G/SPS/N/TPKM/136Add1 
G/SPS/N/TPKM/139Add1 
The Amendment of Standards for Speci fication, Scope, Application and 
Limitation of Food Additives  
DOH Food No. 0980400197, January 22, 2009 
 
Appendix 1: Standards for Scope, Application and Limitation of Food 
Additives 
07. Food quality improvement, fermenta tion and food processing agents 
Code Food 
Additive 
Items Scope and Application 
Standards Limitations 
07045  Kaolin  All foods: not more than 5 
g/kg.  For manufacturing 
or processing 
purpose.  
07046 Talc All foods: not more than 5 
g/kg. Chewing gums and 
bubble gums: not more than 50 g/kg if bentonite, aluminum silicate, or diatomaceous earth, or kaolin
 is not used. For manufacturing or processing purpose. 
 
08. Nutritional Additives 
Code Food 
Additive 
Items Scope and Application 
Standards Limitations 
08132 Synthetic 
Zeaxanthin Foods in capsule or tablet 
forms, labeled with daily dosage: not more than 10 mg ofzeaxanthin in daily intake.  For supplementing purpose. 
 
 1Appendix 2: Standards for Specification of Food Additives 
07. Food quality improvement, fermenta tion and food processing agents 
§ 07017  Sodium Carbonate ；Sodium Carbonate, Anhydrous  
Chemical name Sodium carbonate ；sodium salt of carbonic acid 
Synonyms Soda ash：INS No. 500 (i) ：CAS No. 497-19-8 
Chemical formula Na2CO 3 (anhydrous) 
Na2CO 3 · xH 2O (hydrated) 
Formula weight 106.00 (anhydrous) 
Assay  Not less than 99.0 % after drying 
Description Colourless crystals or white, granular or crystalline 
powder; the anhydrous form is hygroscopic; hydrated 
forms available include the monohydrate and the 
decahydrate; the latter is efflorescent. 
Solubility Freely soluble in water; insoluble in ethanol 
Identification Passes tests for sodium and carbonate 
Loss on drying  Anhydrous: Not more than 2 % 
Monohydrate: Not more than 15 % Decahydrate: 55 – 65 % 
For all forms, heat the sample first at about 70 
o, then 
gradually raise the temperature and finally dry at 250-300 
o to constant weight.
Lead Not more than 2 mg/kg 
Heavy metals (as Pb)
 Not more than 10 mg/kg 
Category  Food additives category (7) 
Functional uses  Food quality improvement, fermentation and food 
processing agents 
 
 209. Colors  
§ 09006  Sunset Yellow FCF ﹙Food Yellow No.5 ﹚ 
Chemical name Disodium 
6-hydroxy-5-(4-sulfonatophenylazo)-2-naphthalene- 
sulfonate 
Synonyms CI Food Yellow 3 ；FD&C Yellow No. 6 ；Crelborange S ；
CI (1975) No. 15985 ；INS No. 110 ；CAS No. 2783-94-0
Chemical formula C16H10N2Na2O7S2 
Formula weight 452.38 
Structural formula  
 
  
 
Definition
 
 Consists essentially of disodium 
6-hydroxy-5-(4-sulfonatopheny lazo)-2-naphthalene-6-sulfo
nate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured 
components. 
Assay  Not less than 85 % total colouring matters 
Description Orange-red powder or granules 
Solubility Soluble in water; sparingly soluble in ethanol 
Identification of colouring matters Passes test 
Loss on drying Not more than 15 % at 135 º together with chloride and 
sulfate calculated as sodium salts 
Water insoluble 
matter Not more than 0.2 % 
Subsidiary 
colouring matters Not more than 5 % Not more than 2 % shall be colours other than trisodium 
2-hydroxy-1-(4-sulfonatopheny lazo)naphthalene-3,6-disulf
onate 
Organic Not more than 0.5 %, sum of  4-amino-1-benzenesulfonic 
 3compounds other 
than colouring 
matters acid, 3-hydroxy-2,7-naphtha lenedisulfonic acid, 
6-hydroxy-2-naphthalenesulfonic acid, 7-hydroxy-1,3-naphthalenedisulfonic acid, 
4,4'-diazoaminodibenzenesulfonic acid, 
6,6'-oxydi-2-naphthalenesulfonic acid 
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 
Arsenic Not more than 2 mg/kg 
Category  Food additives category (9) 
Functional uses  Colors 
 
 4§ 09027  Allura Red AC ﹙Food Red No. 40 ﹚ 
Chemical name Disodium 
6-hydroxy-5-(2-methoxy-5-me thyl-4-sulfonato-phenylazo) 
-2- naphthalenesulfonate 
Synonyms CI Food Red 17 ；FD&C Red No. 40 ；CI (1975) No. 
16035；INS No. 129； CAS No. 25956-17-6 
Chemical formula C18H14N2Na2O8S2 
Formula weight 496.43 
Structural formula   
 
  
Definition
 
 Consists essentially of disodium 6-hydroxy-5-(2-methoxy-5-me thyl-4-sulfonato-phenylazo)-
2-naphthalene-sulfona te and subsidiary colouring matters 
together with sodium chloride and/or sodium sulfate as the principal uncoloured components. 
Assay  Not less than 85 % total colouring matters 
Description Dark red powder or granules 
Solubility Soluble in water; insoluble in ethanol 
Identification of colouring matters Passes test 
Loss on drying Not more than 15 % at 135 º together with chloride and 
sulfate calculated as sodium salts 
Water insoluble 
matter Not more than 0.2 % 
Subsidiary 
colouring matters Not more than 3 % 
Organic compounds other 
than colouring 
matters Not more than 0.3 % of sodi um 6-hydroxy-2-naphtalene 
sulfonate 
Not more than 0.2 % of 
4-amino-5-methoxy-2-methyl-benzene-sulfonic acid 
 5Not more than 1.0 % of disodium 
6,6'-oxybis(2-naphthalene-sulfonate) 
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 
Arsenic Not more than 3 mg/kg 
Category  Food additives category (9) 
Functional uses  Colors 
 
 6§ 09030  Titanium Dioxide 
Synonyms Titania；CI Pigment white 6 ；CI (1975) No. 77891 ；INS No. 
171；CAS No. 13463-67-7 
Chemical formula TiO 2 
Formula weight 79.88 
Definition  
 Titanium dioxide is produced by either the sulfate or the 
chloride process. Processing c onditions determine the form 
(anatase or rutile structure) of the final product. 
In the sulfate process, sulfur ic acid is used to digest 
ilmenite (FeTiO 3) or ilmenite and tita nium slag. After a 
series of purification steps, th e isolated titanium dioxide is 
finally washed with water, calcined, and micronized. In the 
chloride process, chlorine  gas is reacted with a 
titanium-containing mineral under reducing conditions to form anhydrous titanium tetrachloride, which is subsequently purified and c onverted to titanium dioxide 
either by direct thermal oxidation or by reaction with steam in the vapour phase. Alternatively, concentrated 
hydrochloric acid can be reacted with the 
titanium-containing mineral to form a solution of titanium tetrachloride, which is then further purified and converted 
to titanium dioxide by hydrolysis. The titanium dioxide is filtered, washed, and calci ned. Commercial titanium 
dioxide may be coated with  small amounts of alumina 
and/or silica to improve the technological properties of the product. 
Assay Not less than 99.0 % on the dried basis (on an aluminium oxide and silicon dioxide-free basis) 
Description
 White to slightly coloured powder 
Solubility Insoluble in water, hydrochloric acid, dilute sulfuric acid, and organic solvents. Dissolves slowly in hydrofluoric acid 
and hot concentrated sulfuric acid. 
Colour reaction Add 5 mL sulfuric acid to 0.5 g of the sample, heat gently 
 7until fumes of sulfuric acid appear, then cool. Cautiously 
dilute to about 100 mL with water and filter. To 5 mL of 
this clear filtrate, add a few drops of hydrogen peroxide; an 
orange-red colour appears immediately. 
Loss on drying Not more than 0.5 % (105 °, 3 h) 
Loss on ignition Not more than 1.0 % (800 °) on the dried basis 
Aluminium oxide 
and/or 
silicon dioxide Not more than 2 %, either singly or combined 
Acid-soluble 
substances Not more than 0.5 %; Not mo re than 1.5 % for products 
containing alumina or silica. 
Water-soluble matter Not more than 0.5 % 
Antimony Not more than 2 mg/kg 
Arsenic Not more than 1 mg/kg 
Cadmium Not more than 1 mg/kg 
Lead Not more than 10 mg/kg 
Mercury Not more than 1 mg/kg 
Category  Food additives category (9) 
Functional uses  Colors 
 
 808. Nutritional Additives 
§ 0832  Synthetic Zeaxanthin 
Chemical name (all-E)-1,1'-(3,7,12,16-Tetramethyl-1,3,5,7,9,11,13,15,17-
octadecanonaene-1,18-diyl)bis [2,6,6-trimethylcyclohexen
e-3-ol]; 3R,3'R- β, β -Carotene-3,3'-diol 
Synonyms Zeaxanthol ；anchovyxanthin ；INS 160h(i) ；CAS No. 
144-68-3 
Chemical formula C40H56O2 
Formula weight 568.9 
Structural formula   
Assay Not less than 96 % 
Description Orange-red crystalline powder, with little or no odour 
Solubility Sparingly soluble in chlorofo rm, practically insoluble in 
water and ethanol 
Test for carotenoids The colour of the solution of the sample in acetone 
disappears after successive additions of a 5 % solution of 
sodium nitrite and 1N sulfuric acid 
Spectrophotometry An ethanol solution of the sample shows maximum 
absorption between 450 and 454 nm 
Loss on drying Not more than 0.2 % 
Sulfated ash Not more than 0.1 % 
cis-Zeaxanthins Not more than 2.0 % 
12’ -Apo-zeaxanthinal, 
diatoxanthin, 
parasiloxanthin Not more than 1.1 % combined 
Triphenyl phosphine 
oxide (TPPO) Not more than 0.01 % 
Heavy metals Not more than 20 mg/kg (as Pb) 
Lead Not more than 2 mg/kg 
Category Food additives category (8) 
 9Functional uses Nutritional Additive 
 1011. Seasoning Agents 
§ 11008  Citric Acid； Citric Acid, Anhydrous 
Chemical name  2-hydroxy-1,2,3-propanetricarboxylic acid  
Synonyms INS No. 330 ；CAS No. 77-92-9 (anhydrous)； CAS No. 
5949-29-1 (monohydrate)  
Chemical formula  C6H8O7 (anhydrous) 
C6H8O7‧H2O (monohydrate) 
Formula weight  192.13 (anhydrous) 
210.14 (monohydrate) 
Structural formula 
          
  
Anhydrous                  Monohydrate  
Assay Not less than 99.5 % and not more than 100.5 % on the 
anhydrous basis 
Description White or colourless, odourless, crystalline solid; the monohydrate form effloresces in dry air 
Solubility Very soluble in water; freely soluble in ethanol; slightly 
soluble in ether 
Water Anhydrous: Not more than 0.5 % Monohydrate: Not less than 7. 5 % and not more than 8.8 
% 
Sulfated ash Not more than 0.05 % 
Oxalate Not more than 100 mg/kg 
Sulfates Not more than 150 mg/kg 
Readily carbonizable substances Heat 1.0 g of sample with 10 mL  of 98 % sulfuric acid in a 
water bath at 90±1 
o for 60 min. No colour darker than 
MatchingFluid K (25 o) should be produced (not more 
than 0.5 absorbance units at  470 nm in a 10 mm cell). 
Lead Not more than 0.5 mg/kg 
Heavy metals (as Pb) Not more than 5 mg/kg 
Category Food additives category (11) 
Functional uses Seasoning agents 
 11§ 11051  Isomalt ﹙Hydrogenated Palatinose ﹚ 
Chemical name  6-O-alpha-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and 
1-O-alpha-D-Glucopyranosyl -D-mannitol dihydrate 
(1,1-GPM)  
Synonyms Hydrogenated isomaltulose ；INS No. 953； CAS No. 
64519-82-0  
Chemical formula  6-O-alpha-D-Glucopyranosyl-D-sorbitol: C 12H24O11 
1-O-alpha-D-Glucopyranosyl -D-mannitol dihydrate: 
C12H24O11‧2H 2O 
Formula weight  6-O-alpha-D-Glucopyranosyl-D-sorbitol: 344.32 
1-O-alpha-D-Glucopyranosyl -D-mannitol dihydrate: 
380.32 
Structural formula 
 
6-O-alpha-D-Glucopyranosyl-D-sorbitol  
 
1-O-alpha-D-Glucopyranosyl-D-mannitol (without molecules of crystal water)  
 
Assay Not less than 98 % of hydrogenated mono- and 
disaccharides and not less th an 86 % of the mixture of 
6-O-alpha-D-glucopyranosyl-D-sorbitol and 1-O-alpha-D-glucopyranosyl-D-mannitol on the 
anhydrous basis 
Description Odourless, white, crystallin e slightly hygroscopic 
substance 
Solubility Soluble in water, very s lightly soluble in ethanol 
Thin layer Passes test 
 12chromatography 
Water Not more than 7.0 % 
Sulfated ash Not more than 0.05 % 
D-Mannitol Not more than 3 % 
D-Sorbitol Not more than 6 % 
Reducing sugars Not more than 0.3 % 
Nickel Not more than 2 mg/kg 
Lead Not more than 1 mg/kg 
Heavy metals (as Pb) Not more than 10 mg/kg 
Category Food additives category (11) 
Functional uses Seasoning agents 
 
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