
The FSSAI has issued a Gazette Notification dated 6 September, 2021 on the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Amendment Regulations, 2021. These regulations may be called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) first Amendment Regulations, 2021. 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 with effect from 1st April, 2022.
Regulations
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 (hereinafter referred to as the said regulations)
Amendments in regulation 2, Definitions
Under Definitions the category sportsperson has been added to the said regulations which is as follows
“(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 and Sports, Government of India).”
Amendments in Regulation 3. General requirements
Under General Requirements in sub-regulation (1) the following has been amended f from
(1) The articles of food sold in capsule format, hard or soft or vegetarian, shall comply with the general monograph and quality requirements specified for them in Indian Pharmacopoeia
Amended to the following
The articles of food sold in capsule format, hard or soft or vegetarian, shall comply with the general monograph and quality requirements specified for them in Indian Pharmacopoeia, if applicable”
Under General Requirements in sub-regulation (13), after Explanation 2 the following explanation has been added
“Explanation 3: To promote maintenance of health primarily through food formats, as permitted under section 22 of the Act, wherever applicable, tablets, capsules and syrups can also be used as formats for presentation of the products.”;
Under same regulation, sub-regulation (21) has been amended from the following.
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.
Amended to the following
“(21) The combination of vitamins and minerals, including use of single vitamin and mineral, in dosage formats such as tablets, capsules, syrups, at levels equal to a maximum of one Recommended Dietary Allowances or below shall be covered under these regulations.”;
Under Regulation General Requirements the following new sub-regulations have been added
(26) These regulations shall not be applicable to infants up to the age of 24 months. Foods intended for infants up to the age 24 months are specified under the Food safety and Standards (Food for infant nutrition) Regulations, 2020. The products covered under these regulations intended for children 2 to 5 years of age shall only be given under medical advice by any physician or certified dietician or nutritionist.
(27) Cereal grains, legumes, fruits and vegetables mentioned in Indian Food Composition Tables published by National Institute of Nutrition, Indian council of Medical Research, and spices included in the list published by the 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 the 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 or nutraceutical or food for special dietary use or food for special medical purpose, as the case may be, is not permitted without prior approval of the Food Authority.
(31) Products covered under these regulations may also contain such additional ingredients, other than additives, which are either standardised or permitted for use in preparation of the other standardised foods as specified in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.
(32) The food business operator may use water, ethyl alcohol or hydro alcoholic process of extraction for obtaining plants or botanicals extract used in the products covered under these regulations.
(33) Food business operator shall seek approval of the claims for the ingredients or products covered under these regulations as per the Food Safety and Standards (Advertising and Claims) Regulations, 2018.” In the said regulations
Amendments in regulation 4. Claims
In sub-regulation (5) relating to health claims clause (iii) enhanced function claims shall be omitted.
In sub-regulation (6), for the words “The other claims”, the words “Any other claims” shall be substituted.
Amendments in regulation 6. Health Supplements
In sub-regulation (2), clause (i) has been amended to the following
“(i) The health supplement shall contain singly or in combination with any of the ingredients specified in Schedule I or Schedule II or both. It may also contain singly or in combination with any of the ingredients specified in Schedule IV, Schedule VI (protein and enzymes only), Schedule VII and Schedule VIII.”.
Amendments in Regulation 7 Nutraceuticals
In sub-regulation (2) clause (i) has been amended to the following
(i) The nutraceutical shall contain ingredients specified in Schedule VI. It may also contain singly or in combination with any of the ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VII and Schedule VIII.”
Amendments in Regulation 8 Food for special dietary use, other than infants, and those products intended to be taken under medical advice.
The heading of the regulation has been amended to the following
“Food for special dietary use, other than infants, and those products intended to be taken under medical advice of physician or certified dietician or nutritionist”;
Under the same regulation 8 under (i) new category (d) has been added
“(d) food for Sportspersons.”
Under the same regulation 8 after clause (ii), the following proviso has been added
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 by physician or certified dietician or nutritionist.”;
Under same regulation 8 after clause (iv), the following proviso has been added 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 regulation 8 under sub-regulation (2) clause (i) has been amended to the following
“(i) The food for special dietary use shall contain singly or in combination of any of the ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VI, Schedule VII and Schedule VIII.”
Under regulation 8, sub-regulation 2 clause (iv) has been amended from
A food business operator may add the quantity of the nutrients at a level higher than the recommended daily allowance, but not exceeding the limits of vitamins and minerals specified in Schedule III.
Amended to the following
“(iv) The food business operator shall add the quantity of the nutrients at levels equal to a maximum of one Recommended Dietary Allowances or below.
Provided that product with higher Recommended Dietary Allowances in food format (except tablet, capsule, syrup) may be allowed subject to prior approval of the Food Authority which shall be based on adequate scientific evidence.”;
Under regulation 8, sub-regulation 2, new clause has been added which is as follows
“(ix) The 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 a sportsperson.”;
In regulation 8 in sub-regulation (3) in clause (iii) a new sub-clause (ba) has been added which is as follows
“(ba) a statement “FOR SPORTSPERSON ONLY” in close proximity to the name of the articles of food,
“Recommended to be used under medical advice by a physician or certified dietician or nutritionist only” and the logo as specified below for the article of food specially prepared for sportsperson;
In regulation 8 in sub-regulation (3) in clause (iii) sub-clause (c) has been amended to 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.”;
In regulation 8 in sub-regulation (3) clause (iii) sub-clause (e) has been amended from if the product has been formulated for a specific age group, a prominent statement to that effect;
amended to the following
(e) if the product has been formulated for a specific age group, sports activity as per the approved list of Sports Authority of India (Ministry of Youth Affairs and Sports, Government of India), a prominent statement to that effect;”;
In regulation 8 in sub-regulation (3) after sub-clause (i), the following has been added
“Provided that a statement ‘for oral consumption only’ for the article of food specially prepared for sportsperson;”
In regulation 8 in sub-regulation (3) clause (iii), the following sub-clauses have been added to the existing sub-clauses
“(n) a statement ‘the food is not a sole source of nutrition and shall be consumed in conjunction with a nutritious diet’ for the article of food specially prepared for sportsperson;
(o) a statement ‘the food shall be used in conjunction with an appropriate physical training or exercise regime’ for the article of food specially prepared for sportsperson.”;
In regulation 8 new sub-regulations have been added which are as follows
(5) Advertisement of food for special dietary use for general public shall clearly indicate that the product is to be taken under medical advice, wherever applicable.
(6) Prohibited substances declared by the 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 the World Anti-Doping Agency and is effective from the January 1 every year.”
In the said regulations, Amendments in regulation 9 Food for special medical purpose
In 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.”;
In sub-regulation (2), clause (v) has been amended from
In food for special medical purpose, nutrients may be added at levels higher than the recommended daily allowance, but not exceeding the limits of vitamins and minerals as specified in Schedule III.
Amended to the following
(v) Food business operator shall add the quantity of the nutrients at levels equal to a maximum of one Recommended Dietary Allowances or below.
Provided that product other than food specially prepared for weight reduction and intended as total replacement of complete diet with higher RDA in food format (except tablet, capsule, syrup) may be allowed subject to prior approval of the Food Authority which shall be based on adequate scientific evidence.”.
Amendment 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;”
Amendment in regulation 11, Food with added prebiotic ingredient
In sub-regulation (1) new subclause has been added which is as follows
(iv)Maximum limit for prebiotic per day shall not exceed 40g/2000 kcal for adults.”.
Amendments in Schedule I
Under ‘components’ for A (8) relating to “Vitamin D after the following entry has been added
“(iii) Vitamin D3 (cholecalciferol) – Lichen/Algae*
(*The species of lichen/algae shall need prior approval of Food Authority)”;
For A (9) relating to “Vitamin E” the following component has been added
“(viii) Tocotrienols”;
For B (1) relating to “Calcium” (xiii)calcium from algal source (Algus calcarius)” has been amended to (xiii) Calcium from algae including red seaweed”
In the same mineral the following has also been added
(xv) natural forms of calcium obtained from corals, shells, pearls, conch, oysters and milk”;
For B (4) relating to “Copper” the following have been added “(vi) Copper oxide (copper (II) oxide, cupric oxide and black copper oxide)”;
For B (12) relating to “Selenium”, the following has been added – “(v) Selenious acid”;
After serial number B (15), the Note, for the words “Suitable esters and salts of vitamins and salts and chelates of mineral may be used” has been amended to the following
“Suitable esters, derivatives and salts of vitamins and salts and chelates of minerals may be used. Food business operator shall notify in writing to Food Authority, whenever they use such esters, salts, chelates and derivatives. FBOs shall be required to submit additional safety data/information when requested by the Food Authority for such cases.”
Amendments in Schedule II, the Note has been amended to the following
“Suitable esters, derivatives, isomers and salts of amino acids may be used. Food business operator shall notify in writing to Food Authority, whenever they use such esters, salts, isomers and derivatives. Food business operator shall be required to submit additional safety data or information when requested by the Food Authority for such cases.”.
Amendments in Schedule III, the heading has been amended to the following
“[See regulations 3(13), 4(2) and 9(2)(iv)]
Values for vitamins, minerals and trace elements allowed to be used in Food for special medical purpose (other than those intended for use in infant formula)”.
Amendments in Schedule IV
“Schedule – IV
[See regulations 3. (13), 4. (2), 6. (2)(i), 7. (2)(i), 7. (3)(v), 8. (2)(i), 9. (2)(i), 12. (1)(i), 12. (2), 12. (3)(i), 12. (3)(ii) and 12. (3)(iii)]
List of plant or botanical ingredients
The Schedule IV has been amended and the amended Schedule can be accessed on the following webpage link https://fssai.gov.in from page 68 to page 108 (this is a long list of 439 plant and botanical ingredients)
Amendments In Schedule V A List of food additives for health supplements, nutraceuticals and food with added probiotics and prebiotics
Iron Oxide has been added INS number 172(i), 172 (ii), 172 (iii) and the maximum permitted level is 7,500 mg/kg (For use in surface treatment only)”
Amendments in Schedule VF List of food additives to be used in formats such as tablets, capsules and syrups
In the list against serial number “Cross carmellose sodium” the maximum Permitted Level has been amended from 0.5 to 5%
Natural and synthetic colours as per FSSR has been omitted
New food additives have been added
Amendments in “Schedule VI” the list of ingredients as nutraceuticals has been amended and can be accessed from the following link https://fssai.gov.in the list is available form page 108 to 118
“Schedule –VI
[See regulations 3. (13), 4. (2), 6. (2)(i), 7. (2)(i), 7. (3)(i), 7. (3)(v), 8. (2)(i) and 9. (2)(i)]
List of ingredients as nutraceuticals
Amendments in Schedule VII can be accessed from the following link https://fssai.gov.in from page 118 to page 119
“Schedule –VII
[See regulations 3. (13), 6. (2)(i), 7. (2)(i), 8. (2)(i), 9. (2)(i) and 10. (1)(i)]
List of probiotics (live) micro-organisms
Amendments in Schedule VIII
Schedule – VIII
[See regulations 3. (13), 6. (2)(i), 7. (2)(i), 8. (2)(i), 9. (2)(i) and 11. (1)(i)]
List of prebiotic compounds
for serial number 2 Soybean oligosaccharides has been changed to Soya poly-saccharides and soya oligosaccharides
New prebiotic compounds have been added which are as follows
- Partially Hydrolysed Guar Gum (Guar gum derivative)”
- Pectin
- Resistant dextrin”
New Schedule IX has been added which is as follows
“Schedule IX
Standards for ingredients
(1) 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.
Source: FSSAI
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