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On April 19, 2018, Japan Ministry of Health, Labour and Welfare MHLW with the help of Japan Pharmaceutical Affairs and Food Sanitation Council issued a new standard for liquid infant formula, setting the requirements for this product as follows:
1. Definition:
“Liquid infant formula” refers to products obtained by processing raw milk, cow's milk or special milk or made from them as principal raw materials, by adding the necessary nutrients for infants, and by reducing to liquid.
2. Manufacturing Standards:
(a) Liquid Infant formula should be packed in preservation containers and sterilized by heating at 120°C for 4 minutes or with an equivalent or superior method.
(b) Liquid infant formula should be sterilized using a continuous heat sterilizer and be filled aseptically in pre-sterilized containers (as well as having been authorized by MHLW as shelf-stable food).
3. Compositional Standards:
(a) Viable bacterial cells: negative (test method should 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±° C 1or 7 days at 55±1° C).
4. Storage standard: Liquid infant formula should be at room temperature.
5. Container and packaging standards: Same as Ministerial Ordinance on Milk, etc.
6. Other Standards: This 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 the ones that received the approval of MHLW on types and mixing ratios.
The public comment period for this notification will end on June 18th 2018.
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