1 The Amendment of Standard s for Specification, Scope , Application and  
Limitation  of Food Additive s 
   MOHW  Food No.10 9130 2006 , 29 09, 2020 
Appendix 2: Standards for Specification of Food  Additives  
03. Antioxidants  
07. Food quality improvement, fermentation and food processing agents  
10. Flavoring Agents  
§ 03012  
§ 07047  
§ 10090  
L-Cysteine Monohydrochloride  
Chemical names  L-2-Amino -3-mercaptopropanoic Acid Monohydrochloride  
C.A.S. number  Monohydrate: 7048 -04-6 
Anhydrous:  52-89-1 
Chemical formula  Monohydrate: C3H7NO 2S‧HCl‧H 2O 
Anhydrous:  C3H7NO 2S‧HCl  
Structural formula   
Formula weight  Monohydrate: 175.63  
Anhydrous: 157.62  
Assay  98.0% - 101.5% C3H7NO 2S‧HCl, on the dried basis  
Description  White, crystalline powder. It is freely soluble in water and 
in alcohol. The anhydrous form melts with decomposition 
at about 175 ℃. 
Identification  The spectrum of the sample exhibits maxima at the same 
wavelengths as those in the spectrum of the Reference 
standard.  
Lead  Not more than 5 mg/kg  
 2 Loss on drying  8.0%~ 12.0%   
Room temperature for 24 h in a vacuum desiccator using a 
suitable desiccant and maintaining a pressure of not more 
than 5 mmHg  
Specific rotation  [α] D20=+5.0° ~ +8.0° , calculated on the dried basis  
[α] D25=+4.9° ~ +7.9°, calculated on the dried basis  
Residue  on ignition  Not more than  0.1%  
Category  Food additives category (03) (07 ) (10) 
Functional uses  Antioxidants ; Food quality improvement, fermentation and 
food processing agents ; Flavoring Agents . 
 
07. Food quality improvement, fermentation and food processing agents  
08. Nutritional additives  
§ 07022  
§ 08064  
Magnesium Sulfate  
Synonyms  Epsom salt (heptahydrate) ；INS No. 518  
Definition  Magnesium sulfate occurs naturally in sea water, mineral 
springs and  in minerals such as kieserite and epsomite. It is 
recovered from them  or by reacting sulfuric acid and 
magnesium oxide. It is produced with  one or seven 
molecules of water of hydration or in a dried form  
containi ng the equivalent of between 2 and 3 waters of 
hydration.  
Chemical names  Magnesium sulfate  
C.A.S. number  Monohydrate: 14168 -73-1 
Heptahydrate: 10034 -99-8 
Dried: 152 44-36-7 
Chemical formula  Monohydrate: MgSO 4·H2O  3 Heptahydrate: MgSO 4·7H 2O 
Dried: Mg SO 4·xH 2O, where x is the a verage hydration 
value (between  2 and 3)  
Formula weight  Monohydrate: 138.38  
Heptahydrate: 246.47  
Assay  Not less than 99.0 % and not more than 100.5% on the 
ignited basis  
Description  Colourless crystals, granular crystalline powder or white 
powder.  Crystals effloresce in warm, dry air.  
Characteristics   
Identification   
Solubility  Freely soluble in water, very soluble in boiling water, and 
sparingly  soluble in ethanol.  
Test for 
magnesium  Passes test  
Test for sulfate  Passes test  
Purity   
Loss on ignition  Monohydrate: between 13.0 and 16. 0 %, 
Heptahydrate: between 40.0  and 52.0 %,  
Dried: bet ween 22.0 and 32.0 %  
(105℃, 2 h, then 400 ℃ to constant weight)  
pH Between 5.5 and 7.5 (1 in 20 solution)  
Chloride  Not more than 0.03% 
Arsenic  Not more than 3 mg/kg  
Iron Not more than 20 mg/kg  
Selenium  Not more than 30 mg/kg  
Lead  Not more than 2 mg/kg  
Category  Food additives category ( 07) (08) 
Functional uses  Food quality improvement, fermentation and food  4 processing agents ; Nutritional additives . 
 
07. Food quality improvement, fermentation and food processing agents  
08. Nutritional additives  
13. Coagulating Agents  
§ 07026  
§ 08284  
§ 13008  
Potassium Dihydrogen  Phosphate  
Synonyms  Monobasic potassium phosphate, monopotassium 
monophosphate potassium acid phosphate, potassium 
biphosphate; INS No. 340(i)  
Definition   
Chemical names  Potassium dihydrogenphos phate, monopotassium 
dihydrogen orthophosphate, monopotassium dihydrogen 
monophosphate  
C.A.S. number  7778 -77-0 
Chemical formula  KH 2PO 4 
Formula weight  136.09 
Assay  Not less than 98.0% after drying  
Description  Odourless, colourless crystals or white granular or 
crystalline powder  
Characteristics   
Identification   
Solubility  Freely soluble in water; insoluble in ethanol  
pH 4.2 - 4.7 (1 in 100 soln)  
Test for potassium  Passes test  
Test for phosphate  Passes test  
Test for To 5 ml of a 1 in 100 soln of the sample, add silver nitrate  5 orthophosphate  TS. A yellow precipitate is obtained.  
Purity   
Loss on drying  Not more than 2% (105 ℃, 4 h)  
Water insoluble 
substances  Not more than 0.2 % 
Fluoride  Not more than 10 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 4 mg/kg  
Category  Food additives category ( 7) (8) (13) 
Functional uses  Food quality improvement, fermentation  and food 
processing agents ; Nutritional additives ; Coagulating 
Agents . 
 
07. Food quality improvement, fermentation and food processing agents  
13. Coagulating Agents  
§ 070 33 
§ 13015  
Trisodium  Phosphate  
Synonyms  Tribasic sodium phosphate, sodium phosphate;  INS No. 
339(iii)  
Definition   
Chemical names  Trisodium orthophosphate, trisodium phosphate, trisodium 
monophosphate  
C.A.S. number  7601 -54-9 
Chemical formula  Anhydrous: Na 3PO 4 
Hydrated: Na 3PO 4 · xH 2O 
Formula weight  Anhydrous: 163. 94 
Assay  Anhydrous, hemihydrate and monohydrate: Not less than 
97.0% calculated  on the dried basis   6 Dodecahydrate: Not less than 92.0% calculated on the 
ignited basis  
Description  White odourless crystals, granules or a crystalline powder; 
hydrated forms  available include hemi - and monohydrates, 
hexahydrate, octahydrate,  decahydrate and dodecahydrate; 
the dodecahydrate contains 1/4 mol of  sodium hydroxide.  
Characteristics   
Identification   
Solubility  Freely soluble in water; insoluble in ethanol  
pH 11.5 - 12.5 (1 in 100 soln)  
Test for sodium  Passes test . 
Test for phosphate  To 5 ml of a 1 in 100 solution of the sample add 1 ml of 
concentrated nit ric acid and 5 ml of ammonium molybdate 
TS and warm. A bright canary -yellow  precipitate is 
obtained.  
Test for 
orthophosphate  Dissolve 0.1 g of the sample in 10 ml water, acid ify slightly 
with dilute acetic  acid TS, and add 1 ml of silver nitrate TS. 
A yellow precipitate is formed.  
Purity   
Loss on ignition  Anhydrous: Not more than 2% (120 ℃, 2 h, then 800 ℃, 30 
min)  
Monohydrate: Not more than 11% (120 ℃, 2 h, then 800 ℃, 
30 min)  
Dodecahydrate: 45 -58% (120 ℃, 2 h, then 800 ℃, 30 min)  
Water insoluble 
substances  Not more than 0.2%  
Fluoride  Not more than 50 mg/kg  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 4 mg/kg   7 Category  Food additives category ( 07) (13) 
Functional uses  Food quality improvement, fermentation and food 
processing agents ; Coagulating Agents . 
 
07. Food quality improvement, fermentation and food processing agents  
11-1. Sweeteners  
§ 07089  
§ 11-1-003 
Xylitol  
Synonyms  INS No. 967  
Definition   
Chemical names  Xylitol  
C.A.S. number  87-99-0 
Chemical formula  C5H12O5 
Structural formula   
Formula weight  152.15  
Assay  Not less than 98.5% and not more than 101.0% on the 
anhydrous basis  
Description  White, crystalline powder, practically odourless  
Characteristics   
Identification   
Solubility  Very soluble in water, sparingly soluble in ethanol  
Melting range  92 - 96℃  
Infrared absorption  The infrared spectrum of a potassium bromide dispersion of 
 8 the sample corresponds with the reference infrared 
spectrum below  
Purity   
Water  Not more than 0.5% (Karl Fischer Method)  
Sulfated ash  Not more than 0.1%  
Nickel  Not more than 2 mg/kg  
Reducing sugars  Not more than 0.2%  
Other polyols  Not more than 1.0%  
Lead  Not more than 1 mg/kg  
Category  Food additives category (7)(11-1) 
Functional uses  Food quality improvement, fermentation and food 
processing agents ; Sweeteners . 
 
07. Food quality improvement, fermentation and food processing agents  
11-1. Sweeteners  
§ 07092 
§ 11-1-018 
Maltitol Syrup  
Synonyms  Hydrogenated high maltose -content glucose syrup, 
hydrogenated glucose syrup, dried maltitol syrup, maltitol 
syrup powder; INS No. 965(ii)  
Definition  A mixture consisting of mainly maltitol with sorbitol and 
hydrogenated  oligo - and polysaccharides. It is 
manufactured by the catalytic  hydrogenation of high 
maltose -content glucose syrup. The article of  commerce is 
typically supplied as a syrup. It may also be dried and  
supplied as a solid product  
Assay  Not less than 99.0% of total hydrogenated saccharides on 
the anhydrous  basis and not less than 50.0% of mal titol on  9 the anhydrous basis  
 
Description  Colourless and odourless, clear viscous liquids or white 
crystalline masses  
Characteristics   
Identification   
Solubility  Very soluble in water, slightly soluble in ethanol  
Thin layer  
chromatography  Passes test  
Purity   
Water  Not more than 31% (Karl Fischer)  
Sulfated ash  Not mor e than 0.1 % 
Chloride  Not more than 50 mg/kg  
Sulfate  Not more than 100 mg/kg  
Nickel  Not more than 2 mg/kg  
Reducing sugars  Not more than 0.3%  
Lead  Not more than 1 mg/kg  
Category  Food additives category ( 07) (11-1) 
Functional uses  Food quality improvement, fermentation and food 
processing agents ; Sweeteners . 
 
08. Nutritional additives  
09. Colors  
§ 08139  
§ 09034  
Lycopene (Synthetic)  
Synonyms  INS 160d(i)  
Definition  Synthetic lycopene is produced by the Wittig condensation 
of synthetic intermediates commonly used in the production  10 of other  carotenoids used in food. Synthetic lycopene 
consists  predominantly of all -trans -lycopene together with 
5-cis-lycopene  and minor quantities of other isomers.  
Chemical names  ψ,ψ-carotene ; all-trans -lycopene ; (all-E)-lycopene ; (all-E)-
2,6,10,14,19,23,27,31 -octamethyl -2,6,8,10,12,14,16,18,20, 
22,24,26,30 -dotriacontatridecaene  
C.A.S. number  502-65-8 
Chemical formula  C40H56 
Structural formula   
Formula weight 536.9  
Assay  Not less than 96% total lycopenes; not less than 70% all -
trans -lycopene  
Description  Red crystalline powder  
Characteristics   
Identification   
Solubility  Insoluble in water, freely soluble in chloroform  
Test for 
carotenoids  The colo r of the solution of the sample in acetone 
disappears after  successive additions of a 5% solution of 
sodium nitri te and 1N  sulfuric  acid 
Solution in 
chloroform  A 1% solution is clear and h as intensive  red-orange colo r 
Spectrophotometry  A solution in hexane shows an absorption maximum at  
approximately 470 nm  
Purity   
Loss on drying  Not more than 0.5% (40 ℃, 4 h at 10 mm Hg) 
Lead  Not more than 1 mg/kg  
 11 Apo-12’-lycopenal  Not more than 0.15%  
Triphenyl 
phosphine oxide  
(TPPO)  Not more than 0.01%  
Category  Food additives category (08) (09 ) 
Functional uses  Nutritional additive ; Colors . 
 
08. Nutritional additives  
09. Colors  
§ 08322 
§ 09040 
Lycopen e from Blakeslea trispora  
Synonyms  INS 160d(i ii) 
Definition  Lycopene from Blakeslea trispora is extracted from the 
fungal  biomass and purified by crystallization and 
filtration. It consists  predominantly of all -trans -lycopene. It 
also contains minor quantities  of other carotenoids.  
Isopropanol and isobutyl acetate are the only  solvents used 
in the manufacture.  
Chemical names  ψ,ψ-carotene ; all-trans -lycopene; (all -E)-lycopene; (all -E)-
2,6,10,14,19,23,27,31 -octamethyl -2,6,8,10,12,14,16,18,20, 
22,24,26,30 -dotriacontatridecaene  
C.A.S. number  502-65-8 
Chemical formula  C40H56 
Structural formula   
Formula weight  536.9  
Assay  Not less than 9 5% total lycopenes; not less than 90% all -
 12 trans -lycopene  
Description  Red crystalline powder  
Characteristics   
Identification   
Solubility  Insoluble in water, freely soluble in chloroform  
Test for 
carotenoids  The colour of the solution of the sample in acetone 
disappears after  successive additions of a 5% solution of 
sodium nitr ite and 1N  sulfuric acid  
Solution  in 
chloroform  A 1% solution is clear and has intensive red -orange colour  
Spectrophotometry  A solution in hexane shows an absorption maximum at  
approximately 470 nm  
Purity   
Other carotenoids  Not more than 5%  
Loss on drying  Not more than 0.5% (40℃ , 4 h at 20 m mHg) 
Lead  Not more than 1 mg/kg  
Residual solvents  Isopropanol: Not more than 0.1%  
Isobutyl acetate: Not more than 1.0%  
Category  Food additives category (08) (09)  
Functional uses  Nutritional additive ; Colors . 
 
08. Nutritional additives  
09. Colors  
§ 08143 
§ 09014 
β-Carotene  
Synonyms  From Blakeslea trispora : CI Food Orange 5; INS No. 
160a(iii)  
Other source s: CI Fo od Orange 5; INS No. 160a(i); CI  13 (1975) No. 40800  
Definition  These specifications consist  predominantly of all -trans -β-
carotene and  may also  contain minor amounts of cis-
isomers and other carotenoids. Commercial  preparations of 
β-carotene intended for use in food are prepared from β - 
carotene meeting these specifications and are formulated as 
suspensions  in edible oils or water -disper sible powders. 
These preparations may have  different ratio of trans/cis 
isom ers. The colour is also obtain ed by a  fermentation 
process using the fungus Blakeslea trispora . 
 
Chemical names  From Blakeslea trispora : β-Carotene, β, β -carotene  
Other source s: β-Carotene, β, β -carotene  
1,1'-(3,7,12,16 -tetramethyl -1,3,5,7,9,11,13,15,17 -
octadecanonaene -1,18-diyl)bis[2,6,6 -trimethylcyclohexene]  
C.A.S. number  7235 -40-7 
Chemical formula  C40H56 
Structural formula  All-trans -β-carotene (main compound)  
 
Formula weight  536.88 
Assay  Not less than 96.0% of total colouring matter (expressed as 
β-carotene)  
Description  Red to brownish -red crystals or crystalline powder; 
sensitive to oxygen and  light and should therefore be kept 
in a light -resistant container under inert gas. 
Characteristics   
 14 Identification   
Solubility  Insoluble in water; practically insoluble in ethanol; slightly 
soluble in  vegetable oils.  
Test for 
carotenoids  The colour of a solution of the sam ple in acetone 
disappears after  successive additions of a 5% solution of 
sodium nitrite and 0.5 M sulfuric  acid.  
Spectrophotometry  From Blakeslea trispora : 
Determine the absorbance of the diluted sample solution 
used in the Method of Assay at 455 nm and 483 nm. The 
ratio is between 1.14 and 1.19.  
Determine the absorbance of the diluted sample solution 
used in the Method of Assay at 455 nm and 340 nm. The 
ratio is not lower than 0.75.  
Other source s: 
Determine the absorbance of the diluted sample solution 
used in the Method of Assay at 455 nm and 483  nm. The 
ratio A 455/A483 is between 1.14 and 1.19.  
Determine the absorbance of the diluted sample solution 
used in the Method of Assay at 455 nm and 340 nm. The 
ratio A 455/A340 is not lower than 15.  
 
Purity   
Sulfated ash  From Blakeslea trispora : Not more  than 0.2%  
Other sources : Not more than 0. 1% 
Subsidiary 
colouring matters  Carotenoids other than  β-carotene: Not more than  3% of 
total colouring  matters.  
Residual solvent  From Blakeslea trispora :  
Ethanol and Ethyl a cetate:  Not m ore than 0.8% singly or in 
combination   15 Isopr opanol:  Not m ore than 0.1%  
Isobutyl ace tate:  Not m ore than 1.0%  
Other sources :- 
Lead  Not more than 2 mg/kg  
Category  Food additives category (08) (09)  
Functional uses  Nutritional additive ; Colors . 
 
11. Seasoning Agents  
§ 11014  
Monosodium L -Glutamate  
Synonyms  Sodium glutamate, MSG, INS No. 621  
Definition   
Chemical names  Monosodium L -glutamate monohydrate, glutamic acid 
monosodium salt monohydrate  
C.A.S. number  142-47-2 
Chemical formula  C5H8NNaO 4 ·  H 2O 
Structural formula   
Formula weight  187.13  
Assay  Not less than 99.0% on the dried basis  
Description  White, practically odourless crystals or crystalline powder  
Characteristics   
Identification   
Solubility  Freely soluble in water; sparingly soluble in ethanol; 
practically insoluble in ether  
Test for glutamate  Passes test  
Test for sodium  Passes test  
 16 Purity   
Loss on drying  Not more than 0.5% (98℃, 5 h)  
pH 6.7 - 7.2 (1 in 20 soln)  
Specific rotation  [α]20 
D=+24.8～+25.3o (10%  (w/v) solution in 2N  
hydrochloric acid)  
Chlorides  Not more than 0.2%  
Pyrrolidone 
carboxylic acid  Passes test  
Lead  Not more than 1 mg/kg  
Category  Food additives category ( 11) 
Functional uses  Seasoning agent s. 
 
11. Seasoning Agents  
§ 11059 
 
L-Theanine  
Chemical formula: C 7H14N2O3  Molecular weigh t: 174.2  
Chemical names: (2S)-2-Amino -4-(N-ethylcarbamoyl)butanoic acid  
C.A.S. number : 3081 -61-6 
1. Assay  : Not less than 98.0% and not more than 102.0% on the dried 
basis  
2. Appearance  : White crystalline powder, odorless, with a slightly 
characteristic and sweet taste.  
3. Identification  : (1) To 5 mL of a solution of L -Theanine (1 in 1000), add 1 
mL of ninhydrin solution (1  in 1000), and heat for 3 minutes. 
A purple color develops.  
 (2) Dissolve about 1 g of L -Theanine in 10 mL of diluted 
 17 hydrochloric acid (1 in 2),  put in a water bath that is equipped 
with a reflux cooler for 6 hours, and add water to 20 mL. Put 
5 mL of the solution into a test tube and add 2 g of sodium 
hydroxide. Take another piece of red litmus paper to cover the 
mouth of the test tube after wetting it with water. After the 
tube is bathed for 5 minutes, the color of the litmus paper 
turns blue.  
4. Specific 
rotation  : 〔α〕20 
D=+7.7～+8.5 (Add 50 mL of water to 2.5 g of t he 
sample)  
5. Solution 
state : Dissolve 1 g of the sample in 20 mL of water. The solution 
should be colorless and almost clear.  
6. pH : 5.0～6.0 (1 in 100 soln)  
7. Chloride  : Not more than 0.021 % (as Cl). 
8. Lead  : Not more than 2 ppm . 
9. Arsenic  : Not more than 3 ppm (as As 2O3). 
10. Loss on 
drying  : Dry it at 105°C for 3 hours: it loses not more than 0.5% of its 
weight.  
11. Residue on 
ignition  : Not more tha n 0.2% . 
12. Category  : Food Additives Category (11) 
13. Uses  : Seasoning Agents.  
11-1. Sweeteners  
§ 11-1-012 
Steviol glycosides from Stevia rebaudiana  Bertoni  
Synonyms  INS No. 960  
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 orientatio ns occurring in the  18 leaves of 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 sp ray-dried.  
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 
glycosi des. 
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 95% of total of steviol glycosides, on the 
dried basis, determined as the sum of all compounds 
containing a steviol backbone conjugated to any number, 
combination or orientation of saccharides (glucose, 
rhamnose, fructose, deoxyglucose xylose , galactose, 
arabinose and xylose) occurring in the leaves of Stevia 
 19 rebaudiana  Bertoni.  
Description  White to light yellow powder, odourless or having a slight 
characteristic odour. About 200 - 300 times sweeter than 
sucrose.  
Characteristics   
Identification   
Solubility  Freely soluble in a mixture of ethanol and water (50:50)  
HPLC 
chromatographic 
profile  Correspond to steviol glycoside  standard s 
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/k g ethanol  
Arsenic  Not more than 1 mg/kg  
Lead  Not more than 1 mg/kg  
Microbiological 
criteria  Total (aerobic) plate c ount: Not more than 1,000 CFU/g  
Yeasts and moulds: Not more than 200 C FU/g  
E. coli : Negative in 1 g  
Salmonella : Negative in 25 g  
Category  Food additives category ( 11-1) 
Functional uses  Sweeteners . 
  20 Appendix 1:  
 
 
 
 21  
 
 
 
 22  
 23  
 
 
 
 
 24  
 
 
 25  
 26  
 
 27  
 
 
 28  
 
 
 
 29  
 30 12. Pasting Agent  
§ 12012  
Carrageenan  
Synonyms  Irish moss gelose (from Chondrus spp.); Eucheuman (from 
Eucheuma  spp.); Iridophycan (from Iridaea spp.); Hypnean 
(from Hypnea spp.);  Furcellaran or Danish agar (from 
Furcellaria fastigiata ); INS No. 407.  
Definition  A substance with hydrocolloid properties obtained from 
certain members  of the class Rhodophyceae (red seaweeds).  
The principal commercial sources of carrageenans are the 
following  families and genera of the class of 
Rhodophyceae : 
Furcellariacaea such as Furcellaria  
Gigartinaceae such as Chondrus , Gigartina , Iridaea  
Hypnaeceae such as Hypnea  
Phyllophoraceae such as Phyllophora , Gynmogongrus , 
Ahnfeltia  
Solieriaceae such as Eucheuma , Anatheca , Meristotheca . 
Carrageenan is a hydrocol loid consisting mainly of the 
ammonium,  calcium, magnesium, potassium and sodium 
sulfate esters of galactose  and 3,  6-anhydrogalactose 
polysaccharides. These hexoses are alternately  linked α-1,3 
and β-1,4 in the copolymer. The relative proportions of 
catio ns existing in carrageenan may be changed during 
processing to the extent  that one may become predominant.  
The prevalent polysaccharides in carrageenan are 
designated as kappa -, iota-, and lambda -carrageenan. 
Kappa -carrageenan is mostly the  alternating polymer of D -
galactose -4-sulfate and 3,  6-anhydro -D-galactose;  iota- 31 carrageenan is similar, except that the 3,6 -anhydrogalactose 
is sulfated at carbon 2. Between kappa -carrageenan and 
iota-carrageenan  there is a continuum of intermediate 
compositions diffe ring in degree of  sulfation at carbon 2. In 
lambda -carrageenan, the alternating monomeric  units are 
mostly D -galactose -2-sulfate (1,3 -linked) and D -galactose -
2,6- disulfate (1,4 -linked).  
Carrageenan is obtained by extraction from seaweed into 
water or  aque ous dilute alkali. Carrageenan may be 
recovered by alcohol  precipitation, by drum drying, or by 
precipitation in aqueous potassium  chloride and subsequent 
freezing. The alcohols used during recovery and  
purification are restricted to methanol, ethanol, and  
isopropanol.  Articles of commerce may include sugars for 
standardization purposes,  salts to obtain specific gelling or 
thickening characteristics, or emulsifiers  carried over from 
drum drying processes.  
C.A.S. number  9000 -07-1 
Description  Yellowish or t an to white, coarse to fine powder that is 
practically  odourless.  
Characteristics   
Identification   
Solubility  Insoluble in ethanol; soluble in water at a temperature of 
about 80℃,  forming a viscous clear or slightly opalescent 
solution that flows readily;  disperses in water more readily 
if first moistened with alcohol, glycerol, or  a saturated 
solution of glucose or sucrose in water.  
Test for sulfate  Dissolve a 100 -mg sample in 20 ml of water (with heating 
if necessary),  and add 3 ml of barium chl oride TS and 5 ml  32 of hydrochloric acid, dilute  TS; filter if a precipitate forms. 
Boil the solution or the filtrate for 5 min. A  white, 
crystalline precipitate appears.  
Test for galactose 
and 
anhydrogalactose  Galactose and  3, 6-anhydrogalactose should be present.  
Identification of  
hydrocolloid and  
predominant type 
of copolymer  Add 4 g of sample to 200 ml of water, and h eat the mixture 
in a water bath  at 80 ℃, with constant stirring, until 
dissolved. Replace any water lost by  evaporation, and allow 
the solu tion to cool to room temperature. It  becomes 
viscous and may form a gel. To 50 ml of the solution or gel 
add 200 mg of potassium chloride, then reheat, mix well, 
and cool. A short  textured  ("brittle") gel indicates a 
carrageenan of a predominantly kappa  type, and a 
compliant ("elastic") gel indicates a predominantly iota 
type. If  the solution does not gel, the carrageenan is of a 
predominantly lambda  type.  
Infrared absorption  Passes test  
Purity   
Loss on drying  Not more than 12% (105 ℃ to constant weight)  
pH Between 8 and 11 (1 in 100 suspension)  
Viscosity  Not less than 5 cp at 75 ℃ (1.5% solution)  
Sulfate  Not less than 15% and not more than 40% (as SO 42-) on the 
dried basis  
Total ash  Not less than 15% and not more than 40% on the dried 
basis  
Acid -insoluble ash  Not more than 1%  
Acid -insoluble 
matter  Not more than 2%   33 Residual solvents  Not more than 0.1% of ethanol, isopropanol, or methanol, 
singly or in  combination  
Microbiological 
criteria  Initially prepare a 10-1 dilution by adding a 50 -g sample to 
450 ml of  Butterfield’s phosphate -buffered dilution water 
and homogenising the  mixture in a high -speed blender.  
Total (aerobic) plate count: Not more than 5000 cfu/g  
Salmonella  spp.: Negative per test  
E. coli : Negativ e in 1 g  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 5 mg/kg  
Cadmium  Not more than 2 mg/kg  
Mercury  Not more than 1 mg/kg  
Category  Food additives category (12) 
Functional uses  Pasting Agent .  34 17. Others  
§ 17015 
Quillaia Extracts  
Synonyms  Quillaja extract, Soapbark extract, Quillay bark extract, 
Bois de Panama, Panama bark extract, Quillai extract; INS 
No. 999  
Definition  Quillaia extract is obtained by aqueous extraction (Type 1) 
or either by chromatographic separation or ultrafiltration of 
the aqueous extraction (Type 2) of the milled inner  bark or 
of the wood of pruned stems and branches of Quillaja 
saponaria Molina  (family Rosaceae ). It contains 
triterpenoid saponins (quillaia sapo nins, QS)  consisting 
predominantly of glycosides of quillaic acid. Polyphenols 
and tannins are major components and some sugars and 
calcium oxalate will be  present.  
Quillaia extract  is available commercially as liquid product 
or as  spray -dried powder that may contain carriers such as 
lactose, maltitol or  maltodextrin. The liquid product is 
usually preserved with sodium benzoate or  ethanol.  
C.A.S. number  68990 -67-0 
Formula weight  Monomeric saponins range from ca. 1800  to ca. 2300, 
consistent with a  triterp ene with 8 -10 monosaccharide 
residues  
Assay  Saponin content:  
Type 1:  not less than 20% and not more than 26 % on the 
dried  basis  
Type 2: not less than 65% and not more than 90 % on the 
dried basis  
Description  Type 1: Red-brownish liquid or light brown powder with a  35 pink tinge  
Type 2: Light red -brownish liquid or powder  
Characteristics   
Identification   
Solubility  Very soluble in water, insoluble in ethanol, acetone, 
methanol and butanol  
Foam  Dissolve 0.5 g of powder extract in 9.5 g of water  or 1 ml 
of liquid extract in 9  ml of water. Add 1 ml of this mixture  
to 350 ml of water in a 1000 -ml graduated cylinder. Cover 
the cylinder, vigorously shake it 30 times, and  allow 
settling. Record th e foa m level (ml) after 30 min.  Typical 
values : 
Type 1: 150 ml. 
Type 2: 260 ml.  
Chromatography  The retention time of major peak of  the sample corresponds 
to the major saponin peak (QS -18) of the standard.  
Colour and 
turbidity  Powder form only: Dissolve 0.5 g in 9.5 g o f water. The 
solution is not turbid.  Determine the absorbance of the 
solution against water at 520 nm.  
Type 1: The absorbance is less than 1.2.  
Type 1: The absorbance is less than 0.7. 
Purity   
Water  Powder form: not more than 6% (Karl Fischer Method)  
Loss on drying  Liquid form: (2 g, 105 ℃, 5 h)  
Type 1: 50 to 80%  
Type 2: 50 to 9 0% 
pH 3.7 -5.5 (4 % solution)  
Ash Type 1: Not more than 14% on a dried basis  
Type 2: Not more than 5% on a dried basis   36 Use 1.0 g for powder samples; for liquid  samples, use the 
residue from loss on drying.  
Tannins  Not more than 8% on a dried basis  
Lead  Not more than 2 mg/kg.  
Category  Food additives category (17) 
Functional uses  Other s.