1 The Draft  Amendment of Standard s for Specification, Scope , Application 
and Limitation  of Food Additive s 
   MOHW  Food No. 1051301058 , 8 April , 201 6 
Appendix 2: Standards for Specification of Food Additives  
07. Food quality improvement, fermentation and food processing agents  
§ 07001  
Calcium chloride  
Synonyms  INS No. 509  
Definition   
Chemical names  Calcium chloride  
C.A.S. number  10043 -52-4 
Chemical formula  
 Anhydrous: CaCl 2 
Dihydrate: CaCl 2 ·  2H 2O 
Hexahydrate: CaCl 2 ·  6H 2O 
Formula weight  Anhydrous: 110.99  
Dihydrate: 147.02  
Hexahydrate: 219.08  
Assay  Anhydrous: Not less than 93%  
Dihydrate: Not less than 99.0% and not more than the 
equivalent of 107.0% of CaCl 2 ·  2H 2O 
Hexahydrate: Not less than 98.0% and not more than the 
equivalent of 110% of CaCl 2 ·  6H 2O 
Description  Anhydrous: White, deliquescent lumps or porous masses  
Dihydrate: White, hard, deliquescent fragments or granules  
Hexahydrate: Colourless, very deliquescent crystals  
Characteristics   
Identification   
Solubility  Anhydrous: Freely soluble in water and ethanol  
Dihydrate: Freely soluble in water; soluble in ethanol   2 Hexahydrate: Very soluble in water and ethanol  
Test for chloride  Passes test  
Test for calcium  Passes test  
Purity   
Free alkali  Not more than 0.15% as Ca(OH) 2 
Dissolve 1 g of the sample in 20 ml of freshly boiled and 
cooled water, and add 2 drops of phenolphthalein TS. If the 
solution is pink, the pink colo r is discharged by adding 2 ml 
of 0.02 N hydrochloric acid.  
Magnesium and 
alkali salts  
 Not more than 5%  
Fluoride  Not more than 40 mg/kg  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 7) 
Functional uses  Food quality improvement, fermentation and food 
processing agents  
 
11. Seasoning Agents  
§ 11017  
Lactic Acid  
Synonyms  INS No. 270 
Definition  Obtained by the lactic fermentation of sugars or is prepared 
synthetically; may contain condensation products such as 
lactic acid, lactate and dilactide. Common products of 
commerce are 50 -90% solutions. Solid products containing 
about 100 -125% of titratable lactic acid also exist. (Note: 
Lactic acid is hygroscopic and when concentrated by 
boiling or by distillation it forms condensation products  3 which hydrolyze to lactic acid on dilution and heating in 
water).  
Chemical names  Lactic acid, 2 -hydroxypropanoic acid, 2 -hydroxypropionic 
acid 
C.A.S. number  50-21-5 (L-: 79-33-4; D-: 10326 -41-7; DL -: 598 -82-3) 
Chemical formula  C3H6O3 
Formula weight  90.08  
Assay  Not less than 95.0% and not more than 105.0% of the 
labelled concentration.  
Description  Colourless, syrupy liquid or white to light yellow solid or 
powder  
Characteristics   
Identification   
Solubility  Liquid: Soluble in water and in ethanol  
Solid: Sparingly soluble in water, soluble in acetone  
Test for acid A 1 in 10 solution or dispersion of the sample is acid to 
litmus paper  
Test for lactate  Passes test  
Purity   
Sulfated ash  Not more than 0.1%  
Chloride  Not more than 0.2%  
Sulfate  Not more than 0.25%  
Iron Not more than 10 mg/kg  
Cyanide  Passes test  (limit approx. 1 mg/kg).  
Citric, oxalic, 
phosphoric or 
tartaric acid  Dilute 1 g of the sample to 10 ml with water, add 40 ml of 
calcium  hydroxide TS, and boil for 2 min. No turbidity is 
produced  
Sugars  Add 5 drops of the sample solution to 10 ml of hot alkaline 
cupric tartrate TS. No red  precipitate is formed.   4 Readily 
carbonizable 
substances  Superimpose carefully 5 ml of the sample solution kept at 
15o on 5 ml  of sulfuric acid TS  kept at 15o. No deep grey 
color is produced within 15 min at the contact zone of the 
two liquids.  
Lead  Not m ore than 2 mg/kg  
Category  Food additives category ( 11) 
Functional uses  Seasoning Agents  
 
§ 11022  
DL-Malic Acid  
Synonyms  INS No. 296; 2-Hydroxybutanedioic acid  
Definition   
Chemical names  dl-Malic acid, 2 -Hydroxybutanedioic acid, Hydroxysuccinic 
acid 
C.A.S. number  6915-15-7 
Chemical formula  C4H6O5 
Formula weight  134.1 
Assay  Not less than 99.0%  
Description  White or nearly white crystalline powder or granules  
Characteristics   
Identification   
Solubility  Very soluble in water; freely soluble in ethanol  
Melting range  127 - 132℃ 
Test for malate  Passes test  
Test 5 ml of a 1 in 20 solution of the sample, neutralized 
with ammonia TS  
Purity   
Sulfated ash  Not more than 0.1%  
Fumaric and maleic Not more than 1.0% of fumaric  acid and not more than  5 acid 0.05% of maleic acid  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 11) 
Functional uses  Seasoning Agents  
 
§ 11023  
Sodium DL –Malate  
Synonyms  Malic acid sodium salt; INS No. 350(ii)  
Definition   
Chemical names  Disodium DL -malate, hydroxybutanedioic acid disodium 
salt 
C.A.S. number  676-46-0 
Chemical formula  Hemihydrate: C 4H4Na2O5 ·  1/2 H 2O 
Trihydrate: C 4H4Na2O5 ·  3 H 2O 
Formula weight  Hemihydrate: 187.1  
Trihydrate: 232.1  
Assay  Not less than 98% and not more than 102% on the dried 
basis  
Description  Odourless white crystalline powder or lumps  
Characteristics   
Identification   
Solubility  Freely  soluble in water  
Test for sodium  Passes test  
Test for malate  Passes test  
Test 5 ml of a 1 in 20 solution of the sample  
Purity   
Loss on drying  Hem ihydrate: Not more than 7% (130 ℃, 4 h)  
Trihydrate: 20.5% - 23.5% (130 ℃, 4 h)  
Alkalinity  Not more than 0.2% as Na 2CO 3  6 Dissolve 1 g of the sample in 20 ml of freshly boiled and 
cooled water, and  add 2 drops of phe nolphthalein TS. If a 
pink colo r is produced, add 0.4 ml  of 0.1 N sulfuric acid. 
The colo r of the solution disappears.  
Fumaric and maleic 
acid Not more than 1.0% of fumaric acid and not more than 
0.05% of maleic acid  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 11) 
Functional uses  Seasoning Agents  
 
11-1. Sweeteners  
§ 11-1-014 
Acesulfame Potassium  
Synonyms  Acesulfame K; INS No. 950  
Definition   
Chemical names  Potassium salt of   
6-methyl -1,2,3 -oxathiazine -4(3H) -one-2,2-dioxide;  
potassium salt of 
3,4-dihydro -6-methyl -1,2,3 -oxathiazine -4-one-2,2-dioxide  
C.A.S. number  55589 -62-3 
Chemical formula  C4H4KNO 4S 
Formula weight  201.24  
Assay  Not less than 99.0% and not more than 101.0% on the dried 
basis  
Description  Odourless, white crystalline powder  
Characteristics   
Identification   
Solubility  Freely soluble in water, very slightly soluble in ethanol  
Spectrophotometry  Dissolve 10 mg of the sample in 1,000 ml of water. The  7 solution shows an  absorbance maximum at 227±2 nm  
Test for potassium  Passes test  
Test the residue obtained by igniting 2 g of the sample  
Precipitation test  Add a few drops of a 10% solution of sodium cobaltinitrite 
to a solution of  0.2 g of the sample in 2 ml of acetic acid TS 
and 2 ml of water. A yellow  precipitate is produced  
Purity   
Loss on drying  Not more than 1.0% (105 ℃, 2 h)  
pH 5.5 - 7.5 (1% soln)  
Organic impurities  Passes test for 20 mg/kg of UV active components  
Fluoride  Not more than 3 mg/kg  
Lead  Not more than 1 mg/kg  
Category  Food additives category ( 11-1) 
Functional uses  Sweeteners