Draft of Scope and Application Standards of Food Additives 
 
7. 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 manu facturing 
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. 
 
  Draft of Specification Standards of Food Additives 
 
§ 07017 
Sodium Carbonate ；Sodium Carbonate, Anhydrous 
 
Chemical name Sodium carbonate；sodium salt of carbonic acid 
Chemical formula Na2CO 3 (anhydrous) 
Na2CO 3 · xH 2O (hydrated) 
Formula weight 106.00 (anhydrous) 
Synonyms Soda ash；INS No. 500 (i) 
C.A.S. number 497-19-8 
Assay  Not less than 99.0% after drying 
Description  Colourless crystals or white, gra nular or crystalline powder; the 
anhydrous form is hygroscopic; hydrated forms available include the 
monohydrate and the decahydrate; th e 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 250-300o 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 agent 
 Draft of Specification Standards of Food Additives 
 
§ 09006 
Sunset Yellow FCF ﹙Food Yellow No.5 ﹚ 
 
Chemical name Disodium 6-hydroxy-5-(4-sulfonatoph enylazo)-2-naphthalene-sulfonate
Chemical formula C16H10N2Na2O7S2 
Formula weight 452.38  
Structural formula            
Synonyms CI Food Yellow 3 ；FD&C Yellow No. 6 ；Crelborange S ；CI (1975) No. 
15985；INS No. 110 
C.A.S. number 2783-94-0 
Definition Consists essentially of disodium 
6-hydroxy-5-(4-sulfonatophenylazo)-2- naphthalene-6-sulfonate and 
subsidiary colouring matters togeth er 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 135º 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-sulfonatophenylazo)n aphthalene-3,6-disulfonate 
Organic compounds other than colouring matters Not more than 0.5%, sum of 4- amino-1-benzenesulfonic acid, 
3-hydroxy-2,7-naphthalenedisulfonic acid, 6-hydroxy-2-naphthalenesulfonic acid, 7-hydroxy-1,3-naphthalenedisulfonic acid, 
4,4'-diazoaminodibenzenesulfonic acid, 
6,6'-oxydi-2-naphthalenesulfonic acid 
Unsulfonated primary Not more than 0.01% calculated as aniline 
aromatic amines 
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  Color 
 Draft of Specification Standards of Food Additives 
 
§ 09027 
Allura Red AC ﹙Food Red No. 40 ﹚ 
 
Chemical name Disodium 
6-hydroxy-5-(2-methoxy-5-methyl-4-s ulfonato-phenylazo)-2-naphthale
nesulfonate 
Chemical formula C18H14N2Na2O8S2 
Formula weight 496.43  
Structural formula            
Synonyms CI Food Red 17, FD&C Red No.40, CI (1975) No.16035, INS No. 129
C.A.S. number 25956-17-6 
Definition Consists essentially of disodium 
6-hydroxy-5-(2-methoxy-5-methyl-4-s ulfonato-phenylazo)-2-naphthale
ne-sulfonate and subsidiary colour ing matters together with sodium 
chloride and/or sodium sulfate as the principal unco loured 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 135º 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 sodium 6-hydroxy-2-naphtalene sulfonate 
Not more than 0.2% of 4-amino-5- methoxy-2-methyl-benzene-sulfonic 
acid 
Not 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  Color 
 Draft of Specification Standards of Food Additives 
 
§ 09030 
Titanium Dioxide 
 
Chemical formula TiO 2 
Formula weight 79.88  
Synonyms Titania；CI Pigment white 6 ；CI (1975) No.77891；INS No. 171 
C.A.S. number 13463-67-7 
Definition Titanium dioxide is produced by ei ther the sulfate or the chloride 
process. Processing conditions determine the form (anatase or rutile 
structure) of the final product. 
In the sulfate process, sulfuric acid is used to digest ilmenite (FeTiO3) 
or ilmenite and titanium slag. After a series of purification steps, the isolated titanium dioxide is finall y washed with water, calcined, and 
micronized. 
In the chloride process, chlo rine gas is reacted with a 
titanium-containing mineral under reducing conditions to form 
anhydrous titanium tetrachloride, which is subsequently purified and converted 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 calcined. 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 hydrof luoric acid and hot concentrated 
sulfuric acid. 
Colour reaction Add 5 ml sulfuric acid to 0.5 g of the sample, heat gently until 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 
o) 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 more th an 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  Color 
 Draft of Specification Standards of Food Additives 
 
§ 11008 
Citric Acid ；Citric Acid, Anhydrous 
 
Chemical name 2-hydroxy-1,2,3-propane tricarboxylic acid 
Chemical formula C6H8O7 (anhydrous) 
C6H8O7·H2O (monohydrate) 
Formula weight 192.13 (anhydrous) 
210.14 (monohydrate) 
Structural formula 
       
  
Anhydrous               Monohydrate 
Synonyms INS 330 
C.A.S. number 77-92-9 (anhydrous) 
5949-29-1 (monohydrate) 
Assay  Not less than 99.5% and not more than 100.5% on the anhydrous basis 
Description  White or colourless, odourless, crys talline 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±1o 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 agent 
 Draft of Specification Standards of Food Additives 
 
§ 11051 
Isomalt﹙Hydrogenated Palatinose ﹚ 
 
Chemical name 6-O-alpha-D-Glucopyranosyl-D -sorbitol (1,6-GPS) and 
1-O-alpha-D-Glucopyranosyl-D-m annitol dihydrate (1,1-GPM) 
Chemical formula 6-O-alpha-D-Glucopyran osyl-D-sorbitol: C 12H24O11 
1-O-alpha-D-Glucopyranosyl -D-mannitol dihydrate: C 12H24O11 · 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)  
Synonyms Hydrogenated isomaltulose; INS 953 
C.A.S. number 64519-82-0 
Assay  Not less than 98% of hydrogenated mono- and disaccharides and not 
less than 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, crystalline slightly hygroscopic substance 
Solubility Soluble in water, very slightly soluble in ethanol 
Thin layer chromatography Passes test 
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 agent