EFSA Panel advises on how to avoid microbiological risks in infant formulae, at home and in hospital

The European Food Safety Authority’s (EFSA) Scientific Panel on Biological Hazards (BIOHAZ Panel) published today an opinion relating to microbiological risks in infant and follow-on formulae. The Panel concluded that Salmonella and Enterobacter sakazakii (E. sakazakii) are the micro-organisms of greatest concern. In order to minimise exposure among high risk infants, experts advised that where breast-milk substitutes are utilised, it is preferable to choose commercial sterile liquid formulae. Infant and follow-on formulae containing low levels of these micro-organisms do not appear to cause illness in healthy infants and young children. Nevertheless due to the potential for multiplication of these micro-organisms during the preparation and holding time prior to consumption of the reconstituted formula, contamination of powdered infant formula is a considerable risk factor. Compliance with high standard processing conditions and appropriate hygienic measures are of highest importance. The BIOHAZ Panel has therefore recommended guidelines that should be followed – both at home and in hospitals-- in the preparation, handling, storage and use of infant formula.

Infants and young children are particularly vulnerable to food borne infections; therefore, the microbiological safety of infant and follow-on formulae is of utmost importance. Studies demonstrate that contamination of powdered infant formula with E. sakazakii and Salmonella have been a cause of infection and illness in infants and young children, and can severely impact infant and child development and health, leading even to death. However, taking into account the quantities manufactured and the number of servings consumed daily, illness is very rare.

EFSA was asked by the European Commission (EC) to identify the microbiological risks related to infant formulae, to evaluate the significance of these risks to public health and to identify the best control options with regard to their effectiveness in reducing these risks.

The Panel concluded that E. sakazakii and Salmonella are the micro-organisms of greatest concern in both infant and follow-on formulae.

While healthy infants and young children can tolerate the consumption of a low number of these micro-organisms, infants at greatest risk are neonates (up to ca. four weeks), particularly pre-term infants, low-birth-weight or immunocompromised infants. Therefore, in order to minimise the risks Salmonella and E. sakazakii should not be present in formulae given to these ‘high-risk’ groups, for instance by using ready-to-feed commercially sterile formula.

Caregivers in hospital neo-natal units should be repeatedly alerted to the fact that powdered infant formula is not a sterile product and that strict hygiene measures during preparation and reconstitution are necessary. Manufacturers’ instructions should always be strictly followed in order to ensure safe use.

As good hygienic practices are essential at all levels in order to avoid recontamination and/or multiplication of the micro-organisms in the reconstituted formula, the Panel has recommended specific guidelines for the reconstitution, handling, storage and use of formula. When these formulae are used in the home, the Panel advises:

  • Good hygienic measures are essential to avoid contamination (e.g. wash hands, ensure cleanliness of kitchen and equipment...)
  • Prepare powdered infant formula fresh for each meal.
  • Use “sanitised” containers to reconstitute the formula (e.g. use clean bottles, ideally sterilised in boiling water).
  • Always reconstitute formulae in hot water (>70°C) or water that has been boiled and cooled, avoiding recontamination.
  • Cool the reconstituted formula rapidly to use temperature.
  • Use the reconstituted formula immediately.
  • After feeding discard any remaining formula.

In addition, more specific guidelines for use by caregivers in hospitals are indicated in the opinion.

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