1 The Draft  Amendment of Standard s for Specification, Scope , Application 
and Limitation  of Food Additive s 
   MOHW Food No.105 130433 1, 6 February, 2017  
Appendix 2: Standards for Specification of Food Additives  
01. Preservative  
§ 0100 1 
Sorbic Acid  
Synonyms  INS No. 200  
Definition   
Chemical names  Sorbic acid, 2,4 -hexadienoic acid, 2 -propenylacrylic acid  
C.A.S. number  110-44-1 
Chemical formula  C6H8O2 
Formula weight  112.12  
Assay  Not less than 99.0%  (calculated on the anhydrous basis)  
Description  Colorless needles or white free flowing powder, having a 
slight characteristic odour  
Characteristics   
Identification   
Solubility  Slightly  soluble in water; soluble in ethanol  
Melting range  132-135℃ 
Spectrophotometry  A 1 in 400,000 solution in isopropanol solution shows 
absorbance maximum  
at 254±2 nm  
Test for double 
bond  Shake about 0.02 g of the sample with 1 ml bromine TS; the 
colour disappears  
Purity   
Water  Not more than 0.5% (Karl Fischer Method)  
Sulfated ash  Not more than 0. 2% 
Aldehydes  Not more than 0.1% (as formaldehyde)   2 Lead  Not more than 2 mg/kg  
Category  Food additives category ( 1) 
Functional uses  Preservative  
 
§ 01002  
Potassium Sorbate  
Synonyms  INS No. 20 2 
Definition   
Chemical names  Potassium sorbate, potassium salt of trans, 
trans -2,4-hexadienoic acid  
C.A.S. number  24634 -61-5 
Chemical formula  C6H7KO 2 
Formula weight  150.22  
Assay  Not less than 98% and not more than 102% at the dried 
basis  
Description  White or yellowish -white crystals or crystalline powder or 
granules  
Characteristics   
Identification   
Solubility  Freely soluble in water; soluble in ethanol  
Test for potassium  Passes test  
Melting range  132-135℃ 
Test for 
unsaturation  To 2 ml of a 1 in 10 solution of the sample, add a few drops 
of bromine TS. The colour of the bromine disappears  
Purity   
Water  Not more than 1% (105º , 3 h)  
Acidity or 
alkalinity  Not more than about 1% (as sorbic acid or potassium 
carbonate)  
Aldehydes  Not more than 0.1% (as formaldehyde)   3 Lead  Not more than 2 mg/kg  
Category  Food additives category ( 1) 
Functional uses  Preservative  
 
§ 01004  
Calcium Propionate  
Synonyms  Calcium propanoate, INS No. 282  
Definition   
Chemical names  Calcium propionate  
C.A.S. number  4075 -81-4 
Chemical formula  C6H10CaO 4 
Formula weight  186.22  
Assay  Not less than 98.0% on the dried basis  
Description  White crystals, powder or granules with not more than a 
faint odour of propionic acid  
Characteristics   
Identification   
Solubility  Freely soluble in water; soluble in ethanol  
Test for calcium  Passes test  
Test for propionate  Warm the sample with sulfuric acid. The propionic acid 
evolved may be recognized by its odour  
Test for alkali salt 
of organic acid  Ignite the sample at a relatively low temperature. The 
alkaline organic acid residue effervesces with acid  
Purity   
Water  Not more than 4% (105℃, 2 h)  
pH 7.5 - 10.5 (1 in 10 soln)  
Water insoluble 
matter  Not more than 0.3%  
Fluoride  Not more than 30 mg/kg   4 Iron Not more than 50 mg/kg  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 1) 
Functional uses  Preservative  
 
§ 01005  
Sodium Propionate  
Synonyms  Sodium propanoate, INS No. 281  
Definition   
Chemical names  Sodium propionate  
C.A.S. number  137-40-6 
Chemical formula  C3H5NaO 2 
Formula weight  96.06  
Assay  Not less than 9 9.0% on the dried basis  
Description  White or colourless, hygroscopic crystals with not more 
than a faint characteristic odour  
Characteristics   
Identification   
Solubility  Freely soluble in water; soluble in ethanol  
Test for sodium  Passes test  
Test for propionate  Warm the sample with sulfuric acid. The propionic acid 
evolved may be recognized by its odour  
Test for alkali salt 
of organic acid  Ignite the sample at a relatively low  temperature. The 
alkaline residue effervesces with acid  
Purity   
Water  Not more than 4% (105 ℃, 2 h)  
pH 7.5 - 10.5 (1 in 10 soln)  
Water insoluble 
matter  Not more than 0. 1%  5 Iron Not more than 50 mg/kg  
Lead  Not more than 2 mg/kg  
Category  Food additives  category ( 1) 
Functional uses  Preservative  
 
§ 01021  
Propionic Acid  
Synonyms  INS No. 2 80；Propanoic acid, ethylformic acid, 
methylacetic acid  
Definition   
Chemical names  Propionic acid  
C.A.S. number  79-09-4 
Chemical formula  C3H6O2 
Formula weight  74.08  
Assay  Not less than 9 9.5% on the dried basis  
Description  An oily liquid with a slightly pungent odour  
Characteristics   
Identification   
Solubility  Miscible with water and ethanol  
Specific gravity  d20 20: 0.993 -0.997  
Purity   
Distillation range  138.5 - 142.5℃ 
Non-volatile 
residue  Not more than 0.01% when dried at 140 ℃ to constant 
weight  
Formic acid  Not more than 0.1%  
Aldehydes  Not more than 0.2% (as propionaldehyde)  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 1) 
Functional uses  Preservative   6  
 
01. Preservative  
§ 01008  
Benzoic Acid  
 
Synonyms  INS No. 210  
Definition   
Chemical names  Benzoic acid, benzenecarboxylic acid, phenylcarboxylic 
acid 
C.A.S. number  65-85-0 
Chemical formula  C7H6O2 
Formula weight  122.12  
Assay  Not less than 99.5% on the dried basis  
Description  White crystalline solid, usually in the form of scales or 
needles, having not  more than a faint characteristic odour  
Characteristics   
Identification   
Solubility  Slightly soluble in water, freely soluble in ethanol  
Melting range  121 - 123℃ 
Test for benzoate  Passes test  
pH About 4.0 (solution in water)  
Purity   
Loss on drying  Not more than 0.5% (over sulfuric acid, 3 h)  
Sublimation test  Place a small amount of the sample in a dry test tube. Wrap 
the test tube about 4 cm from the bottom with moistened 
filter paper. Heat the test tube over a low flame. Benzoic 
acid sublimes and crystals deposit in the colder part of the 
test tube leaving no residue at the bottom.   7 Sulfated ash  Not more than 0.05%  
Lead  Not more t han 2 mg/kg  
Readily 
carbonizable  
substances  Dissolve 0.5 g of the sample, weighed to the nearest mg, in 
5 ml of sulfuric  
acid TS. The colour 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 in drops, 
until the pink colour persists for 30 sec. Dissolve 1 g of the 
sample, weighed to the nearest mg, in the heated solution, 
and titrate with 0.1N po tassium permanganate to a pink 
colour that persists for 15 sec. Not more than 0.5 ml should 
be required.  
Chlorinated organic  
compounds  Not more than 0.07% (as Cl 2) 
Category  Food additives category ( 1) 
Functional uses  Preservative  
 
   8 01. Preservative  
§ 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  C7H5NaO 2 
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  
Melting range  121 - 123℃ 
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  Dissolve 0.5 g of the sample, weighed to the neares t mg, in 
5 ml of sulfuric acid TS. The colour produced should not be  9 substances  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, 
until the pink colour 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 
colour 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  Preservative  
 
 
 
 
   10 03. Antioxidants  
§ 03008  
Sodium Erythorbate  
 
Synonyms  INS No. 316 ； 
Sodium isoascorbate  
Definition   
Chemical names  Sodium isoascorbate, sodium D -isoascorbic acid, sodium 
salt of 2,3 - didehydro -D-erythro -hexono -1,4-lactone, 
3-keto-D-gulofurano -lactone sodium enolate monohydrate  
C.A.S. number  6381 -77-7 
Chemical formula  C6H7O6Na · H2O 
Formula weight  216.13  
Assay  Not less than 98% after drying  
Description  White, almost odourless crystalline powder  
Characteristics   
Identification   
Solubility  Freely soluble  in water, very slightly soluble in ethanol  
Reducing activity  A solution of the sample will decolourize a solution of 
2,6-dichlorophenolindophenol TS  
Test for ascorbate  Passes test  
Test for sodium  Passes test  
Purity   
Loss on drying  Not more than 0.25%  (in vacuum over sulfuric acid, 24 h)  
Specific rotation  [alpha] 25, D: Between +95.5o and +98.0o (10% (w/v) 
solution)  
pH 5.5 - 8.0 (1 in 10 soln)  
Oxalate  To a solution of 1 g in 10 ml of water add 2 drops of glacial  11 acetic acid and 5 ml of 10% calcium acetate solution. The 
solution should remain clear.  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 3) 
Functional uses  Antioxidant  
 
 
   12 07. Food quality improvement, fermentation and food processing agents  
11-1. Sweeteners  
§ 07087  
§ 11-1-001 
D-Sorbitol  
 
Synonyms  INS No. 420(i) ；D-Glucitol, D -sorbitol, sorbit, sorbol  
Definition   
Chemical names  D-Sorbitol  
C.A.S. number  50-70-4 
Chemical formula  C6H14O6 
Formula weight  182.17  
Assay  Not less than 97.0% of C 6H14O6 of total glycitols  and not 
less than 91.0% of D -sorbitol on the anhydrous basis.  
Description  White hygroscopic powder, crystalline powder, flakes or 
granules  
Characteristics   
Identification   
Solubility  Very soluble in water, slightly soluble in ethanol  
Melting range  88 - 102℃ 
Thin layer 
chromatography  Passes test  
Proceed as directed under Thin Layer Chromatography of Polyols Use 
the following: Standard solution: Dissolve 50 mg of reference 
standard sorbitol (available from US Pharmacopeial Convention, Inc. 
12601 Twinbrook Parkway, Rockville, MD 20852, USA) in 20 ml 
water Test solution: Dissolve 50 mg of the sample in 20 ml of water  
Purity   
Water  Not more than 1% (Karl Fischer Method)  
Sulfated ash  Not more than 0.1%  
Chlorides  Not more than 50 mg/kg   13 Sulfates  Not more than 100 mg/kg  
Nickel  Not more than 2 mg/kg  
Reducing sugars  Not more than 0.3%  
Total sugars  Not more than 1% (as glucose)  
Lead  Not more than 1 mg/kg  
Category  Food additives category ( 11)-1; Food additives category  (7) 
Functional uses  Food quality improvement, fermentation and food 
processing agents  
Sweeteners  
 
 
 
 
 
 
   14 11. Seasoning Agents  
§ 11028  
Glycine  
Synonyms  Aminoacetic acid, Aminoethanoic acid, Glycocoll  
Definition   
Chemical names  Glycine  
C.A.S. number  56-40-6 
Chemical formula  C2H5O2N 
Formula weight  75.07  
Assay  Not less than 98. 5% on the dried basis  
Description  White crystalline powder  
Characteristics   
Identification   
Residue on ignition  Not more than 0.1%  
Purity   
Loss on drying  Not more than 0.2% (105 ℃, 3h) 
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Category  Food additives category ( 11)-1; Food additives category  (7) 
Functional uses  Food quality improvement, fermentation and food 
processing agents  
Sweeteners  
 
 
 
 
 
 
  15 12. Pasting Agents  
§ 12026  
Gellan  Gum  
 
Synonyms  INS No. 418  
Definition  Gellan gum is a high molecular weight polysaccharide gum 
produced by a pure culture fermentation of a carbohydrate 
by Pseudomonas elodea, purified by recovery with ethanol 
or 2-propanol, dried, and milled. The high mo lecular weight 
polysaccharide is principally composed of a tetrasaccharide 
repeating unit of one rhamnose, one glucuronic acid, and 
two glucose units, and is substituted with acyl (glyceryl and 
acetyl) groups as the O -glycosidically -linked esters. The 
glucuronic acid is neutralized to a mixed potassium, 
sodium, calcium, and magnesium salt. It usually contains a 
small amount of nitrogen containing compounds resulting 
from the fermentation procedures.  
C.A.S. number  71010 -52-1 
Formula weight  Approximately 500,000  
Assay  Yields, on the dried basis, not less than 3.3% and not more 
than 6.8% of carbon dioxide (CO 2). 
Description  Off-white powder  
Characteristics   
Identification   
Solubility  Soluble in water, forming a viscous solution; insoluble in 
ethanol  
Gel test with 
calcium ion  Add 1.0 g of the sample to 99 ml of water, and stir for about 
2 h, using a motorized stirrer having a propeller -type 
stirring blade. Draw a small amount of this solution into a  16 wide bore pipet and transfer into a 10% solution of c alcium 
chloride. A tough worm -like gel will be formed 
immediately.   
Gel test with 
sodium ion  Add 1.0 g of the sample to 99 ml of water, and stir for about 
2 h, using a motorized stirrer having a propeller -type 
stirring blade. Add 0.50 g of sodium chloride , heat to 80° 
with stirring, and hold at 80° for 1 min. Allow the solution 
to cool to room temperature. A firm gel is formed.  
Purity   
Loss on drying  Not more than 15% (105 ℃, 2½  h)  
Nitrogen  Not more than 3%  
Residual solvents  not more than 750 mg/kg of 2- propanol  
Microbiological 
criteria  Total plate count: Not more than 10,000 cfu/g  
E. coli: Negative by test  
Salmonella: Negative by test  
Yeasts and moulds: Not more than 400 cfu/g  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 12) 
Functional uses  Pasting Agents