The Amendment of Standards for Specification, Scope, Application 
and Limitation of Food Additives  
MOHW  Food No. 108130 3084 , 7 November , 2019 
Appendix  1: Standards for Scope, Application and Limitation  of Food 
Additives  
11-1. Sweeteners  
Code  Food Additive 
Items  Scope and 
Application 
Standards  Limitations  
11-1-026 Mogroside Extract  All foods: as 
practically needed.  For 
manufacturing or 
processing 
purpos e. 
 
  The Draft  Amendment of Standard s for Specification, Scope , 
Application and  Limitation  of Food Additive s 
   MOHW Food No. 108130 3084 , 7 November , 201 9 
Appendix 2: Standards for Specification of Food Additives  
11-1. Sweeteners   
§ 11-1-026 
Mogroside  Extract  
SYNONYMS  Luohanguo Extract,  Monk Fruit Extract  
DEFINITION   Luohanguo Extract is obtained from the fruits of 
the luohanguo plant  Siraitia grosvenorii 
(Swingle) C. Jeffrey ex A. M. Lu & Zhi Y . 
Zhang (Momordica  grosvenori Swingle) and 
consists mainly of mogrosides.  
Content  ：Luohanguo Extract, w hen dried, contains not 
less than 20% of mogroside V  (C60H102O29 = 
1287.43).  
 
 
 
 
             
 
            Mogroside V  
Description  ：light yellow to light brown powder having  a 
sweet taste.  
CHARACTERISTICS   
 IDENTIFICATION   
 Color reaction  ：To 5–10 mg of Luohanguo Extract, previously 
dried, add 2 mL of acetic anhydride,  warm for 
2 minutes, and slowly add 0.5 mL of sulfuric 
acid. The boundary surface turns  red-brown.  
 Chromatography  ：Major component c orresponds with the 
Mogroside V . 
 Purity   
 Lead  ：Not more than 1.0 mg/kg . 
 Cadmium  ：Not more than 1.0 mg/kg.  
 Arsenic  ：Not more than 0.5 mg/kg . 
 Loss in Drying  ：Not more than 6.0 % (105°C，hours ). 
 Residue on Ignition  ：Not more than 2.0 %. 
Category  ：Food additives category ( 11-1). 
Functional uses  ：Sweeteners . 
 
  7. Food quality improvement, fermentation and food processing 
agents  
§ 070 21 
Magnesium Stearate  
SYNONYMS  ：Magnesium distearate, dibasic magnesium 
stearate, INS No. 470(iii)  
DEFINITION  : Magnesium stearate is a mixture of  
magnesium salts of fatty acids  obtained from 
edible fats and oils.  The product consists 
mainly of  magnesium stearate and palmitate in 
varyi ng proportions. It is  manufactured by one 
of the two followi ng processes: a) direct 
process  wherein fatty acids are directly r eacted 
with a magnesium source,  such as magnesium 
oxide to form magn esium salts of the fatty 
acids;  b) indirect process where a sodium s oap 
is produced by the reaction  of fatty acids with 
sodium hydrox ide in water and the product is  
precipitated by adding magnesium salts to the 
soap.  
Chemical names  : Magnesium stearate, magnesium 
octadecanoate, fatty acids C 16-C18 magnesium 
salts 
C.A.S number  ：557-04-0 (magnesium stearate)  
91031 -63-9 (fatty acids C 16-18 magnesium salts)  
Chemical formula  : Mg(C 18H35O2)2 (magnesium distearate)  
Formula weight  : 591.27 (magnesium distearate)  
Assay  : Magnesium: Not less than 4.0% and not more 
than 5.0%, on dried basis . 
Fatty acids:  Not less than 40.0% stearic a cid in 
the fatty acid fraction;  and not less than 90.0%  
as the sum of stearic acid and  palmitic acid in 
the fatty acid fraction.  
DESCRIPTION  Off-white to white, very fine powder; greasy to the touch  
CHARACTERISTICS   
 IDENTIFICATION   
 Solubility  Practically insoluble in water  
 Magnesium  Presence of magnesium in the  
sample  
 Fatty acid 
composition  Identify the individual fatty acids  in the sample  
 PURITY   
 Loss on drying  Not more than 6% (105° C, constant weight, use 
1 g of sample)  
 Acidity or alkalinity  Passes test  
 Unsaponifiable 
matter  Not more than 2%  
 Cadmium  Not more than 1 mg/kg  
 Lead  Not more than 2 mg/kg  
 Nicke l Not more than 3 mg/kg  
Category  : Food additives category ( 7). 
Functional uses  : Food quality improvement, fermentation and 
food processing agents . 
 
  7. Food quality improvement, fermentation and food processing 
agents  
§ 070 18 
Magnesium  Carbonate  
SYNONYMS  :INS No. 504(i) , Magnesium subcarbonate (light or 
heavy), hydrated basic magnesium carbonate, 
magnesium carbonate hydroxide; INS No. 504(ii)  
DEFINITION  A basic hydrated or a normal hydrated m agnesium 
carbonate or a mixture  of the two  
Chemical names  ：Magnesium carbonate , Magnesium carbonate 
hydroxide hydrated  
C.A.S. number  ：Magnesium Carbonate ：546-93-0 
Assay  Magnesium Carbonate：24.0%  ~ 26.4%  (As Mg) 
Magnesium Hydroxide Carbonate：40.0%  ~ 45.0%  
(As MgO)  
DESCRIPTION  Odourless, light, white friable masses or as a bulky 
white powder  
CHARACTERISTICS   
 IDENTIFICATION   
 Solubility  : Practically insoluble in water; insoluble in ethanol  
 Test for carbonate  Magnesium Carbonate : Passes test  
Magnesium Hydroxide Carbonate : - 
 Test for magnesium  Passes test  
 Alkalinity  Magnesium Carbonate : - 
Magnesium Hydroxide Carbonate:  Slurry shows 
slight alkalinity  
 PURITY   
 Acid insoluble 
substances  Not more than 0.05%  
 Water soluble 
substances  Magnesium Carbonates : Not more than 1%  
Magnesium Hydroxide Carbonate:  - 
 Soluble salts  Magnesium Carbonates:  - Magnesium Hydroxide Carbonate:  Not more than 
1.0%  
 Calcium  Magnesium Carbonates:  Not more than 0.4%  
Magnesium Hydroxide Carbonate ：1.0%以下  
 Lead  Not more than 2 mg/kg  
 Arsenic  Not more than  4 mg/kg  (As As2O3) 
Category  : Food additives category ( 7). 
Functional uses  : Food quality improvement, fermentation and food 
processing agents . 
 
  7. Food quality improvement, fermentation and food processing 
agents  
8. Nutritional additives  
§ 07006 
§ 08113  
Calcium dihydrogen phosphate  
SYNONYMS  :Monobasic calcium phosphate, monocalcium 
orthophosphate, monocalcium phosphate, 
calcium biphosphate, acid calcium phosphate, 
INS No. 341(i)  
DEFINITION   
Chemical names  :Calcium dihydrogen phosphate  
C.A.S. number  : Anhydrous: 7758 -23-8 
Monohydrate: 10031 -30-8 
Chemical formula  : Anhydrous: Ca(H 2PO 4)2 
Monohydrate: Ca(H 2PO 4)2,H2O 
Formula weight  : Anhydrous: 234.05  
Monohydrate: 252.07  
Assay  Anhydrous: Not less than 16.8% and not more 
than 18.3% of Ca  
Monohydrate: Not less than 15.9% and not more 
than 17.7% of Ca  
DESCRIPTION  Hygroscopic white crystals or granules, or 
granular powder  
CHARACTERISTICS   
 IDENTIFICATION   
 Solubility  : Sparingly soluble in water, insoluble in ethanol  
 Test for calcium  : Passes test  
 Test for phosphate  : Passes test  
 PURITY   
 Loss on drying  : Monohydrate: Not more than 1% (60 ℃，3 h) 
 Loss on ignition  : Anhydrous: Between 14.0 and 15.5% (800 ℃，
30 min) 
 Fluoride  : Not more than 50 mg/kg   Arsenic  : Not more than 3 mg/kg  
 Lead  : Not more than 4 mg/kg  
Category  : Food additives category ( 7); (8). 
Functional uses  : Food quality improvement, fermentation and 
food processing agents ; Nutritional additives . 
 
  8. Nutritional additives  
9. Colors  
§ 08133  
§ 09033  
Lutein  
SYNONYMS  ： Vegetable lutein; vegetable luteol  
Definition  ：Crystalline lutein is obtained by extracting with 
solvent, saponifying, centrifuging marigold flower  or 
other plant edible part . The crystal contains a small 
amount of zeaxanthin.  
Chemical names  ：3R,3’R,6’R -β,ε-carotene -3,3'-diol; all -trans -lutein; 
4’,5’ - 
didehydro -5’,6’ -dihydro -beta,beta -carotene -3,3’-diol 
C.A.S. number  ：127-40-2 
Chemical formula  ：C40H56O2 
Structural formula  ： 
Formula weight  ：568.88  
Assay  ：Not less than 80% total carotenoids, not less than 
70% lutein  
DESCRIPTION  A free -flowing, orange -red powder  
CHARACTERISTICS   
 IDENTIFICATION   
 Solubility  ：Insoluble in water, soluble in hexane  
 Spectrophotometry  ：A 2 mg/l solution in acet one shows maximum 
absorbance at  approximately 446 nm.  
 Test for 
carotenoids  The colour of 2 ml of a 2 – 4 mg/l solution of the 
sample in  acetone immediately disappea rs after 
successive addition of  about 0.5 ml of 5% sodium 
nitrite and  about 0.5 ml of 0.5 M  sulfuric acid.   
 PURITY   
 Moisture  Not more than 1.0%  
 Ash Not more than 1.0%  
 Zeaxanthin  Not more than 9.0%  
 Lead  Not more than 3 mg/kg  
 Hexane  Not more than 50 mg/kg  
 Acetone  Not more than 30 mg/kg  
 Methanol  Not more than 10 mg/kg  
 Propylene glycol  Not more than 1 ,000 mg/kg  
 Waxes  Not more than 14.0%  
Category  : Food additives category ( 8); (9). 
Functional uses  : Nutritional additives ; Colors . 
 
  1. Preservatives  
§ 01009  
Sodium Benzoate  
SYNONYMS  INS No. 211  
DEFINITION   
Chemical names  Sodium benzoate, sodium salt of 
benzenecarboxylic acid, sodium salt of 
phenylcarboxylic acid  
C.A.S. number  532-32-1 
Chemical formula  C7H5O2Na 
Formula weight  144.11  
Assay  Not less than 99.0% on the dried basis  
DESCRIPTION  White, almost odourless, crystalline powder, 
flakes or granules  
CHARACTERISTICS   
 IDENTIFICATION   
Solubility  Freely soluble in water, sparingly soluble in 
ethanol  
Test for benzoate  Passes test  
Use a 10% solution of the sample  
Test for sodium  Passes  test 
PURITY   
Loss on drying  Not more than 1.5% (105 ℃，4 h)。 
Acidity or 
alkalinity  Dissolve 2 g of the sample, weighed to the 
nearest mg, in 20 ml of freshly boiled water. Not 
more than 0.5 ml of either 0.1N sodium 
hydroxide or  0.1N hydrochloric acid should be 
required for neutralization, using  
phenolphthalein TS as indicator.  
Lead  Not more than 2 mg/kg  
Readily 
carbonizable  
substances  Dissolve 0.5 g of the sample, weighe d to the 
nearest mg, in 5 ml of  sulfuric acid TS. The 
color produced should not  be darker than a light  
pink ("Matching Fluid Q")  Readily oxidizable  
substances  Add 1.5 ml of sulfuric acid to 100 ml of  water, 
heat to boiling and add  0.1N potassium 
permanganate, dropwise, unt il the pink color 
persists for  30 sec. Dissolve 1 g of the sample, 
weighed to the nearest mg, in the  heated 
solution, and titrate with 0.1N p otassium 
permanganate to a pink  color that persists for 15 
sec. Not more than 0.5 ml should be required.  
Chlorinated 
organic  
compounds  Not more than 0.07% (as chlorine)  
Category  Food additives category ( 1). 
Functional uses  Preservatives . 
 
  8. Nutritional additives  
§ 08040  
Ferrous Lactate  
 
Synonyms  : INS No. 585.  
Chemical formula : 
C6H10FeO 6‧xH 2O, (x = 2 or 3)  Molecular weight: 270.02 
(Dihydrate  
); 288.03 ( Trihydrate ) 
               
 
 
 
 
1. Assay  : Not less than 96% on the dried basis.  
2. Appearance  : Greenish white crystals or light green powder having 
a weak, characteristic smell.  
3. Solubility  : Soluble in water; practically insoluble in ethanol.  
4. pH : 5.0~6.0 (1 in 50 sol ution )  
5. Identification  : (1) Test for lactate : Passes test.  
 (2) Test for ferrous salts : Passes test.  
6. Loss on 
drying  : Not more than 18% (100 ℃ using vacuum, 
14pprox. . 700 mm Hg)  
7. Sulfate  : Not more than 0.1%  
8. Chloride  : Not more than 0.1%  
9. Iron (III)  : Not more than 0.6%  
10. Lead  : Not more than 1 mg/kg.  
11. Category  : Food Additives Category  (8) 
12. Uses  : Nutritional additives  
 
  
8. Nutritional additives  
§ 08043  
Potassium Iodate  
Chemical formula : KIO 3 Molecular  weight: 214.01  
1. Appearance  : White crystalline powder.  
2. Water -insoluble 
matter  : Not more than 50 ppm.  
3. Acidity or 
alkalinity  : Dissolve 3 g of the sample in 40 mL of warm 
water, add 3 drops of phenolphthalein TS. The 
solution should not be red. Then add 0.25 mL of 
0.02 N hydrochloric acid. The red color appears.  
4. Chloride and 
bromide  : Not more than 0.02% of Cl.  
5. Chlorate  : Add 2 mL of sulfuric acid to 2 g of the sample. 
The sample should stay white and generate no 
smell or gas.  
6. Iodide  : Dissolve 1 g of the sample in 20 mL of water,  add 
1 mL of chloroform and 0.5 mL of 1 N sulfuric 
acid. The chloroform layer should not appear violet 
in 1 minute.  
7. Nitrogen  
compound  : Not more than 0.025% of  N. 
8. Sulfate  : Not more than 50 ppm of SO 4. 
9. Heavy metals  : Not more than 10 ppm (as Pb ). 
10. Iron : Not more than 10 ppm.  
11. Positive test for 
sodium  : The flame test of 1 in 10 solution of the sample 
should not show an obvious yellow.  
12. Category  : Food Additives Category 8  
13. Uses  : Nutritional additives