Japan Proposes to Revise the Approval Matters for Powdered Infant Formula

On August 16, 2023, the Minister of Health, Labour and Welfare (MHLW) of Japan issued an Approval Matters Proposal Regarding Formulated Milk Powder Containing Fungus Powder (draft), seeking comments from the public until September 15, 2023. The draft proposes the addition of detailed provisions for powdered infant formula, including the inclusion of specific bacterial strains, intake tests for infants, and data requirements.

Bacterial strains:

The added bacterial strains must be Bifidobacterium species or Lactobacillus species (including strains that were classified under Lactobacillus species prior to the reclassification in 2020) that have a history of use in formulated milk powder and other food products consumed by infants and young children in Japan. The genus, species, and strain of the bacteria must be genetically identified.

However, the bacterial strains added to formulated milk powder to be used as a substitute for breast milk should be limited to Bifidobacterium species, which are major constituents of the infant's gut microbiota.

Intake tests:

One of the approval matters is to "clarify the purpose of adding fungus powder to formulated milk powder," which requires conducting intake tests to provide substantiation.

When conducting intake test targeting infants, the intake period should be long enough, from birth to weaning (approximately 6 to 12 months). During the intake period, observations should be made regarding the infant's body weight, height, frequency and characteristics of bowel movements, amount of formula consumed, general clinical symptoms, and any potential effects on health. Additionally, it is recommended to include an observation period after the intake period until the child reaches two years of age.

Furthermore, in order to reduce the risk of infection with pathogenic microorganisms such as Cronobacter sakazakii in infants during formula preparation, it is necessary for consumers to appropriately follow the guidelines, such as the Safe Preparation, Storage and Handling of Powdered Infant Formula Guidelines developed by FAO/WHO. This includes using water at a temperature of 70°C or above for formula preparation and consuming the prepared formula within 2 hours after preparation.

Other approval matters：

(1) Manufacturing method of fungus powder and its usage in food；

(2) Amount of fungus powder added and its rationale；

(3) Estimated intake of added bacterial strains and its rationale (data on resistance to formula temperature, gastric acid, and bile acids, as well as adhesion to mucus and human epithelial cells, etc.):

(4) Effects of formula preparation (data on the bacterial count of added strains, as well as the presence of pathogenic microorganisms such as Salmonella species and Cronobacter sakazakii):

Recommended reading

According to the Ministerial Ordinance Concerning Compositional Standards, Etc. for Milk and Milk Products, formulated milk powder refers to the powdered product that is created by processing or utilizing raw milk, cow's milk, special cow's milk, or raw water buffalo milk as ingredients. Powdered infant formula is further supplemented with essential nutrients for infants and young children.

Notably, powdered infant formula and liquid infant formula can only contain milk (excluding raw goat's milk, pasteurized goat's milk, and raw camel milk) or dairy products as the main raw material following the types and blending ratios approved by MHLW.