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8.1 Key findings

Intrinsic contamination of powdered formula with E. sakazakii or Salmonella can cause infection and illness in infants, including severe disease, and can lead to serious developmental sequelae and death. Other means for E. sakazakii illness in infants are plausible. A case where sterile formula was contaminated by starch has been documented, but other modes have not been clearly demonstrated. Means of transmission other than powdered infant formula have been demonstrated for infant salmonellosis.

The potential role of other Enterobacteriaceae has not been established but cannot be ruled out, given the limitations of current surveillance systems. While other pathogens (e.g. toxigenic bacteria) have been identified in powdered infant formula, their presence has not been implicated as causing illness in infants.

E. sakazakii has caused disease in all age groups. From the age distribution of reported cases, it is deduced that infants (children <1 year) are at particular risk. The infants at greatest risk from E. sakazakii infection are neonates (<28 days), particularly pre-term infants, low-birth-weight infants or immunocompromised infants. Infants of HIV-positive mothers are also at risk, because they may specifically require infant formula and they may be more susceptible to infection.[14], [15] The latter consideration, as well as low birth weight, may be of particular concern for some developing countries, where the proportion of such infants is higher than in developed countries.

There is a small but finite possibility that one or a small number of organisms in a serving could cause illness. This risk increases rapidly if the level of E. sakazakii is allowed to increase. Low numbers of E. sakazakii in powdered infant formula were also considered to be a significant risk factor, given the potential of even low numbers to multiply during preparation and holding prior to consumption of reconstituted formula.

There is very little known about virulence factors and pathogenicity of E. sakazakii. Phenotypic and genetic studies indicate diversity within the species. There are differences in the microbial ecology of Salmonella and other Enterobacteriaceae. Enterobacteriaceae, such as E. sakazakii, are more commonly found in the manufacturing environment, which serves as the primary source of post-pasteurization contamination. Data from industry and control authorities indicate that the detection of Salmonella in finished powdered infant formula is rare and microbial specifications in the current Codex code are probably adequate, in terms of existing technologies. Specific criteria for Enterobacteriaceae or E. sakazakii are not included in the current Codex code.

Using current mix technology, it does not seem possible to produce commercially sterile powders or to completely eliminate the potential of contamination. Based on a preliminary risk assessment, the inclusion of a bactericidal step at the point of preparation and a decrease in holding and/or feeding time of the reconstituted formula were most effective in reducing risk. A combination of intervention measures had the greatest impact.

8.2 Recommendations

8.2.1 To member countries, NGOs, FAO and WHO

8.2.2 To Codex (e.g. CCFH)

8.2.3 To member countries, FAO, WHO, Codex and NGOs

8.2.4 To FAO, WHO and the scientific community

[14] The UN guidance for these infants is that where replacement feeding is acceptable, feasible, affordable, sustainable and safe, avoidance of all breastfeeding is recommended, and powdered infant formula may be an option. Some of these infants may be HIV-positive and thus immunocompromised.
[15] As a global public health recommendation, infants should be exclusively breastfed for the first 6 months of life to achieve optimal growth, development and health. Thereafter, to meet their evolving nutritional requirements, infants should receive nutritionally adequate and safe complementary foods while breastfeeding continues until up to 2 years of age or beyond. Infants who are not breastfed require a suitable breastmilk substitute, such as an infant formula prepared in accordance with applicable Codex Alimentarius standards. Information provided in this connection to mothers and other family members who need to use it should include adequate instructions for appropriate preparation and the health hazards of inappropriate preparation and use (WHO, 2002).
[16] Nutritional and other factors need to be considered, e.g. alteration of nutritional content, risk from burns due to handling boiling or hot water or formula, and potential for increased risk from germination of bacterial spores. The formula should thereafter be cooled and handled properly.

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