Amendment to the Enforcement Ordinance of the Food Sanitation L aw and the 
Standards and Specification s for Foods and Food Additives  
 
The government of Japan w ill designate Propiconazole  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, w hen 
specifications or standards are established for food additives based on Article 11 of the Law and 
stipulated in the Ministry of Health, Labour and Welfare Notification (Ministry of Health and 
Welfare Notification No. 370, 1959), those additives 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 establi shed under the Pharmaceutical Affairs and Food 
Sanitation Council has discussed the adequacy of the designation of Propiconazole  as a 
food additive. The conclusion of the committee is outlined below.  
 
Outline of conclusion  
The Minister , based on Ar ticle 10 of the Law, should designate Propiconazole , as a 
food additive unlikely to  harm human health , and establish standard s for use and 
compositional specificatio ns, based on Article 11 of the L aw (see Attachme nt). 
 
 
  Attachment  
Propiconazole  
プロピコナゾール  
 
Standards for use (draft)  
Propiconazole is permitted for use on apricot, cherry, citrus fruits (excluding unshū  
oranges), nectarine, peach, and Japanese plum. It shall not remain more than 0.008 
g/kg in citrus fruits (excluding unshū  oranges), 0.004 g/kg in apricot, cherry, nectarine, 
and pea ch(for apricot, nectarine, and peach, the limit is applied to one kilogram of 
each fruit from which the stone is removed and for cherry, the limit is applied to one 
kilogram of the fruit from which the stone and peduncle  are removed) , and 0.0006 
g/kg in Japanese plum (the limit is applied to one kilogram of the fruit from which the 
stone is removed) .    
 
 
Compositional specifications (draft)  
Substance name   Propiconazole  
Structural  formula  
 
 
 
                                                  
Molecular formula   C15H17Cl2N3O2        
Molecular weight   342.22  
Chemical name  [CAS number]  
(2RS, 4RS; 2RS, 4SR)-1-[2-(2,4-dichlorophenyl) -4-propyl -1,3-dioxolan -2-ylmethyl] - 
1H-1,2,4 -triazole［60207 -90-1］ 
Content  Propiconazole contains not less than 95.0% of propiconazole ( C15H17Cl2N3O2). Description   Propiconazole  is a colorless to dark yellow -red viscous liquid. It is 
odorless.   
Identification  Determine the infrared absorption spectrum of Propiconazole, as 
directed in the Liquid Film Paste Method under Infrared Spectrophotometry, and 
compare it with the Reference  Spectrum. Both spectra exhibit absorptions having about 
the same intensity at the same wavenumbers. Use optical plates  made from sodium 
chloride . 
Specific Gravity  d20 20: 1.288 –1.290.  
Purity  
Lead   Not more than 2 g/g as Pb (2.0 g, Method 1, Control Solution: Lead Standard 
Solution 4.0 mL, Flame Method).  After the sample is charred, ignite it at 450°C in an 
electric furnace.   
Assay  
Test Solution and Standard Solution   Weigh accurately about 50 mg each of  
Propiconazole  and propiconazole  for assay, a dd 20 mL of the internal standard solution 
to each, add acetone to dissolve the mixture, and then make each of the solutions up to 
exactly 100 mL with acetone.   
Internal Standard Solution  Dissolve 75 mg of fludioxonil for assay in acetone to 
make exactly 50 mL.  
Procedure  Analyze 1 -L portions of the test solution and the standard solution by 
gas chromatography using the operating conditions given below. Determine the peak 
area ratios of propiconazole to fludioxonil for the test solution and the standard solution, 
and express as Q
T and Q
S , respectively. Calculate the amount of propiconazole by the 
formula:   
Content  (%) 𝑜𝑓 𝑝𝑟𝑜𝑝𝑖𝑐𝑜𝑛𝑎𝑧𝑜𝑙𝑒  (𝐶15𝐻17𝐶𝑙2𝑁3𝑂2 ) 
= 𝑊𝑒𝑖𝑔 ℎ𝑡 (𝑚𝑔) 𝑜𝑓 𝑝𝑟𝑜𝑝𝑖𝑐𝑜𝑛𝑎𝑧 𝑜𝑙𝑒 𝑓𝑜𝑟 𝑎𝑠𝑠𝑎𝑦
𝑊𝑒𝑖𝑔 ℎ𝑡 (𝑚𝑔) 𝑜𝑓 𝑡ℎ𝑒 𝑠𝑎𝑚𝑝𝑙𝑒   × 𝑄𝑇
𝑄𝑆 ×100 
Operating Conditions  
Detector: Hydrogen flame -ionization detector.  
Column: A fused silica tube (0.25 mm internal diameter and 30 m length) coated 
with a 0.25 -m thick layer of dimethylpolysiloxan for gas chromatography.  
Column temperature: Inject at 200ºC, then raise the temperature at a rate of 
5ºC/minute to 280ºC . 
Injection port temperature: A constant temperature of about 250ºC.  Detector temperature: A constant temperature  of about 300ºC.  
Carrier gas: Helium.  
Flow rate: Adjust the retention time of propiconazole to 10 –15 minutes.  
Injection method: Split.  
Split ratio: 1:10.  
 
Reagents and Test Solutions (TS)  
Propiconazole for assay C15H17Cl2N3O2［60207 -90-1］A colorless to yel low 
semi -gelatinous substance or a transparent viscous liquid.  
Content  Not less than 97.0% of propiconazole ( C15H17Cl2N3O2). 
Identification  Measure the absorption spectrum of propiconazole for assay as 
directed in the Liquid Film Method under Infrared Spectrophotometry. It exhibits 
absorptions at about 2960 cm-1, 2870 cm-1, 1587 cm-1, 1506 cm-1, and 1466 cm-1,  1273 
cm-1, 1138 cm-1, and 1028 cm-1.  Use optical plates  made from sodium chloride . 
Specific gravity  d20 20: 1.288 –1.290.  
Assay  Weigh accurately about 40 mg of propiconazole for assay and about 4 mg of 
1,4-BTMSB -d4, and dissolve them together  in 4 mL of deuterated acetone . Transfer the 
resulting solution to an NMR tube of 5 mm in external diameter, stopper tightly, and 
measure 1HNMR spec tra using an NMR spectrometer at a p roton  resonance frequency 
of 400 MHz  or more. Assuming the signal of 1,4 -BTMSB -d4 
–7.13 ppm.  
Assuming the signal area intensity of 1,4 -BTMSB -d4 as 18.00, when the conversion 
value of A and the purity of 1,4 -BTMSB -d4 are designated as I and P(%), respectively,  
determine the content of propiconazole by the following formula. Confirm that the 
signal from propiconazole around  
 –7.13 ppm is not overlapped with that from a 
contaminant.     
 
Content  (%) of propiconazole  (C15H17Cl2N3O2)    
      =Weight  (mg) of 1,4 BTMSB − 𝑑4 × I × P
Weight   (mg) of the sample  ×1.511    
Operating conditions    
Digital resolution: Not more than 0.25.  
Spinning: Off.  
13C decoupling: Present.  
Acquisition time: Not less than 4 seconds.  
Spectral range : Not less than 20 ppm including between −5 ppm and 15 ppm.  
Flip angle: 90º.  Delay time: 60 seconds.  
Dummy scans: 2 or more.  
Number of accumulation: Not less than 8.  
Temperature at measurement: 20 –30°C.  
 
Deuterated acetone  CD 3COCD 3  [666-52-4]  Use a product exclusively produced for 
NMR spectrum measurement.  
 
Reference spectrum  
Propiconazole