Since 1961, two cases of Enterobacter sakazakii meningitis in neonates were reported in the United Kingdom, more outbreaks of Enterobacter sakazakii meningitis in neonates were frequently reported from various countries worldwide. The relative contribution of powdered infant formula sources to the burden of E. sakazakii disease was considered. At the 35th Codex Committee on Food Hygiene, the United States and Canada updated the Risk Profile of Enterobacter sakazakii in Powdered Infant Formula in 2003. In 2004, the 36th Codex Committee on Food Hygiene agreed and set a working group, lead by Canada, with assistance of other countries to proceed with the revision of the International Code of Hygienic Practice for Foods for Infants and Children and to develop the microbiological criteria on E. sakazakii and other relevant microorganisms. The Committee agreed to proceed with this work as quickly as possible.