Article 1
This Standard is prescribed in accordance with the provisions of Article 17 of the Act Governing Food Safety and Sanitation.
Article 2
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.
Article 3
The maximum level of microorganism for infant foods:
┌───────┬──────┬───────┬───────┐
│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. │
└──────────────────────────────┘
Article 4
This Standard shall be implemented at release date.