1 The Amendment of Standard s for Specification, Scope , Application and  
Limitation  of Food Additive s 
   MOHW  Food No. 1091301559 , 11 August , 2020  
Appendix 1:  
07. Food quality improvement, fermentation and food processing agents  
Code  Food Additive Items  Scope and Application Standards  Limitations  
07029  Sodium Dihydrogen Phosphate  All foods: not more than 3 g/kg calculated as 
phosphate.  For manufacturing 
or processing 
purpose.  
07030  Sodium Phosphate, Monobasic 
(Anhydrous)  All foods: not more than 3 g/kg calculated as 
phosphate.  For manufacturing 
or processing 
purpose.  
07075  Calcium Chloride, Anhydrous  All foods: not more than 10 g/kg calculated as 
Ca. For manufacturing 
or processing 
purpose . 
 
08. Nutritional additives  
Code  Food Additive Items  Scope and Application Standards  Limitations  
08194  Calcium Chloride Dehydrate  Foods in capsule or tablet form  and labeled 
with daily dosage: not more than 1800 mg of 
total calcium in daily intake.  For supplementing 
purpose.  
08195  Calcium Chloride Hexahydrate  Foods in capsule or tablet form  and labeled 
with daily dosage: not more than 1800 mg of 
total calcium in daily intake.  For supplementing 
purpose.  
08286  Sodium Dihydrogen Phosphate  
 Foods in capsule or tablet form and labeled 
with daily dosage: not more than 1200 mg of 
total phosphorus  in daily intake.  For supplementing 
purpose.  
 
09. Colors  
Code  Food Additive Items  Scope and Application Standards  Limitations  
09001  Ponceau 4R  All foods: as practically needed.  Not allowed in 
fresh raw meat, 
fish, shellfish, 
beans, vegetables, 
fruits, miso, soy  2 sauces, seaweeds, 
and tea.  
 
11. Seasoning  Agents  
Code  Food Additive Items  Scope and Application Standards  Limitations  
11005  Sodium Fumarate  All foods: as practically needed.  For manufacturing 
or processing 
purpose.  
11018  Sodium Lactate (solution)  All foods: as practically needed.  For manufacturing 
or processing 
purpose.  
11019  Sodium Lactate Solution  All foods: as practically needed.  For manufacturing 
or processing 
purpose.  
 
13. Coagulating Agents  
Code  Food Additive Items  Scope and Application Standards  Limitations  
13009  Sodium Dihydrogen Phosphate  Meat products, minced fish  surimi  products: 
not more than 3 g/kg calculated as phosphate.  For manufacturing 
or processing 
purpose.  
13010  Sodium Phosphate, Monobasic 
(Anhydrous)  Meat products, minced fish  surimi  products: 
not more than 3 g/kg calculated as phosphate.  For manufacturing 
or processing 
purpose.   3 The Amendment of Standard s for Specification, Scope , Application and  
Limitation  of Food Additive s 
   MOHW  Food No.10 91301559 , 11 August , 2020 
Appendix 2: Standards for Specification of Food Additives  
07. Food quality improvement, fermentation and food processing agents  
08. Nutritional additives  
13. Coagulating Agents  
§ 07029  
§ 08286  
§ 13009  
Sodium Dihydrogen Phosphate  
Synonyms  Monobasic sodium phosphate, monosodium 
monophosphate sodium acid 
phosphate, sodium biphosphate; INS No. 339(i)  
Definition   
Chemical names  Sodium dihydrogenphosphate, monosodium 
dihydrogenortho - phosphate, monosodium dihydrogen 
monophosphate  
C.A.S. number  7558 -80-7 
Chemical formula  Anhydrous: NaH 2PO 4 
Monohydrate: NaH 2PO 4 ·  H 2O 
Dihydrate: NaH 2PO 4 ·  2H 2O 
Formula weight  Anhydrous: 119.98  
Monohydrate: 138.00  
Dihydrate: 156.01  
Assay  Not less than 97% after drying  
Description  White odourless, slightly deliquescent powder, crystals, or 
granules  
Characteristics    4 Identification   
Solubility  Freely soluble in water; insoluble in ethanol, ether or 
chloroform  
pH 4.2 - 4.6 (1 in 100 soln)  
Test for sodium  Passes test  
Test for phosphate  Passes test  
Test for 
orthophosphate  To a 1% solution of the sample add silver nitrate TS; the 
yellow precipitate formed is soluble in dilute nitric acid TS.  
Purity   
Loss on drying  Anhydrous: Not more than 2% (60o , 1 h, then 105o , 4 h)  
Monohydrate: Not more than 15%  (60o , 1 h, then 105o , 4 
h) 
Dihydrate: Not mo re than 25% (60o , 1 h, then 105o , 4 h)  
Free acid and 
disodium  
phosphate  2.00 g of the sample dissolved in 40 ml of water require for 
neutralization  not more than 0.3 ml of either N sodium 
hydroxide or N sulfuric acid, using methyl orange TS as 
indicator.  
Fluoride  Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 4 mg/kg  
Category  Food additives category (07) (08) (13) 
Functional uses  Food quality improvement, fermentation and food 
processing agents ; Nutritional additives ; Coagulating 
Agents . 
  5 09. Colors  
§ 09001  
Ponceau 4R  
Synonyms  CI Food Red 7; Cochineal Red A; New Coccine; Brilliant 
Scarlet; CI (1975) No. 16255; INS No. 124  
Definition  Ponceau 4R consists essentially of trisodium 2 -hydroxy -1-
(4-sulfonato -1- naphthylazo) -6,8-naphthalenedisulfonate, 
and subsidiary colouring matters together with sodium 
chloride and/or sodium sulfate as the principal uncoloured 
components.  
May be converted to the corresponding aluminium lake . 
Chemical names  Trisodium  2-hydroxy -1-(4-sulfonato -1-naphthylazo) -6,8- 
naphthalenedisulfonate  
C.A.S. number  2611 -82-7 
Chemical formula  C20H11N2Na3O10S3 
Structural formula   
Formula weight  604.48  
Assay  Not less than 80% total colouring matters  
Description  Reddish powder or granules  
Characteristics   
Identification   
Solubility  Soluble in water; sparingly soluble in ethanol  
Spectrophotometry  Maximum wave length: Between 505 and 510 nm  
Purity   
Loss on drying  Not more than 20% at 135° together with chloride and 
sulfate calculated as sodium salts  
Water -insoluble Not more than 0.2%  
 6 matter  
Subsidiary 
colouring matters  Not more than 1%  
Organic 
compounds other 
than colouring 
matters  4-amino -1-naphthalenesulfonic acid 、7-hydroxy -1,3-
naphthalenedisulfonic acid 、3-hydroxy -2,7-
naphthalenedisulfonic acid 、6-hydroxy -2-
naphthalenesulfonic acid 、7-hydroxy -1,3,6 -
naphthalenetrisulfonic acid : Not more than 0.5%  
Unsulfonated 
primary aromatic 
amines  Not more than 0.01% calculated as aniline  
Ether -extractable 
matter  Not more than 0.2%  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 09) 
Functional uses  Colors  
  7 11. Seasoning Agents  
§ 11005  
Sodium Fumarate  
Synonyms  Monosodium fumarate; INS No. 365  
Definition   
Chemical names  Monosodium fumarate, monosodium trans -butenedioic 
acid, monosodium trans -1,2-ethylenedicarboxylate; 
monosodium trans -1,2-ethylenedicarboxylic acid  
C.A.S. number  7704 -73-6 
Chemical formula  C4H3NaO 4 
Structural formula   
Formula weight  138.06  
Assay  Not less than 98.0% and not more than 102.0% on the dried 
basis  
Description  Odourless, white crystalline powder  
Characteristics   
Identification   
Solubility  Soluble in water  
pH 3 - 4 (1 in 30 solution)  
1,2-Dicarboxylic 
acid Place 50 mg of the sample in a test tube, add 2 to 3 mg of 
resorcinol and 1 ml of sulfuric acid, shake, heat at 130o for 
5 min. and cool. Dilute with water to 5 ml and add sodium 
hydroxide solution (2 in 5) dropwise to render the solution 
alkaline, cool and dilute with water to 10 ml. A greenish 
blue fluorescence is observed under an ultraviolet lamp.  
 8 Test for double 
bond  Add 10 ml of water to 0.5 g of the sample and dissolve by 
boiling. Add 2 or 3 drops of bromine TS to the hot solution. 
The colour of bromine TS disappears . 
Test for sodium  Passes test  
Purity   
Loss on drying  Not more than 0.5% (120o , 4 h)  
Sulfates  Not more than 0.01%  
Maleic acid  Not more than 0.05%  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 11) 
Functional uses  Seasoning Agents  
  9 11. Seasoning  Agents  
§ 11018  
Sodium Lactate (solution)  
Synonyms  INS No. 325  
Definition   
Chemical names  Sodium lactate, sodium 2 -hydroxypropanoate  
C.A.S. number  72-17-3 
Chemical formula  C3H5NaO 3 
Structural formula  
 
Formula weight  112.06 (anhydrous)  
Assay  Not less than 95% and not more than 110% of the labelled 
amount. This specification is based on a 60% w/w solution 
of C 3H5NaO 3 in water.  
Description  Colourless, transparent, liquid. Odourless, or with a slight, 
characteristic odour  
Characteristics   
Identification   
Ignition  Ignite to an ash. The ash is alkaline, and an effervescence 
occurs when acid is added  
Colour reaction  Overlay 2 ml of the sample on 5 ml of a 1 in 100 solution 
of catechol in sulfuric acid. A deep red colour is produced 
at the zone of contact  
Test for la ctate  Passes test  
Test for sodium  Passes test  
 10 Purity   
Acidity  Neutralization of 1 g of sample shall require not more than 
0.5 ml of 0.1 N sodium hydroxide solution, using 
phenolphthalein TS  
pH 6.5 - 7.5 (1 in 5 soln)  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 11) 
Functional uses  Seasoning Agents  
 
  11 12. Pasting Agent  
§ 12001  
Sodium Alginate  
Synonyms  INS No. 401  
Definition  Sodium salt of alginic acid  
C.A.S. number  9005 -38-3 
Chemical formula  (C6H7NaO 6)n 
Structural formula  
The number and sequence of the Mannuronate and 
Glucuronate residues shown above vary in the naturally 
occurring alginate. The water molecules associated with the 
alginate molecule are not shown in the above structural 
formula.  
Formula weight  Structural un it : 198.11 (theoretical), 222 (actual average) 
Macromolecule : 10,000 - 600,000 (typical average)  
Assay  Yields, on the dried basis, not less than 18.0% and not more 
than 21.0% of carbon dioxide (CO 2), equivalent to not less 
than 90.8% and not more than 106.0% of sodium alginate 
(C6H7 NaO 6)n. 
Description  White to yellowish brown filamentous, grainy, granular or 
powdered forms  
Characteristics   
Identification   
Solubility  Dissolves slowly in water, forming a viscous solution; 
 12 insoluble in ethanol and eth er 
Precipitate 
formation with 
calcium chloride  To a 0.5% solution of the sample in sodium hydroxide TS 
add one -fifth of its volume of a 2.5% solution of calcium 
chloride. A voluminous, gelatinous precipitate is formed.  
Precipitate 
formation with 
ammonium 
sulphate  To a 0.5% solution of the sample in sodium hydroxide TS 
add one -half of its volume of a saturated solution of 
ammonium sulfate. No precipitate is formed.  
Test for alginate  Passes test  
Test for sodium  Passes te st 
Purity   
Loss on drying  Not more than 15% (105o , 4 h)  
Water -insoluble 
matter  Not more than 2% on the dried basis  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Microbiological 
criteria  Total plate count: Not more than 5,000 colonies per gram.  
Yeasts and moulds: Not more than 500 colonies per gram  
Coliforms: Negative by test  
Salmonella: Negative by test  
Category  Food additives category (12) 
Functional uses  Pasting Agent  
 
   13 16. Emulsifiers  
§ 16001  
Glycerin Fatty Acid Ester  
Synonyms  Mono - And Diglycerides : Glyceryl monostearate, glyceryl 
monopalmitate, glyceryl monooleate, etc; monostearin, 
monopalmitin, monoolein, etc.; GMS (for glyceryl 
monostearate); INS No. 471  
Acetic and Fatty Acid Esters of Glycerol : Acetic acid esters 
of mono - and diglycerides, acetoglycerides, acetylated 
mono - and diglycerides, INS No.472a  
Definition  Mono - And Diglycerides:  A mixture of mono - and 
diglyceryl  esters of long chain, saturated and unsaturated 
fatty acids that occur in food fats; contain not less than 30% 
of alpha -monoglycerides and may also contain other 
isomeric monoglycerides, as well as di - and triglycerides, 
free glycerol, free fatty acids, s oap and moisture; usually 
manufactured by the glycerolysis of edible fats and oils, but 
may also be prepared by esterification of fatty acids with 
glycerol, with or without molecular distillation of the 
product.  
Acetic and Fatty Acid Esters of Glycerol : Mixed glycerol 
esters of acetic acid and fatty acids of food fats. Contains 
mono - and diesters of fatty acids with glycerol which is 
itself partially acetylated; may also contain free glycerol 
and free fatty acids.  
Structural formula  Mono - And Diglycerides:  
 
 
  14  
 
 
 
where -OCR represents the fatty acid moiety  
Acetic and Fatty Acid Esters of Glycerol : 
 
 
 
 
 
where R1, R2 and R3 each may be a fatty acid moiety, - 
COCH 3 or H  
Formula weight  Mono - And Diglycerides:  
Glyceryl monostearate: 358.6  
Glyceryl distearate: 625.0  
These are two major components of commercial products  
Acetic and Fatty Acid Esters of Glycerol : - 
Description  Mono - And Diglycerides:  White or cream coloured hard 
fats of waxy appearance, plastic products or viscous 
liquids . 
Acetic and Fatty Acid Esters of Glycerol : From liquid to 
solid in consistency; white to pale yellow, may have the 
odour of acetic acid  
The article of commerce may be further specified as the 
saponification value, acid value, free fatty acid content, 
solidification  point of the free fatty acids, Reichert -Meissl 
value, iodine value and free glycerol content.  
Characteristics   
 15 Identification   
Solubility  Mono - And Diglycerides:  Insoluble in water; soluble in 
ethanol, chloroform and benzene  
Acetic and Fatty Acid Ester s of Glycerol : Insoluble in 
water; soluble in ethanol  
Infrared absorption  Mono - And Diglycerides:  The infrared spectrum of the 
sample is characteristic of a partial fatty acid ester of a 
polyol  
Acetic and Fatty Acid Esters of Glycerol:  - 
Tests for fatty acids  Passes tests  
Test for glycerol  Passes tests  
Purity   
Water  Mono - And Diglycerides: Not more than 2.0% (Karl 
Fischer Method)  
Acetic and Fatty Acid Esters of Glycerol:  - 
Acid value  Mono - And Diglycerides:  Not more than 6  
Acetic and Fatty Acid Esters  of Glycerol:  - 
Free glycerol  Mono - And Diglycerides:  Not more than 7%  
Acetic and Fatty Acid Esters of Glycerol:  - 
Soap  Mono - And Diglycerides:  Not more than 6%, calculated as 
a sodium oleate  
Add 10.00 g of the sample to a mixture of 60 ml of acetone 
and 0.15 ml of bromophenol blue solution (0.5%), 
previously neutralized with 0.1 N hydrochloric acid or 0.1 
N sodium hydroxide. Warm gently on a water bath until 
solution is complete, and titrate w ith 0.1 N hydrochloric 
acid until the blue colour is discharged. Allow to stand for 
20 min, warm until any solidified matter has re -dissolved 
and, if the blue colour reappears, continue the titration. 
Each ml of 0.1 N hydrochloric acid is equivalent to 0.0 304  16 g of C 18H33O2Na. 
Acetic and Fatty Acid Esters of Glycerol:  - 
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 16) 
Functional uses  Emulsifiers