IBFAN emphasises that breastfeeding is the norm: it is the gold standard and protects the health of vulnerable infants. Artificial feeding using breastmilk substitutes and feeding bottles and teats (nipples) is a deviation from this norm. It can involve serious health risks and extra precautions should be taken when preparing, storing and handling feeds and selecting feeding utensils.To address this problem, the UN’s World Health Organization and Food and Agriculture Organization have issued Guidelines on safe preparation storage and handling of powdered formula: http://www.who.int/foodsafety/publications/powdered-infant-formula/en/

Are the bacteria in powdered formulas friendly or unfriendly?

Unfounded claims for beneficial bacteria

Baby food companiesmanufacture and marketpowdered milk formulas and cereal products for infants and young children. These companiesmake unfounded claims on product labels, stating that their product contains special ingredients which are alleged to improve growth, make digestion easier or protect against infections. Such additives include probiotics, the so-called ‘friendly bacteria’ which are claimed to improve infant health and make the formula ‘even closer to breastmilk’. The heavy promotion of products claiming such benefits for these added probiotics gives some companies a competitive edge over others.

Yet these claims are unsubstantiated by scientific evidence, meaning that parents, care-givers and health professionals are misled (1).

Failure to warn about harmful bacteria

 

At the same time, the baby food companies fail to state on product labels that powdered infant formulas and cereals may also contain harmful bacteria – the definitely ‘unfriendly bacteria’. Thesecompanies do not inform parents and health professionals that powdered formulas are not sterile and can also contain pathogenic bacteria, such as Salmonella species or Cronobacter/Enterobactersakazakii. These bacteria can be introduced during the manufacturing process and may cause severe invasive infections which can be fatal or cause life-long disability.

All those responsible for the care and healthy development of infants and young children must be warned of this risk.

World Health Organization guidance informs – and warns

For this reason, in 2007 the World Health Organization, WHO, producedGuidelines for the safe preparation, storage and handling of powdered infant formula. These Guidelines state in the very first sentence “Powdered infant formula (PIF) has been associated with serious illness and death in infants due to infections with Enterobactersakazakii. During production, powdered infant formula can become contaminated with harmful bacteria such as Enterobactersakazakii and Salmonella enterica. This is because, using current manufacturing technology, it is not feasible to produce sterile PIF.” In these Guidelines, WHO insists that “Users of PIF are made aware that powdered infant formula is not a sterile product and maybe contaminated with pathogens that can cause serious illness. Correct preparation and handling reduces the risk of illness.” (2).

This risk of contamination can thus have serious consequences for the survival and health of infants and young children.

WHO’s “New Safety Advice”, also issued in 2007, carries the clear and direct message:

“Powdered infant formula is not sterile.  It may contain bacteria that can cause serious illness in infants. By preparing and storing powdered infant formula correctly, you can reduce the risk of illness.”

Steps to reduce a risk that cannot be eliminated

There is no such thing as safe formula feeding, as evidenced by the repeated withdrawals and recalls of potentially contaminated infant and follow-on formulas, as well as baby cereals. Theseofficial withdrawals are regularly documented since 2002 by the International Code Documentation Centre in their Product Recall lists:https://www.ibfan-icdc.org/wp-content/uploads/Product-Recall-List-2014-2019.pdf and https://www.ibfan.org/fact-contaminants-reports-recall/

The WHO Safety Advice “How to Prepare Formula for Bottle-feeding at Home” explains the careful preparation that is needed to reduce risks:

“This leaflet contains new information to help you prepare bottle feeds from powdered infant formula as safely as possible.”http://www.who.int/foodsafety/document_centre/PIF_Bottle_en.pdf

          The decontamination step

Instructions for careful preparation include the decontamination step, also called the lethal or ‘kill’ step. This step is recommended by the WHO Guidelines to inactivate any harmful bacteria which might be present, even in unopened tins of powdered formula.

This is a sensible but stringent precaution for all users of PIF. Species of pathogenic bacteria such as Salmonella and Cronobacter/Enterobacterthrive and multiply in the warm milk when the powdered formula is made up with lukewarm water. However, such bacteria are heat resistant and so the water needs to be very hot to kill them and thus prevent rapid multiplication. Reconstitution with water first boiled and then cooled to no less than 70°C is the lethal step required for inactivation. Prepared formula should be fed to the baby promptly and then any leftovers must be discarded and not re-used.

Several governments have issued guidance and policies to implement the WHO Guidelines, including the decontamination step. However, there is evidence that the companies are actively opposing the WHO Guidelines so as to protect their market for formulas with ‘added probiotics’.  This is because the added probiotics, on which all the company claims are based, are heat-sensitive bacteria: they are killed off by reconstitution with water first boiled and then cooled to no less than 70°C. Therefore the claims made by the companies that their formulas are ‘modelled on breastmilk’ or ‘patterned after breastmilk’ are invalidated. It is only the living fluid, breastmilk, which provides the baby with live anti-infective agents and helps boost the development of its still immature immunesystem.

The new WHO Safety Advice therefore confirms “Breast is best:

“The World Health Organization (WHO) recommends that infants are exclusively breastfed for the first six months of life. Babies who are exclusively breastfed will get the best start for growth, development and health.”

 

Action needed to protect infant and young child health

The survey of examples being prepared by the International Baby Food Action Network,   IBFAN, shows that manufacturers are still failing to warn of risks: labels on powdered formulas, whether milk-based or rice-based, and on baby cereal packages give incomplete and confusing instructions.

IBFAN aims to avoid undue alarm among parents, health professionals and care-givers, but insists on the need to alert them to the risks by providing accurate and objective information.

IBFAN groups therefore work to reduce the risks of invasive infections caused by bacterial contamination of powdered formula. What is urgently required is global action by government agencies to counter the inaction by formula manufacturers to implement the WHO Guidelines.

IBFAN groups worldwide continue to monitor product labels and advocate for mandatory measures by governments. (3)

Notes:

 

The earlier article ‘Time for Governments and Industry to Take Action’ provides more detailed information and includes notes and references to the scientific articles and Expert Meetings jointly organized by the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO). The text was prepared after the deaths and life-long disabilities of infants in the USA and France caused by Enterobacter/Cronobacter and Salmonella infections: https://www.ibfan.org/cronobacter-sakazakii-infections-time-for-governments-and-industry-to-take-action/

For further information on the history of Cronobacter/Enterobacter, see the article by Farmer: ‘My 40-year history with Cronobacter/Enterobacter sakazakii – lessons learned, myths debunked, and recommendations.’
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4662064/

References:

(1)The scientific evidence that these probiotic bacteria confer health benefits was seriously questioned in 2011 by the ESPGHAN Committee on Nutrition: ESPGHAN. The Opinion of the ESPGHANsummarised the lack of evidence to justify most of these claims.

(2) This provides the link to the WHO Guidelines in the six United Nations languages: https://www.who.int/foodsafety/publications/powdered-infant-formula/en

(3) The United States Centers for Disease Control and Prevention updates its advice on Cronobacter infection in infants and the latest version is at:  https://www.cdc.gov/Features/Cronobacter/

and at : https://www.cdc.gov/cronobacter/

    • Manufacturers fail to warn product users about the possibility of intrinsic contamination of powdered milk formulas by harmful bacteria. These bacteria can cause infection in babies and young children.  Manufacturers must inform about the extra precautions to be taken to avoid this risk. Are the bacteria in powdered formulas friendly or unfriendly?
LATEST NEWS:

  • “Powdered formulas are not sterile products and may become contaminated during the manufacturing process by harmful bacteria such as species of Salmonella and Cronobacter/Enterobacter. Manufacturers fail to warn product users of this risk to infant and young child health.

    In 2018 and 2019, withdrawals of potentially contaminated formulas by government health authorities or recalls by baby food companies demonstrate that these are not isolated cases in one country. Instead they are repeated more and more frequently and on a world-wide scale.

    In April 201925 countries issued alerts and withdrawals of contaminated rice-based formulas and baby foods: https://www.ibfan-icdc.org/25-countries-issue-alerts-and-withdrawals-of-contaminated-rice-based-formulas-and-baby-foods/

    In June, 2018, a compilation of reports from 83 countries all over the world demonstrated the extent of the withdrawals and recalls of all Lactalis products potentially contaminated by harmful Salmonella bacteria. In December, 2017 the French Government issued an order for the mandatory withdrawal of over 600 batches (700 tonnes) of potentially contaminated products in France and closed the Lactalis production facilities. By January, 2018, a total of 12 million packages of these products had been recalled and investigations were ongoing:

     https://www.ibfan-icdc.org/ibfan-baby-food-product-recall-list-last-updated-in-april-2018/

    The most recent Product Recall List from 2014-2019 compiled by the International Code Documentation Centre includes further withdrawals in several countries and is available here:https://www.ibfan-icdc.org/wp-content/uploads/Product-Recall-List-2014-2019.pdf

    Previous Product Recall lists compiled by the International Code Documentation Centre document a series of global withdrawals, beginning in 2000:

    https://www.ibfan.org/fact-contaminants-reports-recall/

  • December 2017 –  Lactalis scandal in France goes global
    The scandal of powdered baby milk products contaminated by harmful bacteria erupted in France in December 2017 and rapidly went global.Infant, follow-on and growing up milk powders were manufactured by the French company Lactalis at their manufacturing site in France which also produces powdered baby milks and cereals for export. Some batches were contaminated by Salmonella enterica serotype Agona which can cause serious illness in infants and young children, a vulnerable population.In France 35 babies under 1 year of age fell sick after consuming the products. The French government mandated the withdrawal of potentially contaminated products, not only in France but also in 20 and then in 40 countries.By January 2018 the withdrawals and seizures involved all powdered milk and cereal products manufactured by the Lactalis company in 83 countries, and from all pharmacies, supermarkets, hospitals and crèches.The International Baby Food Action Network, IBFAN, is working with groups all over the world to ensure that governments fully inform their citizens and enforce and monitor strict controls on imports and sales of the incriminated products.Since 2005, IBFAN has been campaigning for warnings on labels of powdered baby milks.  New safety advice by WHO and FAO states that these products are not sterile and may be contaminated with pathogens that can cause serious illness. Extra precautions must be taken in preparation, storage and handling to reduce the risk. These Guidelines for infant formula are also relevant for powdered follow-on and growing up milks because these products are also included in the Lactalis withdrawals: http://www.who.int/foodsafety/document_centre/PIF_Bottle_en.pdf
  • June 2016 – Fatal case of bacterial infection in formula-fed baby in the USA increases urgency of circulating correct information about harmful bacteria 
  • 2016 alert by the US Centers for Disease Control and Prevention on the risks of harmful bacteria in formulas: Cronobacter/Enterobacter sakazakii : ‘Refreshed warning’ of the risks to infant health 
  • 2015 measures to ensure safer feeding for babies who cannot be breastfed: What are the risks of contaminated or adulterated formulas and how effective are different measures to address the problems of product safety and quality? “ How to tackle the problems of safety and quality of formula: examining effective measures   https://ibfan.org/docs/2015-US-Government-Rule-of-2014.pdf

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Cronobacter/Enterobacter sakazakii infections: There is every reason why governments and industry must take action