Authorization of Calcium Saccharin as Food Additives and Revision of the Standards of 
Sodium Saccharin 
 
The government of Japan will designate Calcium Saccharin as authorized food additives, 
and revise the existing use standards for Sodium Saccharin.  
 
Summary  
Under Article 10 of the Food Sanitation Law, food additives may not be used on 
marketed without the authorization by the Minister of Health, Labour and Welfare. 
Where standards for use of additives and/or their compositional specifications are 
established based on Article 11 of the law, those additives may not be used or marketed 
when they do not meet these standards and/or specifications.   
 
In response to a request from the Minister of Health, Labour and Welfare, 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 Calcium Saccharin as a food additive and the revision of the existing 
use standards for Sodium Saccharin. The conclusion of the committee is outlined below.  
 
 
 
Outline of the conclusion  
The Minister of Health, Labour and Welfare, based on Article 10 of the Food Sanitation 
Law, should designate Calcium Saccharin, as food additives unlikely to harm human 
health, and establish compositional specifications and other necessary standards for 
this substance, based on Article 11 of the law (see Attachments 1). Also, the Minister 
should revise use standard for Sodium Saccharin, based on Article 11 of the law (see 
Attachments 2)  
 
  Attachment 1 
 
Calcium Saccharin  
 
Standard for use  
See the Appendixe 1.   
 
Compositional specifications  
Substance name   
Calcium Saccharin 
Structural formula 
 N-S
OOO
2Ca2+•3 1/2 H2O
 
                      
Molecular formula   C 14H8CaN 2O6S2· 3½H 2O 
Mol. Weight   467.48 
Chemical name [CAS number]    
Calcium bis(3-oxo-3 H-1,2-benzothiazol-2-ide) 1,1-dioxide hemiheptahydrat 
[6381-91-5] 
Content  Calcium Saccharin, when dried, contains not less than 98.0% of calcium 
saccharin (C 14H8CaN 2O6S2).  
Description   Calcium Saccharin occurs as white crystals or crystalline powder. It has a 
strong sweet taste.    
Identification   
(1)  To 10 ml of a solution of Calcium Saccharin (1 in 10), add 1 ml of hydrochloric 
acid, collect the resulting crystalline precipitate by filtration, and wash well with cold 
water. Dry the washed precipitate for 2 hours at 105 °C, and measure the melting point. 
It starts to melt at a temperature above 226 °C and melts completely at below 230 °C.         
(2) Mix 0.02 g of Calcium Saccharin with 0.04 g of resorcinol, add 10 drops of 
sulfuric acid, and heat for 3 minutes at 200 °C. Cool, and add 10 ml of water and 10 ml of 
sodium hydroxide solution (1 in 25). The resulting solution emits a green fluorescence.  
(3) To 0.1 g of Calcium Saccharin, add 5 ml of sodium hydroxide solution (1 in 25), evaporate to dryness while gently heating, and fuse the residue, being careful not to 
carbonize it. Keep heating until it no longer evolves the odor of ammonia, and cool. To  
the residue, add about 20 ml of water, make slightly acidic with diluted hydrochloric 
acid (1 in 10), and filter. Add a drop of iron chloride(III) solution (1 in 10) to the filtrate. 
A purple to red-purple color develops.    
(4) Calcium Saccharin responds all tests for Calcium Salt in the Qualitative Tests.   
Purity    
(1) Lead   Not more than 1.0 mg/g as Pb.  
Test Solution  Place 2.0 g of Calcium Saccharin in a 300 ml Kjeldahl flask, and 
add 10 ml of nitric acid and 5 ml of sulfuric acid. Heat until brown fumes are 
produced and then the solution turns light yellow. After cooling, add 10 ml of diluted 
hydrochloric acid (1 in 4), boil for 15 minutes, and cool. Use the resulting solution as 
the sample solution. To the sample solution, add 10 ml of diammonium hydrogen 
citrate solution (1 in 2), make slightly alkaline with ammonia solution, and cool. 
Transfer the solution to a 200-ml separating funnel, wash the inside of the Kjeldahl 
flask with water into the separating funnel, and further add water to make about 
100 ml. Add 5 ml of ammonium pyrrolidine dithicarbamate solution (3 in 100), and 
allow to stand for 5 minutes. Then, add 10 ml of butyl acetate, shake for 5 minutes, 
and allow to stand. Use the butyl acetate layer as the test solution.   
Control Solution  Measure exactly 1 ml of Lead Standard Solution, and add 
water to make exactly 100 ml. Measure exactly 2 ml of this solution, and proceed as 
directed for the sample solution.  
Procedure   Proceed as directed in Method 1 in the Lead Limit Test. 
(2) Selenium   Not more than 30 mg/g as Se.   
(i) Use the apparatus outlined in the Figure.  
 
 
  
 
A: Colorless, hard-glass, thick-walled flask with a flared mouth (2 mm in wall 
thickness and 500-ml in capacity) 
B: Platinum basket or platinum gauze cylinder (hung from the bottom of 
stopper C with a platinum wire) 
C: Hard-glass, ground stopper   
D: Filter paper (Cut out a filter paper to make the shape given in the Figure, 
and make folding lines as described by dot lines. The long end is used for 
light-off.)   
(ii)  Procedure 
Sample Solution   Place 0.20 g of Calcium Saccharine, previous dried and weighed 
accurately, on the center of the filter paper, and wrap carefully along with the folding 
lines without spilling. Place the parcel into B (a platinum basket or platinum mesh 
cylinder), leaving the long end on the outside. Put 25 ml of diluted nitric acid (1 in 30) as 
the absorbing liquid into flak A. Fill the flask with air, moist the ground part of stopper 
C, light off the long end, and immediately place it into the flask. Keep the flask airtight 
until the combustion is completed. Allow it to stand for 15–30 minutes with occasional 
shaking until the white fumes inside the flask completely disappear. Pour a small 
amount of water to the upper part of the flask, carefully remove the stopper, and 
transfer the solution in A to a beaker. Wash C, B, and the inside wall of A with 25 ml of 
water, and add the washings to the beaker. Boil the resulting solution gently for 10 
minutes. Cool to room temperature, add water to make exactly 100 ml, and use the 
sample solution.  
Standard Solution  Weigh 0.060 g of selenium, add 100 ml of diluted nitric acid (1 30 108 
A BC
D in 2) to dissolve while heating on a water bath if necessary, and dilute with water to 
exactly 1,000 ml. To exactly measured 5 ml of this solution, add water to make exactly 
200 ml. Take exactly 2 ml of the resulting solution, and add diluted nitric acid (1 in 60) 
to make exactly 50 ml.  
Procedure  Measure exactly 40 ml each of the sample solution and the standard 
solution into separate beakers, and adjust the pH to 1.8–2.2 with ammonia solution. To 
each, add 0.2 g of hydroxylamine hydrochloride to dissolve while gently shaking, add 5 
ml of a solution that is prepared by dissolving 0.10 g of 2,3-diaminonaphtharine and 0.5 
g of hydroxylamine hydrochloride in 0.1 mol/L hydrochloric acid and then diluting to 
100 ml. Shake and allow to stand for 100 minutes. Transfer them into separate 
separating funnels, wash the beakers with 10 ml each of water, and add the washings to 
the corresponding separating funnels. To each, add 5.0 ml of cyclohexane, and shake 
well for 2 minutes to extract selenium. Collect the cyclohexane layer, and centrifuge to 
remove the water. Use the resulting solutions as the test solution and the control 
solution, respectively. Against the reference solution that is prepared in the same 
manner using 40 ml of diluted nitric acid (1 in 60) instead of the test solution, measure 
the absorbance at maximum absorption wavelength near 378 nm.  The absorbance of 
the test solution is not greater than that of the control solution.                                             
(3) Arsenic   Not more than 4.0 mg/g as As 2O3 (0.50 g, Method 1, Apparatus B).  
(4) Benzoic acid and salicylic acid   Dissolve 0.5 g of Calcium Saccharine in 10 ml of 
water, and add 5 drops of acetic acid and 3 drops of iron(III) chloride solution (1 in 10). 
No precipitate is produced, and a violet to red-violet color is not formed.  
(5) Toluenesulfonamides   Not more than 25 mg/g. 
Test Solution  Dissolve 10.0 g of Calcium Saccharine in 50 ml of water. Extract 
three times with 30 ml of ethyl acetate each time, combine the ethyl acetate layers, 
wash with 30 ml of sodium chloride solution (I in 4), and transfer the ethyl acetate layer 
to a dry flask. Add about 10 g of anhydrous sodium acetate, shake, and filter into an 
eggplant-shape flask. Wash the residue on the filter twice with 10 ml of ethyl acetate 
each time, and add the washings to the flask. Concentrate under reduced pressure to 
remove the ethyl acetate. To the residue, add exactly 1.0 ml of a solution of caffeine in 
ethyl acetate (1 in 4,000), shake, and allow to stand for 1 minute. Use the resulting 
supernatant as the test solution. If necessary, centrifuge to obtain the supernatant.   
Standard Solution  Dissolve about 0.025 g each of o-toluenesulfonamide and 
p-toluenesulfonamide, accurately weighed, in ethyl acetate to make exactly 100 ml. 
Concentrate exactly 1 ml of the resulting solution under reduced pressed to remove the 
ethyl acetate, and to the residue, add a solution of caffeine in ethyl acetate (1 in 4,000) to dissolve it.  
Procedure   Analyze 1 ml portions of the test solution and the standard solution by 
gas chromatography using the operating conditions given below. Measure the peak area 
ratios of o-toluenesulfonamide to caffeine and p-toluenesulfonamide to caffeine for both 
test solution and standard solution, and designate the ratio as  QT1 and QT2 for the test 
solution and as QS1 and QS2 for the standard solution, respectively. Determine the 
amount of toluenesulfonamides by the formula:  
      Amount of toluenesulfonamides (%) 
        =   򸐨򸐨򸐨
򸐨򸐨򸐨× W 򸐨򸐨+򸐨򸐨򸐨
򸐨򸐨򸐨× W 򸐨򸐨×򸐨
򸐨 򸐨򸐨 򸐨򸐨򸐨  򸐨򸐨 򸐨 򸐨򸐨 򸐨 򸐨򸐨 򸐨򸐨 򸐨  × 100    
WS1= weight (g) of o-toluenesulfonamide in 1 ml of the standard solution 
WS2= weight (g) of p-toluenesulfonamide in 1 ml of the standard solution 
 
Operating conditions  
Detector: Flame ionization detector. 
Column: Use a silicate-glass capillary tube (0.32 mm internal diameter and 30 m 
length) coated with a 0.25 mm thick layer of a mixture of 5%diphenyl and 
95%dimethylpolysiloxane for gas chromatography.   
Column temperature: 185 °C.  
Inlet temperature: 250 °C. 
Injection: Sprit ratio (10:1).   
Carrier gas: Helium or nitrogen. 
Flow rate: Adjust so that the peak of caffeine appears about 10 minutes after 
injection.   
(6) Readily carbonizable substances   Dissolve 0.20 g of Calcium Saccharine in 5 ml  
of sulfuric acid for readily carbonizable substances determination, and keep for 10 
minutes at 48–50 °C. The color of the resulting solution is not deeper than that of 
Matching Fluid A.       
Loss on Drying  Not more than 15.0% (120 °C, 4 hours). 
Assay   Weigh accurately about 0.3 g of Calcium saccharine, previously dried, add 40 ml 
of acetic acid for nonaqueous titration to dissolve, and titrate with 0.1 mol/L perchloric 
acid. Use a potentipmeter to confirm the endpoint. Separately, perform a blank test to 
make correction.  Each ml of 0.1 mol/L perchloric acid = 20.22 mg of C 14H8CaN 2O6S2 
 
 
 Reagents  
2,3-Diaminonaphthalene  Light yellow-brown crystals or powder.  
Melting point: 193–198 °C. 
Sensitivity: Measure exactly 40 ml each of Selenium Standard Solution and diluted 
nitric acid (1 in 60), and adjust the pH to 1.8–22 with ammonia solution. To each, add  
0.2 g of hydroxylamine hydrochloride and dissolve while gently shaking, then add 5 ml 
of a solution that is prepared by dissolving 0.10 g of 2,3-diaminonaphtharine and 0.5 g 
of hydroxylamine hydrochloride in 0.1 mol/L hydrochloric acid and then diluting to 100 
ml. Shake, and allow to stand for 100 minutes. Transfer them into separate separating 
funnels, wash the beakers with 10 ml each of water, and add the washings to the 
corresponding separating funnels. Add 5.0 ml of cyclohexane, and shake well for 2 
minutes to extract selenium. Separately, collect the cyclohexane layers, and centrifuge 
to remove the water. Against the cyclohexane solution from diluted nitric acid (1 in 60), 
measure the absorbance of the solution from Selenium Standard Solution by 
ultraviolet-visible spectrophotometry. The absorbance is not less than 0.08 at a 
wavelength of 378 nm. 
Selenium   Se [K8598] 
Standards Solutions  
Selenium Standard Solution  Dissolve 0.04 g of selenium in 100 ml of diluted nitric 
acid (1 in 2) while heat on a water bath if necessary, and add water to make 1,000 ml.  
Measure exactly 5 ml of this solution, and add water to make exactly 200 ml. To exactly 
2 ml of the resulting solution, add diluted nitric acid (1 in 60) to make exactly 50 ml. 
Prepare fresh before use. Each ml of the standard solution contains 0.04 mg of selenium 
(Se).       
  Appendix 1 
  
Standards for use  
 1. Standards applying generally to all food additives  
   
When a food listed in column 2 of the following table that contains additives listed in column 1 
of the same table is used in the process of the manufacturing or processing of any of the foods 
listed in column 3 in the same table, the additives contained in that food are considered to be 
used in the food listed in column 3.  
Column 1 Column 2 Column 3 
Calcium Saccharin  
Sodium Saccharin 
 
 
 
 
 
 Flour paste (hereinafter in section F, referred to 
as any paste food which is prepared by adding 
sugar, fats/oils, powder milk, eggs, or wheat flour 
to main ingredients such as wheat flour, starch, 
nuts or their processed products, cocoa, chocolate, 
coffee, fruit pulps, or fruit juice, pasteurized, and 
used for bread or confectionery as fillings or 
toppings). Confections. 
 
 
 
 
 
 
Note: the underlined part is newly added. 
   
2. Calcium Saccharin 
  
Target Foods Maximum Limit  Other 
Requirements 
  maximum residue limit as sodium saccharine  
Less than:   
An (sweetened bean 
paste).  0.20 g/kg The maximum 
limits given left 
do not apply to 
foods approved or 
recognized to 
have special 
dietary use 
labeling.  
 Confections (including 
liquid-form and 
powdered-form as 
ingredients). 0.10 g/kg 
Edible ices (including 
sherbets,  flavored 
ices, and other similar 0.30 g/kg foods). 
Fermented milk  
(excluding those used 
as ingredients of lactic 
acid bacterial 
beverages). 0.20 g/kg 
When Calcium 
Saccharin is used 
with Sodium 
Saccharine, the 
sum of the 
residues of both 
substances shall 
be less than the 
corresponding 
maximum limits 
as sodium 
saccharine.  Fermented milk (only 
for ingredients of 
lactic acid bacterial 
beverages).    1.5 g/kg 
Fish paste. 0.30 g/kg 
Fish/shellfish 
(processed, excluding  
fish paste, tsukudani  
(foods boiled down 
with soy sauce), 
pickles, and canned or 
bottled products).  1.2 g/kg 
 
Fish/shellfish (canned 
or bottled processed 
foods).   0.20 g/kg 
Flour pastes. 0.20 g/kg 
Ice cream products 
(including liquid-form 
and powdered-form as 
ingredients). 0.20 g/kg   
Jams. 0.20 g/kg   
Kasu-zuke 
(lee-pickled foods).  1.2 g/kg   
Koji-zuke  (koji (A. 
oryzae )-pickled foods).  2.0 g/kg 
  
Lactic acid bacterial 
drinks. 0.30 g/kg 
  
Lactic acid bacterial 
drinks as ingredients.  1.5 g/kg 
  Milk drinks. 0.30 g/kg   
Miso  (fermented 
soybean paste).  0.20 g/kg   
Miso-zuke  
(miso -pickled foods).  1.2 g/kg   
Nonalcoholic 
beverages. 0.30 g/kg   
Nonalcoholic 
beverages (powdered).  1.5 g/kg   
Nonalcoholic 
beverages (only 
products consumed in 
5-fold or more 
dilution).  1.5 g/kg   
Pickles (preserved or 
pickled foods, 
excluding those listed 
in this column).  0.20 g/kg   
Processed sea weeds. 0.50 g/kg   
Sauces. 0.30 g/kg   
Shoyu-zuke  (soy 
sauce-pickled foods).  1.2 g/kg   
Simmered beans. 0.50 g/kg   
Soy sauce. 0.50 g/kg   
Su-zuke  
(vinegar-pickled 
foods).  2.0 g/kg   
Syrup. 0.30 g/kg   
Takuan-zuke  (rice 
bran-pickled 
radishes).   2.0 g/kg   
Tsukudani (foods 
boiled down with soy 
sauce).  0.50 g/kg   
Vinegar. 0.30 g/kg   
Vinegar (used in 0.90 g/kg   3-fold or more 
dilution). 
Other foods. 0.20 g/kg   
 
  Attachments 2 
  
Standards for use  
 
 Sodium Saccharin  
  
Target Foods Maximum Limit  note 
  as maximum residue limit of 
sodium saccharine  
Less than:   
An (sweetened bean paste).  0.20 g/kg The maximum 
limits  given left do 
not apply to foods 
approved or 
recognized to have 
special dietary use 
labeling.  Confections (including liquid-form and 
powdered-form as ingredients). 0.10 g/kg 
Edible ices (including sherbets, flavored 
ices, and other similar foods). 0.30 g/kg 
Fermented milk  (excluding those used 
as ingredients of lactic acid bacterial 
beverages). 0.20 g/kg 
When Sodium 
Saccharin is used 
with Calcium 
Saccharine, the sum 
of the residues of both 
substances shall be 
less than the 
corresponding 
maximum limits.  
  Fermented milk (only for ingredients of 
lactic acid bacterial beverages).    1.5 g/kg 
Fish paste. 0.30 g/kg 
Fish/shellfish (processed, excluding  
fish paste, tsukudani  (foods boiled down 
with soy sauce), pickles, and canned or 
bottled products).  1.2 g/kg 
 
Fish/shellfish (canned or bottled 
processed foods).   0.20 g/kg 
Flour pastes. 0.20 g/kg 
Ice cream products (including 
liquid-form and powdered-form as 
ingredients). 0.20 g/kg 
Jams. 0.20 g/kg   
Kasu-zuke (lee-pickled foods).  1.2 g/kg   
Koji-zuke  (koji (A. oryzae )-pickled foods). 2.0 g/kg   
Lactic acid bacterial drinks. 0.30 g/kg   Lactic acid bacterial drinks as 
ingredients. 1.5 g/kg 
  
Milk drinks. 0.30 g/kg   
Miso  (fermented soybean paste).  0.20 g/kg   
Miso-zuke  (miso -pickled foods).  1.2 g/kg   
Nonalcoholic beverages. 0.30 g/kg   
Nonalcoholic beverages (powdered). 1.5 g/kg   
Nonalcoholic beverages (only products 
consumed in 5-fold or more dilution).  1.5 g/kg   
Pickles (preserved or pickled foods, 
excluding those listed in this column).  0.20 g/kg   
Processed sea weeds. 0.50 g/kg   
Sauces. 0.30 g/kg   
Shoyu-zuke  (soy sauce-pickled foods).  1.2 g/kg   
Simmered beans. 0.50 g/kg   
Soy sauce. 0.50 g/kg   
Su-zuke  (vinegar-pickled foods).  2.0 g/kg   
Syrup. 0.30 g/kg   
Takuan-zuke  (rice bran-pickled 
radishes).   2.0 g/kg   
Tsukudani (foods boiled down with soy 
sauce).  0.50 g/kg   
Vinegar. 0.30 g/kg   
Vinegar (used in 3-fold or more dilution).  0.90 g/kg   
Other foods. 0.20 g/kg   
Note: the underlined part is newly added.