Amendment to the Enforcement Ordinance of the Food Sanitation Law and the 
Standards and Specifications fo r Foods and Food Additives.  
 
The government of Japan will designate Canthaxanthin as an authorized food 
additive. 
 Summary 
Under Article 10 of the Food Sanitation Law (hereinafter referred to as the “Law”), 
food additives shall not be used or marketed  without authorization by the Minister of 
Health, Labour and Welfare (hereinafter referred to as “the Minister”). In addition, when 
specifications or standards are established for f ood additives based on Article 11 of the Law and 
stipulated in the Ministry of Health, Labour a nd Welfare Notification (Ministry of Health and 
Welfare Notification No. 370, 1959), those additiv es shall not be used or marketed unless they 
meet the standards or specifications. 
 
In response to a request from the Minister, the Committee on Food Additives of the 
Food Sanitation Council that is establishe d under the Pharmaceutical Affairs and Food 
Sanitation Council has discussed the adequacy of the designation of Canthaxanthin as a 
food additive. The conclusion of the committee is outlined below.  Outline of conclusion  
The Minister, based on Article 10 of the Law, should designate Canthaxanthin, as a 
food additive unlikely to harm human health, and establish standards for use and compositional specifications, based on Ar ticle 11 of the Law (see Attachment). 
    Attachment 
Canthaxanthin 
カンタキサンチン  
 
 
Standards for use 
Only permitted for use in fish pastes products ( kamaboko  only) up to 0.035 g per kg of 
each product.  
Compositional specifications 
Substance name  Canthaxanthin 
Molecular formula  C40H52O2 
Molecular weight  564.84 
Chemical name [CAS number]    ,-Carotene-4,4'-dione  ［514－78－3］ 
Content  Canthaxanthin contains not less than 96.0% of canthaxanthin (C 40H52O2). 
Description   Canthaxanthin occurs as dark-pur ple crystals or crystalline powder.  
Identification  (1) A solution of Canthaxanthin in acetone (1 in 25,000) develops an 
orange color.  To 5 ml of this solution, add 1 ml of sodium nitrite solution (1 in 20) and 1 ml of 0.5 mol/L sulfuric acid. The so lution is immediately decolored.  
(2) A solution of Canthaxanthin in cyclohex ane (1 in 400,000) exhibits an absorption 
maximum at a wavelength of 470 nm.  
Purity  
(1) Lead  Not more than 2.0 g/g as Pb. 
Test Solution   Weigh 2.0 g of Canthaxanthin in a platinum, quartz, or porcelain 
crucible or a quartz beaker. Heat gradually, an d stop heating before the sample starts to 
carbonize. Add 1 ml of sulfuric acid, and heat by increasing the temperature gradually 
until the sample is carbonized and white fumes are no longer evolved. If necessary, add sulfuric acid again, and heat until the sa mple is almost carbonized. Loosely lid the crucible if necessary, heat in an electric fu rnace by increasing the temperature gradually, 
and incinerate at 450–600 C. If any carbonized matter still remains, crush the residue 
with a glass rod, moisten with 1 ml of diluted sulf uric acid (1 in 4) and 1 ml of nitric acid, 
and heat until white fumes are no longer evolve d. Then, ignite in th e electric furnace to 
complete incineration. To the residue, add 10 ml of diluted sulfuric acid (1 in 4), and 
evaporate on a water bath to dryness. To th e residue, add a small amount of diluted 
nitric acid (1 in 100), and di ssolve it while heating. After co oling, add diluted nitric acid 
(1 in 100) again to make exactly 10 ml. When incineration is done at 500 C or below, a 
heat-resistant glass beaker can be used.    
Control Solution  Add water to exactly measured 1 ml of Lead Standard Stock 
Solution to make exactly 100 ml. To exactly me asured 4 ml of this solution, add diluted 
nitric acid (1 in 100) to make exactly 10 ml. 
Procedure   Proceed as directed under Method 1 in the Lead Limit Test.     
(2) Arsenic  Not more than 4.0 g/g as As 2O3 (0.50 g, Method 3, Apparatus B).  
(3) Subsidiary Colors  Not more than 5%.  
Test Solution  Weigh 0.020 g of Canthaxanthin, and dissolve in 25 ml of 
dichloromethane.  
Procedure  Perform thin-layer chromatography. Use a thin-layer plate coated with 
silica gel for thin-layer chro matography and dried at 110 C for 1 hour. Apply 400 l of 
the test solution in an about 3 mm-wide strip on the original line on the thin-layer plate. 
Develop using a 95:5 mixture of dichloromethane and diethyl ether as the developing solvent and using no control solution.  St op the development when the solvent front 
has ascended to a point about 15 cm above the original line, and air-dry the plate. Scrap 
the darkest colored part—which contains the main constituent—off the plate, and transfer in a centrifuging tube. Add exactl y 40 ml of dichlorometh ane, and shake for 10 
minutes, and centrifuge. Measure exactly 10 ml of the supernatant, and add dichloromethane to make exactly 50 ml. Refer to  this solution as solution A. Similarly, 
scrap off the other colored part into a centrifuging tube, add exactly 20 ml of dichloromethane, shake for 10 minutes, an d centrifuge. Refer to the resulting 
supernatant as solution B. Measure th e absorbances of solutions A and B (A
A, and A B) at 
a wavelength of 485 nm against dichloro methane. Determine the amount of the 
subsidiary colors by the following formula.  
Note: The above procedure should be conducted while avoiding light exposure.  
	Amount	 ሺ%ሻൌ	A୆
A୅	ൈ10൅A ୆ൈ100  
Loss on Drying   Not more than 0.10%. Assay   Weigh accurately about 0.05 g of Cantha xanthin, dissolve in 10 ml of chloroform, 
and add cyclohexane to make exactly 50 ml. Measure exactly 5 ml of this solution, and add cyclohexane to make exactly 100 ml. To  5 ml of the second solution, exactly 
measured, add cyclohexane to  make exactly 100 ml. Measure the absorbance (A) of the 
resulting solution at the maximum at about 470 nm. 
Canthaxanthin	 ሺC
ସ଴HହଶOଶሻሺ%ሻൌଶ଴଴		
୛ୣ୧୥୦୲	ሺ୥ሻ୭୤	୲୦ୣ	ୱୟ୫୮୪ୣൈ୅
ଶ,ଶ଴଴	ൈ100   
Storage standards  Store in a hermetic container, protected from light, under inert gas.    
  
Reagents and Solutions  
Dichloromethane  CH 2Cl2  [K8161]