Japan’s reply to the comments of IOFI regarding 
the WTO notification G/TBT/N/JPN/624 
 
 
Japan appreciates the comments on “Amendment to the Poisonous and Deleterious Substances 
Designation Order” notified to the World Trade Organization (WTO) as G/TBT/N/JPN/624. 
 
1. To provide detailed implementation rules and measures of the Amendment prior to the 
enforcement. 
 
We provided food related associations including Japan Margarine, Shortening and Lard 
Industries Association, food business operators and general consumers with the content of the 
revision concerned. 
Concrete pieces of information provided are as follows (only in Japanese): 
- Amendment to the Poisonous and Deleterious Substances Designation Order (Cabinet Order 
No.31 of June 19, 2019. “KAMPO” (Official Gazette)) 
https://search.npb.go.jp/kanpou/?uji.pageid=5&uji.verb=image&articleName=20190619kg0
0040000020seire&dspPage=29&subWindowId=eMJcaRlo&totalPage=30&uji.verbs=text%2
Cimage&uji.id=mainbody&uji.bean=jp.go.npb.haishin.web.bean.article.ArticleResultListEv
entBean 
- Amendment to the Poisonous and Deleterious Substances Designation Order (Notification 
YakuSeiHatsu 0619 No.1 of June 19, 2019) 
https://www.mhlw.go.jp/hourei/doc/tsuchi/T190619I0020.pdf 
- Public consultation (summary) 
 https://search.e-gov.go.jp/servlet/PcmFileDownload?seqNo=0000186290 
 
2. To grant a sufficiently long transitional period before the Amendment is fully implemented. 
 
Generally, we decided the transitional period of this amendment is from 1st July 2019 to 30th 
September 2019, taking the burden on Poisonous and Deleterious Substances business 
operators into consideration. 
Regarding these substances we are going to designate them as deleterious ones, we started the 
examination for designation more than one year ago and published information on the web page 
of Poisonous Substances and Deleterious Substances sectional meeting of the Pharmaceutical 
Affairs and Food Sanitation Council. (Only in Japanese) 
- https://www.mhlw.go.jp/stf/shingi/shingi-yakuji_127875.html 
 
3. To clarify the scope of “preparations”. For instance, certain food products may contain 
much higher con-centration of the fatty acids as regulated in this Amendment (e.g. 
enzymatically processed cheese) – Actually, would this type of products also fall under the 
scope of PDSCA?  
  
 Products containing Poisonous Substances or Deleterious Substances are regarded as 
"formulation". 
Out of four fatty acids, Pentanoic acid, Hexanoic acid and Heptanoic acid are going to be 
designated as scheduled. 
However, we decided to give up designation of Butyric acid this time, because we realized that 
our examination was insufficient taking into account of the opinion received during public 
consultation. 
Therefore, we decided to examine more data including concentration at which the safety to a 
human body is assured, and decided not to designate Butyric acid as deleterious substance this 
time. 
 
4. To establish appropriate analytical methods for the detection of violations (i.e., exceeding 
the concentration thresholds set forth by this Amendment).  
 
Business operators who manufacture, import or sale, etc. of products need to judge whether 
substances contained fall under Poisonous Substances or Deleterious Substances. 
Since the composition of Poisonous or Deleterious Substances and others differs from product 
by product, it is difficult for us to establish general analytical methods for all of the products. 
We ask each business operators to grasp the amount of chemical substances used in their 
products by cooperation with companies from which they purchase source materials, and by  
appropriate sharing of information , and we ask them to take action needed based on the provision 
of the Poisonous and Deleterious Substances Control Act.