Approval/authorization for use of Fludioxonil  as food additives   
 
Purpose  and background  
This activity is to newly designate Fludioxonil  as authorized food additives.  
Under Article 10 of the Food Sanitation Law, food additives may be used  or marketed  
only when they are authorized  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 be used or marketed only when  they 
meet the  standards and/or specifications.   
 
In response to a request from the Minister, the Subcommittee on Food Additives under 
the Food Sanitation Committee which is established under the Pharmaceutical Affairs 
and Food Sanitation Council has discussed the adequacy of  designation of the substance , 
i.e. Fludioxonil , as food additives . Conclusion of the subcommittee is outlined  below.  
 
 
Outline of conclusion  
The Minister should designate  Fludioxonil , based on  Article 10 of the Food Sanitation 
Law, as food ad ditives unlikely to  harm human health , and establish compositional 
specifications and other necessary standards for this  substance , based on Article 11 of 
the law (see  Attachment ).   
Attachment  
 
Fludioxonil  
 
Standard for use  
The following is the maximum  use amount of the fludioxonil for each target  commodity.   
Kiwifruit: 0.020 g /kg  
Citrus fruits excluding unshu orange: 0.010 g/kg  
Apricot, Apple, Cherry, Japanese plum, Nectarine, Loquat,Peach, Pear, P omegranate , 
Quince: 0.0050 g/kg (for apricot, cherry,  Japanese plum, nectarine, and peach, the limit 
is applied to one kilogram of each fruit from which the stone is removed)  
  
 
Compositional specifications  
 
Substance name:   Fludioxonil  
Structural formula:  
 
HN
CN
O
OF
F
 
Molecular formul a: C12H6F2N2O2 
Mol. Weight :  248.19  
Chemical name  [CAS number ]:    
4-(2,2-difluorobenzo[ d][1,3]dioxol -4-yl)-1H-pyrrole -3-carbonitrile   [131341 -86-1] 
Content :  Fludioxonil  contains not less than 97.0% of f ludioxonil  (C12H6F2N2O2).   
Description :  Fludioxoni l occurs as a white to soft yellow powder. It is odorless.   
Identification :  Determine the infrared absorption spectrum of Fludioxonil , as directed 
in the Paste Me thod under Infrared Spectrophotometry, and compare it with the 
Reference Spectrum.  Both spec tra exhibit absorption s having about the same intensity 
at the same wavenumbers . 
 Purity :   
(1) Melting point  199 –201°C. 
(2) Lead  Not more than 2.0 g/g as Pb.  
Test Solution   Place 1.0 g of Fludioxonil into a 300 -ml Kjeldahl flask , add 10 ml of 
nitric ac id and  5 ml of sulfuric acid, and heat until red -brown fumes are almost no 
longer evolved. After cooling, heat with an additional 2 ml of nitric acid until strong 
white fumes appear. After cooling, add 10 ml of diluted hydrochloric acid (1 in 4), boil for 
15 minutes, and cool. Use the resulting solution as the sample solution . To the  sample 
solution, add 10 ml of a solution of diammonium hydrogen citrate  (1 in 2), and make 
weakly alkaline with ammonia solution using thymol blue as indicator. After cooling, 
transfer the content of the  Kjeldahl  flask into a 200 -ml separating funnel, wash the 
flask with water, and add the washings to the funnel to about 100 ml. Add 5 ml of a 
solution  of ammonium pyrrolidine dithiocarbamate (3 in 100), and allow to stand for 5 
minutes. Add 10 ml of butyl acetate, shake for 5 minutes, and allow to stand. Using the 
butyl acetate phase as the test solution.              
   Control Solution   Measure exactly 1 ml of the Lead Standard Stock Solution, and 
add water to make exactly 100 m l. Using exactly measured 2 ml of the resulting  
solution, proceed in the same manner as for the sample solution, starting from ―add10 
ml of a solution of diammonium hydrogen citrate .‖          
Procedure  Proceed as directed under the Method 1 of the Lead L imit Test.  
Water Content   Not more than 0.50% ( 2.0 g, Direct Titration ). 
Assay :   
Test Solution and Standard Solution  Weigh accurately about 0.06 g each of the test 
sample and f ludioxonil  for assay, and dissolve  each in methanol to make exactly 100 ml.    
Procedure  Analyze 10 l each of the test solution and the standard solution by 
liquid chromatography according to the operating conditions given below. Measure the 
peak areas (A T and AS) of fludioxonil for the test solution and the standard solution, a nd 
determine the content by the formula:  
  
     
   
Operating Conditions   
Detector: Ultraviolet absorption spectrophotometer (determination wavelength: 
270 nm).  
Column: Stainless steel tube of 4.0 mm internal diameter and 25 cm length.  Column  packing material: 5 m octadecylsilanized silica gel for liquid 
chromatography.  
Column temperature: A constant temperature at 25 –40°C. 
Mobile phase: Use a solution prepared as follows —Dissolve  3.8 g of 
monopotassium phosphate and 5.8 g of anhydrous disod ium phosphate in 
water to make 1L. To 100 ml of the resulting solution, add 500 ml of water, 300 
ml of acetonitrile, and 100 ml of methanol.   
Flow rate: 1 ml/minute.   
 
Reagent    
Fludioxonil for Assay  C12H6F2N2O2    White crystals  or crystalline powder.  
Content   Not less than 99% of f ludioxonil  (C12H6F2N2O2), calculated on the 
anhydrous basis.  
Identification  Measure the absorption spectrum of  Fludioxonil for Assay  as 
directed in the Potassium Bromide Disk Method or Paste Method under Infrared 
Spectroph otometry. It exhibits absorption bands at about 3289 cm-1, 2223 cm-1, 1652 
cm-1, 1530 cm-1, and 1236 cm-1.   
Melting point   200–201°C.  
   
 
Reference Spectrum   
 
Fludioxonil