FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA
NOTIFICATION
New Delhi, the 6th September, 2021
F. No. Stds/SP-05/T(Nutraceuticals-02).—The draft regulations further to amend 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, which the Food Safety and Standards Authority of India proposes to make with previous approval of the Central Government, 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) is hereby published as required under 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 the period of sixty days from the date on which copies of the Gazette in which this notification is published are made available to the public;
Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, FDA Bhawan, Kotla Road, New Delhi- 110002 or may be sent by e-mail at regulation@fssai.gov.in;
Objections or suggestions which may be received with respect to the said draft regulations within the period specified above shall be considered by the Food Safety and Standards Authority of India.
Draft Regulations
1. (1) 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, 2021.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. 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,
(a) in regulation 9, for clause (i) of the sub-regulation 1, following shall be substituted, namely,-
“Food for special medical purpose shall include food specially prepared for weight reduction and intended as total replacement of normal diet. Food for special medical purpose may also include Foods intended for Special Diagnostic Purpose with the prior approval of the Authority. Food Business Operator seeking such approval shall take approval of the Authority in accordance with Food Safety and Standards (Approval of non-specified food and food ingredients) Regulations, 2017.”
(b) in Schedule I,-
(i) against serial number A(14) related to „Folic acid‟, below the existing entries at column (3) and (4), following shall be inserted, namely;-
| “(ii) | (6S)-5-methyltetrahydrofolic acid, glucosamine salt” |
(ii) against serial number B(1) related to „Calcium‟, for the entry „Calcium from algal source (Alguscalcarius)‟ in column (4), following shall be substituted, namely;-
“Calcium from algae including red seaweed”
(c) for Schedule II, following schedule shall be substituted, namely,-
Schedule – II
[See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 8.(2)(i) and 9.(2)(i)]
List of amino acids and other nutrients
| A. | Amino Acids | ||
| i. | L-Histidine | ii. | L-Aspartic acid |
| iii. | L-Histidine hydrochloride | iv. | L-Arginine L-aspartate |
| v. | L-Isoleucine | vi. | L-Threonine |
| vii. | L-Isoleucine hydrochloride | viii. | L- Alanine |
| ix. | L-Leucine | x. | L-Phenylalanine |
| xi. | L-Leucine hydrochloride | xii. | L-Cystine |
| xiii. | L-Lysine | xiv. | L-Cystinedihydrochloride |
| xv. | L-Lysine hydrochloride | xvi. | L-Tyrosine |
| xvii. | L-Methionine | xviii. | L-Arginine |
| xix. | L-Cysteine | xx. | L-Tryptophan |
| xxi. | L-Cysteine hydrochloride | xxii. | L-Valine |
| xxiii. | L-Carnitine | xxiv. | L-Arginine hydrochloride |
| xxv. | L-Carnitine hydrochloride | xxvi. | L- Proline |
| xxvii. | L-Glutamic acid | xxviii. | L-LysineL-glutamate dihydrate |
| xxix. | L-Glutamine | xxx. | Magnesium L- aspartate |
| xxxi. | Glycine | xxxii. | Calcium L- glutamate |
| xxxiii. | L-Lysine acetate | xxxiv. | Potassium L- glutamate |
| xxxv. | N-Acetyl L-cysteine | xxxvi. | L-Carnitine tartrate |
| xxxvii. | N-Acetyl L-methionine | xxxviii. | Taurine |
| xxxix. | L- Ornithine | xl. | Choline |
| xli. | L-Ornithine monohydrochloride | xlii. | Choline chloride |
| xliii. | L-Lysine L-Aspartate | xliv. | Choline citrate |
| xlv. | L-Citrulline | xlvi. | L-Serine |
| xlvii. | Choline hydrogen tartrate | xlviii. | Myo-Inositol (=meso-Inositol) |
| xlix. | Choline bitartrate | ||
| B. | Nucleotides | ||
| i. | Adenosine 5-monophosphate (AMP) | ii. | Disodium Uridine 5-monophosphate salt |
| iii. | Cytidine 5-monophosphate (CMP) | iv. | Disodium Guanosine 5-mono phosphate salt |
| v. | Guanosine 5-monophosphate (GMP) | vi. | Disodium Inosine 5-monophosphate salt |
| vii. | Inosine 5-monophosphate (IMP) | ||
Note.- Suitable hydrated and anhydrous forms of amino acids, and the hydrochloride, sodium, and potassium salts of amino acids may be used. In such cases, Food Business Operators shall notify in writing to the Authority. Food Business Operators shall be required to submit additional safety data/information when requested by the Authority.
(d) in Schedule VF,
(i) against the serial number 63 for the entry “Sorbitanoleate esters (Tweens)”, in column (2), following entry shall be substituted, namely,-
“Polysorbates (Tweens)”
(ii) after the serial number 86 and the entries relating thereto, the following serial number and entry shall be inserted, namely,-
| “87 | Magnesium alumina metasilicate | – | 1 % |
(e) in Schedule VII, after the serial number 30 and the entries relating thereto, the following shall be inserted, namely,-
| “31. | Bacillus indicus” |
(f) in Schedule VIII, after the serial number 13 and the entries relating thereto, the following shall be inserted, namely,-
| “14. | Guar gum derivative (partially hydrolysed guar gum)” |
ARUN SINGHAL, Chief Executive Officer
[ADVT.-III/4/Exty./234/2021]
Note : The principal regulations were published in the Gazette of India, Extraordinary, Part III, Section 4, vide notification number F. No. 1-4/Nutraceutical/FSSAI-2013, dated the 23rd December, 2016.
