1 The Draft  Amendment of Standard s for Specification, Scope , Application 
and Limitation  of Food Additive s 
   MOHW  Food No.  1111303494 , 14, 03, 2023 
Appendix 1:  Standards for Scope, Application and Limitation  of Food  
Additives  
07. Food quality improvement, fermentation and food processing agents  
Code  Food Additive Items  Scope and Application Standards  Limitations  
07100 Activated Acid Clay  Fats and oils refining: not more than 1.0 g /kg.  
 
08. Nutritional additives  
Code  Food Additive Items  Scope and Application Standards  Limitations  
08317 L-Carnitin e Tartrate  Special dietary foods: as practically needed.  For supplementing 
purpose.  
 
11-1. Sweeteners  
Code  Food Additive Items  Scope and Application Standards  Limitations  
11-1-012 Steviol glycosides  
 1. Melon seeds, syrup -preserved fruits , and 
plum powder: as practically needed.  
2. Sugar substitutes, including tablet and 
powder forms.  
3. Special dietary foods.  
4. soy milk, milk, fermented milk products and 
its products, ice cream, cakes and cookies 
( including steamed Chinese -styled ones ), 
chewing gums, confectionaries, snack foods 
and cereals: not more than 0.05%.  
5. Beverages, soy sauces, sauces and pickles: 
not more than 0.1%.  Permit from the 
central health 
authority needed 
for special dietary 
foods.  
  1 The Draft  Amendment of Standard s for Specification, Scope , Application 
and Limitation  of Food Additive s 
   MOHW  Food No. 1111303494, 14 ,03, 2023 
Appendix 2: Standards for Specification of Food Additives  
03. Antioxidants  
§ 03026  
α– Glycosyl –isoquercitrin  
 
Synonyms  : Enzymatically modified isoquercitrin; isoquercetin; EMIQ  
 Molecular weight: Approximately 800  
 
 
 
 
 
 
1. Definition  : Isoquercitrin is obtained by enzymatic 
hydrolysis of rutin. After mixed with starch or 
dextrin, it is reacted with cyclodextrin 
glucanotransferase.  
2. Assay  : Not less than 60% of rutin (C 27H30O16) on the 
dried basis.  
3. Appearance  : Yellow to orange powder, lumps or mush, with 
a slightly special odor.  
4. Identification  : (1) Dissolve 5 mg of the sample in 10 mL of 
water and add 1 to 2 drops of 1 in 50 ferric 
chloride solution. A dark brown color appears.  
 (2) Dissolve 5 mg of the sample in 5 mL of 
water, add 2 mL of hydrochloric acid and 0.05 g 
of magnesi um powder. The solution is orange to 
red. 
 (3) Dissolve 0.1g of the sample in 100 mL of 1 
N sulfuric acid, boil for 2 hours. Yellow 
precipitates appear after cooling.  
 (4) Spectrophotometry: Dissolve 10 mg of the 
sample in 500 mL of 1 in 1,000 phosphoric a cid 
 2 solution. The solution has the maximum 
absorption value around the wavelength of 255 
nm and 350 nm.  
 (5) TLC : Analyze the test solution and contr ol 
solution (rutin for assay )in methanol  by TLC . 
Several brown spots are observed: one having an 
Rf value greater than that of the main  spot of 
rutin for assay and others having Rf values the 
same as or smaller than that of the main spot of 
rutin for assay.  
5. Quercetin  : Not more than 1%.  
6. Lead  : Not more than 5 ppm 
7. Arsenic  : Not more than 1.5 ppm 
8. Loss on 
drying  : Not more than 50% (135°C, 2 h).  
9. Category  : Food Additives Category 3  
10. Uses  : Antioxidants  
 
07. Food quality improvement, fermentation and food processing agents  
08. Nutritional additives  
§ 07005  
§ 08137  
Calcium Citrate  
 
Synonyms  INS No. 333(iii)  
Definition   
Chemical names  Tricalcium citrate, tricalcium salt of 2 -hydroxy -1,2,3 - 
propanetricarboxylic acid, tricalcium salt of ß -hydroxy -
tricarballylic acid  
C.A.S. number  813-94-5 
Chemical formula  C12H10Ca3O14‧4H2O  3 Structural formula   
Formula weight  570.51  
Assay  Not less than 97.5% after drying  
Description  Odourless, fine white powder  
Characteristics   
Identification   
Solubility  Very slightly soluble in water. Insoluble in ethanol.  
Test for citrate  Passes test  
Test for calcium  Passes test  
Purity   
Loss on drying  Not less than 10% and not more than 14% (150 °C, 4 h)  
Fluorides  Not more than 30 ppm 
Free acid and alkali  Passes test  
Oxalate  Dissolve 1 g of the sample in 5 ml of warm dilute 
hydrochloric acid TS and filter the solution if necessary.  
Lead  Not more than 2 ppm 
Category  Food additives category ( 7) (8) 
Functional uses  Food quality improvement, fermentation and food 
processing agents ; Nutritional additives . 
 
07. Food quality improvement, fermentation and food processing agents  
§ 070 69 
Acid Clay  
 
Definition  Acid Clay is obtained by purifying montmorillonite clay. It 
consists mainly  of hydrous aluminum silicate.  
 4 Description  Acid Clay occurs as a grayish -white to yellow -brown 
powder or as granules.  
Identification  (1) Mix 1.0 g of Acid Clay with 3.0 g of sodium carbonate 
and 0.4 g of boric acid, and heat the mixture in a 
platinum or nickel crucible until it melts completely. 
Cool, and then add hydrochloric acid until no 
effervescence is observed. Add an additional 10 mL  of 
hydrochloric acid, heat on a water bath until the mixture 
becomes gelatinous, cool, and then filter. The filtrate 
obtained responds to all the tests for Aluminum Salt as 
directed in the Qualitative Tests.  
(2) To a 100 mL measuring cylinder containing 100 m L of 
water, add 2.0 g of Acid Clay in small portions, and 
allow to stand for 24 hours. The precipitate formed is 
not more than 15 mL.  
pH 4.0 ~ 10.0  
Purity   
Water -soluble 
substances  Not more than 0.50%  
Lead  Not more than 40 ppm 
Arsenic  Not more than 3 ppm 
Loss on Ignition  Not more than 35.0% (at 110°C for 3 hours, then at 550°C 
for 3 hours).  
Category  Food additives category 7 
Functional uses  Food quality improvement, fermentation and food 
processing agents  
 
07. Food quality improvement, fermentation and food processing agents  
§ 07100  5 Activated Acid Clay  
 
Definition  Activated Acid Clay is obtained by treating acid clay with 
sulfuric acid. Its  principal constituent is hydrous aluminum 
silicate.  
Description  Activated Acid Clay occurs as a whitish to gray powder or 
as granules.  
Identification  Mix 1.0 g of Activated Acid Clay with 3.0 g of sodium 
carbonate and 0.4  g of boric acid, and heat the mixture in a 
platinum or nickel crucible until it melts  completely. Cool, 
and add hydrochloric acid  until no effervescence is 
observed. Add an  additional 10 mL of hydrochloric acid, 
and heat on a water bath until the mixture  becomes 
gelatinous, cool, and filter. The filtrate obtained responds to 
all the tests for  Aluminum Salt as directed in the 
Qualita tive Tests.  
pH 2.0 ~ 6.0 
Purity   
Water -soluble 
substances  Not more than 1.6% 
Lead  Not more than 40 ppm 
Arsenic  Not more than 3 ppm 
Loss on Ignition  Not more than 35.0% (at 110°C for 3 hours, then at 550°C 
for 3 hours).  
Category  Food additives category 7 
Functional uses  Food quality improvement, fermentation and food 
processing agents  
 
08. Nutritional additives   6 § 08051 
L－Valine  
 
Chemical names  (2S)-2-Amino -3-methylbutanoic acid  
C.A.S. number  72-18-4 
Chemical formula  C5H11NO 2 
Structural formula   
Formula weight  117.15  
Content  L-Valine, when calculated on the dried basis, contains 
98.0–102.0% of L-valine  
Description  L-Valine occurs as white crystals or crystalline powder. It 
is odorless or has  a slight, characteristic odor, and has a 
slight, characteristic taste.  
Identification  To 5 mL of a solution of L -Valine (1 in 1000), add 1 mL of 
ninhydrin  solution (1 in 1000), and heat for 3 minutes. A 
purple color develops.  
Specific Rotation  〔α〕20 
D ：+26.5～+29.0°(Dry at 105 °C for 3  hours. 
Dissolve 4 g of the sample in 6 N hydrochloric acid to 
make a 50 mL solution. ) 
pH 5.5 ~ 7.0 (0.5 g, water 20 mL)  
Purity   
Clarity and color of 
solution  Colorless and clear (0.50 g, water 20 mL)  
Chloride  Not more than 0.021% as Cl  
Arsenic  Not more than 2 ppm as As2O3 
 7 Lead  Not more than 2 ppm 
Loss on Drying  Not more than 0.3% (105°C, 3 hours)  
Residue on Ignition  Not more than 0.1%  
Category  Food additives category 8 
Functional uses  Nutritional additives  
 
 
 
08. Nutritional additives  
§ 08323 
L-Carnitine  
 
Chemical names  4-Amino -3-hydroxybutyric Acid Trimethylbetaine ； 
Levocarnitine ；4-Trimethylamino -3-hydroxybutyrate ； 
(R)-3-Carboxy -2-hydroxy -N,N,N -trimethyl -1-
propanaminium  Hydroxide, Inner Salt  
C.A.S. number  541-15-1 
Chemical formula  C7H15NO 3 
Structural formula   
Formula weight  161.20  
Assay 97.0% ~ 103.0% , calculated on the anhydrous basis  
Description  L-Carnitine occurs as white crystals or as a white, 
crystalline,  hygroscopic powder.  
Identification  Dissolve 1 g of sample in 10 mL of water and  10 mL of 1 N 
hydrochloric acid, and add 5 mL of sodium  
tetraphenylborate test solution.  It forms a white precipitate.  
 8 Solubility  It is freely soluble in water, in alcohol,  in alkaline solutions, 
and in dilute mineral acids. It is  practically ins oluble in 
acetone and in ethyl acetate. It  decomposes without melting 
at about 185°C to 195°C.  
Specific Rotation  〔α〕20 
D：-29.0 ~ -32.0 
pH 5.5 ~ 9.5  
Chloride  Not more than 0.4% 
Water Not more than 4.0% 
Lead  Not more than 1 ppm  
Potassium  Not more than 0.2% 
Sodium  Not more than 0.1% 
Residue on Ignition  Not more than 0. 5% 
Category  Food additives category 8 
Functional uses  Nutritional additives  
 
09. Color s 
§ 09003  
Erythrosine Aluminum Lake  
 
Definition  Aluminium  lakes are prepared under aqueous conditions by 
reacting aluminium oxide with colouring matter complying 
with purity criteria set out in the appropriate specification 
monograph. Undried aluminium oxide is usually freshly 
prepared by reacting aluminium sulf ate or aluminium 
chloride with sodium carbonate or sodium bicarbonate or 
aqueous ammonia. Following lake formation, the product is 
filtered, washed with water and dried. Unreacted 
aluminium oxide may also be present in the final product.  
Assay  Not less than 10% of Erythrosine   9 Characteristics   
Identification   
Solubility  Insoluble in water  
Purity   
Water -soluble 
chlorides and 
sulfates  Not more than 2 .0% calculated as sodium salts  
Hydrochloric acid -
insoluble matters  Not more than 0.5%  
Ether -extractable 
matter  Not more than 0.2%  
Arsenic  Not more than 3 ppm  
Lead  Not more than 5 ppm 
Category  Food additives category 9 
Functional uses  Colors  
 
09. Colors  
§ 0900 5 
Tartrazine Aluminum Lake  
 
Definition  Aluminium  lakes are prepared under aqueous conditions by 
reacting aluminium oxide with colouring matter complying 
with purity criteria set out in the appropriate specification 
monograph. Undried aluminium oxide is usually freshly 
prepared by reacting aluminium sulf ate or aluminium 
chloride with sodium carbonate or sodium bicarbonate or 
aqueous ammonia. Following lake formation, the product is 
filtered, washed with water and dried. Unreacted 
aluminium oxide may also be present in the final product.   10 Assay  Not less than 10% of Tartrazine  
Characteristics   
Identification   
Solubility  Insoluble in water  
Purity   
Water -soluble 
chlorides and 
sulfates  Not more than 2 .0% calculated as sodium salts  
Hydrochloric acid -
insoluble matters  Not more than 0.5%  
Ether -extractable  
matter  Not more than 0.2%  
Arsenic  Not more than 3 ppm  
Lead  Not more than 5 ppm  
Category  Food additives category 9  
Functional uses  Colors  
 
09. Colors  
§ 0900 7 
Sunset Yellow FCF Aluminum Lake  
 
Definition  Aluminium  lakes are prepared under aqueous conditions by 
reacting aluminium oxide with colouring matter complying 
with purity criteria set out in the appropriate specification 
monograph. Undried aluminium oxide is usually freshly 
prepared by reacting aluminium sulf ate or aluminium 
chloride with sodium carbonate or sodium bicarbonate or 
aqueous ammonia. Following lake formation, the product is 
filtered, washed with water and dried. Unreacted  11 aluminium oxide may also be present in the final product.  
Assay  Not less than 10% of Sunset Yellow FCF  
Characteristics   
Identification   
Solubility  Insoluble in water  
Purity   
Water -soluble 
chlorides and 
sulfates  Not more than 2 .0% calculated as sodium salts  
Hydrochloric acid -
insoluble matters  Not more than 0.5%  
Ether -extractable 
matter  Not more than 0.2%  
Arsenic  Not more than 3 ppm  
Lead  Not more than 5 ppm  
Category  Food additives category 9  
Functional uses  Colors  
 
09. Colors  
§ 0900 9 
Fast Green FCF Aluminum Lake  
 
Definition  Aluminium  lakes are prepared under aqueous conditions by 
reacting aluminium oxide with colouring matter complying 
with purity criteria set out in the appropriate specification 
monograph. Undried aluminium oxide is usually freshly 
prepared by reacting aluminium sulf ate or aluminium 
chloride with sodium carbonate or sodium bicarbonate or 
aqueous ammonia. Following lake formation, the product is  12 filtered, washed with water and dried. Unreacted 
aluminium oxide may also be present in the final product.  
Assay  Not less th an 10% of Fast Green FCF  
Characteristics   
Identification   
Solubility  Insoluble in water  
Purity   
Water -soluble 
chlorides and 
sulfates  Not more than 2 .0% calculated as sodium salts  
Hydrochloric acid -
insoluble matters  Not more than 0.5%  
Ether -extractable 
matter  Not more than 0.2%  
Arsenic  Not more than 3 ppm  
Lead  Not more than 5 ppm  
Category  Food additives category 9  
Functional uses  Colors  
 
09. Colors  
§ 09011 
Brilliant Blue FCF Aluminum Lake  
 
Definition  Aluminium  lakes are prepared under aqueous conditions by 
reacting aluminium oxide with colouring matter complying 
with purity criteria set out in the appropriate specification 
monograph. Undried aluminium oxide is usually freshly 
prepared by reacting aluminium sulf ate or aluminium 
chloride with sodium carbonate or sodium bicarbonate or  13 aqueous ammonia. Following lake formation, the product is 
filtered, washed with water and dried. Unreacted 
aluminium oxide may also be present in the final product.  
Assay  Not less than 10% of Brilliant Blue FCF  
Characteristics   
Identification   
Solubility  Insoluble in water  
Purity   
Water -soluble 
chlorides and 
sulfates  Not more than 2 .0% calculated as sodium salts  
Hydrochloric acid -
insoluble matters  Not more than 0.5%  
Ether -extractable 
matter  Not more than 0.2%  
Arsenic  Not more than 3 ppm  
Lead  Not more than 5 ppm  
Category  Food additives category 9  
Functional uses  Colors  
 
09. Colors  
§ 09013 
Indigo Carmine Aluminum Lake  
 
Definition  Aluminium  lakes are prepared under aqueous conditions by 
reacting aluminium oxide with colouring matter complying 
with purity criteria set out in the appropriate specification 
monograph. Undried aluminium oxide is usually freshly 
prepared by reacting aluminium sulf ate or aluminium  14 chloride with sodium carbonate or sodium bicarbonate or 
aqueous ammonia. Following lake formation, the product is 
filtered, washed with water and dried. Unreacted 
aluminium oxide may also be present in the final product.  
Assay  Not less th an 10% of indigo carmine  
Characteristics   
Identification   
Solubility  Insoluble in water  
Purity   
Water -soluble 
chlorides and 
sulfates  Not more than 2 .0% calculated as sodium salts  
Hydrochloric acid -
insoluble matters  Not more than 0.5%  
Ether -extractable 
matter  Not more than 0.2%  
Arsenic  Not more than 3 ppm  
Lead  Not more than 5 ppm  
Category  Food additives category 9  
Functional uses  Colors  
 
09. Colors  
§ 09031 
Allura Red AC Aluminum Lake  
 
Definition  Aluminium  lakes are prepared under aqueous conditions by 
reacting aluminium oxide with colouring matter complying 
with purity criteria set out in the appropriate specification 
monograph. Undried aluminium oxide is usually freshly  15 prepared by reacting aluminium sulf ate or aluminium 
chloride with sodium carbonate or sodium bicarbonate or 
aqueous ammonia. Following lake formation, the product is 
filtered, washed with water and dried. Unreacted 
aluminium oxide may also be present in the final product.  
Assay  Not less than 10% of Allura Red AC  
Characteristics   
Identification   
Solubility  Insoluble in water  
Purity   
Water -soluble 
chlorides and 
sulfates  Not more than 2 .0% calculated as sodium salts  
Hydrochloric acid -
insoluble matters  Not more than 0.5%  
Ether -extractable 
matter  Not more than 0.2%  
Arsenic  Not more than 3 ppm  
Lead  Not more than 5 ppm  
Category  Food additives category 9  
Functional uses  Colors  
 
11. Seasoning Agents  
§ 11003  
Monosodium L –Aspartate  
 
Chemical names  Monosodium (2 S)-2-aminobutanedioate monohydrate  
C.A.S. number  3792 -50-5 
Chemical formula  C4H6O4NNa‧H2O  16 Structural formula   
Formula weight  173.10  
Content  Monosodium L -Aspartate, when calculated on the dried 
basis, contains not less  than 98% of monosodium L-
aspartate  
Description  Monosodium L -Aspartate occurs as colorless to white 
prisms or as a white crystalline powder. It has a 
characteristic taste.  
Identification  (1) To 5 mL of a solution of Monosodium L -Aspartate (1 
in 1000), add 1 mL of ninhydrin solution  (1 in 1000), 
and heat for 3 minutes. A purple color develops.  
(2) Monosodium L -Aspartate responds to all tests for 
Sodium Salt in the Qualitative Tests.  
Specific Rotation  〔α〕20 
D：+18～+21°(vacuum desiccator over sulfuric 
acid, 5h. Dissolve 4 g of the sample i n 6 N  hydrochloric 
acid to make a 50 mL solution ) 
pH 6.0 ~ 7.5 (1.0 g, water 20 mL)  
Purity   
Clarity and color of 
solution  Colorless and clear (1.0 g, water 10 mL)  
Chloride  Not more than 0.0 41% as Cl  
Arsenic  Not more than 2 ppm as As2O3 
Lead  Not more than 2 ppm  
Loss on Drying  Not more than 0.3% ( vacuum desiccator over sulfuric acid, 
5h) 
 17 Category  Food additives category 11 
Functional uses  Seasoning Agents  
 
11. Seasoning Agents  
§ 11021  
Acetic Acid ，Glacial  
 
Synonyms  INS No. 260  
Definition  Acetic acid is manufactured by aerial oxidation of C5 -C6 
fractions of aliphatic hydrocarbons, and separation of the 
various acids by distillation. Also by oxidation of 
acetaldehyde, methanol and of butane or as the reaction 
product of methanol and carbon d ioxide.  
Chemical names  Acetic acid, ethanoic acid  
C.A.S. number  64-19-7 
Chemical formula  CH 3COOH  
Structural formula   
Formula weight  60.05  
Assay  Not less than 9 9.5% 
Description  Colourless liquid, having a pungent characteristic odour  
Characteristics   
Identification   
Solubility  Miscible with water, ethanol, glycerol and diethyl ether  
Test for acid  1 in 3 aqueous solution is acidic  
Test for acetate  Passes test  
Purity   
Solidification point  Not lower than 15.6 °C 
 18 Non-volatile 
residue  Not more than 0.01% after evaporation of 20 g of the 
sample and holding at 100 °C for 2 h.  
Readily oxidizable 
substances  Dilute 2 ml of the sample in a glass -stoppered container 
with 10 ml of water and add 0.1 ml of 0.1 N potassium 
permanganate. The pink color does not disappear  within 30 
min. 
Lead  Not more than 0.5 ppm 
Category  Food additives category 11 
Functional uses  Seasoning Agents  
 
11. Sweeteners  
§ 11-1-012 
Steviol glycosides  
 
Synonyms   
Steviol Glycosides 
from Stevia 
Rebaudiana  
Bertoni  INS No. 960a 
Enzyme modified  
Steviol Glycosides  - 
Definition  Steviol glycosides consist of a mixture of compounds 
containing a steviol backbone conjugated to any number or 
combination of the principal sugar moieties (glucose, 
rhamnose, xylose, fructose, arabinos e, galactose and 
deoxyglucose) in any of the orientations occurring in the 
leaves of Stevia rebaudiana  Bertoni.  
Steviol Glycosides 
from Stevia The product is obtained from the leaves of Stevia 
rebaudiana  Bertoni . The leaves are extracted with hot water  19 Rebaudiana  
Bertoni  and the aqueous extract is passed through an adsorption 
resin to trap and concentrate the component steviol 
glycosides. The resin is washed with a solvent alcohol to 
release the glycosides and the product is recrys tallized from 
methanol or aqueous ethanol. Ion exchange resins may be 
used in the purification process. The final product may be 
spray -dried.  
Enzyme modified  
Steviol Glycosides  The product is obtained from the enzymatic treatment of 
purified steviol glyco sides extracted from the leaves of 
Stevia rebaudiana Bertoni. The purified leaf extract is 
treated with enzymes produced by non -toxigenic non -
pathogenic strains of Pichia pastoris  and Escherichia coli  
that have been genetically modified with genes from 
multiple donor organisms (listed below) to produce 
glucosyltransferase  and sucrose synthase. The resulting 
material is heated and filtered to denature and remove the 
enzymes. The raw product is concentrated using resin 
adsorption/desorption or solid/liquid fi ltration, followed by 
purification and preparation of the product of commerce 
using processes that may include decolourization, 
crystallization, and spray  drying . 
Enzyme production organism  Gene source  
Pichia pastoris  Horedum vulgare L 
Stevia rebaudiana Bertoni   
Vigna radiate  
Escherichia coli  Acidithiobacillus caldus  
Arapidopsis thaliana  
Solanum tuberosum  
Stevia rebaudiana Bertoni  
 
Chemical names  See Appendix 1   20 C.A.S. number  See Appendix 1  
Chemical formula  See Appendix 1  
Structural formula   
 
 
 
 
Steviol (R1 = R2 = H) is the aglycone of the steviol 
glycosides.  
Glc, Rha, Fru, deoxyGlc, Gal, Ara and Xyl represent, 
respectively, glucose, rhamnose, fructose, deoxyglucose 
xylose, galactose, arabinose and xylose sugar moieties.  
Assay  Not less than 99.0%  on the dried basis.  
Description  White to light yellow powder, odourless or having a slight 
characteristic odour. About 200 - 300 times sweeter than 
sucrose.  
Characteristics   
Identification   
Solubility  Very slightly soluble to freely soluble in water; slightly 
soluble to freely soluble in a mixture of ethanol and water 
(50:50 v/v ). 
HPLC 
chromatographic 
profile  Correspond to steviol glycoside standards  
pH Between 4.5 and 7.0 (1 in 100 solution)  
Purity   
Total ash  Not more than 1%  
Loss on drying  Not more than 6% (105℃, 2 h) 
Residual solvents  Not more than 200 ppm methanol and not more than 5000 
 21 ppm ethanol  
Arsenic  Not more than 1 ppm 
Lead  Not more than 1 ppm 
Microbiological 
criteria  Total (aerobic) plate count: Not more than 1,000 CFU/g  
Yeasts and moulds: Not more than 200 CFU/g  
E. coli : Negative in 1 g  
Salmonella : Negative in 25 g  
Category  Food additives category (11 -1) 
Functional uses  Sweeteners  
  22  
 23  
 
 24  
 
 25