1 
 The Draft Amendment of Standards for Specification, Scope, 
Application and Limitation of Food Additives  
MOHW  Food No  1101300380 , 18 03, 2021 
Appendix  1: Standards for Scope, Application  and Limitation  of Food 
Additives  
08. Nutritional additives  
Code  Food Additive Items  Scope and Application 
Standards  Limitations  
08323 Calcium L -5-
Methyltetrahydrofolat e 1. Foods in capsule or 
tablet form and 
labeled with daily 
dosage: not more than 
800 μ g of total folic 
acid in daily intake.  
2. Other general foods: 
not more than 600 μg 
of folic acid for foods 
labeled with daily 
dosage or for every 
300 g of food without 
daily dosage labeling.  
3. Infant 
(supplementary) 
foods: not more than 
225 μ g of folic acid 
for foods labeled with 
daily dosage or for 
every 300 g of food 
without daily dosage 
labeling.  For 
supplementing 
purpose.  
  2 
 The Draft  Amendment of Standard s for Specification, Scope , 
Application and  Limitation  of Food Additive s 
   MOHW  Food No  1101300380 , 18 03, 2021 
Appendix 2: Standards for Specification of Food Additives  
08. Nutritional additives   
§ 08323 
Calcium L -5-Methyltetrahydrofolate  
Synonyms  L-5-Methyltetrahydrofolic acid, calcium salt  
L-Methyltetrahydrofolate, calcium salt  
L-Methylfolate, calcium  
L-5-MTHF -Ca 
Definition  Calcium L -5-methyltetrahydrofolate (L -5-
MTHF -Ca) is a synthetic derivative of folic acid, 
the predominant, naturally occurring form of 
folate. It is synthesized by reduction of folic acid 
to tetrahydrofolic acid followed by methylat ion 
and diastereoselective crystallization (in water) of 
L-5-MTHF as its calcium salt. The product 
contains variable amounts of water of 
crystallization.  
Chemical name  N-{4-[[((6S) -2-amino -3,4,5,6,7,8 -hexahydro -5-
methyl -4-oxo-6-
pteridinyl)methyl ]amino]benzoyl} -L-glutamic 
acid, calcium salt  
C.A.S. number  151533 -22-1 
Chemical formula  C20H23CaN 7O6 (anhydrous form)  
Structural formula  (anhydrous form)  
3 
 Formula weight  497.5 (anhydrous form)  
Assay  95.0 – 102.0% (anhydrous basis)  
Description  White to light yellowish, almost odourless, 
crystalline powder.  
Characteristics   
Identification   
Solubility  Sparingly soluble in water and very slightly 
soluble or insoluble in most organic solvents; 
soluble in alkaline solutions . 
Infrared absorption  The infrared absorption spectrum of a potassium 
bromide dispersion of the sample corresponds to 
that of a L -5-MTHF -Ca standard . 
Calcium  Dilute 30 g of acetic acid (glacial) to 100 m L with 
water. Dissolve 5.3 g of K 4Fe(CN) 6 in 100 m L of 
water. To 5 m L of the acetic acid solution, add 20 
mg of the sample and then 0.5 m L of the 
potassium ferrocyanide solution. Mix and add 50 
mg of ammonium chloride. A white crystalline 
precipitate is formed.  
Liquid 
chromatography  Retention time matches that of a L-5-MTHF -Ca 
standard  used in test.  
Purity   
Water  Not more than 17.0% (Karl Fischer method)  
(Note: Allow sufficient time (15 min) for release 
of bound water.)  
Calcium  7.0 - 8.5% (anhydrous basis)  
Other folates and 
related substances  Not more than 2.5%  
D-5-Methylfolate  Not more than 1.0 % 
Lead  Not more than 1 mg/kg  
Cadmium  Not more than  0.5 mg/kg  
Mercury  Not more than 1 mg/kg  
Arsenic  Not more than 1.5 mg/kg  
Category  Food Additives Category 8  4 
 Uses  Nutritional additives