Through a notification dated 6 November 2020 the FSSAI has proposed the Draft Food Safety and Standards Health Supplements, Nutraceutical, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Amendment Regulations. FSSAI has invited comments and suggestions which may be emailed to regulation@fssai.gov.in by 4 January 2021 or online at
https://fssai.gov.in/comments/Bestviewwl.aspx?NOTIFICATION_ID=2096 the format for sending the comments and suggestions is available at https://fssai.gov.in/upload/uploadfiles/files/Format_Draft_CCP_
TenderOfficeChennai06112020(1).pdf
The following are some of the highlights of the regulation. The full document can be accessed at https://fssai.gov.in/upload/uploadfiles/files/Draft_Notification_
Health_Supplements_06_11_2020.pdf
DRAFT REGULATIONS
These regulations may be called Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Amendment Regulations, 2020. They shall come into force with effective date for implementation to be either 1st January or 1st July subject to a minimum of 180 days from the date of their final publication in the official Gazette.
In the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016 (herein called these regulations)
Proposed amendment in regulation 2 Definitions the following definition has been inserted, –
(q) ―Sportsperson means an individual who is involved in various types of sports activities as approved by Sports Authority of India (Ministry of Youth Affairs & Sports).
Proposed Amendment in regulation 3 General Requirements
- Sub-regulation (1) Para 1 will be substituted with the following
(1) The article of food sold in capsule format hard or soft or vegetarian, shall comply with the General Monograph, wherever applicable and quality requirements specified for them in Indian Pharmacopoeia, if applicable.
- Sub-regulation (21) “The mere combination of vitamins and minerals formulated in tablets, capsules, syrup formats shall not be covered in any of the categories of these regulations except when vitamins and minerals are added to an article of food or in a food format. “
will be substituted with the following
(21) Mere combinations of vitamins, including use of single vitamin, in dosage formats such as tablets, capsules, syrups, at levels equal to one RDA or below shall be covered under these regulations.
The following are new additions proposed in Regulation 3 General Requirements
(26) The products covered under these regulations for children below the age of 5 years shall be given only under medical advice by physician/ certified dietician/nutritionist;
(27) Cereal grains, legumes, fruits and vegetables mentioned in Indian Food Composition Tables published by NIN, ICMR, and spices included in the list published by Spices Board of India, may be used either as such or as processed ingredients including extracts, as a supplement or nutraceutical as applicable. However, for claiming specific health benefits prior approval from Food Authority shall be obtained;
(28) Flavours for products covered under these regulations may be used in accordance with the provisions of regulation 3.3.1 of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.
(29) For combining ingredients there shall be a rationale based on available scientific and technical evidence which shall be made available to the Food Authority as and when called for.
30) Any single purified chemical entity listed in these regulations, except extracts of botanicals, which are to be sold as Health Supplement/Nutraceutical/Food for Special Dietary Use/Food for Special Medical Purpose, is not permitted without prior approval of the Food Authority.
(31) These regulations shall not apply to the infants of the age group 0 to 6 months.
(32) Any products which are to be sold as Health Supplement/Nutraceutical/Specialty food containing plant or botanical ingredients with safe history of usage/food with added probiotic ingredients/ food with added prebiotic ingredients for the age above 6 months till 24 months is not permitted without prior approval of the Food Authority.
Proposed amendment in regulation 6 Health supplements:
- in sub-regulation (2), clause (i) The health supplements shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VII or Schedule VIII or enzymes only of Schedule VI.
shall be substituted with the following
(i) Health supplement shall contain ingredients specified in Schedule I or Schedule II or both. It may also contain any ingredients specified in Schedule IV, Schedule VI (protein and enzymes only), Schedule VII and Schedule VIII‖.
Proposed amendment in regulation 7 Nutraceuticals
- in sub-regulation (2) clause (i) The nutraceuticals shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VI or Schedule VII or Schedule VIII.
shall be substituted with the following
(i) Nutraceutical shall contain ingredients specified in Schedule VI. It may also contain any ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VII and Schedule VIII.
- clause (v), For the purposes of clause (iv), a food business operator shall apply to the Food Authority for approval which shall be accompanied by documented history of usage of at least fifteen years in India, or thirty years in the country of origin;
shall be substituted with the following
(v) For the purposes of clause (iv), a food business operator shall apply to the Food Authority for approval which shall be accompanied by documented history of safe usage of at least fifteen years in India and thirty years in the country of origin
Proposed Amendment in regulation 8
The heading of regulation 8 shall be substituted with the following
- Food for Special Dietary Use, other than infants, and those products intended to be taken under medical advice of physician/ certified dietician/nutritionist.
- In the same regulation 8 under sub-regulation (1) clause (i) shall be substituted with the following
(i) specially processed or formulated to satisfy particular dietary requirements which may exist or arise because of certain physiological or specific health conditions, namely: –
- low weight, obesity, diabetes, high blood pressure;
- pregnant and lactating women;
- geriatric population and celiac disease and other health conditions;
- Sports and related physical activities.
- clause (ii) shall be substituted with the following
(ii) The food business operator shall clearly indicate on the label whether or not the food for special dietary use is to be taken under medical advice:
Provided that Food for Special Dietary Use for Sportsperson shall only be used under medical advice or dietetic supervision.
- clause (iii) shall be substituted with the following
(iii) A food business operator may manufacture or sell an article of FSDU in single use packaging or in dosage form, namely, granules, jelly, semi-solid and other similar forms, sachets of powder, or any other similar forms of liquids and powders designed to be taken in measured unit quantities with a nutritional or physiological effect:
Provided that FSDU products containing vitamins including single vitamin at levels equal to or below one RDA in formats/dosage forms of capsules, tablets, pills and syrups shall be permitted under these regulations;
- clause (iv) shall be substituted with the following
(iv) A food business operator may formulate an article of food for special dietary use in formats meant for oral feeding through enteral tubes but shall not be used for parenteral use: Provided that Food for Special Dietary Use for Sportsperson shall only be in formats meant for oral consumption
In the same regulation 8 under sub-regulation (2)
- clause (i) shall be substituted with the following
(i) Food for special dietary use shall contain any of the ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VI, Schedule VII, and Schedule VIII.
- clause (iv) shall be substituted with the following
(iv) A food business operator may add the quantity of the nutrients up to 50 per cent of tolerable upper limit (TUL) or up to one Recommended Daily Allowance (RDA), whichever is higher. In case, wherever TUL is not specified, FBOs shall not exceed more than one RDA. If both RDA and TUL is not available, the addition may be rationalized and justified based on relevant national/international scientific documents for safety and efficacy.
- the following new clause shall be added
(ix) Food for Special Dietary Use as a formula food for replacement of all meals of the daily diet for slimming, weight management and weight control purposes shall not be considered as Food for Special Dietary Use for sportsperson.
- In regulation 8 under sub-regulation (3) in clause (iii) the following sub-clause shall be added
(ba) a statement ―FOR SPORTSPERSON ONLY” in close proximity to the name of the articles of food; ―Recommended to be used under medical advice or dietetic supervision only‖ and the logo as specified below for the article of food specially prepared for sportsperson
- Under sub-regulation (3) sub-clause (c) shall be substituted with the following
(c) a statement that the product is not to be used by pregnant, nursing and lactating women or by infants, children under 5 years, adolescents and elderly except when medically advised:
provided that in case of the article of food specially prepared for sportsperson a statement that the product is not to be used by pregnant, nursing and lactating women or by infants, children under 5 years and elderly.
- Under sub-regulation (3) for sub-clause (e) shall be substituted with the following
(e) If the product has been formulated for a specific age group, sports activity as per approved list of Sports Authority of India (Ministry of Youth Affairs & Sports), a prominent statement to that effect
- Under sub-regulation (3) for sub-clause (i) shall be substituted with the following
(i) a warning that the product is not for parenteral use
Provided that a statement “for oral consumption only” for the article of food specially prepared for sportsperson;
- under sub-regulation (3) the following sub-clauses have been added
(n) a statement “the food is not a sole source of nutrition and should be consumed in conjunction with a nutritious diet” for the article of food specially prepared for sportsperson;
(o) a statement “the food should be used in conjunction with an appropriate physical training or exercise regime” for the article of food specially prepared for sportsperson.
In regulation 8 the following sub-regulations have been added inserted,
(5) No food business operator shall advertise FSDU for general public.
(6) Prohibited substances declared by World Anti-Doping Agency (WADA) shall not be added in any of the articles of food specified for sport persons. Food Business Operator must ensure to check the list of prohibited substances which is published annually by World Anti-Doping Agency and is effective from January 1 every year.
Proposed amendments in regulation 9 Food for Special medical Purpose
- Under sub-regulation (1), clause (ii) has been changed to the following
(ii) A food business operator may formulate food for special medical purpose in format meant for oral feeding through a enteral tubes.
FSMP products containing vitamins including single vitamin at levels equal to or below one RDA in formats/dosage forms of capsules, tablets, pills and syrups shall be permitted under these regulations.
- Under sub-regulation (2), clause (i), has been amended to the following
(i) Food for special medical purpose shall contain any of the ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VI (enzymes only), Schedule VII, and Schedule VIII‖
- Under sub-regulation (3), clause (b) has been amended to the following
(b) An advisory warning ―Recommended to be used only under medical advice of physician/ certified dietician/nutritionist – appearing on the label in bold letters in an area separated from other written, printed or graphic information
Proposed amendments under regulations, in regulation 10 Food with added probiotic ingredients
- Under sub-regulation 1, clause ii has been amended to the following
(ii) The viable number of added probiotic organisms in food shall be ≥108 CFU in the recommended serving size per day
Proposed amendments under regulation 11, Food with added prebiotic ingredients
- In sub-regulation 1 the following clause has been added
(iii) Maximum limit for prebiotic per day shall not exceed 40g/2000 kcal for adults.
Proposed amendments in regulation 12, Specialty food containing plant or botanical ingredients with safe history of usage
- Under sub-regulation 1, clause iii has been amended to the following
(iii) The application for approval to the Food Authority shall be accompanied by documented history of safe usage of at least fifteen years in India and thirty years in the country of origin.
New regulation has been added which is 14. Standards for ingredients:
- Psyllium (Isabgol) husk:
(i) Psyllium (Isabgol) husk means product manufactured from dry seed coats of Plantago ovate Forsk. (Fam. Plantaginaceae) obtained by crushing the clean seeds and separating the husks by winnowing.
(ii) The product shall be white or translucent, odourless, thin boat shaped structures, 2 to 3 mm long and 0.5 to 1 mm wide. The taste shall be bland and mucilaginous. It should not give any gritty feeling during sensorial (organoleptic) evaluation.
(iii) It shall be free from insect infestation, fungal contamination and fermented, musty or other odours. It shall also be free from any added additives, colours, flavours and harmful foreign materials.
(iv) The product shall conform to the following requirements:
S. N |
Characteristics |
Requirements |
i) |
Moisture, per cent by mass |
Not more than 11.5 |
ii) |
Total ash (on dry basis), per cent by mass |
Not more than 4.0 |
iii) |
Acid Insoluble Ash (on dry basis), per cent by mass |
Not more than 0.45 |
iv) |
Swell Volume, ml/gram |
Not more than 40 |
v) |
Organic extraneous matter*, per cent by mass |
Not more than 2 |
*Organic extraneous matter includes broken or entire embryo, fragments of endosperm or capsular wall of fruits belonging to isabgol crop.
In these regulations, several amendments have been proposed in
Schedule I and Schedule II and Schedule IV List of plant or botanical ingredients. These amendments are available on page 55 to page 88 at the following website https://fssai.gov.in/upload/uploadfiles/files/Draft_Notification_Health_Supplements_06_11_2020.pdf
Schedule -VI amendments which has List of ingredients as nutraceuticals can be viewed at the above-mentioned website from pages 89 to 97
Amendment to Schedule VII List of probiotic (live) micro-organisms is available on page 97 and 98 on the above- mentioned website
Source : FSSAI
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