Categories covered under these regulations shall comply with the following general requirements, unless otherwise provided in subsequent sections.
(1) Delivery format: (a) The products covered under these regulations may be in the form of powders, granules, tablets, capsules, liquids, semi solids, drops, pills, gummies, jelly, chewable and mouth dissolving strips, bars, biscuits, candies that are intended to be consumed orally in defined quantities and duration unless otherwise restricted for specific categories under these regulations. In addition, Food Authority may also specify any other formats from time to time.
(b) In case the delivery format is in conventional form (like bar, biscuit, candy, etc.), information on the label shall not represent the product as conventional and clear differentiation in this regard is to be made on the label.
(c) Ingredients not adhering to conventional delivery formats (or as described in Section 22 of FSS Act, 2006) including Nano derived ingredients and modified drug delivery format shall need prior approval under FSS (approval of non-specified food and food ingredients) Regulations, 2017.
(2) Ingredients: (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 as listed below:
(i) Schedule I: Nutrients (vitamins, minerals, amino acids and other nutrients)
(ii) Schedule II: Plant or botanicals*
(iii) Schedule III: Molecules/isolates/extracts other than Schedule II
(iv) Schedule IV: Prebiotics and Probiotics and
*(Ingredients of plant or botanical origin specified in Schedule II may be used either in the given form, or their extract. In case of extract, the same shall be subject to the extractive ratios in relation to the daily usage value and shall be obtained only from the part of the plant listed in the schedule).
(b) In addition, categories covered under these regulations may also contain such additional ingredients, other than additives, which are either standardized or permitted for use in preparation of the other standardized foods as specified in the FSS (Food Products Standards and Food Additives) Regulations, 2011 [FSS(FPS&FA)].
(c) 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.
(d) 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. Such ingredient/product shall need approval in accordance with Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulation, 2017.
(3) Provision for inclusion of ingredients with incident free history of safe use (HoSU): (a) Ingredients including plant or botanicals or their extracts which are not provided in these regulations but have documented incident free history of safe use (at least thirty years in the country of origin or fifteen years in India) may be allowed, with prior approval by the Food Authority through representation by submitting relevant evidence.
(b) For inclusion of any other new ingredient which does not fall under scope of above provision, the Food Business Operator (FBO) shall apply to the Food Authority as per FSS (approval of non-specified food and food ingredients) Regulations, 2017 [FSS (NSF&FI)]. In such cases, Food Authority may, after proper scientific evaluation, include and notify the nutrients or other ingredients approved under NSF regulations from time to time.
(4) Additives, processing aids and flavours: (a) Additives and processing aids as specified in Appendix A and C of FSS (FPS & FA) regulations for categories under these regulations are permitted for use, unless specifically restricted.
(b) The list of additives/excipients intended specifically for tablet/capsule/syrup/pills format shall be specified separately by the Food Authority from time to time.
(c) Flavours: FBO may use the natural, nature identical or artificial flavours in accordance with regulation 3.3.1 of FSS (FPS&FA).
(d) Use of any additive and processing aid that are not specified under these regulations shall be allowed only with the prior approval of the Food Authority or under FSS (approval of Non-Specified Food and Food Ingredient) regulations,2017.
(e) Esters and salts of any vitamins in particular Vitamin C & Vitamin E mentioned under Additives schedules with the usage level as GMP are permitted in product formulations subject to maximum level specified for usage by Food Authority. In case, levels are not specified by Food Authority the total level shall not exceed RDA specified by ICMR.
(5) Purity criteria for the ingredients: (a) The purity criteria for the ingredients used in the categories of articles of food covered under these regulations shall be specified separately by the Food Authority from time to time.
(b) In case such standards are not specified, the purity criteria generally accepted by pharmacopoeias (namely, Indian Pharmacopoeia, Ayurvedic Pharmacopoeia of India, United States Pharmacopoeia & British Pharmacopoeia), relevant BIS Specifications, Quality Standards of Indian Medicinal Plants as published by ICMR, Joint FAO/WHO Expert Committee on Food Additives or Codex Alimentarius may be adopted by FBO.
(c) The FBO shall provide information on the purity criteria adopted for ingredients at the time of licensing and any subsequent changes.
(6) Provision on single purified chemical entity: Any single purified chemical entity listed in these regulations, except extracts of plant or botanicals and vitamins and minerals, amino acids and nucleotides, are not permitted to be sold as HS, Nutra, FSDU, FSMP or Pre-Pro, without prior approval of the Food Authority.
(7) Ingredient combination rationale: Any combination of ingredients in a formulation shall be based on available scientific and technical evidence; and such evidences shall be made available to the Food Authority as and when called for.
(8) Quality requirements for tablet, capsule format: (a) The quality requirements for tablet, capsule format shall be specified separately by the Food Authority from time to time.
(b) In case such standards are not specified, the same shall comply with general monograph and quality requirements specified for them in Indian Pharmacopoeia, if applicable.
(9) Process to obtain plant or botanical extracts: (a) Food grade solvent, either singly or in combination shall only be used for extraction of plant or botanicals.
(b) Ingredient prepared by extraction and fractionation using any other solvent shall require prior approval by the Food Authority under NSF & FI regulations.
(10) Products for 2 to 5 years of age: The products covered under these regulations intended for children of 2 to 5 years of age, shall only be given under medical advice by a recognized medical doctor or dietician or nutritionist.
(11) Overages & Tolerance limit: (a) Addition of appropriate overages to ensure adequate availability of vitamins and minerals in the products shall be permitted based on scientific rationale; and, such overages shall be specified by the Food Authority from time to time.
(b) The tolerance limit for variation in case of articles of food covered in these regulations during analysis of samples of finished products, shall be in accordance with FSS (L&D) regulations, 2020.
(12) Labelling: (a) In addition to the general labelling requirements specified under FSS (Labelling and Display) Regulations, 2020 [FSS (L&D)], categories specified under these regulations shall carry the following information on the label:
(i) Front of the Pack
(A) The words “HEALTH SUPPLEMENT/ NUTRACEUTICAL/ FOOD FOR SPECIAL DIETARY USE/ FOOD FOR SPECIAL MEDICAL PURPOSE/ PREBIOTIC FOOD /PROBIOTIC FOOD” as applicable to the concerned category, in capital and bold letters in the immediate proximity of the name or brand name of the product;
(B) A prominent statement indicating the target consumer group and/or age group if the product has been formulated for a specific age group;
(ii) Front or Back of the Pack
(A) The statement “NOT FOR MEDICINAL USE” in capital and bold letters prominently written on label, unless exempted for specific categories under these regulations;
(B) ‘Recommended usage level’;
(C) ‘Duration of usage, where applicable’;
(D) ‘Not to exceed the recommended daily usage’ prominently written;
(E) An advisory warning in cases where a danger may exist with excess consumption;
(F) Warning on any other precautions to be taken while consuming, known side effects if any, contraindications and published product or drug interactions, as applicable;
(G) statement or warning stating, ‘product is not to be used as a substitute for a varied diet’ except for FSDU and FSMP category;
(H) A warning statement ‘product is required to be stored out of reach of children’;
(I) The quantity of nutrients, expressed in terms of percentage of the relevant recommended daily allowances, unless exempted by any other regulations in force;
(iii) Front or Back of the Pack or Accompanied Leaflet
(A) A declaration on the amount of the nutrients or substances with a nutritional or physiological effect present in the product;
(B) The label, accompanying leaflet or other labelling and advertisement of each type of article of food, referred to in these regulations shall provide sufficient information on the nature and purpose of the article of food and detailed instructions and precautions for its use, and the format of information given shall be appropriate for the intended use of the consumer;
(b) In addition to the above, the labels shall also comply with any other requirements mentioned specifically against the applicable category under these regulations.
(13) Claims and its approval process: (a) The products falling under these regulations by means of labelling, presentation and advertisement shall not claim to treat, cure, mitigate or prevent any specific disease, disorder or condition or refer to such properties, unless specifically permitted by Food Authority
(b) The statement by FBO relating to structure, function or general well-being of the body may be allowed by the Food Authority if the statement is supported by the generally accepted scientific data.
(c) FBO may make nutritional or health claims or reduction of disease risk claims (DRR) that are listed under FSS (Claims and Advertisements) Regulations, 2018 [FSS (C&A)]. For making any other claims or any exemption to 10(1) of FSS (C&A), prior approval of the Food Authority shall be obtained in accordance with FSS (C&A) Regulations, 2018 by submitting relevant documents and fees.
(14) Other regulations for compliance: (a) Unless otherwise specified, categories under these regulations shall comply to the following regulations also -
(i) Chemical Contaminants: FSS (Contaminants, Toxins and Residues) Regulations,2011.
(ii) Microbial contaminants: Appendix B of FSS(FPS&FA).
(iii) Packaging: FSS (Packaging) Regulations,2018
(b) The products shall be prepared and handled in accordance with the requirements specified in Schedule IV, or as applicable, under the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 and such other guidelines as specified from time to time under the provisions of the Food Safety and Standard Act, 2006.
(15) Other provisions including explanatory notes: (a) An article of food which has not been particularly modified in any way but is suitable for use in a particular dietary regimen because of its natural composition, shall not be designated as ‘health supplement’ or ‘special dietary’ or ‘special dietetic’ or by any other equivalent term, and such food may bear a statement on the label that ‘this food is by its nature X’ (‘X’ refers to the essential distinguishing characteristic as demonstrated by the generally accepted scientific data), provided that the statement does not mislead the consumer.
(b) The Food Authority may suspend or restrict sale of such articles of food as have been placed in the market that are not clearly distinguishable from articles of food for normal consumption and are not suitable for their claimed nutritional purpose, or may endanger human health, in accordance with the provisions of the Act.
(c) Food Authority may also advise the FBO to alter or modify or stop claims which are not supported by scientific evidence.
(d) The articles of food or formulation shall consist of a composition delivering the desired level of energy, protein, vitamins and minerals, and other essential nutrients required for respective age group, gender and physiological stage in accordance with the guidelines made by the ICMR from time to time.