Setting  of the Standards for Liquid Infant Formula  
 
 
Summary  
Pursuant to  the provision of  Paragraph 1 , Article 11  of the Food Sanitation Act,  from  the 
viewpoint of public health , the Minister of Health, Labour and Welfare is authorized to 
establish standards  for the methods of producing, processing, using, cooking, or preserving 
food or additives to be served for the purpose of  marketing ; or to 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.  
In addition, pursuant to  the provision of  Paragraph 1 , Article 18  of the Food Sanitation Act,  
from  the viewpoint of public health , the Minister of Health, Labour and Welfare is authorized 
to establish  standards for the utensils , containers and packaging, or the raw materials thereof 
to be served for the purpose of marketing  or to be used in business, or establish standards  for 
the production methods thereof, by hearing the opinions of the Pharmaceutical Affairs and 
Food Sanitation  Council.  
Compositional standards for milk and milk products , food principally made from milk and 
milk products,  and containers and packaging  thereof are stipulated in the Ministerial Ordinance 
on Milk and Milk products Concerning Compositional Standards, etc. (hereinafter referred to as " the 
Ministerial Ordinance on Milk, etc.")  pursuant to  the provision of  Paragraph 1 , Article 11  and 
Paragraph 1, Article 18 of the  Food Sanitation Act. 
The MHLW intends to amend the Ministerial Ordinance on Milk, etc.  to establish  
specifications and standards  for liquid infant formula  based on the deliber ation result of the 
special committee  of the Pharmaceutical Affairs and Food Sanitation Council  as follows.  
 
Amendments  
Specifications and standards  for liquid infant formula are  stipulated  as follows.  
 
1. Definition  
In the Ministerial Ordinance on Milk, etc. , "liquid infant formula " means the products  which 
are obtained from product made by processing food made from  raw milk, cow's milk or 
special -type cow's milk or made from them as principal raw materials, by adding the 
necessary nutrients for infants , and by reducing to liquid . 
 
2. Standards of manufacturing  
(a) Liquid infant formula shall be packed in preservation container s and sterilized  by 
heating at 120oC for 4 minutes or using a method superior or equivalent  to the former method  in pasteurization effect . 
(b) Liquid infant formula shall be steriliz ed using  a conti nuous heat sterilizer  and be filled  
aseptically  in pre -sterilized container and packaging . (The l iquid infant formula  shall  
be authorized as shelf-stable food by the Minister of Health, Labor and Welfare. ) 
 
3. Compositional standards   
(a) Viable bacterial cells: Negative ( the t est methods shall conform  to that for food packed 
in containers and sterilized by pressurization and heating. ) 
(b) Bacterial count : 0 (per 1 mL by standard plate count method after incubation for 14 
days at  30±1oC or 7 days at 55 ±1oC) 
 
4. Standards of storage  
Liquid infant formula  shall be stored at  temperature not exceeding room  temperature.  
 
5. Standards of containers and packag ing 
Same  standards as that of milk drink stipulated  in the Ministerial Ordinance on Milk, etc.  are 
established.  
 
6. Other standards  
The following stipulation  is established in the same way as  formulated milk powder . 
In liquid infant formula , nothing shall be used other than milk (excluding raw goat ’s milk,  
pasteurized goat ’s milk and raw sheep ’s milk), milk products or those that received the 
approval of  the Minister of Health, Labour and Welfare for their types and mixing ratios.