Amendment to the Ordinance for Enforcement of the Food Sanitation Act  and the 
Specifications and Standards for Food s, Food Additives , Etc . 
 
The government of Japan will designate dipotassium DL-tartrate as an authorized 
food additive  and establish compositional specifications  and use standards for this 
additive . 
 
Background  
Japan prohibits the sale  of food additives that are not designated by the Minister of 
Health, Labour and Welfare (hereinafter referred to as “the Minister”) under Article 
12 of the Food Sanitation Act (Act No. 233 of 1947; hereinafter referred to as “the 
Act”). In addition, when specifications or stand ards for food additives are stipulated 
in the Specifications and Standards for Foods , Food Additives , Etc. (Public Notice of 
the Ministry of Health and Welfare No. 370, 1959) , Japan prohibits the sale  of those 
additives unless they meet the specifications or the standards  pursuant to Article 13 
of the Act . 
 
In response to a request from the Minister, the Committee on Food Additives of the 
Food Sanitation Council under the Pharmaceutical Affairs and Food Sanitation 
Council (hereinafter referred to as “the Committee”)  has discussed the adequacy of 
the designation of dipotassium DL-tartrate  as a food additive. The conclusion of the 
Committee  is outlined below.  
 
Outline of conclusion  
The Minister  should designate dipotassium DL-tartrate  as a food additive unlikely 
to cause harm to human health pursuant to Article 12 of the Ac t and should establish 
compositional specificatio ns and use standards for this additive pursuant to  Article 
13 of the Act (see Attachment  for the details ). 
 
  Dipotassium DL-Tartrate  
DL-酒石酸カリウム  
 
 
Standards for Use (draft)  
Permitted for use in grape wine only . 
 
Compositional Specifications (draft)  
Substance Name  Dipotassium DL-Tartrate  
Structural Formula  
 
 
 
 
Molecular Formula  C4H4K2O6 
Molecular Weight  226.27 
Chemical Name  
Dipotassium (2 RS,3RS)-2,3-dihydroxybutanedioate  
Definition  
Dipotassium D L-Tartrate is a mixture  of equal amounts  of dipotassium L-tartrate  
and dipotassium D-tartrate.  
Description   Dipotassium  DL-Tartrate  occurs as colorless to white crystals , powder, 
or granules . 
Identification  
(1) A solution of Dipotassium DL-Tartrate  (1 in 10)  shows no optical activity . 
(2) Dipotassium DL-Tartrate  responds to  test (1) for Potassium  Salt and to all the 
tests for Tartrate  in the Qualitative Tests.  
Purity  
(1) Lead   Not more than 5 μg/g as Pb (0.80 g, Method 3, Control Solution: Lead  
Standard Solution 4.0 mL, Flame Method).  Attachment  (2) Arsenic   Not more than 3 μg/g as As (0.50 g, Method 1, Standard Color: 
Arsenic Standard Solution 3 .0 mL, Apparatus B).  
(3) Oxalate   Not more than 100 μg/g as C 2H2O4. 
Test Solution  Weigh 0.1 00 g of Dipotassium DL-Tartrate , previously  dried, and 
add sulfuric acid TS ( 0.01 mol/L) to dissolve it and to make exactly 20 mL.  
Control Solution  Weigh 0.140 g of oxalic acid dihydrate, and add sulfuric acid 
TS (0.01 mol/L) to dissolve it and to make exactly 10 00 mL. To exactly 1  mL of this 
solution, add sulfuric acid TS (0.01 mol/L) to make exactly 200 mL.  
Procedure  Analyze 10 -μL po rtions of the test solution and the control  solution 
by liquid chromatography using the operating conditions given below. Measure the 
peak area of oxalic acid for each of the test and control solutions by the automatic 
integration method. The peak area for the test solution is not greater  than that for 
the control solution.  
Operating Conditions  
Detector: Ultraviolet spectrophotometer (wavelength: 210 nm).  
Column: A stainless steel tube (6 –8 mm internal diameter and 30 cm length). 
If necessary, two connected columns may be used.  
Column packing material: 8 -μm H -form cation -exchange resin for liquid 
chromatography.  
Guard column: Use a column with the same internal diameter that is packed 
with the same packing material as for the column above.  
Column temperature : 50°C.  
Eluent: Sulfuric acid TS (0.01 mol/L).  
Flow rate: 0.6 mL/min.  
Loss on Drying   Not more than 4.0% (1 05C, 4 hours).  
Storage Standards  Store in an air -tight  container.  
 
Reagents, Solutions, and Other Reference Materials  
Sulfuric Acid TS (0.01 mol/L)   Add water to 10 mL of sulfuric acid TS (1 mol/L) to 
make 1000 mL.  (This reagent has been already provided in the draft compositional 
specifications for Dipotassium  L-Tartrate.)