F.No.

1-4/Nutraceuticals/FSSAl -
2003 Food Safety and Standards
Authority of India
FDA Bhawan, Kotla Road, New Delhi-110002

Dated: The 24th November, 2016

Subject: Direction under section 16(5) of Food Safety and

Standards Act, 2006 regarding operationalisation of standards
of Health Supplements, Nutraceuticals, Food for Special
Dietary Use, Food for Special Medical Purpose, Functional
Food and Novel Food.

I n exercise of the powers conferred under section 92 of the Food

Safety and Standa rds Act, 2006 (34 of 2006), the FSSAI has framed the
Food Safety and Standards (Health Supplements, Nutraceutical s, Food for
Special Dietary Use, Food for Special Med ical Purpose, Functional Food
and Novel Food) Regulations, 2016.

2. Gazette publication of final regulations would take some more time

as the regulations are being translated in Hindi. Considering that the
regulations are final, the FSSAI has made the above regulations (as
enclosed) operational with immediate effect (i.e. 241" November, 2016) in
order to facilitate food busin esses.

3. I n exercise of the p ower vested und er Sections 16(5) of Food safety

and Standards Act, 2006, the Com petent Authority hereby directs Food
Safety Commissioners of States/ UTs to take note of these standards. The
licenses now be issued und er the categories of 13.3, 13.4, 13.S and 13.6, as
applicable.

4. This issues wi th the approva l of the Competen t Authority

To

1. All Food Safety Commissioners,

2. All Authorized Officers, FSSAI,

3. All Designated Officers,

FSSAI. Copy for information to:

1. PPS to Chairperson, FSSAI

2. PS to CEO, FSSA I

3. All Directors, FSSAI

 [To be published in the Gazette of India, Extraordinary,
Part III, Section 4]

Government of India
Ministry of Health Welfare and Family
Food Safety and Standards Authority
of India

New Delhi, the 24th November,

2016

No. 1-4/ Nutraceutical/ FSSAl-2013.- As requi red by sub-

section(l) of section 92 of the Food Safety and Standards Act, 2006 (34 of
2006) the draft Food Safety and Standards (Food or H ealth Supplements, N
utraceuticals, Foods for Special Dietary Uses, Foods for Special Med ical
Purpose, Functional Foods, and Novel Food) Regulations, 2015, was
published vide notification of the Food Safety and Standards Authori ty of
India No. 1-4/ N utraceutica l/ FSSAI-2013, dated the 30th J uly, 2015 i n the
Gazette of India, Extraordi nary, Part III, Section 4.

The draft regulations were made available to the public on the 11t11
September, 2015. Objections and suggestions were invited from the
persons likely to be affected within sixty days from the above mentioned
date.

And whereas objections and suggestions received from the pu blic

wi thin the specified period on the said draft regulations have been
considered by the Food Safety and Standards Authori ty of Ind ia;

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 Standa rds Act, 2006 (34 of 2006), the Food Safety and Standards Au
thority of India hereby makes the following regula tions, namely:-
 Regulations

1. Short title and commencement. - (1) These regulations may be

called the Food Safety and Standards (Health Supplements, N u traceu ticals,
Food for Special Dieta ry Use, Food for Special Med ical Pu rpose, Fu nctional
Food and Novel Food) Regulations, 2016.
(2) The enforcement of these regulations shall come i nto force from 1st
J anuary 2018.
2. Definitions.- In these regulations, unless the context otherwise requires,-

(a) "Act" m eans the Food Safety and Standards Act, 2006 (34 of 2006);

(b) "Food Authority" means the Food Safety and Standards Au thority
of India establish ed under section 4 of the Act;

(c) "food for special dietary use" shall have the mea ning assigned to it i
n section 22 of the Act;

(d) "food for special medical purpose" mea ns food intended for -

(i) pa rticular dietary use specially processed or formula ted;

(ii) the dietary management of person s and used only u nder med ical
advice;

(iii) ) the exclusive or pa rtial feed ing of persons with a limited,

impaired or disturbed capacity to take, digest, absorb, metabolize
or excrete ordinary foodstuffs or certain nutrients contained
therein or metaboli tes; or

(iv) other medi cally determined nu tri ent requi rements, whose
dietary m anagement cannot be achieved only by modification of
the normal diet, by food for specific nutritional u se, or a combi
nation of them;

(e) "food wi th added prebiotic ingredients" means food that conta

ins added prebiotic ingredients which are non-viable food components
that confer health benefits to the consumer by mod ulation of gutmi
crobiota;
(f) "food with added probiotic ingredients" means food with live
micro-organisms beneficial to human heal th, which when ingested in
adequate numbers as a single F or as a combi nation of cultures, confer
one or more specified or demonstrated health benefits in human
beings;

(g) "functional food" shall have the m eaning assigned to it in section 22 of

the Act;

(h)"health supplements" shall have the mea ning assigned to i t 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;

U) "novel food" sh all have the meaning assigned to it in section 22 of the

Act;

(k) "nutraceuticals" shall have the meaning assigned to i t in section 22 of

the Act;
 (1) "nutritional ingredients" mea ns the ingred ients speci fied in
Schedules other tha n the food addi tives specified in Schedule VA
to Schedule VF, packed and mad e available in a form not for
retail -con su mer use, bu t mea n t for u se in formulating a prod uct
falling u nder va rious categories of these regulations or other
categories specified i n the Food Safety and Standards (Food Prod ucts
Standards and Food Addi tves) Regula tions, 2011;

(m) "nutrient ingredients" mea ns vitam ins, mi nerals, and am ino

acids as specified in
Schedule I and Schedule II;.

(n) "pre-mixes" mea ns a combination of two or more ingredients

specified in the Schedules in a speci fic proportion with or wi thou t
additives, packed and meant for use in formulating a product
falling u nder any category of these regulations or und er the
categories specified in the Food Safety and Standards (Food
Products Standards and Food Add i tves) Regulations, 2011;

(o) "specialty food containing plant or botanical

ingredients" mea ns food which is shown to be containing pla nt
or botanical ingred ients with a history of safe usage; and

(p) "Schedules" mea ns the Sched ules to these regulations.

3. General requirements.- (1) The articles of food sold in capsu le

format, hard or soft or vegetarian, shall com ply with the general
monogra ph and quality requi rements specified for them in Indian
Pha rmacopoeia :

Provid ed that the food busi ness operator may use the approved
colou rs and add itives permi tted in Schedule VF;

Provided further that the food busi ness operator may use the natu
ral flavors or natu re id entical flavou rs or synthetic flavors in
accoradance with the provisions of regula tion 3.3.1 of Food Safety
and Standards (Food Product Standards and Food Additives)
Regulations, 2011.
(2) Forthe purposes of sub-regulat ion (1) the food bu siness operator
may declare the addition of flavou r on labels of such prod
ucts in accoradance wi th the provisions of Food Safety and
Standards (Labelling and Packagi ng) Regula tions, 2011.

(3) The tablets, capsu les and syrups shall ful fil the general quality
requi remen ts and standards as specified in Indian Pharmacopoeia,
Bri tish Pharmacopoeia or Uni ted States Pha rmacopoeia.

(4) The quantity of nutrients added to the articles of food shall not
exceed the recommended daily allowance as specifi ed by the
Indian Council of Med ical

3
 Resea rch and in case such standards are not specified, the standards
laid down by international food standards body, namely, Codex
Ali mentarius Commission, shall apply.

(5) In case of food prod ucts falling u nd er heal th supplement

categories, the individual nutrien t content shall not be less than
fifteen per cent of the recommended daily allowance where a nutri
ent content clai m is bei ng made:

Provided that, if claim of higher nu trient content is made, the

nutrient conten t shall not be less th an thirty per cent of the recom
mended daily allowance.

(6) For the articles of food specified in these regulations, the Food
Authori ty may permi t the food business operator to add food
colou rs subj ect to the level restrictions as mentioned in Food
Safety and Standards (Food Product Standard s and Food Ad
ditives) Regulations, 2011.

(7) The articl es of food with standard nutrient or n utri tionally

complete formulation shall consist of a composi tion delivering
the desired level of energy, protei n, vitamins and minerals, and
other essentia l nutrients required for respective age grou p, gender
and physiological stage in accorda nce with the guidelines made by
the Indian Cou ncil of Medical Resea rch.

(8) The pu rity criteria for the ingred ients used i n the categories of
articles of food covered u nder these regulations shall be as
determined and notified in the officia l gazette by the Food Authori
ty from time to time.

(9) In case such standards are not specified, the purity criteria
generally accepted by pha rmacopoeias, namely, Ind ian Pharmaco
poeia, Ayu rvedic Pharmacopoeia of Ind ia, releva nt Bureau of Indian
Standards Speci fications, Quality Standards of Indian Medicinal
Plants, Ind ian Cou ncil of Medical Reseach, British Pharmacopoeia,
U nited States Pharmacopoeia, Food Chemical Codex, Joint Food and
Agricul ture Organization or World Health Organisation Expert
Committee on Food Ad ditives or CODEX Alimenta rius may be
adopted by food Business operators.
(10)The food busi ness operator shall intimate the purity criteria
adopted for ingredients to the Food Authority incl uding any change
when adopted.

(11)The tolerance limit for variation in case of articl es of food

covered in these regulations duri ng analysis of samples of
finished products, shall not be more than (-) ten per cent from the
declared val ue of the nutrients or n utritional ingredients on the
label .

4
(12)The m anufactu ring of ingred ients and prod ucts covered under
th ese regulation s shall be carried out in com pliance with the
established good manufactu ring practi ces.

(13) For purposes of these regulations, any of the ingred i ents specified
i n Schedule I, Schedule II, Schedule Il l, Schedule IV, Schedule
VI, Schedule VII, and Schedule VIII may be u sed in food in
accordance with the provisions of these regulations, and for the said
pu rpose, may use additives as applicabl e to categories specified
in Schedule VA to Schedule VF.

Explanation 1.- For the purposes of these regulations food or

i ngredients referred to i n Food Safety and Sta ndards Regulations,
2011, and for which sta nda rds are provided, and the pla n ts and
botanicals specified in Schedule IV of these regulations offered in
normal or natu rally occu rring forms shall not constitute a health
supplement or nutraceutical, or food for special dietary use or food
for special med ical purpose.

Explanation 2.- Mere food forms such as vegeta bles, namely, bhi
ndi, ka rela and other vegetables; cereals, namely, ragi, jowar,
millets and other cereals; legumes, na mely, rajmah and other legu
mes; spices, namely, pepper, jeera, tu rmeric and other spices; fruits,
nam ely, amla, jamu n, grapes and other fru i ts; and other plants or
botani cals, mini mally processed (cleaned, de-weeded, sorted, dried or
powdered), in either as juice or cooked form, shall not constitu te
'health su pplement' or 'nutraceu tical' or 'food for special dietary use'
or 'food for special medical purpose'.

(14)The formulation of articles of food shall be based on the pri nciples

of sou nd medicine or nutrition and supported by validated scientifi c
data, wherever requ i red.

No hormones or steroids or psychotropic ingred i ents shall be

(15)
added in any of the articles of food specified i n these regulations.

(16)The label on articles of food shall specify the purpose, the

target consu mer group a n d the physiological or disease cond
itions which they address, recom mended duration of use, and the
speci fic labelling requirements as mentioned against each type of
article of food.

(17)The label, accom panying leaflet or other labell ing and

advertisement of each type of article of food, referred to in these
regulations shall provide sufficient i nform ation on the nature and
pu rpose of the article of food and d eta iled instructions and
precautions for its use, and the format of i nformation given shall be
appropriate for the intended consu mer.

(18)An article of food which has not been particularly mod ified in
any way bu t is su itabl e for use in a particula r dietary regimen becau
se of i ts natural composition, shall not be designated as 'health
supplement' or 'special dietary' or 'special dietetic'
5
 or by any other equivalent term, and such food may bear a statemen
t on the label tha t 'this food is by its natu re X' ('X' refers to the
essential distnguishing characteristic as demonstrated by the
generally accepted scientific data), provided that the statement does
not mislead the consumer.

(19) The Food Au thority may suspend or restri ct sale of such articles
of food as have been placed in the market that are not clearly
distinguishable from articles of food for normal consum ption and
are not suitable for their claimed nu tritional purpose, or may
endanger hu man heal th, in accordance with the provisions of the Act.

(20) The Food Authority may, at any time, direct a food busi ness
operator manufacturi ng and selling such special type of article of
food, to furnish details regard ing 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 vita mins and mi nerals
are added to an article of food or in a food format.

(22)The labelling on the article of food shall be i n 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
Standard s (Contami na nts, Toxins and Resid ues) Regulations, 2011.

(24) No person shall manufacture, pack, sell, offer for sale, market
or otherwise d istribute or import any food products referred to in
these regulations unless they comply with the requ irements laid
down in these regulations.

(25) Whoever contravenes the provisions of these regulations shall

be liable for punish men t provided u nder Chapter IX of the Act.

4. Claims. - (1) Every food business operator may make

nutritional or heal th claims in respect of an article of food.

(2) For the purposes of sub - regulation (1), a n utritional claim shall
consist of the 'Ingredients (nutrient or nutritional) content' of an
article of food which shall be subject to the nu trition a l su
pplement requirements specified in Schedule I, Schedule II,
Schedule Il l, 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

6
 Exists between the constituent of that nutrient or nu tritional, h
ealth, and specific disease cond itions.
(4) The health claim in respect of an article of food consists of th
e follow ing two essen tia l components, nam ely:-

(i) nutrien t or nu tritional ingredients; and

(ii) h ealth related benefits.

(5) The health claim in respect of an article of food may i ncl ude the
followi ng types, but not limited to

(i) ingredients (nutrient or nutritional) fu

nction claims; (i i) enhanced function
claims;
(iii) disease risk red uction claims;
(iv) health maintenance claims;
(v) im mu nity cla ims - 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 th e Food Authori ty.

(7) The health claims in respect of an article of food shall be

commensu rate with the adequate level of docu m entation and
valid proof made availa b le for review by the Food Au thority
when called for.

(8) To claim ingred ients, n u trient or nutritional, in respect of an

article of food for enhan ced function and disease risk reduction,
regard shall be had to-
(i) claims tha t led to ingredien ts (nutrient or nu tritional);
(ii) available scien tific literature i ncl udi ng official traditional
texts and post market data or consu mer studies or cohort
or retroactive studies based on eating pattern and h ealth
benefi ts, epidemiological in ternational and national data,
and other well documented data;
(iii) consensual, congruen t and concurrent vali dity stu d ies;
(iv) h ealth promotive and disease risk reduction based
on proof from l i teratu re and human data of efficacy and
safety of the n utrient;
(v) not only controlled clinical trials for efficacy and safety
data; bu t also nutraepidemiologi cal data;
(vi) quali fied structure function claims for speci fic organ or
function wh ich are comprehensi ble to consumer;
(vii) proh i bi tion of im pl ied claims for curing disease or
claims of drug like efficacy such as 'Prevents bonefragi lity
in post menopausal women';

7
 (viii) ) prohibition of implied cure for d isease claims by the name
of the product such as cancer cu re or through pictu res,
vignettes or symbols, namely, electroca rdiogram traci ng,
lipid profile; and
(ix) for stru cture-function claims, a case-to-case basis consumer
inform ation for specifi c age or gender or vul nerable
population .

(9) (i) For the prod uct led claims in respect of an article of food
based on hu man studies with evidence based data, regard shall be
had to-

(a) valid data and suita ble statistical design proving the
benefit for disease risk reduction, that is, human in tervention
studies;
(b) ingredient, tha t i s, nu trient or nutritional;
(c)the prod uct compa tibility for the proposed claim benefit
and suitable qualifiers such as heart healthy claim on polyu
nsaturated fatty acids;
(d)the use of word "shown" as depicted in the exam ple
below when a single hum an interven tion study shows
significan t benefit:
"Product <Name of the Prod uct> is 'shown ' to be helping
in <keeping your hea rt healthy> or <heart healthy>:
(e) theu se of word "Proven" as depicted in the example
below when more tha n one h um an intervention studies or
epidemiological evidence on Ind ian population have been
provided with concu rrent validity:
"Prod uct <Na me of the Prod uct> is ‘proven’ <to make
you l o s e weig ht>:
(ii)For health claims where scientific support does not exist, or if a
novel i ngredient is to be introd uced, there shall be a prior
approval of the Authoi ty which shall be based on adequate
scientific evidence.
(iii) If
the health claims are prod uct led, the food business operator
shall notify to the Food Authority before putting the same in the
market, by submi tting relevant documents along with a copy of the
label.
5. General principles for query or challenge.-The food busi ness operator
shall-

(i) prepare and make available the compreh ensive produ ct

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 experien ce of the
reviewer as an essential pa rt of the docu ment;

8
 (iii) clarify, in case of a technical query from the Food Authori ty
or on a publi c com plaint lodged with the Food Authority, and
assist the rood Au thori ty to examine or authorise an appropri
ate expert group to review the case; and
(iv) Alter or modify or stop claim when d irected by the Food
Authori ty which shall be based on the opinion of an expert
group.

6. Health supplements.- (1) (i) Health supplements may be u sed

to supplement the normal diet of a person above the age of five
years.

(ii) the health supplements shall contain concentrated sou rce of

one or more n utrients, namely, amino acids, enzymes, minerals,
protein s, vi tamins, other dietary
(iii) substances, plants or botanicals, prebiotics, probiotics and
su bstances from animal origin o r other similar substances with
known and establi shed nutritional or ben eficial physiological
effect, which are presented as such and are offered alone or in
combination, bu t are not drugs as defined in the clau se (b) of
section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and
the rules made thereunder.

(iv) the health supplemen ts shall be marketed i n single u se packa

ging as appropriate to maintain in tegrity and quality of the prod u
ct, or in dosage forms namely, capsules, tablets, p ills, sachets; jelly
or gel, semi-solids and other sim ilar forms or any other forms of
liquids and powders designed to be taken in measured unit
quantities.

(v) the health supplements shall not incl ude any of the food prod u
cts or categories of articles of food for which specific stand ards
h ave been laid down in any other parts of these regulations.

(2) (i) The health supplements shall con tain any of the ingred ien ts
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- regula tion (2) may be used in manufactu ring of health
suppl ements without prejud ice to modifications for on e or more
of these nutrients rendered necessary by the intended u se 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 Cou n cil of Med ical Research and in case such standards
are not specified, standards laid d own by the i n ternational food
standards body, na mely, Codex Alimenta rius Com mission shall
apply.

9
(iv) The food business operator shall apply to the Food Au thori ty for
incl usion of any new nutrien t or other substance with a nutritional
or physiological function, which has no history of use in Ind ia or
that wi thout evidence, establishi ng that the nutrient may resul t in
certain n u tritional and physiological benefits with ju stifica tion
for approval.

(v) The Food Au thority may, after proper scientific evaluation, specify
the nutrients approved by i t 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 h uman disease, or refer to such prop erties;

(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 Authori ty if the statement is supported by the
generally accepted scientific data;

(iii) Every package of health supplement shall carry the followi ng i

nforma tion on the label, na mely.-

(a) the words "HEALTH SUPPLEMENT";

(b) the com mon name of the health supplement, or a description

sufficient to indicate the true nature of the h ealth su
pplement includ ing the common na mes of the categories of n
utrients or substances that characterise the product;

(c) a declaration as to the amount of the nutrients or

substances with a nutritional or physiological effect present in
the prod uct;

(d) an advisory warning 'NOT FOR MEDICINAL USE' prominently

written;

(e) the quantity of nutrients, where applicabl e 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

10
 (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.-
(i) The nutraceuticals shall provide a physiological benefit and
help maintain good health.

(ii) A food busi ness operator may extract, isolate and purify nu
traceuticals from food or non-food sources, tha t is preparing amino
acids and their derivatives by bacterial fermentation under
controlled conditions.

(iii) A food busi ness operator may prepare and sell the nutraceu
ticals 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
measu red unit quantities except those formats that are mea nt for
parenteral administration .

(2) (i) The nu traceu ticals shall contain any of the ingred ients specified
in Schedule I
or Schedule IIor Schedule IV or Schedule VI or Schedule VII or
Schedule VIII.

(ii) A food business operator may use ingred ients specified in the
Sched ules referred to in clause (i) of sub-regulation (2) in
manufacturing an article of food containing nutraceuticals without
prejudice to mod ifications for one or more of these nutrients
render ed necessary by the intended use of the prod uct;

(iii) The quantity of nutrients added where applicable, shall

not exceed the recom mended daily allowance as specified by
the India n Cou ncil 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 Ind ia or in any other country, shall
be manufactured or sold i n Indi a only on prior approval of the
Food Authority;

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

(vi) The Food Authority may from time to time specify the nu traceu
ticals as approved by it after undertaking proper scientific
evaluation.

11
(3) (i) No ingredient other than those specified in Schedule VI shall be
used as n utraceutical with standardisation to marker compounds
specified and at daily usage levels specified therein;

(ii) The ingred ient for which the standardisation of the marker cou m
pound 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 mini mum and maxim um
usage levels have not been specified, the food busi ness operator
shall adopt the usage level based on relevan t scientific data and
retai n 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 ingred ient 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 h uman disease, or refer to such properties ;

(ii) The statement by the food busi ness opera tor relati ng to the
structure or function or the general well-being of th e body may be
allowed by the Food Au thority, if the statemen t is supported by the
generally accepted scientific data;

(iii) Every package of food containi ng nutraceutical shall carry the

following information on the label, namely:-

(a) the word ' N UTRACEUTlCA L";

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

(d) where it is appropriate, the quantity of nutrient shall be

expressed in terms of percentage of the relevant recommended
daily allowances as specified by the Indian Council of Med
ical Research even when the nutrient is present along with a
nu traceutical as an adjunct and shall bear an advisory warning
'Not to exceed the stated recommended daily usage';
12
 (e) an advisory warning for 'recommended usage';
(f) an adv i sory warning 'NOT FOR M ED ICINAL USE' promi nently
written;
(g) an advisory warni ng in cases where a danger may exist with
excess consumption;

(h) an advisory warning or any other precau tions to be taken

while consuming, known side effects, if any,
contraindications, and product-drug interactions, as
applicable;

(i) a statement that the prod uct is required to be stored out of

reach of children;

(5) No food business operator shall use additives for nu traceutical

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 busi ness 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 beca use of certain
physiological or specific health conditions, namely:-

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

(b) pregnant and lactati ng women; and

(c) Geriatric population and celiac disease and other health

conditions.

(ii) The food business operator shall clearly indi cate on the label
whether or not the food for special dietary use is to be taken u nder
medical advice;

(iii) A food business operator may manufacture or sell an article of food

for special dietary use in single use packagi ng or in dosage form,
 namely, granules, capsul es, 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 u ni t
quantities wi th a nutritional or physiological effect;

(iv) A food busi ness operator may formulate an article of food for
special dietary use in formats meant for oral feeding through
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 wh ich is merely enriched or mod ified with nutrien ts
and meant for mass consumption, intend ed for improvement of
general health for day to day use and do not claim to be targeted to
consumers with specific d isease cond itions and also not include

13
 the article of food intended to replace complete diet covered
under food for special med ical pu rpose specified in regulation 9.

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

(ii) A food business operator may use the ingred ients specified in the
Schedules referred to in cla use (i) of sub-regul ation (2) in
manufactu ring food for special dietary use withou t prejudice to
mod ifications for one or more of these nutrients rendered
necessary by the intended use of the prod uct.

(iii) For any new nutrient, which has no history of use in India or that
without a proof establishing that the n u trient may resul t in certain
nutritional and physiological benefi ts, 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 i t after proper scientific evaluation.

(iv) A food busi ness operator may add the quantity of the nutrients at
a level higher tha n the recommended daily allowa nce, bu t not
exceedi ng the limits of vi tamins and mi nerals 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 slimmi ng, weight
management and weight control purposes shall comply with the
following, na mely:-

provide energy not less than 800 kcal (3,350 kJ) and not
(a)
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 presen ted as a repl acemen t for one or more meals of
the daily diet shall comply with the following, namely:-
 (a)provide energy not J ess 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 i n take shall not exceed
1,200 kcal (5,020 kJ).

(iii) Not Jess than twenty five per cent and not more than fifty per cent
of the energy availa b le from the food, when ready-to-serve, shall be
derived from its protein conten t and the total amou n t of protein shall
not exceed 125 g per day.
14
(iv) The quality of protein shall have-

(a)the protein d igestibil i ty corrected amino acid score of

1.0 known as,the reference protein;

(b) the protein digestibili ty corrected amino acid score where

less tha n 1.0, the minimum level shall be increased to
compensate for the lower protein quality;

(c)the protein with a protein digesti bili ty corrected amino acid

score of 0.8 or more shall be used in a formula food for use in
a weight control diet; and

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

(vi) Not more than thirty per cent of the energy available f r o m 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 reccom
mended daily allowance of vitamins and mineral s in the daily
intake.

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

(3) (i) No statement or claim shall be made on the label im plyi ng

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 tem porar ily, unless otherwise approved by the
Food Au thority;

(ii) The statement by the food busi ness operator relating to the
structure or function or the general well-bei ng of the body may
be allowed by the Food Authority, if the statement is supported
by the generally accepted scientific d ata;
(iii) Every package containing food for special dietary use shall
carry the following i nformation on the label, nam ely:-

(a) The words "FOOD FOR SPECIAL DIETARY USE" followed

by "Food for........." (mentioning the pa rticular physiological
or health condition)";

(b) a statement "For weight control and management" in close

proximi ty to the name of the articles of food specially prepa
red for weigh t ma n agemen t and control;

(c) a statement that the prod uct is not to be used by pregnant,

nursi ng and lactating women or by infants, children,
adol escents and elderly, except wh en medically advised;

15
 (d) a statement on the target consumer group, rationale for use
of the product and a description of the propertie s or
characteristics that make it useful;

(e) if the product has been formulated for a specific age

group, a prom inent statement to that effect;

(f) a statement specifying the nutrient which is red uced,

deleted, increased or oth erwise modified, relating to
normal requirement, and the rationale for the red uction,
deletion, increa se or other mod ification;

(g) an advisory wa rning 'NOT FOR M EDICI NAL USE'

prominently wri tten;

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

consumption;

(i) a warning that the prod uct 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;

(I) information on osmolality or osmolarity or on acid-base

balance where appropriate ; and

(m) a statemen t that the product shall be stored out of reach of

child ren.

(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 specal
medical purpose shall include food specially prepa red for
 weight reduction and intended as total replacement of norm a l
diet.

(ii) A food business operator may formulate food for special

medical purpose in format meant for oral feeding through en
teral tubes.

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

(iv) The articles of food for special m edical purpose, other tha n
those i ntended for infa nts, may either be nu tritionally complete
food which, when used in accordance wi th the man ufacturer's
instructions, shall constitu te the sole source of nourishment
for th e persons for whom they are intended or nutritionally

16
 incom plete food with formu lation speci fic for a disease,
disorder or medical condition, but are not suitable to be used as the
sole source of nou rish ment.

(v) For the purposes of these regula tions, the food for special med ical
pu rpose may be classified in to following three categor ies, namely:-

(a) 'nutritionally complete food wi th a standard nutrient

formula tion', wh ich when used in accordance wi th the ma
nufacturer 's instructions, may con stitute the sole source of
nourishment for the perso ns for whom they are intended;
(b) 'nutritionally complete food with a n u trient-ado pted
formulation specific for a disease, disorder or med ical cond
ition', which when used in accordance with the manufactu
rer's instructions, may constitu te the sole source of
nourishment for the persons for whom they are i n tended; and
(c) 'Nutritionally incomplete food with a standard formulation
or a nutrient- adopted formulation specific for a disease,
d isorder or medical condi tion', which is not Sui table to be
used as the sole source of nou rishment.
Note.- the food specified in sub-clauses (b) and (c) of clause (v) may be
used as a partial replacement or as a supplemen t to the person's diet.

(2) (i) Food for special med ical purpose shall contain any of the ingred
ients 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 busi ness operator shall use only the i ngredien ts specified in
the Schedules referred to in clause (i) of sub-regulation (2) in
manufacturing food for special med ical purpose without prejud ice
to modifications for one or more of these nutrients rendered
necessary by the intended use of the product.

(iii) A food busi ness operator may apply to the Food Author ity for any
new n u trient, which has no history of u se in Ind ia or those without
proof establ ishing tha t the nutrient may resul t in certa i n
nutritional and physiological benefi ts with ju stification for approva
l and the Food Authority may from time to time specify the nutrients
 approved by i t after proper scientific evaluation.

(iv) The articles of food specially prepa red for weight reduction and
i ntended as total replaceme nt of complete d iet shall, apart from
complyi ng wi th Schedule Ill, shall also ensure the following,
namely:-

(a) that a formula food for very low energy d iet i s prepared
according to instructions, with a daily energy intake of 450-800
kcal as the only source of energy;
(b) that not less tha n 50g protein with a protein digestibility
corrected am ino acid score of 1 is present in the
recommended daily intake of energy, and
17
 essential amino acids may be added to improve protei n
quality only in amou nts necessary for this pu rpose;
(c) for the purposes of cla use (b) the food busi ness operator
shall add only L- forms of essential amino acids except for
methioni ne where DL form is allowed.
(d) very low energy diet provides not less tha n-
(I) 3 g of linoleic acid; and
(II) 0.5 g a-linolenic acid in the recommended daily
intake with the a- linoleic acid and linolenic acid ra
tio 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) ln food for special medical purpose, n utrients may be added at

levels higher than the recommended daily allowance, but not
exceeding the limits of vita mins and mi nerals as specified in
Schedule IlI.

(3) Every package of food for special medical pur pose shall carry
the following information on the label, namely:-

(a) the words 'FOOD FO R SPECIAL MEDICAL PU RPOSE'

pri nted in the im mediate proxi mity of th e name or brand
name of the product;
(b) an advisory warni ng "RECOM MEN DED TO BE USED
UNDER MEDICAL ADVICE ONLY" appeari ng on the label
i n bold letters i n an area separated from other written, pri
nted or graphic informa tion;
(c) the statement "For the dietary ma nagement of " ( with
the blank to be filled in with the specific disease, disord eror
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 su bject to i ts approval by the Food Au thori ty;
(d) a statement 'NUTRITIO NALLY COMPLETE' if the food is
intend ed to be used as a n utri tionally complete food;
(e) a statement on the rationale for use of the prod uct by the
target consumer group and a description of the properties
or characteri sti cs that make i t useful;
(f) a statement if the prod uct has been formulated for a specific
age grou p;
(g) a statement specifying th e nutrient which have been
redu ced, deleted, in creased or otherwise mod ified,
relatiing to norm al requirements, and the rationale for th e
red uction, deletion, increase or other mod ification;
18
 (h) the quantity of n u trients expressed in terms of
percentages of the recommended daily allowances, where it
is appropriate;
(i) i nformation on osmolali ty or osmolarity, Renal Solute Load,
Potentia l Renal Solute Load or acid-base balance, wherever
applicable;
(j) Instructions for appropriate p r e p a r a t io n , feed ing, use and
storage of the product after the openi ng of the container;
(k) a wa rning th at the prod uct is not for parenteral use; and
(I) a statement that the product required to be stored out of reach
of children.

(4) No food busi ness operator shall use additives for food for special
med ical 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 med
ical pur pose for use by general public.

10. Food with added

11. 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

ingred ients shall be 2 x10 power of 8 CFU/g:

Provided tha t a lower viable number may be specified with proven

studies on health benefits with those numbers subject to the prior
approval of the Food Au thority.

(iii) The Food Authori ty may, from time to time, speci fy the probiotic
microorganisms approved by it after proper scientific evaluation:
 Provided tha t the presence of the common ly used starter cultu res
of lactic acid prod uci ng bacteria such as Lactococcus spp., earlier
known as Streptococcus spp., Lactobaci/Jus spp. and other such
microorganisms used in the preparation of fermented milk (dahi)
and related products shall not be considered as prob iotics, if the
probiotic properties have not been substa ntiated.

Note. The guidelines issued by the Inda i n Council of Medical Research and Department of
Biotechnology with respect to probiotics provide add i tional i nformation on their use.

19
(2) (i) The labelling, presenta tion and advertisement shall not claim
that the probiotic food has the property of preventing, treating or
curing a human d isease, 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 Au thori ty, 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 "PROBIOTI C FOOD" ;
(b) gen us and species incuding strain designation or culture
collection number, where applicable, in brackets where
probiotics are mentioned in the list of ingredients;
(c) viable numbers at the end of the shelf-life of probiotic strain
correspondi ng to the level at which the efficacy is claimed;
(d) the recommended serving size which shall deliver the effective
viable dose of probiotics related to health claims and
recommend edduration of use, proper storage temperature
conditions, and time limt for 'Best Use' after opening the
container;
(e) an advisory wa rning 'N OT FOR MEDICINAL USE' prominently
written; and
(f) awarning or any other precaution to be taken while
consumi ng, known side effects, if any, contraindications, and
product-drug interactions, as applicable.
(3) No food business opera tor shall use additives in probiotic
preparations except those specified in Schedule VA to Schedule
VF.

12. Food with added prebiotic ingredients.- (1) (i) No food

busi ness operator shall use prebiotics in manufactu ring food containing
prebiotics except those specified in Schedule VIII or those prebioti cs
approved by the Food Au thority from time to time.

(ii) The prebiotic component, not an organism, to which the claim of

 being made, shall be characterised for a given prod uct by providi
ng the source, origin, pu ri ty, chemical composi tion and structure,
vehicle, concentration and amou n t in which it is to be delivered to
the host.

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

20
(ii) The statement by the food business operator relati ng to structure
or function or the general well-being of the body may be allowed
by the Food Authori ty, 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 "PREBIOTlC FOOD";

(b) name of prebiotic;
(c) the suggested or recommended serving size which shall
deliver the effective dose of prebiotic related to the health
claim;
(d) an advisory warning 'NOT FOR MEDICINAL USE' promi nently
written;
(e) Awarning or any other precau tions to be taken while
consumi ng, 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.

13. Special ty food containing plant or botanical ingredients

with safe history of usage.- (1) (i) A food busi ness operator
shall use only plant or botanical ingredients specified in Schedule
IV for the prepa ra tion of specialty food containi ng plant or
botanical ingredients.

(ii) The plant or botanical ingredient which is not specified in these

regulations but i ts safety has been established in India or in
any other country, may be man ufactured or sold in India only
after taking prior approva l of the . Food Au thority.

(iii) The application for approva l to the Food Au thority shall be

accompanied by documented history of usage of at least fifteen
years in India, or thirty yea rs in the country of origin.
(2) The health supplement or nu traceutical or food for special dietary
use or food for special medical pu rpose may contain the ingred ient
as specified in Schedule IV, form ula ted either alone or in
combination of ingredients or botanicals or their extracts either in
unprocessed or in approved processed forms, formulated i n a regula
r or conventional food format such as liquid or syrup, suspension
or powder, granule, tablet or capsule or any other format approved
by the Food Au thority.

21
(3) (i) Every ma nufactu rer or importer shall prepare and maintain a
product information file, which shall contain information on the
ingredients from Schedule IV used, finished prod uct quality
confirmation, and the test methods to demonstrate the presence of
the active ingred ient in the food.

(ii) The usage level of the specialty food containi ng 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 opera tor shall seek
prior approval of the Food Au thority by submitti ng-

(a) a product information file containi ng informa tion on

the material used;

(b) quality confirmation, test methods to demonstrate the

presence of the ingredient in the food;

(c) releva nt published literature providing scientific and

technical information of the material or prod uct related
to safety and health benefi ts; and

(d) any human intervention study pu blished or

conducted, and other relevant inform ation.

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

(v) The prod uct information file shall prim arily consist of tech nical
and scientific information covering the followi ng, na mely:-

(a) information on quality of all raw ingredients with official

scientific or bota nical name;
(b) details of formulation or block diagram and brief
 description of the processing m ethods or steps adopted;
(c) shelf life study data;
(d) quality specifica tions and test methods for analysis of the
finished prod uct;
(e) safety and pharmaco logical inform ation, literatu re base,
and additional study, if any cond u cted;

22
 (f) i nformation on human studies, i f any;
(g) regulatory status in other countries, if any; and
(h) Any other relevant prod uct informa tion.
(4) No food business operator shall use additives for preparation o f
specialty food containing plant or botanical i ngred ients 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 h uman consum ption; or

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

(c) a food or ingredient obtained by new tech nology with innovative

engineeri ng process, where the process may give rise to
significant change in the com posi tion or structu re or size of the
food or food ingredients which may alter the n utritional value,
metabolism or level of undesirable substances.

(ii) No novel food shall be m a n u f a c t u r e d or i m p o r t e d f o r

commercial p u r pose withou t the prior approval of the Food
Authority by filing an application along with all relevant
documents and details as specified by the Food Au thority from
time to time.

(2) The labelling of novel food shall be-

(i) in accordance with the specific labelli ng requi rements, if

any; or

(ii) specific to claims relating to the novel prod uct; or

) as per the category notified by the Food Au thority

(iii)
in the s p e c i f i c regulations.
23
 '
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 Components

A. Minerals
Vitamins-
1. Vitamin A (i) Retinol - all trans retinol
(ii) Retinyl acetate
(iii) Retinyl palmitate
2. Provitamin A (i) Beta-Carotene
3. Vitamin 81 (i) Thiamine chloride hydrochloride
(ii) Thiamine mononitrate
3. Vitamin Bz (i) Riboflavin
(ii) Riboflavi n S'- phosphate, sodium
4. Vitamin Be; (i) Pyridoxi ne hydroch loride
(ii) Pyridoxal S'-phosphate
5. Vitamin 812 (i) Cyanocobalamin
(ii) Hyclroxocobalamin
6. Vitamin C (i) L-ascorbic acid
(ii) Sodium-L-ascorbate
(iii) Calciu m-L-ascorbate
(iv) Potassiu
(v) m-L-ascorbate
6-palmitoyl-L-ascorbic acid
(vi) Ascorbyl palmitate
7. Vitamin D (i) Vitamin 03 (cholecalciferol) - Anima l
(ii) source
Vitami n Dz (ergocalciferol) - Plant
Vitamin E (i) source
D-alpha-tocopherol
8.
(ii) DL-alpha-tocopherol
(iii) D-al pha-toco pheryl 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
9. Vitamin K1 (i) Phylloqui none
(ii) Phytomenadione (2-methyl 3-phytyl-1)
(iii) 1,4-napthoqu i none

24
S.No. Vitamins and Components
Minerals (iv) Phytonamid ione

9. Vitamin K2 (MK-7) (i) Menaqui none

10. Vitamin l{z (MK-4) (i) Menatetrenone
12. Biotin (i) 0-biotin
13. Folic Acid (i) n-pteroyl-1-glutamic acid
14. Niacin (i) Nicotinic acid
(ii) Nicotinamide
(iii) Nicotinic acid amide
15. Pantothenic acid (i) 0-pantothenate, calcium
(ii) 0-pantothenate, sodium
(iii) 0-panthenol
(iv) OL- panthol nol
(v) Sodium-0 -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 produ cts shall
make a declaration of the same as "appropriate overages added" in the
composition declaration Panel.

B. M inerals (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) Calci um oxide
(ix) Calciu m phosphate, monobasic
(x) Calcium phosphate, dibasic
(xi) Calcium phosphate, tribasic
(xii) Calcium sulphate
(xiii) Calcium from algal source (Algus
(xiv) calcarius)
Calcium lactate
2. Chloride (i) Calcium chloride
(ii) Choline chloride
(iii) Magnesium chloride
(iv) Mangan ese chloride
25
S.No. I Vitamins and Minerals Comoonents
(v) Potassiu m chloride
(vi) Sodium chloride
3. Chromium (i) Chromium (III) chloride
(ii) Chromiu m (II I) sulphate
4. Copper (i) Cupric carbonate
(ii) Cupric citrate
(iii) Cupric gluconate
(iv) Cupric sulphate
(v) Copper lysine complex
5. Iodine (i) Sodium i o d i d e
(ii) Sodium iodate
(iii) Potassi um iodide
(iv) Potassium iodate
6. Iron (i) Ferrous succinate
(ii) Ferrous citrate
(iii) Ferric ammonium citrate
(iv) Ferrous glu conate
(v) Ferrous fumarate
(vi) Ferric sodium di-phosphate
(vii) Ferrous lactate
(viii) Ferrous sulphate
(ix) Ferric di-phosphate
(x) Ferric saccharate
(xi) Ferrous bis glycinate
(xii) Hydrogen redu ced iron
(xiii) Sodium iron EDTA
(xiv) Carbonyl iron
(xv) Ferrous orthophosphate
(xvi) Ferrous sodium pyrophosph ate
(xvii) Elemental iron
(xviii) Electrolytic iron
7. Magnesium (i) Magnesium a p a r t a t e
(ii) Magnesium ca rbonate
(iii) Magnesium chloride
(iv) Magnesium gluconate
(v) Magnesium phosphate dibasic (Magnesium
26
S.No. I Vitamins and Minerals Components
hydrogen ph osphate)
(vi) Magnesium phosphate tribasic
(Trimagnesiu m phosphate)
(vii) Magnesiu m oxide
(viii) Magnesium sulphate
8. Manganese (i) Mangan ese carbonate
(ii) Manganese chloride
(iii) Manga nese citra te
(iv) Magnanese sulphate
(v) Magnan ese 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) Potassiu m ph osphate, monobasi c
(iii) Potassium phosphate, dibasic
11. Potassium (i) Potassiu m bicarbona te
(ii) Potassiu m carbonate
(iii) Potassiu m chloride
(iv) Potassium citrate
(v) Potassium gluconate
(vi) Potassium glycerophosphate
(vii) Potassium lactate
(viii) Potassium monobasic phosphate
(ix) Potassiu m dibasic phosphate
12. Selenium (i) Sodium selenate
(ii) Sodium selenite
(iii) Sodium hydrogen selenite
(iv) Selenomethionine
13. Sodium (i) Sodium bicarbonate
(ii) Sodium carbonate
(iii) Sodium chlo ride
(iv) Sodium citrate (Trisodium citrate)
(v) Sodiu m gluconate
(vi) Sodium lactate

27
S.No. I Vitamins and Minerals Components
(vii) Sodium phosphate monoba sic (Sodium
dihydrogen phosphate)
(viii) Sodium phosph ate dibasic
(disodi u m hydrogen p h o s p h a t e )
(ix) Sodium sulphate

14. Zinc (i) Zinc acetate

(ii) Zinc chloride
(iii) Zinc citrate
(iv) Zinc glu conate
(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 mi nerals may be used

Table C. Permissible overages*

S.No. Micronutrient Overage [per cent)
1. Vi tami n A 30
2. Vi ta m i n C 20
3. Vitami n D 30
4. Vitamin E 10
5. Thiami ne (vi tamin 81) 25
6. Riboflavi n (vitami n 82) 25
7. Niaci n [vitami n 83) 10
8. Vitami n 86 25
9. Vitamin 812 25
10. Folic acid 25
11. Pantothenic acid 10
12. Vitami n Ki 30
13. Mi neral s 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.

28
 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-Asoar tic acid
(ii) L-Histidine hydrochloride (xiii) L-Argin e L-aspartate
(iii) L-Isoleucine (xiv) L-Threoni ne
(iv) L-Isoleuci ne hydrochloride (xv) L- Alanin e
(v) L-Leu cine (xvi) L-Phenylalanine
(vi) L-Leucine hydrochloride (xvii) L-Cyststeine hydroch loride
(vii) L-Lysi ne (xviii) L-Tyrosi ne
(viii) L-Lysine hydrochloride (xix) L-Argini ne
(ix) DL-Methionine (xx) L-Tryptoph an
(x) L-Cysteine (xxi) L-Valine
(xi) L-Cysteine hyd rochloride (xxii) L-Arginine hydrochl oride
B. Non- Essential Amino Acids
(i) L-Carnitine (xv) L- Prali ne
(ii) L-Carnitine hyd rochlorid e (xvi) L-Lycin e-L-glutamate dehydrate
(iii) Carnitine, acetyl-L (xvii) Megnesium L- aspartate
(iv) L-Glu tamic acid (xviii) Calciu m L- glutamate
(v) L-Glutami ne (xix) Potassi u m - L- glu tamate
(vi) Glycine (xx) Carn itine tartrate
(vii) L-1-Iyd roxylysine (xxi) Taurine
·(viii) L-Hyd roxvoroline (xxii) Choline
(ix) L-Lycine acetate fxxiii) Choline chloride
(x) N-acetvl-L-cysteine (xxiv) Choline citrate
(xi) L- Ornithine (xxv) L-Seri ne
(xii) L-Ornithine mono hydro chl (xxvi) Tyrosine, acetyl-L
(xiii) orid e ne -L- aspartate
L-Lyci f xxvii) Choline hydrogen tartrate
(xiv) L-Citru line (xxviii) Myo-inositol
c. Nucleotides
(i) Adenosine 5- (v) Disodiumuridine 5-monoph osphate
monophosphate (AMP)

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

phosphate fCMP) phospha te

(iii) Guanosine 5-mono (vii) Disodiumionosine 5-mono

phosphate (GM P) phosphate

(iv) lnosine 5-mono

phosphate (IMP)

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

29
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 R E) 8.4 43 35 180
Vitamin D (µg) 0.12 0.65 (0.75) 1 0.5 2.5 (3)1
Vitami n I{(µg) 0.85 5 3.5 20
Vitami n C (mg) 0.54 5.25 2.25 22
Thiamin (mg) 0.015 0.12 0.06 0.5
Riboflavi n (mg) 0.02 0.12 0.08 0.5
Vitamin 86 (mg) 0.02 0.12 0.08 0.5
Niaci n (mg NE) 0.22 0.75 0.9 3
Folic acid (µg) 2.5 12.5 10 50
Vitamin B12 (µg) 0.017 0.17 0.07 0.7
Pantothenic acid (mg) 0.035 0.35 0.15 1.5
Biotin (tg) 0.18 1.8 0.75 7.5
0.5/g of polyu 0.5/g of poly
nsatu rated fatty unsaturated
acids expressed as fattyacids
linoleic acid but expressedas
Vi tami n E (mg a-TE) in no case less 0.75 3
linoleic acid but
than 0.1 mg per in no case less
100 available kj 0.1 mg per 100
available kcal
For products intended for children of 1to 10 years of age; NE - Niacin equ ivalent;
(1):

TE - Toco pherol 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)

30
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)1 42 (60)1 35 (50)1 175 (250)1
Phosphorus 7.2 19 30 80
(mg)
Magnes ium (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
Molybdenu m 0.72 4.3 3.5 18
(µg)
(ll: For products intended for child ren of 1to 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)
 31
Schedule - IV
[See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 7.(3)(v), 8.(2)(i),
9.(2)(i), 12.(l) (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 Comm Permitted range of

on usage for adults per
name
day (given in tenns
1. Abelmoschus escu/entus (L.) Moen ch. of raw herb/
Fru it/ Root Bhindi material)
5-10 g (as powder)
z. Abies spectabilis (D.Don) / A. pind row Royle
Leaves Talis 2-4 g (as powder)
patra /
3. Asculus indica colebs./ A. hiooocastanum
Talis bhed
Fruit / kernel Indian 10-20 g
Horse
Chestnut/
4. Abelmoschus moschatus kanar
Seed lata lwsturi 3-5 g

5. Abuti/on indicum (L.) Sweet ssp. Jndicum IA. fruiticosu m

Seed/ Root Ati bala 5-10 g (as powder)

6. Acacia arabica Will d. (Now known as Acacia nilotica (L.) Willd. ex Del. ssp.
indica
Gum
(Benth.) Brenan) Ba bbu la 5-10 g
Stem bark Babbula 5-10 g
7. Acacia catechu
Extract Katha/khair 1-3 g
o. Achyranthes aspera (L.)/ A. bidentala
Seed/Plant Chirchida 3-5 g (as powder)
9. Adhatoda zeylan ica IA. vasalw
Leaf/ Root/Flower Adusa/Vasa 5-10 g
10. Ae,q / e marmelos (L.) Corr.
Unri pe fruit pulp Bae! 5-10 g
Ri pe fruit Bael 50-100 g ras pulp)
Leaves/Bark Bael 5·-10 g (as pulp)
Pather/Ba
el chhal
11. Af u.qa bracteosa wall
Plant N eel Kanthi 2-3 g
12. Alan.qium salvifolium (L.f.) Wang. ssp. sa lvif olium
Fru i t Ankota 10-20 g (as powder )
13. Albizia lebbecl< (L.) Benth/A. Procera/A.odoratissima
Flower Siris
3-6 g (as powder)
Seed Siris 1-3 g (as powder)
Stem bark Siris 3-6 g
Leaf Siris 3-6 g (as powd er)
32
14. A/ pinia ,qa/an.qa
Rhizom e Ku lanjan 2-4 g
15. Allium cepa L. I 10-20 g
Bulb Pyaja 10-20 ml (as jui ce)
Seed Pya ja 1-3 g (as powder)
Leaf Pyaja 20-40 g (as vegetable)

16. Allium sativum L.

Bulb Lahsuna 3-6 g
(Not recommended
duri ng pregna ncy)

Leaf Lahsu na 20-40 g (as vegetable)

17. Allium stracheyi Bakerno
Whole plant Farana 2-3 g
18. Aloca sia 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 jui ce Elua - 0.5 -1 g
M ussabar
20. Altha ea of{icinalis Linn
Flower/Root Resh- 5-10 g (as powder)
21. A/ternanth era sessilis (L.) R. Br. ex DC. I<hatmi
Whole plant Gudarisaga 3-5 g (as powder)
22. Amaranth us gangeticu s L. (Now known as Amaranthus tricolor L.) /
Amaranthus blitum
L.
Aeria l part Lal marsa 10-20 g (as
- Sag leafy
marsa vegetable)
23. Amaranthu s spino sus L. I A. A. hvbrid us L.)
paniculatu
Whol e pla ns tL. Chaulai 20- 30 g (as
Kateli leafy
/ J al Chaulai vegetable)
24. Amomum aromaticum Roxb. I A. aromaticum
Seed Bangiya Ela 2-4 g (as powder)
25. Amomum subulatum Roxb./ A. aromaticum
Fru it Badi Elaichi 1-3 g (as powder)
Seed Badi Elaichi 1-2 g (as powder )
26. Amorpho phal/ us campa nulatus (Roxb.) Blum e ex Decne
Corm J imikanda 20-50 g (as vegetables)
27. Anacardium occidentale L.
Fru it Kernel Kaiu 10-20 g
28. Ana cvclus pvrethum DC.
Root Akarkara 100 - 250 mg (as
powder) (Not
recommended for children
Seed Akarkara 100 -5 years)
below 250 mg (as
powder) (Not
recommended for child ren
29. Anana s comosus (L.) Merr. Pineapple 50-1005 gyears)
below (as
fruit) 50-100 ml
(as juice)
(Not recommended
30. Anethum sowa Roxb. ex Flem. ( N ow known as Anethum .Qraveo / ens L.)
during pregnancy)
Fru it Sowa 3-6 g (as powder (fruit))
Leaf Sowa 10-20 g (as powder
(leaf1)
3
3
31. An,qelica ,qlauca Edgew./An,qe/ica archan,qe/ica L.
Root and Root stock Chara 1-3 g (as powder)
32. Annona squamosa L./A.reticulata /A. m uricata/ A. Cherimola
Frui t pul p Sha reefa / 20-30 g (as fru it pulp)
Shareefa
bhed
Leaf Shareefa 3-5 g (as powder)
(Not recommended for ch il dren
bel ow 16 yea rs)
33. Apiu m / epto ph yl/ um (Pers.) Muell. I A. Graveolens Lin n.
Frui t Ajamod / 1-3 g (as powd
er) Ajm oda bhed
34. Ara chis hvPo.aaea L.
Seeds Chinia 10-20 g
Badam
Seed oil IMungaphali
Mu ngphali 5-10 ml
tail
35. Areca catechu L.
Seed Supari 1-2 g (as powder)
(only to be used after shodha
na
(pu r ifica tion) )
(Not recom m en ded for
children5 yea rs)
below

36. Artemisia absinthium Linn

IWhole pl ant Afsanti n / 3-6 g
Astimisi
a/
37. Artocarpus heterophyllu s Chauhar
Ripe I un ripe fru it
Lam. IKatahal 20-50 g
Seeds Kataha I 5-10 g
38. Artocarpu s lalwocha Roxb.
Ripe Fruit I unri pe fruit Badhal 20-30 g
Seed Badhal 5-10 g
39. Arn ebia nobilis/A.
benthamii
Root Ratanjot 2-4 g
4·0. Asp ara,qus adscend ens
Roxb.
Tuberous root Safed musali 3-6 g (as powder)

4·1. Aspa ra.aus officin alis L.

Root Shatavar 3-6 g (as powd er)
bhed
Tender Shoots Shatavar 20-50 g
bhed
4·2. Aspara.aus racemosus Willd
.Tuberous root Sitawar 3-6 g (as powder)
Tender Shoots Sitawar 20-50 g
4·3. Aspara,qus sarmentosus
Linn.
Tuberous root Badi Shatr 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
4·6. Azadirachta indica A. luss.
Leaf N eem 1-3 g (as powder)
(Not recomm ended for males
and females plan ning to
34
 conceive)
Fru i t Neem 1-2 g (as pu lp)
(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 Ne em 3-6 g (as powder)
47. Bambusa arundinacea (Retz.) Willd.
Tender shoots (You ng leaf) Bansh 20-30 g (as vegeta ble)
Seed Bansh chaval 20-30 g (as powder)
Crystals Bansalochan 0.5-2g (as powd er)
48. Bacopa monnieri
Whole plan t Brahmi 5-10 g (as powder)
Extract Brahmi,qha 1-2 g
49. Basel/ a alba L.
Leaf Poyi Saag 20-30 g (as vegetable)
50. Bauhinia varie.oata L. / Bauhinia vurpurea L. / 8. Tomentosa. Linn
Stem bark Kachnar 3-6 g
/ Sona
Flower / Buds Kachnar 10-20 g (as ju ice)
/ Sona
51. Benincasa hispid a (Thunb.) Cogn.
Fru it Petha, 8hatua 30-50 g (as vegetab l e)
52. Berberis aristata DC./ B. asiatica / 8. Lycium I 8. vu lgaris
Fru it Daruhaldi 5-10 g (as fru it)
Stem extract Rasau nt 0.5-1 g
53. Beta vu f.qaris L.
Tuber Chu kandar 10-20 ml (as ju ice)
54. Boerhaavia diffusa L. (Now known as Boerhaavia repens L. var. diffusa
(L.) Hook.f.) / B. verticillata
Aerial part Saag i tsi t 20-30 g (as aerial parts)
Root Vishkha prs 10-15 g (as root)
55. Bombax ceiba L.
Stem bark SernaI 5-10 g
Flower Serna I 10-20 ml (as ju ice)
Gu m Serna) 1-3 g (as powder)
Root Serna!M 5-10 g (as powder)
56. Bombax malabarica ISa/ maf ia malabarica
usali
Fruit/Flower/Root Semal/Sema 10-20 g
57. Boswellia serrata Roxb. r
Oleoresin Salai guggal 2-4·g
58. Borassus fl abe/lifer L.
Dried inflorescence Tarku 1-3 g (as powder)
Seed pu lp of un ripe fru it l/Taad
Tarku 10-30 g
Exudate of stem I sap Tarkul
l/Taad 100-200 ml (as ju ice)
59. B. vertici// ata /Taad 10-15 g
60. Brassica
Root campestris L. (Now known as Brassica rapa L. so. campestr is (L.)
Clapham)
Seed Sarson 10-20 g (as paste)
Seed oil Sarson 10-20 ml
Leaf Sarson 10-30 g (as leafy
vegetable)

35
61. Brassica jun cea (L.) Czern.
Seed Rai 1-2 g
Leaf Rai 10-20 g (as
leafy
62. Brassica n(qra (L.) Koch. vegetable)
Seeds Bana rasi rai 0.5-1 g
63. Brassica rapa L.
Tu ber Shalgam 20-40 g
Leaf Shalgam 20-30 g ras vegetabl e)
64. Buchanania lanzan Spreng.
Seed Cherou njee 5-10 g ras powder)
65. Butea monosperma
Seed/Gu m/Root/Bark Dhark 3-6 g
66. Bixa orellana Annato Plant 1-3 g
67. Caesalp inia bonducella (L.) Fl em. (Now known as Caesalpinia bonduc (L.)
Leaf
Roxb.) Karanjuv a 2-3 g
Seed Karanju va 2-3 g
68. Cajarws cajan (Linn.)M illsp.
Seed Arahar 30-50 g
/
69. Camellia sinensis Tuvar
Tea leaf / extract Chaya / 1-2 g
Tea
Tea catachins Green
extract 0.5-1 g
tea
70. Canavalia ensiformi s sensu Baker (Now known as Canavalia _qladiata
catechin
riacq.)
Seed DC.) Serna
s 5-10 g
71. Canscora decussata [Roxb.l J .F. an d J .H. Schult.
Leaf Bangiya 2-4 g (as powder)
Sankhapus
72. CaJJ JJaris decid ua (Forssk.) Edgew. pi
Fruit Kareer I 10-20 g
73. Caps icum annum L. va r. annum Dela
U nripe 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. Carico JJavava L.
Ripe fruit Pa pita 50-100 g ras ripe fru i t)
U nripe fruit Papita 30 -50 g (as u nripe fruit)
76. Carissa carandas L.
Fruit Karou nda 5-10 g
77. Carissa spin arum L.
Fruit Karawan 5-10 g
78. Carthamus tinctorius L.
Flower Head Barre 2-4 g fas powd er)
Seed Barre 2-4·g (as powder)
Seed oil Barre -tail 5-10 m l
79. Corum carvi L.
Fruit Syaha j eera 1-3 g (as powder)

36
80. Cassia absus L.
Seed Chaksu 2-5 g
81. Cassia occidentalis L.
Leaf Kasoundi 5-10 g
Seed Kasou nd i 1-3 g
82. Cassia tora L.
Leaf Chakvad / 10-20 g
Chakarma
Seed Chakwad
rd 3-5 g (as powder)
83. Cassia fistula
Fru it pulp Amaltas 10-20 g (as pulp)
Seed J\maltas 2-5 g (as seed)
84. Cassia angustifolia/ C. acutifolia
Seed/leaves Sanay 3-6 g
/
85. Cedrus deodar Roxb. Senn
Seed/Wood/Oil aDevdar 5-10 g /2-4 m l
86. Celosia argentea L. var. argentea
Seed Su rwali / 3-6 g
Safed
murga
87. Celastrus panicula tus
Seed/Oil Malkanguni 5-10 g, (as powder
(seed)) 2-4 ml (as oi\)
88. Centella asiatica (L.) U rban
Leaf/Whole Plant Brahmi 20-30 g (as vegetable)
(Galoatri)
Extract Brahmi 1-3 g
[Galpatr
i)
89. Centratherum anthelminticum
Fru i t/Seed Kali-ji rii 3-6 g
/ Van- ji
90. Chenopodium album L. rii

Whole plan t/leaves Bathua 20-30 g (as

leafy vegetable)

Seed Bathua 2-5 g

91. Chlorophytum borivillianum Musali 5- 10 g
/ C. arundinaceum/C.
tuberosum
92. Cicca acida (L.) Merrill
Fru i t Harfa 10-20 g
rewadi
93. Cicer arietinum L.
Tender leaf Chana / 30-50 g (as
Kalachan leafy
a vegetable)
Seed Chana / 20-30 g
Kalachan
a
94. Cichorium endivia
 Seed kasani 5-10g
95. Cinnamomum tamala Nees and Eberm. I C. wightii
Leaf Tejapatra 2-3 g
96. Cinnamomum zeylanicum Blume [Now known as Cinnamomum verum J . S.
Stem
Presl.)ba rk Dalchini 1-2 g
(Ceylon (Not recommended
during pregnancy)
i)
97. Cissampe los pareria L. var. hirsuta (Buch.-Ham. ex DC.) Forman.

37
 Leaf I Plant Pad hi 10-20 g (as powder)
98. Cissus quadran.qu/aris L.
Aerial part Hadjod 10-20 g (as wet chu
tney (paste))
Stem Hadiod 3-6 g
99. Citrullus co/ ocvnthis (L.) Schard.
Frui t lndarun 0.25-0.5 g (as
/ powder) ( Not
l ndraya recommended during
Citrullus vu/,qaris Schrad. ex Eckland Zeyh. var.fi stu/ osus (Stocks) Stewart
100.
Fruit n
Tinda
ore1mancv)
20-40 g (as vegetable)
101. Citrullus /anatus (Thu nb.) Matsura and Nakai
Fruit pulp Tarbui 50-100 g
Seed Tarbui 3-6 g r
Seed oil Tarbu i 1-3 ml
102. Citrus aurantifolia (Christm. and Panz.) Swingle
Frui t N imbu 3-5·ml (as jui ce)
103. Citrus limon (Li nn .) Burm.f .
Frui t Jameerini bu 5-10 ml [as jui ce)
104. Citrus maxima (Burm.)Merr.
Fruit Chakotara 5-10 m l (as
juice) 30-50 g
105. Citrus medico L.var. med ica (as fruit)
Frui t Bi joura 5-10 ml [as juice)
106. Citrus reticu/ ata Blanc.
Fruit Narang i 30-50 ml (as juice)
107. Citrus sinensis [L.) Osbeck
Fruit Mousami 50-100 ml (as ju ice)
108. Clerodendrum ph lomidis
Whole plant Arani 10-20 g
109. Clerodendrum serratu m
Whole plant Bharangi 10-20 g
110. Coccinia, qrandis (L.) Voigt. I C. indica
Leaf Kundru 5-10 g
phal (Not recom mended for
/ Kun tru children below 5 yea rs)
shak

Stem Kundru 3-6 g [as powd er)

Whole plant Kundru 3-6 g (as
powder) 5-10 ml
Fruit Kun dru (20as-50
juic
g e)(as vegetable)
111. Cocos nucif era L.
Endosperm Nariyal 10-20 g
Water Nariyal jala 100-200 ml
Flower Narival 5-10 g
112. Coccu/us hirsutus (L.) Theob.
Leaf Jalaj amani 10-20 g
113. Coix lacrvma -iobi L.
Seed Gargri 10-20 g
114. Coffea arabica
Seed/Dry/Green Coffea 3-5 g
(Not recommended for
children below 5 vears)
115. Coleusfors lwhlii / C.aromaticus Pathachoo 5-10 g
r, Parn- ( Not recommended for
children below 5 years)
yavani

38
116. Colocasia antiquorum Schott. (N ow known as Colocasia escu/enta (L.)
Rh izome
Schott.) Aru i 20-30 g (as vegeta ble)
(Not recommended for
children below 16 years)
117. Commelina ben.q a/ ensis L.
Whole plant Kausa r 3-6 g
118. Commiph ora wi.Qhtii
Oleoresin Guggal 2-4 g
(Not recommended for
children below 5 yea rs)

119. Commiphora myrrha

Oleoresin Hirabol 2-4 g
( Not recommended for
children below 5 years)
120. Convolvulus p/uricaulis
Whole plant Shank 10-20 g
h- push
121. Corchorus acutan.qu/us Lam. (Now known pi as Corchorus aestuans L.)
Aerial part Chench 10-20 ml
122. Corchorus capsularis L.
Aerial part Narcha 10-20 ml (as jui ce)
123. Corchorus olitorius L.
Aerial part Paiva Saag 10-20 ml (as jui ce)
124. Cordia dichotoma Forst. f .(Cordia wallichii G.Don)
Fru it Lisora 10-20 g
125. Cordia rotthii Roem. And Sch ult. (Now known as Cordia gharaf
(Forssk.) Ehrenb and Asch.
Fruit Chhota 10-20 g
126. Coriand rum sativum L. Lisora
Fru i t Dhaniya 1-3 g (as powder)
Aerial part Dh aniya 10-20 ml (as ju ice)
127. Costus speciosus Kemuk 2-4 g (as powder)
(Not recommended for
children bel ow 5 years)
128. Crataeva nurvala
Fru i t/Bark/leaf Varana 10-20 g
129. Crocus sativus L.
Style and Stigma Kumku 25-50 mg
m (Not recom mended for
children below 16 years)
(Kesar)

130. Cucumis melo L.

Fru i t I Kharbooia I 50-100 g
Seed I Kharbooia I 1-3 g (as powder)
131. Cucumis melo L. var. momordica Duthie and Fuller
Fruit I Phoot I 40-50 g (as vegetable)
132. Cucumis me/o L. var. utilissimus (Roxb.)Du thie and Fuller
Seed I Kakri I 3-6 g
Fru it I Kakri I 50-100 g (as vegetable)
133. Cucumis sativus L.
Seed I Khira I 3-6 g (as powd er)
Fru i t I Khira I 50-100 g (as vegetable)
134. Cucurbita maxima Duch. ex Lam.
Seed I Kashiphal I 5 -10 g
39
 Frui t Kashi phal 50-100 g (as vegetable)
135. Cucurbita pepo L.
Fruit Safed Kad du 50-100 g (as vegetable)
I safed petha
Seed Safed petha 5-10 g (as powder)
136. Cuminum cvminu m L.
Frui t J eera 1-3 g (as powder)
137. Curculi.CIO orchioides Gaertn.
Tuber Kalimushli 3-5 g
138. Curcuma amada Roxb.
Rhizom e Amahaldi 5-10 g (as
fresh) 2-4 g (as
powd er)
139. Curcuma an.Qustifolia
Root Tavkshir 2-5 g
140. Curcuma lon.aa L.
Rhi zome Hald i 2-5 g (as powder)
Fresh Rhizome Hald i 5-10 ml ( as juic e)
141. Curcuma zedoaria Roxb. (Now known as Curcuma aromatica Salisb.)
Rhizome Kachu r 2-5 g ( as powder)
142. Cyamopsis tetra.aonoloba
Pod/Seed/Gum Guar, Gua r 20-30 g (as
powder: gum pod/seed)

5-10 g ( as powder: gu m)
14·3. Cvmbopo.aon citratus
(DC.l Stapf
Whole plant Harichava 1-3 g
144. Cymbo po.Qon coloratus Stapf
Aerial part Man an pu ll u 1-3g
145. CymboJJO.Qon jwara nlwsa (!ones) Schult
Root Lamajja ka 1-3 g
146. Cymbo po, qon martini (Roxb.)WATS.
Whole olant Rosha ghas 1-3 g
14·7. C1111odon dactvlon (L.) Pers.
Leaf Duba 3-5 g
148. Cvperus rotund us L.
Rhizome Nagarm otha 2-5 g
149. Daucus carota L.
Tuberous root Gajar 50-100 g (as
vegetable) 50-100 ml
( as j u ice)
Seed Gajar 1-2 g (as powder)
(Not recommended
during pregna ncy)
150. Desmodium .CIG/1.Cl eticum I D. latifolium
Whole p lant Sarvan 5-10 g
151. Dillenia indica L.
Fleshy fresh sepals (Frui t) Chaita 40-50 g ( as vegetable1
152. Dioscorea alata L. / D. deltoidea
Tuber/Corm Kathalu 10-20 g
153. Dioscorea bulbifera L.
 Tuber Genthi / 20-30 g (as
vegetable) Taradi 5-10 g
(as powder)
Extract Genthi / 1-2 g (as
extract) Taradi
154. Dioscorea esculenta (Lou r.) Burkill
40
 Tuber Su than i 5-10 g
155. Dioscorea penta ph ylla L.
Tuber Kantal u 5-10 g
156. Dip/ezia maxima
Tender shoots Lungru 30-50 g
157. D iospyros pere, qrina Gu rke (Now known as Diosv vros ma/abarica (Desr.)
Kostel)
Ripe fruit Gab 50-100 g
Unri pe fruit Gab 4-8 g (as powd er)
158. Dolichos biflo rus L. (Now known as Vigna unauiculata (L.) Walp.)
Seed Kulathi 30-50 g
159. Dolichos lab/ab L. (Now! mown as Lab/ab pur pureus (L.) Sweet)
Seed 1 Sem
20-40 g (as seed)
Tend er Pod 1 Sem 30-40 g (as vegetable)
160. Echinochloa frumentacea Link
Fruit Sanwa 50-100 g
161. Ec/ ipta pro stata L.
Whole plant Bhangra 3-6 g (as powder)
162. Elettaria cardamomum (L.) Maton
Seed Choti elaich i 250-500 mg (as powder)
163. Eleusine coracana (L.) Gaertn. ssp. coracana
Caryopsis Madua 20-50 g
164. Emblica o{ficinalis Gaertn. (Now known as Phvllanthus emblica L.1
Fruit Anwala 20-30 g (as fresh
/ Amia fru it) 3-6 g (as
powder )
Extract 2-4
5-10gml (as(as
extract)
j uice)
165. Embe/ia ribes Bu rm. f.
Frui t Bhabhira nga 1-2 g
(Not recommended for
females planning to
166. Enicostemma littorale Blume Mamejw a 2-3 g
conceive)
167. Ephedra _qerardiana Wall.
Leaves/Whole plant Somlata 2-5g
168. Euphorbia neriifo lia/ E. pi/osa
Stem (tender) after boiling / Leaf Thuhar 10-20 g (as
stem) 3-5 g (as
leaf)
(Not recommende d for
169. Eurya / e ferox Salish.
children below 5 years)
Seed Makhana 20-30 g (as
seed) 3-5 g (as
170. Eva/ vu/us alsinoides powder)
Plant Vishnukrant 10-20 g
171. Fa,qopyrum esculenttum Moench. a
Seed Kottu 50-100 g
172. Ferula asafoetida L.
Oleo-gum resi n Hi ng 125 mg, Max (as
173. Ficus ben,qhalensis L. powder)
Frui t / Shoots Baragad 40-50 g (as fruit)/ 5-
10 g (as shoots)
174. Ficus carica L. I F. palmata/ F. lacor
Fruit I Leaf Anje er 20-30 g
175. Ficus ,q/omerata Roxb. (N ow known as Ficus racemosa L.)
Frui t / Leaf Gular 20-30 g (as vegetable)
41
176. Ficus hispida L.f.
Frui t Ka thgulara 10-20 g
f
Tender leaf Kathgulara 20-40 ml f as juice)
I<akodumba)
177. Ficus reli.qiosa L.
Fruit Pipal 5-10 g
Tender Leaf Pi pal 5-10 g
178. Flacourtia jan,qomas (Lou r.)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 5-10 g
/
180. Foeniwlum vul,qare Mill. Kangh
Fruit Sounf 5-10 g (as powder)
u
181. Fumaria vaillantii (Lois.) Hook. f. and Thoms. var. indica Haussk. (Now
known as
Fumaria
Leaves indica f Haussk.) Pugsley) Pittapapda 5-10 g
182. Garcinia indica (Thour.) Choisy I G. cambogia
Mature fruit / Butter/ Oil Kokam 10-20 ml (as juice)
5-10 g f as powder)
183. Garcinia pedunculata Roxb. ex Buch.-Ham.
rruit rind Amalbed a 5-10 ml/g
(as ju
184. Gardenia turgida Roxb. (N ow known as Ceriscoides turgida (Roxb.)
ice/Powder)
Tirveng.)
Gum Kha rahar 1-3 r
g as powder)
185. Giselda pharnaceoide s L.
Leaf Bal uka Saga 5-10 g
186. Glycine max f L.) Merr.
Seed Sovabean 20-40 g
187. G/ycyrrhiza .Qlabra L.
Root and Stolon M ulethi 5-10 g fas powder)
188. Gmelina arborea Roxb.
Frui t Gamhari 20-30 g
189. Gmelina asiatica L.
Frui t Badhara 20-30 g
190. Gossypium herbaceum
Seed/ Root Kapas 10-20g
191. Grewia hir_suta Vahl
Root Gulsakari 5-10 g
192. Grewia po pulifolia Vahl (Now known as Grewia tenax (Forssk.) Fiori)
Stem bark I Fruit Ga ngeran 5-10 g (as powder)
193. Grewia tiliaefolia Vahl I G.sclerophylla
Frui t Dhami n 20-30 g
194. Gymnema sylvestre
Plant Gud mar 5-10 g
Extract Gud mar 1-2 g
195. Gynandro psis avnand ra (L.) Briq. (Nowknown as Cleome a vnandra L.)
Seed H urhu r 1-3 g f as powder)
Whole plant H u rhu r 10-20 ml (as ju i ce)
196. Habenaria intermedia
Root tuber, Rhizome Rid hi 3-5 g
197. Hed vchium S/Jicatum Ham ex Smith
Rhizome Kapur- 3-5 g
42
 Kachari
198. H emid esmus indicus
Root I Stem Anantm ula 3-6 g
199. Hibiscus rosa-sinensis L.
Flower Gudaha l 1-3 g (as powder)
(Not recomm ended
during pregnancy)
200. Hibiscus sabdariffa L.
Leaf Patawa 5-10 g (as powder)
Seed Patawa 1-3 g (as powd er)
Ripe calyx Patawa 5-10 g (as powder)
201. Hippo pha e rhamnoides L. I H. salicifolia
Fru i t I Leaf Amlavetasa 10-20 g
Extract Amalvets 1-3 g
202. Hord eum vu/aare L.
Fru it laou 100-200 g (as powder)
Whole plant l aou 10-20 g
203. Hygrophila Sp inosa Makhana / 20-30 g
Tai
204. Hyp ericum perforatum makhana
Leaf Basant 3-6 g
Plant extract Basant 1-1.5 g (as extract)
205. Illi cium verum Hook. f.
Fruit Badiya 250 - 500 mg As powder
n -
Khatai
206. /nu/ a racemosa. Hook
Root Pushkar 3- 6 g (as powd er)
207. J p omoea aquatica Forssk. mool
Leaf Kalamisaag 20-30 g
208. lp omoea batatas (L.) La m .
Tuber Shakarkand 20-30 g
209. lpomoea di,q itata auct. non L. (Now known as J pomoea mauritiana j acq.)
Root/Tuber Bilaikand 3-6 g
210. ju g /ans reaia Linn.
Fru it/Leaf/Bark Akhrot 10-20 g
211. /unip erus communis
Flower /Leaf Hauber 5-10 g
212. la.aenaria vul.aaris Ser. ( Now known as la ienaria siceraria (Mo!.) Standi.)
Fresh fru it Alabu 100 -150 g (as
Seed Alabu 1-3 g (as powder)
vegetable)
213. la.Qerstroemia indica
Leaf j arul 6 - 12 g (as powder )
Fruit extarct Frash 1-2 g (as extract)
214. lagerstroemia pa rviflora
Leaf Sidh 6-12 g (as powd er)
Fru i t extract Sidh 1-2 g (as extract)
215. lens culinaris Med ik.
Seed Masu ra 20-40 g ( as seed)
216. Lepidium sativum L.
Seed Chansur 3-6 g (as powder)
(Not recom m ended
duri ng pregnancy)
Aeri al part Chansu r 50-100 g (as vegetable)
43
217. Leptadenia reticulata (Retz.)W. and A.
Leaf Dodisaka 20-30 g (as vegetable)
218. Leucas cephal otus (Koenig ex Roth) Spreng.
Leaf Guma 20-30 g
219. Limonia acid issima L.
Fruit J<ai th 20- 40 g (as fruit)
220. Unum usitatissimum L.
Seed Atasi 10-20 g
Seed Oil Atasi 10-20 ml
221. Litchi chinensis Sonner
Fruit Litchi 50-100 g
222. luf fa acutan.aula (L.)Roxb.
Whole plant Torai 5 -10 g (as powd er)
Fruit Torai 30-50 g (as vegetab le)
Seed Torai 1-3 g (as powd er)

223. Luf fa cylindrica (L.) M. Roem.

Fruit Nenua 20-40 g (as vegetable)
Seed Nenua 1-3 g (as powd er)
224·. lycop ersicon esculentum Mill. ( Now known as Lycop ersicon / ycop ersicum
FruiKarsten.)
(L.) t Tamatar 20-40 g (as vegetable)

225. M aclhuca indica Gmel. (N ow known as M adhuca longifolia (Koen.)

Macbride var.
latifolia
Flower ) Mahua 10-15 g (as flower)
Fruit Mahua 10-15 g
Seed oil Kovna ka tel 2-5 ml
226. Madlw ca lon.aifoli a (Koenig) Macbride var. lon.aifolia
Flower/ Fruit lal mahua 10-15 g
227. M alva sylvestris L.
Fruit Gu l kha i r 5-7 g (as powder)
Leaf Gu l khai r 3-6 g (as powder)
228. M an,qif era indica L.
Ripe fruit Aam 50-150 g
U nripe fruit pulp Aa m 10-30 g
Seed Kernel Aam Beej 1-2 g (as powder)
/ Majja
Leaf Aam 3-5 g
Extract Ama ra 0.5-1g
229. M aranta arundinacea L. (.qha n)
Rhizome Ararota 10-30 g (as powder)
230. M arsil ea minuta L.
Leaf Chowpatia 20-30 g (as vegetable)
2-4 g [ as powde r)
1-2 g (as extract)
Extract Chowpatia
231. M entha spicata L. M entha arvensis L. I M. aquatica Linn.
Aerial part Pudi na 5-10 g
232. Mentha pi perata L./ M entha Peppermi 10-30 mg
species nt/ Sat
pudin a
233. M esuaf errea Linn.
Stemen/flower Nagkesar 2-5 g
234· M icrostylis musif era Ridley
. Tuber livaka 5-10 g
44
235. Microstylis wallichii Lindi. (Now known as Ma/axi s acuminate D. Don)
Tuber Rishabhka 5-10 g
236. Mimosa pudica
Whole plant/Seed Laiwan ti 3-6 g
237. Mimusops elengi L.
Peri carp Maulsi ri 20-40 g
Flower Maulsi ri 5-10 g
Stem bark Maulsiri 3-5 g
238. Mimusops hexandra Roxb. (Now known as Manilkara hexandra (Roxb.) Du b.)

Pericarp Khi rni 20-40 g

239. Momordica charantia L.
Fresh fru it / Seed Karela 30-50 g (as
vegetable) 3-5 g
(as seed)
(Not recom mended for
females plann ing to
240. Momordica dioica Roxb. Ex Willd. conceive)
Root Khekhasa 3-6 recommended
(Not g (as powder) for
Fruit Khekhasa children
30-50 g below 5 years)
241. Monochoria va.CJinalis (Burm.f.)Presl.
Rhizome Ind ivara 3-6 g
242. Morin.Qa oleifera Lam. I M.concanensi s Ni mmo
Leaf Sahijan / 10-20 g (as
M u ringya vegetable or paste)
/ Lal
Seed Sahijan 2-6 g (as vegetabl e)
sehanjan
/ M uri
Pod Sahijan
ngya 40-80 g
/ Mu
Flower Sahijan
rinl!va 10-20 g
/ Mu
Stem bark Sahijan
ringya 10-20 g
/ M uri 2-5 g (as powder)
243. Marus alba L. I M. lndica I M.nigra nl!va
Fruit / Leaves / Bark / Flower Shahtoot 20-30 g (as
fruit) 3-5 g (as
leaf)
244. Moschella esculenta/M. elata
Plant Guch hi 10-30 g
245. Mucuna pruriens (L.) DC.
Root Kawach 10-20 g
Pod Kawa ch 20-30 g (as vegetable)
Seed Kawa ch 5-10 g
246. Murraya lw eni, qii (L.) Spreng. / M. exotica Li nn (kamini)

Leaf / Fruit Kadhi patta 5-10 g

247. Musa paradisiaca L.
Flower Kela 20-30 g
Fresh shoot Kela 20-50 g
10-20 ml (as iuice)
Ripe Fruit Kela 100-200 g
Unripe Fruit Kela 50-100 g
248. Mvrica escµlenta Buch. Ham. I M. na gi Hook

Pru i t Kaiph al 5-10 g

Stem ba rk Kaiph al 2 -3 g

4
5
249. M vristica fra.arans H outt.
Seed J aiphala 0.25- 1.0 g
(Caution: excessive use
may cause giddiness)
Ari! J avitri r
0.25 -1 g as powder)
250. M yristica malabarica La m.
Seed Jangali 0.5 -2 g
Jayaphala
Ari! Jangali jav 0.25 -1g
251. Nardostachvs iatamansi Jitriatamansi 2-5 g
252. Nasturtium of{icinale/ N. Water-cress 20-40 g
253. Nelumbo
aauaticumnucifera Gaertn.
Flower Kamal 3-6 g [as powder)
Rhizome Shen 30-50 g
Stalk M u ra r 30-50 g [ as powder)
Seed Kamalgatta 3-6 g (as powder)
254. Nymp haea alba Linn/ N. rubra/ N. stellate
Rhizome/ Seed/ Flower Kamlin i 10-20 g
3-6 g [ as flower)
255. Ni.aella sa tiva L.
Seed Kalaunji 5-10 g
(Not recomm ended·du
ring pregnancy)
256. Nyctanthes arbortristis L.
Flower Harshringar 1-2 g
Leaf 1-Iarshri
a 1-3 g
257. N ymp haea rubra Roxb. ex Salisb ngara
Flower Lal Kumud 3-6 g (as powder)
258. N ympha ea stellata Willd.
Flower N eelofer 3-6 g (as powder1
259. Ocimum basilicum L.
Leaf (Bhavar 3-6 ml (as j ui
i Tulsi) ce) 1-3 g (as
N iajboo powder)
Seed Tul asi 125-250 mg
(]angali
260. Ocimum ,qratissimum L. )
Leaf Ram 2-4 g (as powder)
Tulasi (M
261. Ocimum sanctum L. (Now kn own as Ocimum
u mbai) tenuiflorum L.)
Leaf Tulasi 2-5 g
Seed Tulasi I 1-2 g
262. Olea europaea
Seed/Oil ]aitu n /Tail 10-20 g/ml
263. Onosma bracteatum
Whole plant/Leaf Gau jva n 5-10 g
264. Onosma hispidum
Root Rataniol 3-5 g
265. Op erculina turp ethum
Root/seed Nishoth 3-5 g
(Not recommended for
children below 5 years)
266. Opuntia vuf.qaris I 0. c/ illenii
Fru its N agph ani 10-20 g
267. Orchis latifo lia L. (Now known as Dactylorhiza hate,qeria (D. Don) Soo)
46
 Tu ber Salampa n j a 5-10 g (as powder)
268. Origanum maiorana L.
Leaf Marubaka 5-10 drops (as juice)
269. Oroxvlum indicum
Bark/Seed Shyonok 5-10 g
270. Orvza sativa L.
Seed Chawa l - shal i 100-200 g [as powder)
271. Oxalis corniculata L.
Leaf Tinpatia 5-10 ml [ as jui ce)
272. Pand anus odoratissimus L.f.
Oil I Flower Kewada 2-5 drops /2-5 g
273. Panicum miliaceum L.
Seed Cheen 50-100 g
274. Papaver somn if erum L.
Seed Postaclana 2-5 g (as powder)
275. Parmelia perlata
Whole plant Chharila 3-5 g
276. Paspa/um scrobicu latum L.
Seed/Caryopsis Kodo 50-100 g
277. Paspalum scrobicu latum
Fru itLSeed Kodon 30-500 g
278. Pedalium murex Bada gokharu 5-10 g
279. Pennisetum typhoideum L. C. Rich. (Now known as Pennisetu m
americanum (L.) IC Schu m )
Seed Bajra 20-40 g
280. Peucedanum ,qraveo/ ens (L.) Benth. and Hook.f
Seed Shepu 1-3 g
281. Phaseolus aconitifolius ]acq. [ Now known as Vi_qna aconitifolia
[]acq.) Marechal) Seed Moth 20-50 g
282. Phaseo lus aureus Roxb. [ Now known as Vi 1na radiata [L.) Wilczek var.
radiata)
Seed ]angali 20-50 g
moong
283. Phaseolus lunatus L.
Pod Sem 25-50 g [as pulse)
284. Phaseolus mun,qo L. [ N ow known as Viq,na mun,qo [L.) Hepper)
Seed U rad - 20-50 g (as pulse)
285. Phaseolus radiatus L. I P. trilobus
sensu
Seed Moong 50-100 g (as pu lse)
286. Phaseolus vul.aaris L.
Pod Lobia 10-20 g [as pulse)
287. Phoenix dactilifera L.
Frui t Chuhara 20-50 g
/ Khaju r
288. Phoenix svlvestris (L.) Roxb. I P.
acaulis
Fruit Khajoor 20-50 g
Ni ra (Sap) Khajoor 30-50 ml (as fresh jui ce)
289. Phy/la nthus amarus / P. urinaria
Plant Tamlaki 5-10 g (as pla nt)
Extract Tamlaki 1-2 g (as extract)
290. Phvsalis all<el<en.ai L.
Fruit Kaknai 5-10 g
291. Phvsalis minima L.
47
 Frui t Papoto 10-20 g
292. Phvsalis JJ eruviana L.
Frui t Rasbhari 10-20 g
293. PimJJin ella anisum L.
Frui t Anisoon 1-3 g
294. Pin us excelsa
Frui t /Oil Kail 5-10 g/1-2 ml
(Not recomm ended for
children below 5 yea rs)

295. Pinus .Qerardiana Wall.

Endosperm Chilgo ja 5-10 g
296. Pinus roxbur,qhii
Frui t /Oil Chiia 5-10 g / 1-2 ml
(Not recommended for
children below 5 years)
297. PiJJ er betie L.
Leaf Pana 2-S g
(Not recommended
below the age of 5 years)
298. Pip er chaba Hu nter (non Blume) ( N ow known as PiJJ er retrofractum Vahl)
Leaf Chabh 1-3 g (as powder)
299. PiJJ er cubeba L.f.
Frui t Ka bab chini 1-3 g (as powd er)
300. Pip er lon.qum L.
Fruit Pipa r O.S-2 g (as
powder) (Not
recommended for
301. Pip er ni,qrum L. prolonged use)
Fruit Kali Maricha 0.5-2 g
302. Pistacia integerrima Stewart (Now known as Pistacia chinensis Bunge ssp.
lntegerrima
(Stewart) Rech.f.
Gall Kakadasingi 1-2 g
303. Pistacia vera L.
Seed Pista 5-10 g
304. Pisum sativum L.
Seed Mata r 50-150 g (as vegetable)
305. Planta.ao ovata
Seed I Husk
Forssk. I sabgol 5-10 g (as vegetab le)
306. Po/ yqonatum (Wall.) Royle
cirrhifolium
Rhizom e M eda 5-10 g
307. Polyqonatum verticillatu m
(L.) All.
Rhizome Maham eda 5-10 g
308. Portulaca o/ eracea L.
Aerial part Kulpha - 20-30 g (as vegetable)
309. Portulaca quadrifida L. sag
Aerial part Nonia - sag 20 -30 g
310. Premna inte.arifolia I P. latif
olia plant I Bark
Whole Agni ma nth S-10g
311 Pru nus amyqd alus Baill. var.
. dKernel
u/chin Badama 10-20 g
Seed oil Badama ka 3-5 ml
tel
312. Pnuws armen iaca L.
Pericarp Khumani 10-20 g
Kernel I<hu mani 3-S g
48
 Seed oil Khum ani 3-5 ml
313. Prunus cerasoides
Wood/Flower Padamkasht 5-10 g
I Paj ja
314. Prunus persi ca (L.) Batsch.
Pericarp Adu 10-20 g
315. Psidium .quajava L.
Fruit Am rud a 20-50 g (as fresh fruit)
Leaf Am ruda 3-5 g
316. Pterocarpus marsupium
H t. Wood Viiavsar 5-10 g
317. Pteroca rpus santalinus
Ht Wood Lal chand an 5-10 g
318. Pueraria tuberosa (Roxb. ex Willd.) DC.
Tuber Pata!Kohda 10-20 g
319. Punica .aranatum L.
Seed Anar 20-50 g (as seed)
Fruit ri nd Anar 5-10 g (as fruit rind)
320. Putranj iva roxbur,qhii
Fruit J iya-pota 3-6 g
(Not recommend ed for
children below 5 yea rs)

321. Pyrus communis L.

Fru i t Nashpaati 50-100 g
322. Pyrus malus L. [Now known as M alus pumila Mill.)
Fru i t Seb 100-200 g
20-40 ml (as juice)
323. Raphanu s sativus L.
Root Mu li 20-50 g
Leaf M u li 20-50 g
Seed M uli 125-250 mg
324. Reinwardtia indica
Whole plan t/ Basanti 5-10 g
leaf/ extract (as powder) 0.5-
1 g (as extract)
325. Rhodod end ron arboreum Sm. I R. companulatum I R. lepidotum Wall
Flower Bu ransa 20-30 g (as flower)
Extract Bu ransa 2-3 g (as extract)
326. Rheum emodi Wall. ex Meissn. / R. officinale
Leaf Revancl 0.5-1 g
327. Rhus parviflora Roxb. ex DC. chini
Fruit Samakdana 30-75 g
328. Ricinus communis
Seed/ Root/Leaf Erand 5-10 g
(Not recommen ded for
child ren below 5 yea rs)
329. Rosa alba L.
Flower Safed gulab 10-20 g
330. Rosa centifolia L.
Flower Guiab 10-20 g (as flower)
Oil Guiab 2-5 drop (as oil)
331. Rosa damascena Mill.
Flower/oil Gu iab Fasa li 10-20 g I 2-5 drops
332. Roscoea pro cera Wall.
Ro ot tu ber Kandamula 5-10 g (as powde r)
49
333. Rubia cordifo fia
Root/Stem Ma nieeth 3-6 g
334. Rumex vesicarius L.
Leaf Am ba 10-20 g
t chu
335. Rumex nepalensis / R.maritimus / Shak/
kka Fafru 20-40 g
R.acetosella (Not recom mended for
child ren below 5 yea rs)
336. Saccharum officinarum L.
Stem / Ju ice /Roo t / Decoction Ganna 100-200 ml (as juice )
(Not recommended for
diabetics)
Sugar Chi ni / 50-100 g
Shakka (Not recommen ded for
r diabetics)

J aggery Gud 50-100 g

[Not recommended for
diabetics)

337. Salacia chinensis L. / Sa/acia oblonga

Wal l. ex Wigh t and Arn I Salacia reticulata Wigh t / S. roxbwqhii I S.
macrosperma
Root Saptrangi 5-10 g
Stem extract Saptrangi 0.5-1 g
338. Salvadora persica/ S. o/eoides
Fruit/ Leaf Peelu / 5-10 g
Bada pelu
339. Santa/ um album L.
Oil Cha ndan 3-5 drops (as oil)
ka tel
H ard wood 1-2 g [as hard wood)
340. Saraca asoca
Bark/Leaf Ashok 5-10 g
(Not recommended for
children below 5 years)
341. Saussurea /aJJ JJa
Root/Rhi zome Ku th 3-5 g
(Not recommended for
children below 5 years)
342. ScindaJ]sus of{icinalis
Stem Gaj pippali 3-5 g
343. Scirpus kysoor Roxb. (Now known as Scirpus ,qrossus (L.f.) Palla)
Rhizome Kasheru 20-50 g fas vegetable)
344. Sefinum tenuifolium I S.va.qinatum
Rhizome /Root Bhootkesi 3-5 g
345. Sesamum indicum L. [ N ow known as Sesamum
orientate
Seed L. Tila 10-20 g
Oil Tila 5-10 ml
346. Sesbania .arandiflora fL.) Pair.
Flower Agathi 10-20 g (as vegetable)
Leaf Agathi 10-20 g
347. Setaria italica fL.) P. Beauv.
Seed Kangu 10-50 g
348. Sida cordifolia L. I S. rhombifolis Linn/ S. acuta
Whol e plant I Extract Bariyara 10-30 g
Seed Bariyara 3-5 g
34.9, Solan um indicum IS.surattense IS.torvum
Whole plant Kantkari 5-10 g
Frui t extract KateIi 1-2 g (as extract)

50
350. Solanum melon.qena L.
Fruit Baigan 50-100 g
351. Solanum ni,qrum L.
Leaf / Plant Choti Makov 30-60 g
352. Sor,qhum vul,qare Pers.
Seed J wara 50-100 g
353. Sphaeranthus indicus
Flower Gorakmu ndi 5-10 g
354. Sninacia oleracea L.
Leaf Palak 50-100 g
355. Snondias man.aifera Willd. (Now known as Snondias pinna ta (L.f.) Kurz.)
Frui t / Leaf Ambada 20-50 g
1-3 g (as powder)
356. Strychnos potatorum L.
Seed Ni rmali 5-10 g (as powder)
357. Swertia chiravita I S.ciliata I S.an.austifolia
Whole plant Chiraita 3-5 g (as whole plant)
Extract Chiraita O.S-1g (as extract)
358. Svmnlocos racemosa
Bark/Leaf Lodhar 3-S g
359. Syz yqium aromaticum (L.) Merr. and L.Perrv
Flower bud Lau ng O.S-1g
360. Syzy,qium cuminii (L.) Skeels
Pericarp and mesocarp Jamun 10-50 g
Seed J amu n S-10 g
361. Tacca aspera Roxb.
Tuber Bhevara ke 20-50 g
kand
362. Tamarind us indica L.
Frui t pulp I ma Ii 5-10 g
(Not recommen ded du ring skin
ailments)
Seed lmali S-10 g
363. Tenhrosia purnurea
Whole plant Sarponkha S-10 g
364. Teramnus labia/is (L.f.) Spreng.
Whole plant Mashaparni 20-50 g •
365. Terminalia arjuna

Bark/Leaf /Fru i t Arju n 5-10 g

Extract Ariu n O.S -1 g (as extract)
366. Terminalia belerica (Gaertn.) Roxb.
Fru i t pericarp Bahera 3-S g (as fruit pericarp)
Extract Bahera O.S-1 g (as extract)
367. Terminalia catappa L.
Kernel Desi badama 10-20 g
368. Terminalia chebula Retz.
Fru it pericarp I-farad 3-S g (as powder)
Extra ct Harar O.S-1g (as extract)
369. Terminalia tomentosa
Stem/Bark/ Leaf Jarandrum / S-10 g
Asan
370. Thymus semvllum auct. non L. (Now known as Thymus linearis Benth.)
Leaf Ban ajwain 1-3 g (as powder)
51
371. Trachyspermum ammi (L.) Sprague
Seed Ajwai n 1-3 g (as powder)
Leaf Ajwai n 10-20 g
372. Trava bisoinosa Roxb. (Now known as Trapa natans L. var. bispinosa (Roxb.) Makino)
Endosp erm / Fruit Singhada 30-60 g
373. Trianthema vortu/acastrum L.
W hole plant Swet 10-20 g
punarnav
374·. Tribt1/us terrestris a
I
Frui t/Whole plant Gokh ru 5-10 g
375. Tricholevis .alaberrima
Plant Brah m dandi 3-6 g
376. Trichosanthes an.auina L.
rruit Chichind a 30-60 g
377. Trichosanthes dioica Roxb.
Fruit/ Leaf Parawa l 30-60 g
378. Tri,qonella foenum- .araceum L.
Seed Meth i 5-10 g
Leaf M ethi 50-100 g
379. Triticum aestivum L.
Seed Gehu n 50-100 g
Tender shoot/spou t Ankurita 10-50 g
Geh u
380. Typhonium trilobatt1m (L.) Schott.
Tu ber Kon chu 20-50 g
381. Tinospora cardifolia M iers. (menispermaceae) Syn. T.,qlabra (n. Burm)
Roots/stem 5-lO g (as powder)
10-20 ml (as decoction)
400 mg, Max (as sattva)
Extract 1-2 g
382. Urtica pa rviflo ra / U. dioica
Tender Leaf Bicchubu ti 10-20 g
383. Uraria p icta
Whole plant Pi thvin 5-10 g
384·. Valeriana iatamansi Jon es / V.
wallichii
Rhizome Tagar 1-3 g (as powder)
385. Vetiveria ziza nioid es
Whole plant Khas 10-20 g
386. Via.na trilobata (L.) Verde.
Whole plant M ugvan 20-50 g
387. Viola odorata I V.pi / osa I V.
sy/vestris
Whole plant/flower Vanksha 3-5 g
(Not recomm ended for
children
below 5 years)
388 Vitex agnt1s-castus Linn.
.
Seed / Leaf Ren uka 3-6 g
beej /
Sage (Not recommended for
children
389. Vitex ne.aund o I V. trifo lin below 5 years)
Fru it/Seed/Leaves N i rgu ndi 3-5 g
390 Vitis vinif era L.
. Fruit Munakka 10-30 g
Seed I Fruit ski n Mu nakka 1-3 g

52
 391. Wedelia calendulacea (L.) Less. ( N ow known as Wede/ia chinensis [Osbeck)
Leaf
Mer.) Pila bhagra 5-10 g (as powder)
392. Withania coaaulans (Stocks) Dunal
Frui t Paneer Doda 5-10 g
393. Withania somnifera (L.) Du nal.
Root Asgandh 3F-6 g (as powd er)
Extract Asgandh 0.5-1 g (as extract)
394 Woodfordia fruticosa
. Flower Dhay 5-lOg
ke
395. Wriahtia tinctoria I W tomentosa phool
Ba rk/ Leaf/Seed Meetha kutaj 5-10 g
396. Zanthoxylum alatum Roxb. ( Now known as Zanthoxvlum armatum DC.)
Seed I Stem bark Timura 1-3 g
397. Zea mays L.
Seed Makka 20-100 g
Anthers Makka 5-10 g
398 Zin.CJ iber of f icinale Rose.
. Rhizome Ad rakh 5-10 g
(Not recommended
during hypertension
and bleeding
399. Zizyphus ju juba Lam. disorders)
Pericarp Ber 10-50 g
400. Zizyphus nummularia (Bu rm.f.)W. and A.
Peri carp J angali Ber 15-30 g
/ J har h er

Note 1.- I ngredients listed i n the above Schedule shall be used after due
processing or in their extract forms subject to permissib le usage ra nge
given in the last column of the Table. Offeri ng these ingred i ents,
either alone or in combinations as such or mini mally processed
(cleaned, de-weeded, sorted, dried or powdered) is/are not permitted.

Note 2.- The ingredien ts l isted above shall comply wi th Food Safety and
Standa rds (Contaminants, Toxins and Residues) Regu lations, 2011.

Note 3.- Permitted range of usage for ch ildren between 5-16 years is 1/2 of the
permitted range of usage for adu lts.

Not e 4.- Permitted range of u sage for children between 1-5 yea rs is 14 of th e
permitted range of usage for adults.

53
 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 Additiv e or Group Maximum

permitted
1. 950 Acesulfame potassium levelmg/kg
2,000
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 hydroxya nisole (BHA) 400 mg/ kg
9. 321 Butylated hydroxytoluen e ( 400 mg/ kg
10. 902 Candelilla wax GM P
11. 150c )
Caramel Ill - Ammon i a caramel 20,000 mg/kg
12. 150d Caramel IV - Sulfite 20,000 mg/kg
ammonia caramel
13. 903 Carna uba wax 5,000 mg/kg
14·. 160a(ii) beta-Carotenes (vegetable) 600 mg/ kg
15. 160a(i), (iii), 160e, Carotenoids 300 mg/kg
16. 160f
1503 Castor oil 1,000 mg/kg
17. 141(i),(i i) Chlorophylls and 500 mg/kg
Chlorophyllins, Copper
18. 472e Diacetyltartaric and fatty acid
Complexes 5,000 mg/kg
esters of glycerol

19. 385, 386 Ethylene diamine tetra acetates 150 mg/kg

20. 143 Fast green FCF 600 mg/kg
21. 163(i i) Grape skin extract 500 mg/kg
22. 132 l ndigotine (Indigo carmi ne) 300 mg/ kg
23. 961 N eotame 90 mg/kg
24. 338, 339(i)-(iii), Phosphates 2,200 mg/kg
340(i)-(iii), 341(i)-
(iii),
34·2(i),(ii), 343(i)-
(iii),
450(i)-(iii),(v)-(vii),
45 1(i),(ii), 452(i)-(v),
54·2
25. 1203 Polyvinyl alcohol 45,000 mg/kg
54
S. No. INS No. Food Additive or Group Maximum
permitted
26. 900a Polyclim ethylsiloxane level
50 mg/kg
27. 1521 Polyethylene Glycol 70,000 mg/kg
28. 432-436 Polysorbates 25,000 mg/kg
29. 1201 Polyvinyl pyrrol idone G MP
30. 124 Ponceau 4R (Cochineal red A) 300 mg/kg
31. 310 Propyl gallate 400 mg/kg
32. 101(i)-(iii) Ri boflavi ns 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 Glycosicles 2,500 mg/kg
.37. 955 Sucralose 2,400 mg/kg
38. 474 (Trichlorogalactosucrose)
Sucroglycerides 2,500 mg/kg
39. 110 Su nset yellow FCF 300 mg/kg

55
 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
1. 950 Acesulfame potassium 450 mg/kg
Level
2. 956 Alitame 300 mg/kg
3. 304, 305 Ascorbyl Esters 500 mg/kg
4. 951 1,000 mg/kg
5. 962 Aspartame-acesu lfame salt 450 mg/kg
6. 210, 211, 212, 213 Benzoa tes 2,000 mg/kg
7. 133 tame
Brilliant blue FCF 300 mg/kg
8. 150c Caramel Ill - Ammonia caramel 20,000 mg/kg
9. 150d Ca ramel IV - Sulfi te ammonia 20,000 mg/kg
10. 160a(ii) caramel
Beta-Carotenes (vegetable) 600 mg/kg
11. 160a(i), (iii), Carotenoids 300 mg/kg
160e, 160f
12. 472e Diacetyl tartaric and fatty acid 5,000 mg/kg
esters of glycerol

13. 163(ii) Grape skin extract 250 mg/kg

14. 132 l n digotine (Indigo carm ine) 300 mg/kg
15. 961 Neotam e 65 mg/kg
16. 338, 339(i)-(iii), Ph osphates 2,200 mg/kg
340(i)-(iii), 341(i)-
(iii),
342(i),(ii), 343(i)-
(iii),
450(i)-(iii),(v)-(vii),
451(i),(ii),452(i) -
(v),
17. 542
900a Polydimethylsilo xane 50 mg/kg
18. 124 Ponceau 4R (Cochineal red A) 300 mg/kg
19. 101(i)-(iii) Ri boflavins 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 400 mg/kg
24. 110 (Trichlorogalactosucrose)
Sunset yellow FCF 300 mg/ kg
56
 Schedule - VC
[See regula tions 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
1. 9SO Acesulfame potassiu m SOO mg/kg
Level
2. 9S1 Aspartame 1,000 mg/kg
3. 962 Aspartame-acesulfame salt SOO mg/kg
4. 210 - 213 Benzoates 1,500 mg/kg
5. 133 Brilliant blue FCF SO mg/kg
6. lSOc Caramel Ill - Ammonia 20,000 mg/kg
lSOd caramel
Caramel IV - Sulfite 20,000 mg/ kg
7.
Ammonia caramel
8. 160a(ii) beta-Carotenes (vegetable) 600 mg/kg
9. 160a(i), (iii), 160e, 160f Carotenoids SO mg/kg
10. 472e Diacetyltartaric and fatty S,000 mg/kg
acid esters of glycerol
11. 163(ii) Grape skin extract 2SO mg/kg
12. 132 Ind igotine (Ind igo carmine) SO mg/kg
13. 961 Neotame 33 mg/kg
14. 338, 339(i)-(iii), 340 (i)-(iii), Phosphates 2,200 mg/kg
341(i )-(iii), 342 (i),(ii),
343(i),
(iii), 4SO (i)-(iii), (v)-(vii),
15. 4S1(i),
900a (ii), 4S2(i)-(v), S4·2 Polyd i methylsiloxane SO mg/kg
16. 432 - 436 Polysorbates 1,000 mg/kg
17. 124 Ponceau 4R (Cochi neal red SO mg/kg
18. 477 A)
Propylene glycol esters of 5,000 mg/kg
fatty acids
19. 101(i)-iii) Riboflavi ns 300 mg/kg
20. 9S4 (i)-(iv) Saccharins 200 mg/kg
21. 200-203 Sorbates l,SOO mg/kg
22. 960 Steviol glycosides 3SO mg/kg
23. 9SS Sucralose 400 mg/kg
(Trichlorogalactosucro
24. 474 Sucroglycerides
se) S,000 mg/ kg
25. 110 Sunset yellow FCF SO mg/kg
57
 Schedule - VD
[See regulati ons 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
1. 950 Acesulfame potassium 4·SO mg/kg
Level
2. 304, 30S Ascorbyl Esters SOO mg/ kg
3. 951 Aspartame 800 mg/kg
4. 962 Aspartame-a cesulfame salt 4SO mg/kg
5. 210 - 213 Benzoates 1,SOO mg/kg
6. 133 Brilliant blu e FCF SO mg/kg
7. 150c Caramel Ill - Ammonia 20,000 mg/kg
8. 150d caramel
Caramel IV - Sulfi te 20,000 mg/kg
Ammon ia caramel
9. 160a(ii) Beta-Caroten es (vegetable) 600 mg/kg
10. 160a(i), (iii), 160e, 160f Carotenoids 50 mg/ kg
11. 472e Diacetyltartaric and fatty 5,000 mg/kg
acid esters of glycerol
12. 163(ii) Grape skin extract 250 mg/kg
13. 132 Indigoti ne (Indigo carmi ne) 50 mg/kg
14. 961 Neotame 33 mg/kg
15. 338, 339(i)-(iii), 340(i)-(iii), Phosphates 2,200 mg/kg
341(i)-(iii), 342(i),(ii), 343(i)-
(iii),
450 (i)-(iii),(v)-(vii), 451(i),(ii),
16. 900a
452(i)-(v), 542 Polydi methylsiloxane 50 mg/kg
17. 432 - 4·36 Polysorbates 1,000 mg/kg
18. 124 Ponceau 4R (Coch i neal red 50 mg/kg
19. 477 A)
Propylen e glycol esters of 5,000 mg/kg
fatty acids
20. 101(i)-iii) Riboflavi ns 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 Su cralose 320 mg/kg
(Trichlorogalactosucrose)
25. 474 Sucroglycerides S,000 mg/kg
26. 110 Sunset yellow FCF SO mg/kg

58
 Schedule - VE
[See regulations 3.(13), 6.(4), 7.(5), 8.(4), 9.(4), 10.(3), 11.(3) a nd 12.(4) ]

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

(I) N u traceu ticals,
(II) Foods for special dietary use other than foods for infants,
(III) Foods for special medical purpose,
(IV) Foods with added probiotic ingred ients and prebiotic ingredients,
(V) Specialty foods contain ing pl ant or botanical ingredients,
and (VT) Heal th supplements

S. No. INS No . Additive Functional Class

1. 260 Acetic acid, glacial Acidity regu lator, Preservative
2. 472a Acetic and fatty acid Em u lsifier, Sequestrant, Stabilizer
esters of glycero l
3. 1422 Acetylated distarch adipa Emulsifier, Stabilizer, Thickener
4. 1417 te
Acetylated dista rch Emulsifier, Stabilizer, Thickener
5. 1451 phosphate
Acetylated oxidized starch Emulsifier, Stabilizer, Thickener
6. 1401 Acid treated starch Emulsifier, Stabilizer, Thickener
7. 406 Agar Bul king agent, Carrier,
Emulsifier, Gelli ng agent,
Glazing agent,
8. 400 Alginic acid Bulki ng agent,
H u mectant, Carrier, Em
Stabilizer, u
Thickener
lsifier, Foaming agent, Gelling
agent, Glazing agent,
H umectant, Sequestrant,
9. 1402 Alkali ne trea ted starch Emulsifier,Thickener
Stabilizer, Thickener
Stabilizer,
10. 1100 (i) alpha-Amylase from Flour treatment agent
Aspergillus oryzae

11. 1100 (vi) Carbohydrase from Flou r treatmen t agent

Bacillus licheniformis
12. 1100 (iv) alpha-Amylasefrom Flour treatment agent
Bacillus megaterium
expressed i n Bacillus
13. 1100 (ii) alpha-Amyla
sub ti/is se from Flou r treatment agent
Ba cillus
14. 1100 (v) stearothermophilus
alpha-Amylase from Flou r treatment agent
Bacillus
stearot hermophilus
expressed i n Bacillus
subtilis
15. 1100 (iii) alpha-Amylase from Flou r trea tment agent
Bacillus subtilis
16. 264 Ammoni um acetate Acidity regulator
17. 403 Ammoniu m alginate Bul ki ng agent, Carrier,
Emulsifier,
Foa mi ng agent, Gelling agent,
Glazing agent, Hu mectant,
Sequestran t,
59 Stabilizer, Thickener
S. No. INS No. Additive Functional Class
18. 503(i) Ammoni um carbonate Acidity regu lator, Raising agent
19. 510 Ammoniu m chloride Fl ou r treatment agent
20. 503(ii) Am monium Acidity regulator, Raising agen t
hydrogen
21. 527 carbonate
Am moniu m hydrox ide Acidity regulator
22. 328 Ammonium lactate Acidi ty regulator, Flou r
treatment agent
23. 300 Ascorbi c acid, L. Acidity regu lator, A nti-oxidant,
Flour treatmen t agent
24·. 162 Beet red Colour
25. 14·03 Bleached starch Emulsifier, Stabilizer, Thickener
26. 1101(iii) Bromelain Flavour en hancer, Flour
treatment agent, Stabilizer
27. 629 Calcium 5'-guanylate Flavou r enhancer
28. 633 Calci u m 5'-inosi nate Flavour enhancer
29. 634 Calcium 5'-ribonucleotides Flavour enhancer
30. 263 Calcium acetate Acidity regul ator, Preserva
tive, Stabilizer
31. 404 Calcium a lginate Anti-foaming agent, Bulking agent,
Carrier, Foaming agent, Gelling
agent,
G l azing agent, Humectant,
32. 302 Calciu m ascorbate Anti-oxidant
Sequestrant, Stabilizer
33. 170(i) Calciu m carbonate Acidity regu lator, Anti- caking
agent, Carrier, Firming agent,
Flour treatment agent, Stabilizer
34. 509 Calcium chloride Firming agent, Stabilizer, Thickener
35. 623 Calciu m di-L-glutamate Flavou r enhancer
36. 578 Ca lcium gluconate Acid i ty regulator, Firming
agent, Sequestrant
37. 526 Calciu m hydroxide Acidity regu lator, Fi rming agent
38. 327 Calciu m lactate Acidity regulator, Fl our
treatment agent
39. 352(ii) Calciu m malate, DL- Acidi ty regulator
40. 529 Ca lcium oxide Acidi ty regulator, Flour
treatment agent
4·1. 282 Calcium propion ate Preservative
42. 552 Calciu m silicate Stabilizer
43. 516 Calciu m sul fate Firmi ng agent, Flour trea tment
agent, Sequestrant, Stabilizer
44. 150a Caramel I - plai n caramel Colou r
4·5. 290 Carbon diox ide Carbonating agent, Packaging
gas, Preservative, Propellant

60
S. No. INS No. Additive Functional Class
46. 410 Ca rob bean gum Emu lsifier, Stabilizer, Thickener
47. 407 Carrageenan Bu l king agent, Carrier, Emu lsifier,
Gelling agent, Glazi ng agent,
H u mectant, Stabilizer, Thickener
48. 427 Cassia gu m Emulsifier, Gelling agent, Stabilizer,
Thickener
49. 140 Chlorophylls Colour
50. 1001 Choline salts and esters Emulsifier
51. 330 Citric acid Acid i ty regulator, Anti-oxidant,
Sequ estrant
52. 4·72C Citric and fatty acid esters of Anti-oxidan t, Em u lsifier, Flou r
glycerol treatment agent,
Sequestrant, Stabilizer
53. 466 Cross carm ellose sodium Binder, Thickening agent, Disi ntegrant
54. 4·68 Cross-linked sodium Stabili zer, Thickener
carboxymethyl cellulose
(Crosslinked - cellulose gum)
55. 424 Curd I an Firmi ng agent, Gelli ng agent, Stabilizer,
Thickener
56. 457 Cyclodextrin, alpha- Stabilizer, Thickener
57. 458 Cyclodextri n, gamma- Stabilizer, Thickener
58. 1504 (i) Cyclotetragl ucase Carrier, Glazi ng agent
59. 1504 (ii) Cyclotetraglucose syrup Carrier
60. 1400 Dextri ns, roasted starch Emulsifier, Stabili zer, Thickener
61. 628 Dipotassium 5'-guanylate Flavou r enhancer
62. 627 Disodiu m 5'-guanylate Flavou r enhancer
63. 631 Disodium 5'-inosi nate Flavou r enhancer
64. 635 Disodium 5'-ribonucleotides Flavou r enhancer
65. 1412 Distarch phosphate Emulsifier, Stabilizer, Thickener
66. 315 Erythorbic Acid (Isoascorbic Anti-oxidant
acid)
67. 968
Sweetener
68. 462 Ethyl cellulose Bulki ng agent, Carrier, Glazing agent,
Thickener
69. 467 Ethyl hydroxyethy l cellulose Emulsifier, Stabilizer, Thickener
70. 297 Fu maric acid Acid ity regulator
71. 418 Gellan gum Stabilizer, Thickener
72. 575 Glucono delta-lactone
Erythritol Acidity
Flavourregulator, Raising
enhancer, agent,
Humectant,
Stabilizer
73. 1102 Glucose oxidase Anti-oxidant
74. 620 Gluta mic acid, L(+)- Flavour enhancer
75. 422 Glycerol Hu mectant, Thickener
61
S. No. INS No. Additive Functional Class
76. 626 Guanylic acid, 5'- Flavou r enhancer
77. 412 Guar gum Emulsifier, Stabilizer, Thickener
78. 414 Gum ara bic (Acacia gum) Bu lking agen t, Carrier, Emulsifier,
Glazing agent, Stabilizer, Thickener
79. 507 H ydrochloric acid Acidity regu lator
80. 463 Hydroxypropyl cellulose Bu lking agent, Emulsifier,
Foami ng agent,
G lazing agent, Stabilizer, Thickener
81. 1442 Hydroxypropy l Emulsifier, Stabilizer, Thickener
distarch phosphate
82. 464 Hydroxypropyl Emulsifier, Glazing agent,
methyl cellulose Stabilizer, Thickener
83. 1440 Hydroxypro pyl starch Em ulsifier, Stabilizer, Thickener
84. 630 I nosinic acid, 5' Flavour enhancer
85. 953 lsomalt Anti-caking agent, Bulking
(Hydrogena ted agent, Glazi ng agent,
86. 416 Karaya gum
isomaltu lose) Emulsifier, Stabilizer, Thickener
Sweetener
87. 425 Konjac flou r Carrier, Emu lsifier, Gelling agent,
Glazing agent, J-l umectant,
Stabilizer, Thickener
88. 270 Lactic acid, L-, 0- and DL- Acidity regulator
89. 472b Lactic and fatty acid Emulsifier, Sequestrant, Stabilizer
esters of glycerol
90. 966 Lacti tol Emu lsifier, Sequestrant, Stabilizer
91. 322(i) Lecithi n (and its salts Anti-oxidant, Emulsifier
and esters from soya
or other sources)

92. 1104 Lipases Stabilizer

93. 160d(iii) Lycopene, Blakeslea Colou r
94. 160d(i) trispora
Lycopene, synthetic Colou r
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, Firmi ng

agent, Preservative
98. 625 Magn esiu m di-L- Flavou r enhancer
99. 580 glutamateu m gluconate
Magnesi Acidity regulator, Firming
agent, Flavou r enhancer
10 . 528 Magnesium hyd roxide Acidity regu lator, Colour
0 retention agent
10 . 504{ii) Magnesium Acidity regu lator, Anti-cak ing
1 hydroxide agent, Carrier, Colour
ca rbonate retention agen t
10 . 329 Magnesi um lactate, DL- Acid ity regulator, Flour treatment
2
62
S. No. INS No. Additive Functional Class
agent
103 530 Magnesium oxide Anti-caki ng agent
.
104 553(i) Magnesi um sil icate, An ti -caking agent
.105 518 synthetic
Magnesiu m sulfate Firmi ng agent, Flavour enha ncer
.106 296 Malic acid, DL- Acidi ty regulator
.107 965(i) Maltito l Bulki ng agent, Emulsifier, H u
. mectant, Stabilizer, Sweetener
108 965(ii) Malti tol syrup Bulki ng agent, Emulsifier, H
. umectant, Stabilizer, Sweetener
109 421 Manni tol Anti-caki ng agent, Bulking
. agent, Hu m ectant,
110 461 Methyl cellulose Stabilizer,
Bulking agenSweetener
t, Glazi ng
. agent, Humectant,
111 465 Methyl ethyl cellulose Stabilizer,
Emulsifier,Thickener
Gelling agen t,
. Stabilizer, Thickener
112 460(i) M icrocrystalline Anti-caking agent, Bu lking
. cellulose (Cellulose agent, Carrier, Emu lsifier,
gel) Foaming agent, Glazing agen
t, Stabilizer, Thickener

113 471 Mono and di- Anti-foa ming agent,

. glycerides of fatty Emulsifier, Stabilizer
114 624 Monoam monium L-
acids Flavou r enha ncer
.115 622 glutamate
Monopotassi um L- Flavour enhancer
.116 621 glutamate
Monosodium L-glutamate Flavou r enhancer
.117 1410 Monostarch phosphate Emulsifier, Stabilizer, Thickener
.118 941 Ni trogen Packaging gas, Prope llant
.119 942 Nitrou s oxide Anti -oxidant, Foami ng agent,
. Packagi ng gas, Propellant
120 1404 Oxidized starch Emulsifier, Stabilizer, Thickener
.121 llOl(ii) Papa in Flavou r enhancer
.122 440 Pecti ns Emulsifier, Gelling agen t,
. Stabilizer, Thickener
123 1413 Phosphated cl i Em ulsi fier, Stabilizer, Thickener
. starch phosph ate
124 1200 Polydextroses Bulki ng agent, Glazing agent,
. Hu mectant, Stabilizer, Thickener
125 964 Polyglycito l syrup Sweetener
.
126 1202 Poly vinyl Colour reten tion agent, Stabilizer
. pyrrolidone,
insoluble, includ ing
127 632 Potassi
cross u m 5'-inosinate
povidone Flavour enhancer
.
128 261 Potassium acetates Acid i ty regulator, Stabilizer
.129 402 Potassium alginate Bulki ng agent, Carrier,
. Emulsifier, Foaming agen t,
Gelling agent, Glazing agent, H
63 umectant, Seauestrant,
S. No. INS No. Additive Functional Class
Stabilizer, Thickener
130. 303 Potassium ascorbate Anti-oxidant
131. 501(i) Potassiu m carbonate Acid ity regulator, Stabilizer
132. 508 Potassiu m chloride Flavour enhan cer, Gelling agen t,
Stabilizer, Thickener
133. 332(i) Potassium di hydrogen citrate Acidity regulator, Sequestrant,
Stabilizer
134. 577 Potassiu m gluconate Acidi ty regulator, Stabilizer
135. 501(ii) Potassiu m hydroge n Acidity regulator, Raising agent,
carbonate Stabilizer
136. 351(i) Potassiu m hydrogen malate Acidi ty regulator
137. 515 (ii) Potassium hydrogen sulfate Acidity regulator
138. 525 Potassi um hydroxide Acidity regu lator
139. 326 Potassi u m lactate Acid ity regulator, Anti-oxid ant
14·0. 351(ii) Potassium malate Acidity regulator
141. 283 Potassiu m pro pionate Preservative
142. 515(i) Potassiu m sulfate Acidity regulator
Powdered cellu lose An ti -caking agent, Bulki ng agent,
Carrier, Emulsifier, Foaming agent,
Glazing agent, Stabilizer, Thickener
144.. 407a Processed eucheuma seaweed Bu lking agent, Carrier, Emu lsifier,
Gelling agent, Glazing agent,
143. 460(ii) Humectant, Stabilizer,Thickener
145. 944 Propane Propellant
146. 280 Prop ionic acid Preservative
14·7. 1101(i) Protease Flavou r enhancer, Flour treatmen t
agent, 1999
Glazing agent, Stabilizer
14·8. 1204 Pullulan Glazing agent, Thickener
149. 470(i) Salts of myristic, pa lmitic and An ti-caking agent, Emulsifier, Stabilizer
stearic acids with ammonia,
calciu m, potassium and
sodium
150. 470(ii) Salts of oleic acid with calciu m, Anti-caking agent, Emulsifier, Stabilizer
potassium and sodium
151. 551 Silicon dioxide, amorphous An ti-caki ng agent, Anti-foami ng agent,
Carrier
152. 262 (i) Sodium acetate Acidi ty regulator, Preservative,
Sequestrant
153. 401 Sodiu m alginate Bulking agent, Carrier, Emulsifier,
Foaming
agent, Gelling agent, Glazing agent,
Humectant, Sequestrant, Stabilizer,
Thickener
154. 301 Sodium ascorbate A nti -oxidant
64
S. No. INS No. Additive Functional Class
155. SOO(i) Sodium carbonate Acidi ty regu lator, Anticaking
agent, Raising agent
156. 466 Sodium Bulking agent, Emulsifier,
carboxymethyl Firmi ng agent, Gelling agent,
cellulose (Cellu lose Glazing agent, Humectant,
157 469 gum)
Sodium Stabilizer,
Stabilizer, Thicken
Thickenerer
. carboxymethyl
cellulose,
enzymatically
hyd ro lysed (Cellulose
gum, enzymatica lly
hydrolyzed)
158 331(i) Sodium dihydrogen citrate Acidity regu lator,
. Emulsifier, Sequestrant,
Thickener
159 350(ii) Sodium DL-malate Acidity regulator, H umectant
.160 316 Sodium erythorbate Anti-oxida n t
. (Sodiu m isoascorbate)
161 365 Sodium fumarates Acidity regula tor
.162 576 Sodium glucona te Sequestrant, Stabilizer, Thickener
.163 500(ii) Sodium hyd rogen Acidity regu lator, Anti-caking
. carbonate agent, Ra ising agent
164 350(i) Sodium hydrogen DL- Acidi ty regulator, H umectant
.165 514(ii) malate
Sodium hydrogen sulfate Acidity regulator
.166 524 Sodium hydroxid e Acidity regu lator
.167 325 Sodium lactate Acidity regulator, Anti-oxidant, Bu
. lking agent, H u mectan t, Thicken
168 281 Sodium prop ionate er
Preservativ e
.169 500(iii) Sodium sesqu icarbonate Acidi ty regu l ator, Anti-caking
. agent, Raising agen t
170 - Sodium starch glycolate Binder, Thicken ing agent, Disin
.171 514(i) Sodium sulfate tegrant regulator
Acidity
.172 420(i) Sorbitol Bulking agent, Hu mectant,
. Sequestrant, Stabilizer, Sweetener
173 420(ii) Sorbitol syru p Bulking agen t, Hu mectan t,
. Sequestrant, Stabilizer, Sweetener
174 1420 Starch acetate Emulsifier, Stabilizer, Thickener
.175 1450 Starch sodium Emulsifier, Stabilizer, Thickener
. octenyl succinate
176 1405 Starches, enzyme treated Emulsifier, Stabilizer, Thickener
.177 473a Sucrose Oligoesters, Emu lsifier, Stabilizer
. Type I and Type II
178 553(iii) Talc Anti-caki ng agent, Glazing
. agent, Thicken er
·-
179 417 Tara gu m Gelling agen t, Stabilizer, Thickener
.
180 957 Thau matin Flavour en hancer, Sweetener
.181 171 Titani um dioxide Colou r
.182 413 Tragacan th gu m Emulsifier, Stabilizer, Thickener
. 65
 S. No. INS No. Additive Functional Class
183. 1518 Triacetin Carrier, Emulsifier, Hum ectant
184. 380 Triammonium citrate Acidity regulator
185. 333(iii) Tricalciu m citrate Acid i ty regulator, Firming
agen t, Sequestrant,
186. 332(ii) Tripotassi um citrate Stabilizerregu lator,
Acidity
Sequestrant, Stabilizer
187. 331(iii) Trisod ium citrate Acidity regu lator,
Emulsifier, Sequestrant,
188. 415 Xanthan gum Stabilizer
Emulsifier, Gelling agent,
Stabilizer, Thickener
189. 967 Xylitol Emulsifier, Hu mectan t,
Stabilizer, Thickener
66
 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) N utraceuticals,
(II) Foods for special d ietary uses other than foods for i n fants,
(III) Foods for special medical purpose,
(IV) Foods with added probiotic ingred ients and prebiotic ingred ients,
(V) Speciality foods containing pla n t or botan ical ingredi en ts, and
(VI) Health supplements

S.No. Additive Functionality Maximum

(Pharmaceutical Permitted Level
Aid)
1. Acacia gum Binding agent GMP
2. Acetone Solvent for coating GM P (does not
remain in the tablet
and residual levels
to be as per IP)

3. Ascorbic acid and its Antioxid ant 0.5%

esters and sal ts
4. Benzoic acid and its salts Preservative 0.5%
5. BHA Antioxidant 0.5%
6. BHT Antioxida nt 0.5%
7. Bronopol Preservative 0.5%
8. Calciu m carbonate Dilu ent, GM P
9. Calcium stearate Dissintegrant
Lubricant 1%
10. Carboxymethylcellu Bi nding agent 5-15%
lose Calcium
11. Carrageenan gu m Binding agent 2%
12. Cellulose acetate phth alate Coa ting agent 2%
13. Citric acid Disintegrant 2%
14. Citric and fatty acid Stabilizer 2%
esters of glycerol

15. Copovidone Bi nd ing agent 2-5%

16. Corn oil Vehicle GM P
17. Corn starch Diluent, Binding GMP
agent,
Dissintegran
18. Cross carmellose sodium Disintegrant 2%
19. Cyclodextrin Dilu ent GM P
20 . Dextrose Diluent GMP
21. Di calcium phosphate Diluent GMP
22 . Ethyl acetate Solvent for coa ti ng GM P (does not remai
n in the tablet and
residual
levels to be as per IP)
23. Ethyl alcohol Solvent for coating GM P (does not
remain in the tablet
and residual levels to
be as per IP)

67
24·. Ethyl cellulose Coating agen t, GM P
Ingredien t of
25. Fructose capsule shells
Diluent GM P
26. Gelatin Bind ing agen t, GMP
Ingredient of
capsule shells
27. G lycerin Vehicle, Hu GM P
mectant for ca psule
28. Guar gum shells agent
Binding GM P
29. Hydrogenated castor oil Lubricant 2%
30. Hydrogenated vegetable oil Lubricant 1%
31. Hydroxy Coating agent, GM P
propyl m Ingredient of
ethylcellulos capsule shells
32. eI somalt Soluble fiber 15%
33. Kaolin Diluent GMP
34. Lactitol Dil uent 200 mgper capsule
35. Lactose Diluent GM P
36. Lecithin and i ts Emulsifier, GM P
salts/esters from soya Stabilizer
or other sources
37. Light magn esium Anticaking agent 0.5%
38. carbonate
Light magnesium oxide Anticaki ng agent 0.5%
39. Liquid glucose Binding agent GM P
40. Magn esium carbonate Adsorbant 0.3%
4·1 Magnesium steara te A ntisticking 2%
. agent, Glidant

4·2. Maize Starch Diluent, Binding GM P

agent,
Dissintegrant
43. Malti tol Sweetener, Diluent GM P
44. Maltodextrin Diluent GM P
4.5, Maltose Diluent GMP
46. Manito! Diluent, Sweetner GM P
47. Methyl paraben and i ts Preservative 0.2%
salts
48. Mi crocrystalline cellu lose Diluent GM P
49 Natural and synthetic Coloring agents Li mi ts as per FSSR
colors as per FSSR
Peanut oil Vehicle GM P
5o.
51. Pectin Binding agent GM P
52. PEG 4000 Diluent for d irect GMP
compression tablets
53. Colors permitted under Coloring agents GMP
Rule 127 of Drugs &
Cosmeti cs Rules
including lake colours

54. Poly ethylene glycol (PEG) Vehicle, 1-Ium GMP

ectant for capsule
shells
55. Povidone Binding agent 5%
56. Propyl paraben and its Preservative 0.02%
salts

68
57. Propylene glycol Vehicle, Hu mecta GMP
nt for capsule sh ells

58. Purified Talc Glidant,Dusting 2%

powder for
coating
59. Saff flower oil Vehicle GMP
60. Sodium alginate Bindi ng agent 5%
61. Sodium starch glycolate Disintegrant, 2%
Binder,
Thickeningagen t

62. Sorbitan crystalli ne Diluent 15%

63. Sorbitan oleate Solubalizers 0.5%
esters
(Tweens)
64. Sorbitol liquid Vehicle, Humectant G MP
for capsule shells
65. Starch, pregelatinized Disi ntegrant 1%
66. Stearic acid Antisticki ng 2%
agent, G lidant
67. Sucrose Diluent, Coa ti ng GMP
68. Sunflower oil agent
Vehicle GM P
69. TBHQ Antioxidant 0.5%
70. Tocoferol and its esters Antioxidant 0.5%
71. Tragacanth gum Bind ing agent GMP
72. Tribasic calcium Dil uent, an GMP
phosphate ticaking agent
73. Tricalcium phosphate Dilu ent G MP
74. Vegetable oils Vehicle GM P
75. Xanth an gum Bindi ng agent GMP
76. Xyli tol Diluent, Sweetner GM P
77. Zi nc stearate Lubricant 0.5-1.5%

69
 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)]

Li st of ingredients as nutraceuticals
PART A
S. No. Nutraceutical Common name Puri ty Criteria Permitted
ingredients Range

1. Astaxanthin - Astaxanthi n content 4 mg/day, Max

(from Haemato cocus
pluvalis), powder or
oleoresin

2. Boswellia serrate - gum Salai guggul / Tota l boswelic acids or 250 - 1,500 m g
resin extract Kundru 11- keto-beta boswelic extract/ day
acids content

3. Caffiene Caffiene Percent caffeine Within levels

specified i n FSS
Regulation s

4.. Chromium picolinate/ - Chromium 200 - 400 mcg / day

nicoti nate picolinate/ nicoti
5. Cimicifuga racemosa (or Blacl< cohosh nate content
Total tri terpene glycosid es 40 - 200 mg
Actaea racemosa). (min imu m 0.4%), calculated /day, Max
Extracted from rhizomes as 23-epi-2 6-deoxyactein).
and roots

6. Citrns Biofla vonoicls (Citrus Citrus Bioflavinoids a11d 150 - 600 mg I

x paradi si, Citrus reticulata total p olyphenol day, Max
x maxima, C. x si11e11sis and content
Citrus limon)

7. CoQ10 from 11011 GM Co enzym e QlO Ubiqinone and ubiqinol 100- 1,000 mg I
source content day, Max

8. Echinacea (£. ang11stif olia,
E. p11r purea, and £.
pa /Iida ) liquid/ powder
extract
Echinacea Alkamide s (0.25 mg/m l) and 900 mg / day,
cichoric acid (2.5 mg/ml), if Max
the extract u s e d i s in l i q u i d
f o r m .incase of
Hydroethanolic Echi nacea
extract is in a powdered form
co mputation may b e done
proportionate ly to th e weigh
t/weight d ry powder extract
based on l iq uid extract used to
obtain a dry powd er format.
9. Ginkgo biloba extract
obtained ji ·om dried leaves of
Ginl<gu (Ginkgo bilo/Ja. L.).
10. Glucosamie
hydrochloride
11. Glucosamine sulphat e
G inkgo biloba extract G inkgo flavone glycosides a nd 120-240 mg/ day,
Ginkgolides (diterpene lactoncs). Max
Total flavonoids con tent
(20.2 to 27% calculated a s
flavanol glycosides and tested
for total terpene l actones (5.4%
to 12.0%). Presence of
Ginkgolides A, B, C needs to
be tested qualitatively.
Glucosamine Glucosamine content 1,500-3,000
mg/day, Max
Gl ucosamine Glucosami ne content 2,500-5,000
mg/day, Ma x
70
 PART A
S. No. Nutraceutical Common Purity Criteria Permitte
ingredients name d Range
12. Gymnema sylvestre Gudmar Gymnemic acid conten t 500-1,500mg I
extract powder extract day, Max
13. Lactase CP- - Enzyme activity 3,000 - 9,000 J U
galactosidase) * (or FCC units)
/ day, Max

14. Panax ginseng ( Ginseng Ginsenoside con tent 90 - 400 mg

Syn;l<orea n Ginseng) extract ranging from 0.7 to 3°/ti . /day, Max
extract - (obtai ned
from
0.6 to 2.0 gm of
Ginseng root, (
Panaxginseng .C A.
Meyer, Araliaceae)

15. Phycocyninfrom Spirulina Protein : 50-70 %; SO - 250 mg

Spirnlina plantesi s Carbohyd ra tes: 20-40%; /d ay, Max
{Aethrospira plante sis) Minera l s (Ash): 5.0 -
Dried powder 15%;
16. Piper nigrum / Peeper I Moisture: 3.0 - 6.0 %
Pi perine content 15 mg/day of
Piper longum Pi ppa Ii piperine,
extract Max(Duration of
use: maximu m
30 days)
17. Quercetin obtai ned - Quercetin content 100 mg / day,
from extracts of citrus Max
fruits
and other vegetables
10 Schizandra berry Five- Schizand rin berries 1- 3 g / day, Max
. extract flavor containi ng 2.5-
berry 3.0% schizandrin
19. Scutellaria bicalensis Skullcap Aq. Extract of Scutellaria 250 - 1,000 mg/
bicalensis standard ized to day, Max
bicallin con tent (N LT 50%)
20. Selenium Yeast - Selenium content and number 2 mg/day of
oj yeast seleni um,
21 Siberian ginseng- Ginseng Releutherosides content Max
100 - 450 mg I
. obtained from 0.6 to extract day, Max
2.0 gm of Ginseng
root (A ca nthopanax
counts {Cfu/g)
senticosus, belonging
to panax type, C A.
Meyer, J\raliaceae)
22. Silybum Milk Thistle Standardized extract - 250 - 1,000 mg/
marianum extract silimarin content day
(silymarin
extract)

23 Spirulina (algae) from Spirulina (Protei n (min.) - 55%, 500 - 3,ooo mg I

. Spi rulina platensis Carbohydrates (max.)-30%, day
(Arthrospira fats (lipid) - not more than
platensis)
 10%,
m in erals (ash)-5-10%,
moi sture- 3-6% (also fatty acid
profile to be mentioned on the
package)

24. Vaccinium Bilbeny Anthocy anin content 50 - 600 mg I

myrstillus extract extract day, Max

71
 Part B
S.No. Nutraceutica ls / Ingredients Common name.
1. (+) 1-lydroxyci tric acid

2. Alli11m sativum - bulbs dried powder / extract

powd er standa rdized Garlic

3. Aloe vera -ju ice /co 11ce11trate / po wder of sap /gel Indian aloe, Ghri t kumari
4. Alpha amylase* -
5. Alph a rnangostin -
6. Alpha-galactosidase* -
7. Alpha-li poic acid -
0. Amaranthus tri color - leaf powd er / extract -
9. Amylase* -
10. Amyloglucosidase* -
11. Anethum graveolens L.- seeds and oi l Dill
12 . Anthocyani n -
13. Arabi nogalactan -
14. Arachidonic acid -
15. Aspa ragus densiflorus - extract Aspa ragus
16. Bacopa mo1111ieri - leaf extract Brahmi
17. Barley seed powdr Barley
18. Berberis v11/garis - stem/root extract Berberry
Beta ca rotene - standardized soft concentrate / em
19.
ulsified concentrate / powd er -
20. Beta ecdysteron e -
21. Beta gl ucans -
22 . Beta vulgaris - root extract Beet
23. Beta sitosterol -
24.. Betula platyphyl/a - bark extract Birch
25. Biota orientalis - seed powder Biota
26. Black /green tea extract, standard ized powder -
27 . Baraga ojficinalis - oil Borage
2·0. Cam pestanol -
29. Cam pesterol -
30. Capsicum annum - extract / standardized to capsicin Cayen ne pepper
31. content
Caricus pa paya - leaf extract Papaya
32. Carotenoids (natu ral mixed, including from algal sources) -
33. Casein and casei nates
34·. Caulophyllum thalictroides - root extract Blue cohosh
35. Cellulase* -
36. Centella asiatica - leaf/aeria l parts standardized extract Mandu kpa rni / Gotu
37. M atricaria chamomil/ a (Matricaria recutita) - aerial Kola
Chamomile
parts extract

72
 Part B
S.No. Nu traceutica ls / Ingredients Common name.
38. Chiarella platensis - dried powder Green algae
39. Chlorogenic acids and caffei c acid -
40. Chondroitin sulphate Chond roitin
41. Cichorium inlybus - roasted root powder Chicory
4·2. Cinnamomum verum - bark powder / extract Cinnamon
43. Citrulline -
44. Citrus aurantium - peel extract / biotlavonoids standard Bitte r orange
4S. ized
Citrus naringen in -
46. Citrus naringin ine -
47. Clove powd er Lava ng
48. Cnicus benedictus - aerial parts extract / root extract Blessed thistle
49. Cocoa (chocolate) bean - extract -
so. Coccinia grand is (L.) Voigt - extract Ivy gou rd
S1. Collagen hyd rolysed -
S2. Conjugated linoleic acid concentrate -
S3. Crustacean shells -
S4. Cuminum cyminum L - oil / extract Cumin
SS. Curcuma longa - rhizome powder / extract standardized Tu rmeric
S6. Curcum inoids - soft extract / powder and curcumin -
com plex
S7. Cyperus rota11d11s - extract Nirgu ndi
58. Dehydroe piandrosterone (DHEA) and 7-Keto DH EA
S9. Diastase* -
60. D-Pinitol -
Edible legumes (seed powder), legume proteins
61.
(protein isolates/ concentrates/ hydrolysates) -
62. Ellagic acid -
63. Emblica officinalis - dried fru i t extract / spray dried pu lp Ind i an gooseberry/ aml a
powder
64. Eriocitrin (from citrus fruit) -
6S. Evening primrose oil -
66. Fagopyrum esculentum - seed Buckwheat
67. Fish oil -
68. Foe11icu / 11m vulgare - fruit - oil / extract Fennel
69. Freeze-dried banana powder -
70. Galactomannan -
71. Gallic acid -
72. Gamma-Jinoleic acid (GLA ) -
73. Gam ma-oryzanol -
74. Garcinia gummi-gatti and Garci11ia cambogia - fru i t Kokum / Brindall
rind extract standa rdized to hydroxyl citric acid, 13erry / Malabar ta
powder) marind

7S. Garcinia mangostana - seed extract standardized Mangosteen

76. Gl ucoamylase* -
73
 Part B
S.No. N utraceut i cals / Ingredients Common name.
77. Glucomannan -
70. Glycyrrhiza g labra - extract Licorice
79. Grape seed extract -

Green coffee seed extract standardized, including decaffeinated

80.
coffee bea n powder/extra ct -
81. Crifolafrondosa - standardi zed extract Maitakc mushroom
Guar gum and gum arabic and its derivatives as a sou rce offibers;
02.
and fibers from other food sources
03. Hemicellulase* -
8'1.. Hesp eridin -
High oleic sun flower oil and other vegetable oils with high oleic
05.
content -

86. H ipp op /werh amnoides - frui t dried powd er / extract / juice Sea buckthorn
07. Humu lus lup ulus L - powder / extract Hops
80. Hyd ro lysed whey pe ptide Whey
89. 1-fy pericum perforatum - aerial parts standard ized extract St. johns Wort
90. /11 ula racemosa - root extract Pushkarmoola
91. lnvertase* -
92. lsoflavones (genistein, da idzein) -

93. Kelp (brown algae) -

94.. Krill oil - standard ized for D I-IA / E PA -

95. Lacta lbumin -
96. Lactoferr i n -
97. Lactoperoxidase* -
90. lagerstroemia speciosa L (leaf extract) Banaba
99. Leci thins -
100. Lignans -

101. Lin um usitatissimum - seed powder and oil Flaxseed

102. Lipase* -
103. Lu tei n -
104. Lu tein/zeaxa nthi n com plex -

105. Lycopene -

lycium eleagnus - fruit - dried powder / concentrate

10 6.
standard ized Goji berry (wolfbcrry)
107. Maltase* -
108. Medicago sativa extract Alfalfa
109. Med i um chain triglycerides -
110. Menyantil estrifoliata - Leaf powder Buckbean / bogbean
111. M i llets and their powder -
74
 Part B
S.No. Nutraceuticals / Ingredients Common name.
115 Moringa o/eifera leaf / pods / seed extract powder Moringa / drum stick
.116 M ulberry tea - leaf / fru i t extract M ulberry
.117 Myrica cerifera - bark extract Bayberry
.118 Myristica ji"agra ns Mace
.
119 N-Acetyl 0-glucosamine -
.120 Nasturtium officina/e - extract Watercress
.121 Nattokinase enzyme (as Soy 13ean fiibrinase) -
. Ocimum tenuijlorum /Ocimum sanctum - aerial
122
. parts / seed extract Basil /tu lasi

Omega-3 fatty acids (docosa hexaenoic acid -

123
.
eicosapentaenoic acid - alpha - linolenic acid) -
124 Omega-6-fatty acids (l i noleic aci d, -
. arachidonic acid and conjugated linoleic acid)

125 Oyster shell powder -

.126 Pancreatin* -
.127 Pancrelipase* -
.128 Papa in* -
.
129 Passiflora fo etida - extract Passion flower
.130 Arachis hypogaea - (roasted) powder Pea nut
.131 Pectin -
.132 Pepsin* -
.133 Phellodendron am11rense l eaf oil Phellod endron
.134 Phosphatides /Phospholip ids -
.135 Phyllantlws amarus - extract Bhuiamal aki
.136 Phyta se* -
.137 Picrorhiza ( Picrorhiza lwrroa) - extract Kurchi
.138. P imento officinal is L. - extract/ powder Allspice
139 Pim1s gerardiana - bark extract
Pinenu t
.
140 Piper long um - extract Long pepper (pippali)
. 41
1 Piper nigram - green extract Green pepper
.
142 Piper nigrum- powder / sta ndardized extract Black peppe r
.14- Policosanol -
3.
144 Protease* -
.145 Prunus serotina - extract Black cherry
.14 Psyllium (lspaghula) - seed husk Isaphgul
6.
147 Pum pkin seed oil /mea l -
.148 Punica granatum - fruit /seed /skin extract /powder Pomegranate / dadima
.14- Raph anus sativus var. niger - root powder/ extract Black radish
9.
150 Red wi ne - extract /concentrate -
.151 Red yeast rice -
.152 Resveratrol -
.
75
 Pa rt B
S. Nutraceuticals / Ingredients Common name.
No
153. Rhododend ron arboretum - j u ice/extract Rhododendron
.
154. Rice bran -
155. Rice bran arabinoxylan compound -
156. Rose hips -
157. Rosmarimts offtcinalis - leaves/ needles extract /oil Rosemary
158. Roya l jelly -
159. Rutin from fru i t peels -
160. Salvia officinalis - leaf extract Sage
161. Sam/J ucus nigra - extract Elderberry/ Black elderberry

162. Sha rk cartilage /sq ualene oil -

163. Shi itake m ushroom - extract -
164.. Solanum lycopersicum - fru it powder/ extract Tomato
165. Soy sprouts - d ried powder -
166. Soya protei n isolate/ edible legume seed protei n isolate -
167. Spearmint - leaf and d istillate -
160. Stanols and sterols incl uding cholesterols -
169. Tagetes sp. - petals oleo resin / extract Marigold
170. Tea catechins (epiga llo catechin gallate, epicate ch -
in, catech i n gall ates)
171. Terminalia arjuna - ba rk / leaf extract (standardized Arjuna
172. extract)
Terminalia bellerica - fru it extract Myroba lan / Baheda
173. Terminalia c/ 1ebulia - frui t extract Myrobalan / Harad
174. Theaflavin -
175. Thea n i ne -
176. Theobrom ine --
177. Tocopherols -
178. Trigo nel/a-foenum -gra ecum - seeds extract l'en ugreek
179. Triticum sa tivum - bra n Wheat
180 Trypsin* -
181. Vaccinium co1y mbosum - fru i t - d ried powder / Bl ueberry
concentrate standardized
182. Vaccinium o.rycoccos - fru i t - dried powder / Cranberry
concentra te standardized
183. Vitis alba and Vitis vinifera - fru it - dried powder / Blue grapes
concentra te standardized
184. Wheat germ -
185. Zeaxanth in (max. 4 mg/ day) -
186. Zingiber offtcinale - rhizome standardized extracts Ginger
1 a-galactosidase* -
Note.- *Enzymes- The enzymes listed in this schedule are pri marily used as processing aids, but also may
8
be7used i n nutraceutical products.
.
76
 Schedule -VII
[See regulations 3.(13), 6.(2)(i), 7.(2)(i), 0.(2) (i), 9.(2)(i) and 10.(l)(i)]
List of strains as probiotics (live micro-organisms)

S. No. Name of the Microorganism

1. Lactoba cillus acidophilus
2. Lactobacillus plantarum
3. Lactobacillus reuteri
4. Lactobacil/ us rhamnosus
5. Lactobacil/ us salivarius
6. Lactobacillus casei
7. La ctobasillus brevis
8. Lactoba cillusj ohnsoni
9. Lactobacil/ us de/brueckii sub- sp. bulgaricus
10. Bacillus coagulans
11. Lactobacillus fermentum
12. Lactobacillus caucasicus
13. Lactobacillu s helveticus
14. Lactobacillus lactis
15. Lactobacil/ us amylovorus
16. Lactoba cillusgallinarum
17. Lactobacillus d elbrueckii
18. Bifidobacterium bifid um
19. Bifidobacterium /actis
20. Bifidobacterium breve
21. Bifidoba cterium longum
22. Bifidbacterium a nimalis
23. Bifidobacterium infantis
24. Streptococcus thermophilus
25. Saccharomyces boulardii
26. Saccharomyces cerevisiae
27. Lactobacil/ us pa racasei
28. Lactobacillus gasseri
29 Bacillus clausii
30 Bacillus subtilis
Note.- (1) These organ i sms may be used either singly or in combination but shal l be
declared on the label wi th full information and has to be Non-G MO.
(2) The Food Authori ty may add any new strain of microorganism, possesing
probitici c properties, after pro per scientific evaluation, and incl ude in this
Schedule.
77
 Schedule - VIII
[See regulati ons 3.(13), 6.(2)(i), 7.(2) (i), 8.(2)(i), 9.(2)(i) and 11.(l)(i)]

List of prebiotic
compounds

S. No. Prebiotic Compounds

1. Polydextrose
2 Soybean oligosaccharides/ Soya poly saccharides
3. lsomal to-oligosaccharid es
4·. Fructo-oligosaccharides
5. Gluco-oligosaccharides
6. Xylo-o ligosaccharides
7. lnuli n
8. Isomal tu lose
9. Gentio-ologsaccharides
10. Lactulose
11. Lactoferrin
12. Sugar alcohols such as lactitol, sorbitol, m altitol, i nositol, isomalt
13. Galacto-oligosaccharides

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

78