1 
 The Draft Amendment of Standards for Specification, Scope, 
Application and Limitation of Food Additives  
MOHW  Food No. 1091302610, 02 12, 2020 
Appendix  1: Standards for Scope, Application  and Limitation  of Food 
Additives  
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.  
  2 
 The Draft  Amendment of Standard s for Specification, Scope , 
Application and  Limitation  of Food Additive s 
   MOHW Food No. 1091302610, 02 12, 2020 
Appendix 2: Standards for Specification of Food Additives  
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  dried basis.  
Iron 100-160 mg/kg  
Water  Not more than 4.5%.  
Solubility  Dissolve 2 g of the sample in 100 mL of water. 
The solution should be “transparent ”. 
pH 5.5-6.5 (20oC) (2% soln)  
Ash Not more than 1%  (550oC). 
Heavy metals  Not more than 1 mg/kg.(the total content  of 
Cadmium, Lead, Arsenic, Mercury) . 
Category  Food Additives Category 8  
Uses  Nutritional additives  
 
 
 
 
 
 
 
 
 
 
 
 
 3 
 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 mon o- and diglycerides of fatty 
acids in the presence of tartaric acid.  
Because of inter - and intramolecular acyl -group 
exchange, both methods of production lead to the 
same essential components, the distribution of 
which depends on the relative proportions o f 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  
4 
 - 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