Draft Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022.

FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA

NOTIFICATION

New Delhi, the 24th June, 2022

F. No. Std/SP-05/T(Nutraceutical-2022).—The following draft of certain regulations which the Food Safety and Standards Authority of India proposes to make in supersession of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, with previous approval of Food Authority, in exercise of the powers conferred by clause (v) of sub section (2) of section 92 read with sub section (1) of section 22 of Food Safety and Standards Act, 2006 (34 of 2006) hereby published as required by sub­section (1) of section 92 of the said act, for the information of all persons likely to be affected thereby and notice is hereby given that the said draft regulations shall be taken into consideration after the expiry of the period of sixty days from the date on which copies of the Gazette containing this notification are made available to the public.

Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, FDA Bhawan, Kotla Road, New Delhi- 110002 or sent on email at [email protected]

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 Safety and Standards Authority of India.

Draft Regulations

1. These regulations may be called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022.

2. Scope and categories covered

(1) Articles of food falling under these regulations are specially processed or formulated for specific nutritional or dietary purpose and shall be clearly distinguishable from foods intended for normal consumption by their special composition. These foods are intended for population above the age of 2 years1 and shall fulfill the characteristics as laid down in these Regulations. They are intended to be consumed orally in defined quantities and duration and shall not include products intended for parenteral use.

(2) Categories covered under these regulations include the following:

(a) Health Supplements (HS)

(b) Nutraceuticals (Nutra)

(c) Food for Special Dietary Use (FSDU)

(d) Food for Special Medical Purpose(FSMP)

(e) Prebiotic food and Probiotic food (Pre-Pro)

(3) Food or ingredients referred to in Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, and for which standards are provided, and the plants and botanicals specified in these regulations offered in normal or naturally occurring forms shall not constitute a health supplement or nutraceutical, or food for special dietary use or food for special medical purpose.

(4) The products falling under these regulations shall not include a drug as defined in clauses (a), (b) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder.

(5) The products falling under these regulations shall not contain hormones or steroids or a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act,1985 (61 of 1985) and rules made thereunder and substances listed in Schedules E and E-1 of the Drugs and Cosmetics Rules,1945.

(6) The Products claiming cure, prevention or mitigation of any specific disease, disorder or condition shall also not fall under these regulations, unless specifically permitted by Food Authority under FSS regulations.

(7) Mere food forms such as vegetables, for example, bhindi, karela and other vegetables; cereals, for example, ragi, jowar, millets and other cereals; legumes, for example, rajmah and other legumes; spices, for example, pepper, jeera, turmeric and other spices; fruits, for example, amla, jamun, grapes and other fruits; and other plants or botanicals, minimally processed (cleaned, de-weeded, sorted, dried or powdered), in either as juice or cooked form, shall not constitute ‘health supplement‘ or ‘nutraceutical‘ or ‘food for special dietary use‘ or ‘food for special medical purpose‘.

Note 1: Foods intended for infants up to the age of 2 years shall comply with FSS (Food for Infant Nutrition) Regulations, 2020.

3. Definitions. – In these regulations, unless the context otherwise requires

(1) Act means the Food Safety and Standards Act, 2006 (34 of 2006);

(2) Food Authority means the Food Safety and Standards Authority of India established under section 4 of the Act;

(3) Food for special dietary use is a category of foods, which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition and/or specific diseases and disorders and which are presented as such. The composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist. FSDU which are intended to be used as an adjunct for the management of diseases/disorders only under medical prescription and supervision shall normally be categorized under FSMP.

(4) Food for special medical purpose is a category of foods for special medical uses, which are specially processed or formulated and presented for the dietary management of patients and may be used only under medical supervision. They are intended for the exclusive or partial feeding of patients with limited or impaired capacity to take, digest, absorb or metabolize ordinary foodstuffs or certain nutrients contained therein, or who have other special medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for special dietary uses, or by a combination of the two.

(5) Health supplement is a category of foods, which consists of a concentrated source of nutrients (like proteins, minerals, vitamins, amino acids) and/or other ingredients with nutritional or physiological effects, singly or in combination, whose purpose is to supplement the normal diet.

(6) Ingredient means plant or botanicals and their extracts, probiotics, prebiotics, and molecules/isolates as listed by Food Authority in its Schedule II, III and IV.

(7) Nutraceutical is a category of foods which consists of extracts, isolates and purified chemical compounds having a physiological benefit and help to maintain health.

(8) Nutrient means vitamins, minerals, amino acids and other nutrients as specified by Food Authority from time to time.

(9) Premix means a combination of two or more ingredients specified in the Schedules in a specific proportion with or without additives, packed and meant for use in formulating a product falling under any category of these regulations.

(10) Prebiotic food means food that contains added ingredients which are non-viable food components that confer health benefits to the consumer by modulation of gut microbiota.

(11) Probiotic food means food with live micro-organisms beneficial to human health, which when ingested in adequate numbers as a single strain or as a combination of cultures, confer one or more specified or demonstrated health benefits in human beings.

(2) Schedule means the Schedules to be specified by the Food Authority through executive orders under these regulations.

(13) Sportsperson means an individual who regularly participates in various types of sports activities as approved by Sports Authority of India (Ministry of Youth Affairs & Sports).

4. Applicability. – No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any food products referred to in these regulations unless they comply with the requirements laid down in these regulations.

5. General requirements for all categories. – 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.

6. Category specific requirements

(1) Health supplements:

(a) Scope: Health supplements are meant to supplement the normal diet of a person and not intended to treat or cure any deficiency.

(b) Nutrients/Ingredients allowed: Proteins, vitamins, minerals, amino acids or other ingredients with nutritional or physiological effects, singly or in combination, specified under schedules (except Schedule III) by the Food Authority from time to time.

(c) Nutrients/Ingredients usage level: (i) Nutrients: Usage levels shall not be more than the level specified by the Food Authority. In case, the levels are not specified by the food Authority, usage level shall be minimum 15 % of RDA as specified by ICMR, where a nutrient content claim is being made, provided that, if claim of higher nutrient content is made, the nutrient content shall not be less than thirty per cent of the recommended daily allowance and shall not exceed one RDA in any case. In case such standards are not specified, the standards laid down by an international food standards body namely, Codex Alimantarius Commission shall apply.

(ii) Ingredients: Limits as specified in schedule. In case daily minimum and maximum usage levels have not been specified, the FBO shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data. FBO shall submit such data to the Food Authority, as and when called for.

(d) Delivery format(s): Shall comply with general requirements 5(1).

(e) Additive(s): (i) For products in tablet/capsule/pills/liquid format: Only additives as specified by the Food Authority from time to time.

(ii) For products other than tablet/capsule/pills/liquid format: Only additives within the limits specified as permitted for category 13.6 and GMP table of Appendix ‘A‘ of FSS (FPS & FA) Regulations, 2011 are permitted.

(f) Labelling requirement(s): (i) Shall comply with general requirements 5(12).

(ii) In addition, Food Authority may allow Health supplements term on the label may be interchangeably use by the terms, namely, Dietary supplements or Food supplements.

(2) Nutraceutical

(a) Scope: The nutraceuticals are meant to provide a physiological benefit and help maintain good health and not intended to treat or cure any medical condition, disease, or disorder.

(b) Nutrients/Ingredients allowed: Molecules/ isolates/extract from the Schedule III as specified by Food Authority from time to time. In addition, it may also contain nutrients and ingredients from other schedules as approved and specified by Food Authority from time to time as an optional ingredient.

(c) Nutrients/Ingredients usage level: (i) Ingredients: Limits as specified in Schedule III with standardization to marker compounds specified and at daily usage levels specified therein. In case daily minimum and maximum usage levels have not been specified, the FBO shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data. The ingredient for which the standardization of the marker compound has not been specified shall comply with manufacturer specifications or quality requirements and purity criteria as specified in regulation. FBO shall submit such data to the Food Authority as and when called for.

(ii) Nutrients: Usage levels shall not be more than the level specified by the Food Authority. In case, the levels are not specified by the food Authority, usage level shall be minimum 15 % of RDA as specified by ICMR, where a nutrient content claim is being made, provided that, if claim of higher nutrient content is made, the nutrient content shall not be less than thirty per cent of the recommended daily allowance and shall not exceed one RDA in any case. In case such standards are not specified, the standards laid down by an international food standards body namely, Codex Alimantarius Commission shall apply.

(d) Delivery format(s): Shall comply with general requirements 5(1).

(e) Additive(s): (i) For products in tablet/capsule/pills/liquid format: Only additives as specified by the Food Authority from time to time.

(ii) For products other than tablet/capsule/pills/liquid format: Only additives within the limits specified as permitted for category 13.6 and GMP table of Appendix ‗A‘ of FSS (FPS & FA) Regulations, 2011 are permitted.

(f) Labelling requirement(s): Shall comply with general requirements 5(12).

(3) Food for Special Dietary Use (FSDU)

(a) Scope: (i) This standard applies to all prepackaged foods for special dietary uses, in case of weight management, obesity, diabetes, high blood pressure, pregnant and lactating women, geriatric population, celiac disease, sleep management, food for Sportspersons and other health conditions.

(ii) Any other special dietary use products containing the approved ingredients shall need prior approval from the Food Authority by submitting the representation along with scientific justification.

(iii) FSDU shall not include the normal food which is merely enriched or modified with nutrients and meant for mass consumption, intended for improvement of general health for day to day use and do not claim to be targeted to consumers with specific disease conditions and also not include the article of food intended to replace complete diet covered under food for special medical purpose.

(b) Nutrients/Ingredients allowed: Carbohydrates, proteins, vitamins, minerals, amino acids, fats/essential fatty acids, fibre including dietary fibre and other ingredients such as botanicals and their extracts, enzymes, probiotics, prebiotics, and other dietary substances (singly or in combination) as specified in different Schedules by Food authority from time to time.

(c) Nutrients/Ingredients usage level: (i) Nutrients: Usage levels shall not be more than the level specified by the Food Authority. In case, the levels are not specified by the food Authority, usage level shall not exceed one RDA as specified by ICMR in any case. However, usage level beyond those specified by Food Authority or RDA in food format (except tablet, capsule, syrup) are permitted only with prior approval of Food Authority by providing adequate scientific evidence to the Food Authority.

(ii) Ingredients: Limits as specified in schedule. In case daily minimum and maximum usage levels have not been specified, the FBO shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data. FBO shall submit such data to the Food Authority as and when called for.

(d) Delivery format(s): (i) Shall comply with general requirements 5(1).

(ii) In addition, FBO may formulate an article of food for special dietary use in formats meant for oral feeding through an enteral tube unless otherwise restricted under sub-categories of FSDU but shall not be used for parenteral use.

(e) Additive(s): (i) For products in tablet/capsule/pills/liquid format: Only additives as specified by the Food Authority from time to time.

(ii) For products other than tablet/capsule/pills/liquid format: Only additives within the limits specified as permitted for category 13.5 and GMP table of Appendix ‘A‘ of FSS (FPS & FA) Regulations, 2011 are permitted.

(f) Labelling requirement(s): Shall comply with general requirements except 5(12)(a)(ii)(A). In addition, every package of Food for Special Dietary Use shall carry the following information on the label:

(i) Front of Pack

(A) the words ―FOOD FOR SPECIAL DIETARY USE” followed by ―Food for… ” (mentioning the particular physiological or health condition or particular usage group as the case may be).

(B) a statement to indicate on the label whether or not the food for special dietary use is to be taken under medical advice of physician or certified dietician or nutritional professional

(ii) Front or Back of Pack

(A) a statement that the product is not to be used by pregnant, nursing and lactating women or children under 5 years, adolescents and elderly, except when medically advised by physician or certified dietician or nutrition professional;

(B) a statement on rationale for use of the product and a description of the properties or characteristics that make it useful;

(C) a statement specifying the nutrient which is reduced, deleted, increased or otherwise modified, relating to normal requirement, and the rationale for the reduction, deletion, increase or other modification;

(D) a warning that the product is not for parenteral use or for oral use only; (Note: replacement of terms like ‘Parenteral‘ needs to be clarified as ‘a cautionary statement that ‘the product is for oral consumption only’;

(E) information on osmolality or osmolarity or on acid-base balance where appropriate.

(g) Any other requirement not covered above: Advertisement of FSDU for general public shall clearly indicate that the product is to be taken under medical advice, wherever applicable.

3.1 Categories of FSDU

3.1.1 FSDU for weight management:

In addition to other FSDU requirements above, product intended for weight management shall comply with the following:

(a) Scope: (i) This standard applies to foods which, when presented as “ready-to-serve” or when prepared in conformity with the directions for use by the manufacturer, are presented as a replacement for all or part of the total daily diet for use in weight control.

(ii) It does not apply to prepackaged meals controlled in energy and presented in the form of conventional foods.

(b) Essential Composition: (i) Energy:

(A) FSDU presented as a replacement for all meals of the daily diet- Minimum 800 kcal (3,350 kJ); not more than 1,200 kcal (5,020 kJ). The individual portions or servings contained in the formula food shall provide approximately one-third or one-fourth of the total energy of the food in the pack depending on whether the recommended number of portions or servings per day is three or four, as the case may be, respectively.

(B) FSDU presented as a replacement for one or more meals of the daily diet – Minimum 200 kcal (835 kJ); not more than400 kcal (1,670 kJ) per meal. When such products are presented as a replacement for the major part of the diet, the total energy intake shall not exceed 1,200 kcal (5,020 kJ).

(ii) Protein: Not less than 25 per cent and not more than 50 per cent of the energy available from the food, when ready-to-serve, shall be derived from its protein content; and the total amount of protein shall not exceed 125 g per day. The quality of protein shall have-

(A) the protein digestibility corrected amino acid score of 1.0 known as, the reference protein;

(B) the protein digestibility corrected amino acid score where less than 1.0, the minimum level shall be increased to compensate for the lower protein quality;

(C) the protein with a protein digestibility corrected amino acid score of 0.8 or more shall be used in a formula food for use in a weight control diet; and

(D) for improving the protein quality, the FBO shall add only L- forms of essential amino acids except for methionine where DL form is allowed.

(iii) Fat and linoleate: Not more than 30 per cent of the energy available from fat and not less than 3 per cent of the energy from linoleic acid in the form of a glyceride.

(iv) Vitamins and minerals: FSDU represented as a replacement for all meals per day, shall contain at least one RDA of vitamins and minerals in the daily intake. However, usage level beyond RDA are permitted only with prior approval of Food Authority by providing adequate scientific evidence to the Food Authority.

(v) Dietary fiber: These products shall have adequate dietary fiber.

(c) Additive(s): Only additives within the limits specified as permitted for category 13.5 of Appendix ‗A‘ and GMP table of FSS (FPS & FA) Regulations, 2011 are permitted.

(d) Labelling requirement(s): In addition to 5(12) and 6(3)(f), every package of Food for Special Dietary Use intended for weight management shall carry the following information on the label– a statement “Meal Replacement for Weight Control/Management ” in close proximity to the name of the articles of food;

3.1.2 Food for Sportsperson

(a) Scope: This standard applies to foods which are presented as a food for sportspersons in formats meant for oral consumption and to be used only under medical advice by physician or certified dietician or nutritional professional and shall not be applicable to liquid products/beverages and premixes (to be reconstituted) which are specified under Appendix A; Food category system 14.1.4 of FSS (FPS &FA) Regulations.

(b) Labelling requirement(s): In addition to 5(l) and 6(3)(f), every package of Food for Sportsperson shall carry the following information on the label–

(i) Front of Pack

(A) a statement ―FOR SPORTSPERSON ONLY” in close proximity to the name of the articles of food;

(B) a statement ―Recommended to be used under medical advice by a physician or certified dietician or nutrition professional only‖ on the front of the pack;

(C) the logo as specified below-

(ii) Front or Back of Pack

(A) a statement that the product is not to be used by pregnant, nursing and lactating women or by infants, children under 5 years and elderly;

(B) if the product has been formulated for a specific age group, sports activity as per the approved list of Sports Authority of India (Ministry of Youth Affairs and Sports, Government of India), a prominent statement to that effect;

(C) a statement ‘for oral consumption only‘;

(D) a statement ‘the food is not a sole source of nutrition and shall be consumed in-conjunction with a nutritious diet‘;

(E) a statement ‘the food shall be used in conjunction with an appropriate physical training or exercise regime‘.

(c) Any other requirement not covered above: Prohibited substances declared by the World Anti-Doping Agency (WADA) shall not be added in any of the articles of food specified for sport persons. FBO must ensure to check the list of prohibited substances which is published annually by the WADA and is effective from the January 1 every year.

(4) Food for Special Medical Purpose

(a) Scope: (i) This standard applies to the foods specially meant for dietary management of persons with specific medical condition or disease or disorder.

(ii) The articles of food for special medical purpose, other than those intended for infants, may either be nutritionally complete food which, when used in accordance with the manufacturer’s instructions, shall constitute the sole source of nourishment for the persons for whom they are intended or nutritionally incomplete food with formulation specific for a disease, disorder or medical condition, but are not suitable to be used as the sole source of nourishment. Accordingly, FSMP may be classified in to following three categories

(A) ‘Nutritionally complete food with a standard nutrient formulation‘, which when used in accordance with the manufacturer’s instructions, may constitute the sole source of nourishment for the persons for whom they are intended.

(B) ‘Nutritionally complete food with a nutrient-adopted formulation specific for a disease, disorder or medical condition‘, which when used in accordance with the manufacturer’s instructions, may constitute the sole source of nourishment for the persons for whom they are intended; and

(C)’Nutritionally incomplete food with a standard formulation or a nutrient adopted formulation specific for a disease, disorder or medical condition‘, which is not suitable to be used as the sole source of nourishment

Note. – the food specified in item (B) and (C) of sub-clause (ii) may be used as a partial replacement or as a supplement to the person‘s diet.

(b)Nutrients/Ingredients allowed: Carbohydrates, proteins, vitamins, minerals, amino acids, fats/essential fatty acids, fibre including dietary fibre and other ingredients such as botanicals and their extracts, enzymes, probiotics, prebiotics, and other dietary substances (singly or in combination) as specified in different Schedules by Food Authority from time to time.

(c) Nutrients/Ingredients usage level: (i) Nutrients: Usage levels shall not be more than the level specified by the Food Authority. In case, the levels are not specified by the food Authority, usage level shall not exceed one RDA as specified by ICMR in any case. However, usage level beyond those specified by Food Authority or RDA in food format (except tablet, capsule, syrup) are permitted only with prior approval of Food Authority by providing adequate scientific evidence to the Food Authority.

(ii) Ingredients: Limits as specified in schedule. In case no daily minimum and maximum usage levels have not been specified the FBO shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data. FBO shall submit such data to the Food Authority as and when called for.

(d) Delivery format(s): (i) Shall comply with 5(1). However, formats namely, tablet/capsule/pills/liquid drops, gummies, jelly, chewable and mouth dissolving strips are not permitted under this category.

(ii) A FBO may formulate food for special medical purpose in format meant for oral feeding through enteral tubes but shall not be used for parenteral use.

(e) Additive(s): Only additives within the limits specified as permitted for category 13.3 and 13.4 of Appendix ‘A‘ and GMP table of FSS (FPS & FA) Regulations, 2011 are permitted.

(f) Labelling requirement(s): In addition to 5(12) except 5(12)(a)(ii)(A), every package of Food for Special Medical Purpose shall carry the following information on the label–

(i) Front of Pack

(A) an advisory warning ―”RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” appearing on the label in capital and bold letters on Front of pack;

(B) the statement ―For the dietary management of_________ ‖ (the blank to be filled with the specific
disease, disorderor medical conditionfor which the product is intended subject to its approval by the Food Authority through representation by submitting appropriate scientific, and clinical and epidemiological data;

(C) a statement ‘NUTRITIONALLY COMPLETE‘ if the food is intended to be used as a nutritionally complete food;

(ii) Front or Back of Pack

(A) a statement on the rationale for use of the product by the target consumer group and a description of the properties or characteristics that make it useful;

(B) a statement specifying the nutrients, which have been reduced, deleted, increased or otherwise modified, relating to normal requirements, and the rationale for the reduction, deletion, increase or other modification;

(C) information on osmolality or osmolarity, renal solute load, potential renal solute load or acid-base balance, wherever applicable;

(D) instructions for appropriate preparation, feeding, use and storage of the product after the opening of the container;

(E) a warning that the ‘product is not for parenteral use‘;

(g) Any other requirement not covered above: No FBO shall make nutrition and health claims on food for special medical purposes. Further, no food business operator shall advertise the food for special medical purpose for use by general public.

4.1 FSMP for Weight Reduction

(a) Scope: (i) This standard applies to formula foods for use in very low energy diets for weight reduction intended as total replacement of diet. These foods are defined as foods for special medical purposes and must be used under medical supervision by individuals with moderate or severe obesity.

(ii) It does not apply to prepackaged meals presented in the form of conventional foods.

(b) Essential Composition: When prepared according to instructions,

(i) Energy: a daily energy intake of 450-800 kcal as the only source of energy;

(ii) Protein: Not less than 50 g with a protein digestibility corrected amino acid score of 1.0 is present in the recommended daily intake of energy. Essential amino acids may be added to improve protein quality only in amounts necessary for this purpose. Only L-forms of amino acids shall be used, except that DL-methionine may be used.

(iii) Fats: 3 g of linoleic acid; and 0.5 g α-linolenic acid in the recommended daily intake with the α-linoleic acid and linolenic acid ratio between 5 and 15;

(iii) Carbohydrates: NLT 50 g of available carbohydrates in the recommended daily intake of energy;

(iv) Dietary fiber: Product shall have adequate dietary fiber.

(c) Nutrients/Ingredients usage level: (i) Nutrients: Usage levels shall not be more than the level specified by the Food Authority. In case, the levels are not specified by the food Authority, usage level shall not exceed one RDA as specified by ICMR in any case. However, usage level beyond those specified by Food Authority or RDA in food format (except tablet, capsule, syrup) are permitted only with prior approval of Food Authority by providing adequate scientific evidence to the Food Authority.

(ii) Ingredients: Limits as specified in schedule. In case no daily minimum and maximum usage levels have not been specified the FBO shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data. FBO shall submit such data to the Food Authority as and when called for.

4.2 Foods intended for Special Diagnostic Purpose

(a) Scope: This standard applies to formula foods used during Special Diagnostic Purpose.

(b) Requirements: FBO shall seek approval for Foods intended for Special Diagnostic Purpose in accordance with NSF&FI regulations.

(5) Prebiotic and Probiotic Food (Pre-Pro)

(a) Scope: (i) Prebiotic Food: These are non-viable food components that confer health benefits by modulating gut microflora.

(ii) Probiotic Food: The foods with added viable microorganisms which when consumed in adequate amount confer health benefits. Provided that the presence of the commonly used starter cultures of lactic acid producing bacteria such as Lactococcus spp., earlier known as Streptococcus spp., Lactobacillus spp. and other such microorganisms used in the preparation of fermented milk (dahi) and related products shall not be considered as probiotics, if the probiotic properties have not been substantiated.

(b) Nutrients/Ingredients allowed: (i) Prebiotic Food: Prebiotic ingredients specified by the Food Authority from time to time.

(ii) Probiotic Food: Probiotic microorganisms specified by the Food Authority from time to time. In addition, it may also contain prebiotics permitted under these regulations.

(c) Nutrients/Ingredients usage level: (i) Prebiotic Food: Not more than 40g/day for adults

(ii) Probiotic Food: Minimum viable number of added probiotic organisms in food shall be ≥108 CFU in the recommended serving size per day. Provided that a lower viable number may be allowed with proven studies on health benefits with those numbers subject to the prior approval of the Food Authority.

(d) Delivery format(s): Shall comply with 5(1). However, formats namely, tablet/capsule/pills/liquid drops are permitted only with prior approval of Food Authority.

(e) Additive(s): Only additives within the limits specified as permitted for category 13.6 of Appendix ‘A‘ of FSS (FPS & FA) Regulations, 2011 and GMP table are permitted.

(f) Labelling requirement(s): In addition to 5(12), every package of Probiotic food shall carry the following information on the label, –

(i) Front or Back of Pack

(A) genus and species including strain designation or culture collection number, in brackets where probiotics are mentioned in the list of ingredients; In such cases, internationally accepted short names are allowed;

(B) viable numbers at the end of the shelf-life of probiotic strain corresponding to the level at which the efficacy is claimed;

(C) the recommended serving size, which shall deliver the effective viable dose of probiotics related to health claims;

(D) proper storage temperature conditions, and time limit for ‘Best Use‘ after opening the container;

(g) Any other requirement not covered above: Any new approval of new probiotic strain shall be based on data collected in accordance with guidelines issued by the Indian Council of Medical Research and Department of Biotechnology with respect to probiotics and approval under NSF&FI regulations.

ARUN SINGHAL, Chief Executive Officer

[ADVT.-III/4/Exty./142/2022-23]

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