Amendment to the Enforcement Ordina nce of the Food Sanitation Law 
 
The government of Japan will designate Sunflower lecithin as authorized food additives. 
 
Summary 
Under Article 10 of the Food Sanitation Law, food additives shall not be used or marketed without 
authorization by the Minister of Health, Labour an d Welfare (hereinafter referred as “the Minister”). 
In addition, when specifications or standards are established for food additives based on Article 
11 of the act and stipulated in the Ministry of  Health, Labour and Welfar e 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 established under the Pharmaceutical Affairs and Food Sanitation Council 
has discussed the adequacy of the designation of Sunflower lecithin 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 Sunflower lecithin, as food additives unlikely to harm human health. 
The compositional specifications for Lecithin that are specified in the Ministry of Health, Labour 
and Welfare Notification (Ministry of Health and We lfare Notification No. 370, 1959) are applied to 
Sunflower lecithin.  
  Attachment  
 
Lecithin 
レシチン  
 
The List of Existing Food Additives contains three types of lecithin: Vegetable Lecithin, Egg Lecithin, and Fractionated Lecithin. These three type s of lecithin are subject to the compositional 
specifications given below. The specifications will also apply to Sunflower Lecithin.       
Standards for use 
Not established. 
 
Compositional specifications  
Definition    Lecithin is obtained from oil seeds or animal materials. It consists mainly of 
phospholipids. 
Description    Lecithin occurs as a white to brown powder or granules or as light yellow to dark 
brown lumps or viscous fluid. It has a slight, characteristic odor. 
Identification    
(1) Proceed as directed in Identification (1 ) for Enzymatically Decomposed Lecithin.  
(2) To 0.5 g of Lecithin, add 5 mL of diluted hydrochloric acid (1 in 2), heat in a water bath for 2 
hours, and filter. Use this solution as the test solution. Analyze 10 L of the test solution by paper 
chromatography, using choline chloride solution (1 in 200) as the control solution and a 4:2:1 
mixture of butanol/water/acetic acid as the developing solvent. For the filter paper, use a No. 2 filter paper for chromatography. Stop the development when the developing solvent ascends to a point about 25 cm above the base line, air-dry, spray with Dragendorff TS to let color develop, and observe in daylight. A red-orange spot corresponding to the spot obtained from the control solution is observed.  
Purity    
(1) Acid value  Not more than 40. 
Test Solution   Weigh accurately about 2 g of Lecithin, dissolve it in 50 mL of petroleum ether, 
and add 50 mL of ethanol (95).  
Procedure   Proceed as directed in the Acid Value Test in the Fats and Related Substances Tests, 
using this solution as the test solution. 
(2) Toluene-insoluble substances  Not more than 0.30%.   Weigh accurately about 10 g of Lecithin, dissolve it in 100 mL of toluene, and filter the insoluble 
substances through a crucible-type glass filter (1G4). Wash several times with 25 mL of toluene, dry 
together with the glass filter at 105 C for 1 hour, and allow to cool in a desiccator. Weigh accurately 
the glass filter containing the residue. 
(3) Acetone-soluble substances   Not more than 40%.   
Weigh accurately about 2 g of Lecithin in a scaled, 50-mL centrifuge tube with a ground-glass 
stopper, dissolve by adding 3 mL of petroleum ether, add 15 mL of acetone, and stir well, and allow to stand in ice water for 15 minutes. Then procee d as directed in Purity (2) for Enzymatically 
Decomposed Lecithin.  
(4) Peroxide value  Not more than 10.   
Weigh accurately about 5 g of Lecithin, transf er into a 250-mL Erle nmeyer flask with a 
ground-glass stopper, add 35 mL of  a 2:1 mixture of chloroform/acetic acid, and dissolve to a 
transparent state while shaking ge ntly. Then proceed as directed in Purity (3) for Enzymatically 
Decomposed Lecithin.   
(5) Heavy metals  Not more than 20  g/g as Pb (1.0 g, Method 2, Control solution Lead Standard 
Solution 2.0 mL). 
(6) Arsenic  Not more than 4.0  g/g as As 2O3 (0.50 g, Method 3, Apparatus B). 
Loss on Drying   Not more than 2.0%.   
Proceed as directed in the Loss on Drying Te st for Enzymatically Decomposed Lecithin.