Amendment to  the Specifications and Standards for Food s, Food Additives , Etc . 
 
For calcium carbonate (a designated additive) , the government of Japan will change 
the name  of the substance , for which  compositional specif ications are already 
established , from calcium carbonate to calcium carbonate I , and will establish 
compositional specifications and use standards for calcium carbonate II.  
 
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 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) , Japan prohibits the sale of those 
additives unless they meet the specifications or the standards  pursuant to Article 1 3 
of the Act . 
 
In response to a request from the Minister, the Committee on Food Additives of the 
Food Sanitation Council under the Phar maceutical Affairs and Food Sanitation 
Council (hereinafter referred to as “the Committee”)  has discussed the adequacy of 
the revision of the specifications and the standards for calcium carbonate . The 
conclusion of the Committee  is outlined below.  
 
Outline of conclusion  
The Minister  should change the substance  name of calcium carbonate with 
compositional specif ications to calcium carbonate I , and should  establish 
compositional specifications and use standards for calcium carbonate II pursuant to  
Article 1 3 of the Act (see Attachment  for the details ). 
  Calcium Carbonate  II 
炭酸カルシウム  II 
 
 
Standards for Use (draft)  
Permitted for use in grape juice used for wine production and grape wine only.  
 
Compositional Specifications (draft)  
Substance Name  Calcium Carbonate  II  
Molecular F ormula  CaCO3 
Molecular Weight  100.09  
Chemical Name [CAS number]  
Calcium carbonate [471 -34-1, Calcium carbonate]  
Definition  Calcium Carbonate  II consists  mainly of calcium carbonate . It is produced 
by a method through which the resulting product possibly contai ns the calcium double 
salt of L-tartaric and L-malic acids.  
Content   Calcium Carbonate  II, when calculated on the dried basis,  contains 98.0–
102.0% of calcium carbonate (CaCO 3). 
Description   Calcium Carbonate  II occurs as a fine white powder. It is odorless.  
Identification  To 1 g of Calcium Carbonate  II, add 10 mL of water and 7 mL of diluted 
acetic acid (1 in 4). It effervesces and dissolves. When boiled and neutralized with 
ammonia TS, this solution responds to all tests for Calcium Salt in the Qualitative Tests.  
Purity  
(1) Hydrochloric acid -insoluble substances   Not more than 0.20%.  
Weigh 5.0 g of Calcium Carbonate  II, add 10 mL of water, then gradually add 12 mL 
of hydrochl oric acid dropwise while stirring, and add water to make 200 mL. Filter 
through a filter paper for quantitative analysis (5C), and wash the residue on the filter 
paper with boiling water until the washings are free of chloride. Heat gradually the 
residue t ogether with the filter paper to carbonization, incinerate at 450 –550 °C for 3 
hours or more, and weigh.  
(2) Free alkali   Weigh 3.0 g of Calcium Carbonate  II, add 30 mL of freshly boiled and Attachment  cooled water, shake for 3 minutes, and filter the solution. To 20 mL of the filtrate, add 2 
drops of phenolphthalein TS. A pink color develops, and it disappears when 0.20 mL of 
0.1 mol/L hydrochloric acid is added.  
(3) Lead   Not more than 3 μg/g as Pb (2.0 g, Method 5, Control Solution: Lead 
Standard Solution 6.0 mL, Fl ame Method).  
Sample Solution   To the specified amount of Calcium Carbonate  II, add 20 mL of 
diluted hydrochloric acid (1 in 4), and boil gently for 15 minutes with a watch glass 
covering it. Allow to cool, add 30 mL of water, and use the resulting solution as the 
sample solution. If the sample does not dissolve completely, evaporate it to dryness, and 
add 20 mL of diluted hydrochloric acid (1 in 4) to the residue. Boil gently for 5 minutes 
with a watch glass covering it, allow to cool, and add 30 mL of water.  
In Method 5 of the Lead Limit Test, use 50 mL of a solution of diammonium hydrogen 
citrate (1 in 2) and 1 mL of bromothymol blue TS as the indicator instead of thymol blue 
TS, and then add ammonia solution until the color of the solution changes from yellow 
to yellow -green.  
(4) Alkali metals and magnesium   Not more than 1%.  
Weigh 1.0 g of Calcium Carbonate  II, dissolve it by gradually adding 30 mL of diluted 
hydrochloric acid (1 in 10), and let the carbon dioxide out by boi ling. Cool, neutralize 
with ammonia TS, add 60 mL of a solution of ammonium oxalate monohydrate (1 in 25), 
and heat on a water bath for 1 hour. After cooling, add water to make 100 mL, and stir 
thoroughly. Centrifuge it, and filter the supernatan t. Measure  50 mL of the filtrate, add 
0.5 mL of sulfuric acid, evaporate to dryness, ignite to constant weig ht at 600 °C, and 
weigh.  
(5) Barium   Not more than 0.030% as Ba.  
Test Solution   Weigh 1.0 g of Calcium Carbonate  II, dissolve it in 8 mL of diluted  
hydrochlori c acid (1 in 4), and add water to make 20 mL.  
Procedure   Add 2 g of sodium acetate trihydrate, 1 mL of diluted acetic acid (1 in 20),  
and 0.5 mL of potassium chromate solution (1 in 20) to the test solution, and allow to  
stand for 15 minutes. The solution is not more turbid than a control solution prepared  
as follows: To 0.30 mL of Barium Standard Solution, add water to make 20 mL, and then  
treat in the same manner as  for the test solution.  
(6) Arsenic   Not more than 3 μg/g as As (0.50 g, Standard Color: Ar senic Standard  
Solution 3.0 mL, Apparatus B).  
Test Solution   Weigh the specified amount of Calcium Carbonate  II, moisten with 1 
mL of water, and dissolve it in 4 mL of diluted hydrochloric acid (1 in 4).  
Loss on Drying   Not more than 2.0% (200 °C, 4 hours).  
Assay   Weigh accurately about 2 g of Calcium Carbonate  II, and add gradually exactly 50 mL of 1 mol/L hydrochloric acid. Heat the con tainer containing the solution in a water 
bath for abou t 10 minutes. After cooling, titrate the excess hydrochloric acid  with 1mol/L 
sodium hydroxide (indicator: 4 –5 drops of methyl red TS). The endpoint is when red color 
of the solution changes to yellow. Calculate on the dried basis.  
Each mL of 1 mol/L hydrochloric acid = 50.04 mg of CaCO 3