The Amendment of Standard s for Specification, Scope , Application and 
Limitation  of Food Additive s 
   MOHW  Food No. 1121301321, 10 , Aug, 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  
07069  Acid  Clay  Fats and oils refining: not more than 1.0 g/kg.   
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. 
 The Amendment of Standards for Specification, Scope, Application and 
Limitation of Food Additives  
   MOHW  Food No. 1121301321, 10 ,Aug , 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  
 
 
 
  
 
Definition  : Isoquercitrin is obtained by enzymatic hydrolysis of 
rutin . After mixed with starch or dextrin, it is reacted with 
cyclodextrin glucanotransferase.  
Assay  : Not less than 60% of rutin (C 27H30O16) on the dried 
basis.  
Appearance  : Yellow to orange powder, lumps or mush, with a slightly 
special odor.  
Identificatio n : (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 magnesium 
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 acid 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.  
Quercetin  : Not more than 1%.  
Lead  : Not more tha n 2 mg/kg  
Arsenic  : Not more than 1.5 mg/kg  
Loss on 
drying  : Not more than 50% (135°C, 2 h).  
Category  : Food Additives Category 3  
Functional 
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 
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 mg/kg  
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  mg/kg  
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  
§ 07069 
Acid Clay  
 
Definition  Acid Clay is obtained by purifying clay(such as 
montmorillonite clay, bentonite clay, etc.) . It consists mainly  of hydrous aluminum silicate.  
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 hydrochl oric 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 t he Qualitative Tests.  
(2) To a 100 mL measuring cylinder containing 100 mL 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 mg/kg  
Arsenic  Not more than 3  mg/kg  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 
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 obtai
ned responds to 
all the tests for  Aluminum Salt as directed in the 
Qualitative Tests.  
pH 2.0 ~ 6.0  
Purity  
Water -soluble 
substances  Not more than 1.6 % 
Lead  Not more than 40 mg/kg  
Arsenic  Not more than 3  mg/kg  
Loss on Ignition  Not more than 35% (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  
§ 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 mg/kg as As2O3 
Lead  Not more than 2  mg/kg  
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  
§ 08082 
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.  
Solubility  It is freely soluble in water, in alcohol,  in alkaline solutions, 
and in dilute mineral acids. It is practically insoluble 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,  calculated on the anhydrous basis  
pH 5.5 ~ 9.5 
Chloride  Not more than 0.4 % 
Water  Not more than 4 .0% 
Lead  Not more than 1 mg/kg  
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 sulfate or aluminium chloride with sodium carbonate or sodium bicarbonate or aqueous ammoni
a. 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 
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 mg/kg  
Lead  Not more than 5  mg/kg  
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 sulfate or aluminium chloride with sodium carbonate or sodium bicarbonate or aqueous ammoni
a. 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 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 mg/kg  
Lead  Not more than 5 mg/kg  
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 sulfate or aluminium chloride with sodium carbonate or sodium bicarbonate or aqueous ammoni
a. 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 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 mg/kg  
Lead  Not more than 5 mg/kg  
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 sulfate or aluminium chloride with sodium carbonate or sodium bicarbonate or aqueous ammoni
a. 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 Fast Green FCF 
Characteristics  
Identification   
Solubility  Insoluble in wa ter 
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 mg/kg  
Lead  Not more than 5 mg/kg  
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 sulfate or aluminium chloride with sodium carbonate or sodium bicarbonate or aqueous ammoni
a. 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 mg/kg  
Lead  Not more than 5 mg/kg  
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 sulfate or aluminium chloride with sodium carbonate or sodium bicarbonate or aqueous ammoni
a. 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 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 mg/kg  
Lead  Not more than 5 mg/kg  
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 
prepared by reacting aluminium sulfate or aluminium chloride with sodium carbonate or sodium bicarbonate or aqueous ammoni
a. 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 mg/kg  
Lead  Not more than 5 mg/kg  
Category Food additives category 9  
Functional uses Colors  11. Seasoning Agents  
§ 11003  
Monosodium L –Aspartate  
 
Chemical names  Monosodium (2S )-2-aminobutanedioate monohydrate 
C.A.S. number  3792 -50-5 
Chemical formula C4H6O4NNa‧H2O 
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 fo r 
Sodium Salt in the Qualitative Tests.  
Specific Rotation  〔α〕
20 
D：+18～+21° 
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 0.04 1% as Cl  
Arsenic  Not more than 2 mg/kg as As2O3 
Lead  Not more than 2 mg/kg  
Loss on Drying  Not more than 0.3%  
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 dioxide.  
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 
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 Dilute 2 ml of the sample in a glass -stoppered container 
substances  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  mg/kg  
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, arabinose, galactose and deoxyglucose) in any of the orientations occurring in the 
leaves of Stevia rebaudiana Bertoni.  
Steviol Glycosides 
from Stevia 
Rebaudiana Bertoni  
The product is obtained from the leaves of Stevia rebaudiana 
Bertoni. The leaves are extracted with hot water 
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 recrystallized 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 glycosides 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. T he resulting 
material is heated and filtered to denature and remove the enzymes. The raw product is concentrated using resin adsorption/desorption or solid/liquid filtration, followed by purification and preparation of the product of commerce 
using process es 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  
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 mg/kg methanol and not more than 
5000 mg/kg ethanol  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
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