 
 The quantity specified by  the Minister of Health, Labour and Welfare as the quantity that is 
unlikely harm to human health  
 
The government  of Japan will establish  “the quantity specified by  the Minister of Health, 
Labour and Welfare as the quantity that is unlikely harm to human health” for raw materials 
used for  food utensils, containers, and packaging  (UCP) . 
 
Summary  
 The Act Partially Amending the Food Sanitation Act, etc. (Act No. 46 of 2018 ; hereinafter  
referred to as “the Amendment Act ”), promulgated  in June  2018 , requires  the Positive List  
(PL) system  be established . Under  this system,  substances that are included in the raw 
materials  of the material categories  specified by the Cabinet Order ( the targeted category:  
synthetic resin) shall have been  evaluated as safe  when used  in UCP . By this amendment,  
“the quantity specified by  the Minister of Health, Labour and Welfare as the quantity that 
is unlikely harm to human health ” prescribed  in the proviso  of Paragraph (3) of Article 18 
of the  Food Sanitation Act amended by the Amendment Act  (Act no.233 of  1947 ; hereinafter 
referred to as "the amended Food Sanitation Act")  will be  established.  
 Stipulations on the quantity  will be  promulgate d in the winter of  2019 and enforced  in the 
summer of 2020.  
   
Outline of the stipulations  
 Paragraph (3) of Article 18 of the amended Food Sanitation  Act pres cribes that the raw 
material of the material categories  specified by the Cabinet Order ( synthetic resin)  shall be 
the substances listed in the PL ; however, this shall not apply when substances are used in 
the part that does not contact with food and the substance not migrate  into food with  a 
quantity exceeding the quantity specifie d as being unlikely harm to human health . In this 
case, the substances not listed in the PL may be used for UCP.  
 
 The Minister of Health, Labour and Welfare  intends to d ecide the quantity that is unlikely 
harm to human health , which is prescribed in  the proviso  of paragraph (3) of Article 18 of 
the amended Food Sanitation  Act, shall be 0.01 mg/kg in food  based on the deliberation s 
of the  Committee on Utensils, Containers and Packaging of the Food Sanitation Council 
established under the Pharmaceutical Affairs and Food Sanitation Council . 
 
 The quantity migrated into food is calculated by multiplying the concentration of the food -
simulating  solvent by the factor (weight of food that contacts with UCP/ amount  of food -
simulating solvent). This factor may be approximated to 1. Therefore, the quantity of 
migra tion into food  (0.01mg/kg) may be considered to be  0.01mg/L as the concentration of Attachment   
 the food-simulating solvent.  
 
Confirmation with  food-simulating solvent shall  be based on  the migration  test method  
provided in the Guideline for Assessment of the Effect of Food on Human Health 
Regarding Food Utensils, Containers and Packaging (issued by the Food Safety 
Commission of Japan on May 28, 2019).  