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Infant formula

Since limited Australian data on microbiological quality of powdered infant formula sold in NSW existed, the NSW Food Authority conducted a market survey.

Powdered infant formula (PIF) is readily available for retail sale in NSW as a supplement or replacement for breast milk.

PIF is heat-treated during processing but it is not subjected to sufficient treatment to make the final packaged product commercially sterile.

PIF production is undertaken using rigorous hygienic precautions coupled with monitoring of the process environment and finished product by the manufacturer. These activities assist in reducing the microbial load.

The organisms of greatest risk with PIF have been identified as:

  • Salmonella:
    A well-known foodborne human pathogen. Overseas, at least 6 reported outbreaks of salmonellosis involving approximately 250 infants were associated with powdered formula between 1985 and 2009.
  • Cronobacter sakazakii (formerly known as Enterobacter sakazakii)
    An opportunistic pathogen emerging as a public health concern. Considerable progress has been made in understanding the ecology of this organism, but there is still little known about its pathogenesis and virulence factors.  

Market survey

91 powdered formulas and 3 ready-made formulas were purchased from retailers in Sydney from September 2009 to December 2010.

At least one sample from each product range available in the market was included in this survey.

Samples were tested for Salmonella, C. sakazakii, and Enterobacteriaceae.


Results were compared against the microbiological requirements of Standard 1.6.1 of the Australian New Zealand Food Standards Code.

Organisms that are not included in Standard 1.6.1 were assessed against the CODEX Microbiological criteria for powdered infant formula (excluding follow-on formula) as specified in the Code of Hygienic Practice for Powdered Formulae for Infants and Young Children CAC/RCP 66 – 2008.

100% of products tested met the limits for Salmonella and C. sakazakii specified in the codes.

Enterobacteriaceae was detected in 3 samples at a low level. The inclusion of this microorganism in testing is not intended to be used for assessing the safety of a specific lot of product. Instead, it is intended to be used for verification of the hygiene programs.

Results of the survey are outlined in:

Table of contents
Executive Summary
1. Introduction
2. Method of analysis
3. Results and discussion
4. Conclusion
5. References
Appendix 1: Epidemiological data that implicate powdered infant formula
Appendix 2: Previous studies
Appendix 3: Survey results 

Safe home preparation

Control strategies are required, both during manufacturing of powdered infant formula and during:

  • rehydration
  • use
  • handling.

If present, pathogens can pose a potential risk after rehydration, especially if the rehydrated product is temperature abused.

Contamination may also occur as a result of the equipment or utensils used eg bottles, spoons etc.

For recommendations on safe preparation and use at home see: