Japan | New Standards for Liquid Infant Formula (MHWL No. 0808 No. 2 of 2018)
The Ministry of Health, Labour and Welfare (MHLW) of Japan has announced partial revisions to "The Ministerial Ordinance on Milk and Milk Products Concerning Compositional Standards, etc. (Setting of the Standards for Liquid Infant Formula)" (MHWL No. 106 of 2018).
The specifications and compositional standards for milk and so on has been defined by the “Ministerial Ordinance Concerning Compositional Standards, etc. for Milk and Milk Products” pursuant to Article 11(1) and Article 18(1) of the Food Sanitation Act (Act No. 233 of 1951, hereinafter referred to as the "Act"). Food targeting infants has been defined as “powdered infant formula” and its specifications and standards have been established.
However, the ministerial ordinance shall be amended to ensure the safety of liquid infant formula (hereinafter referred to as “liquid infant formula”) which has been added with the nutrients for infants similar to that of powdered infant formula. The definition and required compositional standards of liquid infant formula shall be established.
Definition of “liquid infant formula”:
Pursuant to 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 then reducing to liquid.
Manufacturing standards:
(a) Liquid infant formula shall be packed in preservation containers and sterilized by heating at 120 ℃ for 4 minutes or using a method superior or equivalent to the former method in pasteurization effect.
(b) Liquid infant formula shall be sterilized using a continuous heat sterilizer and be filled aseptically in pre-sterilized container and packaging. (The liquid infant formula shall be authorized as shelf-stable food by the Minister of Health, Labour and Welfare.)
Compositional standards:
(a) Viable bacterial cells: Must be tested negative The test 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±1 ℃ or 7 days at 55±1℃)
Standards of storage:
Liquid infant formula shall be stored at temperature not exceeding room temperature. Standards of containers and packaging:Same standards as that of milk drink stipulated in the Ministerial Ordinance on Milk, etc. are established.
Other standards:
The following stipulation is established in the same way as infant formula 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.
Pursuant to this amendment,
Sodium Selenite and Biotin will be allowed to be used in liquid infant formula.
Please refer to my article, "Japan|Partial Amendment of Standards and Specifications for Foods and Food Additives (MHWL No. 302 of 2018)"
Further, in accordance to the partial revision of the "Enforcement Regulations of the Food Sanitation Act and The Ministerial Ordinance on Milk and Milk Products Concerning Compositional Standards, etc." (no. 38 of 1983 revised as of Aug 8, 2018), the wordings for the standards of use of breast milk substitute food such as sodium selenite, zinc gluconate, ferrous gluconate, copper gluconate, biotin, zinc sulfate, copper sulfate, etc. where it states
“powdered infant formula for consumption as breastmilk substitutes and other infant milk powders”
shall be amended as
“powdered and liquid infant formula for consumption as breastmilk substitutes and other powdered infant formula”.
Source:
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