This regulation would replace the previous regulations of 2016 for these products.
According to the FSSAI, it was done to overhaul the entire segment and make it more ‘stakeholder’ friendly and as articles of food falling under these regulations are specially processed or formulated for specific nutritional or dietary purpose and should be clearly distinguishable from foods intended for normal consumption, these regulations will benefit the nutraceuticals sector to have clear guidelines and will also enable field functionaries to ensure better compliance at the ground level.
Categories covered under these regulations include, (a) Health Supplements (HS) (b) Nutraceuticals (Nutra) (c) Food for Special Dietary Use (FSDU) (d) Food for Special Medical Purpose (FSMP) and (e) Prebiotic food and Probiotic food (Pre-Pro).
FSSAI added that there was not much fundamental change in the provisions and only a reorganisation of clauses was done for ease of understanding and objections or suggestions, which may be received from any person with respect to the said draft regulations before the expiry of period so specified, shall be considered by the Food Authority.
About ingredients, the regulations lay that (a) The products shall contain approved ingredients as applicable to different categories of foods to be specified separately by the Food Authority in the form of Schedules including Schedule I: Nutrients (vitamins, minerals, amino acids and other nutrients), Schedule II: Plant or botanicals, Schedule III: Molecules/isolates/extracts other than Schedule II, & Schedule IV: Prebiotics and Probiotics.
“In addition, categories covered under these regulations may also contain such additional ingredients, other than additives, which are either standardised or permitted for use in preparation of the other standardised foods,” reads the draft.
Further, according to the draft, products covered under these regulations may also contain cereal grains, legumes, fruits and vegetables mentioned in the latest edition of the Indian Food Composition Tables (IFCT) published by ICMR-National Institute of Nutrition (ICMR-NIN) and spices included in the list published by the Spices Board of India either as such or as processed ingredients including extracts while non-specified foods including novel foods and non-specified ingredients, even if intended for use as any of the above categories, are not covered under these regulations and such ingredient/product shall need approval in accordance with Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulations, 2017.