Revision of the Ministerial Order on Milk and Milk Products Concerning 
Compositional Standards, Etc. 
 
Summary 
Pursuant to Article 13, Paragraph (1) of the Food Sanitation Act, and from the viewpoint 
of public health, the Minister of Health, Labour and Welfare may establish the criteria 
for the methods of producing, processing, using, cooking, or preserving food or additives to 
be served for the purpose of marketing; or may establish standards for the ingredients of 
food or additives to be served for the purpose of marketing by hearing the opinions of the 
Pharmaceutical Affairs and Food Sanitation Council (“the PAFSC”). 
 
Standards and criteria for milk, milk products, and food mostly made from milk and milk 
products are stipulated in the Ministerial Order on Milk and Milk Products Concerning 
Compositional Standards, Etc. ("the Ministerial Order on Milk, Etc.") pursuant to the 
stipulation in Article 13, Paragraph (1) of the Food Sanitation Act. 
 
Based on the deliberation results of the expert committee of the Food Sanitation Council 
established under the PAFSC, the Ministry of Health, Labour and Welfare will amend 
the Ministerial Order on Milk, Etc. to establish standards and criteria for the cow’s milk, 
etc. (i.e., cow’s milk, composition modified milk, low fat milk, skimmed milk, processed 
milk, liquid infant formula, and milk drink) that are not required to be stored at 10°C or 
below, as given below: 
1. Products that are sterilized, and then aseptically filled into containers/packages; and 
2. Products that are filled into containers/packages, and then sterilized. 
 
Amendments (draft) 
Establishment of standards and criteria for the cow’s milk, etc. that are not required to be 
stored at 10°C or below. 
 
1.  Products that are sterilized, and then aseptically filled into containers/packages 
(1) Compositional standards 
Viable bacterial cells: Negative (the test methods must conform to those for “food 
packed in containers and sterilized by pressurization and heating.”) (2) Criteria for manufacturing 
The manufactures concerned must establish methods (i) and (ii) as given below, and 
must carry out the methods. 
(i) a method to sterilize by heating at 120°C for 4 minutes, which provides sufficient 
effects to kill bacterial cells in such products that are derived from their raw 
materials and are viable in these products, or any other method providing a 
comparable or superior effect 
(ii) a method to aseptically fill into pre-sterilized containers/packages 
(3) Criteria for storage 
The products concerned must be stored at a temperature not exceeding room 
temperature. 
(4) Other criteria 
The records on sterilization with automatic recording thermometers must be retained 
for a reasonable period considering the period until consumption. 
 
2. Products that are filled into containers/packages, and then sterilized 
(1) Compositional standards (excluding liquid infant formula) 
Viable bacterial cells: Negative (the test methods shall conform to those for “food 
packed in containers and sterilized by pressurization and heating.”) 
(2) Criteria for manufacturing (excluding liquid infant formula and milk drink) 
The products concerned must be packed in preservation containers and sterilized by 
heating at 120°C for 4 minutes or sterilized using any other method providing a 
comparable or superior effect. 
(3) Other criteria 
The records on sterilization with automatic recording thermometers must be retained 
for reasonable period considering the period until consumption.