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Background
E. sakazakii is an opportunistic pathogen widely found in a variety of foods and generally in the environment, in homes, hospitals, water and in factories. The World Health Organization (WHO), among other experts, points out that illness that can be attributed to the presence of this micro-organism in reconstituted infant formula is rare. While tens of millions of infants have thrived on infant formula over decades, in the past 40 years, there have been 55 documented cases of infant infection from E. sakazakii, most of them premature or very low-birth-weight infants.
Investigations in hospitals, where most of the cases were recorded, showed that recommended procedures for the preparation and storage of the formula had not been followed. All available data indicate that risk of infection arises when reconstituted formula is kept at room temperature (or warmer) for prolonged periods of time. The FAO/WHO workshop (February 2004) noted that reduction in the frequency of E. sakazakii contamination of infant formula powder might only reduce the risk of infection 4 to 5 fold, while minimizing the time between preparation and consumption might reduce the risk 30 fold. Appropriate training and hygiene in hospitals is, therefore, critically important in avoiding E. sakazakii outbreaks.
Conclusions
- The infant food industry takes any report of infection resulting from the reconstitution of powdered infant formula extremely seriously.
- The industry is deeply concerned by attempts to exaggerate the danger of E. sakazakii in infant formula out of proportion to its extremely rare occurrence and contrary to the low risk that WHO assigns to it.
- Proposals to put labels on infant formula warning against E. sakazakii contamination misrepresent the scientific evidence. Infant formula is produced according to international standards of composition and hygiene, and WHO recognizes it as the only safe alternative to breast milk.
- Industry supports WHA Resolution WHA58.32, which urges Member States to “ensure that clinicians and other health-care personnel, community health workers and families, parents and other caregivers, particularly of infants at high risk, are provided with enough information and training by health-care providers, in a timely manner on the preparation, use and handling of powdered infant formula in order to minimize health hazards.”
- Labels on infant formula already contain clear and extensive information about proper preparation, handling and storage procedures. Relying on warning labels without effective caregiver education can needlessly alarm parents and motivate them to use a product like powdered milk which has no caution label, even though it is nutritionally inappropriate for an infant.
- Public health interest is not served by requiring a warning label on powdered infant formula. Rather than needlessly alarming consumers, the health community should unite with the industry to focus on providing and implementing information on appropriate handling and storage of the reconstituted product.
- Combined control measures and continued close cooperation between global and national health agencies, the infant food industry and health providers has been shown to be the best way of reducing risk of infection.
January 2007
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