Amendment to the Enforcement Ordinance of the Food Sanitation Law and the 
Standards and Specifications for Foods and Food Additives 
 
The government of Japan will designate Hy pobromous acid water as an authorized 
food additive. 
 Summary 
Under Article 10 of the Food Sanitation Law (hereinafter referred to as the “Law”), 
food additives shall not be used or marketed  without authorization by the Minister of 
Health, Labour and Welfare (hereinafter referred to as “the Minister”). In addition, when 
specifications or standards are established for f ood additives based on Article 11 of the Law and 
stipulated in the Ministry of Health, Labour a nd Welfare Notification (Ministry of Health and 
Welfare Notification No. 370, 1959), those additiv es shall not be used or marketed unless they 
meet the standards or specifications. 
 
In response to a request from the Minister, the Committee on Food Additives of the 
Food Sanitation Council that is establishe d under the Pharmaceutical Affairs and Food 
Sanitation Council has discussed the adequacy of the designation of Hypobromous acid water as a food additive. The conclusion of the committee is outlined below.  Outline of conclusion  
The Minister, based on Article 10 of the Law, should designate Hypobromous acid 
water, as a food additive unlikely to harm  human health, and establish standards for 
use and compositional specifications, based on  Article 11 of the Law (see Attachment). 
    Attachment 
Hypobromous Acid Water 
 
次亜臭素酸水  
 
 Standard for use  
Hypobromous Acid Water is permitted only for the surface disinfection of edible meat. The maximum use level (as the amount of bromine in 1 kg of a dipping or spray solution) is 0.90 g for edible meat (exc luding poultry) and 0.45 g for poultry. 
 
Compositional specifications  
Substance name  Hypobromous acid water  
Definition  Hypobromous Acid Water is an aqueous solution consisting mainly of 
hypobromous acid. It is obtained  by hydrolyzing 1,3-dibromo-5,5-dimethylhydantoin.     
Content  Hypobromous Acid Water contains 75–900 mg/kg of available bromine.  
Description   Hypobromous Acid Water is a colorless liquid. It is odorless or has a slight 
characteristic odor.   
Identification   
(1) To 10 ml of Hypobromous Acid Water, a dd 0.15 g of potassium iodide. A yellow to 
brown color is produced.   
(2) Prepare a test solution by adding 1 ml  of Hypobromous Acid Water to 89 ml of 
water. To 0.5 ml of DPD–EDTA TS, add 0.5 ml of phosphate buffer (containing disodium 
ethylenediaminetetraacetate) and 10 ml of the test solution. A light red color is produced. 
(3) The solution obtained by adding 1 drop of sodium hydroxide solution (1 in 2) to 10 
ml of Hypobromous Acid Water exhibits an  absorption maximum at a wavelength of 
324–330 nm. 
Purity  
pH  4.0–7.5. 
Assay   Weigh accurately about 20 g of Hypobr omous Acid Water, add 50 ml of water, 
and then add 1 g of potassium iodide and 5 ml of diluted acetic acid (1 in 4). Immediately stopper tightly and allow to st and in a dark place for 15 minutes. Titrate 
the liberated iodine with 0.01 mo l/L sodium thiosulfate (indic ator: 3 ml of starch TS). Add starch TS near the endpoint, when the so lution is pale yellow. The endpoint is when 
the blue color produced disappears. Separately, perform a blank test to make any necessary correction. 
Each ml of 0.01 mol/L sodium thiosulfate = 0.7990 mg of Br 
 
Regents and Solutions 
N,N-Diethyl- p-phenylenediamine Sulfate   (C 2H5)2NC 6H4NH 2･
H2SO 4  A white to slightly pale brown gr anules, or powder. Soluble in water. 
Content   Contains not less than 98.0% of  N,N -diethyl- p-phenylenediamine sulfate 
((C2H5)2NC 6H4NH 2･H2SO 4).  
Identification  5 ml of a 1 in 40 solution of N,N-Diethyl- p-phenylenediamine 
Sulfate produces a white precipitate when 1 ml  of barium chloride solution (1 in 10) is 
added. 
Purity  (1)  Clarity of solution  Almost clear (0.5 g, water 20 ml). 
(2) Absorbance  Weigh exactly 0.02 g of  N,N -Diethyl- p-phenylenediamine Sulfate, 
add 2.5 ml of phosphate buffer (pH 6.5, co ntaining 1,2-cyclohexanediaminetetraacetic 
acid) and 0.48 g of sodium sulfate, dissolve the solids, and dilute to exactly 50 ml with 
water. Refer to this solution as Solution A. Measure the absorbance of the solution 
against water by ultraviolet-visible spectrop hotometry. It is not more than 0.005 at a 
wavelength of 555 nm. Then, prepare a solu tion obtained by dissolving 0.3 g of 
potassium iodide in 30 ml of Solution A and leaving for 2 minutes and measure its 
absorbance against water in the same ma nner. It is not more than 0.005 at a 
wavelength of 555 nm. Separately, perform a bl ank test for each solution to make any 
necessary correction.  
Assay  Weigh accurately about 0.2 g of N,N-Diethyl- p-phenylenediamine Sulfate 
and dissolve it in 50 ml of water. Titrate the solution with 0.1 mol/L sodium hydroxide. Use a potentiometer to confirm the endpoint.  The endpoint is when the titration curve 
shows a second inflection point. Make correc tion with the volume of titration consumed 
by the first inflection point.  
Each ml of 0.1 mol/L sodium hydroxide = 26.23 mg of (C
2H5)2NC 6H4NH 2･H2SO 4 
1,2-Cyclohexanediaminetetr aacetic Acid Monohydrate  C14H22N2O8･H2O  A white 
powder. 
Content  Contains not less than 99.0% of trans -1,2-cyclohexanediaminetetraacetic 
acid monohydrate (C 14H22N2O8･H2O). 
Identification  Determine the absorption spectrum of 
1,2-Cyclohexanediaminetetraacetic Acid Monohydrate as directed in the Potassium Bromide Disk Method under Infrared Spectrometry. The spectrum exhibits absorption 
at about 3000 cm-1，1750 cm-1，1710 cm-1，1590 cm-1，1430 cm-1，1400 cm-1，1240 cm-1, 
and 1220cm-1. 
Purity  Clarity of solution  Almost clear. Pr epare a test solution  by dissolving 4.0 
g of 1,2-Cyclohexanediaminetetraacetic Acid Monohydrate in 25 ml of sodium hydroxide 
TS and diluting the solution to 100 ml with water. 
Assay  Weigh accurately 0.4 g of 1,2-Cy clohexanediaminetetraacetic Acid 
Monohydrate, and dissolve it in 11 ml of sodium hydroxide. Add 2 ml of ammonia–ammonium chloride buffer (pH 10.7) and wa ter to make 100 ml. Titrate the resulting 
solution with 0.05 mol/L zinc chloride (ind icator: 5 drops of er iochrome black TS). 
Each ml of 0.05 mol/L zinc chloride = 18.22 mg of C
14H22N2O8･H2O 
DPD–EDTA TS  Pulverize 1.1 g of  N,N -diethyl- p-phenylenediamine sulfate in an agate 
mortar. Add 0.2 g of disodium ethylenedi aminetetraacetate dihydrate and a small 
amount of water to dissolve them if necessa ry by heating with stirring.  Add 8 ml of 
25% (w/v) of diluted sulfuric acid, and mix.  Dilute the resulting solution to 1000 ml with 
water. 
Phosphate Buffer (containing disodium ethylenediaminetetraacetate)  Dissolve 24.0 g 
of anhydrous disodium potassium, 46.0 g of monopotassium phosphate, and 0.8 g of disodium ethylenediaminetetraacetate di hydrate in water to make 1000 ml.    
Phosphate Buffer (pH6.5, containing 1,2- cyclohexanediaminetetraacetic acid)  Dissolve 
2.7 g of monopotassium phosphat e in water to make exactly 100 ml. Adjust the pH to 6.5 
with 0.2 mol/L sodium hydroxide. Dissolve 0.13 g of 1,2-cyclohexanediaminetetraacetic acid in the resulting solution.