1 The Draft  Amendment of Standard s for Specification, Scope , Application 
and Limitation  of Food Additive s 
   MOHW  Food No.1081300200 , 31 July, 2019  
Appendix 2: Standards for Specification  of Food Additives  
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 orientations occurring in the 
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 spray -dried.  
Chemical names  See Appendix 1  
C.A.S. number  See Appendix 1  
Chemical formula  See Appendix 1  
Structural formula   
 
 
 
 2 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 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 (gluc ose, rhamnose, fructose, 
deoxyglucose xylose, galactose, arabinose and xylose) 
occurring in the leaves of Stevia 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  The main peaks in a chromatogram obtained by analysing a 
sample correspond to steviol glycosides  
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 Total (aerobic) plate count: Not more than 1,000 CFU/g   3 criteria  Yeasts and moulds: Not more than 200 CFCU/g  
E. coli: Negative in 1 g  
Salmonella: Negative in 25 g  
Category  Food additives category (11-1) 
Functional uses  Sweeteners . 
Appendix 1  
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12  
  
 13 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  
Purity   
Loss on drying  Not more than 0.5% (98o , 5 h)  
pH 6.7 - 7.2 (1 in 20 soln)  
Specific rotation  [alpha] 20, D: : Between +24.8 and +25.3o (10% (w/v) 
solution in 2N hydrochloric acid)  
Chlorides  Not more than 0.2%  
Pyrrolidone Passes test  
 14 carboxylic acid  
Lead  Not more than 1 mg/kg  
Category  Food additives category  (11) 
Functional uses  Seasoning Agents  
 
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 hydrocolloid 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 o f 
cations existing in carrageenan may be changed during  15 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 alternat ing polymer of 
D-galactose -4-sulfate and 3,6 -anhydro -D-galactose; 
iota-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 di ffering 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 a queous 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  Red crystal line powder  
Characteristics  Yellowish or tan to white, coarse to fine powder that is 
practically odourless.  
Identification   
Solubility  Insoluble in ethanol; soluble in water at a temperature of  16 about 80o , 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 chloride TS and 5 ml 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 galacto se 
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 heat the mixture 
in a water bath at 80o , with constant stirring, unti l 
dissolved. Replace any water lost by evaporation, and allow 
the solution 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 shorttexture d ("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% (105o to constant weight)  
pH Between 8 and 11 (1 in 100 suspension)  
Sulfate  Not less than 15% and not more than 40% (as SO 42- ) on the 
dried basis   17 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%  
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 : Negative 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 . 
 
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  18 by the catalytic hydrogenation of high maltose -content 
glucose syrup. The article of commerce is typically supplied 
as a syrup. It may als o 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 maltitol on 
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 more 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 . 
 
07. Food quality improvement, fermentation and food processing agents  
13. Coagulating Agents  
§ 07033   19 § 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  
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, octahydra te, 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  To 5 ml of a 1 in 20 solution of the sample add 1 ml of 
acetic acid TS and 1 ml of uranyl zinc acetate TS. A yellow 
crystalline precipitate is formed within a few min.  
Test for phosphate  To 5 ml of a 1 in 100 solution of the sample add 1 ml of 
concentrated nitric acid and 5 ml of ammonium molybdate 
TS and warm. A bright canary -yellow precipitate is  20 obtained.  
Test for 
orthophosphate  Dissolve 0.1 g of the sample in 10 ml water, acidify slig htly 
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% (120o , 2 h, then 800o , 30 
min)  
Monohydrate: Not more than 11% (120o , 2 h, then 800o , 
30 min)  
Dode cahydrate: 45 -58% (120o , 2 h, then 800o , 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  
Category  Food additives category (07) (13) 
Functional uses  Food quality improvement, fermentation and food 
processing agents ; Coagulating Agents . 
 
03. Antioxidants  
§ 03012  
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   21 Structural formula   
Formula weight  Monohydrate: 175.63  
Anhydrous:  157.62  
Assay  98.0%  - 101.5% C 3H7NO 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 175o. 
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  
Loss on drying  8 ~ 12%  
Room temperature for 24 h in a vacuum desiccator using a 
suitable desiccant and maintaining a pressure of 5 mm Hg  
Optical ( specific) 
rotation  [α]D20 between +5.0° and +8.0°, calculated on the dried 
basis  
[α]D25 between +4.9°  and +7.9°, calculated on the dried 
basis  
Residue on ignition  Not more than 0.1%  
Category  Food additives category (03) (07) 
Functional uses  Antioxidants ; Food quality improvement, fermentation and 
food processing agents . 
 
08. Nutritional additives  
09. Colors  
§ 09014  
β-Carotene  
 22 Synonyms  CI Food Orange 5; INS No. 160a; CI (1975) No. 40800  
Definition  These specifications apply to synthetic β -carotene which 
consists predominantly of all -trans -β-carotene. Synthetic 
β-carotene may also contain minor amounts of cis-isomers 
and other carotenoids such as all -trans -retinal, 
β-apo-12’-carotenal, and β -apo-10’-carotenal. Commercial 
preparations of β -carotene intended for use in food are 
prepared from βcarotene meeting these specifications and 
are formulated as suspensions in edible oils or 
water -dispersible powders. These preparations may have 
different ratio of trans/cis isomers.  
Chemical names  ß-Carotene, ß,ß -carotene 
1,1'-(3,7,12,16 -tetramethyl -1,3,5,7,9,11,13,15,17 -octadecan
onaene -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% total colouring matters, expressed as 
ß-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   
Identification   
 23 Solubility  Insoluble in water; practically insoluble in ethanol; slightly 
soluble in vegetable oils.  
Test for carotenoids  The colour  of a solution of the sample 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:  
Determine the absorbance of the di luted 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 source: Not more than 0.1%  
Subsidiary 
colouring matters  Carotenoids other than ß -carotene: Not more than 3 .0% of 
total colouring matters.  
Residual solvent  From Blakeslea trispora : 
Ethanol and Ethyl acetate: Not more than 0.8% singly or in 
combination  
Isopropanol: Not more than 0.1%  
Isobutyl acetate: Not more than 1.0%   24 Other source: - 
Lead  Not more than 2 mg/kg  
Category  Food additives category  (08) (09) 
Functional uses  Nutritional additives ; Colors . 
 
07. Food quality improvement, fermentation and food processing agents  
08. Nutritional additives  
§ 07022 
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 
containing 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: 15244 -36-7 
Chemical formula  Monohydrate: MgSO 4·H2O 
Heptahydrate: Mg SO 4·7H 2O 
Dried: MgSO 4.xH 2O, where x is the average 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   25 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  Passe s 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: between 22.0 and 32.0 % 
(105°, 2h, 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 
processing agents ; Nutritional additives . 
 
17. Food quality improvement, fermentation and food processing agents  
§ 17015  
Quillaia Extract  
Synonyms  Quillaja extract, Soapbark extract, Quillay bark extract, 
Bois de Panama, Panama bark extract, Quillai  extract; INS 
No. 999  
Definition  Quillaia extract (Type 1) is obtained by aqueous extraction  26 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 saponins, 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 
(Type 1) 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.  
Quillaia extract (Type 2) is obtained either by 
chromatographic separation or ultrafiltration of the aqueo us 
extraction 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 
saponins, QS) consisting predominantly of glycosides of 
quillaic acid. Polyphenol s and tannins are minor 
components. Some sugars and calcium oxalate will also be 
present. Quillaia extract (Type 2) is available commercially 
as a liquid product or as a 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 triterpene with 8 -10 monosaccharide 
residues  
Assay  Saponin content:  
Type 1: not less than 20 % and not more than 26 % on the  27 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 
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  Type 1 : 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 the foam level (ml) after 30 min. Typical 
values are 150 ml of foam  
Type 2 : Dissolve 0.5 g of the powder form in 9.5 ml  of 
water or 1 ml of the liquid form in 9 ml of water. Add 1 ml 
of this solution to 350 ml of water in a 1000 -ml graduated 
cylinder. Cover the cylinder, vigorously shake it 30 times, 
and allow settling. Record the foam volume (ml) after 30 
min. Typical vol umes are about 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  Type 1 : Powder form only: Dissolve 0.5 g in 9.5 g of water. 
The solution is not turbid. Determine the absorbance of the 
solution against water at 520 nm. The absorbance is less 
than 1.2.  
Type 2 : Powder form only: Dissolve 0.5 g in 9.5 ml of  28 water. The solution shall not be turbid. Determine the 
absorbance of the solution against water  at 520 nm. The 
absorbance shall be less than 0.7.  
PURITY   
Water  Powder form: not more than 6% (Karl Fischer Method)  
Loss on drying  Type 1 : Liquid form: 50 to 80% (2 g, 105°, 5 h)  
Type 2 : Liquid form: 50 to 90% (2 g, 105°, 5 h)  
pH 3.7 -5.5 (4 % solution)  
Ash Type 1 : Not more than 14% on a dried basis (use 1.0 g for 
powder samples; for liquid samples, use the residue from 
loss on drying)  
Type 2 : Not more than 5% on a dried basis (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  Others .