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ISDI position on Enterobacter sakazakii in Powdered Infant Formula

Background
ISDI takes very seriously the reports identifying powdered infant formula as a source and vehicle for E. sakazakii infections. Reported cases of E. sakazakii infection in which powdered infant formula was identified as a source are uncommon and have occurred mainly in hospitalised, pre-term and very low-birth weight infants; nevertheless they were serious episodes.

ISDI, therefore, welcomes the Joint FAO/WHO Workshop on Enterobacter sakazakii and Other Microorganisms in Powdered Infant Formula2 held in response to a request for scientific advice on the issue from the Codex Committee on Food Hygiene.

Infant formula manufacturers are committed to providing safe and nutritionally adapted products. They do so in strict compliance with national legislation and international (CODEX) recommendations based on the scientific expertise of FAO and WHO.

About E. sakazakii
E. sakazakii is a bacterium which belongs to the Enterobacteriaceae family. Its presence is not limited to infant formula production units; it is widely found in the environment, including hospitals and homes.

E. sakazakii contamination of infant formula can occur at very low levels during the production process. However, all available data indicate the increased infection risk arising from multiplication of potentially pathogenic bacteria in reconstituted formula kept at room or warmer temperatures for prolonged periods of time , primarily in hospital neonatal intensive care units.

Risk reduction in production
No other breast-milk substitute is as safe as commercial infant formula, when produced according to international standards. Ensuring the highest level of product quality and safety is the primary concern of infant formula manufacturers. Specific and very strict hygiene and quality management procedures are implemented and continuously improved during infant formula production to maximally reduce Enteriobacteriaceae post contamination, including E.sakazakii. ISDI thus welcomes the FAO/WHO risk reduction strategies, specifically, that industry:

• Should continue to reduce the prevalence of Enteriobacteriaceae in the manufacturing environment and in powdered infant formula
• Use an effective environmental management program
• Promote the use of Enterobacteriaceae as an indicator of hygienic control in factories.

Importance of Handling Infant Formula
Powdered infant formula, as in the case of foods in general, is not sterile. Providing correct information, education and labeling about hygienic practices when handling infant food is, therefore crucial. When preparing and handling infant formula the recommended hygiene measures must be followed.

ISDI welcomes the Joint FAO/WHO Workshop recommendations to develop guidelines for the preparation, use and handling of infant formula endorsing the following preventive measures:

To minimize the risk of contamination of reconstituted formula during preparation-

• Ensure the application of good hygienic practice in the preparation area at hospitals and adequate information and labeling of the products for the consumer. When necessary, mothers should be taught to prepare formula correctly before they leave hospital.

To minimize the growth of E. sakazakii following reconstitution and prior to consumption-

• See that the product is consumed immediately upon reconstitution and in accordance with the advice of health professionals. In hospitals, where large amounts of formula may be prepared at once, the product should be cooled rapidly and time between preparation and consumption minimized.

ISDI therefore strongly supports the use of freshly prepared infant formula.

ISDI supports

• Recommending breastfeeding as the ideal to mothers in all instances, while ensuring that those who cannot, or choose not to breastfeed, receive accurate information and education about basic hygiene practices in connection with handling, storage and formula preparation. Mothers should be taught to correctly prepare formula before leaving hospital, when necessary.
  
  
• That public health authorities ensure that health professionals receive effective risk management guidelines and training about basic hygiene practices in connection with handling, storage and formula preparation to avoid bacterial multiplication and E. sakazakii outbreaks, particularly in neonatal units.

ISDI member companies are committed to providing safe and nutritionally adapted infant foods in strict compliance with national legislation and international recommendations based on the scientific expertise. ISDI will continue to cooperate with FAO and WHO, governments and other concerned parties in any revision of existing Codex standards and regulations to include aspects regarding Enterobacteriacae and other micro-organisms.

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