Do you know that powdered baby milks or formulas, even in sealed and unopened packets, are not sterile products?

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In 2002, the US Food and Drug Administration alerted health care providers to the risks to premature infants posed by the intrinsic contamination of powdered infant formula”. This means that small numbers of harmful bacteria may already be present in sealed packages of powdered formula. Powdered formula is not a sterile product and bacterial contamination can already occur at several entry points at factory level. Parents and caregivers therefore need clear instructions on how to prepare, handle and store powdered formula to minimise this unavoidable risk.

In 2003, the Risk Profile on Enterobacter sakazakii, prepared at the request ofthe Codex Committee on Food Hygiene by USA and Canada,identified the presence of heat-resistant pathogens such as Enterobacter sakazakii in powdered infant formula as a “known public health risk“. The Risk Profile noted thatE. sakazakii is known to be present in a proportion of powdered infant formula, such formula has been epidemiologically linked with illness in neonates, and such illness may be life threatening. That alone is enough to seriously consider appropriate strategies to reduce this documented risk”. Codex defines such a known public health risk as having “high impact in terms of severity for a wide range of consumers and for specific sensitive populations“.

Enterobacter sakazakii is among several of these harmful bacteria that may be present in tins of powdered formula. It is also the pathogen that causes the most severe disease in newborns: research studies in industrialised countries document outbreaks of invasive infections with high mortality rates in newborns. Enterobacter sakazakii has been implicated in many of these countries in outbreaks of meningitis, sepsis or necrotizing enterocolitis.

IBFAN has documented recalls of batches of powdered infant formula that were contaminated by harmful bacteria: Salmonella species, Enterobacter sakazakii.  After these bacteria were detected in tins and packages of powdered formula, governments required the manufacturers to recall the products. However, these recalls took place mainly in industrialised countries: there is at present little data on contamination of powdered formula used in developing countries, and yet defective or expired tins of formula are often repackaged and reported to these countries. 

IBFAN´s working group collaborates with consumer organisations and dialogues with WHO´s Department of Food Safety to reflect the strong concerns of parents and product users.  In 2004 and 2006, FAO and WHO held two Joint expert meetings on Enterobacter sakazakiiSalmonella and other microorganisms in powdered infant formula (see 

IBFAN participates in the standard setting processes for infant formulas at the Codex Alimentarius to ensure that the protection of breastfeeding and infant and young child health is maintained through the application of the International Code of Marketing and Breastmilk Substitutes and full and informative labelling to minimize the unnecessary use of infant formulas.   For example, IBFAN represents product users at the Codex Committee on Food Hygiene (CCFH) and on the CCFH Working Group which is drafting the Proposed Draft Recommended International Code of Hygienic Practice for Powdered Formulae for Infants and Young Children, to revise the previous code dating from 1979, the year before Enterobacter sakazakii was identified as a separate species.

In 2005, IBFAN successfully advocated for a strong World Health Assembly resolution to urge governments to take national measures to inform product users of risks. Resolution WHA 58.32 urges governments to: “ensure that clinicians and other health-care personnel, community health workers and families, parents and other care-givers, particularly of infants at high risk, are provided with enough information and training that powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately; and .. that this information is conveyed through an explicit warning on packaging“. 

The IBFAN network is working globally to maintain pressure on governments to implement this resolution. Governments should ensure that all parents and caregivers receive information about the need to take extra precautions in preparation, storage and handling of powdered baby milk, and that they are warned about how to minimise the risk through specific notices on product labels.

The baby food industry is also working globally to minimise public concern about the safety of its products, and has published articles on its websites implying that the fault lies with mothers and carer-givers rather than with present manufacturing processes. IBFAN´s working group has provided factual information from WHO, FAO and Codex publications for evidence-based articles published in scientific journals (see The India Journal of Community Medicine, Jan 2007). These articles on the risks to infant health caused by intrinsic contamination of powdered formula all emphasise the critical importance of optimal breastfeeding practices to avoid the risk of severe illness and disability in vulnerable infants (see Indian Pediatrics article).

IBFAN member groups on all continents are requesting their national authorities to take action to protect the most vulnerable product users of all – our babies. In the USA, the National Alliance for Breastfeeding Action has written to the Center for Food Safety emphasising that infant formula manufacturers should be required to place accurate information, stating that powdered infant formula is not sterile and can contain disease-causing germs, on labels of all powdered infant formula products, on their websites and on all printed materials distributed to health care professionals and parents.

IBFAN will continue its campaign to ensure that all parents and caregivers are warned that so that there is no repetition of these avoidable tragedies.