Thursday, February 01, 2007

Powdered infant formula is not sterile

Perhaps you already know that powdered infant formula is not sterile. That it may contain pathogens such as salmonella and enterobacter sakazakii despite the pasteurisation process during manufacture. So what are the implications?

This intrinsic contamination is surprisingly commonplace. In one study referenced by the Food and Drug Administration in the US it was found 14% of tins tested were infected with Enterobacter Sakazakii. This led to a warning that powdered infant formula should not be used for at risk babies, particularly premature babies. See

Enterobacter Sakazakii can lead to meningitis, a very serious disease that can kill. The issue came to prominence in 2001 when a 5-day-old child died after being fed with Nestlé Beba infant formula believed to have been contaminated. See

The US FDA said ready-to-feed formula should be used if formula feeding is necessary for premature and other at risk infants because this is sterile. (The better option for premature infants, of course, is pasteurised human milk from donors if mother's milk is not available - this does contain living substances: antibodies and other anti-infective properties that protect the infant).

In 2005 the World Health Assembly called for warnings on labels of powdered infant formula and improved instructions. See Resolution 58.32

This is something we support and have called on the baby food companies to support this. We raised it at the Nestlé shareholder meeting in 2005, but Nestlé has no plans to put warnings on its labels until compelled to do so. Now we are calling for the Codex Alimentarius Commission (see my blog on the food code) to finalise standards.

Why? It is not to scare mothers from using formula, though the risks of contamination do highlight again the advantages of breastfeeding. No, the reason is to protect infants who are formula fed.

The advice now being given by the Department of Health and Food Standards Agency in the UK is to mix up formula with water at 70 degrees centigrade as this will kill any pathogens in the powder. It then has to cool (and at our suggestion the Department of Health added to their advice that care is taken to ensure the milk has reached a safe temperature). Formula once made up should not be kept for long periods and bottles not made up in advance or bacteria may reproduce in it to dangerous levels. So unused formula should be discarded. You can read the Department of Health advice at

UNICEF UK Baby Friendly Initiative has labels in many different languages at:

The industry has responded with warnings that mixing up formula with water at this temperature could lead to an increase in cases of scalding of carers mixing up feeds. I thought they may have a point until I made my next cup of tea, using water that had JUST BOILED!! Fortunately the tea-making operation proceeded without scalding.

We are suggesting research is done on the possibility of mixing up powdered formula with a smaller volume of just boiled water or water that has cooled to 70 degrees and then making up the water with cool, previously boiled water (that could be kept stored in the fridge). This could provide a way to prepare a feed which does not have to be left to cool. Any academics interested in investigating, please contact us.

The question about what warning and instructions to be put on labels is now being considered by the UK Food Standards Agency (FSA), which has just published some research it did into the understanding of the expression 'not sterile'. It seems few mothers or health workers were aware that powdered formula is not sterile and are concerned to find this out.

There are few proven cases of infection linked directly to contaminated formula - the FSA suggests just 50-60 cases in the last 40 years. There is likely to have been under reporting and the higher incidence of bottle-fed infants being hospitalised in rich countries and dying in poor settings may be due to contamination as well as the better known risks of artificial feeding.

Parents, of course, want to know what to do to reduce the risks. There were some comments in the FSA study about the lack of information on preparing bottles - implying that there are shortcomings with information on labels and that the mass of promotion done by baby milk companies does little to provide information. This finding also implies a need for greater dissemination of the resources mentioned above for mothers who decide to bottle feed. See

Last year we were involved in a news story when Hipp tried to promote itself as more ethical than its competitors by claiming it was publicising the new guidance from the Department of Health.

There were several shortcomings with the information was providing, however. It did not give the information that powdered formula is not sterile. Nor did it warn of the risks of contamination with Enterobacter Sakazakii. It did not advise on mixing up formula with water at 70 degrees centigrade.

The one piece of information that Hipp was promoting was to throw away unused feed and to make up a fresh bottle every time. Now, why could that be?

For the full story of Hipp with lots of links to supporting documents, see


Mike Brady said...

For further news on how companies are failing to give all warnings and information, or are even contradicting it, see:

Anonymous said...

Sebenarnya ada kok standard ISO tahun 2006 yang membahas tentang ini kenapa BPOM menutup mata?

Ada duit ada fatwa kali yaa coba lihat: