G/SPS/N/TPKM/147Add.1
Amendment of Standards for Specification, Scope, Application and 
Limitation of Food Additives  
DOH Food No. 0980403340, April 24, 2009 
 
Appendix 1: Standards for Scope, Application and Limitation of Food 
Additives 
03. Antioxidants 
Code Food 
Additive 
Items Scope and Application 
Standards Limitations 
03026 α– Glycosyl– 
isoquercitrin 1. Beverages, fruit juices,  
vegetable juices, frozen 
dairy, gelatins, puddings, jams, jellies, soft candy, cakes, cookies, pastries, pies, powdered or canned soup: not more than 150 mg/kg.  
2. Chewing gum: not more than 
1500 mg/kg.  
 07. Food quality improvement, fermenta tion and food processing agents 
Code Food 
Additive 
Items Scope and Application 
Standards Limitations 
07048 Sodium 
Ferrocyanide Edible salt: not more than 13 mg/kg calculated as anhydrous sodium ferrocyanide. For manufacturing or processing purpose. 
07084 Potassium 
Ferrocyanide Edible salt: not more than 13 mg/kg calculated as anhydrous sodium ferrocyanide. For manufacturing or processing purpose. 
07085 Calcium 
Ferrocyanide Edible salt: not more than 13 mg/kg calculated as anhydrous sodium ferrocyanide. For manufacturing or processing purpose. 
 
08. Nutritional Additives 
Code Food 
Additive Scope and Application 
Standards Limitations 
 1Items 
08140 Calcium 
Gluconate 1. General foods: not more than 
1,800 mg of calcium for 
foods labeled with daily dosage or for every 300 g of food without daily dosage labeling. 
2. Infant (supplementary) 
foods: not more than 750 mg of calcium for foods labeled with daily dosage or for every 300 g of food without daily dosage labeling. For supplementing purpose. 
08141 Calcium 3– 
Hydroxy– 3– Methyl Butyrate Monohydrate Special dietary foods: as practically needed. Not suitable for pregnant women and people under 18 years of age.  
08142 Synthetic 
Genistein Foods in capsule or tablet forms, labeled with daily dosage: not more than 30 mg ofgenistein in daily intake.  1. For supplementing purpose. 
2. Require label advisory statements on the products that this product may not be suitable for children, infants, and pregnant or 
lactating 
women. 
 
 2Appendix 2: Standards for Specification of Food Additives 
03. Antioxidants 
§ 03026 α– Glycosyl–isoquercitrin 
Synonyms Enzymatically modified isoquercitrin ；isoquercetin ；EMIQ
Formula weight  ～800 
Structural formula 
 
  
Definition The starting product, rutin, firs t enzymatically converted to 
isoquercitrin. Subsequently, an aqueous solution of 
isoquercitrin and dextrin is treated with cyclodextrin 
glucanotransferase to a dd glucose units, forming α– 
glycosyl–isoquercitrin. 
Assay  After drying, it should contain no less than 60 % (as rutin, 
C27H30O16). 
Description Yellow to yellowish brown powder with a slight 
characteristic scent 
Identification  1. 5 mg of the sample is dissolved in 10 mL of water. 
When 1～2 drops of ferric chloride solution (1 →50) are 
added to this solution, it becomes brown in color. 
2. 5 mg of the sample is dissolv ed in 5 mL of water, where 
2 ml of hydrochloric acid and 0.05 g of magnesium 
powder are added. The color of the solution changes to 
orange～red color. 
3. 0.1 g of the sample is dissolved in 100 mL of 1 N 
sulfuric acid. When this solution is boiled for 2 hours 
and cooled, yellow precipitates are formed. 
4. Spectrophotometry: 10 mg of the sample dissolved in 
500 mL of phosphoric acid solution (1 →1,000) shows 
an absorption maximum at approximately 255 nm and 
 3350 nm. 
5. Thin layer chromatography: th e main spot in the test 
solution has the bigger Rf valu e than that of the main 
spot of lutin solution. 
Quercetin  Not more than 1 % 
Heavy metals Not more than 10 mg/kg (as Pb) 
Lead Not more than 5 mg/kg 
Arsenic Not more than 2 mg/kg (as As 2O3) 
Loss on drying Not more than 50 % (135 ℃, 2 hr) 
Category  Food additives category (3) 
Functional uses  Antioxidants 
 
 407. Food quality improvement, fermenta tion and food processing agents 
§ 07048  Sodium Ferrocyanide 
Chemical name Sodium ferrocyanide; Sodium hexacyanoferrate (II) 
Synonyms Yellow prussiate of soda; hexacyanoferrate of sodium; INS 
No. 535; CAS No. 13601-19-9 
Chemical formula Na4Fe(CN) 6 · 10H 2O 
Formula weight 484.1 
Assay  Not less than 99.0 % 
Description Yellow crystals or crystalline powder 
Solubility Soluble in water; insoluble in ethanol 
Identification 1. Test for ferrocyanide: To 10 mL of a 1 % solution of the 
sample add 1 mL of ferric chloride TS. A dark blue 
precipitate is formed. 
2. Test for sodium: Passes test 
Cyanide Not detectable 
Ferricyanide Not detectable 
Arsenic Not more than 3 mg/kg 
Lead Not more than 5 mg/kg 
Category  Food additives category (7) 
Functional uses  Food quality improvement, fermentation and food processing agents 
 
 5§ 07084  Potassium Ferrocyanide 
Chemical name Potassium ferrocyanide; Pota ssium hexacyanoferrate (II) 
Synonyms Yellow prussiate of potash; hexacyanoferrate of potassium; 
INS No. 536; CAS No. 13943-58-3 
Chemical formula K4Fe(CN) 6 · 3H 2O 
Formula weight 422.4 
Assay  Not less than 99.0 % 
Description Yellow crystals or crystalline powder 
Solubility Soluble in water; insoluble in ethanol 
Identification 1. Test for ferrocyanide: To 10 mL of a 1 % solution of the 
sample add 1 mL of ferric chloride TS. A dark blue 
precipitate is formed. 
2. Test for potassium: Passes test 
Cyanide Not detectable 
Ferricyanide Not detectable 
Arsenic Not more than 3 mg/kg 
Lead Not more than 5 mg/kg 
Category  Food additives category (7) 
Functional uses  Food quality improvement, fermentation and food processing agents 
 
 6§ 07085  Calcium Ferrocyanide 
Chemical name Calcium ferrocyanide; Calc ium hexacyanoferrate (II) 
Synonyms Yellow prussiate of lime; hexacyanoferrate of calcium; INS 
No. 538; CAS No. 1327-39-5 
Chemical formula Ca2Fe(CN) 6 · 12H 2O 
Formula weight 508.3 
Assay  Not less than 99.0 % 
Description Yellow crystals or crystalline powder 
Solubility Soluble in water 
Identification 1. Test for ferrocyanide: To 10 mL of a 1 % solution of the 
sample add 1 mL of ferric chloride TS. A dark blue 
precipitate is formed. 
2. Test for calcium: Passes test 
Cyanide Not detectable 
Ferricyanide Not detectable 
Arsenic Not more than 3 mg/kg 
Lead Not more than 5 mg/kg 
Category  Food additives category (7) 
Functional uses  Food quality improvement, fermentation and food processing agents 
 
 708. Nutritional Additives 
§ 08140  Calcium Gluconate 
Same as § 07004 
 8§ 08142  Synthetic Genistein  
Chemical name 5, 7-dihydroxy-3-(4-hydroxy phenyl)chromen-4-one 
Synonyms 4’,5,7-trihydroxyisoflavone ; genisteol; sophoricol; CAS 
No. 446-72-0 
Chemical formula C15H10O5 
Formula weight 270.2 
Structural formula  
 
Assay Not less than 98.5 % 
Description Off-white to slightly yellowish fine powder 
Water content Not more than 0.2 % 
Sulfated ash Not more than 0.1 % 
Arsenic Not more than 1 mg/kg 
Lead Not more than 2 mg/kg 
Heavy metals Not more than 10 mg/kg (as Pb) 
Category Food additives category (8) 
Functional uses Nutritional Additive 
 
 916. Emulsifiers 
§ 16011  Polysorbate 80 （Polyoxyethylene (20) Sorbitan Monooleate ） 
Assay Not less than 65.0 and not more than 69.5% of 
oxyethylene groups, equivalent to not less than 96.5 and 
not more than 103.5% of polys orbate 80, calculated on the 
anhydrous basis. 
Description Polysorbate 80 is a mixture of oleate partial esters of sorbitol and sorbitol anhydride condensed with 
approximately 20 moles of ethylene oxide（ C
2H4O）for 
each mole of sorbitol and its mono- and dianhydrides. It is 
a yellow- to orange-colored, oily liquid having a faint, 
characteristic odor and a warm, somewhat bitter taste. It is 
very soluble in water, producing an odorless, nearly 
colorless solution, and is solu ble in alcohol, in fixed oils, 
in ethyl acetate, and in toluene.  
Identification 1. To 5 mL of a 1 in 20 solution add 5 mL of solution hydroxide TS, boil for a few min, cool, and acidify 
with diluted hydrochloric acid TS. The solution is 
strongly opalescent. 
2. To a 1 in 20 solution add bromine TS, dropwise. The 
bromine is decolorized. 
3. A mixture of 60 volumes of  polysorbate 80 with 40 
volumes of water at 25 ℃ or below yields a gelatinous 
mass. 
Acid value Not more than 2. 
Hydroxy value Between 65 and 80. 
Saponification value Between 45 and 55. 
Oleic Acid Between 22 and 24 %. 
Water content Not more than 3 %. 
1,4-Dioxane Not more than 10 mg/kg. 
Arsenic Not more than 3 ppm (as As). 
Heavy metals Not more than 10 ppm (as Pb) 
Residue on Ignition Not more than 0.25 %. 
 10Category Food additives category (16) 
Functional uses Emulsifiers 
 
 11