S.no. | Section | Notification |
1 | In regulation 9, for clause (i) of the sub-regulation 1 |
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.”
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2 | In Schedule I, against S.No A (14) |
in Schedule 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)
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(6S)-5-methyltetrahydrofolic acid, glucosamine salt”
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3 | In Schedule I, against S.No B (1) |
In Schedule-I, 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”
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4 | In Schedule II |
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.
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Amino Acids
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i.
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L-Histidine
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ii.
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L-Aspartic acid
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iii.
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L-Histidine hydrochloride
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iv.
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L-Arginine L-aspartate
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v.
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L-Isoleucine
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vi.
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L-Threonine
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vii.
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L-Isoleucine hydrochloride
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viii.
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L- Alanine
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ix.
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L-Leucine
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x.
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L-Phenylalanine
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xi.
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L-Leucine hydrochloride
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xii.
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L-Cystine
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xiii.
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L-Lysine
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xiv.
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L-Cystinedihydrochloride
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xv.
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L-Lysine hydrochloride
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xvi.
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L-Tyrosine
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xvii.
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L-Methionine
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xviii.
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L-Arginine
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xix.
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L-Cysteine
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xx.
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L-Tryptophan
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xxi.
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L-Cysteine hydrochloride
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xxii.
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L-Valine
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xxiii.
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L-Carnitine
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xxiv.
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L-Arginine hydrochloride
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xxv.
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L-Carnitine hydrochloride
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xxvi.
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L- Proline
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xxvii.
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L-Glutamic acid
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xxviii.
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L-LysineL-glutamate dihydrate
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xxix.
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L-Glutamine
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xxx.
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Magnesium L- aspartate
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xxxi.
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Glycine
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xxxii.
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Calcium L- glutamate
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xxxiii.
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L-Lysine acetate
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xxxiv.
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Potassium L- glutamate
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xxxv.
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N-Acetyl L-cysteine
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xxxvi.
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L-Carnitine tartrate
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xxxvii.
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N-Acetyl L-methionine
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xxxviii.
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Taurine
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xxxix.
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L- Ornithine
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xl.
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Choline
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xli.
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L-Ornithine monohydrochloride
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xlii.
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Choline chloride
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xliii.
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L-Lysine L-Aspartate
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xliv.
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Choline citrate
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xlv.
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L-Citrulline
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xlvi.
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L-Serine
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xlvii.
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Choline hydrogen tartrate
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xlviii.
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Myo-Inositol (=meso-Inositol)
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xlix.
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Choline bitartrate
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B.
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Nucleotides
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i.
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Adenosine 5-monophosphate (AMP)
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ii.
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Disodium Uridine 5-monophosphate salt
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iii.
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Cytidine 5-monophosphate (CMP)
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iv.
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Disodium Guanosine 5-mono phosphate salt
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v.
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Guanosine 5-monophosphate (GMP)
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vi.
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Disodium Inosine 5-monophosphate salt
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vii.
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Inosine 5-monophosphate (IMP)
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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.
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5 | In Schedule VF, against S.No 63 |
in Schedule VF, against the serial number 63 for the entry “Sorbitanoleate esters (Tweens)”, in column (2), following entry shall be substituted, namely,-
“Polysorbates (Tweens)”
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6 | In Schedule VF after the serial number 86 |
In Schedule VF, after the serial number 86 and the entries relating thereto, the following serial number and entry shall be inserted, namely,-
“87
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Magnesium alumina metasilicate
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-
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1 %
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7 | In Schedule VII, after the serial number 30 |
In Schedule VII, after the serial number 30 and the entries relating thereto, the following shall be inserted, namely,-
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8 | In Schedule VIII, after the serial number 13 |
In Schedule VIII, after the serial number 13 and the entries relating thereto, the following shall be inserted, namely,-
“14.
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Guar gum derivative (partially hydrolysed guar gum)”
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