Food Safety and Standards (Health Supplements, etc.) Regulations, 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.
[See Regulations 3(13), 4(2), 6(2)(i), 7(2)(i), 8(2)(i) and 9(2)(i)]
| 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.
[See Regulations 3(13), 4(2), 6(2)(i), 7(2)(i), 8(2)(i) and 9(2)(i)]
| 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.
[See Regulations 3(13), 4(2), 8(2)(i), 8(2)(iv), 9(2)(i), 9(2)(iv) and 9(2)(v)]
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) |
||||
[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)]
| 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.
[See Regulations 3(13), 6(4), 7(5), 10(3) and 11(3)]
| 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 |
[See Regulations 3(13), 8(4), 10(3) and 11(3)]
| 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 |
[See Regulations 3(13), 9(4), 10(3) and 11(3)]
| 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 |
[See Regulations 3(13), 9(4), 10(3) and 11(3)]
| 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 |
[See Regulations 3(13), 6(4), 7(5), 8(4), 9(4), 10(3), 11(3) and 12(4)]
(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 |
[See Regulations 3(1), 3(13), 6(4), 7(5), 8(4), 9(4), 10(3), 11(3) and 12(4)]
(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% |
[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)]
| 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.
[See Regulations 3(13), 6(2)(i), 7(2)(i), 8(2)(i), 9(2)(i) and 10(1)(i)]
| 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.
[See Regulations 3(13), 6(2)(i), 7(2)(i), 8(2)(i), 9(2)(i) and 11(1)(i)]
| 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.