The summary of the amendment to the Cabinet Order and Ordinance for 
Enforcement of the Food Sanitation Act  
 
 
The government of Japan is planning to amend the Cabinet  Order and 
Ordinance for Enforcement of the Food Sanitation Act (hereinafter referred 
to as “the Cabinet Order” and “the Ordinance” respectively)  in order to 
introduce  the system  only substances  evaluated their safety  are allowed to 
be used  for utensils, c ontainers and packaging , which establish ed by the 
amendment to the Food Sanitation Act (hereinafter referred to as “ the Act”) 
promulgated in June 2018 . 
 
Background  
○ The amendment to the Act was established in June 2018 and its 
summary was previously informed to the WTO as G/ TBT/N/JPN/5 82 in 
January 2018 . 
○ In response t o the amendment to the Act , the system  only substances 
evaluated their safety are allowed to be used for utensils, containers 
and packaging  are established , and the Cabinet  Order and the 
Ordinance  will be amend ed to specify the details . 
○ Amendment to the Cabinet Order and the Ordinance  will be adopted  
in the summer of 2019  and will entry into force  in the summer of 2020 . 
 
Outline of the amendment  
Improvement of sanitary regulations for utensils, containers and packaging 
considering international consistency  
○ The material specified by the Cabinet Order according to paragraph 
(3) of Article 18 of the Act (The material subject to the Positive List: 
specifications and standards) is synt hetic resin.  
○ The following issues are established according to the guideline for 
safety assurance in the manufacture etc. of food utensils, containers 
and packaging 
(https://www.mhlw.go.jp/english/topics/foodsafety/containers/dl/guideli
ne-english.pdf).  
 The standards specified by the Ordinance according to item (i) of 
paragraph (1) of Article 52 of the Act (The standards of the 
prerequisite programs)  
 The standards specified by the Ordinance according to item (ii) of 
paragraph (1) of Article 52 of the Act (The standards of Good 
Manufacturing Practice)   Matters for information provision specified by the Ordinance 
according to paragraph (1) and (2) of Article 53 of the Act (Obligation 
to provide information by the business operators who manufacture 
and sell ut ensils, containers, and packaging; and obligation to make 
effort to provide information by the business operators who 
manufacture and sell raw materials)  
Matters for explanation specified in paragraph (1) and (2) of Article 53 
of the Act are as follows:  
1. Information confirms the following points: the products using the 
materials specified by the Cabinet Order according to paragraph (3) of 
Article 18 of the Act are those specified in item (i) or (ii) of paragraph 
(1) of Article 53 of the Act, or the raw ma terials using the materials 
specified by the Cabinet Order  are appropriate as raw materials used 
for the products satisfy the item (i) or (ii)  
2. Information confirms the subjects of above information 1  
 
 The Positive List (specifications and standards) and  the exceptions of 
regulations by the List (migration levels that are no concern relevant 
to human health) will be established separately.  
 
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