Amendment to the Standards and Specifi cations for Foods and Food Additives 
(Ministry of Health and Welf are Notification No. 370, 1959). 
 
  The government of Japan is to revise the existing compositional specifications and use 
standards for Isopropanol as a food additive. 
 
Summary 
  Under Article 10 of the Food Sanitation Act, food additives shall not be used or marketed 
without authorization by the Minister of H ealth, Labour and Welfare (MHLW). In addition, 
when specifications or standards are established for food additives based on Article 11 of the act 
and stipulated in the Ministry of Health, Labour  and Welfare Notification (Ministry of Health 
and Welfare Notification No. 370, 1959), those additives shall not be used or marketed unless 
they meet the standards or specifications.  
In response to a request from the MHLW, the Committee on Food Additives of the Food 
Sanitation Council that is established under th e Pharmaceutical Affairs and Food Sanitation 
Council has discussed the adequacy of revision of the existing specifications and use standards 
for Isopropanol. The conclusion of the committee is outlined below. 
 
Outline of conclusion  
  The MHLW should revise the specifications and use standards for Isopropanol based on Article 11 
of the act (see Attachments).  
 
  Attachment 
Isopropanol 
 
 
Standard for use  
  Currently, Isopropanol is permitted for use only  to flavor food. This amendment will ease the 
current regulation to permit its use to extract components in food as well.  Underlined parts will be added.   
● Flavoring agent 
● Extracting agent  
Isopropanol is permitted to remain in the foll owing products at levels not to exceed the 
corresponding levels (the maximum residue limit). 
Hop extract1  20 g/kg 
Fish protein concentrate2  0.25 g/kg 
Extracts of other foods3   0.2 g/kg of each extract 
 
Notes:  
1. Hop extract is limited to the substance that  is added to the wort during the manufacturing 
of beer and low malt beer (including sparkling liquor).   
2. Fish protein concentrate is fish meat from which the moisture and fat are removed. 
3. Extracts of other foods and products made of these extracts (except products made of hop 
extract and fish protein concentrate). 
 
 
Compositional specifications  
  Sections (4) and (5) of Purity will be newly added. Also two names will be newly adopted as the 
official name of this substance. Underlined parts will be added.  
 
Substance name  Isopropanol, Isopropyl Alcohol, 2-Propanol  
Molecular formula  C3H8O       
Molecular Weight   60.10 
Chemical name [CAS number]   Propan-2-ol  [67-63-0] 
Content  Isopropanol contains not less than 99.7% of isopropanol (C 3H8O). 
Description    Isopropanol is a colorless, transparen t liquid having a characteristic odor.   
Identification   Determine the absorption spectrum of isopropanol as directed in the Liquid Film 
Method under Infrared Spectrophotometry, and compare with the Reference Spectrum. Both spectra 
exhibit similar intensities of absorption at the same wavenumbers.   
Purity  
(1) Refractive index  20
Dn: 1.374–1.380. 
(2) Specific gravity  0.784–0.788.   
(3) Free acids  To 15.0 ml of Isopropanol, add 50 ml of freshly boiled and cooled water and 2 
drops of phenolphthalein TS, and then 0.400.20 ml of 0.01 mol/L sodium hydroxide solution. The 
solution develops red color.  
(4) Lead  Not more than 1.0µg/g as Pb.  
Test Solution   Evaporate 10.0 g of Isopropanol to dryness by heating.  After cooling, add 1 ml 
of sulfuric acid, and heat until white fumes are no longer evolved. Heat at 500ºC for 3 hours in an 
electric furnace. Add 10 ml of diluted hydrochloric ac id (1 in 4), and evaporate to dryness by heating. 
To the residue, and add diluted nitric acid (1 in 150) to dissolve it and make 10 ml.  
Control Solution    To 1.0 ml of Lead Standard Solution, add diluted nitric acid (1 in 150) to 
make 10 ml.  
Procedure   Proceed as directed in Method 1 in the Lead Limit Test.  
(5) Residue on Evaporation  Not more than 0.002 %(w/v) 
Heat an evaporating dish at 105ºC for 30 minut es, cool it in a desiccator, and weigh accurately. 
Measure 100 ml of Isopropanol into the tared evaporating dish, and evaporate to dryness on a water 
bath. Heat the dish at 105ºC for 30 minutes or to constant weight, and weigh it.    
Water  Content Not more than 0.20% (10 g, Direct Titration).     
Assay  Proceed as directed in Method 1 in the Gas Chromatographic Assay in  the Flavor Substance 
Tests, using operating conditions (2).