Authorization for Use as Food Additive s (3-Ethylpyridine and Pyrimethanil)  
 The government of Japan will designat e 3-Ethylpyridine and Pyrimethanil as 
authorized food additives. 
 Summary
 
Under Article 10 of the Food Sanitation Law,  food additives may not be used marketed 
without the authorization by the Minister  of Health, Labour and Welfare. Where 
standards for use of additives and/or their compositional specifications are established 
based on Article 11 of the law, those additives may not be used or marketed when they do not meet these standards and/or specifications.    In response to a request from the Minist er of Health, Labour and Welfare, the 
Committee on Food Additives of the Food Sanitation Council that is established under the Pharmaceutical Affairs and Food Sanitation Council has discussed the adequacy of the designation of 3-Ethylpyridine and Pyrime thanil as food additives. The conclusion 
of the committee is outlined below.     Outline of conclusion 
 
The Minister of Health, Labour and Welfare, based on Article 10 of the Food Sanitation 
Law, should designate 3-Ethylpyridine and Py rimethanil, as food additives unlikely to 
harm human health, and establish standard for use and compositional specifications, 
based on Article 11 of the law (see Attachments 1 and 2).     Attachment 1 
 
3-Ethylpyridine 
3-エチルピリジン 
N
CH3 
 
 
Standard for use  
It shall not be used for purposes other than flavoring.        
  
Compositional specifications  
Substance name  3-Ethylpyridine  
Molecular formula   C 7H9N  
Mol. Weight   107.15 
Chemical name [CAS number]    
3-Ethylpyridine [536-78-7] 
Content  3-Ethylpyridine contains not le ss than 98.0% of 3-Ethylpyridine (C 7H9N).  
Description   3-Ethylpyridine occurs as a colorless to brown liquid having a 
characteristic odor. 
Identification   Determine the infrared absorptio n spectrum of 3-Ethylpyridine as 
directed in the Liquid Film Method under Infrared Spectrophotometry, and compare 
with the Reference Spectrum. Both spectra  exhibit absorptions having about the 
same intensity at the same wavenumbers. 
Purity   
(1) Refractive index   n20
D: 1.499−1.505.  
(2) Specific gravity   d25
25: 0.937−0.943 . 
Assay  Proceed as directed in the Peak Area Percentage Method in the Gas 
Chromatographic Assay under the Flav or Substance Tests. Use operating 
conditions (1).  Attachment 2 
 
Pyrimethanil 
ピリメタニル  
 
 
 
Standard for use  
Pyrimethanil can be used on apple, apri cot, cherry, citrus fruits (excluding unshū 
oranges), peach, pear, plum, and quince.  It shall not remain more than 0.010 g/kg 
in apricot, cherry, citrus fruits plum, peac h and more that 0.014 g/kg in apple, pear, 
and quince as pyrimethanil.    
 
  
Compositional specifications  
Substance name  Pyrimethanil       
Molecular formula   C 12H13N3 
Mol. Weight   199.25 
Chemical name [CAS number]    
N-(4,6-dimethylpyrimidin-2-yl)aniline ［53112-28-0 ］ 
Content  Pyrimethanil contains 96.0–101.0% of pyrimethanil (C 12H13N3). 
Description   Pyrimethanil occurs as a white to yellowish white, odorless powder.      
Identification    
Determine the infrared absorption spectrum of Pyrimethanil as directed in the 
Potassium Bromide Disk Method under In frared Spectrophotometry, and compare 
it with the Reference Spectrum. Both spe ctra exhibit absorptions having about the 
same intensity at the same wavenumbers.   
Purity    
(1) Melting point   96–98ºC. 
(2) Lead   Not more than 2.0 g/g as Pb (5.0 g, Method 1). Water Content  Not more than 1.0% (2.0 g, Direct Titration). 
Assay   Weigh accurately about 0.05 g each of Pyrimethanil and pyrimethanil for 
assay. Dissolve each in methanol to make  exactly 50 ml. Take 1 ml each, add a 3:1 
mixture of acetonitrile/water to make exactly 20 ml each.  Use them as test 
solution and standard solution respectively. Aanalyze 10 l portions of the test 
solution and the standard solution by liquid chromatography using the operating 
conditions given below. Measure the peak areas (A T and A S) of pyrimethanil for the 
test solution and the standard solution. Calculate the pyrimethanil content by the formula: 
Content ሺ%ሻ of pyrimethanil ሺC
ଵଶHଵଷNଷሻൌ 
Weight ሺgሻ of pyrimethanil for assay 
Weight ሺgሻ of the sampleൈAT
ASൈ100  
Operating conditions 
Detector: Ultraviolet spectrophotometer  (measurement wavelength: 268 nm). 
Column: A stainless steel tube of 4.6 mm internal diameter and 25 cm length. 
Column packing material: 5- m octadecyl silanized silica gel for 
liquidchromatography.     
Column temperature: A co nstant temperature of 24 −40ºC. 
Mobile phase: To 750 ml of acetonitrile, add 250 ml of water and 2 g of 
ammonium acetate, and dissolve. 
Flow rate: Adjust so that the retent ion time of pyrimethanil is about 5 −6 
minutes. 
 
 
Regents and Solutions  
Deuterated methanol  CD 3OD  Use deuterated methano l produced exclusively for 
NMR spectral measurement.  
Pyrimethanil for Assay   C 12H13N3   A white crystalline powder. 
Content   Not less than 99.0% of pyrimetahnil (C 12H13N3).  
   Identification  Determine the infrared absorption spectrum of Pyrimethanil as 
directed in the Potassium Bromide Disk Me thod under Infrared Spectrophotometry. 
It exhibits absorption bands at about 3263 cm-1, 1588 cm-1, 1496 cm-1, 1251 cm-1, 
757 cm-1, 715 cm-1.   
Melting point  96–98ºC.  
Assay   Weigh accurately about 20 mg of Pyrimethanil for Assay and about 4 mg of 1,4-BTMSB- d4, and add 2 ml of deuterated me thanol to dissolve them together. 
Transfer the resulting solution to an NMR tube of 5 mm in external diameter, stopper tightly, and measure 
1HNMR spectra using a spectrometer at a proton 
resonance frequency of 400 MHz or more. Assuming the signal of 1,4-BTMSB- d4 as  
0.23 ppm, when the signal intensities around  0.23 ppm,  2.32 ppm, and  6.56, 
6.80–7.40, and  7.66 ppm are designated as A 1 (corresponding to 6 hydrogens), A 2 
(corresponding to 1 hydrogen), A 3 (corresponding to 3 hydrogens), and A 4 
(corresponding to 2 hydrogens), respectively, confirm that each of (A 1/6)/A 2, 
(A1/6)/(A 3/3),  (A1/6)/(A 4/2), A 2/(A3/3), A 2/(A4/3), and (A 3/3)/(A 4/2) is 1.0.  Then, 
assuming the signal intensity of 1,4-BTMSB- d4 as 18.00, when the sum of A 1, A2, A3, 
and   A4 is designated as 1, when the sum of the number of hydrogens and the purity 
of 1,4-BTMSB- d4 are designated as N and P(%), respectively,  determine the content 
of pyrimethanil by the following formula. If the signal from Pyrimethanil for Assay 
is overlapped with the signal from a co ntaminant, do not use its signal area 
intensity for the assay. 
  
Content ሺ%ሻ of pyrimethanil ሺC ଵଶHଵଷNଷሻൌ 
ସ ൈIൈP 
Weight  ሺmgሻofthe sample ൈ Nൈ0.8797  
 
Operating conditions  
Spinning:  Off. 
13C decoupling: Present.  
Acquisition time: 4 seconds.  
Spectral range: At least 20 ppm including between −5 ppm and 15 ppm. 
Flip angle: 90º. 
Delay time: Not less than 60 seconds. 
Dummy scans: Not less than 1.  
Number of accumulation: Not less than 8.  
       IR Spectrum 
    Pyrimethanil