1 Amendment to the Ordinance for Enforcement of the Food Sanitation Act and the 
Specifications and Standards for Foods, Food Additives, Etc. 
 
The government of Japan will designate Calcium L-tartrate as an authorized food additive 
and establish compositional specifications and standards for use of this additive. 
 
Background 
Japan prohibits the sale of food additives that are not designated by the Minister of Health, 
Labour and Welfare ( “the Minister”) under Article 12 of the Food Sanitation Act (Act No. 
233 of 1947; “the Act”). In addition, when specifications or standards 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) pursuant to Article 13 of the 
Act, the sale of those additives are prohibited unless they meet the specifications or the 
standards. 
 
In response to a request from the Minister, the Committee on Food Additives of the Food 
Sanitation Council established under the Pharmaceutical Affairs and Food Sanitation 
Council has discussed the adequacy of the designation of Calcium L-tartrate as a food 
additive. The conclusion of the committee is outlined below. 
 
Outline of conclusion 
The Minister should designate Calcium L-tartrate as a food additive unlikely to cause 
harm to human health pursuant to Article 12 of the Act and should establish compositional 
specifications and use standards for this additive pursuant to Article 13 of the Act (see 
Attachment for the details). 
  2 
 
  Calcium L-Tartrate 
Ｌ-酒石酸カルシウム 
 
 
Standards for Use (draft) 
Permitted for use only in grape wine. Must be used at not more than 2.0 g/L in grape wine as 
calcium L-tartrate. 
 
 
Compositional Specifications (draft) 
Substance Name  Calcium L-Tartrate 
Structural Formula 
 
 
 
Molecular Formula  C4H4CaO6•nH2O (n= 2 or 4) 
Molecular Weight  Dihydrate 224.18  
Tetrahydrate 260.21 
Chemical Name [CAS number] 
Calcium(2R, 3R)-2,3-dihydroxybutanedioate dihydrate 
Calcium(2R, 3R)-2,3-dihydroxybutanedioate tetrahydrate [5892-21-7] 
Content  Calcium L-Tartrate, when dried, contains not less than 98.0% of calcium L-tartrate 
(C4H4CaO6). 
Description  Calcium L-Tartrate occurs as a white to grayish white powder. 
Identification 
(1) Dissolve 1 g of Calcium L-Tartrate by adding hydrochloric acid TS (1 mol/L) to make 50 
mL. This solution is dextrorotatory. 
(2) Calcium L-Tartrate responds to test (1) for Calcium Salt in the Qualitative Tests. 
(3) A solution of 1 g of Calcium L-Tartrate in 50 mL of hydrochloric acid TS (1 mol/L) 
responds to test (3) for Tartrate in the Qualitative Tests. 
Specific Rotation  [α]: +6.2 to +7.4. Attachment 3 
 
  Weigh accurately about 1 g of Calcium L-Tartrate, and dissolve it by adding hydrochloric 
acid TS (1 mol/L) to make exactly 50 mL. Measure the optical rotation of this solution. 
pH  6.0–9.5. 
Test Solution  To 3.0 g of Calcium L-Tartrate, add 60 mL of water, shake it for 1 hour, and 
centrifuge for 5 minutes at 3000 rpm. Use the supernatant. 
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). 
(2) Arsenic  Not more than 3 μg/g as As (0.50 g, Standard Color: Arsenic Standard Solution 
3.0 mL, Apparatus B). 
Test Solution  Dissolve the specified amount of Calcium L-Tartrate by adding 5 mL of 
diluted hydrochloric acid (1 in 4).   
(3) Sulfate  Not more than 0.1% as SO4. 
Test Solution  Dissolve 1.2 g of Calcium L-Tartrate by adding 30 mL of hydrochloric acid 
TS (1 mol/L), and further add hydrochloric acid TS (1 mol/L) to make 50 mL. 
Control Solution  To 2.5 mL of 0.005 mol/L sulfuric acid, add hydrochloric acid TS (1 mol/L) 
to make 50 mL.  
(4) Basic residues  Not more than 3% as CaCO3. 
Weigh accurately about 2 g of Calcium L-Tartrate in a container, add gradually exactly 
measured 25 mL of 1 mol/L hydrochloric acid, and heat the container with the solution in a 
water bath for about 10 minutes. After cooling, titrate the excess hydrochloric acid with 1 mol/L 
sodium hydroxide (indicator: 4–5 drops of methyl red TS). The endpoint is when the color of 
the solution changes from red to yellow. Separately, perform a blank test, and determine the 
amount of basic residues by the formula: 
The amount of basic residues (CaCO3) =(  ) × .
 ()     
a = volume (mL) of 1 mol/L sodium hydroxide consumed in the blank test, 
b = volume (mL) of 1 mol/L sodium hydroxide consumed in the test. 
 
Loss on Drying  Not more than 30.0% (200C, 7 hours). 
Assay   
Test Solution  Weigh accurately about 1 g of Calcium L-Tartrate, mix it with 8 mL of diluted 
hydrochloric acid (1 in 4), and dissolve by adding about 20 mL of water. Warm if necessary to 
dissolve it, and cool to room temperature. To this solution, further add water to make exactly 
50 mL. 
Procedure  Quantify calcium L-tartrate in the sample by Method 1 of Calcium Salt 
Determination. Calculate the content on dried basis. 
Each mL of 0.05 mol/L of disodium dihydrogen ethylenediaminetetraacetate = 9.407 mg of 
C4H4CaO6