act 034 of 2006 : Food Safety and Standards (Health Supplements, etc.) Regulations, 2016

Food Safety and Standards (Health Supplements, etc.) Regulations, 2016

ACTNO. 34 OF 2006
23 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

Section 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.

Section 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.

Section 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.

Section 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.

Section 5. General principles for query or challenge

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.

Section 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.

Section 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.

Section 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.

(ii) 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;

(iii) 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;

(iv) 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;

(v) 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.

Section 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 -linolenic acid in the recommended daily intake with the -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.

Section 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.

Section 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.

Section 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.

Section 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

Sl. No.

Vitamins and Minerals

Components

A.

Vitamins-

1.

Vitamin A

(i)

Retinol all trans retinol

(ii)

Retinyl acetate

(iii)

Retinyl palmitate

2.

Provitamin A

(i)

Beta-Carotene

3.

Vitamin B1

(i)

Thiamine chloride hydrochloride

(ii)

Thiamine mononitrate

4.

Vitamin B2

(i)

Riboflavin

(ii)

Riboflavin 5 -phosphate, sodium

5.

Vitamin B6

(i)

Pyridoxine hydrochloride

(ii)

Pyridoxal 5 -phosphate

6.

Vitamin B12

(i)

Cyanocobalamin

(ii)

Hydroxocobalamin

7.

Vitamin C

(i)

L-ascorbic acid

(ii)

Sodium-L-ascorbate

(iii)

Calcium-L-ascorbate

(iv)

Potassium-L-ascorbate

(v)

6-palmitoyl-L-ascorbic acid

(vi)

Ascorbyl palmitate

8.

Vitamin D

(i)

Vitamin D3 (cholecalciferol) Animal source

(ii)

Vitamin D2 (ergocalciferol) Plant source

9.

Vitamin E

(i)

D-alpha-tocopherol

(ii)

DL-alpha-tocopherol

(iii)

D-alpha-tocopheryl acetate

(iv)

DL-alpha-tocopheryl acetate

(v)

D-alpha-tocopheryl acid succinate

(vi)

DL-alpha-tocopheryl acid succinate

(vii)

DL-alpha-tocopheryl polyethylene glesol succinate

10.

Vitamin K1

(i)

Phylloquinone

(ii)

Phytomenadione (2-methyl 3-phytyl-1)

(iii)

1, 4-napthoquinone

(iv)

Phytonamidione

11.

Vitamin K2 (MK-7)

(i)

Menaquinone

12.

Vitamin K2 (MK-4)

(i)

Menatetrenone

13.

Biotin

(i)

D-biotin

14.

Folic Acid

(i)

n-pteroyl-l-glutamic acid

15.

Niacin

(i)

Nicotinic acid

(ii)

Nicotinamide

(iii)

Nicotinic acid amide

16.

Pantothenic acid

(i)

D-pantothenate, calcium

(ii)

D-pantothenate, sodium

(iii)

D-panthenol

(iv)

DL-pantholnol

(v)

Sodium-D-pantothenate

Note. Addition of appropriate overages to ensure adequate availability of vitamins in the products shall be permitted based on scientific rationale. However, the maximum proportion of overages shall not exceed as given in the Table C , below, unless scientifically justified. Labels of such products shall make a declaration of the same as appropriate overages added in the composition declaration Panel.

B.

Minerals (Chemical sources)

1.

Calcium

(i)

Calcium carbonate

(ii)

Calcium chloride

(iii)

Calcium salts of citric acid

(iv)

Calcium gluconate

(v)

Calcium glycerophosphate

(vi)

Calcium orthophosphate

(vii)

Calcium hydroxide

(viii)

Calcium oxide

(ix)

Calcium phosphate, monobasic

(x)

Calcium phosphate, dibasic

(xi)

Calcium phosphate, tribasic

(xii)

Calcium sulphate

(xiii)

Calcium from algal source (Algus calcarius)

(xiv)

Calcium lactate

2.

Chloride

(i)

Calcium chloride

(ii)

Choline chloride

(iii)

Magnesium chloride

(iv)

Manganese chloride

(v)

Potassium chloride

(vi)

Sodium chloride

3.

Chromium

(i)

Chromium (III) chloride

(ii)

Chromium (III) sulphate

4.

Copper

(i)

Cupric carbonate

(ii)

Cupric citrate

(iii)

Cupric gluconate

(iv)

Cupric sulphate

(v)

Copper lysine complex

5.

Iodine

(i)

Sodium iodide

(ii)

Sodium iodate

(iii)

Potassium iodide

(iv)

Potassium iodate

6.

Iron

(i)

Ferrous succinate

(ii)

Ferrous citrate

(iii)

Ferric ammonium citrate

(iv)

Ferrous gluconate

(v)

Ferrous fumarate

(vi)

Ferric sodium di-phosphate

(vii)

Ferrous lactate

(viii)

Ferrous sulphate

(ix)

Ferric di-phosphate

(x)

Ferric saccharate

(xi)

Ferrous bis glycinate

(xii)

Hydrogen reduced iron

(xiii)

Sodium iron EDTA

(xiv)

Carbonyl iron

(xv)

Ferrous orthophosphate

(xvi)

Ferrous sodium pyrophosphate

(xvii)

Elemental iron

(xviii)

Electrolytic iron

7.

Magnesium

(i)

Magnesium aspartate

(ii)

Magnesium carbonate

(iii)

Magnesium chloride

(iv)

Magnesium gluconate

(v)

Magnesium phosphate dibasic (Magnesium hydrogen phosphate)

(vi)

Magnesium phosphate tribasic (Trimagnesium phosphate)

(vii)

Magnesium oxide

(viii)

Magnesium sulphate

8.

Manganese

(i)

Manganese carbonate

(ii)

Manganese chloride

(iii)

Manganese citrate

(iv)

Magnanese sulphate

(v)

Magnanese gluconate

(vi)

As amino acid chelate

9.

Molybdenum

(i)

Ammonium molybdate (Molybdenum (VI)

(ii)

Sodium molybdate (Molybdenum (VI)

(iii)

As amino acid chelate

10.

Phosphorous

(i)

Potassium glycerophosphate

(ii)

Potassium phosphate, monobasic

(iii)

Potassium phosphate, dibasic

11.

Potassium

(i)

Potassium bicarbonate

(ii)

Potassium carbonate

(iii)

Potassium chloride

(iv)

Potassium citrate

(v)

Potassium gluconate

(vi)

Potassium glycerophosphate

(vii)

Potassium lactate

(viii)

Potassium monobasic phosphate

(ix)

Potassium dibasic phosphate

12.

Selenium

(i)

Sodium selenate

(ii)

Sodium selenite

(iii)

Sodium hydrogen selenite

(iv)

Selenomethionine

13.

Sodium

(i)

Sodium bicarbonate

(ii)

Sodium carbonate

(iii)

Sodium chloride

(iv)

Sodium citrate (Trisodium citrate)

(v)

Sodium gluconate

(vi)

Sodium lactate

(vii)

Sodium phosphate monobasic (Sodium dihydrogen phosphate)

(viii)

Sodium phosphate dibasic (disodium hydrogen phosphate)

(ix)

Sodium sulphate

14.

Zinc

(i)

Zinc acetate

(ii)

Zinc chloride

(iii)

Zinc citrate

(iv)

Zinc gluconate

(v)

Zinc lactate

(vi)

Zinc oxide

(vii)

Zinc carbonate

(viii)

Zinc sulphate

15.

Boron

(i)

Boron proteonate

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

Table C. Permissible overages*

Sl. No.

Micronutrient

Overage (per cent)

1.

Vitamin A

30

2.

Vitamin C

20

3.

Vitamin D

30

4.

Vitamin E

10

5.

Thiamine (vitamin B1)

25

6.

Riboflavin (vitamin B2)

25

7.

Niacin (vitamin B3)

10

8.

Vitamin B6

25

9.

Vitamin B12

25

10.

Folic acid

25

11.

Pantothenic acid

10

12.

Vitamin K1

30

13.

Minerals

10

14.

Iodine

20

*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

A.

Essential Amino Acids

(i)

L-Histidine

(xii)

L-Aspartic acid

(ii)

L-Histidine hydrochloride

(xiii)

L-Argine L-aspartate

(iii)

L-Isoleucine

(xiv)

L-Threonine

(iv)

L-Isoleucine hydrochloride

(xv)

L-Alanine

(v)

L-Leucine

(xvi)

L-Phenylalanine

(vi)

L-Leucine hydrochloride

(xvii)

L-Cyststeine hydrochloride

(vii)

L-Lysine

(xviii)

L-Tyrosine

(viii)

L-Lysine hydrochloride

(xix)

L-Arginine

(ix)

DL-Methionine

(xx)

L-Tryptophan

(x)

L-Cysteine

(xxi)

L-Valine

(xi)

L-Cysteine hydrochloride

(xxii)

L-Arginine hydrochloride

B.

Non- Essential Amino Acids

(i)

L-Carnitine

(xv)

L-Proline

(ii)

L-Carnitine hydrochloride

(xvi)

L-Lycine-L-glutamate dihydrate

(iii)

Carnitine, acetyl-L

(xvii)

Megnesium L-aspartate

(iv)

L-Glutamic acid

(xviii)

Calcium L-glutamate

(v)

L-Glutamine

(xix)

Potassium L-glutamate

(vi)

Glycine

(xx)

Carnitine tartrate

(vii)

L-Hydroxylysine

(xxi)

Taurine

(viii)

L-Hydroxyproline

(xxii)

Choline

(ix)

L-Lycine acetate

(xxiii)

Choline chloride

(x)

N-acetyl-L-cysteine

(xxiv)

Choline citrate

(xi)

L-Ornithine

(xxv)

L-Serine

(xii)

L-Ornithine mono hydrochloride

(xxvi)

Tyrosine, acetyl-L

(xiii)

L-Lycine L-aspartate

(xxvii)

Choline hydrogen tartrate

(xiv)

L-Citruline

(xxviii)

Myo-inositol

C.

Nucleotides

(i)

Adenosine 5-monophosphate (AMP)

(v)

Disodium uridine 5-monophosphate

(ii)

Cystidine 5-mono phosphate (CMP)

(vi)

Disodium guanosine 5-mono phosphate

(iii)

Guanosine 5-mono phosphate (GMP)

(vii)

Disodium ionosine 5-mono phosphate

(iv)

Inosine 5-mono phosphate (IMP)

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

RDA for Vitamins

Vitamins

Per 100 kJ

Per 100 kcal

Minimum

Maximum*

Minimum

Maximum*

Vitamin A ( g RE)

8.4

43

35

180

Vitamin D ( g)

0.12

0.65 (0.75)1

0.5

2.5 (3)1

Vitamin K ( g)

0.85

5

3.5

20

Vitamin C (mg)

0.54

5.25

2.25

22

Thiamin (mg)

0.015

0.12

0.06

0.5

Riboflavin (mg)

0.02

0.12

0.08

0.5

Vitamin B6 (mg)

0.02

0.12

0.08

0.5

Niacin (mg NE)

0.22

0.75

0.9

3

Folic acid ( g)

2.5

12.5

10

50

Vitamin B12 ( g)

0.017

0.17

0.07

0.7

Pantothenic acid (mg)

0.035

0.35

0.15

1.5

Biotin ( g)

0.18

1.8

0.75

7.5

Vitamin E (mg -TE)

0.5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0.1 mg per 100 available kJ

0.75

0.5/g of poly unsaturated fatty acids expressed as linoleic acid but in no case less 0.1 mg per 100 available kcal

3

(1): For products intended for children of 1 to 10 years of age; NE Niacin equivalent;

TE Tocopherol equivalent.

*When no upper safe level (maximum permissible level higer than 1 (100 per cent) RDA) has been specified for a particular vitamins and minerals, the content of such nutrient shall not exceed NOAEL (No observed adverse effect level) or one tenth of LOAEL (Lowest observed adverse effect level)

2. Minerals

RDA for Minerals

Minerals

Per 100 kJ

Per 100 kcal

Minimum

Maximum*

Minimum

Maximum*

Sodium (mg)

7.2

42

30

175

Chloride (mg)

7.2

42

30

175

Potassium (mg)

19

70

80

295

Calcium (mg)

8.4(12)1

42(60)1

35(50)1

175(250)1

Phosphorus (mg)

7.2

19

30

80

Magnesium (mg)

1.8

6

7.5

25

Iron (mg)

0.12

0.5

0.5

2.0

Zinc (mg)

0.12

0.36

0.5

1.5

Copper ( g)

15

125

60

500

Iodine ( g)

1.55

8.4

6.5

35

Selenium ( g)

0.6

2.5

2.5

10

Manganese (mg)

0.012

0.12

0.05

0.5

Chromium ( g)

0.3

3.6

1.25

15

Molybdenum ( g)

0.72

4.3

3.5

18

(1): For products intended for children of 1 to 10 years of age;

*When no upper safe level (maximum permissible level higer that 1 (100 per cent) RDA) has been specified for a particular nutrient the content of such nutrient shall not exceed NOAEL (No observed adverse effect level) or one tenth of LOAEL (Lowest observed adverse effect level)

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

Sl. No.

Botanical name and part used

Common name

Permitted range of usage for adults per day (given in terms of raw herb/material)

1

Abelmoschus esculentus (L.) Moench.

Fruit/Root

Bhindi

5-10 g (as powder)

2

Abies spectabilis (D.Don)/A. pindrow Royle

Leaves

Talis patra/Talis bhed

2-4 g (as powder)

3

Asculus indica colebs./A. hippocastanum

Fruit/kernel

Indian Horse Chestnut/kanar

10-20 g

4

Abelmoschus moschatus

Seed

Lata kasturi

3-5 g

5

Abutilon indicum (L.) Sweet ssp. Indicum/A. fruiticosum

Seed/Root

Atibala

5-10 g (as powder)

6

Acacia arabica Willd. (Now known as Acacia nilotica (L.) Willd. ex Del. ssp. indica (Benth.) Brenan)

Gum

Babbula

5-10 g

Stem bark

Babbula

5-10 g

7

Acacia catechu

Extract

Katha/khair

1-3 g

8

Achyranthes aspera (L.)/A. bidentala

Seed/Plant

Chirchida

3-5 g (as powder)

9

Adhatoda zeylanica/A. vasaka

Leaf/Root/Flower

Adusa/Vasa

5-10 g

10

Aegle marmelos (L.) Corr.

Unripe fruit pulp

Bael

5-10 g

Ripe fruit

Bael

50-100 g (as pulp)

Leaves/Bark

Bael Pather/Bael chhal

5-10 g (as pulp)

11

Ajuga bracteosa wall

Plant

Neel Kanthi

2-3 g

12

Alangium salvifolium (L.f.) Wang. ssp. Salvifolium

Fruit

Ankota

10-20 g (as powder)

13

Albizia lebbeck (L.) Benth/A. Procera/A.odoratissima

Flower

Siris

3-6 g (as powder)

Seed

Siris

1-3 g (as powder)

Stem bark

Siris

3-6 g

Leaf

Siris

3-6 g (as powder)

14

Alpinia galanga

Rhizome

Kulanjan

2-4 g

15

Allium cepa L.

10-20 g

Bulb

Pyaja

10-20 ml (as juice)

Seed

Pyaja

1-3 g (as powder)

Leaf

Pyaja

20-40 g (as vegetable)

16

Allium sativum L.

Bulb

Lahsuna

3-6 g (Not recommended during pregnancy)

Leaf

Lahsuna

20-40 g (as vegetable)

17

Allium stracheyi Bakerno

Whole plant

Farana

2-3 g

18

Alocasia indica Spach (Now known as Alocasia macrorhiza (L.) G. Don)

Tuber

Mankanda

5-10 g

19

Aloe barbadensis Mill./A. Ferox/A. vera

Leaf

Ghikvar

5-10 g

Dry leaf juice

Elua-Mussabar

0.5-1 g

20

Althaea officinalis Linn

Flower/Root

Resh-Khatmi

5-10 g (as powder)

21

Alternanthera sessilis (L.) R. Br. ex DC.

Whole plant

Gudarisaga

3-5 g (as powder)

22

Amaranthus gangeticus L. (Now known as Amaranthus tricolor L.)/Amaranthus blitum L.

Aerial part

Lal marsa Sag marsa

10-20 g (as leafy vegetable)

23

Amaranthus spinosus L./A. paniculatus L. (A. hybridus L.)

Whole plant

Chaulai Kateli/Jal Chaulai

20-30 g (as leafy vegetable)

24

Amomum aromaticum Roxb./A. aromaticum

Seed

Bangiya Ela

2-4 g (as powder)

25

Amomum subulatum Roxb./A. aromaticum

Fruit

Badi Elaichi

1-3 g (as powder)

Seed

Badi Elaichi

1-2 g (as powder )

26

Amorphophallus campanulatus (Roxb.) Blume ex Decne

Corm

Jimikanda

20-50 g (as vegetables)

27

Anacardium occidentale L.

Fruit Kernel

Kaju

10-20 g

28

Anacyclus pyrethum DC.

Root

Akarkara

100-250 mg (as powder)

(Not recommended for children below 5 years)

Seed

Akarkara

100-250 mg (as powder)

(Not recommended for children below 5 years)

29

Ananas comosus (L.) Merr.

Pineapple

50-100 g (as fruit)

50-100 ml (as juice)

(Not recommended during pregnancy)

30

Anethum sowa Roxb. ex Flem. (Now known as Anethum graveolens L.)

Fruit

Sowa

3-6 g (as powder (fruit))

Leaf

Sowa

10-20 g (as powder (leaf))

31

Angelica glauca Edgew./Angelica archangelica L.

Root and Root stock

Chora

1-3 g (as powder)

32

Annona squamosa L./A.reticulata/A. muricata/A. Cherimola

Fruit pulp

Shareefa/Shareefa bhed

20-30 g (as fruit pulp)

Leaf

Shareefa

3-5 g (as powder)

(Not recommended for children below 16 years)

33

Apium leptophyllum (Pers.) Muell./A. Graveolens Linn.

Fruit

Ajamod/Ajmoda bhed

1-3 g (as powder)

34

Arachis hypogaea L.

Seeds

Chinia Badam/Mungphali

10-20 g

Seed oil

Mungaphali tail

5-10 ml

35

Areca catechu L.

Seed

Supari

1-2 g (as powder)

(only to be used after shodhana (purification))

(Not recommended for children below 5 years)

36

Artemisia absinthium Linn/

Whole plant

Afsantin/Astimisia/ Chauhar/

3-6 g

37

Artocarpus heterophyllus Lam.

Ripe/unripe fruit

Katahal

20-50 g

Seeds

Katahal

5-10 g

38

Artocarpus lakoocha Roxb.

Ripe Fruit/unripe fruit

Badhal

20-30 g

Seed

Badhal

5-10 g

39

Arnebia nobilis/A. benthamii

Root

Ratanjot

2-4 g

40

Asparagus adscendens Roxb.

Tuberous root

Safed musali

3-6 g (as powder)

41

Asparagus officinalis L.

Root

Shatavar bhed

3-6 g (as powder)

Tender Shoots

Shatavar bhed

20-50 g

42

Asparagus racemosus Willd.

Tuberous root

Sitawar

3-6 g (as powder)

Tender Shoots

Sitawar

20-50 g

43

Asparagus sarmentosus Linn.

Tuberous root

Badi Shataver

3-6 g (as powder)

44

Avena sativa L.

Seed

Oat

10-30 g (as powder)

45

Averrhoa carambola L.

Fruit

Kamarakh

10-20 g

46

Azadirachta indica A. Juss.

Leaf

Neem

1-3 g (as powder)

(Not recommended for males and females planning to conceive)

Fruit

Neem

1-2 g (as pulp)

(Not recommended for males and females planning to conceive)

(Not recommended for children below 5 years)

Flower

Neem

2-4 g (as powder)

Root bark

Neem

3-6 g (as powder)

47

Bambusa arundinacea (Retz.) Willd.

Tender shoots (Young leaf)

Bansh

20-30 g (as vegetable)

Seed

Bansh chaval

20-30 g (as powder)

Crystals

Bansalochan

0.5-2g (as powder)

48

Bacopa monnieri

Whole plant

Brahmi

5-10 g (as powder)

Extract

Brahmigha

1-2 g

49

Basella alba L.

Leaf

Poyi Saag

20-30 g (as vegetable)

50

Bauhinia variegata L./Bauhinia purpurea L./B. tomentosa. Linn

Stem bark

Kachnar/Sona

3-6 g

Flower/Buds

Kachnar/Sona

10-20 g (as juice)

51

Benincasa hispida (Thunb.) Cogn.

Fruit

Petha, Bhatua

30-50 g (as vegetable)

52

Berberis aristata DC./B. asiatica/B. lycium/B. vulgaris

Fruit

Daruhaldi

5-10 g (as fruit)

Stem extract

Rasaunt

0.5-1 g

53

Beta vulgaris L.

Tuber

Chukandar

10-20 ml (as juice)

54

Boerhaavia diffusa L. (Now known as Boerhaavia repens L. var. diffusa (L.) Hook.f.)/B. verticillata

Aerial part

Saag itsit

20-30 g (as aerial parts)

Root

Vishkhaprs

10-15 g (as root)

55

Bombax ceiba L.

Stem bark

Semal

5-10 g

Flower

Semal

10-20 ml (as juice)

Gum

Semal

1-3 g (as powder)

Root

Semal Musali

5-10 g (as powder)

56

Bombax malabarica/Salmalia malabarica

Fruit/Flower/Root

Sema1/Semar

10-20 g

57

Boswellia serrata Roxb.

Oleoresin

Salai guggal

2-4 g

58

Borassus flabellifer L.

Dried inflorescence

Tarku1/Taad

1-3 g (as powder)

Seed pulp of unripe fruit

Tarku1/Taad

10-30 g

Exudate of stem/sap

Tarku1/Taad

100-200 ml (as juice)

59

B. verticillata

Root

10-15 g

60

Brassica campestris L. (Now known as Brassica rapa L. sp. campestris (L.) Clapham)

Seed

Sarson

10-20 g (as paste)

Seed oil

Sarson

10-20 ml

Leaf

Sarson

10-30 g (as leafy vegetable)

61

Brassica juncea (L.) Czern.

Seed

Rai

1-2 g

Leaf

Rai

10-20 g (as leafy vegetable)

62

Brassica nigra (L.) Koch.

Seeds

Banarasi rai

0.5-1 g

63

Brassica rapa L.

Tuber

Shalgam

20-40 g

Leaf

Shalgam

20-30 g (as vegetable)

64

Buchanania lanzan Spreng.

Seed

Cherounjee

5-10 g (as powder)

65

Butea monosperma

Seed/Gum/Root/Bark

Dhark

3-6 g

66

Bixa orellana

Annato Plant

1-3 g

67

Caesalpinia bonducella (L.) Flem. (Now known as Caesalpinia bonduc (L.) Roxb.)

Leaf

Karanjuva

2-3 g

Seed

Karanjuva

2-3 g

68

Cajanus cajan (Linn.)Millsp.

Seed

Arahar/Tuvar

30-50 g

69

Camellia sinensis

Tea leaf/extract

Chaya/Tea extract

1-2 g

Tea catachins

Green tea catechins

0.5-1 g

70

Canavalia ensiformis sensu Baker (Now known as Canavalia gladiata (Jacq.) DC.)

Seed

Sema

5-10 g

71

Canscora decussata (Roxb.) J.F. and J.H. Schult. 1

Leaf

Bangiya Sankhapuspi

2-4 g (as powder)

72

Capparis decidua (Forssk.) Edgew.

Fruit

Kareer/Dela

10-20 g

73

Capsicum annum L. var. annum

Unripe fruit

Hari Mircha

1-2 g

(Not recommended for children below 5 years)

Ripe fruit

Lal Mircha

0.5-1.0 g (as powder)

(Not recommended for children below 5 years)

74

Capsicum frutescens L.

Fruit

Simla Mirch

30-50 g (as vegetable)

75

Carica papaya L.

Ripe fruit

Papita

50-100 g (as ripe fruit )

Unripe fruit

Papita

30-50 g (as unripe fruit)

76

Carissa carandas L.

Fruit

Karounda

5-10 g

77

Carissa spinarum L.

Fruit

Karawan

5-10 g

78

Carthamus tinctorius L.

Flower Head

Barre

2-4 g (as powder)

Seed

Barre

2-4 g (as powder)

Seed oil

Barre tail

5-10 ml

79

Carum carvi L.

Fruit

Syaha jeera

1-3 g (as powder)

80

Cassia absus L.

Seed

Chaksu

2-5 g

81

Cassia occidentalis L.

Leaf

Kasoundi

5-10 g

Seed

Kasoundi

1-3 g

82

Cassia tora L.

Leaf

Chakvad/Chakarmard

10-20 g

Seed

Chakwad

3-5 g (as powder)

83

Cassia fistula

Fruit pulp

Amaltas

10-20 g (as pulp)

Seed

Amaltas

2-5 g (as seed)

84

Cassia angustifolia/C. acutifolia

Seed/leaves

Sanay/Senna

3-6 g

85

Cedrus deodar Roxb.

Seed/Wood/Oil

Devdar

5-10 g/2-4 ml

86

Celosia argentea L. var. argentea

Seed

Surwali/Safed murga

3-6 g

87

Celastrus paniculatus

Seed/Oil

Malkanguni

5-10 g, (as powder (seed))

2-4 ml (as oil)

88

Centella asiatica (L.) Urban

Leaf/Whole Plant

Brahmi (Galpatri)

20-30 g (as vegetable)

Extract

Brahmi (Galpatri)

1-3 g

89

Centratherum anthelminticum

Fruit/Seed

Kali-jirii/Vanjirii

3-6 g

90

Chenopodium album L.

Whole plant/leaves

Bathua

20-30 g (as leafy vegetable)

Seed

Bathua

2-5 g

91

Chlorophytum borivillianum/C. arundinaceum/C. tuberosum

Musali

5-10 g

92

Cicca acida (L.) Merrill

Fruit

Harfa rewadi

10-20 g

93

Cicer arietinum L.

Tender leaf

Chana/Kalachana

30-50 g (as leafy vegetable)

Seed

Chana/Kalachana

20-30 g

94

Cichorium endivia

Seed

kasani

5-10g

95

Cinnamomum tamala Nees and Eberm./C. wightii

Leaf

Tejapatra

2-3 g

96

Cinnamomum zeylanicum Blume (Now known as Cinnamomum verum J. S. Presl.)

Stem bark

Dalchini (Ceyloni)

1-2 g

(Not recommended during pregnancy)

97

Cissampelos pareria L. var. hirsuta (Buch.-Ham. ex DC.) Forman.

Leaf/Plant

Padhi

10-20 g (as powder)

98

Cissus quadrangularis L.

Aerial part

Hadjod

10-20 g (as wet chutney (paste))

Stem

Hadjod

3-6 g

99

Citrullus colocynthis (L.) Schard.

Fruit

Indarun/Indrayan

0.25-0.5 g (as powder)( Not recommended during pregnancy)

100

Citrullus vulgaris Schrad. ex Eckl.and Zeyh. var. fistulosus (Stocks) Stewart

Fruit

Tinda

20-40 g (as vegetable)

101

Citrullus lanatus (Thunb.) Matsura and Nakai

Fruit pulp

Tarbuj

50-100 g

Seed

Tarbuj

3-6 g

Seed oil

Tarbuj

1-3 ml

102

Citrus aurantifolia (Christm. and Panz.) Swingle

Fruit

Nimbu

3-5 ml (as juice)

103

Citrus limon (Linn.)Burm.f.

Fruit

Jameerinibu

5-10 ml (as juice)

104

Citrus maxima (Burm.)Merr.

Fruit

Chakotara

5-10 ml (as juice)

30-50 g (as fruit)

105

Citrus medica L.var. medica

Fruit

Bijoura

5-10 ml (as juice)

106

Citrus reticulata Blanc.

Fruit

Narangi

30-50 ml (as juice)

107

Citrus sinensis (L.) Osbeck

Fruit

Mousami

50-100 ml (as juice)

108

Clerodendrum phlomidis

Whole plant

Arani

10-20 g

109

Clerodendrum serratum

Whole plant

Bharangi

10-20 g

110

Coccinia grandis (L.) Voigt./C. indica

Leaf

Kundru pha1/Kuntru shak

5-10 g

(Not recommended for children below 5 years)

Stem

Kundru

3-6 g (as powder)

Whole plant

Kundru

3-6 g (as powder)

5-10 ml (as juice)

Fruit

Kundru

20-50 g (as vegetable)

111

Cocos nucifera L.

Endosperm

Nariyal

10-20 g

Water

Nariyal jala

100-200 ml

Flower

Nariyal

5-10 g

112

Cocculus hirsutus (L.) Theob.

Leaf

Jalajamani

10-20 g

113

Coix lacryma-jobi L.

Seed

Gargri

10-20 g

114

Coffea arabica

Seed/Dry/Green

Coffea

3-5 g

(Not recommended for children below 5 years)

115

Coleus forskohlii/C.aromaticus

Pathachoor, Parn-yavani

5-10 g

( Not recommended for children below 5 years)

116

Colocasia antiquorum Schott. (Now known as Colocasia esculenta (L.) Schott.)

Rhizome

Arui

20-30 g (as vegetable)

(Not recommended for children below 16 years)

117

Commelina bengalensis L.

Whole plant

Kausar

3-6 g

118

Commiphora wightii

Oleoresin

Guggal

2-4 g (Not recommended for children below 5 years)

119

Commiphora myrrha

Oleoresin

Hirabol

2-4 g (Not recommended for children below 5 years)

120

Convolvulus pluricaulis

Whole plant

Shankh-pushpi

10-20 g

121

Corchorus acutangulus Lam. (Now known as Corchorus aestuans L.)

Aerial part

Chench

10-20 ml

122

Corchorus capsularis L.

Aerial part

Narcha

10-20 ml (as juice)

123

Corchorus olitorius L.

Aerial part

Palva Saag

10-20 ml (as juice)

124

Cordia dichotoma Forst. f.(Cordia wallichii G.Don)

Fruit

Lisora

10-20 g

125

Cordia rotthii Roem. and Schult. (Now known as Cordia gharaf (Forssk.) Ehrenb and Asch.

Fruit

Chhota Lisora

10-20 g

126

Coriandrum sativum L.

Fruit

Dhaniya

1-3 g (as powder)

Aerial part

Dhaniya

10-20 ml (as juice)

127

Costus speciosus

Kemuk

2-4 g (as powder)

(Not recommended for children below 5 years)

128

Crataeva nurvala

Fruit/Bark/leaf

Varana

10-20 g

129

Crocus sativus L.

Style and Stigma

Kumkum (Kesar)

25-50 mg

(Not recommended for children below 16 years)

130

Cucumis melo L.

Fruit

Kharbooja

50-100 g

Seed

Kharbooja

1-3 g (as powder)

131

Cucumis melo L. var. momordica Duthie and Fuller

Fruit

Phoot

40-50 g (as vegetable)

132

Cucumis melo L. var. utilissimus (Roxb.)Duthie and Fuller

Seed

Kakri

3-6 g

Fruit

Kakri

50-100 g (as vegetable)

133

Cucumis sativus L.

Seed

Khira

3-6 g (as powder)

Fruit

Khira

50-100 g (as vegetable)

134

Cucurbita maxima Duch. ex Lam.

Seed

Kashiphal

5-10 g

Fruit

Kashiphal

50-100 g (as vegetable)

135

Cucurbita pepo L.

Fruit

Safed Kaddu/safed petha

50-100 g (as vegetable)

Seed

Safed petha

5-10 g (as powder)

136

Cuminum cyminum L.

Fruit

Jeera

1-3 g (as powder)

137

Curculigo orchioides Gaertn.

Tuber

Kalimushli

3-5 g

138

Curcuma amada Roxb.

Rhizome

Amahaldi

5-10 g (as fresh) 2-4 g (as powder)

139

Curcuma angustifolia

Root

Tavkshir

2-5 g

140

Curcuma longa L.

Rhizome

Haldi

2-5 g (as powder)

Fresh Rhizome

Haldi

5-10 ml (as juice)

141

Curcuma zedoaria Roxb. (Now known as Curcuma aromatica Salisb.)

Rhizome

Kachur

2-5 g (as powder)

142

Cyamopsis tetragonoloba

Pod/Seed/Gum

Guar, Guar gum

20-30 g (as powder: pod/seed) 5-10 g (as powder: gum)

143

Cymbopogon citratus (DC.) Stapf

Whole plant

Harichaya

1-3 g

144

Cymbopogon coloratus Stapf

Aerial part

Manjan pullu

1-3g

145

Cymbopogon jwarankusa (Jones) Schult.

Root

Lamajjaka

1-3 g

146

Cymbopogon martini (Roxb.)Wats.

Whole plant

Rosha ghas

1-3 g

147

Cynodon dactylon (L.) Pers.

Leaf

Duba

3-5 g

148

Cyperus rotundus L.

Rhizome

Nagarmotha

2-5 g

149

Daucus carota L.

Tuberous root

Gajar

50-100 g (as vegetable) 50-100 ml (as juice)

Seed

Gajar

1-2 g (as powder) (Not recommended during pregnancy)

150

Desmodium gangeticum/D. latifolium

Whole plant

Sarvan

5-10 g

151

Dillenia indica L.

Fleshy fresh sepals (Fruit)

Chalta

40-50 g (as vegetable)

152

Dioscorea alata L./D. deltoidea

Tuber/Corm

Kathalu

10-20 g

153

Dioscorea bulbifera L.

Tuber

Genthi/Taradi

20-30 g (as vegetable) 5-10 g (as powder)

Extract

Genthi/Taradi

1-2 g (as extract)

154

Dioscorea esculenta (Lour.) Burkill

Tuber

Suthani

5-10 g

155

Dioscorea pentaphylla L.

Tuber

Kantalu

5-10 g

156

Diplezia maxima

Tender shoots

Lungru

30-50 g

157

Diospyros peregrina Gurke (Now known as Diospyros malabarica (Desr.) Kostel)

Ripe fruit

Gab

50-100 g

Unripe fruit

Gab

4-8 g (as powder)

158

Dolichos biflorus L. (Now known as Vigna unguiculata (L.) Walp.)

Seed

Kulathi

30-50 g

159

Dolichos lablab L. (Now known as Lablab purpureus (L.) Sweet)

Seed

Sem

20-40 g (as seed)

Tender Pod

Sem

30-40 g (as vegetable)

160

Echinochloa frumentacea Link

Fruit

Sanwa

50-100 g

161

Eclipta prostata L.

Whole plant

Bhangra

3-6 g (as powder)

162

Elettaria cardamomum (L.) Maton

Seed

Choti elaichi

250-500 mg (as powder)

163

Eleusine coracana (L.) Gaertn. ssp. coracana

Caryopsis

Madua

20-50 g

164

Emblica officinalis Gaertn. (Now known as Phyllanthus emblica L.)

Fruit

Anwala/Amla

20-30 g (as fresh fruit)

3-6 g (as powder )

5-10 ml (as juice)

Extract

2-4 g (as extract)

165

Embelia ribes Burm. F.

Fruit

Bhabhiranga

1-2 g

(Not recommended for females planning to conceive)

166

Enicostemma littorale Blume

Mamejwa

2-3 g

167

Ephedra gerardiana Wall.

Leaves/Whole plant

Somlata

2-5g

168

Euphorbia neriifolia/E. pilosa

Stem (tender) after boiling/Leaf

Thuhar

10-20 g (as stem)

3-5 g (as leaf)

(Not recommended for children below 5 years)

169

Euryale ferox Salisb.

Seed

Makhana

20-30 g (as seed)

3-5 g (as powder)

170

Evolvulus alsinoides

Plant

Vishnukranta

10-20 g

171

Fagopyrum esculenttum Moench.

Seed

Kottu

50-100 g

172

Ferula asafoetida L.

Oleo-gum resin

Hing

125 mg, Max (as powder)

173

Ficus benghalensis L.

Fruit/Shoots

Baragad

40-50 g (as fruit)/5-10 g (as shoots)

174

Ficus carica L./F. palmata/F. lacor

Fruit/Leaf

Anjeer

20-30 g

175

Ficus glomerata Roxb. (Now known as Ficus racemosa L.)

Fruit/Leaf

Gular

20-30 g (as vegetable)

176

Ficus hispida L.f.

Fruit

Kathgulara (Kakodumba)

10-20 g

Tender leaf

Kathgulara

20-40 ml (as juice)

177

Ficus religiosa L.

Fruit

Pipal

5-10 g

Tender Leaf

Pipal

5-10 g

178

Flacourtia jangomas (Lour.)Raeusch syn. F. cataphracta Roxb. ex Willd.

Fruit

Paniyala

10-20 g

179

Flacourtia ramontchi L'Herit (Now known as Flacourtia indica (Burm.f.) Merr.)

Fruit

Katai/Kanghu

5-10 g

180

Foeniculum vulgare Mill.

Fruit

Sounf

5-10 g (as powder)

181

Fumaria vaillantii (Lois.) Hook. f. and Thoms. var. indica Haussk. (Now known as Fumaria indica (Haussk.) Pugsley)

Leaves

Pittapapda

5-10 g

182

Garcinia indica (Thour.) Choisy/G. cambogia

Mature fruit/Butter/Oil

Kokam

10-20 ml (as juice)

5-10 g (as powder)

183

Garcinia pedunculata Roxb. ex Buch.-Ham.

Fruit rind

Amalbeda

5-10 m1/g (as juice/Powder)

184

Gardenia turgida Roxb. (Now known as Ceriscoides turgida (Roxb.) Tirveng.)

Gum

Kharahar

1-3 g (as powder)

185

Gisekia pharnaceoides L.

Leaf

Baluka Saga

5-10 g

186

Glycine max (L.) Merr.

Seed

Soyabean

20-40 g

187

Glycyrrhiza glabra L.

Root and Stolon

Mulethi

5-10 g (as powder)

188

Gmelina arborea Roxb.

Fruit

Gamhari

20-30 g

189

Gmelina asiatica L.

Fruit

Badhara

20-30 g

190

Gossypium herbaceum

Seed/Root

Kapas

10-20g

191

Grewia hirsuta Vahl

Root

Gulsakari

5-10 g

192

Grewia populifolia Vahl (Now known as Grewia tenax (Forssk.) Fiori)

Stem bark/Fruit

Gangeran

5-10 g (as powder)

193

Grewia tiliaefolia Vah1/G.sclerophylla

Fruit

Dhamin

20-30 g

194

Gymnema sylvestre

Plant

Gudmar

5-10 g

Extract

Gudmar

1-2 g

195

Gynandropsis gynandra (L.) Briq. (Now known as Cleome gynandra L.)

Seed

Hurhur

1-3 g (as powder)

Whole plant

Hurhur

10-20 ml (as juice)

196

Habenaria intermedia

Root tuber, Rhizome

Ridhi

3-5 g

197

Hedychium spicatum Ham ex Smith

Rhizome

Kapur-Kachari

3-5 g

198

Hemidesmus indicus

Root/Stem

Anantmula

3-6 g

199

Hibiscus rosa-sinensis L.

Flower

Gudahal

1-3 g (as powder)

(Not recommended during pregnancy)

200

Hibiscus sabdariffa L.

Leaf

Patawa

5-10 g (as powder)

Seed

Patawa

1-3 g (as powder)

Ripe calyx

Patawa

5-10 g (as powder)

201

Hippophae rhamnoides L./H. salicifolia

Fruit/Leaf

Amlavetasa

10-20 g

Extract

Amalvets

1-3 g

202

Hordeum vulgare L.

Fruit

Jaou

100-200 g (as powder)

Whole plant

Jaou

10-20 g

203

Hygrophila spinosa

Makhana/Tal makhana

20-30 g

204

Hypericum perforatum

Leaf

Basant

3-6 g

Plant extract

Basant

1-1.5 g (as extract)

205

Illicium verum Hook. f.

Fruit

Badiyan Khatai

250-500 mg As powder-

206

Inula racemosa. Hook

Root

Pushkar mool

3-6 g (as powder)

207

Ipomoea aquatica Forssk.

Leaf

Kalamisaag

20-30 g

208

Ipomoea batatas (L.) Lam.

Tuber

Shakarkand

20-30 g

209

Ipomoea digitata auct. non L. (Now known as Ipomoea mauritiana Jacq.)

Root/Tuber

Bilaikand

3-6 g

210

Juglans regia Linn.

Fruit/Leaf/Bark

Akhrot

10-20 g

211

Juniperus communis

Flower/Leaf

Hauber

5-10 g

212

Lagenaria vulgaris Ser. (Now known as Lagenaria siceraria (Mol.) Standl.)

Fresh fruit

Alabu

100-150 g (as vegetable)

Seed

Alabu

1-3 g (as powder)

213

Lagerstroemia indica

Leaf

Jarul

6-12 g (as powder )

Fruit extarct

Frash

1-2 g (as extract)

214

Lagerstroemia parviflora

Leaf

Sidh

6-12 g (as powder)

Fruit extract

Sidh

1-2 g (as extract)

215

Lens culinaris Medik.

Seed

Masura

20-40 g (as seed)

216

Lepidium sativum L.

Seed

Chansur

3-6 g (as powder)

(Not recommended during pregnancy)

Aerial part

Chansur

50-100 g (as vegetable)

217

Leptadenia reticulata (Retz.)W. and A.

Leaf

Dodisaka

20-30 g (as vegetable)

218

Leucas cephalotus (Koenig ex Roth) Spreng.

Leaf

Guma

20-30 g

219

Limonia acidissima L.

Fruit

Kaith

20-40 g (as fruit)

220

Linum usitatissimum L.

Seed

Atasi

10-20 g

Seed Oil

Atasi

10-20 ml

221

Litchi chinensis Sonner

Fruit

Litchi

50-100 g

222

Luffa acutangula (L.)Roxb.

Whole plant

Torai

5-10 g (as powder)

Fruit

Torai

30-50 g (as vegetable)

Seed

Torai

1-3 g (as powder)

223

Luffa cylindrica (L.)M. Roem.

Fruit

Nenua

20-40 g (as vegetable)

Seed

Nenua

1-3 g (as powder)

224

Lycopersicon esculentum Mill. (Now known as Lycopersicon lycopersicum (L.) Karsten.)

Fruit

Tamatar

20-40 g (as vegetable)

225

Madhuca indica Gmel.(Now known as Madhuca longifolia (Koen.) Macbride var. latifolia)

Flower

Mahua

10-15 g (as flower)

Fruit

Mahua

10-15 g

Seed oil

Koyna ka tel

2-5 ml

226

Madhuca longifolia (Koenig) Macbride var. longifolia

Flower/Fruit

Jal mahua

10-15 g

227

Malva sylvestris L.

Fruit

Gulkhair

5-7 g (as powder)

Leaf

Gulkhair

3-6 g (as powder)

228

Mangifera indica L.

Ripe fruit

Aam

50-150 g

Unripe fruit pulp

Aam

10-30 g

Seed Kernel

Aam Beej/Majja

1-2 g (as powder)

Leaf

Aam

3-5 g

Extract

Amara (ghan)

0.5-1 g

229

Maranta arundinacea L.

Rhizome

Ararota

10-30 g (as powder)

230

Marsilea minuta L.

Leaf

Chowpatia

20-30 g (as vegetable)

2-4 g (as powder)

Extract

Chowpatia

1-2 g (as extract)

231

Mentha spicata L. Mentha arvensis L./M. aquatica Linn.

Aerial part

Pudina

5-10 g

232

Mentha piperata L./Mentha species

Peppermint/Sat pudina

10-30 mg

233

Mesua ferrea Linn.

Stemen/Flower

Nagkesar

2-5 g

234

Microstylis musifera Ridley

Tuber

Jivaka

5-10 g

235

Microstylis wallichii Lindl. (Now known as Malaxis acuminate D. Don)

Tuber

Rishabhka

5-10 g

236

Mimosa pudica

Whole plant/Seed

Lajwanti

3-6 g

237

Mimusops elengi L.

Pericarp

Maulsiri

20-40 g

Flower

Maulsiri

5-10 g

Stem bark

Maulsiri

3-5 g

238

Mimusops hexandra Roxb. (Now known as Manilkara hexandra (Roxb.) Dub.)

Pericarp

Khirni

20-40 g

239

Momordica charantia L.

Fresh fruit/Seed

Karela

30-50 g (as vegetable)

3-5 g (as seed)

(Not recommended for females planning to conceive)

(Not recommended for children below 5 years)

240

Momordica dioica Roxb. ex Willd.

Root

Khekhasa

3-6 g (as powder)

Fruit

Khekhasa

30-50 g

241

Monochoria vaginalis (Burm.f.)Presl.

Rhizome

Indivara

3-6 g

242

Moringa oleifera Lam./M.concanensis Nimmo

Leaf

Sahijan/Muringya/Lal sehanjan

10-20 g (as vegetable or paste)

Seed

Sahijan/Muringya

2-6 g (as vegetable)

Pod

Sahijan/Muringya

40-80 g

Flower

Sahijan/Muringya

10-20 g

Stem bark

Sahijan/Muringya

10-20 g 2-5 g (as powder)

243

Morus alba L./M. Indica/M.nigra

Fruit/Leaves/Bark/Flower

Shahtoot

20-30 g (as fruit)

3-5 g (as leaf)

244

Moschella esculenta/M. elata

Plant

Guchhi

10-30 g

245

Mucuna pruriens (L.) DC.

Root

Kawach

10-20 g

Pod

Kawach

20-30 g (as vegetable)

Seed

Kawach

5-10 g

246

Murraya koenigii (L.) Spreng./M. exotica Linn (kamini)

Leaf/Fruit

Kadhipatta

5-10 g

247

Musa paradisiaca L.

Flower

Kela

20-30 g

Fresh shoot

Kela

20-50 g 10-20 ml (as juice)

Ripe Fruit

Kela

100-200 g

Unripe Fruit

Kela

50-100 g

248

Myrica esculenta Buch. Ham./M. nagi Hook

Fruit

Kaiphal

5-10 g

Stem bark

Kaiphal

2-3 g

249

Myristica fragrans Houtt.

Seed

Jaiphala

0.25-1.0 g

(Caution: excessive use may cause giddiness)

Aril

Javitri

0.25-1 g (as powder)

250

Myristica malabarica Lam.

Seed

Jangali Jayaphala

0.5-2 g

Aril

Jangali javitri

0.25-1 g

251

Nardostachys jatamansi

Jatamansi

2-5 g

252

Nasturtium officinale/N. aquaticum

Water-cress

20-40 g

253

Nelumbo nucifera Gaertn.

Flower

Kamal

3-6 g (as powder)

Rhizome

Bhen

30-50 g

Stalk

Murar

30-50 g (as powder)

Seed

Kamalgatta

3-6 g (as powder)

254

Nymphaea alba Linn/N. rubra/N. stellate

Rhizome/Seed/Flower

Kamlini

10-20 g 3-6 g (as flower)

255

Nigella sativa L.

Seed

Kalaunji

5-10 g

(Not recommended during pregnancy)

256

Nyctanthes arbortristis L.

Flower

Harshringara

1-2 g

Leaf

Harshringara

1-3 g

257

Nymphaea rubra Roxb. ex Salisb

Flower

Lal Kumud

3-6 g (as powder)

258

Nymphaea stellata Willd.

Flower

Neelofer

3-6 g (as powder)

259

Ocimum basilicum L.

Leaf

(Bhavari Tulsi) Niajboo

3-6 ml (as juice)

1-3 g (as powder)

Seed

Tulasi (Jangali)

125-250 mg

260

Ocimum gratissimum L.

Leaf

Ram Tulasi (Mumbai)

2-4 g (as powder)

261

Ocimum sanctum L. (Now known as Ocimum tenuiflorum L.)

Leaf

Tulasi

2-5 g

Seed

Tulasi

1-2 g

262

Olea europaea

Seed/Oil

Jaitun/Tail

10-20 g/ml

263

Onosma bracteatum

Whole plant/Leaf

Gaujvan

5-10 g

264

Onosma hispidum

Root

Ratanjol

3-5 g

265

Operculina turpethum

Root/seed

Nishoth

3-5 g

(Not recommended for children below 5 years)

266

Opuntia vulgaris/O. dillenii

Fruits

Nagphani

10-20 g

267

Orchis latifolia L. (Now known as Dactylorhiza hategeria (D. Don) Soo)

Tuber

Salampanja

5-10 g (as powder)

268

Origanum majorana L.

Leaf

Marubaka

5-10 drops (as juice)

269

Oroxylum indicum

Bark/Seed

Shyonok

5-10 g

270

Oryza sativa L.

Seed

Chawal-shali

100-200 g (as powder)

271

Oxalis corniculata L.

Leaf

Tinpatia

5-10 ml (as juice)

272

Pandanus odoratissimus L.f.

Oi1/Flower

Kewada

2-5 drops/2-5 g

273

Panicum miliaceum L.

Seed

Cheen

50-100 g

274

Papaver somniferum L.

Seed

Postadana

2-5 g (as powder)

275

Parmelia perlata

Whole plant

Chharila

3-5 g

276

Paspalum scrobiculatum L.

Seed/Caryopsis

Kodo

50-100 g

277

Paspalum scrobiculatum

Fruit/Seed

Kodon

30-500 g

278

Pedalium murex

Bada gokharu

5-10 g

279

Pennisetum typhoideum L. C. Rich. (Now known as Pennisetum americanum (L.) K. Schum.)

Seed

Bajra

20-40 g

280

Peucedanum graveolens (L.) Benth. and Hook.f

Seed

Shepu

1-3 g

281

Phaseolus aconitifolius Jacq. (Now known as Vigna aconitifolia (Jacq.) Marechal)

Seed

Moth

20-50 g

282

Phaseolus aureus Roxb. (Now known as Vigna radiata (L.) Wilczek var. radiata)

Seed

Jangali moong

20-50 g

283

Phaseolus lunatus L.

Pod

Sem

25-50 g (as pulse)

284

Phaseolus mungo L. [Now known as Vigna mungo (L.) Hepper]

Seed

Urad

-20-50 g (as pulse)

285

Phaseolus radiatus L./P. trilobus sensu

Seed

Moong

50-100 g (as pulse)

286

Phaseolus vulgaris L.

Pod

Lobia

10-20 g (as pulse)

287

Phoenix dactilifera L.

Fruit

Chuhara/Khajur

20-50 g

288

Phoenix sylvestris (L.) Roxb./P. acaulis

Fruit

Khajoor

20-50 g

Nira (Sap)

Khajoor

30-50 ml (as fresh juice)

289

Phyllanthus amarus/P. urinaria

Plant

Tamlaki

5-10 g (as plant)

Extract

Tamlaki

1-2 g (as extract)

290

Physalis alkekengi L.

Fruit

Kaknaj

5-10 g

291

Physalis minima L.

Fruit

Papoto

10-20 g

292

Physalis peruviana L.

Fruit

Rasbhari

10-20 g

293

Pimpinella anisum L.

Fruit

Anisoon

1-3 g

294

Pinus excelsa

Fruit/Oil

Kail

5-10 g/1-2 ml

(Not recommended for children below 5 years)

295

Pinus gerardiana Wall.

Endosperm

Chilgoja

5-10 g

296

Pinus roxburghii

Fruit/Oil

Chiia

5-10 g/1-2 ml

(Not recommended for children below 5 years)

297

Piper betle L.

Leaf

Pana

2-5 g

(Not recommended below the age of 5 years)

298

Piper chaba Hunter (non Blume) (Now known as Piper retrofractum Vahl)

Leaf

Chabh

1-3 g (as powder)

299

Piper cubeba L.f.

Fruit

Kabab chini

1-3 g (as powder)

300

Piper longum L.

Fruit

Pipar

0.5-2 g (as powder)

(Not recommended for prolonged use)

301

Piper nigrum L.

Fruit

Kali Maricha

0.5-2 g

302

Pistacia integerrima Stewart (Now known as Pistacia chinensis Bunge ssp. Integerrima (Stewart) Rech.f.

Gall

Kakadasingi

1-2 g

303

Pistacia vera L.

Seed

Pista

5-10 g

304

Pisum sativum L.

Seed

Matar

50-150 g (as vegetable)

305

Plantago ovata Forssk.

Seed/Husk

Isabgol

5-10 g (as vegetable)

306

Polygonatum cirrhifolium (Wall.) Royle

Rhizome

Meda

5-10 g

307

Polygonatum verticillatum (L.) All.

Rhizome

Mahameda

5-10 g

308

Portulaca oleracea L.

Aerial part

Kulpha-sag

20-30 g (as vegetable)

309

Portulaca quadrifida L.

Aerial part

Nonia-sag

20-30 g

310

Premna integrifolia/P. latifolia

Whole plant/Bark

Agnimanth

5-10g

311

Prunus amygdalus Baill. var. dulchin

Kernel

Badama

10-20 g

Seed oil

Badama ka tel

3-5 ml

312

Prunus armeniaca L.

Pericarp

Khumani

10-20 g

Kernel

Khumani

3-5 g

Seed oil

Khumani

3-5 ml

313

Prunus cerasoides

Wood/Flower

Padamkasht/Pajja

5-10 g

314

Prunus persica (L.) Batsch.

Pericarp

Adu

10-20 g

315

Psidium guajava L.

Fruit

Amruda

20-50 g (as fresh fruit)

Leaf

Amruda

3-5 g

316

Pterocarpus marsupium

Ht. Wood

Vijaysar

5-10 g

317

Pterocarpus santalinus

Ht Wood

Lal chandan

5-10 g

318

Pueraria tuberosa (Roxb. ex Willd.) DC.

Tuber

Patal Kohda

10-20 g

319

Punica granatum L.

Seed

Anar

20-50 g (as seed)

Fruit rind

Anar

5-10 g (as fruit rind)

320

Putranjiva roxburghii

Fruit

Jiya-pota

3-6 g

(Not recommended for children below 5 years)

321

Pyrus communis L.

Fruit

Nashpaati

50-100 g

322

Pyrus malus L. (Now known as Malus pumila Mill.)

Fruit

Seb

100-200 g 20-40 ml (as juice)

323

Raphanus sativus L.

Root

Muli

20-50 g

Leaf

Muli

20-50 g

Seed

Muli

125-250 mg

324

Reinwardtia indica

Whole plant/leaf/extract

Basanti

5-10 g (as powder)

0.5-1 g (as extract)

325

Rhododendron arboreum Sm./R. companulatum/R. lepidotum Wall

Flower

Buransa

20-30 g (as flower)

Extract

Buransa

2-3 g (as extract)

326

Rheum emodi Wall. ex Meissn./R. officinale

Leaf

Revand chini

0.5-1 g

327

Rhus parviflora Roxb. ex DC.

Fruit

Samakdana

30-75 g

328

Ricinus communis

Seed/Root/Leaf

Erand

5-10 g

(Not recommended for children below 5 years)

329

Rosa alba L.

Flower

Safed gulab

10-20 g

330

Rosa centifolia L.

Flower

Gulab

10-20 g (as flower)

Oil

Gulab

2-5 drop (as oil)

331

Rosa damascena Mill.

Flower/oil

Gulab Fasali

10-20 g/2-5 drops

332

Roscoea procera Wall.

Root tuber

Kandamula

5-10 g (as powder)

333

Rubia cordifolia

Root/Stem

Manjeeth

3-6 g

334

Rumex vesicarius L.

Leaf

Ambat chukka

10-20 g

335

Rumex nepalensis/R.maritimus/R.acetosella

Shak/Fafru

20-40 g

(Not recommended for children below 5 years)

336

Saccharum officinarum L.

Stem/Juice/Root/Decoction

Ganna

100-200 ml (as juice)

(Not recommended for diabetics)

Sugar

Chini/Shakkar

50-100 g

(Not recommended for diabetics)

Jaggery

Gud

50-100 g

(Not recommended for diabetics)

337

Salacia chinensis L./Salacia oblonga Wall. ex Wight and Arn/Salacia reticulata Wight/S. roxburghii/S. macrosperma

Root

Saptrangi

5-10 g

Stem extract

Saptrangi

0.5-1 g

338

Salvadora persica/S. oleoides

Fruit/Leaf

Peelu/Bada pelu

5-10 g

339

Santalum album L.

Oil

Chandan ka tel

3-5 drops (as oil)

Hard wood

1-2 g (as hard wood)

340

Saraca asoca

Bark/Leaf

Ashok

5-10 g

(Not recommended for children below 5 years)

341

Saussurea lappa

Root/Rhizome

Kuth

3-5 g

(Not recommended for children below 5 years)

342

Scindapsus officinalis

Stem

Gaj pippali

3-5 g

343

Scirpus kysoor Roxb. (Now known as Scirpus grossus (L.f.) Palla)

Rhizome

Kasheru

20-50 g (as vegetable)

344

Selinum tenuifolium/S.vaginatum

Rhizome/Root

Bhootkesi

3-5 g

345

Sesamum indicum L. (Now known as Sesamum orientale L.)

Seed

Tila

10-20 g

Oil

Tila

5-10 ml

346

Sesbania grandiflora (L.) Poir.

Flower

Agathi

10-20 g (as vegetable)

Leaf

Agathi

10-20 g

347

Setaria italica (L.) P. Beauv.

Seed

Kangu

10-50 g

348

Sida cordifolia L./S. rhombifolis Linn/S. acuta

Whole plant/Extract

Bariyara

10-30 g

Seed

Bariyara

3-5 g

349

Solanum indicum/S.surattense/S.torvum

Whole plant

Kantkari

5-10 g

Fruit extract

Kateli

1-2 g (as extract)

350

Solanum melongena L.

Fruit

Baigan

50-100 g

351

Solanum nigrum L.

Leaf/Plant

Choti Makoy

30-60 g

352

Sorghum vulgare Pers.

Seed

Jwara

50-100 g

353

Sphaeranthus indicus

Flower

Gorakmundi

5-10 g

354

Spinacia oleracea L.

Leaf

Palak

50-100 g

355

Spondias mangifera Willd. (Now known as Spondias pinnata (L.f.) Kurz.)

Fruit/Leaf

Ambada

20-50 g 1-3 g (as powder)

356

Strychnos potatorum L.

Seed

Nirmali

5-10 g (as powder)

357

Swertia chirayita/S.ciliata/S.angustifolia

Whole plant

Chiraita

3-5 g (as whole plant)

Extract

Chiraita

0.5-1 g (as extract)

358

Symplocos racemosa

Bark/Leaf

Lodhar

3-5 g

359

Syzygium aromaticum (L.) Merr. and L.Perry

Flower bud

Laung

0.5-1 g

360

Syzygium cuminii (L.) Skeels

Pericarp and mesocarp

Jamun

10-50 g

Seed

Jamun

5-10 g

361

Tacca aspera Roxb.

Tuber

Bhevara ke kand

20-50 g

362

Tamarindus indica L.

Fruit pulp

Imali

5-10 g

(Not recommended during skin ailments)

Seed

Imali

5-10 g

363

Tephrosia purpurea

Whole plant

Sarponkha

5-10 g

364

Teramnus labialis (L.f.) Spreng.

Whole plant

Mashaparni

20-50 g

365

Terminalia arjuna

Bark/Leaf/Fruit

Arjun

5-10 g

Extract

Arjun

0.5-1 g (as extract)

366

Terminalia belerica (Gaertn.) Roxb.

Fruit pericarp

Bahera

3-5 g (as fruit pericarp)

Extract

Bahera

0.5-1 g (as extract)

367

Terminalia catappa L.

Kernel

Desi badama

10-20 g

368

Terminalia chebula Retz.

Fruit pericarp

Harad

3-5 g (as powder)

Extract

Harar

0.5-1 g (as extract)

369

Terminalia tomentosa

Stem/Bark/Leaf

Jarandrum/Asan

5-10 g

370

Thymus serpyllum auct. non L. (Now known as Thymus linearis Benth.)

Leaf

Ban ajwain

1-3 g (as powder)

371

Trachyspermum ammi (L.) Sprague

Seed

Ajwain

1-3 g (as powder)

Leaf

Ajwain

10-20 g

372

Trapa bispinosa Roxb. (Now known as Trapa natans L. var. bispinosa (Roxb.) Makino)

Endosperm/Fruit

Singhada

30-60 g

373

Trianthema portulacastrum L.

Whole plant

Swet punarnava

10-20 g

374

Tribulus terrestris

Fruit/Whole plant

Gokhru

5-10 g

375

Tricholepis glaberrima

Plant

Brahm dandi

3-6 g

376

Trichosanthes anguina L.

Fruit

Chichinda

30-60 g

377

Trichosanthes dioica Roxb.

Fruit/Leaf

Parawal

30-60 g

378

Trigonella foenum-graceum L.

Seed

Methi

5-10 g

Leaf

Methi

50-100 g

379

Triticum aestivum L.

Seed

Gehun

50-100 g

Tender shoot/spout

Ankurita Gehu

10-50 g

380

Typhonium trilobatum (L.) Schott.

Tuber

Konchu

20-50 g

381

Tinospora cardifolia Miers. (menispermaceae) Syn. T. glabra (n. Burm)

Roots/stem

5-10 g (as powder)

10-20 ml (as decoction)

400 mg, Max (as sattva)

Extract

1-2 g

382

Urtica parviflora/U. dioica

Tender Leaf

Bicchubuti

10-20 g

383

Uraria picta

Whole plant

Pithvin

5-10 g

384

Valeriana jatamansi Jones/V. wallichii

Rhizome

Tagar

1-3 g (as powder)

385

Vetiveria zizanioides

Whole plant

Khas

10-20 g

386

Vigna trilobata (L.) Verdc.

Whole plant

Mugvan

20-50 g

387

Viola odorata/V. pilosa/V. sylvestris

Whole plant/Flower

Vanksha

3-5 g

(Not recommended for children below 5 years)

388

Vitex agnus-castus Linn.

Seed/Leaf

Renuka beej/Sage

3-6 g

(Not recommended for children below 5 years)

389

Vitex negundo/V. trifolia

Fruit/Seed/Leaves

Nirgundi

3-5 g

390

Vitis vinifera L.

Fruit

Munakka

10-30 g

Seed/Fruit skin

Munakka

1-3 g

391

Wedelia calendulacea (L.) Less. (Now known as Wedelia chinensis (Osbeck) Mer.)

Leaf

Pila bhagra

5-10 g (as powder)

392

Withania coagulans (Stocks) Dunal

Fruit

Paneer Doda

5-10 g

393

Withania somnifera (L.) Dunal.

Root

Asgandh

3-6 g (as powder)

Extract

Asgandh

0.5-1 g (as extract)

394

Woodfordia fruticosa

Flower

Dhay ke phool

5-10g

395

Wrightia tinctoria/W.tomentosa

Bark/Leaf/Seed

Meetha kutaj

5-10 g

396

Zanthoxylum alatum Roxb. (Now known as Zanthoxylum armatum DC.)

Seed/Stem bark

Timura

1-3 g

397

Zea mays L.

Seed

Makka

20-100 g

Anthers

Makka

5-10 g

398

Zingiber officinale Rosc.

Rhizome

Adrakh

5-10 g

(Not recommended during hypertension and bleeding disorders)

399

Zizyphus jujuba Lam.

Pericarp

Ber

10-50 g

400

Zizyphus nummularia (Burm.f.)W. and A.

Pericarp

Jangali Ber/Jhar ber

15-30 g

Note 1. Ingredients listed in the above Schedule shall be used after due processing or in their extract forms subject to permissible usage range given in the last column of the Table. Offering these ingredients, either alone or in combinations as such or minimally processed (cleaned, de-weeded, sorted, dried or powdered) is/are not permitted.

Note 2. The ingredients listed above shall comply with Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.

Note 3. Permitted range of usage for children between 5-16 years is of the permitted range of usage for adults.

Note 4. Permitted range of usage for children between 1-5 years is of the permitted range of usage for adults.

SCHEDULE V-A

[See Regulations 3(13), 6(4), 7(5), 10(3) and 11(3)]

List of food additives for health supplements, nutraceuticals and food with added probiotics and prebiotics

Sl. No.

INS No.

Food Additive or Group

Maximum permitted level

1.

950

Acesulfame potassium

2000 mg/kg

2.

304, 305

Ascorbyl Esters

500 mg/kg

3.

951

Aspartame

5500 mg/kg

4.

962

Aspartame-Acesulfame salt

2000 mg/kg

5.

901

Beeswax

GMP

6.

210, 211, 212, 213

Benzoates

2000 mg/kg

7.

133

Brilliant blue FCF

300 mg/kg

8.

320

Butylated hydroxyanisole (BHA)

400 mg/kg

9.

321

Butylated hydroxytoluene (BHT)

400 mg/kg

10.

902

Candelilla wax

GMP

11.

150c

Caramel III Ammonia caramel

20,000 mg/kg

12.

150d

Caramel IV Sulfite ammonia caramel

20,000 mg/kg

13.

903

Carnauba wax

5000 mg/kg

14.

160a(ii)

beta-Carotenes (vegetable)

600 mg/kg

15.

160a(i), (iii), 160e, 160f

Carotenoids

300 mg/kg

16.

1503

Castor oil

1000 mg/kg

17.

141(i),(ii)

Chlorophylls and Chlorophyllins, Copper Complexes

500 mg/kg

18.

472e

Diacetyltartaric and fatty acid esters of glycerol

5000 mg/kg

19.

385, 386

Ethylene diamine tetra acetates

150 mg/kg

20.

143

Fast green FCF

600 mg/kg

21.

163(ii)

Grape skin extract

500 mg/kg

22.

132

Indigotine (Indigo carmine)

300 mg/kg

23.

961

Neotame

90 mg/kg

24.

338, 339(i)-(iii),

340(i)-(iii), 341(i)-(iii),

342(i),(ii), 343(i)-(iii),

450(i)-(iii),(v)-(vii),

451(i),(ii), 452(i)-(v),

542

Phosphates

2200 mg/kg

25.

1203

Polyvinyl alcohol

45,000 mg/kg

26.

900a

Polydimethylsiloxane

50 mg/kg

27.

1521

Polyethylene Glycol

70,000 mg/kg

28.

432-436

Polysorbates

25,000 mg/kg

29.

1201

Polyvinylpyrrolidone

GMP

30.

124

Ponceau 4R (Cochineal red A)

300 mg/kg

31.

310

Propyl gallate

400 mg/kg

32.

101(i)-(iii)

Riboflavins

300 mg/kg

33.

954(i)-(iv)

Saccharins

1200 mg/kg

34.

904

Shellac, Bleached

GMP

35.

200-203

Sorbates

2000 mg/kg

36.

960

Steviol Glycosides

2500 mg/kg

37.

955

Sucralose (Trichlorogalactosucrose)

2400 mg/kg

38.

474

Sucroglycerides

2500 mg/kg

39.

110

Sunset yellow FCF

300 mg/kg

SCHEDULE V-B

[See Regulations 3(13), 8(4), 10(3) and 11(3)]

List of food additives for foods for special dietary use and food with added probiotics and prebiotics

Sl. No.

INS No.

Food Additive or Group

Maximum permitted Level

1.

950

Acesulfame potassium

450 mg/kg

2.

956

Alitame

300 mg/kg

3.

304, 305

Ascorbyl Esters

500 mg/kg

4.

951

Aspartame

1000 mg/kg

5.

962

Aspartame-acesulfame salt

450 mg/kg

6.

210, 211, 212, 213

Benzoates

2000 mg/kg

7.

133

Brilliant blue FCF

300 mg/kg

8.

150c

Caramel III Ammonia caramel

20,000 mg/kg

9.

150d

Caramel IV-Sulfite ammonia caramel

20,000 mg/kg

10.

160a(ii)

Beta-Carotenes (vegetable)

600 mg/kg

11.

160a(i), (iii), 160e, 160f

Carotenoids

300 mg/kg

12.

472e

Diacetyltartaric and fatty acid esters of glycerol

5000 mg/kg

13.

163(ii)

Grape skin extract

250 mg/kg

14.

132

Indigotine (Indigo carmine)

300 mg/kg

15.

961

Neotame

65 mg/kg

16.

338, 339(i)-(iii),

340(i)-(iii),

341(i)-(iii),

342(i),(ii),

343(i)-(iii),

450(i)-(iii),(v)-(vii),

451(i),(ii),

452(i)-(v),

542

Phosphates

2200 mg/kg

17.

900a

Polydimethylsiloxane

50 mg/kg

18.

124

Ponceau 4R (Cochineal red A)

300 mg/kg

19.

101(i)-(iii)

Riboflavins

300 mg/kg

20.

954(i)-(iv)

Saccharins

200 mg/kg

21.

200-203

Sorbates

1500 mg/kg

22.

960

Steviol glycosides

660 mg/kg

23.

955

Sucralose (Trichlorogalactosucrose)

400 mg/kg

24.

110

Sunset yellow FCF

300 mg/kg

SCHEDULE V-C

[See Regulations 3(13), 9(4), 10(3) and 11(3)]

List of Food Additives for foods for special medical purpose (other than those products intended for foods for infants) and food with added probiotics and prebiotics

Sl. No.

INS No.

Food Additive or Group

Maximum Permitted Level

1.

950

Acesulfame potassium

500 mg/kg

2.

951

Aspartame

1000 mg/kg

3.

962

Aspartame-acesulfame salt

500 mg/kg

4.

210-213

Benzoates

1500 mg/kg

5.

133

Brilliant blue FCF

50 mg/kg

6.

150c

Caramel III Ammonia caramel

20,000 mg/kg

7.

150d

Caramel IV-Sulfite Ammonia caramel

20,000 mg/kg

8.

160a(ii)

beta-Carotenes (vegetable)

600 mg/kg

9.

160a(i), (iii), 160e, 160f

Carotenoids

50 mg/kg

10.

472e

Diacetyltartaric and fatty acid esters of glycerol

5000 mg/kg

11.

163(ii)

Grape skin extract

250 mg/kg

12.

132

Indigotine (Indigo carmine)

50 mg/kg

13.

961

Neotame

33 mg/kg

14.

338, 339(i)-(iii),

340 (i)-(iii),

341(i)-(iii),

342 (i),(ii),

343(i), (iii),

450 (i)-(iii), (v)-(vii),

451(i), (ii),

452(i)-(v), 542

Phosphates

2200 mg/kg

15.

900a

Polydimethylsiloxane

50 mg/kg

16.

432-436

Polysorbates

1000 mg/kg

17.

124

Ponceau 4R (Cochineal red A)

50 mg/kg

18.

477

Propylene glycol esters of fatty acids

5000 mg/kg

19.

101(i)-iii)

Riboflavins

300 mg/kg

20.

954 (i)-(iv)

Saccharins

200 mg/kg

21.

200-203

Sorbates

1500 mg/kg

22.

960

Steviol glycosides

350 mg/kg

23.

955

Sucralose (Trichlorogalactosucrose)

400 mg/kg

24.

474

Sucroglycerides

5000 mg/kg

25.

110

Sunset yellow FCF

50 mg/kg

SCHEDULE V-D

[See Regulations 3(13), 9(4), 10(3) and 11(3)]

List of Food Additives for foods for special medical purpose (other than those intended for infant foods); formula for slimming purpose and weight reduction and food with added probiotics and prebiotics

Sl. No.

INS No.

Food Additive or Group

Maximum permitted Level

1.

950

Acesulfame potassium

450 mg/kg

2.

304, 305

Ascorbyl Esters

500 mg/kg

3.

951

Aspartame

800 mg/kg

4.

962

Aspartame-acesulfame salt

450 mg/kg

5.

210-213

Benzoates

1500 mg/kg

6.

133

Brilliant blue FCF

50 mg/kg

7.

150c

Caramel III Ammonia caramel

20,000 mg/kg

8.

150d

Caramel IV Sulfite Ammonia caramel

20,000 mg/kg

9.

160a(ii)

Beta-Carotenes (vegetable)

600 mg/kg

10.

160a(i), (iii), 160e, 160f

Carotenoids

50 mg/kg

11.

472e

Diacetyltartaric and fatty acid esters of glycerol

5000 mg/kg

12.

163(ii)

Grape skin extract

250 mg/kg

13.

132

Indigotine (Indigo carmine)

50 mg/kg

14.

961

Neotame

33 mg/kg

15.

338, 339(i)-(iii),

340(i)-(iii),

341(i)-(iii),

342(i),(ii),

343(i)-(iii),

450 (i)-(iii),(v)-(vii),

451(i),(ii),

452(i)-(v), 542

Phosphates

2200 mg/kg

16.

900a

Polydimethylsiloxane

50 mg/kg

17.

432-436

Polysorbates

1000 mg/kg

18.

124

Ponceau 4R (Cochineal red A)

50 mg/kg

19.

477

Propylene glycol esters of fatty acids

5000 mg/kg

20.

101(i)-iii)

Riboflavins

300 mg/kg

21.

954 (i)-(iv)

Saccharins

300 mg/kg

22.

200-203

Sorbates

1500 mg/kg

23.

960

Steviol Glycosides

270 mg/kg

24.

955

Sucralose (Trichlorogalactosucrose)

320 mg/kg

25.

474

Sucroglycerides

5000 mg/kg

26.

110

Sunset yellow FCF

50 mg/kg

SCHEDULE V-E

[See Regulations 3(13), 6(4), 7(5), 8(4), 9(4), 10(3), 11(3) and 12(4)]

List of Food additives to be used (at GMP levels) for

(I) Nutraceuticals,

(II) Foods for special dietary use other than foods for infants,

(III) Foods for special medical purpose,

(IV) Foods with added probiotic ingredients and prebiotic ingredients,

(V) Specialty foods containing plant or botanical ingredients, and

(VI) Health supplements

Sl. No.

INS No.

Additive

Functional Class

1.

260

Acetic acid, glacial

Acidity regulator, Preservative

2.

472a

Acetic and fatty acid esters of glycerol

Emulsifier, Sequestrant, Stabilizer

3.

1422

Acetylated distarch adipate

Emulsifier, Stabilizer, Thickener

4.

1417

Acetylated distarch phosphate

Emulsifier, Stabilizer, Thickener

5.

1451

Acetylated oxidized starch

Emulsifier, Stabilizer, Thickener

6.

1401

Acid treated starch

Emulsifier, Stabilizer, Thickener

7.

406

Agar

Bulking agent, Carrier, Emulsifier, Gelling agent, Glazing agent, Humectant, Stabilizer, Thickener

8.

400

Alginic acid

Bulking agent, Carrier, Emulsifier, Foaming agent, Gelling agent, Glazing agent, Humectant, Sequestrant, Stabilizer, Thickener

9.

1402

Alkaline treated starch

Emulsifier, Stabilizer, Thickener

10.

1100 (i)

alpha-Amylase from Aspergillus oryzae

Flour treatment agent

11.

1100 (vi)

Carbohydrase from Bacillus licheniformis

Flour treatment agent

12.

1100 (iv)

alpha-Amylase from Bacillus megaterium expressed in Bacillus subtilis

Flour treatment agent

13.

1100 (ii)

alpha-Amylase from Bacillus stearothermophilus

Flour treatment agent

14.

1100 (v)

alpha-Amylase from Bacillus stearothermophilus expressed in Bacillus subtilis

Flour treatment agent

15.

1100 (iii)

alpha-Amylase from Bacillus subtilis

Flour treatment agent

16.

264

Ammonium acetate

Acidity regulator

17.

403

Ammonium alginate

Bulking agent, Carrier, Emulsifier, Foaming agent, Gelling agent, Glazing agent, Humectant, Sequestrant, Stabilizer, Thickener

18.

503(i)

Ammonium carbonate

Acidity regulator, Raising agent

19.

510

Ammonium chloride

Flour treatment agent

20.

503(ii)

Ammonium hydrogen carbonate

Acidity regulator, Raising agent

21.

527

Ammonium hydroxide

Acidity regulator

22.

328

Ammonium lactate

Acidity regulator, Flour treatment agent

23.

300

Ascorbic acid, L.

Acidity regulator, Anti-oxidant, Flour treatment agent

24.

162

Beet red

Colour

25.

1403

Bleached starch

Emulsifier, Stabilizer, Thickener

26.

1101(iii)

Bromelain

Flavour enhancer, Flour treatment agent, Stabilizer

27.

629

Calcium 5 -guanylate

Flavour enhancer

28.

633

Calcium 5 -inosinate

Flavour enhancer

29.

634

Calcium 5 -ribonucleotides

Flavour enhancer

30.

263

Calcium acetate

Acidity regulator, Preservative, Stabilizer

31.

404

Calcium alginate

Anti-foaming agent, Bulking agent, Carrier, Foaming agent, Gelling agent, Humectant, Sequestrant, Stabilizer

32.

302

Calcium ascorbate

Anti-oxidant

33.

170(i)

Calcium carbonate

Acidity regulator, Anti-caking agent, Carrier, Firming agent, Flour treatment agent, Stabilizer

34.

509

Calcium chloride

Firming agent, Stabilizer, Thickener

35.

623

Calcium di-L-glutamate

Flavour enhancer

36.

578

Calcium gluconate

Acidity regulator, Firming agent, Sequestrant

37.

526

Calcium hydroxide

Acidity regulator, Firming agent

38.

327

Calcium lactate

Acidity regulator, Flour treatment agent

39.

352(ii)

Calcium malate, DL-

Acidity regulator

40.

529

Calcium oxide

Acidity regulator, Flour treatment agent

41.

282

Calcium propionate

Preservative

42.

552

Calcium silicate

Stabilizer

43.

516

Calcium sulfate

Firming agent, Flour treatment agent, Sequestrant, Stabilizer

44.

150a

Caramel I plain caramel

Colour

45.

290

Carbon dioxide

Carbonating agent, Packaging gas, Preservative, Propellant

46.

410

Carob bean gum

Emulsifier, Stabilizer, Thickener

47.

407

Carrageenan

Bulking agent, Carrier, Emulsifier, Gelling agent, Glazing agent, Humectant, Stabilizer, Thickener

48.

427

Cassia gum

Emulsifier, Gelling agent, Stabilizer, Thickener

49.

140

Chlorophylls

Colour

50.

1001

Choline salts and esters

Emulsifier

51.

330

Citric acid

Acidity regulator, Anti-oxidant, Sequestrant

52.

472c

Citric and fatty acid esters of glycerol

Anti-oxidant, Emulsifier, Flour treatment agent, Sequestrant, Stabilizer

53.

466

Cross carmellose sodium

Binder, Thickening agent, Disintegrant

54.

468

Cross-linked sodium carboxymethyl cellulose (Crosslinked-cellulose gum)

Stabilizer, Thickener

55.

424

Curdlan

Firming agent, Gelling agent, Stabilizer, Thickener

56.

457

Cyclodextrin, alpha-

Stabilizer, Thickener

57.

458

Cyclodextrin, gamma-

Stabilizer, Thickener

58.

1504 (i)

Cyclotetraglucose

Carrier, Glazing agent

59.

1504 (ii)

Cyclotetraglucose syrup

Carrier

60.

1400

Dextrins, roasted starch

Emulsifier, Stabilizer, Thickener

61.

628

Dipotassium 5 -guanylate

Flavour enhancer

62.

627

Disodium 5 -guanylate

Flavour enhancer

63.

631

Disodium 5 -inosinate

Flavour enhancer

64.

635

Disodium 5 -ribonucleotides

Flavour enhancer

65.

1412

Distarch phosphate

Emulsifier, Stabilizer, Thickener

66.

315

Erythorbic Acid (Isoascorbic acid)

Anti-oxidant

67.

968

Erythritol

Flavour enhancer, Humectant, Sweetener

68.

Ethyl cellulose

Bulking agent, Carrier, Glazing agent, Thickener

69.

467

Ethyl hydroxyethyl cellulose

Emulsifier, Stabilizer, Thickener

70.

297

Fumaric acid

Acidity regulator

71.

418

Gellan gum

Stabilizer, Thickener

72.

575

Glucono delta-lactone

Acidity regulator, Raising agent, Stabilizer

73.

1102

Glucose oxidase

Anti-oxidant

74.

620

Glutamic acid, L(+)-

Flavour enhancer

75.

422

Glycerol

Humectant, Thickener

76.

626

Guanylic acid, 5 -

Flavour enhancer

77.

412

Guar gum

Emulsifier, Stabilizer, Thickener

78.

414

Gum arabic (Acacia gum)

Bulking agent, Carrier, Emulsifier, Glazing agent, Stabilizer, Thickener

79.

507

Hydrochloric acid

Acidity regulator

80.

463

Hydroxypropyl cellulose

Bulking agent, Emulsifier, Foaming agent, Glazing agent, Stabilizer, Thickener

81.

1442

Hydroxypropyl distarch phosphate

Emulsifier, Stabilizer, Thickener

82.

464

Hydroxypropyl methyl cellulose

Emulsifier, Glazing agent, Stabilizer, Thickener

83.

1440

Hydroxypropyl starch

Emulsifier, Stabilizer, Thickener

84.

630

Inosinic acid, 5

Flavour enhancer

85.

953

Isomalt (Hydrogenated isomaltulose)

Anti-caking agent, Bulking agent, Glazing agent, Sweetener

86.

416

Karaya gum

Emulsifier, Stabilizer, Thickener

87.

425

Konjac flour

Carrier, Emulsifier, Gelling agent, Glazing agent, Humectant, Stabilizer, Thickener

88.

270

Lactic acid, L-, D-and DL-

Acidity regulator

89.

472b

Lactic and fatty acid esters of glycerol

Emulsifier, Sequestrant, Stabilizer

90.

966

Lactitol

Emulsifier, Sequestrant, Stabilizer

91.

322(i)

Lecithin (and its salts and esters from soya or other sources)

Anti-oxidant, Emulsifier

92.

1104

Lipases

Stabilizer

93.

160d(iii)

Lycopene, Blakeslea trispora

Colour

94.

160d(i)

Lycopene, synthetic

Colour

95.

160d (ii)

Lycopene, tomato

Colour

96.

504(i)

Magnesium carbonate

Acidity regulator, Anti-caking agent, Colour retention agent

97.

511

Magnesium chloride

Colour retention agent, Firming agent, Preservative

98.

625

Magnesium di-L-glutamate

Flavour enhancer

99.

580

Magnesium gluconate

Acidity regulator, Firming agent, Flavour enhancer

100.

528

Magnesium hydroxide

Acidity regulator, Colour retention agent

101.

504(ii)

Magnesium hydroxide carbonate

Acidity regulator, Anti-caking agent, Carrier, Colour retention agent

102.

329

Magnesium lactate, DL-

Acidity regulator, Flour treatment agent

103.

530

Magnesium oxide

Anti-caking agent

104.

553(i)

Magnesium silicate, synthetic

Anti-caking agent

105.

518

Magnesium sulfate

Firming agent, Flavour enhancer

106.

296

Malic acid, DL-

Acidity regulator

107.

965(i)

Maltitol

Bulking agent, Emulsifier, Humectant, Stabilizer, Sweetener

108.

965(ii)

Maltitol syrup

Bulking agent, Emulsifier, Humectant, Stabilizer, Sweetener

109.

421

Mannitol

Anti-caking agent, Bulking agent, Humectant, Stabilizer, Sweetener

110.

461

Methyl cellulose

Bulking agent, Glazing agent, Humectant, Stabilizer, Thickener

111.

465

Methyl ethyl cellulose

Emulsifier, Gelling agent, Stabilizer, Thickener

112.

460(i)

Microcrystalline cellulose (Cellulose gel)

Anti-caking agent, Bulking agent, Carrier, Emulsifier, Foaming agent, Glazing agent, Stabilizer, Thickener

113.

471

Mono and di-glycerides of fatty acids

Anti-foaming agent, Emulsifier, Stabilizer

114.

624

Monoammonium L-glutamate

Flavour enhancer

115.

622

Monopotassium L-glutamate

Flavour enhancer

116.

621

Monosodium L-glutamate

Flavour enhancer

117.

1410

Monostarch phosphate

Emulsifier, Stabilizer, Thickener

118.

941

Nitrogen

Packaging gas, Propellant

119.

942

Nitrous oxide

Anti-oxidant, Foaming agent, Packaging gas, Propellant

120.

1404

Oxidized starch

Emulsifier, Stabilizer, Thickener

121.

1101(ii)

Papain

Flavour enhancer

122.

440

Pectins

Emulsifier, Gelling agent, Stabilizer, Thickener

123.

1413

Phosphated distarch phosphate

Emulsifier, Stabilizer, Thickener

124.

1200

Polydextroses

Bulking agent, Glazing agent, Humectant, Stabilizer, Thickener

125.

964

Polyglycitol syrup

Sweetener

126.

1202

Poly vinyl pyrrolidone, insoluble, including cross povidone

Colour retention agent, Stabilizer

127.

632

Potassium 5 -inosinate

Flavour enhancer

128.

261

Potassium acetates

Acidity regulator, Stabilizer

129.

402

Potassium alginate

Bulking agent, Carrier, Emulsifier, Foaming agent, Gelling agent, Glazing agent, Humectant, Sequestrant, Stabilizer, Thickener

130.

303

Potassium ascorbate

Anti-oxidant

131.

501(i)

Potassium carbonate

Acidity regulator, Stabilizer

132.

508

Potassium chloride

Flavour enhancer, Gelling agent, Stabilizer, Thickener

133.

332(i)

Potassium dihydrogen citrate

Acidity regulator, Sequestrant, Stabilizer

134.

577

Potassium gluconate

Acidity regulator, Stabilizer

135.

501(ii)

Potassium hydrogen carbonate

Acidity regulator, Raising agent, Stabilizer

136.

351(i)

Potassium hydrogen malate

Acidity regulator

137.

515 (ii)

Potassium hydrogen sulfate

Acidity regulator

138.

525

Potassium hydroxide

Acidity regulator

139.

326

Potassium lactate

Acidity regulator, Anti-oxidant

140.

351(ii)

Potassium malate

Acidity regulator

141.

283

Potassium propionate

Preservative

142.

515(i)

Potassium sulfate

Acidity regulator

143.

460(ii)

Powdered cellulose

Anti-caking agent, Bulking agent, Carrier, Emulsifier, Foaming agent, Glazing agent, Stabilizer, Thickener

144.

407a

Processed eucheuma seaweed

Bulking agent, Carrier, Emulsifier, Gelling agent, Glazing agent, Humectant, Stabilizer,Thickener

145.

944

Propane

Propellant

146.

280

Propionic acid

Preservative

147.

1101(i)

Protease

Flavour enhancer, Flour treatment agent, 1999 Glazing agent, Stabilizer

148.

1204

Pullulan

Glazing agent, Thickener

149.

470(i)

Salts of myristic, palmitic and stearic acids with ammonia, calcium, potassium and sodium

Anti-caking agent, Emulsifier, Stabilizer

150.

470(ii)

Salts of oleic acid with calcium, potassium and sodium

Anti-caking agent, Emulsifier, Stabilizer

151.

551

Silicon dioxide, amorphous

Anti-caking agent, Anti-foaming agent, Carrier

152.

262(i)

Sodium acetate

Acidity regulator, Preservative, Sequestrant

153.

401

Sodium alginate

Bulking agent, Carrier, Emulsifier, Foaming agent, Gelling agent, Glazing agent, Humectant, Sequestrant, Stabilizer, Thickener

154.

301

Sodium ascorbate

Anti-oxidant

155.

500(i)

Sodium carbonate

Acidity regulator, Anticaking agent, Raising agent

156.

466

Sodium carboxymethyl cellulose (Cellulose gum)

Bulking agent, Emulsifier, Firming agent, Gelling agent, Glazing agent, Humectant, Stabilizer, Thickener

157.

469

Sodium carboxymethyl cellulose, enzymatically hydrolysed (Cellulose gum, enzymatically hydrolyzed)

Stabilizer, Thickener

158.

331(i)

Sodium dihydrogen citrate

Acidity regulator, Emulsifier, Sequestrant, Thickener

159.

350(ii)

Sodium DL-malate

Acidity regulator, Humectant

160.

316

Sodium erythorbate (Sodium isoascorbate)

Anti-oxidant

161.

365

Sodium fumarates

Acidity regulator

162.

576

Sodium gluconate

Sequestrant, Stabilizer, Thickener

163.

500(ii)

Sodium hydrogen carbonate

Acidity regulator, Anti-caking agent, Raising agent

164.

350(i)

Sodium hydrogen DL-malate

Acidity regulator, Humectant

165.

514(ii)

Sodium hydrogen sulfate

Acidity regulator

166.

524

Sodium hydroxide

Acidity regulator

167.

325

Sodium lactate

Acidity regulator, Anti-oxidant, Bulking agent, Humectant, Thickener

168.

281

Sodium propionate

Preservative

169.

500(iii)

Sodium sesquicarbonate

Acidity regulator, Anti-caking agent, Raising agent

170.

-

Sodium starch glycolate

Binder, Thickening agent, Disintegrant

171.

514(i)

Sodium sulfate

Acidity regulator

172.

420(i)

Sorbitol

Bulking agent, Humectant, Sequestrant, Stabilizer, Sweetener

173

420(ii)

Sorbitol syrup

Bulking agent, Humectant, Sequestrant, Stabilizer, Sweetener

174.

1420

Starch acetate

Emulsifier, Stabilizer, Thickener

175.

1450

Starch sodium octenyl succinate

Emulsifier, Stabilizer, Thickener

176.

1405

Starches, enzyme treated

Emulsifier, Stabilizer, Thickener

177.

473a

Sucrose Oligoesters, Type I and Type II

Emulsifier, Stabilizer

178.

553(iii)

Talc

Anti-caking agent, Glazing agent, Thickener

179.

417

Tara gum

Gelling agent, Stabilizer, Thickener

180.

957

Thaumatin

Flavour enhancer, Sweetener

181.

171

Titanium dioxide

Colour

182.

413

Tragacanth gum

Emulsifier, Stabilizer, Thickener

183.

1518

Triacetin

Carrier, Emulsifier, Humectant

184.

380

Triammonium citrate

Acidity regulator

185.

333(iii)

Tricalcium citrate

Acidity regulator, Firming agent, Sequestrant, Stabilizer

186.

332(ii)

Tripotassium citrate

Acidity regulator, Sequestrant, Stabilizer

187.

331(iii)

Trisodium citrate

Acidity regulator, Emulsifier, Sequestrant, Stabilizer

188.

415

Xanthan gum

Emulsifier, Gelling agent, Stabilizer, Thickener

189.

967

Xylitol

Emulsifier, Humectant, Stabilizer, Thickener

SCHEDULE V-F

[See Regulations 3(1), 3(13), 6(4), 7(5), 8(4), 9(4), 10(3), 11(3) and 12(4)]

List of food additives to be used in formats such as tablets, capsules and syrups

(I) Nutraceuticals,

(II) Foods for special dietary uses other than foods for infants,

(III) Foods for special medical purpose,

(IV) Foods with added probiotic ingredients and prebiotic ingredients,

(V) Speciality foods containing plant or botanical ingredients, and

(VI) Health supplements

Sl. No.

Additive (Pharmaceutical Aid)

Functionality

Maximum Permitted Level

1.

Acacia gum

Binding agent

GMP

2.

Acetone

Solvent for coating

GMP (does not remain in the tablet and residual levels to be as per IP)

3.

Ascorbic acid and its esters and salts

Antioxidant

0.5%

4.

Benzoic acid and its salts

Preservative

0.5%

5.

BHA

Antioxidant

0.5%

6.

BHT

Antioxidant

0.5%

7.

Bronopol

Preservative

0.5%

8.

Calcium carbonate

Diluent, Dissintegrant

GMP

9.

Calcium stearate

Lubricant

1%

10.

Carboxymethylcellulose Calcium

Binding agent

5-15%

11.

Carrageenan gum

Binding agent

2%

12.

Cellulose acetate phthalate

Coating agent

2%

13.

Citric acid

Disintegrant

2%

14.

Citric and fatty acid esters of glycerol

Stabilizer

2%

15.

Copovidone

Binding agent

2-5%

16.

Corn oil

Vehicle

GMP

17.

Corn starch

Diluent, Binding agent, Dissintegrant

GMP

18.

Cross carmellose sodium

Disintegrant

2%

19.

Cyclodextrin

Diluent

GMP

20.

Dextrose

Diluent

GMP

21.

Dicalcium phosphate

Diluent

GMP

22.

Ethyl acetate

Solvent for coating

GMP (does not remain in the tablet and residual levels to be as per IP)

23.

Ethyl alcohol

Solvent for coating

GMP (does not remain in the tablet and residual levels to be as per IP)

24.

Ethyl cellulose

Coating agent, Ingredient of capsule shells

GMP

25.

Fructose

Diluent

GMP

26.

Gelatin

Binding agent, Ingredient of capsule shells

GMP

27.

Glycerin

Vehicle, Humectant for capsule shells

GMP

28.

Guar gum

Binding agent

GMP

29.

Hydrogenated castor oil

Lubricant

2%

30.

Hydrogenated vegetable oil

Lubricant

1%

31.

Hydroxy propyl methylcellulose

Coating agent, Ingredient of capsule shells

GMP

32.

Isomalt

Soluble fiber

15%

33.

Kaolin

Diluent

GMP

34.

Lactitol

Diluent

200 mg per capsule

35.

Lactose

Diluent

GMP

36.

Lecithin and its salts/esters from soya or other sources

Emulsifier, Stabilizer

GMP

37.

Light magnesium carbonate

Anticaking agent

0.5%

38.

Light magnesium oxide

Anticaking agent

0.5%

39.

Liquid glucose

Binding agent

GMP

40.

Magnesium carbonate

Adsorbant

0.3%

41.

Magnesium stearate

Antisticking agent, Glidant

2%

42.

Maize Starch

Diluent, Binding agent, Dissintegrant

GMP

43.

Maltitol

Sweetener, Diluent

GMP

44.

Maltodextrin

Diluent

GMP

45.

Maltose

Diluent

GMP

46.

Manitol

Diluent, Sweetner

GMP

47.

Methyl paraben and its salts

Preservative

0.2%

48.

Microcrystalline cellulose

Diluent

GMP

49.

Natural and synthetic colors as per FSSR

Coloring agents

Limits as per FSSR

50.

Peanut oil

Vehicle

GMP

51.

Pectin

Binding agent

GMP

52.

PEG 4000

Diluent for direct compression tablets

GMP

53.

Colors permitted under Rule 127 of Drugs & Cosmetics Rules including lake colours

Coloring agents

GMP

54.

Poly ethylene glycol (PEG)

Vehicle, Humectant for capsule shells

GMP

55.

Povidone

Binding agent

5%

56.

Propyl paraben and its salts

Preservative

0.02%

57.

Propylene glycol

Vehicle, Humectant for capsule shells

GMP

58.

Purified Talc

Glidant, Dusting powder for coating

2%

59.

Saff flower oil

Vehicle

GMP

60.

Sodium alginate

Binding agent

5%

61.

Sodium starch glycolate

Disintegrant, Binder, Thickening agent

2%

62.

Sorbitan crystalline

Diluent

15%

63.

Sorbitan oleate esters (Tweens)

Solubalizers

0.5%

64.

Sorbitol liquid

Vehicle, Humectant for capsule shells

GMP

65.

Starch, pregelatinized

Disintegrant

1%

66.

Stearic acid

Antisticking agent, Glidant

2%

67.

Sucrose

Diluent, Coating agent

GMP

68.

Sunflower oil

Vehicle

GMP

69.

TBHQ

Antioxidant

0.5%

70.

Tocoferol and its esters

Antioxidant

0.5%

71.

Tragacanth gum

Binding agent

GMP

72.

Tribasic calcium phosphate

Diluent, anticaking agent

GMP

73.

Tricalcium phosphate

Diluent

GMP

74.

Vegetable oils

Vehicle

GMP

75.

Xanthan gum

Binding agent

GMP

76.

Xylitol

Diluent, Sweetner

GMP

77.

Zinc stearate

Lubricant

0.5-1.5%

SCHEDULE VI

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

List of ingredients as nutraceuticals

Part A

Sl. No.

Nutraceutical ingredients

Common name

Purity Criteria

Permitted Range

1.

Astaxanthin (from Haematococus pluvalis), powder or oleoresin

-

Astaxanthin content

4 mg/day, Max

2.

Boswellia serrate-gum resin extract

Salai guggu1/ Kundru

Total boswelic acids or 11-ketobeta boswelic acids content

250-1500 mg extract/day

3.

Caffiene

Caffiene

Per cent caffiene

Within levels specified in FSS Regulations

4.

Chromium picolinate/ nicotinate

-

Chromium picolinate/nicotinate content

200-400 mcg/day

5.

Cimicifuga racemosa (or Actaea racemosa). Extracted from rhizomes and roots

Black cohosh

Total triterpene glycosides (minimum 0.4%), calculated as 23-epi-26-deoxyactein).

40-200 mg/day, Max

6.

Citrus Bioflavonoids (Citrus x paradisi, Citrus reticulata x maxima, C. x sinensis and Citrus limon)

Citrus

Bioflavinoids and total polyphenol content

150-600 mg/day, Max

7.

CoQ10 from non GM source

Co enzyme Q10

Ubiqinone and ubiqinol content

100-1000 mg/day, Max

8.

Echinacea (E. angustifolia, E. purpurea, and E. pallida) Liquid/ powder extract

Echinacea

Alkamides (0.25 mg/ml) and cichoric acid (2.5 mg/ml), if the extract used is in liquid form. In case of Hydroethanolic Echinacea extract is in a powdered form computation may be done proportionately to the weight/weight dry powder extract based on liquid extract used to obtain a dry powder format.

900 mg/day, Max

9.

Ginkgo biloba extract obtained from dried leaves of Ginkgo (Ginkgo biloba.L.).

Ginkgo biloba extract

Ginkgo flavone glycosides and Ginkgolides (diterpene lactones). Total flavonoids content (20.2 to 27% calculated as flavanol glycosides and tested for total terpene lactones (5.4% to 12.0%). Presence of Ginkgolides A, B, C needs to be tested qualitatively.

120-240 mg/day, Max

10.

Glucosamine hydrochloride

Glucosamine

Glucosamine content

1500-3000 mg/day, Max

11.

Glucosamine sulphate

Glucosamine

Glucosamine content

2500-5000 mg/day, Max

12.

Gymnema sylvestre extract powder

Gudmar extract

Gymnemic acid content

500-1500mg/day, Max

13.

Lactase ( -galactosidase)*

-

Enzyme activity

3000-9000 IU (or FCC units)/day, Max

14.

Panax ginseng (Syn; Korean Ginseng) extract-(obtained from 0.6 to 2.0 gm of Ginseng root, (Panaxginseng.C A. Meyer, Araliaceae)

Ginseng extract

Ginsenoside content ranging from 0.7 to 3%.

90-400 mg/day, Max

15.

Phycocynin from Spirulina plantesis (Aethrospira plantesis) Dried powder

Spirulina

Protein: 50-70 %; Carbohydrates: 20-40%; Minerals (Ash): 5.0-15%; Moisture: 3.0-6.0 %

50-250 mg/day, Max

16.

Piper nigrum/Piper longum extract

Peeper/Pippali

Piperine content

15 mg/day of piperine, Max(Duration of use: maximum 30 days)

17.

Quercetin obtained from extracts of citrus fruits and other vegetables

-

Quercetin content

100 mg/day, Max

18.

Schizandra berry extract

Five-flavor berry

Schizandrin berries containing 2.5-3.0% schizandrin

1-3 g/day, Max

19.

Scutellaria bicalensis

Skullcap

Aq. Extract of Scutellaria bicalensis standardized to bicallin content (NLT 50%)

250-1000 mg/day, Max

20.

Selenium Yeast

-

Selenium content and number of yeast counts (Cfu/g)

2 mg/day of selenium, Max

21.

Siberian ginseng-obtained from 0.6 to 2.0 gm of Ginseng root (Acanthopanax senticosus, belonging to panax type, C A. Meyer, Araliaceae)

Ginseng extract

Releutherosides content

100-450 mg/day, Max

22.

Silybum marianum extract (silymarin extract)

Milk Thistle

Standardized extract-silimarin content

250-1000 mg/day

23.

Spirulina (algae) from Spirulina platensis (Arthrospira platensis)

Spirulina

(Protein (min.)-55%, carbohydrates (max.)-30%, fats (lipid)-not more than 10%, minerals (ash)-5-10%, moisture-3-6% (also fatty acid profile to be mentioned on the package)

500-3000 mg/day

24.

Vaccinium myrstillus extract

Bilberry extract

Anthocyanin content

50-600 mg/day, Max

Part B

Sl. No.

Nutraceuticals/Ingredients

Common name.

1.

(+) Hydroxycitric acid

2.

Allium sativum bulbs dried powder/extract powder standardized

Garlic

3.

Aloe vera juice/concentrate/powder of sap/gel

Indian aloe, Ghrit kumari

4.

Alpha amylase*

-

5.

Alpha mangostin

-

6.

Alpha-galactosidase*

-

7.

Alpha-lipoic acid

-

8.

Amaranthus tricolor leaf powder/extract

-

9.

Amylase*

-

10.

Amyloglucosidase*

-

11.

Anethum graveolens L.-seeds and oil

Dill

12.

Anthocyanin

-

13.

Arabinogalactan

-

14.

Arachidonic acid

-

15.

Asparagus densiflorus-extract

Asparagus

16.

Bacopa monnieri-leaf extract

Brahmi

17.

Barley seed powder

Barley

18.

Berberis vulgaris stem/root extract

Berberry

19.

Beta carotene standardized soft concentrate/emulsified concentrate/powder

-

20.

Beta ecdysterone

-

21.

Beta glucans

-

22.

Beta vulgaris root extract

Beet

23.

Beta sitosterol

-

24.

Betula platyphylla-bark extract

Birch

25.

Biota orientalis-seed powder

Biota

26.

Black/green tea extract, standardized powder

-

27.

Borago officinalis-oil

Borage

28.

Campestanol

-

29.

Campesterol

-

30.

Capsicum annum-extract/standardized to capsicin content

Cayenne pepper

31.

Caricus papaya leaf extract

Papaya

32.

Carotenoids (natural mixed, including from algal sources)

-

33.

Casein and caseinates

34.

Caulophyllum thalictroides-root extract

Blue cohosh

35.

Cellulase*

-

36.

Centella asiatica leaf/aerial parts standardized extract

Mandukparni/Gotu Kola

37.

Matricaria chamomilla (Matricaria recutita) aerial parts extract

Chamomile

38.

Chlorella platensis dried powder

Green algae

39.

Chlorogenic acids and caffeic acid

-

40.

Chondroitin sulphate

Chondroitin

41.

Cichorium intybus roasted root powder

Chicory

42.

Cinnamomum verum bark powder/extract

Cinnamon

43.

Citrulline

-

44.

Citrus aurantium peel extract/bioflavonoids standardized

Bitter orange

45.

Citrus naringenin

-

46.

Citrus naringinine

-

47.

Clove powder

Lavang

48.

Cnicus benedictus aerial parts extract/root extract

Blessed thistle

49.

Cocoa (chocolate) bean-extract

-

50.

Coccinia grandis (L.) Voigt-extract

Ivy gourd

51.

Collagen hydrolysed

-

52.

Conjugated linoleic acid concentrate

-

53.

Crustacean shells

-

54.

Cuminum cyminum L oi1/extract

Cumin

55.

Curcuma longa rhizome powder/extract standardized

Turmeric

56.

Curcuminoids soft extract/powder and curcumin complex

-

57.

Cyperus rotandus-extract

Nirgundi

58.

Dehydroepiandrosterone (DHEA) and 7-Keto DHEA

59.

Diastase*

-

60.

D-Pinitol

-

61.

Edible legumes (seed powder), legume proteins (protein isolates/concentrates/hydrolysates)

-

62.

Ellagic acid

-

63.

Emblica officinalis dried fruit extract/spray dried pulp powder

Indian gooseberry/amla

64.

Eriocitrin (from citrus fruit)

-

65.

Evening primrose oil

-

66.

Fagopyrum esculentum-seed

Buckwheat

67.

Fish oil

-

68.

Foeniculum vulgare-fruit-oi1/extract

Fennel

69.

Freeze-dried banana powder

-

70.

Galactomannan

-

71.

Gallic acid

-

72.

Gamma-linoleic acid (GLA )

-

73.

Gamma-oryzanol

-

74.

Garcinia gummi-gatti and Garcinia cambogia fruit rind extract standardized to hydroxyl citric acid, powder)

Kokum/Brindall Berry/Malabar tamarind

75.

Garcinia mangostana seed extract standardized

Mangosteen

76.

Glucoamylase*

-

77.

Glucomannan

-

78.

Glycyrrhiza glabra-extract

Licorice

79.

Grape seed extract

-

80.

Green coffee seed extract standardized, including decaffeinated coffee bean powder/extract

-

81.

Grifola frondosa standardized extract

Maitake mushroom

82.

Guar gum and gum arabic and its derivatives as a source of fibers; and fibers from other food sources

83.

Hemicellulase*

-

84.

Hesperidin

-

85.

High oleic sun flower oil and other vegetable oils with high oleic content

-

86.

Hippophaerh amnoides fruit dried powder/extract/juice

Sea buckthorn

87.

Humulus lupulus L powder/extract

Hops

88.

Hydrolysed whey peptide

Whey

89.

Hypericum perforatum aerial parts standardized extract

St. Johns Wort

90.

Inula racemosa-root extract

Pushkarmoola

91.

Invertase*

-

92.

Isoflavones (genistein, daidzein)

-

93.

Kelp (brown algae)

-

94.

Krill oil-standardized for DHA/EPA

-

95.

Lactalbumin

-

96.

Lactoferrin

-

97.

Lactoperoxidase*

-

98.

Lagerstroemia speciosa L (leaf extract)

Banaba

99.

Lecithins

-

100.

Lignans

-

101.

Linum usitatissimum-seed powder and oil

Flaxseed

102.

Lipase*

-

103.

Lutein

-

104.

Lutein/zeaxanthin complex

-

105.

Lycopene

-

106.

Lycium eleagnus-fruit-dried powder/concentrate standardized

Goji berry (wolfberry)

107.

Maltase*

-

108.

Medicago sativa extract

Alfalfa

109.

Medium chain triglycerides

-

110.

Menyanth estrifoliata-Leaf powder

Buckbean/bogbean

111.

Millets and their powder

-

112.

Momordica charantia-fruit/seed extract

Bitter melon (bitter gourd)

113.

Monodora myristica (Gaertn.) Dunal oi1/extract

Nutmeg

114.

Morinda citrifolia extract

Noni

115.

Moringa oleifera leaf/pods/seed extract powder

Moringa/drum stick

116.

Mulberry tea leaf/fruit extract

Mulberry

117.

Myrica cerifera bark extract

Bayberry

118.

Myristica fragrans

Mace

119.

N-Acetyl D-glucosamine

-

120.

Nasturtium officinale-extract

Watercress

121.

Nattokinase enzyme (as Soy Bean Fibrinase)

-

122.

Ocimum tenuiflorum/Ocimum sanctum aerial parts/seed extract

Basi1/tulasi

123.

Omega-3 fatty acids (docosahexaenoic acid-eicosapentaenoic acid-alpha-linolenic acid)

-

124.

Omega-6-fatty acids (linoleic acid, arachidonic acid and conjugated linoleic acid)

-

125.

Oyster shell powder

-

126.

Pancreatin*

-

127.

Pancrelipase*

-

128.

Papain*

-

129.

Passiflora foetida-extract

Passion flower

130.

Arachis hypogaea-(roasted) powder

Pea nut

131.

Pectin

-

132.

Pepsin*

-

133.

Phellodendron amurense leaf oil

Phellodendron

134.

Phosphatides/Phospholipids

-

135.

Phyllanthus amarus-extract

Bhuiamalaki

136.

Phytase*

-

137.

Picrorhiza (Picrorhiza kurroa)-extract

Kurchi

138.

Pimento officinalis L.-extract/powder

Allspice

139.

Pinus gerardiana-bark extract

Pine nut

140.

Piper longum-extract

Long pepper (pippali)

141.

Piper nigram-green extract

Green pepper

142.

Piper nigrum powder/standardized extract

Black pepper

143.

Policosanol

-

144.

Protease*

-

145.

Prunus serotina-extract

Black cherry

146.

Psyllium (Ispaghula)-seed husk

Isaphgul

147.

Pumpkin seed oi1/meal

-

148.

Punica granatum fruit/seed/skin extract/powder

Pomegranate/dadima

149.

Raphanus sativus var. niger-root powder/extract

Black radish

150.

Red wine-extract/concentrate

-

151.

Red yeast rice

-

152.

Resveratrol

-

153.

Rhododendron arboretum-juice/extract

Rhododendron

154.

Rice bran

-

155.

Rice bran arabinoxylan compound

-

156.

Rose hips

-

157.

Rosmarinus officinalis leaves/needles extract/oil

Rosemary

158.

Royal Jelly

-

159.

Rutin from fruit peels

-

160.

Salvia officinalis leaf extract

Sage

161.

Sambucus nigra-extract

Elderberry/Black elderberry

162.

Shark cartilage/squalene oil

-

163.

Shiitake mushroom-extract

-

164.

Solanum lycopersicum fruit powder/extract

Tomato

165.

Soy sprouts dried powder

-

166.

Soya protein isolate/edible legume seed protein isolate

-

167.

Spearmint leaf and distillate

-

168.

Stanols and sterols including cholesterols

-

169.

Tagetes sp. petals oleo resin/extract

Marigold

170.

Tea catechins (epigallo catechin gallate, epicatechin, catechin gallates)

-

171.

Terminalia arjuna-bark/leaf extract (standardized extract)

Arjuna

172.

Terminalia bellerica-fruit extract

Myrobalan/Baheda

173.

Terminalia chebulia-fruit extract

Myrobalan/Harad

174.

Theaflavin

-

175.

Theanine

-

176.

Theobromine

-

177.

Tocopherols

-

178.

Trigonella-foenum-graecum seeds extract

Fenugreek

179.

Triticum sativum-bran

Wheat

180.

Trypsin*

-

181.

Vaccinium corymbosum-fruit-dried powder/concentrate standardized

Blueberry

182.

Vaccinium oxycoccos-fruit-dried powder/concentrate standardized

Cranberry

183.

Vitis alba and Vitis vinifera-fruit-dried powder/concentrate standardized

Blue grapes

184.

Wheat germ

-

185.

Zeaxanthin (max. 4 mg/day)

-

186.

Zingiber officinale-rhizome standardized extracts

Ginger

187.

-galactosidase*

-

Note. *Enzymes The enzymes listed in this schedule are primarily used as processing aids, but also may be used in nutraceutical products.

SCHEDULE VII

[See Regulations 3(13), 6(2)(i), 7(2)(i), 8(2)(i), 9(2)(i) and 10(1)(i)]

List of strains as probiotics (live micro-organisms)

Sl. No.

Name of the Microorganism

1.

Lactobacillus acidophilus

2.

Lactobacillus plantarum

3.

Lactobacillus reuteri

4.

Lactobacillus rhamnosus

5.

Lactobacillus salivarius

6.

Lactobacillus casei

7.

Lactobasillus brevis

8.

Lactobacillus johnsonii

9.

Lactobacillus delbrueckii sub-sp. bulgaricus

10.

Bacillus coagulans

11.

Lactobacillus fermentum

12.

Lactobacillus caucasicus

13.

Lactobacillus helveticus

14.

Lactobacillus lactis

15.

Lactobacillus amylovorus

16.

Lactobacillus gallinarum

17.

Lactobacillus delbrueckii

18.

Bifidobacterium bifidum

19.

Bifidobacterium lactis

20.

Bifidobacterium breve

21.

Bifidobacterium longum

22.

Bifidbacterium animalis

23.

Bifidobacterium infantis

24.

Streptococcus thermophilus

25.

Saccharomyces boulardii

26.

Saccharomyces cerevisiae

27.

Lactobacillus paracasei

28.

Lactobacillus gasseri

Note. (1) These organisms may be used either singly or in combination but shall be declared on the label with full information and has to be Non-GMO.

(2) The Food Authority may add any new strain of microorganism, possessing probiotic properties, after proper scientific evaluation, and include in this Schedule.

SCHEDULE VIII

[See Regulations 3(13), 6(2)(i), 7(2)(i), 8(2)(i), 9(2)(i) and 11(1)(i)]

List of prebiotic compounds

Sl. No.

Prebiotic Compounds

1.

Polydextrose

2.

Soybean oligosaccharides

3.

Isomalto-oligosaccharides

4.

Fructo-oligosaccharides

5.

Gluco-oligosaccharides

6.

Xylo-oligosaccharides

7.

Inulin

8.

Isomaltulose

9.

Gentio-ologsaccharides

10.

Lactulose

11.

Lactoferrin

12.

Sugar alcohols such as lactitol, sorbitol, maltitol, inositol, isomalt

13.

Galacto-oligosaccharides

Note. The Food Authority may add any new specific prebiotic after proper scientific evaluation and include in this Schedule.

1. Ministry of Health and Family Welfare (Food Safety and Standards Authority of India), Noti. No. No. 1-4/Nutraceutica1/FSSAI-2013, dated December 23, 2016, published in the Gazette of India, Extra., Part III, Section 4, dated 26th December, 2016, pp. 72-131.

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