G/SPS/N/TPKM/136Add1 G/SPS/N/TPKM/139Add1 The Amendment of Standards for Specification, 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, fermentation and food processing agents Code Food Additive Items Scope and Application Standards 07045 Kaolin All foods: not more than 5 g/kg. 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. Limitations For manufacturing or processing purpose. For manufacturing or processing purpose. 08. Nutritional Additives Food Code Additive Items 08132 Synthetic Zeaxanthin Scope and Application Standards Limitations Foods in capsule or tablet For forms, labeled with daily supplementing dosage: not more than 10 mg of purpose. zeaxanthin in daily intake. 1
Appendix 2: Standards for Specification of Food Additives 07. Food quality improvement, fermentation 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 Na 2 CO 3 (anhydrous) Na 2 CO 3 xh 2 O (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. Not more than 2 mg/kg Heavy metals (as Not more than 10 mg/kg Pb) Category Food additives category (7) Functional uses Food quality improvement, fermentation and food processing agents 2
09. Colors 09006 Sunset Yellow FCF ( Food Yellow No.5 ) Chemical name Disodium 6-hydroxy-5-(4-sulfonatophenylazo)-2-naphthalenesulfonate 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 C 16 H 10 N 2 Na 2 O 7 S 2 Formula weight 452.38 Structural formula Definition Assay Description Solubility Identification of colouring matters Loss on drying Water insoluble matter Subsidiary colouring matters Organic Consists essentially of disodium 6-hydroxy-5-(4-sulfonatophenylazo)-2-naphthalene-6-sulfo nate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Not less than 85 % total colouring matters Orange-red powder or granules Soluble in water; sparingly soluble in ethanol Passes test Not more than 15 % at 135 º together with chloride and sulfate calculated as sodium salts Not more than 0.2 % Not more than 5 % Not more than 2 % shall be colours other than trisodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-3,6-disulf onate Not more than 0.5 %, sum of 4-amino-1-benzenesulfonic 3
compounds other acid, 3-hydroxy-2,7-naphthalenedisulfonic acid, than colouring 6-hydroxy-2-naphthalenesulfonic acid, matters 7-hydroxy-1,3-naphthalenedisulfonic acid, 4,4'-diazoaminodibenzenesulfonic acid, 6,6'-oxydi-2-naphthalenesulfonic acid Unsulfonated Not more than 0.01 % calculated as aniline primary aromatic amines Ether extractable Not more than 0.2 % matter 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 Synonyms Disodium 6-hydroxy-5-(2-methoxy-5-methyl-4-sulfonato-phenylazo) -2- naphthalenesulfonate CI Food Red 17;FD&C Red No. 40;CI (1975) No. Chemical formula C 18 H 14 N 2 Na 2 O 8 S 2 Formula weight 496.43 Structural formula 16035;INS No. 129;CAS No. 25956-17-6 Definition Assay Description Solubility Identification of colouring matters Loss on drying Water insoluble matter Subsidiary colouring matters Organic compounds other than colouring matters Consists essentially of disodium 6-hydroxy-5-(2-methoxy-5-methyl-4-sulfonato-phenylazo)- 2-naphthalene-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Not less than 85 % total colouring matters Dark red powder or granules Soluble in water; insoluble in ethanol Passes test Not more than 15 % at 135 º together with chloride and sulfate calculated as sodium salts Not more than 0.2 % Not more than 3 % 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 5
Not more than 1.0 % of disodium 6,6'-oxybis(2-naphthalene-sulfonate) Unsulfonated Not more than 0.01 % calculated as aniline primary aromatic amines Ether extractable Not more than 0.2 % matter 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. Chemical formula TiO 2 Formula weight 79.88 Definition Assay Description Solubility Colour reaction 171;CAS No. 13463-67-7 Titanium dioxide is produced by either 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 (FeTiO 3 ) or ilmenite and titanium slag. After a series of purification steps, the 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 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. Not less than 99.0 % on the dried basis (on an aluminium oxide and silicon dioxide-free basis) White to slightly coloured powder Insoluble in water, hydrochloric acid, dilute sulfuric acid, and organic solvents. Dissolves slowly in hydrofluoric acid and hot concentrated sulfuric acid. Add 5 ml sulfuric acid to 0.5 g of the sample, heat gently 7
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 ) on the dried basis Aluminium oxide Not more than 2 %, either singly or combined and/or silicon dioxide Acid-soluble Not more than 0.5 %; Not more than 1.5 % for products substances containing alumina or silica. Water-soluble Not more than 0.5 % matter Antimony Not more than 2 mg/kg Arsenic Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Not more than 10 mg/kg Mercury Not more than 1 mg/kg Category Food additives category (9) Functional uses Colors 8
08. Nutritional Additives 0832 Synthetic Zeaxanthin Chemical name Synonyms (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 Zeaxanthol;anchovyxanthin;INS 160h(i);CAS No. 144-68-3 Chemical formula C 40 H 56 O 2 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 chloroform, 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 Not more than 1.1 % combined -Apo-zeaxanthinal, diatoxanthin, parasiloxanthin Triphenyl phosphine Not more than 0.01 % oxide (TPPO) Heavy metals Not more than 20 mg/kg (as Pb) Not more than 2 mg/kg Category Food additives category (8) 9
Functional uses Nutritional Additive 10
11. Seasoning Agents 11008 Citric Acid;Citric Acid, Anhydrous Chemical name Synonyms Chemical formula Formula weight Structural formula 2-hydroxy-1,2,3-propanetricarboxylic acid INS No. 330;CAS No. 77-92-9 (anhydrous);cas No. 5949-29-1 (monohydrate) C 6 H 8 O 7 (anhydrous) C 6 H 8 O 7 H 2 O (monohydrate) 192.13 (anhydrous) 210.14 (monohydrate) 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 Heat 1.0 g of sample with 10 ml of 98 % sulfuric acid in a substances 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). 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 Synonyms 6-O-alpha-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and 1-O-alpha-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM) Hydrogenated isomaltulose;ins No. 953;CAS No. 64519-82-0 Chemical formula 6-O-alpha-D-Glucopyranosyl-D-sorbitol: C 12 H 24 O 11 1-O-alpha-D-Glucopyranosyl-D-mannitol dihydrate: C 12 H 24 O 11 2H 2 O 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 Description Solubility Thin layer 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 Odourless, white, crystalline slightly hygroscopic substance Soluble in water, very slightly soluble in ethanol Passes test 12
chromatography 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 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 13