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 Phytate  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 Minist ry 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 Phytate  as a food 
additive. The conclusion of the committee is outlined below.  
 
Outline of conclusion  
The Minister should designate Calcium Phytate  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  Phytate  
フィチン酸 カルシウム  
 
 
Standards for Use (draft)  
Permitted for use only in grape wine. Must be used at not more than 0.08 g /L in grape wine as 
calcium phytate.  
 
 
Compositional Specifications (draft)  
Substance Name  Calcium Phytate  
CAS number    [3615 -82-5] 
Definition  Calcium  Phytate  consists mainly of the calcium salt of inositol hexaphosphate 
(including double salt of calcium and magnesium).  
Content   Calcium Phytate, when dried, contains 15 –30% of calcium phytate as total 
phosphorus . 
Description   Calcium  Phytate occurs as a white powder.  
Identification  
(1) Neutralize 2 mL of Solution A prepared in Assay with sodium hydroxide solution (1 in 
25). The resulting solution responds to test ( 2) for Phosphorous Salt in the Qualitative Tests.  
(2) Boil 0.1 g of Calcium Phytate with 5 mL of acetic acid (1 in 4). After cooling, filter it, and 
add 5 m L of a solution of ammonium oxalate monohydrate (1 in 30) to the filtrate. A white 
precipitate is formed . The separated precipitate dissolves in hydrochloric acid (1 in 4).  
Purity  
(1) Lead   Not more than 5 μg/g as Pb  (0.80 g  of a died sample , 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  of a dried sample , Method 3,  Standard 
Color: Arsenic Standard Solution 3.0 mL, Ap paratus B).  
 (3) Free inorganic phosphorus  Not more than 1.0% ( dried sample).  
Test Solution   Weigh accurately about 0.5 g of Calcium Phytate, previously dried, add 
about 150 mL of water, gently shake 2 to 3 times, and filter. To the filtrate, add water to make 
exactly 200 mL. To exactly 3 mL of the resulting solution, add 5 mL of L (+)-ascorbic ac id 
solution (1 in 100). Add 5 mL of a solution prepared by dissolving 1 g of hexaammonium 
heptamolybdate tetrahydrate  in 100 mL of sulfuric acid TS (0.025mol/L). Then add acetic 
buffer (pH 4.0) to make exactly 50 mL, and allow to stand for 15 minutes.  
Reference Solution    To 5 mL of L (+)-ascorbic acid solution (1 in 100), add 5 mL of a Attachment  3 
 
 solution prepared by dissolving 1 g of hexaammonium heptamolybdate tetrahydrate in  
100 mL of sulfuric acid TS (0.025 mol/L). Then add acetic acid buffer (pH 4.0) to make exa ctly 
50 mL.  
Procedure   Measure  the absorbance of the test solution at a wavelength of 750 nm  
against the reference solution. Prepare a calibration curve by measuring the absorbance  
of the following three solutions. Determine the concentration of free inorg anic phosphorus from 
the calibration curve and the absorbance of the test solution, and then  
calculate the amount (%) of free inorganic phosphorus in the sample.  
Solutions for Calibration Curve  To exactly 5 mL of Phosphorus Standard Solution,  
add water to make 1000 mL. Transfer exactly 5 mL, 10 mL, and 20 mL of this solution into 
separate volumetric flasks,  add 5 mL of L (+)-ascorbic acid solution (1 in 100) to each, and 
proceed as directed for the test solution to develop the color.  
Loss on  Drying   Not more than  12% (1 g, 105C, 4 hours).  
Assay  
Test Solution   Weigh accurately about 0.6 g of Calcium Phytate, previously dried, into  a 
Kjeldahl  flask or heat -resistant glass beaker, and add 4 mL each of sulfuric acid and nitric acid. 
For a beaker, cover by a watch glass. Heat it by gradually increasing the temperature from 
about  150°C. Continue heating until  brown  fumes of nitric acid almost cease to be evolve d, the 
liquid is transparent, and  then white fumes are evolved; and decompose it. If the contents 
become blackened while heating, add about  2 mL of nitric acid and keep heating. After cooling, 
add 100 mL of wa ter, mix, and filter.  Wash the filter with water, combine the filtrate with the 
washings, and then add water to make 200 mL. Designate it as Solution A. Transfer exactly 2 
mL of Solution A into a 100 -mL volumetric flask, add 1 drop of phenol phthalein TS, neutralize 
with ammonia solution (1 in 4), and add nitric acid (1 in 10) until the solution is colorless to 
make the solution slight acidic. To this solution, add 20 mL of vanadic acid –molybdic a cid TS , 
and make up to exactly 100 mL with water. Shake it we ll, and allow to stand for 30 minutes.  
Procedure   Measure the absorbance of the test solution at a wavelength of 420 nm.  
Prepare a calibration curve by measuring the absorbance of the following three solutions. 
Determine the total phosphorus concentration in the test solution from the calibration curve 
and the absorbance of the test solution, and then calculate the total phosphorus amount (%) 
in the sample.  
Solutions for Calibration C urve  To exactly 10 mL of Phosphorus Standard Solution, add 
water to make exactly 100 mL. Transfer exactly 5 mL, 10 mL, and 20 mL of this solution into 
separate 100 -mL separate volumetric flasks, proceed as directed for the test solution, and 
develop the color.