Safer Feeds For Babies: International Recognition and Detection of Cronobacter spp as an Emergent Bacterial Pathogen Associated with Neonatal Meningitis

Microbiology research at NTU has had a worldwide impact through helping to lower the risk of severe infections among new-born babies from consuming bacterially-contaminated powdered infant formula.

The work addressed widespread public concern over the emerging dangers of the bacterial pathogen Cronobacter spp. Research findings by Professor Stephen Forsythe and his team have informed and facilitated improvements in methods for Cronobacter spp detection and the understanding of neonatal exposure routes and risk factors. In turn, this knowledge has contributed to:

  • safer production of the formula itself
  • changes in international legislation and regulation
  • from 2008, the implementation of new World Health Organisation (WHO) infant formula preparation guides.

Research findings and advice from Professor Forsythe's team have led to:

  • revisions in international regulations on the safe feeding of infants in hospitals and in the home
  • improvements in the microbiological safety of manufactured powdered infant formula.

Influence on international regulatory affairs

Three risk assessments by the Food and Agriculture Organization (FAO)-WHO on the microbial safety of powdered infant formula (2004, 2006, 2008) made recommendations to worldwide regulatory authorities.

WHO risk communication guidelines on the hygienic preparation of powdered infant formula were revised in 2007 and were used to inform individual governmental regulatory authorities.

The recommendations above were adopted (2008 onwards) by the worldwide regulatory community regarding the safe preparation of formula in hospitals and homes.

The development of an online risk assessment model by the Joint FAO-WHO Expert Meetings on Microbiological Risk Assessment (JEMRA) was based on the FAO-WHO reports above for use by formula manufacturers and regulatory bodies.

Prior to 2008 there was no international requirement for the detection of Cronobacter in powdered infant formula. The research has led to changes in risk management by the Codex Alimentarius Commission, with the introduction of international microbial criteria (<1 Cronobacter cell/10g powdered infant formula) for commercially-produced powdered infant formula.

Cronobacter genus recognition and detection methodology implementation

A consequence of the FAO-WHO risk assessments was the new international legal requirement for the absence of Cronobacter spp. in powdered infant formula. Therefore robust and reliable detection methods were needed to ensure both consumer protection and manufacturer protection. Professor Forsythe, in collaboration with industry, co-developed the selective DFI chromogenic agar for Cronobacter spp. This agar is now:

  • commercially available from international microbiological media manufacturers
  • used by powdered infant formula manufacturers
  • compliant with International Standards Organization (ISO) standard ISO/TS 22964
  • a Food and Drug Administration (USA) recommended method (FDA 2012).

Size of at-risk population (beneficiaries) and commercial interest

The size of the at-risk population is estimated to be 150,000-300,000 per annum.

Award-winning research

The impact of Professor Stephen Forsythe's research was recognised as part of NTU's Queen's Anniversary Prize 2015 Award. This is the highest national honour for a UK university.

Queen's Anniversary Prize logo 2015
A gloved hand holding a petri dish in a lab
A father looks at his baby
Baby feet