1 The Draft  Amendment of Standard s for Specification, Scope , Application 
and Limitation  of Food Additive s 
   MOHW  Food No.1071303341 , 25 March , 2019  
Appendix 2: Standards for Specification of Food Additives  
07. Food quality improvement, fermentation and food processing agents  
13. Coagulating Agents  
§ 07026  
§ 13008  
Potassium Dihydrogen Phosphate  
Synonyms  Monobasic potassium phosphate, monopotassium 
monophosphate potassium acid phosphate, potassium 
biphosphate; INS No. 340(i)  
Definition   
Chemical names  Potassium dihydrogenphosphate, monopotassium 
dihydrogenorthophosphate, 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  2 orthophosphate  TS. A yellow precip itate is obtained.  
Purity   
Loss on drying  Not more than 2% (105oC , 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  
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  
 3 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 - 96oC 
Infrared absorption  The infrared spectrum of a potassium bromide dispersion of 
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 . 
 
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  4 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. 
Commercial lycopene preparations intended for use in food 
are formulated as suspensions i n edible oils or 
water -dispersible powders and are stabilised with 
antioxidants.  
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 colour of the solution of the sample in acetone 
disappears after successive additions of a 5% solution of 
sodium nitrate and 1N sulfuric acid  
 5 Solution in 
chloroform  A 1% solution is clear a nd has intensive red -orange colour  
Spectrophotometry  A solution in hexane shows an absorption maximum at 
approximately 470 nm  
Loss on drying  Not more than 0.5% (40°, 4 h at 10 mm Hg)  
Lead  Not more than 1 mg/kg  
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 additives ; Colors . 
 
08. Nutritional additives  
09. Colors  
§ 08322 
§ 090 40 
Lycopene from Blakeslea trispora  
Synonyms  INS 160d( iii) 
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. Commercial lycopene preparations intended 
for use in food are formulated either as suspensions in 
edible oils  or as water -dispersible powders and are 
stabilised with antioxidants.  
Chemical names  Ψ,Ψ-carotene   6 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 95% total lycopenes; not less than 90% 
all-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 nitrite 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  
Other carotenoids  Not more than 5%  
Loss on drying  Not more than 0.5% (40°, 4 h at 10 mm Hg)  
Lead  Not m ore than 1 mg/kg  
Residual solvents  Isopropanol: Not more than 0.1%  
 7 Isobutyl acetate: Not more than 1.0%  
Category  Food additives category (08) (09) 
Functional uses  Nutritional additives ; Colors . 
 
11. Seasoning Agents  
§ 11059  
L-Theanine  
 
 
 
 
Chemical formula  C7H14N2O3 
Formula weight  174.2  
Chemical names  (2S)-2-Amino -4-(N-ethylcarbamoyl)butanoic acid  
C.A.S. number  3081 -61-6 
1. Content  L-Theanine, when calculated on the dried basis,  
contains 98.0  - 102.0% of L -theanine (C 7H14N2O3). 
2. Description  L-Theanine occurs as a white crystalline powder.  It 
is odorless and has a slightly characteristic and 
sweet  taste.  
3. Identification  (1) To 5 ml of a solution of L -Theanine (1 in 
1,000), add 1  ml of ninhydrin solution (1 in 1,000), 
and heat for 3 minutes.  A purple color develops.  
(2) Dissolve about 1 g of L -Theanine in 10 ml of 
diluted  hydrochloric acid (1 in 2), heat on a water 
bath under a reflux  condenser for 6 hours, and add 
water to make 20 ml.  Transfer 5 ml of this solution 
into a test tube, and add 2 g of sodium hydroxide. 
Suspend a red litmus paper moistened  with water in 
the test tube, cover the mouth of the test tube,  and 
heat in a water bath for 5 minutes. The litmus paper  
turns blue.  
4. Specific rotation  [α]20
D=+7.7 ~ +8.5 °(2.5 g, water, 50 ml, o n the 
 8 dried basis ). 
5. Clarity and color of 
solution  Colorless and almost  clear (1.0 g, water 20 ml).  
6. pH 5.0 - 6.0 (1.0 g, water 100 ml).  
7. Chloride  Not more than 0.021% as Cl (0.50 g, Control  
solution 0.01 mol/L hydrochloric acid 0.30 ml).  
8. Lead  Not more than  2 mg/kg.  
9. Arsenic  Not more than  4 mg/kg (as As2O3). 
10. Loss on Drying  Not more than 0.50% (105°C, 3 hours).  
11. Residue on Ignition  Not more than 0.20%.  
12. Category  Food additives category ( 11) 
13. Functional uses  Seasoning Agents