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In 2014 the Government of Malaysia made changes to the instructions given for preparation of powdered formulas. This follows government action in Hong Kong, the UK and the USA to alert parents and care-givers of babies that powdered formulas are not sterile products and even unopened containers may contain harmful or pathogenic bacteria which may be introduced at factory level during the manufacturing process.
These pathogenic bacteria are called Enterobacter sakazakii, now renamed Cronobacter sakazakii, and species of Salmonella. They can cause rare but severe invasive infection in infants. They are highly heat-tolerant and will increase very rapidly in warm formula milk. So really hot water is needed to render them inactive – in short to kill them. It is vital to include instructions for the lethal or decontamination step of mixing the powdered formula with water which has been first boiled and then cooled to no less than 70°C. The prepared formula should of course be further cooled before feeding the baby.
In Malaysia, labels on formula containers now state in Malay and English : « Put the correct amount of boiled water into bottle and allow to cool down but not cooler than 70°C. Add exact amount of formula. »
This text is written in very small print, but it is important that the lethal or decontamination step of mixing with water at no less than 70°C is now included. The preparation instructions do not explain why the lethal step is vital to protect the health of formula fed babies.
The Malaysian Government has also exempted formulas with added probiotics from the revised preparation instructions, so the lethal or decontamination step does not apply to these formulas. This is because these probiotic bacteria are sensitive to heat and are killed off at temperatures above 40°C – the very temperature at which Cronobacter thrives and multiplies.
Does this exemption create a safety problem for these formulas with added prebiotics and probiotics ? Read more … FAQ : What are Prebiotics and Probiotics?
Action by the US Federal Government – long overdue ?
Government action on Cronobacter/Enterobacter sakazakii in USA, UK and Hong Kong and court case against formula manufacturer
USA health authorities emphasize the life-saving importance of breastfeeding and the need to protect babies against life-threatening infections caused by harmful bacteria in powdered formula: Following the infections described in the article below, the Centers for Disease Control and Prevention, CDC, issued an updated version on April 6 2012 of the document “Cronobacter Illness and Infant Formula”, warning of the risks of rare but severe and sometimes fatal infections caused by contaminated powdered infant formula: http://www.cdc.gov/features/cronobacter/
This revised version of the earlier document also includes the lethal or decontamination step to prepare powdered infant formula (use hot water – 158°F/70°C and above to make formula) and advises to quickly use formula prepared in this way, within 2 hours of preparation and discard unused formula if the baby does not finish the entire bottle of formula.
UK government underscores the need for the precautionary approach to reduce risks to infant health and minimise the risk of infection: On January 28, 2013, the Chief Medical Officer and Director for Public Health and Nursing in England wrote a cascade letter to health professionals expressing concern over methods of preparing powdered infant formula. The letter emphasises once again the vital importance of using water below a temperature of 70°C, the lethal or decontamination step:
“”We would like to reiterate that the position of the Department of Health and the Food Standards Agency is that it is best practice to make up infant feeds by reconstituting formula powder using water at a temperature of 70C or above. This guidance is in line with World Health Organization recommendations and aims to ensure that the potential microbiological risks associated with these products are kept to a minimum.”
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/127411/update-from-the-Chief-Medical-Officer-and-Director-for-Public-Health-Nursing.pdf.pdf
The UK Department of Health and the Food Standards Agency have issued revised guidance on the preparation and storage of powdered formula milk. The document Advice on Preparation of Formula Milks Restated includes the risks to infants, guidance for preparing feeds in the home and in care settings, advice on safer fridge temperatures and a useful section on Questions and Answers: https://www.gov.uk/government/publications/advice-on-preparation-of-formula-milks-restated
http://www.food.gov.uk/multimedia/pdfs/formulaguidance.pdf
Hong Kong authorities give clear recommendation and explanation: On January 30, 2013, the Hong Kong government sent a letter from the Department of Health to all medical practitioners: http://www.medicine.org.hk/hkps/download/dh-fhs-advice-on-milk-feeding-2013-01.pdf
The letter, sent in the context of the shortage of supply of formula milk, includes the lethal or decontamination step of first boiling the water and letting it cool to no less than 70°C before mixing the formula powder, and explains why: “Use boiled hot water of no less than 70°C (water left in the kettle for no more than 30 minutes after boiling can achieve this temperature) to make up the formula milk as this kills harmful bacteria”.
Court case in the USA: On October 16, 2012, a suit was filed against Mead Johnson over death and illness linked to contaminated formula. It claims that the company knew but failed to warn the public of risks posed by Enfamil powdered formula. The suit alleges that Mead Johnson refused to publicize or educate care-givers on the importance of safe preparation practices such as heating water to at least 150°F, 70°C. The suit seeks damages for negligence, failure to warn, strict liability … express warranty and fraud: http://www.businesswire.com/news/home/20121016006742/en/Brown-Crouppen-Files-Suit-Infant-Death-Illness