The Food Safety and Standards (Advertisements and Claims) Regulations, 2018

The Food Safety and Standards Act, 2006

Official text

MINISTRY OF HEALTH AND FAMILY WELFARE

(FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA)

NOTIFICATION

New Delhi, the 19th November, 2018

F. No. 1-94/FSSAI/SP(Claims and Advertisements)/2017.—Whereas the draft of the Food Safety

and Standards (Advertising and Claims) Regulations, 2018 was published as required under sub-section(1) of

section 92 of the Food Safety and Standards Act, 2006 (34 of 2006) vide notification of the Food Safety and

Standards Authority of India F.No. 1-94/FSSAI/SP(Claims and Advertisements)/2017, dated the 13th March,

2018, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the

persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the

copies of the Official Gazette containing the said notification were made available to the public;

And whereas copies of the said Official Gazette were made available to the public on the 23rd, March

2018;

And whereas objections and suggestions received on the said draft regulations have been considered

by the Food Safety and Standards Authority of India;

Now, therefore, in exercise of the powers conferred by clauses (k) and (v) of sub-section (2) of section

92, read with the section 23 and section 24 of Food Safety and Standards Act, 2006 (34 of 2006), the Food

Safety and Standards Authority of India hereby makes the following regulations, namely:-

Regulations

1. Short title and commencement- (1) These regulations may be called the Food Safety and Standards

(Advertising and Claims) Regulations, 2018.

(2) They shall come into force on the date of their publication in the Official Gazette and Food Business

Operator shall comply with all the provisions of these regulations by 1st July, 2019.

2. Definitions – (1) In these regulations unless the context otherwise requires,-

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

(b) “advertisement” means any audio or visual publicity, representation or pronouncement made

by means of any light, sound, smoke, gas, print, electronic media, internet or website and

includes through any notice, circular, label, wrapper, or other documents;

quantities and in appropriate proportions that meet the requirements;

(d) “claim” means any representation which is printed, oral, audio or visual and states, suggests,

or implies that a food has particular qualities relating to its origin, nutritional properties,

nature, processing, composition or otherwise;

(e) “dietary fiber” means carbohydrate polymers with a degree of polymerisation (DP) not

lower than three, which are not hydrolysed by the endogenous enzymes in the small intestine

of humans and the same consists of one or more of-

(i) edible carbohydrate polymers naturally occurring in the food as consumed;

(ii) carbohydrate polymers, which have been obtained from food raw material by physical,

enzymatic or chemical means;

(iii) synthetic carbohydrate polymers;

(f) “equivalence claims” means claims that attempt to promote the equality in value, amount and

importance of one food attribute to another;

(g) “fat” means total lipids including saturated fat, monounsaturated fat, polyunsaturated fat and

trans fat.

Explanation.- for the purposes of this clause,-

(i) “saturated fats” means fatty acids without double bonds;

(ii) “monounsaturated fats” means fatty acids with one cis double bond;

(iii) “polyunsaturated fats” means fatty acids with cis-cis methylene interrupted double

bonds; and

(iv) “trans fat” means all the geometrical isomers of monounsaturated and

polyunsaturated fatty acids having non-conjugated, interrupted by at least one

methylene group, carbon-carbon double bonds in the trans configuration;

(h) “health claim” means any representation that states, suggests, or implies that a relationship

exists between a food or a constituent of that food and health, which includes the following,

namely:-

(i) “nutrient function claim” is that which describes the physiological role of the nutrient in

growth, development and normal functions of the body;

Example: Nutrient ‘A’ - naming a physiological role of nutrient ‘A’ in the body in

maintenance of health and promotion of normal growth and development. (Food X is a rich

source of or high in nutrient ‘A’);

(ii) “other function claim” that describes the specific beneficial effects of the consumption

of foods or their constituents, in the context of the total diet or normal functions or

biological activities of the body, which relate to a positive contribution to health or to the

improvement of a function or to modifying or preserving health.

Example: Substance A naming the effect of substance A on improving or modifying

physiological function or biological activity, associated with health (Food Y contains X

grams of substance ‘A’).;

(iii) “reduction of disease risk claims” refers to claims that state, suggest or imply that

consumption of such foods or food constituents, in the context of total diet, reduce the risk

of developing a disease or health related condition.

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Explanation.- for the purpose of this sub-clause, “reduction of disease risk” means

significantly altering major risk factors, for a disease or health related condition as diseases

have multiple risk factors and altering one of these risk factors may or may not have a

beneficial effect and the presentation of risk reduction claim must ensure, for example, by

use of appropriate language and reference to other risk factors, that consumers do not

interpret them as prevention claims.

Examples:

(a) A healthful diet low in nutrient or substance ‘A’ may reduce the risk of disease D.

Food X is low in nutrient or substance ‘A’;

(b) A healthful diet rich in nutrient or substance ‘A’ may reduce the risk of disease D.

Food X is rich in nutrient or substance ‘A’;

(i) “marketer” refers to persons or companies, including advertisers, and direct marketers,

including e-platforms who or on whose behalf marketing communications are published for

the purpose of promoting their products or influencing consumer behaviour;

(j) “marketing communications” includes advertising as well as other techniques, such as

promotions, sponsorships and direct marketing, and shall be interpreted broadly to mean any

communications produced directly by or on behalf of marketers intended primarily to promote

products or to influence consumer behaviour;

(k) “nutrient” means a constituent of food, which-

(i) provides energy ; or

(ii) has specific metabolic or physiological functions; or

(iii) is needed for growth and development and maintenance of healthy life;

(l) “nutrition claim” means any representation which states, suggests or implies that a food has

particular nutritional properties including but not limited to the energy value and to the

content of protein, fat and carbohydrates, as well as the content of vitamins, minerals and

other permitted listed nutrients and nutrition claims may include the following:

(i) “nutrient content claim” is a nutrition claim that directly or indirectly describes the level

of a nutrient contained in a food. (Examples: contains or source of; high in; rich in; low in,

etc.);

(ii) “nutrient comparative claim” is a claim that compares the nutrient levels or energy value

of two or more foods. (Examples: reduced; less than; fewer; increased; more than, etc.);

(m) “non-addition claim” means any claim that an ingredient or additive has not been added to a

food, either directly or indirectly and the ingredient or additive is one whose presence or

addition is permitted in the food and which consumers would normally expect to find in the

food;

(n) “recommended dietary allowances” means the average daily dietary nutrient intake level

sufficient to meet the nutrient requirement of nearly all (97 to 98 per cent.) healthy individuals

in a particular life stage and gender group.

Explanations.- For the purposes of this clause, recommended dietary allowances values as

provided in current Indian Council of Medical Research Nutrient Requirements and

Recommended Dietary Allowances for Indians shall be applicable and if Indian

recommended dietary allowances is not available for any nutrient then values provided in

Codex or World Health Organization guidelines shall be applicable;

(o) “sugars” means all monosaccharides (glucose, fructose, etc.) and disaccharides (maltose,

sucrose, lactose, etc.).

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(2) All other words and expressions used herein and not defined, but defined in the Act, rules or

regulations made thereunder, shall have the meanings assigned to them in the Act, rules or

regulations, respectively.

3. Food business operator and marketers to follow general principles.- Every food business operator and

marketer while advertising and publishing or disseminating marketing communication meant for promotion or

sale of any article of food including labelling claims shall comply with the following general principles:

Provided that advertisements and claims in respect of food meant for infants shall be in accordance

with the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and

Distribution) Act, 1992 (41 of 1992) Act).

4. General principles.-

(1) Claims must be truthful, unambiguous, meaningful, not misleading and help consumers to comprehend

the information provided.

(2) Claims shall not encourage or condone excess consumption of a particular food.

(3) Claims shall not state, suggest or imply that a balanced and varied diet cannot provide appropriate

quantities of nutrients as required by the body.

(4) Where the claim benefit is related to or dependent on the method of preparation of the food the same

shall be provided on the label.

(5) Claims shall specify the number of servings of the food per day for the claimed benefit.

(6) The claim that a food has certain nutritional or health attributes shall be scientifically substantiated by

validated methods of characterising or quantifying the ingredient or substance that is the basis for the

claim.

(7) Where the meaning of a trade mark, brand name or fancy name containing adjectives such as “natural”,

“fresh”, “pure”, “original”, “traditional”, “authentic”, “genuine”, “real”, etc., appearing in the labelling,

presentation or advertising of a food is such that it is likely to mislead consumer as to the nature of the

food, in such cases a disclaimer in not less than 3mm size shall be given at appropriate place on the label

stating that –

“*This is only a brand name or trade mark and does not represent its true nature”.

(8) All disclaimers related to a claim shall be conspicuous and legible.

(9) Notwithstanding the mandatory declaration of Food Safety and Standards Authority of India logo and

license number as per Food Safety and Standards (Packaging and Labelling) Regulations, 2011, no claim

or promotion of sale, supply, use and consumption of articles of foods shall be made using Food Safety and

Standards Authority of India logo and license number.

(10) Advertisements shall also not undermine the importance of healthy lifestyles.

(11) Advertisements for food or beverages shall not be promoted or portrayed as a meal replacement unless

otherwise specifically permitted as a meal replacement under any other Regulations made under Food

Safety and Standards Act, 2006 (34 of 2006)

(12) Claims in advertisements shall be consistent with information on the label of the food or beverage.

(13) No advertisement shall be made for food products which is deceptive to the consumers.

(14) Every declaration which is required to be made on advertisements under these regulations shall be

conspicuous and legible.

5. Nutrition claims.-

(1) Nutrition claims may be.-

(a) nutrient content claim; or

(b) nutrient comparative claim

(2) The following do not constitute nutrition claims, namely:-

22 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]

(a) the mention of substances in the list of ingredients;

(b) the mention of nutrients as a mandatory part of nutrition labelling;

Food Safety and Standards Act, 2006 (34 of 2006) and the rules and regulations made thereunder.

(3) Nutrient content or nutrient comparative claim or any synonymous claim shall be made in accordance

with the conditions specified in Schedule I, provided flexibility in the wording of a nutrition claim is as

per Schedule II, or the use of any other word if they are in accordance with conditions specified in

Schedule I and the meaning of the claim is not altered.

(4) Where a nutrient comparative claim is made, the foods shall be different versions of the same food or

similar foods being compared and shall be easily identifiable and the relative difference of the claimed

parameter between the compared foods is-

(a) at least twenty-five per cent. in the energy value or nutrient content and a minimum absolute

difference equivalent to the figure defined as “low” or as a “source” in Schedule I, for claims about

energy or macronutrients and sodium respectively.

(b) at least ten per cent. of recommended dietary allowances, for claims about micronutrients other

than sodium.

(5) In addition, where a comparative claim is made, the identity of the foods being compared and the

amount of difference expressed as a percentage, fraction or an absolute amount shall be given in close

proximity to the claim.

(6) The equivalence claims in form of phrases such as "contains the same amount of [nutrient] as a [food]"

and "as much [nutrient] as a [food]" may be used on the label or in the labeling of foods, provided that the

amount of the nutrient in the reference food is enough to qualify that food as a "source" of that nutrient,

and the labeled food, on per 100g or 100ml, is an equivalent, source of that nutrient (e.g., "as much fiber

as an apple," and "contains the same amount of vitamin C as ….. glass of orange juice.")

6. Non-addition claims.-

(1) Non-addition of sugars.- (a) Claims regarding the non-addition of sugars to a food may be made if the

following conditions are met, namely:-

(i) no sugars of any type have been added to the food (Examples: sucrose, glucose, honey,

molasses, corn syrup, etc.);

(ii) the food contains no ingredients that contain sugars as an ingredient (Examples: jams,

jellies, sweetened chocolate, sweetened fruit pieces, etc.);

(iii) the food contains no ingredients containing sugars that substitute for added sugars

(Examples: non-reconstituted concentrated fruit juice, dried fruit paste, etc.); and

(iv) the sugars content of the food itself has not been increased above the amount contributed

by the ingredients by some other means (Example: the use of enzymes to hydrolyse starches

to release sugars).

(b) Claims regarding the non-addition of sugars to a food may also be made, where sugars are naturally

present in the food, and in such case the following indication shall also appear on the label.

‘CONTAINS NATURALLY OCCURRING SUGARS’.

(2) Non-addition of salt (Sodium chloride).- Claims regarding the non-addition of salt (sodium chloride)

to a food, including “no added salt”, may be made if the following conditions are met, namely:-

(a) The food contains no added salt (sodium chloride); and

(b) The food contains no ingredients that contain added salt (sodium chloride) including but not

limited to sauces, pickles, pepperoni, soya sauce, salted fish, fish sauce.

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(3) Non-Addition of additives.- Claims regarding the non-addition of additives including functional

classes of additives as specified in Food Safety and Standards (Food Product Standards and Food

Additives) Regulations, 2011 to a food, may be made if that the additive for which claim is made-

(a) has not been added to the food;

(b) is not contained in any ingredient of the food;

Standards (Food Product Standards and Food Additives) Regulations, 2011; and

(d) has not been substituted by another additive giving the food equivalent characteristics

(4) Additional conditions for non-addition claims.- The additional conditions or disclaimer statements

may be used with non-addition claims to assist consumer understanding of the claims provided that the

disclaimer statements shall be conspicuous and legible.

7. Health claims.- (1) Health claims shall comply with the following conditions and declarations, namely:-

(a) the health claim must consist of two parts, namely:-

(i) information on the physiological role of the nutrient or substance or an accepted diet- health

relationship; and

(ii) information on the composition of the product relevant to the physiological role of the

nutrient or substance or the accepted diet-health relationship unless the relationship is based on

a whole food or foods whereby the research does not link to specific constituents of the food;

(b) if the claimed benefit is attributed to a constituent in the food, for which a recommended dietary

allowance value is established, the food in question shall be-

(i) a source of or high in the constituent, in accordance with conditions specified in Schedule I,

in the case where increased consumption is recommended; or,

(ii) low in, reduced in or free of the constituent, in accordance with conditions specified in

Schedule I, in the case where reduced consumption is recommended;

100ml or per pack (single consumption pack) of the food;

(d) where applicable, target group shall be mentioned or where a certain contraindication exists,

advice to vulnerable groups on consumption or avoidance of the food shall be made available;

(e) directions for use of the food to obtain the claimed benefit in the context of the diet and other

lifestyle factors where appropriate;

(f) maximum safe intake of the food or the constituent, if necessary.

(2) Nutrient function claims and other function claims may be made based on current relevant scientific

substantiation and to provide sufficient evidence on the type of claimed effect and the relationship to health

as recognised by generally accepted scientific review of the data and the scientific substantiation shall be

reviewed by food business operator as new knowledge becomes available and claims updated accordingly.

(3) No reduction of disease risk claims shall be made that is not in accordance with the conditions specified

in Schedule III.

(4) Food articles that are fortified as per Food Safety and Standards (Fortification of Foods) Regulations,

2018 may make health claims as provided in Schedule IV and flexibility in the wordings of the claim

statement is acceptable, if the meaning of the claim is not altered.

(5) Where a claimed health benefit is attributed directly to the product, it shall be based on statistically

significant results from well-designed human intervention studies, conducted by or under guidance of

established research institutions, in line with the principles of GCP (Good Clinical Practices) and peer

reviewed or published in a peer reviewed reputed scientific journal.

24 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]

8. Claims related to dietary guidelines or healthy diets.- (1) claims may be made related to a “healthy diet” or

any synonymous term referring to the pattern of eating as per current Indian Council of Medical Research

Dietary Guidelines for Indians and the label shall carry a statement relating the food to the pattern of eating

described thereof.

(2) Foods, which are described as part of a healthy diet, balanced diet shall not be based on selective

consideration of one or more aspects of the food and shall also satisfy the criteria for other major nutrients

related to the current Indian Council of Medical Research Nutrient Requirements and Recommended

Dietary Allowances for Indians and Indian Council of Medical Research Dietary Guidelines for Indians,

based on scientific evidence.

(3) Foods shall not be described as “healthy” or be represented in a manner that implies that a food in and

of itself will impart health.

(4) Flexibility in the wordings is acceptable, if the claims remain faithful to the pattern of eating outlined in

the current Indian Council of Medical Research Nutrient Requirements and Recommended Dietary

Allowances for Indians and Indian Council of Medical Research Dietary Guidelines for Indians.

9. Conditional Claims.- (1) a claim may be made where a food is by its nature high or low or free of a specific

nutrient provided the name of the nutrient or substance is preceded by the words ‘natural or naturally’ in

the claim statement.

Explanation: “a naturally low (naming a nutrient or substance) food” or “a naturally (naming the nutrient

or the substance) free food”.

(2) claims containing adjectives such as “natural”, “fresh”, “pure”, “original”, “traditional”, “Authentic”,

“Genuine”, “Real”, etc. , when used, shall be in accordance with conditions laid down in Schedule V and

the claims containing words or phrases like “home-made”, “home cooked”, etc., which may give an

erroneous impression to the consumer shall not be used.

10. Prohibited claims.- (1) no claims shall be made which refer to the suitability of the food for use in the

prevention, alleviation, treatment or cure of a disease, disorder or particular physiological condition unless

specifically permitted under any other regulations made under Food Safety and Standards Act, 2006 (34 of

2006).

(2) There shall not appear in the label of any package, containing food for sale the words

“recommended by the medical or nutrition or health professionals” or any words which imply or

suggest that the food is recommended, prescribed, or approved by medical practitioners or approved for

medical purpose.

(3) No product shall claim the term “added nutrients”, if such nutrients have been added merely to compensate

the nutrients lost or removed during processing of the food

(4) Foods for special dietary uses or foods for special medical purposes shall not carry a claim unless

specifically permitted under any other regulations made under Food Safety and Standards Act, 2006 (34 of

2006).

(5) Claims which do give rise to doubt or suspicion about the safety of similar food or which may arouse fear

shall not be made.

(6) No health claims shall be made for foods that contain nutrients or constituents in quantity that increase the

risk of disease or an adverse health-related condition.

(7) No advertisements or claims for articles of foods shall be made by any food business operator that

undermines the products of any other manufacturer for the purpose of promoting their products or influencing

consumer behavior.

11.Approval of claims.- The food business operator or marketer shall seek prior approval from the Food

Authority for reduction of disease risk claims other than those that are defined and for which criteria are laid

out under these regulations or any other regulations made under the Food Safety and Standards Act, 2006 (34

of 2006).

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12. Procedure for approval of claims.- (1) The food business operator shall submit an application along with

applicable fees as prescribed by Food Safety and Standards Authority of India consisting of the following

information, namely:-

(i) Claim to be made;

(ii) Name of ingredient, nutrient or substance on the basis of which the claim is to be made;

(iii) Validated Method of analysis of ingredient or substance for which the claim is to be made;

(vi) Scientific information or materials substantiating the claim;

(v) How is the claim clear and meaningful and help consumers to comprehend the information

provided;

(vi) Well-designed human intervention studies in case of health claims conducted by or under

guidance of established research institutions; and

(vii) Any other useful information.

(2) The food authority itself or may appoint an agency or panel to carry out preliminary scrutiny of the

application submitted by food business operators or marketers for approval of their claims.

(3) On scrutiny, deficiencies, if any, shall be informed to applicant within ninety days from the date of receipt

of application and the applicant shall provide the information required by the food authority within thirty days

of the receipt of the communication, failing which the application shall be rejected without any further

reference.

(4) The fees paid by the applicant for recognition shall not be refunded under any circumstances.

(5) After scrutiny, the Food Authority may pass a speaking order either for approval or rejection of concerned

claims and may also suggest an amendment for the concerned claim.

(6) The amended claim referred to in sub-regulations (5) may be submitted to the Food Authority within thirty

days for reconsideration.

(7) In case of rejection, the food business operator or marketer shall not use that claim in their advertising and

marketing communication in respect of articles of food offered for sale or for promotion of sale, supply, use or

consumption.

13. Redressal of non-compliance.- (1) Any person who advertises or is a party to the publication of any

advertisement or claims not complying with this regulation shall be penalised as per section 53 of Food Safety

and Standards Act, 2006 (34 of 2006).

14. Procedure for redressal of non-compliance.- (1) The misleading claims shall be referred to the food

authority or the Food Authority may on its own motion take on file any misleading claim and the Food

Authority may itself analyse or may appoint an agency or panel to analyse such misleading claims.

(2) In case the agency or Food Authority requires information from the food business operator or marketer,

the food authority will seek clarification failing which action shall be initiated as per sub-regulation (1) of

regulation 13.

(3) the food business operator or the marketer shall submit the information sought for within thirty days from

the issue of the letter.

(4) After scrutiny of the submitted information, the officer nominated by the Authority shall pass a speaking

order within ninety days either for acceptance or rejection of submitted clarification on misleading claims.

(5) The Food Authority may also suggest an improvement for the concerned claim and the improved claim

shall be intimated to the Food Authority within forty- five days after issuance of letter.

15. Corrective advertisement.- If an advertisement is found to be in violation of the provisions of these

regulations, the Food Authority may, by order, require the concerned food business operator or advertiser to

stop it immediately and to issue corrective advertisement within thirty days through the same medium for

neutralising the effect of such advertisement.

26 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]

SCHEDULE – I

[See regulation 5 (3) and (4) and regulation 7 (1)(b)]

NUTRITION CLAIMS

A claim that a food containing the nutrient mentioned in column (2) is likely to have the benefits as mentioned

in column (3) or has the same meaning for the consumer may be made subject to the conditions as mentioned

in column (4) below:

(1) (2) (3) (4)

Sl. No Nutrient/ component Claim Conditions

Energy/Calorie Low

Not more than

40 kcal

per 100 g for solids

20 kcal per 100 ml for liquids.

Free Not more than

4 kcal per 100 ml for liquids.

2. Fat Low Not more than

3 g of fat per 100 g for solids or

1.5 g of fat per 100ml for liquids.

Free Not more than

0.5 g of fat per 100 g for solids or 100 ml for liquids.

3. Cholesterol Low Not more than

20 mg cholesterol per 100 g for solids and 1.5 g saturated fat

per 100 g for solids or

10 mg per 100 ml for liquids and 0.75 g of saturated fat per

100 ml for liquids

and in either case must provide not more than 10% of energy from

saturated fat.

Free* Not more than

5 mg cholesterol per 100g for solids or 100 ml for liquids.

Additionally the food shall contain no more than

1.5 g saturated fat per 100 g for solids or

0.75 g of saturated fat per 100 ml for liquids

and in either case must provide not more than 10% of energy from

saturated fat.

4. Saturated fat Low* Not more than

1.5 g per 100 g for solids or

0.75 g per 100 ml for liquids

and in either case must provide not more than 10% of energy from

saturated fat.

Free Saturated fatty acids do not exceed

0.1 g per 100 g or 100 ml of food.

5. Unsaturated fat High* At least 70% of the fatty acids present in the product are derive

from unsaturated fat under the condition that unsaturated fat

provides more than 20% of energy of the product

6. Trans fat Free The food contains less than 0.2g trans fat per 100 g or 100ml of

food

7. MUFA High in

MUFA*

Shall only be made where at least

45% of the total fatty acids present in the product are derived from

mono unsaturated fat and under the condition that monounsaturated

fat provides more than 20% of energy of the

product

8. PUFA High in

PUFA*

Shall only be made where at least

45% of the total fatty acids present in the product are derived from

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(1) (2) (3) (4)

Sl. No Nutrient/ component Claim Conditions

poly unsaturated fat and under the condition that polyunsaturated

fat provides more than 20% of energy of the

product

9. Omega 3 fatty acids Source The product contains:

at least 0.3g alpha-linolenic acid per 100 g and per 100kcal, or

at least 40 mg of the sum of eicosapentaenoic acid and

docosahexaenoic acid per 100g and per 100kcal

High The product contains:

at least 0.6 g alpha-linolenic acid per 100g and per 100kcal, or at

least 80mg of the sum of eicosapentaenoic acid and

docosahexaenoic acid per 100g and per 100kcal

10. Sugars Low The product contains not more than

5 g of sugars per 100 g for solids or

2.5 g of sugars per 100 ml for liquids.

Free The product contains not more than

0.5 g of sugars per 100 g for solids or 100 ml for liquids.

11. Protein Source*

10% of RDA per 100 g for solids

5% of RDA per 100 ml for liquids

or 5% of RDA per 100 kcal

Rich / High * 20% of RDA per 100 g for solids

10% of RDA per 100 ml for liquids

or 10% of RDA per 100 kcal

12. Vitamin(s) and/or

Mineral(s)

Source The food provides at least

15% of RDA of the vitamin/mineral per 100g for solids or

7.5% of RDA of the vitamin/mineral per 100 ml for liquids

High The food provides at least

30% of RDA per 100 g for solids or

15% of RDA per 100 ml for liquids

13. Sodium Low Product contains not more than

0.12 g of sodium per 100 g for solids or 100 ml for liquids.

Very low Product contains not more than

0.04 g of sodium per 100 g for solids or 100 ml for liquids.

Sodium free Product contains not more than

0.005g of sodium per 100 g for solids or 100 ml for liquids.

14. Dietary fibre Source Product contains at least

3 g of fibre per 100 g or

1.5 g per 100kcal

High Or Rich The product contains at least

6 g per 100 g or

3 g per 100 kcal

15. Probiotics Source Product contains ≥10

CFU in the recommended serving size per

day

16. Glycemic index (GI) Low GI GI value below 55

A food’s GI indicates the rate at which the carbohydrate in the food

is broken down into glucose and absorbed from the gut into the

blood

and expressed as a per cent of the response to the same amount of

carbohydrate from a standard food, white bread

28 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]

Note: Nutrient content claims for food products falling under health supplement categories shall be governed by Food

Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical

Purpose, Functional Food and Novel Food) Regulations, 2016.

# 1 kcal = 4.2 kJ

* To make these claims the specific nutrient in the food must provide the minimum amount of energy specified.

SCHEDULE – II

[See regulation 5(3)]

Synonyms which may be used for claims defined in these regulations

Free Low Reduced/Less High

Source

Zero, No, Without, ,

Negligible Source

Little, few (for

calories),

contains a small

amount of, low

source of, Light

Lower, fewer (for

calories)

Higher, Increased, More, Rich,

Enhanced

Provides,

Contains

SCHEDULE – III

[See regulation 7 (3)]

HEALTH CLAIMS

Introductory

note:

Health claims are structured on the following criteria:

1. Health claims are always to be stated as part of a balanced diet.

2. To obtain the claimed benefit two conditions are to be complied with

a. A specified amount of the nutrient/ingredient per serving of the food for

example 1 g ‘X’ nutrient)

b. A statement that in order to obtain the claimed benefits, the daily intake of the

nutrient/ingredient (for example 3g of ‘X’ nutrient) should be taken either from

the same food or any other food that provides the beneficial nutrient/ingredient.

3. The health claims regarding vitamins and minerals – a statement regarding the RDA for

the specific vitamin and mineral shall be given. Where no RDA is established by ICMR,

the RDA provided in Codex/WHO guidelines shall be applicable.

4. The claim statements provided below may be used on labels and/or advertisements.

Provided further that Food Businesss Operators may choose to use same or similar

terms in the claim statements as provide in the schedule under this regulation while

ensuring that the intent and meaning of the claim is not changed.

SI. No. Nutrient/Food-Health

Relationship

Conditions for claim Claim Statement

1 Calcium or Calcium and

Vitamin D and osteoporosis

o the food is a source or high in

calcium or in calcium and vitamin D

and

o a statement that the beneficial effect

is obtained with a daily

recommended intake (RDA)

Adequate Calcium (or

Calcium and Vitamin D)

intake throughout life,

through a balanced diet are

essential for bone health

and to reduce the risk of

osteoporosis

2 Sodium and Hypertension A food which

o is low in sodium (0.12g sodium/100g

or 100ml)

o a statement that the beneficial effect

is obtained with a low sodium diet.

Diets low in sodium may

help in reducing the risk of

high blood pressure.

¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 29

3 Dietary saturated fat and blood

cholesterol level

o low saturated fat

o a statement that the beneficial effect

is obtained with a diet low in fat,

saturated fat and physical activity

Diets low in saturated fat

contributes to the

maintenance of normal

blood cholesterol levels.

4 Potassium and risk of high blood

pressure

the food is a good source of potassium

and is

o low in sodium

o low in total fat and saturated fat.

Diets containing good

sources of potassium and

low in sodium, fat and

saturated fat may help

reduce the risk of high

blood pressure.

5 Alpha – linolenic acid (ALA)

and blood cholesterol level

o the food contains at least 1g of

omega-3 fatty acids per 100g or

100ml or 100kcal.

o statement that the beneficial effect is

obtained with daily intake of 2g of

ALA

Alpha – linolenic acid

(ALA) contributes to the

maintenance of normal

blood cholesterol levels.

Soluble Dietary Fibre and lipid

profile

o soluble dietary fibre from food

sources including but not limited to

oats, barley, millets or mixtures

thereof

o contains at least 1g per serving

o statement that the beneficial effect is

obtained with daily intake of 3g of

soluble dietary fibre.

Soluble Dietary Fibre taken

as part of a diet may help in

the maintenance of normal

lipid profile.

7 Phytosterol or stanol

and lipid profile

food with phytosterol or stanol

o contains at least 1g plant sterols or

stanols per serving and

o a statement that the beneficial effect

is obtained with a daily intake of up

to 3g per day.

Foods containing plant

sterols or stanols (as

applicable) containing at

least 1g of plant sterols or

stanols eaten twice a day

with meals for a daily

intake of up to 3g may help

in improving the lipid

profile.

8 Beta-glucans (oats, barley) and

blood glucose

o the food is oats and/or barley,

o contains at least 4g beta-glucans for

each 30g of available carbohydrates

in the quantified portion

o statement that it is taken as part of

the meal.

Beta- glucans from oats or

barley when taken as part

of a meal may help in

reduction of rise in blood

glucose after that meal.

SCHEDULE – IV

[See regulation 7 (4)]

Health Claims for Fortified Food Articles

SI. No. Nutrients Claims

1. Vitamin A Vitamin A helps against night blindness.

2. Vitamin D Vitamin D supports strong bones.

3. Vitamin B12 Vitamin B12 is important for maintaining normal functioning of Nervous

system and blood formation.

4. Folate & Folic acid Folate & Folic acid is important for foetal development and blood

formation.

5. Iron Iron fights Anemia.

6. Iodine Iodine is required for normal growth, thyroid and brain function.

7. Zinc Zinc supports a healthy immune system.

30 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]

8. Thiamine Thiamine is required for normal nerve and heart function.

9. Riboflavin Riboflavin is necessary to release the energy from food.

10. Niacin Niacin is necessary to release the energy from food.

11. Pyridoxine Pyridoxine is necessary to release the energy from food.

SCHEDULE – V

[See regulation 9 (2)]

Use of certain words or phrases

The following words or phrases used as specified in column 1 shall be used according to the conditions listed in

column 2:

Sl. No. Column 1 Column 2

1. Natural The word may be used to describe:

(a) A single food, derived from a recognised source viz., plant, animal,

microorganism or mineral and to which nothing has been added and which have

been subjected only to such processing which would only render it suitable for

human consumption like:

(i)smoking without chemicals, cooking processes such as roasting, blanching

and dehydration and physical refining;

(ii)freezing, concentration, pasteurization, sterilisation and fermentation; and

(Iii)packaging done without chemicals and preservatives.

(b) Permitted food additives that are obtained from natural sources by appropriate

physical processing.

as “natural” but such foods may be described as “made from natural ingredients”

if all the ingredients or food additives meet the criteria in (a) and (b) above:

Provided that, the above principles shall also apply to use of other words or expressions

such as “real”, “genuine”, when used in place of “natural “in such a way as to imply

similar benefits.

Provided further that the, claims such as “natural goodness”, “naturally better”, “nature’s

way” shall not be used.

2. Fresh (a) The term “fresh” shall only be used on products which have not been processed in any

manner except, washed, peeled, chilled, trimmed or cut, irradiated by ionizing radiation

not exceeding 1kGy or other processing necessary for making the product safe for

consumption without altering its basic characteristics in any manner. If such processing

also leads to extension in the shelf-life of the product the term “fresh” shall not be used.

(b) The term “fresh” or “freshly” shall have no other connotation than the immediacy of

the action being described. A food containing additives or subjected to packaging, storing

or any other supply chain processes that control freshness shall not be termed as “freshly

stored”, “freshly packed”, etc.:

Provided that “Fresh” may be permitted to be used along with “frozen” if it is clear from

the context. - “Frozen from fresh” “fresh frozen” “Freshly frozen”– which would indicate

that the food was quickly frozen while still fresh.

3. Pure (a) The term “pure” shall only be used to describe a single ingredient food to which

nothing has been added and which is free from avoidable contamination and the levels of

unavoidable contaminants shall need to be below the levels prescribed in the Food Safety

and Standards (Contaminants, Toxins and Residues) Regulations, 2011 or in any other

standard given under Food Safety and Standards Act, Rules and Regulations thereof.

(b) Compound foods shall not generally be described, directly or by implication, as “pure”

but such foods may be described as “made with pure ingredients” if all the ingredients

meet the criteria in (a) above.

phrases, in such a way as to imply that a food that does not meet the criteria above is pure

or made from pure ingredients.

¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 31

Sl. No. Column 1 Column 2

4. Authentic,

Genuine,

Real

These terms may be used only if the label or advertisement

also clarify in what way the overall quality is tangibly justified and why the particular

term has been used.

5. Traditional The term “traditional” shall demonstrably be used to describe a recipe, fundamental

formulation or processing method for a product that has existed for a generation (thirty

years), should have been available substantially unchanged, for that same period.

6. Original (a)The term “original” shall only be used to describe a food that is made to a formulation,

the origin of which can be traced, and that has remained essentially unchanged over time.

It should not contain replacements for major ingredients. It may similarly be used to

describe a process, provided it is the process first used in the making of the food, and

which has remained essentially unchanged over time, although it may be mass-produced.

(b) To be termed “original”, a product shall not have changed to any material degree and

shall remain available as the ’standard’ product when new variants are introduced. A

product re-introduced onto the market after a period of absence shall only be described as

“original” if it can be shown to meet these criteria.

PAWAN AGARWAL, Chief Executive Officer

[ADVT.-III/4/Exty./356/18]

Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064

and Published by the Controller of Publications, Delhi-110054.

Final -Press release

Claims Notification