Recently, FSSAI threw light on its Direction under section 16(5) of the Food Safety and Standards Act, 2006 regarding operationalization of FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Probiotic Food) Regulations, 2022. In sequel of direction on 29th March 2022, following is the observation during the examination of recently operationalized regulations;
As per provision 5(4)(a) of’ Nutra Regulations 2022. A cross reference to the GMP table (Appendix ‘A’) of the FSS (FPS&FA) Regulations. 2011 has been given for the list of food additives to be used at GMP levels.
Significantly, some of the additives namely- Ammonium acetate, Ammonium lactate, choline, salt and esters, Croscarmellose sodium, Potassium hydrogen malate , Sodium starch glycolate and Sucrose oligoesters-Type I and II which were present in the Schedule VE of the previous FSS (Nutraceuticals) Regulations 2016 are not present in the GMP table (Appendix ‘A’) of the FSS(FPS &FA) Regulations 2011.
Enzymes and Proteins listed under Schedule III of the FSS (Nutra) Regulations 2022 are allowed in the manufacture of health supplements.
The above regulation has been issued with the approval of the competent authorities.