[To be published in the Gazette of India, Extraordinary, Part III, Section 4]Government of IndiaMinistry of Health and Family WelfareFood Safety and Standards Authority of India
Notification
New Delhi, the _______ , 2015.
No. 1-4/ Nutraceutical/ FSSAI-2013.- The following draft of the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical purpose, Functional Foods, and Novel Food) Regulations, 2015, which the Food Safety and Standards Authority of India proposes to make in exercise of the powers conferred by clause (v) of sub-section (2) of section 92 read with sub-section (1) of section 22 of the Food Safety and Standards Act, 2006 (34 of 2006), with the previous approval of the Central Government, is hereby published as required by sub-section (1) of section 92 of the said Act, for the information of all persons likely to be affected thereby; and notice is hereby given that the said draft regulations shall be taken into consideration after the expiry of a period of sixty days from the date on which the copies of the Official Gazette in which this notification is published are made available to the public;
Objections or suggestions, if any, duly supported with scientific evidence, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, Food and Drug Administration Bhawan, Kotla Road, New Delhi – 110 002;
The objections and suggestions, which may be received from any person with respect to the said draft regulations before the expiry of the period specified above, shall be considered by the Food Authority.
Draft Regulations
1. Short title and commencement. - (1) These regulations may be called as the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical purpose, Functional Foods, and Novel Food) Regulations, 2015.
(2) They shall come into force with effect from the ensuing 1st January or 1st July of the year, as the case may be, subject to a minimum of 180 days from the date of final notification of these regulations in the Official Gazette.
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CHAPTER – I
2. Definitions.-
In these regulations,- unless the context otherwise requires,-
(a) Foods containing prebiotic ingredients means foods that contain approved prebiotics and are a non-viable food component which confers a health benefit to the consumer by modulation of gut micro biota.
(b) “Foods containing Probiotic Ingredients” means foods with live micro-organisms beneficial to human health, which when ingested in adequate amounts (as a single strain or as a combination of cultures) confer one or more specified/or demonstrated health benefits in human beings; and the microorganism strain used in these foods shall be deemed to possess probiotic property when it is capable of surviving passage through the digestive tract, and has the capability to adhere and proliferate in the gut and be able to confer a physiological benefit.
(c) “Foods for Special Dietary Uses (FSDU) (other than infants, and those to be taken under medical advice)” (i) means and includes the foods specially processed or formulated to satisfy particular dietary requirements which may exist or arise because of certain physiological or specific health conditions like low weight, obesity, diabetes, high blood pressure and foods like gluten free foods, etc and these foods may be taken without medical advice unless otherwise stated; (ii) do not include the normal foods which are merely enriched or modified with nutrients and meant for mass consumption, intended for improvement of general health and are meant for day to day use and do not claim to be targeted to consumers with specific diseased conditions and also these not include the foods intended to replace complete diet covered under Food for Special Medical Purpose in these regulations.
(d) “Food or health supplements” means the foods which are intended to supplement the normal diet of a person, and which are concentrated sources of one or more nutrients, like minerals, vitamins, proteins, mineral complexes, amino acids or enzymes, other dietary substances, plants or botanicals, substances from animal origin or other similar substances with known and established nutritional or beneficial physiological effect, and which are presented as such and are offered alone or in combination, but are not drugs as defined in the Drugs and Cosmetics Act, 1940 and the rules made thereunder.
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(e) “Foods for Special Medical Purposes (FSMP)” means (i) the foods intended for particular dietary uses specially processed or formulated and intended for the dietary management of patients and shall be used only under medical advice and they are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolize or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by foods for specific nutritional use, or a combination of them; (ii) include the foods specially prepared for weight reduction and intended as total replacement of normal diet.
(f) “Nutraceuticals” means a naturally occurring chemical compound having a physiological benefit or provide protection against chronic disease, isolated and purified from food or non-food source and may be prepared and marketed in the food-format of granules, powder, tablet, capsule, liquid or gel and may be packed in sachet, ampoule, bottle, etc and to be taken as measured unit quantities.
(g) “Novel Foods” means the food that does not have a history of human consumption or has any other ingredient used in it which or the source from which it is derived does not have a history of human consumption as a food ingredient or foods or has ingredients obtained by new technologies or processes and includes the foods and food ingredients which have been produced by a new technology with innovative engineering processes, where the process gives rise to significant changes in the composition or structure or size of the foods or food ingredients which affect the nutritional value, metabolism or level of undesirable substances and not apply to any reformulation of food products produced from the existing food ingredients by altering the composition, percentage or amounts of food ingredients and additives.
(h) “Schdules” means the schdules to the regulations.
(i) Specialty Foods containing ingredients based on Ayurveda, Unani and Siddha and Traditional Health Systems of India means the foods which are shown to be safe by science based evidence and health uses referred in the authoritative texts (books of Schedule I of the Drugs and Cosmetic Act, 1940) and other Standard texts (History of evidence based use and not for curative purposes).
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CHAPTER- II
3. Foods for Special Nutritional purposes or dietary uses (Generic). – 1) The foods for special nutritional purposes or dietary uses, means food which are clearly distinguishable from foods intended for normal consumption by their special composition, shall indicate their suitability for their supplementary or dietary purposes and composition of these foodstuffs must differ significantly from the composition of normal foods of comparable nature, if such normal foods exist.
(2) All foods referred to in sub-regulation (1) shall be manufactured specifically as supplements to regular diet either for general maintenance of health or in certain physiological or disease conditions.
(3) All foods referred to in sub-regulation (1) shall fulfill the characteristics as laid down in these Regulations.
4. General conditions for manufacture and sale of foods as referred in these Regulations. – (1) No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any food products referred to in these regulations unless they comply with the requirements laid down under these regulations.
(2) The formulation of the foods shall be based on sound medical or nutritional principles and supported by validated scientific data, wherever required.
(3) No hormones or steroids or psychotropic ingredients shall be added in these foods.
(4) The labels shall clearly mention the purpose, the target consumer group and the physiological or disease conditions which they address, apart from the specific labelling requirements as mentioned against each type of food.
(5) The labels, accompanying leaflets /or other labelling and advertising of all types of foods, referred to in these regulations shall provide sufficient information on the nature and purpose of the food as well as detailed instructions and precautions for their use and the format of information given shall be appropriate for the person for whom it is intended.
(6) A food, which has not been particularly modified in any way but is suitable for use in a particular dietary regimen because of its natural composition, shall not be designated as “Food Supplements” or “Special Dietary” or “Special Dietetic” or by any other equivalent term and such food may bear a statement on the label that “this food is by its nature “X” (“X” refers to the essential distinguishing characteristic as demonstrated by generally accepted scientific data) and such statement does not mislead the consumer.
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(7) The Food Authority may suspend or restrict the trade of such foods as have been placed in the market that are not clearly distinguishable from foods for normal consumption nor are suitable for their claimed nutritional purpose, or may endanger the human health.
(8) The Food Authority may, at any time, ask a Food Business Operator manufacturing and selling such special types of foods to furnish details regarding the history of use of the nutrients added or modified and their safety evaluation.
CHAPTER- III
a. Food or health supplements.- (1) The purpose of such foods is to supplement the normal diet and to be marketed in single use packaging or in dosage form, namely forms such as capsules, tablets, pills and other similar forms, sachets of powder, etc. or any other similar forms of liquids and powders designed to be taken in measured unit quantities and not include any of the food products or categories of foods for which specific standards have been laid down in any other parts of these regulations.
(2) Essential Composition: (i) The Food or Health supplements may contain vitamins and minerals as specified in Schedule I, and in the forms as given in Schedule II; Amino acids specified in Schedule III; Plants or botanicals as specified in Schedule V; substances from animal origin as listed in Schedule VI; Mineral or metal sources as specified in Schedule VII; and the enzymes as specified in Schedule IX of these regulations, which may be used in the manufacture of food supplements without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product.
(ii) The quantity of nutrients added shall not exceed the Recommended Daily Allowance as specified in India by the Indian Council of Medical Research (ICMR) or maximum dosage, whichever is applicable and in case such standards are not prescribed, the Food Authority may consider adoption of standards laid down by the international food standards body, namely Codex Alimentarius, a joint Food and Agricultural Organisation or the World Health Organisation.
(iii) Any new nutrient, which has no history of safe use in India or those without evidence establishing that the nutrient may result in certain nutritional and physiological benefits, shall apply to the Food Authority for approval.
(iv) The purity criteria for the nutrients used, including vitamins and minerals, shall be as determined and notified by the Food Authority from time to time
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and in case such standards are not specified, the purity criteria accepted by international bodies such as Codex Alimentarius may be adhered to.
(v) The Food Authority may, after proper scientific evaluation, enlist specific nutrients as approved nutrients from time to time.
(3) Labelling.- (i) The Labelling of food supplements shall comply with the packaging and labelling requirements as laid down under the Food Safety and Standards (Packaging and Labelling) Regulations, 2011.
(i) No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any package or container containing any food supplement, if the package or container does not bear a label containing all the particulars and requirements specifically laid down in these regulations.
(iii) The labelling, presentation and advertising shall not attribute to food or health supplements the property of preventing, treating or curing a human disease, or refer to such properties. The statements relating to structure or function or for the general well-being of the body are allowed as long as they are truthful and are also supported by generally accepted scientific data and in addition, the product shall bear a statement, “This product is not intended to diagnose, treat, cure or prevent any disease(s).
(iv) Every package of food or health supplements shall carry the following information on the label, namely.-
(a) the words “FOOD or HEALTH SUPPLEMENT”
(b) the common name of the Food or Health Supplement, or a description sufficient to indicate the true nature of the food supplement including the common names of the categories of nutrients or substances that characterize the product;
(c) the amount of the nutrients or substances with a nutritional or physiological effect present in the product shall be declared on the label in numerical form in descending order;
(d) the term ‘NOT FOR MEDICINAL USE’ shall be prominently written on the label;
(e) the quantity of nutrients shall be expressed in terms of percentages of the relevant Recommended Daily Allowances as prescribed in India by the Indian Council of Medical Research and shall bear a warning “Not to exceed the recommended daily dose”;
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(f) a statement to the effect that the food or health supplement should 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 product-drug interactions, as applicable;
(h) a statement to the effect that the products shall be stored out of the reach of children.
(4) Use of Additives in Food or Health Supplements. - The additives given in Schedule VIII (a) and VIII (e) of these regulations shall be permitted for use in the Food or Health Supplements.
(5) Contaminants, Toxins and Residues.- The product shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011, as amended from time to time.
CHAPTER- IV
6. Nutraceuticals. – (1) Essential composition: (i) The Nutraceuticals may be extracted, purified and concentrated from food or non-food source plants, microbes or animals that have a history of safe use.
(i) The Nutraceuticals may also be extracted and purified from non-food sources e.g. Amino acids and their derivatives may be prepared by bacteria grown in fermentation systems.
(ii) The Nutraceuticals may contain- (a) the vitamins and minerals as specified in Schedule I, and in the forms as given in Schedule II; (b) the Amino acids specified in Schedule III; (c) the Plants or botanicals as specified in Schedule V; (d) the substances from animal origin as listed in Schedule VI; and (e) the nutraceuticals as specified in Schedule IX of these regulations, which may be used in the manufacture of food containing nutraceuticals without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product.
(iii) The quantity of nutrients added shall not exceed the Recommended Daily Allowance as specified in India by the Indian Council of Medical Research or maximum dosage, whichever is applicable and in case such standards are not prescribed, the food authority may consider adoption of standards laid down by international food standards body, namely Codex Alimentarius, a joint Food and Agricultural Organisation or the World Health Organisation.
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(iv) As for a Nutraceutical which does not have a history of safe usage in India, but such safety has been established in other countries, it may be manufactured or sold in India only after taking prior approval from the Food Authority. Application for such approval to the Food Authority shall provide documented safe history of usage of at least ten years in India or thirty years in the country of origin.
(v) The Food Authority may enlist specific nutraceuticals as approved from time to time after undertaking proper scientific evaluation.
(vi) The purity criteria for the nutraceutical used shall be as determined and notified by the Food Authority from time to time for each of the nutraceuticals specified in the Schedules V, VI and IX and in case such standards are not prescribed, the purity criteria generally accepted by pharmacopoeias like Indian Pharmacopoeia (IP) or British Pharmacopoeia (BP) or United States Pharmacopoeia (USP) or international bodies such as CODEX Alimentarius may be referred or adopted by the Food Authority.
(2) Labelling: (i) Labelling of Nutraceuticals shall comply with the packaging and labelling requirements as laid down under Food Safety and Standards (Packaging and Labelling) Regulations, 2011.
(ii) No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any package or container containing any nutraceutical, if the package or container does not bear a label containing all the particulars required by these regulations.
(iii) The labelling, presentation and advertising shall not attribute the property of preventing, treating or curing a human disease to nutraceuticals or refer to such properties and the statements relating to structure or function or for the general well-being of the body are allowed as long as they are truthful and are also supported by generally accepted scientific data and the product shall bear a statement, “This product is not intended to diagnose, treat, cure or prevent any disease”.
(iv) Every package of food containing nutraceuticals shall carry the following information on the label, namely:-
(a) the words “NUTRACEUTICAL”;
(b) the common name of the nutraceutical;
(c) the amount of the active nutraceutical in the product that either has a nutritional or physiological effect;
(d) where it is appropriate the quantity of nutrients shall be expressed in terms of percentages of the relevant Recommended Daily Allowances as
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prescribed in India by the Indian Council of Medical Research even when it is present along with a nutraceutical as an adjunct and shall bear a warning “not to exceed the stated recommended daily dose”;
(e) the term “Recommended usage” shall be used on the label;
(f) recommended usage including information concerning excessive intake of the product shall be provided on the label (e.g. Oleic acid contributes to the normal growth of fetus, but does not improve the growth of fetus with excessive intake);
(g) the term ‘NOT FOR MEDICINAL USE’ shall be prominently written on the label;
(h) a warning in cases where a danger may exist with excess consumption;
(i) a warning or any other precautions to be taken while consuming, known side effects if any, contraindications and product-drug interactions, as applicable;
(j) a statement to the effect that the products shall be stored out of the reach of children;
(k) the letters and numerals in every word or statement required to be printed on the label under items (a), (b), (e) and (g) above shall be of minimum 3 mm font size.
(3) Use of Additives in Nutraceutical formulations. – The Additives given in Schedule VIII (a) and VIII (e) of these regulations shall be permitted for use in Food Supplements.
(4) Contaminants, Toxins and Residues.- The product shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011, as amended from time to time.
(5) Claims. –
(i) Nutritional claim. - It shall consist of the ‘Nutrient content’ claim and is governed by the nutritional supplements requirements described earlier.
(ii) Health claims. –(A) Health claim means any representation that states, suggests, or implies that a relationship exists between the constituent of that nutraceutical and health. (B) A health claim has two essential components, namely:-
(a) Nutraceutical ingredients; and
(b) A health related benefits.
(C) The health claims may include the following types, but not limited to.-
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(a) nutrient function claims;
(b) enhanced function claims;
(c) disease risk reduction claims;
(d) health maintenance claims;
(e) immunity claims – Increased Resistance (excluding vaccines);
(f) enhanced healthy ageing; and
(g) nutrient led claims excluding enhanced function or disease reduction claims.
(D) The other benefits that are not drug claims, may be allowed subject to pre-approval by Food Safety and Standards Authority of India.
(E) The Health claims must be commensurate with adequate level of documentation with valid evidence made available for review and approval by the Food Authority.
(6) The Nutrient led but inclusive of enhanced function claims and disease risk reduction claims as given below.-
(i) the claims shall only be nutrient led;
(ii) the claims shall be based on scientific literature - adequate substantiation needed;
(iii) the claims shall be substantiated with available literature including official traditional texts plus post market data or consumer studies or cohort or retroactiveor trohoc studies based on eating pattern and health benefits, epidemiological (Indian) data, seen from well documented data;
(iv) the consensual, congruent and concurrent validity studies may be considered;
(v) the health promotive and disease risk reduction claims shall be made only if based on evidence from literature and human data of efficacy and safety of the nutrient;
(vi) the controlled clinical trials shall not be the only options for efficacy and safety data, Nutraepidemiology also may needs to be encouraged;
(vii) the qualified structure function claims for specific organ or function which are comprehensible to consumer shall be permitted;
(viii) the implied cures of disease claims such as e.g. ‘Prevents bone fragility in post menopausal women’ shall not be allowed;
(ix) The implied cures for disease claims via the name of the product (Example: Cancer Cure) or through pictures, vignettes or symbols (Example: ECG tracing, lipid profiles) shall not be allowed;
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(x) the structure-function claims, the case-to-case basis consumer information for specific age or gender or vulnerable population shall be given for the product;
(xi) The Food Authority may periodically review or revise the positive claims and safety guidelines or principles depending on new scientific knowledge emerging and request from stakeholders, based on recommendation of the expert body as above who may be requested to review such cases or requests from time to time.
(xii) Health claims which are product led shall be notified to the Food Authority by the manufacturer or marketer of the nutraceutical before putting the same in the market by submitting relevant documents along with a copy of the label.
(7) The Product led claims based on human studies done with the product intended for sale with evidence based data for claims are -
(i) claims based on valid data suitable statistical design proving the benefit for disease risk reduction (human intervention studies conducted by the company);
(ii) all claims shall be nutraceutical led;
(iii) the product compatibility for the proposed claim benefit shall be taken into account and suitable qualifiers shall be proposed such as heart healthy claim on Polyunsaturated fatty acids;
(iv) the word “Shown” shall be used as mentioned below when one human intervention study has shown significant benefit:
“Product (………. <Name of the Product>) is shown to be helping in keeping your heart healthy or heart healthy”.
(v) the word “Proven" shall be used as specified below when more than one human intervention studies or epidemiological evidence on Indian population have been provided with concurrent validity:
“Product (……….<Name of the Product>) is proven to make you lose weight”.
(vi) The health claims, which are product led, shall be notified to the Food Authority.
(vii) The pre-approval shall be required only for health claims with adequate scientific data where scientific evidence does not exist or a new molecule has been introduced.
(8) General principles for query or challenge. -
It shall comply with the following requirements, namely:-
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(i) The comprehensive product information and safety and claims support data must be prepared and available with the manufacturing or marketing organization;
(ii) This shall be got reviewed and scrutinized by an independent scientist or expert with relevant qualifications and experience by the manufacturer;
(iii) The scientific view of the reviewer on claims and its veracity along with the qualification and experience of the reviewer shall be attached as an essential part of the document; and
(iv) In case of a technical query from within the Food Authority or on a public complaint lodged with the Food Authority, the said Authority may examine or authorize an appropriate expert group to review the case. Based on the opinion of the expert group, the Food Safety and Standards Authority of India may direct the notifier to alter or modify or stop claims with such directions being binding on the firm.
CHAPTER- V
7. Foods for Special Dietary Uses (other than infants, and those to be taken under medical advice). – The foods for special dietary uses exclude food supplements which is defined as food which supplements the normal diet and to be marketed in single use packaging or in dosage form, namely, forms such as granules, capsules, tablets, pills and other similar forms, sachets of powder, etc. or any other similar forms of liquids and powders designed to be taken in measured small unit quantities with a nutritional or physiological effect: provided that any of the food products or categories of foods for which specific standards have been laid down in any other parts of these regulations are not excluded.
(1) Essential Composition:
(i) The Foods for special dietary uses may contain.- (a) the vitamins and minerals as specified in Schedule I, and in the forms as given in Schedule II; (b) Amino acids specified in Schedule III; (c) the Plants or botanicals as specified in Schedule V; (d) the Minerals and metal sources as specified in Schedule VII; (e) the substances from animal origin as listed in Schedule VI; (f) and enzymes as specified in Schedule IX of these regulations. which may be used in the manufacture of Foods for special dietary uses without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product;
(ii) Any new nutrient, which has no history of safe use in India or those without an evidence establishing that the nutrient may result in certain nutritional and
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physiological benefits, shall apply to the Food Authority for approval, and the Food Authority may, from time to time, enlist specific nutrients as approved nutrients after proper scientific evaluation;
(iii) The quantity of the nutrients added shall not exceed the upper safe level established by the scientific risk assessment for each nutrient;
(iv) The foods specially prepared for slimming, weight management and weight control purposes shall comply with the following, namely: -
(a) a formula food presented as a replacement for all meals of the daily diet shall provide not less than 800 kcal (3350 kJ) and not more than 1200 kcal (5020 kJ) and the individual portions or servings contained in these products shall provide approximately one third or one fourth of the total energy of the product depending on whether the recommended number of portions or servings per day is 3 or 4, respectively;
(b) a formula food presented as a replacement for one or more meals of the daily diet shall provide not less than 200 kcal (835 kJ) and not more than 400 kcal (1670 kJ) per meal and when such products are presented as a replacement for the major part of the diet, the total energy intake shall not exceed 1200 kcal (5020 kJ);
(c) Protein - a minimum of 25 per cent and a maximum of 50 per cent of the energy available from the food, when ready-to-serve, shall be derived from its protein content and the total amount of protein shall not exceed 125 g per day and it shall be:- (I) Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 1.0 (the reference protein);
(II) where the protein quality is less than 1.0 , the minimum levels should be increased to compensate for the lower protein quality and no protein with a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of less than 0.8 shall be used in a formula food for use in a weight control diet;
(III) essential amino acids may be added to improve protein quality only in amounts necessary for this purpose and only L-forms of amino acids shall be used, except that DL-methionine may be used;
(d) Fat and linoleate- Not more than 30 per cent of the energy available from the food shall be derived from fat including not less than 3 per cent of the energy available derived from linoleic acid (in the form of a glyceride);
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(e) Vitamins and minerals- For a formula food represented as a replacement for all meals per day, at least 100 per cent of Reccommended Daily Allowance of vitamins and minerals shall be present in the daily intake;
(f) the purity criteria for the nutrients used, including vitamins and minerals, shall be as determined by the Food Authority from time to time and in cases where the criteria are not prescribed, the purity criteria generally accepted by international bodies like Codex Alimentarius may be referred and adopted.
(2) Labelling.-
(i) The labelling of Foods for Special Dietary Uses shall follow the requirements as laid down in the Food Safety and Standards (Packaging and Labelling) Regulations, 2011 along with the labelling conditions for nutritional labeling and claims;
(ii) No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any package containing any foods for special dietary uses, if the package does not bear a label containing all the particulars and requirements as laid down in these regulations.
(iii) No statement or claim shall be made on the label implying prevention, cure or treatment of any specific disease or its diagnosis or otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, unless otherwise approved by the Food Authority and statements relating to structure or function or for the general well-being of the body are allowed so long as they are truthful and are also supported by generally accepted scientific data and in addition, the product shall bear a statement, “This product is not intended to diagnose, treat, cure or prevent any disease”.
(iv) Every package containing Food for Special Dietary Uses (FSDU) shall carry the following information on the label, namely:-
(a) the words “FOOD FOR SPECIAL DIETARY USES” shall be followed by “Food for……...” <mentioning the particular physiological or health condition>” to signify that the food has been specially formulated for a particular physiological condition;
(b) the foods specially prepared for weight management and control shall bear a statement “For the Weight Control and Management" in close proximity to the name of the food and also a statement that the product should not be used by pregnant, nursing and lactating women or by
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infants, children, adolescents and elderly, except when medically advised;
(c) a statement on the target consumer group, rationale for the use of the product and a description of the properties or characteristics that make it useful;
(d) if the product has been formulated for a specific age group, it should carry a prominent statement to this effect;
(e) a statement specifying the nutrient which shall be reduced, deleted, increased or otherwise modified, relative to normal requirements, and the rationale for the reduction, deletion, increase or other modification;
(f) a warning in cases where a danger may exist with excess consumption;
(g) a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications and product-drug interactions, as applicable;
(h) in addition, where it is appropriate, the quantity of nutrients may be expressed in terms of upper safe level;
(i) information on osmolality or osmolarity or on acid-base balance shall be given where appropriate;
(j) a statement to the effect that the products shall be stored out of the reach of children.
(3) Use of Additives. - The Additives given in Schedule VIII (b) and VIII (e) are permitted to be used in foods for special dietary uses (other than infants).
(4) Contaminants, Toxins and Residues. - The product shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.
Chapter VI
8 . Foods for Special Medical Purposes (FSMP). – The foods for special medical purposes, other than those intended for infants, may either be nutritionally complete foods which, when used in accordance with the manufacturer's instructions, shall constitute the sole source of nourishment for the persons for whom they are intended or nutritionally incomplete foods with formulation specific for a disease, disorder or medical condition, but are not suitable to be used as the sole source of nourishment.
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(1) Categories.- The dietary foods for special medical purposes can be classified in the following three categories, namely:-
(a) nutritionally complete foods with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended;
(b) nutritionally complete foods with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended; and
(c) nutritionally incomplete foods with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which are not suitable to be used as the sole source of nourishment.
Note: The foods specified to in items (b) and (c) above may also be used as a partial replacement or as a supplement to the patient's diet.
(2) Essential Composition:
(i) the foods for special medical purposes may contains.- (a) the amino acids specified in Schedule III; (b) the vitamins and minerals as per level specified in Schedule IV; (c) the Plants or botanicals as specified in Schedule V; (d) the substances from animal origin as listed in Schedule VI; (e) the minerals and metal sources as specified in Schedule VII; (f) the substances from animal origin as listed in Schedule VI; and (g) the enzymes as specified in Schedule IX of these regulations, which may be used in the manufacture of food containing foods for special medical purposes without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product.
(ii) for any new nutrient, which has no history of safe use in India or those without an evidence establishing that the nutrient may result in certain nutritional and physiological benefits, shall apply to the Food Authority for approval and the Food Authority may enlist specific nutrients as approved nutrients after proper scientific evaluation from time to time.
(iii) the foods specially prepared for weight reduction and intended as total replacement of complete diet shall, apart from complying with Schedule IV, may also ensure the following, namely:-
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(a) a formula food for very low energy diets shall provide, when prepared according to instructions, a daily energy intake of 450-800 kcal as the only source of energy.
(b) Protein - Not less than 50 g protein with a Protein-Digestibility-Corrected Amino Acid Score (PDCAAS) of 1 shall be present in the recommended daily intake of energy and essential amino acids may be added to improve protein quality only in amounts necessary for this purpose and only L-forms of amino acids shall be used, except that DL-methionine may be used.
(c) Fats - Very low energy diets shall provide not less than-
(I) 3 g of linoleic acid; and
(II) 0.5 g α-linolenic acid in the recommended daily intake with the linoleic acid or α-linolenic acid ratio between 5 and 15.
(III) Carbohydrates- Very low energy diets shall provide not less than 50 g of available carbohydrates in the recommended daily intake of energy.
(iv) In foods for special medical purpose, nutrients may be added at levels higher than one (100%) RDA, and, if added, the technological need may have to be established by scientific risk assessment based on generally accepted scientific data wherever available, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups and wherever scientific data is not available, specific approval for usage of the specified level and cautionary labeling, if any, shall have to be obtained from Food Authority.
(v) The purity criteria for the nutrients used including vitamins and minerals shall be as determined by the Food Authority from time to time and in case such criteria are not prescribed, the purity criteria generally accepted by international bodies such as Codex Alimentarius may be allowed.
(2) Labelling. -
(i) The labelling shall follow the requirements as provided in the Food Safety and Standards (Packaging and Labelling) Regulations, 2011.
(ii) In addition to (i) above, no person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any package containing any foods for special medical purposes, if the package does not bear a label containing all the particular requirements as laid down in these regulations.
(iii) Further, every package of foods for special medical purposes shall carry the following information on the label, namely:
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(a) the words ‘FOODS FOR SPECIAL MEDICAL PURPOSE’ shall be printed in the immediate proximity of the name or brand name of the product;
(b) a prominent statement “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” shall appear on the label in bold letters in an area separated from other written, printed or graphic information.
(c) the statement “For the dietary management of ________” <with the blank to be filled in with the specific disease(s), disorder(s) or medical condition(s) for which the product is intended, and for which it has been shown to be effective shall also be included in the label> will have to be supported by appropriate scientific and clinical or epidemiological data backup and subject to its approval by the Food Authority;
(d) a statement ‘NUTRITIONALLY COMPLETE’ if the food is intended to be used as a nutritionally complete food;
(e) expiry date;
(f) a statement on the rationale for the use of the product by the target consumer group and a description of the properties or characteristics that make it useful;
(g) a prominent statement if the product has been formulated for a specific age group;
(h) a statement specifying the nutrient which have been reduced, deleted, increased or otherwise modified, relative to normal requirements, and the rationale for the reduction, deletion, increase or other modification;
(i) in addition, where it is appropriate, the quantity of nutrients may be expressed in terms of percentages of the Recommended Daily Allowances;
(j) information on osmolality or osmolarity and/or on acid-base balance shall be given wherever applicable;
(k) instructions for appropriate preparation, feeding, use and storage of the product after the opening of the container;
(l) a warning that the product is not for parenteral use;
(m) a statement to the effect that the products shall be stored out of the reach of children.
(3) Use of additives.- The additives specified in Schedule VIII (c), (d) and (e) of these regulations shall be permitted to be used in Foods for Special Medical Purpose.
(4) Contaminants, Toxins and Residues.- The product shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.
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(5) Regulation of advertising. - Advertising of these products to the general public shall include a specific reference to the approval of such product by the Food Authority.
CHAPTER - VII
9. Foods containing Probiotic Ingredients. -
(1) Essential Composition. -
(i) Only probiotic cultures of specific strain of the microorganisms as specified in Schedule X of these regulations or those approved by the Food Authority from time to time may be used.
(ii) The Food Authority may enlist specific probiotic microorganisms after proper scientific evaluation from time to time.
(iii) The presence of commonly used starter culture of lactic acid producing bacteria such as Lactococcus spp. (earlier known as Streptococcus spp.), Lactobacillus spp. and others used in the preparation in curd and related products shall not be considered as probiotics, if the probiotic properties have not been substantiated.
(iv) Any new strains of microorganisms, possessing probiotic properties, may be approved by the Food Authority after proper scientific evaluation, and the Food Authority may from time to time enlist specific microorganisms possessing probiotic properties (Schedule X).
(2) Labelling. –
(i) The labelling of probiotic foods shall follow Food Safety and Standards (Packaging and Labelling) Regulations, 2011.
(ii) In addition to (i) above, no person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any package containing any probiotic food, if the package does not bear a label containing all the particulars required by these regulations.
(iii) The labelling, presentation and advertising shall not attribute the property of preventing, treating or curing a human disease, or refer to such properties to Probiotics and the statements relating to structure or function or for the general well-being of the body are allowed as long as they are truthful and are also supported by generally accepted scientific data and in addition, the
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product shall bear a statement, “This product is not intended to diagnose, treat, cure or prevent any diseases.”
(iv) Every package of probiotic foods shall carry the following information on the label, namely:-
(a) the words “PROBIOTIC FOOD”;
(b) genus, species, strain designation or International Culture Collection Number (International Culture Deposit Number in the bracket where probiotics are mentioned in the ingredient lists);
(c) minimum viable numbers of probiotics strain at the level at which the efficacy is claimed and at the end of the shelf-life;
(d) the recommended serving size which must deliver the effective dose of probiotics related to the health claim and duration of use to have the optimal effect.
(e) proper storage temperature conditions and time limit for ‘Best Use’ after opening the container.
(f) a warning or any other precautions to be taken while consuming, known side effects if any, contraindications and product-drug interactions, as applicable; and
(g) expiry date.
(3) Use of additives. - The additives specified in Schedule VIII (a) to VIII (e) of these regulations may be permitted to be used in probiotics also.
(4) Contaminants, Toxins and residues. - The product shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.
CHAPTER- VIII
10. Foods containing prebiotic ingredients. –
(1) Essential composition.-
(i) Only prebiotics specified in Schedule XI or those approved by the Food Authority from time to time may be used in the manufacture of foods containing prebiotics.
(ii) The Food Authority may enlist specific prebiotic components after proper scientific evaluation from time to time.
(iii) The prebiotic component (not an organism), to which the claim of being prebiotic is attributed, must be characterized for any given product by
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providing the source, origin, purity, chemical composition and structure, vehicle, concentration and amount in which it is to be delivered to the host.
(2) Labelling. -
(i) The labelling of prebiotic foods shall follow the requirements as laid down in the Food Safety and Standards (Packaging and Labelling) Regulations, 2011.
(ii) In addition to (i) above, no person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any package containing any prebiotic food, if the package does not bear a label containing all the particulars required by these regulations.
(iii) The labelling, presentation and advertising shall not attribute to prebiotics the property of preventing, treating or curing a human disease, or refer to such properties and the statements relating to structure or function or for the general well-being of the body are allowed as long as they are truthful and are also supported by generally accepted scientific data and in addition, the product shall bear a statement, “This product is not intended to diagnose, treat, cure or prevent any disease”.
(iv) Every package of food containing nutraceuticals shall carry the following information on the label, namely:-
(a) the words “PREBIOTIC FOOD”;
(b) name of prebiotics;
(c) the suggested/ recommended serving size which must deliver the effective dose of prebiotics related to the health claim;
(d) a warning or any other precautions to be taken while consuming, known side effects if any, contraindications and product-drug interactions, as applicable;
(e) the expiry date.
(3) Use of additives. - The additives specified in Schedule VIII (a) to VIII (e) of these regulations may be permitted to be used in prebiotics also.
(4) Contaminants, Toxins and Residues. - The product shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.
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CHAPTER- IX
g. Specialty Foods containing ingredients based on Ayurveda, Unani and Siddha and Traditional Health Systems of India. -
(1) Essential Composition. -
(i) The Food or Health Supplements or Foods for Special Dietary Uses may contain the ingredient(s) used in Ayurveda, Siddha and Unani System Medicines as specified in Schedules V, VI and VII, formulated either alone or in combinations of ingredients of botanical or animal or mineral or metal source or either in unprocessed or in approved processed forms, formulated in a regular or conventional food format such as liquids or syrups, suspensions or powders, granules, tablets or capsules or any other formats approved by the Food Authority.
(ii) Only Plants or materials specified in Schedules V, VI and VII of these regulations shall be used.
(iii) Each manufacturer or importer shall prepare and maintain a product information file, which shall contain information on the material from Schedule V, VI and VII used, quality confirmation and test methods to demonstrate the presence of the material in the food.
(iv) The lists specified in the Schedules V, VI and VII are based on historically documented evidence recognized in the official authoritative texts (in the First Schedule of Drugs and Cosmetic Act, of 1940) and the Drugs and Cosmetic Rules, 1945) and Nighantus.
Note: This First Schedule is a list of fifty seven books of Ayurveda, thirty books of Siddha and fourteen books of Unani and including Official Formularies and Pharmacopoeias of Ayurveda, Siddha, and Unani (ASU) systems.
(v) The materials specified in Schedules V, VI and VII may be formulated using processes similar or same as known in Ayurveda, Siddha, and Unani System described in the official books.
(vi) The usage levels shall ordinarily be not exceeding those specified in Schedules V, VI and VII. However, the usage level may be distributed or provided or formulated for delivery in one portion of usage daily or may be distributed in more than one portion to be taken in a day.
(vii) The list does not cover the ingredients from countries other than India, which are not listed in any of the official authoritative texts and Nighantus. Any other
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plant or mineral or other ingredients, known in traditional usage in any country other than India, if intended to be used without a history of safe use in India in food, but has a history of safe use in other countries, shall be manufactured or imported and sold only after approval of its usage from the Food Authority and the Application for such approval by the Food Authority shall furnish documented safe history of usage of at least ten years in India or thirty years in the country of origin.
(viii) To use any Ayush ingredient, which is not specified in Schedule V, VI and VII, the Food Business Operators shall seek prior approval of the Food Authority by submitting a product information file containing information on the material used, quality confirmation, test method to demonstrate the presence of the material in the food, relevant published literature providing scientific and technical information of the material or product related to safety and health benefits, any human intervention study published or conducted by the firm and such other relevant information and this product information file shall be produced for inspection and review by the designated authority as and when demanded.
(ix) The product information file shall primarily consist of technical and scientific information covering the following, namely:-
(a) information on quality of all raw materials;
(b) formulation details or block diagram and brief description of the processing methods or steps adopted.
(c) details of packaging materials used, packs and shelf life study data;
(d) quality specifications and test methods for analysis of the finished food or health supplement;
(e) safety and pharmacological information (literature based and if any additional study conducted);
(f) information on Human studies, if any;
(g) regulatory status in other countries, if any; and
(h) any other relevant product information.
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CHAPTER- X
h. Novel Foods. –
(1) Approval required. – Approval of the Food Authority shall be a pre-condition before manufacturing or sale of such novel food and the manufacturer or importer shall have to submit an application for approval along with all relevant documents and details as prescribed by the Food Authority time to time.
(2) Approval process. – A food business operator engaged in manufacturing or import of novel foods or novel food ingredients shall apply to the Food Authority by furnishing details of the product, ingredients used, technology and production process involved and proposed claim or declarations to be made on the label along with sufficient scientific data and documents related to safety and efficacy of the food including the following additional information, namely:-
(i) the common name of the novel food;
(ii) the name and address of the manufacturer or importer;
(iii) a description of the novel food;
(iv) details of the product;
(v) ingredients used;
(vi) technology and production process involved including method by which it is manufactured, prepared, preserved, packaged and stored;
(vii) proposed claim or declarations to be made on the label along with sufficient scientific data;
(viii) documents related to safety and efficacy of the food;
(ix) information relating to its development;
(x) method(s) of analysis;
(xi) estimated shelf life of the product;
(xii) adverse effect, if any;
(xiii) details of the major change, if any, from conventional foods;
(xiv) information relating to its intended use and directions for its preparation;
(xv) information relating to its history of use as a food in a country other than India, if applicable;
(xvi) information relied upon to establish that the novel food or ingredient or process is safe for consumption;
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(xvii) information relating to the estimated levels of consumption by consumers of the novel food;
(xviii) the text of all labels to be used in connection with the novel food;
(xix) the name and title of the person who signed the application and the date of signing;
(xx) the following information shall be included in any claimed novel foods, namely:-
(a) chemical composition of the engineered food;
(b) surface modification/ surface chemistry;
(c) primary particle size;
(d) solubility;
(e) digestibility;
(f) amount of nanomaterial if any in the food product;
(g) specific claim, if applicable.
(3) Labelling. -
(i) The labelling of novel foods shall follow the requirements as laid down under the Food Safety and Standards (Packaging and Labelling) Regulations, 2011 and any other specific labelling requirements and specific claims relating to specific product or category as contained in the specific regulations to these products or category notified by the Food Authority.
(ii) No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any package containing any novel food, if the package does not bear a label containing all such particulars as may be required under these regulations.
(4) Contaminants, Toxins and Residues. - The product shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, as amended from time to time.
