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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
 

                                                                                             
  
S.no.SectionNotification
1In 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.”

 

2In 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)

(6S)-5-methyltetrahydrofolic acid, glucosamine salt”

3In 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”

4In 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.

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.

5In 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)”

6In 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

Magnesium alumina metasilicate

-

1 %

7In 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,-

 

“31.

Bacillus indicus”

8In 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.

Guar gum derivative (partially hydrolysed guar gum)”

 


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