Revising  Specifications and Standards  (Updat ing the Official Compilation 
of Food Additives ) 
 
 
The government of Japan wi ll revise t he ex isting specifications and standards for 
food additives  and food additive composition . 
 
 
Summary  
The Food Sanitation Act  of Japan  (Act No. 233, 1947)  (“the Act”), in Article 10 , 
prohibits the use and sale  of food additives  that the Minister of Health, Labour and 
Welfare ( “the Minister”)  does not designate  as approved . In addition, when 
specifications or standards for food additives are established based on Article 11 of 
the Act, those additives shall not be used or sold unless they meet the standards or 
specifications.  
 
The specificatio ns and standards established based on Article 11 of the Act are 
stipulated in the Ministry of Health, Labour and Welfare Notification (Ministry of 
Health and Welf are Notification No. 370, 1959) . The Notification  contains general 
notices, general tests, and reagents and solutions required for the t esting of food 
additives as well as compositional specifications for additives and standards for the 
storage, manufacturing, and use there of.  
 
On the  other hand, t he Act requires  the Minister  and the Prime Minister , in 
Article 21 , to prepare the Official Compilation  of Food Additives  contain ing 
compositional specifications and standards and labeling for food additives. The 
compilation contains almost all items for food additives s tipulated in the 
Notification. In 1960 the first edition of the compilation was prepared . Since then  
the compilation ha d been updated regularly  until t he eighth edition  in 2007 .  
 
The Ministry of Health, Labour and Welfare ( “the MHLW ”) is work ing to prepar e 
the ninth edition . Specifically, the M HLW has listed substances that have  been 
designated since the publication  of the eighth edition, revie wed existing testing 
methods and compositional  specifications, and newly set specifications for some 
existing food  additives (food additives from natural origin s). 
 
In August 2016, i n response to a request from the Minister, the Committee on Food 
Additives of the Food Sanitation Council that is established under the 
Pharmaceutical Affairs and Food Sanitation Council  (“the committee ”)  discussed 
whether it was adequate to revise the specifications and standards  for food additives to update  the official c ompilation of food a dditives . The committee  
concluded that the revis ion of the specifications and standards  was adequate.  
 
Since  the committee ’s discussion  in August , specifications have been newly 
established for six substances:  Asparaginase ( A. oryzae  NZYM -SP-derived), 
Sodium selenite, Octanoic acid, Peracetic acid composition, Hypobromous acid 
water , and 1 -Hydroxyethylidene -1,1-diphosphonic acid (HEDP) . In March 2017, 
the committee discussed the description of specifications for the six additives to 
align them with the description requirements for the ninth edition of the Official  
Compilation  of food additive s.  
 
The committee has concluded that the Minister should revise the specifications 
and standards based on Article 11 of the Act in step with the updating of the 
compilation . For details, see Attachment  . 
 
 
Outline  
 The revision of specifications and standards is outlined in Attachment.  Attachment  
Revising Specifications and Standards  
(Updating the Official Compilation of Food Additives ) 
(Additional parts)  
 
Outline of the revision  
The specifications  for the six additives ( Asparaginase  (A. oryzae  NZYM -SP-derived), 
Sodium selenite, Octanoic acid, Peracetic acid composition, Hypobromous acid 
water , and 1 -Hydroxyethylidene -1,1-diphosphonic acid (HEDP) ) will be  revised  as 
below . 
 
1. Conver sion of arsenic specification limits  
In the Arsenic Limit Test , the specification limit, currently expressed as As 2O3, will 
be expressed as As.  Following this change in conversion, specifications for the 
three additives will be revised as follows:  
 
Substance Name Change of specifications limit for 
Arsenic  ( As 2O3 → As) 
(µg／g) 
Asparaginase (asparaginase ( A. oryzae  
NZYM -SP-derived))  4.0 → 3 
Sodium selenite  4.0 → 3 
HEDP  6.7 → 5 
   
The change in the description of the specification limit is to harmonize with JECFA 
arsenic standards  expressed as As. Please note that this change is simply  
conversion and there will be no substantial change in specification limit.  
 
2.  Others  
Some descriptions will be aligned  for consistency in wording  including examples.