Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016

Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016[1]

[23rd December, 2016]

Whereas the draft of the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods, and Novel Food) Regulations, 2015, was published as required by sub-section(1) of Section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), vide notification of the Food Safety and Standards Authority of India No. 1-4/Nutraceutica1/FSSAI-2013, dated the 30th July, 2015, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the persons likely to be affected thereby, before the expiry of a period of sixty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas the copies of the said Gazette were made available to the public on the 11th September, 2015;

And whereas objections and suggestions received from the public within the specified period on the said draft regulations have been considered by the Food Safety and Standards Authority of India;

Now, therefore, 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 the Food Safety and Standards Act, 2006 (34 of 2006), the Food Safety and Standards Authority of India hereby makes the following regulations, namely—

Regulation 1. Short title and commencement

(1)     These regulations may be called 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.

(2)     They shall come into force on the date of their publication in the Official Gazette and Food Business Operator shall comply with all the provisions of these regulations by 1st January, 2018.

Regulation 2. Definitions

In these regulations, unless the context otherwise requires,—

(a)      “Act” means the Food Safety and Standards Act, 2006 (34 of 2006);

(b)      “Food Authority” means the Food Safety and Standards Authority of India established under Section 4 of the Act;

(c)      “food for special dietary use” shall have the meaning assigned to it in Section 22 of the Act;

(d)      “food for special medical purpose” means food intended for—

(i)       particular dietary use specially processed or formulated;

(ii)      the dietary management of persons and used only under medical advice;

(iii)     the exclusive or partial feeding of persons with a limited, impaired or disturbed capacity to take, digest, absorb, metabolize or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites; or

(iv)    other medically determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by food for specific nutritional use, or a combination of them;

(e)      “food with added prebiotic ingredients” means food that contains added prebiotic ingredients which are non-viable food components that confer health benefits to the consumer by modulation of gut microbiota;

(f)       “food with added probiotic ingredients” 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;

(g)      “functional food” shall have the meaning assigned to it in Section 22 of the Act;

(h)     “health supplements” shall have the meaning assigned to it in Section 22 of the Act;

(i)       “non-food” means an ingredient or a substance which is not a ‘food’ as referred to in clause (j) of Section 3 of the Act;

(j)       “novel food” shall have the meaning assigned to it in Section 22 of the Act;

(k)      “nutraceuticals” shall have the meaning assigned to it in Section 22 of the Act;

(l)       “nutritional ingredients” means the ingredients specified in Schedules other than the food additives specified in Schedule V-A to Schedule V-F, packed and made available in a form not for retail-consumer use, but meant for use in formulating a product falling under various categories of these regulations or other categories specified in the Food Safety and Standards (Food Products Standards and Food Additves) Regulations, 2011;

(m)    “nutrient ingredients” means vitamins, minerals, and amino acids as specified in Schedule I and Schedule II;.

(n)     “pre-mixes” 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 or under the categories specified in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011;

(o)      “specialty food containing plant or botanical ingredients” means food which is shown to be containing plant or botanical ingredients with a history of safe usage; and

(p)      “Schedules” means the Schedules to these regulations.

Regulation 3. General requirements

(1)     The articles of food sold in capsule format, hard or soft or vegetarian, shall comply with the general monograph and quality requirements specified for them in Indian Pharmacopoeia:

Provided that the food business operator may use the approved colours and additives permitted in Schedule V-F;

Provided further that the food business operator may use the natural flavors or nature identical flavours or synthetic flavors in accordance with the provisions of Regulation 3.3.1 of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.

(2)     For the purposes of sub-regulation (1) the food business operator may declare the addition of flavour on labels of such products in accordance with the provisions of Food Safety and Standards (Labelling and Packaging) Regulations, 2011.

(3)     The tablets, capsules and syrups shall fulfil the general quality requirements and standards as specified in Indian Pharmacopoeia, British Pharmacopoeia or United States Pharmacopoeia.

(4)     The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standards laid down by international food standards body, namely, Codex Alimentarius Commission, shall apply.

(5)     In case of food products falling under health supplement categories, the individual nutrient content shall not be less than fifteen per cent of the recommended daily allowance 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.

(6)     For the articles of food specified in these regulations, the Food Authority may permit the food business operator to add food colours subject to the level restrictions as mentioned in Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.

(7)     The articles of food with standard nutrient or nutritionally complete 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 Indian Council of Medical Research.

(8)     The purity criteria for the ingredients used in the categories of articles of food covered under these regulations shall be as determined and notified in the Official Gazette by the Food Authority from time to time.

(9)     In case such standards are not specified, the purity criteria generally accepted by pharmacopoeias, namely, Indian Pharmacopoeia, Ayurvedic Pharmacopoeia of India, relevant Bureau of Indian Standards Specifications, Quality Standards of Indian Medicinal Plants, Indian Council of Medical Research, British Pharmacopoeia, United States Pharmacopoeia, Food Chemical Codex, Joint Food and Agriculture Organization or World Health Organisation Expert Committee on Food Additives or CODEX Alimentarius may be adopted by food Business operators.

(10)   The food business operator shall intimate the purity criteria adopted for ingredients to the Food Authority including any change when adopted.

(11)   The tolerance limit for variation in case of articles of food covered in these regulations during analysis of samples of finished products, shall not be more than (-) ten per cent from the declared value of the nutrients or nutritional ingredients on the label.

(12)   The manufacturing of ingredients and products covered under these regulations shall be carried out in compliance with the established good manufacturing practices.

(13)   For purposes of these regulations, any of the ingredients specified in Schedule I, Schedule II, Schedule III, Schedule IV, Schedule VI, Schedule VII, and Schedule VIII may be used in food in accordance with the provisions of these regulations, and for the said purpose, may use additives as applicable to categories specified in Schedule V-A to Schedule V-F.

Explanation 1 - For the purposes of these regulations food or ingredients referred to in Food Safety and Standards Regulations, 2011, and for which standards are provided, and the plants and botanicals specified in Schedule IV of 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.

Explanation 2 - Mere food forms such as vegetables, namely, bhindi, karela and other vegetables; cereals, namely, ragi, jowar, millets and other cereals; legumes, namely, rajmah and other legumes; spices, namely, pepper, jeera, turmeric and other spices; fruits, namely, 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’.

(14)   The formulation of articles of food shall be based on the principles of sound medicine or nutrition and supported by validated scientific data, wherever required.

(15)   No hormones or steroids or psychotropic ingredients shall be added in any of the articles of food specified in these regulations.

(16)   The label on articles of food shall specify the purpose, the target consumer group and the physiological or disease conditions which they address, recommended duration of use, and the specific labelling requirements as mentioned against each type of article of food.

(17)   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 consumer.

(18)   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.

(19)   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.

(20)   The Food Authority may, at any time, direct a food business operator manufacturing and selling such special type of article of food, to furnish details regarding the history of use of the novel or modified ingredients added and their safety evaluation.

(21)   The mere combination of vitamins and minerals formulated in tablets, capsules, syrup formats shall not be covered in any of the categories of these regulations except when vitamins and minerals are added to an article of food or in a food format.

(22)   The labelling on the article of food shall be in accordance with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011, and the specific labelling requirements provided in these regulations.

(23)   The articles of food shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.

(24)   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.

(25)   Whoever contravenes the provisions of these regulations shall be liable for punishment provided under Chapter IX of the Act.

Regulation 4. Claims

(1)     Every food business operator may make nutritional or health claims in respect of an article of food.

(2)     For the purposes of sub-regulation (1), a nutritional claim shall consist of the ‘Ingredients (nutrient or nutritional) content’ of an article of food which shall be subject to the nutritional supplement requirements specified in Schedule I, Schedule II, Schedule III, Schedule IV, and Schedule VI.

(3)     For the purposes of these regulations, health claim means any representation in respect of an article of food that states, suggests or implies that a relationship exists between the constituent of that nutrient or nutritional, health, and specific disease conditions.

(4)     The health claim in respect of an article of food consists of the following two essential components, namely—

(i)       nutrient or nutritional ingredients; and

(ii)      health related benefits.

(5)     The health claim in respect of an article of food may include the following types, but not limited to—

(i)       ingredients (nutrient or nutritional) function claims;

(ii)      enhanced function claims;

(iii)     disease risk reduction claims;

(iv)    health maintenance claims;

(v)      immunity claims − increased resistance (excluding vaccines); and

(vi)    anti-ageing claims.

(6)     The other claims in an article of food that are not drug claims may be allowed subject to prior approval of the Food Authority.

(7)     The health claims in respect of an article of food shall be commensurate with the adequate level of documentation and valid proof made available for review by the Food Authority when called for.

(8)     To claim ingredients, nutrient or nutritional, in respect of an article of food for enhanced function and disease risk reduction, regard shall be had to—

(i)       claims that led to ingredients (nutrient or nutritional);

(ii)      available scientific literature including official traditional texts and post market data or consumer studies or cohort or retroactive studies based on eating pattern and health benefits, epidemiological international and national data, and other well documented data;

(iii)     consensual, congruent and concurrent validity studies;

(iv)    health promotive and disease risk reduction based on proof from literature and human data of efficacy and safety of the nutrient;

(v)      not only controlled clinical trials for efficacy and safety data; but also nutraepidemiological data;

(vi)    qualified structure function claims for specific organ or function which are comprehensible to consumer;

(vii)   prohibition of implied claims for curing disease or claims of drug like efficacy such as ‘Prevents bone fragility in post menopausal women’;

(viii)  prohibition of implied cure for disease claims by the name of the product such as cancer cure or through a pictures, vignettes or symbols, namely, electrocardiogram tracing, lipid profile; and

(ix)    for structure-function claims, a case-to-case basis consumer information for specific age or gender or vulnerable population.

(9)     (i) For the product led claims in respect of an article of food based on human studies with evidence based data, regard shall be had to—

(a)      valid data and suitable statistical design proving the benefit for disease risk reduction, that is, human intervention studies;

(b)      ingredient, that is, nutrient or nutritional;

(c)      the product compatibility for the proposed claim benefit and suitable qualifiers such as heart healthy claim on polyunsaturated fatty acids;

(d)      the use of word “shown” as depicted in the example below when a single human intervention study shows significant benefit:

“Product <Name of the Product> is ‘shown’ to be helping in <keeping your heart healthy> or <heart healthy>:

(e)      the use of word “Proven” as depicted in the example below when more than one human intervention studies or epidemiological evidence on Indian population have been provided with concurrent validity:

“Product <Name of the Product> is ‘proven’ <to make you lose weight>:

(ii) For health claims where scientific support does not exist, or if a novel ingredient is to be introduced, there shall be a prior approval of the Authority which shall be based on adequate scientific evidence.

(iii) If the health claims are product led, the food business operator shall notify to the Food Authority before putting the same in the market, by submitting relevant documents along with a copy of the label.

Regulation 5. General principles for query or challenge.-

The food business operator shall—

(i)       prepare and make available the comprehensive product information, safety and claims support data and shall periodically get it reviewed and scrutinised by a scientist or expert with relevant qualifications and experience;

(ii)      attach the scientific view of the reviewer on claims and its veracity along with the qualification and experience of the reviewer as an essential part of the document;

(iii)     clarify, in case of a technical query from the Food Authority or on a public complaint lodged with the Food Authority, and assist the Food Authority to examine or authorise an appropriate expert group to review the case; and

(iv)    alter or modify or stop claim when directed by the Food Authority which shall be based on the opinion of an expert group.

Regulation 6. Health supplements

(1)     (i) Health supplements may be used to supplement the normal diet of a person above the age of five years.

(ii) the health supplements shall contain concentrated source of one or more nutrients, namely, amino acids, enzymes, minerals, proteins, vitamins, other dietary substances, plants or botanicals, prebiotics, probiotics and substances from animal origin or other similar substances with known and established nutritional or beneficial physiological effect, which are presented as such and are offered alone or in combination, but are not drugs as defined in the clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder.

(iii) the health supplements shall be marketed in single use packaging as appropriate to maintain integrity and quality of the product, or in dosage forms namely, capsules, tablets, pills, sachets; jelly or gel, semi-solids and other similar forms or any other forms of liquids and powders designed to be taken in measured unit quantities.

(iv) the health supplements shall not include any of the food products or categories of articles of food for which specific standards have been laid down in any other parts of these regulations.

(2)     (i) The health supplements shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VII or Schedule VIII or enzymes only of Schedule VI.

(ii) The ingredients specified in the Schedules referred to in clause (i) of sub-regulation (2) may be used in manufacturing of health supplements without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product.

(iii) The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, standards laid down by the international food standards body, namely, Codex Alimentarius Commission shall apply.

(iv) The food business operator shall apply to the Food Authority for inclusion of any new nutrient or other substance with a nutritional or physiological function, which has no history of use in India or that without evidence, establishing that the nutrient may result in certain nutritional and physiological benefits with justification for approval.

(v) The Food Authority may, after proper scientific evaluation, specify the nutrients approved by it from time to time.

(3)     (i) The labelling, presentation and advertisement shall not claim that the health supplement has the property of preventing, treating or curing a human disease, or refer to such properties;

(ii) The statement by the food business operator relating to the structure or function or the general well being of the body may be allowed by the Food Authority if the statement is supported by the generally accepted scientific data;

(iii) Every package of health supplement shall carry the following information on the label, namely—

(a)      the words “HEALTH SUPPLEMENT”;

(b)      the common name of the health supplement, or a description sufficient to indicate the true nature of the health supplement including the common names of the categories of nutrients or substances that characterise the product;

(c)      a declaration as to the amount of the nutrients or substances with a nutritional or physiological effect present in the product;

(d)      an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;

(e)      the quantity of nutrients, where applicable expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research and bear a warning, “Not to exceed the recommended daily usage”;

(f)       a statement that the health supplement is not be used as a substitute for a varied diet;

(g)      a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and published product or drug interactions, as applicable; and

(h)     a statement that the product is required to be stored out of reach of children.

(4)     No food business operator shall use additives for health supplement formulation except those specified in Schedule V-A or Schedule V-E or Schedule V-F.

Regulation 7. Nutraceuticals

(1)     (i) The nutraceuticals shall provide a physiological benefit and help maintain good health.

(ii) A food business operator may extract, isolate and purify nutraceuticals from food or non-food sources that is preparing amino acids and their derivatives by bacterial fermentation under controlled conditions.

(iii) A food business operator may prepare and sell the nutraceuticals in the food-format of granules, powder, tablet, capsule, liquid, jelly or gel, semi-solids and other formats and may be packed in sachet, ampoule, bottle, and in any other format as measured unit quantities except those formats that are meant for parenteral administration.

(2)     (i) The nutraceuticals shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VI or Schedule VII or Schedule VIII.

(ii) A food business operator may use ingredients specified in the Schedules referred to in clause (i) of sub-regulation (2) in manufacturing an article of food containing nutraceuticals without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product;

(iii) The quantity of nutrients added where applicable, shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standard laid down by international food standards body, namely Codex Alimentarius Commission shall apply;

(iv) A nutraceutical which is not provided in these regulations but its safety has been established in India or in any other country, shall be manufactured or sold in India only on prior approval of the Food Authority;

(v) For the purposes of clause (iv), a food business operator shall apply to the Food Authority for approval which shall be accompanied by documented history of usage of at least fifteen years in India, or thirty years in the country of origin;

(vi) The Food Authority may from time to time specify the nutraceuticals as approved by it after undertaking proper scientific evaluation;

(3)     (i) No ingredient other than those specified in Schedule VI shall be used as nutraceutical with standardisation to marker compounds specified and at daily usage levels specified therein;

(ii) The ingredient for which the standardisation of the marker compound has not been specified shall comply with manufacturer specifications or quality requirements and purity criteria as specified in Regulation 3;

(iii) For the ingredient for which the daily minimum and maximum usage levels have not been specified, the food business operator shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data;

(iv) For the purpose of clause (iii), the food business operator shall submit the documented scientific data to the Food Authority as and when called for;

(v) No food business operator shall use the extract of ingredient as nutraceutical other than that specified in Schedule IV;

Provided that the ingredient of plant or botanical origin specified in Schedule IV and Schedule VI may be used either in the given form, or their extract, subject to the extractive ratios in relation to the daily usage value.

(4)     (i) The labelling, presentation and advertisement shall not claim that the nutraceutical has the property of preventing, treating or curing a human disease, or refer to such properties;

(ii) The statement by the food business operator relating to the structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data;

(iii) Every package of food containing nutraceutical shall carry the following information on the label, namely—

(a)      the word “NUTRACEUTICAL”;

(b)      the common name of the nutraceutical;

(c)      a declaration as to the amount of each nutraceutical ingredient in the product that either has a nutritional or physiological effect;

(d)      where it is appropriate, the quantity of nutrient shall be expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research even when the nutrient is present along with a nutraceutical as an adjunct and shall bear an advisory warning ‘not to exceed the stated recommended daily usage’;

(e)      an advisory warning for ‘recommended usage’;

(f)       an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;

(g)      an advisory warning in cases where a danger may exist with excess consumption;

(h)     an advisory warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable;

(i)       a statement that the product is required to be stored out of reach of children;

(5)     No food business operator shall use additives for nutraceutical formulation except those specified in Schedule V-A or Schedule V-E or Schedule V-F.

Regulation 8. Food for special dietary use, other than infants, and those products intended to be taken under medical advice

(1)     No food business operator shall manufacture, formulate or process an article of food for special dietary use unless—

(i)       specially processed or formulated to satisfy particular dietary requirements which may exist or arise because of certain physiological or specific health conditions, namely—

(a)      low weight, obesity, diabetes, high blood pressure;

(b)      pregnant and lactating women; and

(c)      geriatric population and celiac disease and other health conditions.

(iii)     The food business operator shall clearly indicate on the label whether or not the food for special dietary use is to be taken under medical advice;

(ii)      A food business operator may manufacture or sell an article of food for special dietary use in single use packaging or in dosage form, namely, granules, capsules, tablets, pills, jelly, semi-solid and other similar forms, sachets of powder, or any other similar forms of liquids and powders designed to be taken in measured unit quantities with a nutritional or physiological effect;

(iii)     A food business operator may formulate an article of food for special dietary use in formats meant for oral feeding through an external tubes but shall not be used for parenteral use;

(iv)    An article of food for special dietary use 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 specified in Regulation 9.

(2)     (i) The articles of food for special dietary use shall contain any of the ingredients specified in Schedules I or Schedule II or Schedule III or Schedule IV or Schedule VI or Schedule VII or Schedule VIII.

(ii) A food business operator may use the ingredients specified in the Schedules referred to in clause (i) of sub-regulation (2) in manufacturing food for special dietary use without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product.

(iii) For any new nutrient, which has no history of use in India or that without a proof establishing that the nutrient may result in certain nutritional and physiological benefits, the food business operator shall apply to the Food Authority with justification for approval, and the Food Authority may, from time to time specify the nutrients approved by it after proper scientific evaluation.

(iv) A food business operator may add the quantity of the nutrients at a level higher than the recommended daily allowance, but not exceeding the limits of vitamins and minerals specified in Schedule III.

(v) (i) The articles of food used as a formula food presented as a replacement for all meals of the daily diet for slimming, weight management and weight control purposes shall comply with the following, namely—

(a)      provide energy not less than 800 kcal (3350 kJ) and not more than 1200 kcal (5020 kJ);

(b)      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.

(ii) A formula food presented as a replacement for one or more meals of the daily diet shall comply with the following, namely—

(a)      provide energy not less than 200 kcal (835 kJ) and not more than 400 kcal (1670 kJ) per meal;

(b)      when such products are presented as a replacement for the major part of the diet, the total energy intake shall not exceed 1200 kcal (5020 kJ).

(iii) Not less than twenty five per cent and not more than fifty 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.

(iv) 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

(v) For improving the protein quality, the food business operator shall add only L-forms of essential amino acids except for methionine where DL form is allowed.

(vi) Not more than thirty per cent of the energy available from fat and not less than three per cent of the energy from linoleic acid in the form of a glyceride.

(vii) A formula food represented as a replacement for all meals per day, shall not have less than a hundred per cent of the reccommended daily allowance of vitamins and minerals in the daily intake.

(viii) The formula food for special dietary use shall have adequate dietary fiber.

(3)     (i) No statement or claim shall be made on the label implying prevention, cure or treatment of any specific disease or its diagnosis or otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, unless otherwise approved by the Food Authority;

(ii) The statement by the food business operator relating to the structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data;

(iii) Every package containing food for special dietary use shall carry the following information on the label, namely—

(a)      the words “FOOD FOR SPECIAL DIETARY USE” followed by “Food for……...” (mentioning the particular physiological or health condition)”;

(b)      a statement “For weight control and management” in close proximity to the name of the articles of food specially prepared for weight management and control;

(c)      a statement that the product is not to be used by pregnant, nursing and lactating women or by infants, children, adolescents and elderly, except when medically advised;

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

(e)      if the product has been formulated for a specific age group, a prominent statement to that effect;

(f)       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;

(g)      an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;

(h)     a warning in cases where a danger may exist with excess consumption;

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

(j)       a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable;

(k)      the quantity of nutrients expressed in terms of percentage of the recommended daily allowance where it is appropriate;

(l)       information on osmolality or osmolarity or on acid-base balance where appropriate; and

(m)    a statement that the product shall be stored out of reach of children.

(4)     No food business operator shall use additives for food for special dietary uses, except those specified in Schedule V-B or Schedule V-E or Schedule V-F.

Regulation 9. Food for special medical purpose

(1)     (i) Food for special medical purpose shall include food specially prepared for weight reduction and intended as total replacement of normal diet.

(ii) A food business operator may formulate food for special medical purpose in format meant for oral feeding througha external tubes.

(iii) The articles of food for special medical purpose shall not be used for parenteral use.

(iv) 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.

(v) For the purposes of these regulations, the food for special medical purpose may be classified in to following three categories, namely—

(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 sub-clauses (b) and (c) of clause (v) may be used as a partial replacement or as a supplement to the person's diet.

(2)     (i) Food for special medical purpose shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule III or Schedule IV or Schedule VII or Schedule VIII or enzymes only of Schedule VI .

(ii) A food business operator shall use only the ingredients specified in the Schedules referred to in clause (i) of sub-regulation (2) in manufacturing food for special medical purpose without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product.

(iii) A food business operator may apply to the Food Authority for any new nutrient, which has no history of use in India or those without proof establishing that the nutrient may result in certain nutritional and physiological benefits with justification for approval and the Food Authority may from time to time specify the nutrients approved by it after proper scientific evaluation.

(iv) The articles of food specially prepared for weight reduction and intended as total replacement of complete diet shall, apart from complying with Schedule III, shall also ensure the following, namely—

(a)      that a formula food for very low energy diet is prepared according to instructions, with a daily energy intake of 450-800 kcal as the only source of energy;

(b)      that not less than 50 g protein with a protein digestibility corrected amino acid score of 1 is present in the recommended daily intake of energy, and essential amino acids may be added to improve protein quality only in amounts necessary for this purpose;

(c)      for the purposes of clause (b) the food business operator shall add only L-forms of essential amino acids except for methionine where DL form is allowed.

(d)      very low energy diet provides not less than—

(I)      3 g of linoleic acid; and

(II)     0.5 g β-linolenic acid in the recommended daily intake with the β-linoleic acid and linolenic acid ratio between 1:5 and 1:15;

(e)      very low energy diet provides not less than 50 g of available carbohydrates in the recommended daily intake of energy;

(f)       that the formula food for special medical purpose have adequate dietary fiber.

(v) In food for special medical purpose, nutrients may be added at levels higher than the recommended daily allowance, but not exceeding the limits of vitamins and minerals as specified in Schedule III.

(3)     Every package of food for special medical purpose shall carry the following information on the label, namely—

(a)      the words ‘FOOD FOR SPECIAL MEDICAL PURPOSE’ printed in the immediate proximity of the name or brand name of the product;

(b)      an advisory warning “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” appearing on the label in bold letters in an area separated from other written, printed or graphic information;

(c)      the statement “For the dietary management of ………………” (with the blank to be filled in with the specific disease, disorderor medical condition for which the product is intended, and for which it has been shown to be effective) supported by appropriate scientific, and clinical or epidemiological data, and subject to its approval by the Food Authority;

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

(e)      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;

(f)       a statement if the product has been formulated for a specific age group;

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

(h)     the quantity of nutrients expressed in terms of percentages of the recommended daily allowances, where it is appropriate;

(i)       information on osmolality or osmolarity, Renal Solute Load, Potential Renal Solute Load or acid-base balance, wherever applicable;

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

(k)      a warning that the product is not for parenteral use; and

(l)       a statement that the product required to be stored out of reach of children.

(4)     No food business operator shall use additives for food for special medical purpose except those specified in Schedule V-C or Schedule V-D or Schedule V-E or Schedule V-F.

(5)     No food business operator shall advertise the food for special medical purpose for use by general public.

Regulation 10. Food with added probiotic ingredients

(1)     (i) No food business operator shall use probiotic ingredients in food except the probiotic culture of the microorganisms specified in Schedule VII or those probiotic microorganisms approved by the Food Authority from time to time. Probiotic preparations may contain added prebiotics permitted under these regulations.

(ii) The viable number of organisms in food with added probiotic ingredients shall be ≥10₈ CFU/g:

Provided that a lower viable number may be specified with proven studies on health benefits with those numbers subject to the prior approval of the Food Authority.

(iii) The Food Authority may, from time to time, specify the probiotic microorganisms approved by it after proper scientific evaluation:

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.

Note- The guidelines issued by the Indian Council of Medical Research and Department of Biotechnology with respect to probiotics provide additional information on their use.

(2)     (i) The labelling, presentation and advertisement shall not claim that the probiotic food has the property of preventing, treating or curing a human disease, or refer to such properties.

(ii) The statement by the food business operator relating to structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data.

(iii) Every package of probiotic food shall carry the following information on the label, namely—

(a)      the words “PROBIOTIC FOOD”;

(b)      genus and species including strain designation or culture collection number, where applicable, in brackets where probiotics are mentioned in the list of ingredients;

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

(d)      the recommended serving size which shall deliver the effective viable dose of probiotics related to health claims and recommended duration of use, proper storage temperature conditions, and time limit for ‘Best Use’ after opening the container;

(e)      an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written; and

(f)       a warning or any other precaution to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable.

(3)     No food business operator shall use additives in probiotic preparations except those specified in Schedule V-A to Schedule V-F.

Regulation 11. Food with added prebiotic ingredients

(1)     (i) No food business operator shall use prebiotics in manufacturing food containing prebiotics except those specified in Schedule VIII or those prebiotics approved by the Food Authority from time to time.

(ii) The prebiotic component, not an organism, to which the claim of being made, shall be characterised for a given product by providing the source, origin, purity, chemical composition and structure, vehicle, concentration and amount in which it is to be delivered to the host.

(2)     (i) The labelling, presentation and advertising shall not claim that the prebiotic has the property of preventing, treating or curing a human disease, or refer to such properties.

(ii) The statement by the food business operator relating to structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data.

(iii) Every package of food containing prebiotics shall carry the following information on the label, namely—

(a)      the words “PREBIOTIC FOOD”;

(b)      name of prebiotic;

(c)      the suggested or recommended serving size which shall deliver the effective dose of prebiotic related to the health claim;

(d)      an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;

(e)      a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable.

(3)     No food business operator shall use additives in prebiotic preparations except those specified in Schedule V-A to Schedule V-F.

Regulation 12. Specialty food containing plant or botanical ingredients with safe history of usage

(1)     (i) A food business operator shall use only plant or botanical ingredients specified in Schedule IV for the preparation of specialty food containing plant or botanical ingredients.

(ii) The plant or botanical ingredient which is not specified in these regulations but its safety has been established in India or in any other country, may be manufactured or sold in India only after taking prior approval of the Food Authority.

(iii) The application for approval to the Food Authority shall be accompanied by documented history of usage of at least fifteen years in India, or thirty years in the country of origin.

(2)     The health supplement or nutraceutical or food for special dietary use or food for special medical purpose may contain the ingredient as specified in Schedule IV, formulated either alone or in combination of ingredients or botanicals or their extracts either in unprocessed or in approved processed forms, formulated in a regular or conventional food format such as liquid or syrup, suspension or powder, granule, tablet or capsule or any other format approved by the Food Authority.

(3)     (i) Every manufacturer or importer shall prepare and maintain a product information file, which shall contain information on the ingredients from Schedule IV used, finished product quality confirmation, and the test methods to demonstrate the presence of the active ingredient in the food.

(ii) The usage level of the specialty food containing plant or botanical ingredients shall not exceed those levels specified in Schedule IV:

Provided that the usage level may be distributed or provided, or formulated for delivery in one portion daily, or distributed in more than one portion to be taken in a day.

(iii) To use any other plant or botanical ingredient, which is not specified in Schedule IV, the food business operator shall seek prior approval of the Food Authority by submitting—

(a)      a product information file containing information on the material used;

(b)      quality confirmation, test methods to demonstrate the presence of the ingredient in the food;

(c)      relevant published literature providing scientific and technical information of the material or product related to safety and health benefits; and

(d)      any human intervention study published or conducted, and other relevant information.

(iv) The product information file shall be produced for inspection and review by the Food Authority as and when called for.

(v) The product information file shall primarily consist of technical and scientific information covering the following, namely—

(a)      information on quality of all raw ingredients with official scientific or botanical name;

(b)      details of formulation or block diagram and brief description of the processing methods or steps adopted;

(c)      shelf life study data;

(d)      quality specifications and test methods for analysis of the finished product;

(e)      safety and pharmacological information, literature base, and additional study, if any conducted;

(f)       information on human studies, if any;

(g)      regulatory status in other countries, if any; and

(h)     any other relevant product information.

(4)     No food business operator shall use additives for preparation of specialty food containing plant or botanical ingredients except those specified in Schedule V-E or Schedule V-F.

Regulation 13. Novel food

(1)     (i) For the purposes of these regulations novel food is a food that—

(a)      may not have a history of human consumption; or

(b)      may have any ingredient used in it which or the source from which it is derived, may not have a history of human consumption; or

(c)      a food or ingredient obtained by new technology with innovative engineering process, where the process may give rise to significant change in the composition or structure or size of the food or food ingredients which may alter the nutritional value, metabolism or level of undesirable substances.

(ii) No novel food shall be manufactured or imported for commercial purpose without the prior approval of the Food Authority by filing an application along with all relevant documents and details as specified by the Food Authority from time to time.

(2)     The labelling of novel food shall be—

(i)       in accordance with the specific labelling requirements, if any; or

(ii)      specific to claims relating to the novel product; or

(iii)     as per the category notified by the Food Authority in the specific regulations.

SCHEDULE I

[See Regulations 3(13), 4(2), 6(2)(i), 7(2)(i), 8(2)(i) and 9(2)(i)]

List of vitamins and minerals and their components

Note- Suitable esters and salts of vitamins and salts and chelates of minerals may be used

*Overage means the amount of excess nutrients added above label claim during manufacture as a means of maintaining at least the claimed amount of the ingredient(s) for the normal shelf life of the product to compensate for the expected manufacturing/storage loss and to allow for variation in assay performance. Where overages are more than those listed in Schedule I, Table C, the same shall be scientifically substantiated.

SCHEDULE II

[See Regulations 3(13), 4(2), 6(2)(i), 7(2)(i), 8(2)(i) and 9(2)(i)]

List of amino acids and other nutrients

Note- Suitable esters and salts of amino acids may be used.

SCHEDULE III

[See Regulations 3(13), 4(2), 8(2)(i), 8(2)(iv), 9(2)(i), 9(2)(iv) and 9(2)(v)]

Values for vitamins, minerals and trace elements allowed to be used in food for special dietary use and food for special medical purpose (other than those intended for use in infant formula)

1. Vitamins

2. Minerals

SCHEDULE IV

[See Regulations 3(13), 4(2), 6(2)(i), 7(2)(i), 7(3)(v), 8(2)(i), 9(2)(i), 12(1)(i), 12(2), 12(3)(i), 12(3)(ii) and 12(3)(iii)]

List of plant or botanical ingredients