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, 20160

The Food Safety and Standards Act, 2006

Official text

MINISTRY OF HEALTH AND FAMILY WELFARE

(FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA)

NOTIFICATION

New Delhi, the 23

December , 2016

No. 1-4/ Nutraceutical/ FSSAI-2013.— 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/

Nutraceutical/ FSSAI-2013, dated the 30

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 11

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:-

Regulations

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 1

January, 2018.

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;

(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 VA to Schedule VF, 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 Additves) 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.

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 VF;

Provided further that the food business operator may use the natural flavors or nature identical flavours or

synthetic flavors in accoradance 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 accoradance 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.

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(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 Reseach, 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 VA to Schedule VF .

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 accoradance 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.

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;

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(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

througha 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;

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 Authoity 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.

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.

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;

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 VA or Schedule VE or Schedule VF .

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;

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(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 coumpound 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;

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

VA or Schedule VE or Schedule VF .

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

(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 througha enteral 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 (3,350 kJ) and not more than 1,200 kcal (5,020 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 (1,670 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 1,200 kcal (5,020 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;

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:-

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(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;

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 VB or Schedule VE or Schedule VF .

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 enteral 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

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;

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 α -linolenic acid in the recommended daily intake with the α -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;

disease, disorderor medical conditionfor 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 VC or Schedule VD or Schedule VE or Schedule VF .

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

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 ≥ 10

CFU/g:

82 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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 Indain 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;

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 VA to

Schedule VF .

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;

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 VA to

Schedule VF .

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;

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;

(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 VE or Schedule VF .

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

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.

84 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

Schedule – I

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

List of vitamins and minerals and their components

S.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 B 1 (i) Thiamine chloride hydrochloride

(ii) Thiamine mononitrate

4. Vitamin B 2 (i) Riboflavin

(ii) Riboflavin 5’- phosphate, sodium

5. Vitamin B 6 (i) Pyridoxine hydrochloride

(ii) Pyridoxal 5’-phosphate

6. Vitamin B 12 (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 D 3 (cholecalciferol) – Animal source

(ii) Vitamin D 2 (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 K 1 (i) Phylloquinone

(ii) Phytomenadione (2-methyl 3-phytyl-1)

(iii) 1,4-napthoquinone

(iv) Phytonamidione

11. Vitamin K 2 (MK-7) (i) Menaquinone

12. Vitamin K 2 (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

S.No. Vitamins and Minerals Components

(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

86 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

S.No. Vitamins and Minerals Components

(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

S.No. Vitamins and Minerals Components

(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*

S.No. Micronutrient Overage (per cent)

1. Vitamin A 30

2. Vitamin C 20

3. Vitamin D 30

4. Vitamin E 10

5. Thiamine (vitamin B 1 ) 25

6. Riboflavin (vitamin B 2 ) 25

7. Niacin (vitamin B 3 ) 10

8. Vitamin B 6 25

9. Vitamin B 12 25

10. Folic acid 25

11. Pantothenic acid 10

12. Vitamin K 1 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.

88 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

Schedule – II

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

List of amino acids and other nutrients

A. Essential Amino Acids

(i) L-Histidine (xii) L-Aspartic acid

(ii) L-Histidine hydrochloride (xiii) L-Argine L-aspartate

(iii) L-Isoleucine (xiv) L-Threonine

(iv) L-Isoleucine hydrochloride (xv) L- Alanine

(v) L-Leucine (xvi) L-Phenylalanine

(vi) L-Leucine hydrochloride (xvii) L-Cyststeine hydrochloride

(vii) L-Lysine (xviii) L-Tyrosine

(viii) L-Lysine hydrochloride (xix) L-Arginine

(ix) DL-Methionine (xx) L-Tryptophan

(x) L-Cysteine (xxi) L-Valine

(xi) L-Cysteine hydrochloride (xxii) L-Arginine hydrochloride

B. Non- Essential Amino Acids

(i) L-Carnitine (xv) L- Proline

(ii) L-Carnitine hydrochloride (xvi) L-Lycine-L-glutamate dihydrate

(iii) Carnitine, acetyl-L (xvii) Megnesium L- aspartate

(iv) L-Glutamic acid (xviii) Calcium L- glutamate

(v) L-Glutamine (xix) Potassium – L- glutamate

(vi) Glycine (xx) Carnitine tartrate

(vii) L-Hydroxylysine (xxi) Taurine

(viii) L-Hydroxyproline (xxii) Choline

(ix) L-Lycine acetate (xxiii) Choline chloride

(x) N-acetyl-L-cysteine (xxiv) Choline citrate

(xi) L- Ornithine (xxv) L-Serine

(xii) L-Ornithine mono hydrochloride (xxvi) Tyrosine, acetyl-L

(xiii) L-Lycine –L- aspartate (xxvii) Choline hydrogen tartrate

(xiv) L-Citruline (xxviii) Myo-inositol

C. Nucleotides

(i) Adenosine 5- monophosphate (AMP) (v) Disodium uridine 5-monophosphate

(ii) Cystidine 5- mono phosphate (CMP) (vi) Disodium guanosine 5-mono phosphate

(iii) Guanosine 5- mono phosphate (GMP) (vii) Disodium ionosine 5-mono phosphate

(iv) Inosine 5- mono phosphate (IMP)

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

Schedule – III

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

Values for vitamins, minerals and trace elements allowed to be used in food for special dietary use and food for

special medical purpose (other than those intended for use in infant formula)

1. Vitamins

RDA for Vitamins

Vitamins Per 100 kJ Per 100 kcal

Minimum Maximum* Minimum Maximum*

Vitamin A (μg RE) 8.4 43 35 180

Vitamin D (μg) 0.12 0.65 (0.75)

0.5 2.5 (3)

Vitamin K (μg) 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 B 6 (mg) 0.02 0.12 0.08 0.5

Niacin (mg NE) 0.22 0.75 0.9 3

Folic acid (μg) 2.5 12.5 10 50

Vitamin B 12 (μg) 0.017 0.17 0.07 0.7

Pantothenic acid (mg) 0.035 0.35 0.15 1.5

Biotin (μg) 0.18 1.8 0.75 7.5

Vitamin E (mg α -TE)

0.5/g of

polyunsaturated fatty

acids expressed as

linoleic acid but in no

case less than 0.1 mg

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

(

): 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 percent ) 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

2 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)

42 (60)

35 (50)

175 (250)

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 (μg) 15 125 60 500

Iodine (μg) 1.55 8.4 6.5 35

Selenium (μg) 0.6 2.5 2.5 10

Manganese (mg) 0.012 0.12 0.05 0.5

Chromium (μg) 0.3 3.6 1.25 15

Molybdenum (μg) 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)

90 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

Schedule – IV

[See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 7.(3)(v), 8.(2)(i), 9.(2)(i), 12.(1)(i), 12.(2), 12.(3)(i), 12.(3)(ii) and

12.(3)(iii)]

List of plant or botanical ingredients

S. 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

8 Achyranthes aspera ( L.)/ A. bidentala

Seed/Plant Chirchida 3-5 g (as powder)

9 Adhatoda zeylanica / A. vasaka

10 Aegle marmelos (L.) Corr.

Unripe fruit pulp Bael 5-10 g

Ripe fruit Bael 50-100 g (as pulp)

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 )

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

92 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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

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

57 Boswellia serrata Roxb.

Oleoresin Salai guggal 2-4 g

58 Borassus flabellifer L.

Dried inflorescence Tarkul/Taad 1-3 g (as powder)

Seed pulp of unripe fruit Tarkul/Taad 10-30 g

Exudate of stem / sap Tarkul/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)

94 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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

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.

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

(Galpatri)

20-30 g (as vegetable)

Extract Brahmi

(Galpatri)

1-3 g

89 Centratherum anthelminticum

jirii

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.

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

96 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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 phal /

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

(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

129 Crocus sativus L.

Style and Stigma Kumkum

(Kesar)

25-50 mg

(Not recommended for children

below 16 years)

98 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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

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.

168 Euphorbia neriifolia/ E. pilosa

100 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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.

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

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 Vahl / 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)

102 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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.)

210 Juglans regia Linn.

211 Juniperus communis

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.

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.

104 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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 )

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

263 Onosma bracteatum

Whole plant/Leaf Gaujvan 5-10 g

264 Onosma hispidum

Root Ratanjol 3-5 g

265 Operculina turpethum

(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

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.

Oil / Flower Kewada 2-5 drops /2-5 g

273 Panicum miliaceum L.

106 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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.

277 Paspalum scrobiculatum

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

Pajja

5-10 g

314 Prunus persica (L.) Batsch.

Pericarp Adu 10-20 g

108 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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

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

(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

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

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

(Not recommended for children

below 5 years)

341 Saussurea lappa

(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

110 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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

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

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

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)

112 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

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 ½ of the permitted range of usage for

adults.

Note 4.- Permitted range of usage for children between 1-5 years is ¼ of the permitted range of usage for adults.

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

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

Schedule – VA

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

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

S. No. INS No. Food Additive or Group Maximum permitted

level

1. 950 Acesulfame potassium 2,000 mg/kg

2. 304, 305 Ascorbyl Esters 500 mg/kg

3. 951 Aspartame 5,500 mg/kg

4. 962 Aspartame-Acesulfame salt 2,000 mg/kg

5. 901 Beeswax GMP

6. 210, 211, 212, 213 Benzoates 2,000 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 5,000 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 1,000 mg/kg

17. 141(i),(ii) Chlorophylls and Chlorophyllins, Copper

Complexes

18. 472e Diacetyltartaric and fatty acid esters of

glycerol

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

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 1,200 mg/kg

34. 904 Shellac, Bleached GMP

35. 200-203 Sorbates 2,000 mg/kg

36. 960 Steviol Glycosides 2,500 mg/kg

37. 955 Sucralose (Trichlorogalactosucrose) 2,400 mg/kg

38. 474 Sucroglycerides 2,500 mg/kg

39. 110 Sunset yellow FCF 300 mg/kg

114 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

Schedule – VB

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

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

S. 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 1,000 mg/kg

5. 962 Aspartame-acesulfame salt 450 mg/kg

6. 210, 211, 212, 213 Benzoates 2,000 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 5,000 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

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 1,500 mg/kg

22. 960 Steviol glycosides 660 mg/kg

23. 955 Sucralose (Trichlorogalactosucrose) 400 mg/kg

24. 110 Sunset yellow FCF 300 mg/kg

Schedule – VC

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

List of food Additives for foods for special medical purpose (other than those products intended for foods for

infants) and food with added probiotics and prebiotics

S. No. INS No. Food Additive or Group Maximum Permitted

Level

1. 950 Acesulfame potassium 500 mg/kg

2. 951 Aspartame 1,000 mg/kg

3. 962 Aspartame-acesulfame salt 500 mg/kg

4. 210 - 213 Benzoates 1,500 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

S. No. INS No. Food Additive or Group Maximum Permitted

Level

9. 160a(i), (iii), 160e, 160f Carotenoids 50 mg/kg

10. 472e Diacetyltartaric and fatty acid esters of

glycerol

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

15. 900a Polydimethylsiloxane 50 mg/kg

16. 432 - 436 Polysorbates 1,000 mg/kg

17. 124 Ponceau 4R (Cochineal red A) 50 mg/kg

18. 477 Propylene glycol esters of fatty acids 5,000 mg/kg

19. 101(i)-iii) Riboflavins 300 mg/kg

20. 954 (i)-(iv) Saccharins 200 mg/kg

21. 200-203 Sorbates 1,500 mg/kg

22. 960 Steviol glycosides 350 mg/kg

23. 955 Sucralose (Trichlorogalactosucrose) 400 mg/kg

24. 474 Sucroglycerides 5,000 mg/kg

25. 110 Sunset yellow FCF 50 mg/kg

Schedule – VD

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

List of food additives for foods for special medical purpose (other than those intended for infant foods); formula

for slimming purpose and weight reduction and food with added probiotics and prebiotics

S. 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 1,500 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

116 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

S. No. INS No. Food Additive or Group Maximum permitted

Level

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

16. 900a Polydimethylsiloxane 50 mg/kg

17. 432 - 436 Polysorbates 1,000 mg/kg

18. 124 Ponceau 4R (Cochineal red A) 50 mg/kg

19. 477 Propylene glycol esters of fatty acids 5,000 mg/kg

20. 101(i)-iii) Riboflavins 300 mg/kg

21. 954 (i)-(iv) Saccharins 300 mg/kg

22. 200-203 Sorbates 1,500 mg/kg

23. 960 Steviol Glycosides 270 mg/kg

24. 955 Sucralose (Trichlorogalactosucrose) 320 mg/kg

25. 474 Sucroglycerides 5,000 mg/kg

26. 110 Sunset yellow FCF 50 mg/kg

Schedule – VE

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

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

(I) Nutraceuticals,

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

(III) Foods for special medical purpose,

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

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

(VI) Health supplements

S. 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

S. No. INS No. Additive Functional Class

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, Glazing 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,

118 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

S. No. INS No. Additive Functional Class

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. 462 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

S. No. INS No. Additive Functional Class

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

120 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

S. No. INS No. Additive Functional Class

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,

S. No. INS No. Additive Functional Class

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

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

122 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

Schedule VF

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

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

(I) Nutraceuticals,

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

(III) Foods for special medical purpose,

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

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

(VI) Health supplements

S.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 mgper 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

59. Saff flower oil Vehicle GMP

60. Sodium alginate Binding agent 5%

61. Sodium starch glycolate Disintegrant, Binder,

Thickening agent

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

124 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

68. Sunflower oil Vehicle GMP

69. TBHQ Antioxidant 0.5%

70. Tocoferol and its esters Antioxidant 0.5%

71. Tragacanth gum Binding agent GMP

72. Tribasic calcium phosphate Diluent, anticaking agent GMP

73. Tricalcium phosphate Diluent GMP

74. Vegetable oils Vehicle GMP

75. Xanthan gum Binding agent GMP

76. Xylitol Diluent, Sweetner GMP

77. Zinc stearate Lubricant 0.5-1.5%

Schedule –VI

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

List of ingredients as nutraceuticals

PART A

S. 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 guggul /

Kundru

Total boswelic acids or 11-keto-

beta boswelic acids content

250 - 1,500 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 100-1,000 mg /

day, Max

8. Echinacea (E. angustifolia,

E. purpurea, and E.

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

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

120-240 mg/ day,

Max

PART A

S. No. Nutraceutical

ingredients

Common

name

Purity Criteria Permitted Range

A, B, C needs to be tested

qualitatively .

10. Glucosamine

hydrochloride

Glucosamine Glucosamine content 1,500-3,000

11. Glucosamine sulphate Glucosamine Glucosamine content 2,500-5,000

12. Gymnema sylvestre extract

powder

Gudmar extract Gymnemic acid content 500-1,500mg /

day, Max

13. Lactase ( β -galactosidase)* - Enzyme activity 3,000 – 9,000 IU

(or FCC units) /

day, Max

14. Panax 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 – 1,000 mg/

day, Max

20. Selenium Yeast - Selenium content and number 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 - 1,000 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 - 3,000 mg /

day

24. Vaccinium myrstillus

extract

Bilberry

extract

Anthocyanin content 50 - 600 mg / day,

Max

126 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

Part B

S.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

Part B

S.No. Nutraceuticals / Ingredients Common name.

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 – oil / 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 - oil / 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

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

128 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

Part B

S.No. Nutraceuticals / Ingredients Common name.

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 -

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 – oil / 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 Basil /tulasi

123.

Omega-3 fatty acids (docosahexaenoic acid - eicosapentaenoic acid -

alpha - linolenic acid) -

Part B

S.No. Nutraceuticals / Ingredients Common name.

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 oil /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 -

130 THE GAZETTE OF INDIA : EXTRAORDINARY [P ART III—S EC . 4]

Part B

S.No. Nutraceuticals / Ingredients Common name.

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. α -galactosidase* -

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

nutraceutical products .

Schedule –VII

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

List of strains as probiotics (live micro-organisms)

S. No. Name of the Microorganism

1. Lactobacillus acidophilus

2. Lactobacillus plantarum

3. Lactobacillus reuteri

4. Lactobacillus rhamnosus

5. Lactobacillus salivarius

6. Lactobacillus casei

7. Lactobasillus brevis

8. Lactobacillus johnsonii

9. Lactobacillus delbrueckii sub- sp. bulgaricus

10. Bacillus coagulans

11. Lactobacillus fermentum

12. Lactobacillus caucasicus

13. Lactobacillus helveticus

14. Lactobacillus lactis

15. Lactobacillus amylovorus

16. Lactobacillus gallinarum

17. Lactobacillus delbrueckii

18. Bifidobacterium bifidum

19. Bifidobacterium lactis

20. Bifidobacterium breve

21. Bifidobacterium longum

22. Bifidbacterium animalis

23. Bifidobacterium infantis

24. Streptococcus thermophilus

25. Saccharomyces boulardii

26. Saccharomyces cerevisiae

27. Lactobacillus paracasei

28. Lactobacillus gasseri

Note.- (1) These organisms may be used either singly or in combination but shall be declared on the label with

full information and has to be Non-GMO.

(2) The Food Authority may add any new strain of microorganism, possessing probiotic properties, after

proper scientific evaluation, and include in this Schedule .

Schedule – VIII

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

List of prebiotic compounds

S. 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.

PAWAN AGARWAL, Chief Executive Officer

[ADVT.-III/4/Exty./352/16(187)]