the new FSS (Nutra) Regulations, 2022 to give clear and concise information about the food products. However, the final draft publication might be delayed; hence, Annexure 1 will be in effect from the 1st of April 2022, along with Annexure 2 (Schedule as applicable) and Annexure 3 (list of additives). In addition, the New FSS regulation 2022 wlll supersede the FSS regulation for Nutraceuticals
Notable Products:FSS Regulation 2022, Prebiotic and probiotic
Applicable For:Importer & Manufacturer
Reference Number:Std/SP-05/T(Nutraceutical-2022)[E-5184]
The document included Annexures 1, 2 and 3 for providing better clarity on the food and supplements. Annexure 1 include the general scope and categories to be covered in the upcoming draft with the product falling in the new FSS regulation categories such as, (i) Health supplements (HS) (ii) Nutraceuticals (Nutra)(iii) Food for Special Dietary Use (FSDU)(iv) Food for Special Medical Purpose (FSMP)(v) Prebiotic food and Probiotic food (Pre-Pro) As mentioned above, any product falling in these categories should not be in any defined drugs clauses as per the Drugs and Cosmetics Act, 1940.This product should not be in any category of psychotropic substances or should be a steroid or narcotic drug. Annexure 1 further included the list of definitions for each product, applicability, and general requirements. The overall description of these products was mentioned with the labelling conditions to be followed by a manufacturer. Special labelling should be done by mentioning the word 'Health supplement/Nutraceutical Food for special dietary use/ Food for special medical purpose/ Prebiotic food/probiotic food' in front of the pack and the use of the product for the specified age group. For every product category, the scope, requirements and labelling were included in Annexure I. Annexure-II includes the entire list differentiated into four Schedules as; Schedule I - vitamins, minerals and amino acids. Schedule II - Plant or botanicals with official and common names and the allowed range. Schedule III - Molecules/isolates/extracts not included in Schedule II Schedule IV - which included the prebiotics and probiotics contents and the list of microorganism strains. Annexure 3, on the other hand, included a complete list of additives that can be used in dietary formulation (weight reduction) and herbal, nutraceutical, prebiotic and probiotic products.