Sanitation Standard for the Microorganism in Infant Foods

This Standard is prescribed in accordance with the provisions of Article 17 of the Act Governing Food Safety and Sanitation.

This standard applies to powdered or liquid formula for infants not more than 12 months of age, intended to supplement breast milk, and the follow-up infant formula manufactured primarily from the edible components of cereals and legumes which should constitute at least 25% of the final mixture on a dry weight basis.

┌───────┬──────┬───────┬───────┐│Microorganisms│Samplingplan│Limits(2) │Remark ││ │(1) │ │ ││ ├──┬───┼──┬────┤ ││ │n │c │m │M │ │├───────┼──┼───┼──┼────┼───────┤│Coliform │5 │2 │(3) │10 │The detected ││(MPN/g) │ │ │＜ 3│ │results ││ │ │ │ │ │allowable ││ │ │ │ │ │between m and ││ │ │ │ │ │M from ≦ c ││ │ │ │ │ │sample ││ │ │ │ │ │quantity. ││ │ │ │ │ │Unacceptable ││ │ │ │ │ │≧M. │├───────┼──┼───┼──┼────┼───────┤│Enterobacter │10 │0 │0 │negative│Apply to ││sakazakii │ │ │ │ │powdered ││(Cronobacter │ │ │ │ │infant ││species) │ │ │ │ │formula. │├───────┼──┼───┼──┼────┼───────┤│Salmonella │10 │0 │0 │negative│ ││spp. │ │ │ │ │ │├───────┼──┼───┼──┼────┼───────┤│Listeria │10 │0 │0 │negative│ ││monocytogenes │ │ │ │ │ │├───────┴──┴───┴──┴────┴───────┤│(1)n= number of units comprising the sample. ││ c= maximum allowable number of sample units yielding ││ results between m and M (marginally acceptable). ││(2)m= a microbiological limit that separates good quality ││ from marginally acceptable quality. ││ M= a microbiological limit above which sampling results ││ are unacceptable or defective. ││(3)m= " ＜ 3"is the MPNs per gram that refer to the methods ││ of test for Coliform bacteria. │└──────────────────────────────┘

This Standard shall be implemented at release date.