1 
 The Amendment of Standards for Specification, Scope, Application 
and Limitation of Food Additives  
MOHW Food No.1101301224, 10 Mar, 2022  
Appendix 1: Standards for Scope, Application and Limitation of Food 
Additives 
07. Food quality improvement, fermentation and food processing agents 
Code Food Additive Items  Scope and Application 
Standards Limitations 
07099 Nitrogen All foods: as practically 
needed. For packaging 
gas, propellant, 
and foaming 
agent purpose. 
Note:“All foods” mentioned in the hereinbefore table except 07099 
nitrogen do not include fresh milk and sterilized milk. 
08. Nutritional additives 
Code Food Additive Items  Scope and Application 
Standards Limitations 
08112 Lactoferrin 1.  General foods: not 
more than 300 mg of 
lactoferrin for foods 
labeled with daily 
dosage. 
2. Special dietary foods: 
as practically needed.  For 
supplementing 
purpose. 
08323 Calcium L-5-
Methyltetrahydrofolate  1. Foods in capsule or 
tablet form and 
labeled with daily 
dosage: not more than 
800 μg of total folic 
acid in daily intake. 
2. Other general foods: 
not more than 600 μ g 
of folic acid for foods For 
supplementing 
purpose. 2 
 labeled with daily 
dosage or for every 
300 g of food without 
daily dosage labeling.  
3. Infant 
(supplementary) 
foods: not more than 
225 μg of folic acid 
for foods labeled with 
daily dosage or for 
every 300 g of food 
without daily dosage 
labeling. 
  3 
 The Amendment of Standards for Specification, Scope, Application 
and Limitation of Food Additives  
   MOHW Food No.1101301224, DD MM, YYYY 
Appendix 2: Standards for Specification of Food Additives 
07. Food quality improvement, fermentation and food processing 
agents  
§ 07099 
Nitrogen 
Synonyms INS No. 941 
Definition  
Chemical name  Nitrogen 
C.A.S. number 7727-37-9 
Chemical formula N2 
Formula weight 28.0 
Assay Not less than 99.0% v/v 
Description Colourless, odourless gas or liquid  
Characteristics  
Identification  
Flame test A flame is extinguished in an atmosphere of the 
sample. 
Purity  
Oxygen Not more than 1% v/v 
Carbon monoxide Not more than 10 μl/l 
Category Food Additives Category 7 
Uses Food quality improvement, fermentation and food 
processing agents 
 
 
  4 
 08. Nutritional additives  
§ 08112 
Lactoferrin 
Description Obtained by degreasing, separating and refining 
the milk. White to pink powder. 
Crude protein  Not less than 93% (TN×6.38, on the dried basis).  
Lactoferrin Not less than 95% on the protein basis. 
Iron 30 mg/100 g 
Water Not more than 4.5%. 
Solubility Dissolve 2 g of the sample in 100 mL of water. 
The solution should be “transparent”. 
pH 5.2-7.2 (20oC) (2% soln) 
Ash Not more than 1% 
Heavy metals 
Arsenic Not more than 20 mg/kg as Pb 
Not more than 2 mg/kg as As 
Category Food Additives Category 8 
Uses Nutritional additives 
 
 
 
 
 
 
 
 
 
 
 
 5 
 § 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 methylation 
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  C20H23CaN7O6 (anhydrous form)  
Structural formula  (anhydrous form)  
 
Formula weight  497.5 (anhydrous form)  
Assay 95.0 – 102.0% (anhydrous basis)  
Description  White to light yellowish, almost odourless, 
crystalline powder.  
6 
 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 mL with 
water. Dissolve 5.3 g of K 4Fe(CN) 6 in 100 mL of 
water. To 5 mL of the acetic acid solution, add 20 
mg of the sample and then 0.5 mL 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 
Uses Nutritional additives 7 
 16. Emulsifier  
§ 16006 
Diacetyl Tartaric Acid Esters of Mono- and Diglycerides  
Synonyms  Diacetyltartaric acid esters of mono- and 
diglycerides; DATEM; Tartaric, acetic and fatty 
acid esters of glycerol, mixed; Mixed acetic and 
tartaric acid esters of mono and diglycerides of 
fatty acids; INS No. 472e.  
Definition  The product consists of mixed glycerol esters of 
mono- and diacetyltartaric acid and fatty acids 
from edible fats and oils. It is made by the 
interaction of diacetyltartaric anhydride and 
monoand diglycerides of fatty acids in the 
presence of acetic acid, or by interaction of acetic 
anhydride and mono- and diglycerides of fatty 
acids in the presence of tartaric acid.  
Because of inter- and intramolecular acyl- group 
exchange, both methods of product ion lead to the 
same essential components, the distribution of 
which depends on the relative proportions of the  
basic raw materials, on temperature, and on 
reaction time. The product may contain small 
amounts of free glycerol, free fatty acids, and free 
tartaric and acetic acids.  
C.A.S. numbers  308068-42-0  
100085-39-0  
Structural formula  
in which one or two of the R groups is a fatty 
acid moiety and the other R groups are either: 
- diacetylated tartaric acid moiety 
- monoacetylated tartaric acid moiety 
- tartaric acid moiety 
8 
 - acetic acid moiety 
- hydrogen 
Description Liquid, paste, or wax-like solid 
Characteristics  
 Identification  
 Solubility Dispersible in cold and hot water; soluble in 
methanol, ethanol, acetone, and ethyl acetate. 
 1,2-diols To a solution of 500 mg in 10 ml methanol, add 
dropwise, lead acetate TS. A white, flocculent, 
insoluble precipitate is formed. 
 Fatty acids Passes test 
 Acetic acid Passes test 
 Tartaric acid Passes test 
 Glycerol Passes test 
 Purity  
 Acids Acids other than acetic, tartaric and fatty acids, 
shall not be detectable. 
 Sulfated ash Not more than 0.5% (determined at 800±25 ℃) 
 Acid value 40-130 
 Total acetic acid 8%-32% after hydrolysis 
 Total tartaric acid 10%-40% after saponification 
 Total glycerol 11%-28% after saponification 
 Free glycerol Not more than 2.0% 
 Lead Not more than 2 mg/kg 
Category Food Additives Category 8 
Uses Nutritional additives