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Take action to strengthen EU baby milk regulations

Hipp endangers infants with misleading information on formula preparation

4 January 2006

Hipp, (the German baby food manufacturer which aggressively promotes baby milks and foods in the UK and Europe and is renowned for child rights abuses in Central and Eastern Europe (note 1)) is attempting to portray itself as a leader in responsible marketing with its new advice on the preparation of bottle feeds for infants. But Hipp’s failure to address the fact that powdered formula is not a sterile product and may contain disease-causing bacteria called Enterobacter Sakazakii has elicited criticism from health campaigners and from WHO.

Following the publication of new guidance on formula preparation issued by the Department of Health and the Food Standards Agency, (note 2) Hipp announced its new advice with a press release and a set of confusing and convoluted suggestions on its website and in a leaflet accompanying its new packages of infant formula: “Hipp leads the way in babymilk safety.” (note 3) Hipp’s advice rightly states that any feed left after one hour should be discarded, but fails to convey the critically important message that the powdered infant formula is not sterile and may be contaminated and should be mixed with water which is at least 70 degrees Centrigrade – a decontamination step which experts say is needed to kill off bacteria that may be present and which if used consistently could result in 10,000-fold risk reduction. If this treatment is applied only 80% of the time the estimated risk reduction would be only 5 fold. (note 4).

Commenting on Hipp’s advice, Dr Jorgen Schlundt, Director of WHO’s Department of Food Safety, Zoonoses and Foodborne Diseases, said:

“Although any effort to eliminate the practice of keeping left-over, re-constituted formula at dangerous temperatures for later use should be commended, I am surprised that they seem to be dealing with less than half of the problem, and have not dealt with the bacteria that may be present in the powder itself”

The contamination of powdered infant formula with E. sakazakii and other pathogens has been implicated in outbreaks of sepsis, meningitis or necrotising enterocolitis, and has lead to severe lasting complications in babies including neurological disorders and in some cases to death. E. Sakazakii, is a heat resistant bacteria that can contaminate powdered infant formula milk during its production process - even when these have passed legally required standards of hygiene. The mortality rate of neonatal infections caused by E sakazakii dropped in recent years from 50% to 20%, but there is evidence that the organism seems to be becoming increasingly resistant to antibiotic treatment. (note 4).

In a letter to health professionals in 2002, the US Food and Drug Administration (FDA) refers to a 1988 study from several countries which found E. sakazakii in 14% of samples of powdered infant formulas (note 5). A 2004 study carried out by researchers at Nottingham Trent University found disease-causing bacteria, including E.Sakazakii, in 8 out of 82 packs powdered infant formulas (note 6) Unfortunately it seems that any level of E.Sakazakii contamination can lead to infections. (note 4).

Patti Rundall, Policy Director of Baby Milk Action (note 7) says:

“It is shocking that manufacturers are still failing to meet this problem head-on, and even more disturbing that Hipp should use this as an opportunity to promote itself, whilst diverting attention away from important information that parents need to protect their children. It is nearly four years since this specific problem came to public attention with the case of a 5-day old baby in Belgium. This baby died of meningitis in March 2002 because he was fed Nestlé infant formula which was contaminated with Enterobacter sakazakii. (note 8) Since then there have been several more avoidable deaths and serious damage to infants. In all these cases the parents had no idea that the product inside the tin could contain a disease-causing bacteria. If manufacturers refuse to state these risks on the label parents won’t understand why they are being asked to take extra precautions and are less likely to follow the guidance.“

The full magnitude of the problem of intrinsic contamination of powdered infant formula remains unknown because of significant under-reporting and lack of facilities for testing in many countries (note 9). But the matter has been taken very seriously by many governments (note 10) , the World Health Organisation (WHO) and other international bodies:

  • WHO and the Food and Agriculture Organisation (FAO) convened an expert meeting in January 2004 which issued clear recommendations to minimise risks and called for health workers to alert carers to the fact that “powdered infant formula is not a sterile product and that even a product meeting existing Codex standards can be contaminated with pathogens that can cause serious illnesses.” (note 4) .

  • This was followed in November 2004 with more advice from the European Food Safety Authority (EFSA) including that “the most effective control measure to minimise risks of Salmonella and E. sakazakii in high-risk infants (pre-term, underweight, immunocompromised), would be to use commercial sterile liquid formula. “ (note 11)

  • In May 2005 a World Health Assembly Resolution was passed which called on Member States to reduce the concentration and prevalence of pathogens in powdered infant formula and ensure that the public is informed through explicit warnings on packaging and other means.(note 12)

  • The matter has been the subject of debate at meetings of the Codex Alimentarius Commission, the body which sets global food standards. It will also be discussed again at an FAO/WHO expert meeting in Rome January 16-20 2006.

  • The UK Department of Health and Food Standards Agency issued new guidance which was posted on the FSA website on 29th November 2005, pointing out that infant formula powder is not sterile and that feeds should be made up one at a time using boiled water that is greater than 70C. (note 2)

Throughout all these international negotiations Baby Milk Action and its partners in IBFAN have lobbied for parent’s rights to full and clear information on the labels of products and for a halt to the health claims and misleading promotional strategies which idealise breastmilk substitutes and mislead parents. In contrast the baby food industry has done everything it can to slow down proceedings and to hide information from parents, as Hipp is now doing with a press release which implies it has taken speedy action: ”Hipp became aware of the risks associated with advanced preparation of milks back in the summer and took immediate action to change the preparation instructions on their packs.”

The commercial promotion of artificial feeding in the UK has been so successful that a recent survey found that 30% of mothers had been given the impression that formula feeds were ‘as good’ or ‘better’ than breastfeeding. (note 13) Baby Milk Action, together with 15 leading health and consumer organisations who are members of the Baby Feeding Law Group, has been urging the UK Government and the European Commission to ensure that powdered infant formulas carry explicit warnings that they are not sterile and may be contaminated by Enterobacter sakazakii and/or other pathogens. (note 14)

In an article in the Daily Mail 6th January 2005, Roger Clarke, the Director General of the Infant and Dietetic Foods Association failed to explain why manufacturers had not yet complied with the recommendations. He suggested that there would be more risk of scalding if carers mixed formula at 70 C, yet those same carers are capable of making tea and coffee uses boiling water.

Contacts

Patti Rundall, Policy Director, Baby Milk Action 07786 523493
Mike Brady, Campaigns and Networking Coordinator, Baby Milk Action 07986 736179.

Notes for Editors:

  1. Hipp aggressively markets a range of organic baby food products in the UK and other countries using claims and other promotional tactics that are prohibited by  the WHO International Code of Marketing of Breastmilk Substitutes and subsequent relevant WHA Resolutions .    See: www.ibfan.org/hipp/  
    www.ibfan.org/english/codewatch/btr04/btr04contents.html

  2. UK Guidance on preparing infant formula 29 November 2005 www.food.gov.uk/news/newsarchive/2005/nov/
    infantformulastatementnov05

  3. For the HIPP press release see:   www.hipp.co.uk/products/milkfeeding.htm  and click on the "making  Milks up in advance" tab.  

  4. Joint FAO/WHO Workshop on Enterobacter sakazakii and other Microorganisms in Powdered Infant Formula , Geneva, 2-5 February 2004:       
    www.who.int/foodsafety/micro/meetings/feb2004/en
    Enterobacter sakazakii and other microorganisms in powdered infant formula . Geneva, FAO/WHO, 2004
    www.who.int/foodsafety/publications/micro/en/es.pdf
     International Food Safety Authorities Network, INFOSAN, Information Note No. 1/2005, Enterobacter sakazakii
    www.who.int/foodsafety/micro/meetings/feb2004/en

    Section 7.2 recommends the "use of hot water (70-90 degrees C) during the reconstitution of powder. A number of powders clump when water is used at very high temperatures. Other risks that need to be taken into consideration include scalding and the potential for activation of bacterial spores.”
    The Q&A that accompanied the report states: “In situations where the mother cannot breastfeed, or chooses not to breastfeed for any reason, caregivers should use, whenever possible and feasible, commercially sterile liquid formula or include a decontamination step in the preparation of powdered infant formula (such as reconstituting with boiling water or heating reconstituted formula). Footnote 2: Nutritional and other factors need to be considered, e.g. alteration of nutritional content, risk from burns due to handling boiling or hot water/formula. The formula should thereafter be cooled and handled appropriate.”

  5. Health Professionals Letter on Enterobacter sakazakii Infections Associated With Use of Powdered (Dry) Infant Formulas in Neonatal Intensive Care Units, U. S. Food and Drug Administration, April 11 2002 Ref: Muytjens HL, Roelofs-Willemse H, Jaspar GHJ. Quality of powdered substitutes for breast milk with regard to members of the family Enterobacteriacae. J Clin Microbiol 1988;26:743-746.

  6. Iversen, C., & Forsythe, SJ. 2004 Isolation of Enterobacter sakazakii and other Enterobacteriaceae from powdered infant formula milk and related products. Food Microbiology as cited in New Scientist 5 June 2004.

  7. Baby Milk Action is the UK member of the global network, IBFAN – The International Baby Food Action Network , www.ibfan.org

  8. Belgian baby death sparks safety questions www.babymilkaction.org/update/update31.html

  9. Cases of E. Sakazakii infection have been reported from Israel, USA, Iceland, Belgium and many other countries. For example in Iceland and Germany healthy full term infants died from infection caused by E. sakazakii in the tin. In Bangkok, bacterial contamination of bottle milk from 500 infants attending the Out-Patients Clinic showed bacterial contamination in 91.8% of samples. Bacteria included Klebsiella sp. (56%); Enterobacter sp. (41.3%) etc. In the USA in 2001: Portagen (Mead Johnson) contaminated with E. sakazakii caused infection in newborns and 2002: Wyeth recalled store brand powdered milk contaminated by E. sakazakii. Alerts were sent to doctors in the Gulf that E. sakazakii is linked to diseases with a high mortality rate. In October 2004 infection by Enterobacter Saazakii in premature babies in France led to the death of 2 babies and disease and infection in 13 others. On May 3, 2005 the French authorities announced an epidemic of Salmonellosis in 123 babies fed on the Picot, Gallia/Blédina and Blédilait/Blédina brands (note 4) . In this outbreak the incriminated product was exported to 11 countries and territories. French Institut de Veille Sanitaire, Point InVS 3 mai 2005 www.invs.sante.fr/presse/2005/le_point_sur/salmonella_agona_040505/

  10. IBFAN Compilation of Official Action:Risk of Contamination of Powdered Infant Formula with Enterobacter sakazakii

  11. EFSA Panel advises on how to avoid microbiological risks in infant formulae at home and in hospital  18 November 2004
    www.efsa.eu.int/press_room/press_release/696_en.html
    http://www.efsa.eu.int/science/biohaz/biohaz_opinions/691_en.html
    ”Temperature is the main factor responsible for the multiplication of the microorganism in the reconstituted formula. Rhodehamel (1992) found that temperature in many home refrigerators ranged from 7 to 10 C. Harris (1989),reported that 20% of the home refrigerators surveyed were between 5 and 10 C, while van Garde and Woodburn (1987) found that refrigerator temperatures in 21% of households surveyed were above 10 C. Daniels (1991) reported that more than 25% of home refrigerators were above 7.2 C and almost 10% above 10 C. A study by Audits International (2000) on temperatures of food products at different stages of storage, including the home, showed that 18% of samples had a temperature between 5.5 and 6.6 C and the 3% had a temperature between 8.8 and 10 C. Those temperatures would allow growth of E. sakazakii if present in the reconstituted infant formula. The temperatures in domestic refrigerators from eight surveys were overviewed by James (2003). The average temperature in consumer refrigerators was calculated to be around 6-7 C. However, from the minimum and maximum temperatures there was a large variation between individual refrigerators. Around 30 % of the refrigerators were at average temperatures above 7 C.”

  12. WHA RESOLUTION  58.32 Infant and young child nutrition. www.ibfan.org/english/resource/who/whares5832.html
    Para 1 (3) Urges member States to “to ensure that clinicians and other health-care personnel, community health workers and families, parents and other caregivers, particularly of infants at high risk, are provided with enough information and training by health-care providers, in a timely manner on the preparation, use and handling of powdered infant formula in order to minimize health hazards; are informed that powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately; and, where applicable, that this information is conveyed through an explicit warning on packaging;
    International Food Safety Authorities Network, INFOSAN, Information Note No. 1/2005, Enterobacter sakazakii : "The inclusion of a lethal step, e.g. the use of hot water at 70°-90°C during the reconstitution of powder as well as a decrease in the holding time before feeding as well as the feeding time itself would effectively reduce the existing risk".

  13. www.babymilkaction.org/press/press19sept05.htm

  14. http://www.babyfeedinglawgroup.org.uk/advocacy.html The 16 members of the Baby Feeding Law Group: the Association of Breastfeeding Mothers, the Association for Improvements in the Maternity Services, the Association of Radical Midwives, Baby Milk Action, the Breastfeeding Network, the Food Commission, the Community Practitioners and Health VisitorsÅf Association, Lactation Consultants of Great Britain, La Leche League (GB), Maternity Alliance, Midwives Information and Resource Service, the National Childbirth Trust, the Royal College of Midwives, the Royal College of Nursing, the Royal College of Paediatrics and Child Health and the Unicef UK Baby Friendly Initiative.

For more information see:
http://www.ibfan.org/english/news/press/press25may05.htm
http://www.ibfan.org/english/news/press/press18may05.htm

Stating consequences in warnings

ELM ('elaboration likelihood model') developed by Petty & Cacioppo 1986. When highly involved, one is more persuaded by good arguments than by the credibility of the source.

• Mark R Lehto, 'Designing warning signs and warning labels: Part 1 - Guidelines for the Practitioner', Int'l J of Industrial Ergonomics 10:105-113, 1992
Content guidelines,

#2 Focus on reminding of a routine action or of the consequences of what you do.

#12 “Where judgment-based, consider stating hazard and the value of compliance, using high-credibility sources.”

• Venema, Anita and Zieverink HJ. 1992. Product information effectiveness: Implications for the design and standardization of product information. The Hague: Inst for Consumer Research.

• Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA, 2001

http://www.fda.gov/cdrh/ohip/guidance/1128.html

" There are four elements generally recognized by the courts and research [...]

4. the consequences, specifying the serious adverse events, potential safety hazards and limitations in device use that result if users do not follow instructions. The purpose is to give them a clear idea of the risk, which is likely to increase compliance. Hazard alert research has shown that this element has a significant effect on readers. If the consequences are not included, the alert is likely to be less effective." Michael S. Wogalter. Factors Influencing the Effectiveness of Warnings. 2005
http://www.electromark.com/help/research/research_reg_specs.asp

" [...] One of the main motivators in a warning message is the consequence statement, in which the potential negative outcomes that can result from noncompliance are described. In order for this component to be effective, the consequence information should be presented using explicit language (Laughery et al., 1993b). That is, users should be told exactly (specifically) what can result if they do not comply. In addition to providing the user with a better understanding of the nature of the potential hazard, explicitness provides the user with a proper appreciation of the severity of potential injury. As described earlier in the attitudes/beliefs stage, perceptions of how severe an injury might be (more than, for example, likelihood information or personal familiarity with the equipment) to be a major factor driving people’s precautionary actions (Wogalter and Barlow, 1990; Wogalter et al., 1991; Young et al., 1990, 1992). Accidents are relatively low probability events, and combined with the fact that people have difficulty discriminating or comprehending very low probabilities, it makes some sense that people do not pay much attention to likelihoods of injury. Warnings that describe the severity of the consequences explicitly have the power to motivate people to comply with the accompanying warning instructions because the hazard-related consequences are usually outcomes that people want to avoid."

• David M Dejoy 'Motivation' , in Wogalter, DeJoy and Laughery 'Warning and Risk communication,' Taylor & Francis, 1999
especially p. 228

See also: the cost-benefit perspective on warnings in Viscusi et al 1986 and Viscusi 1994:

Vlscusl, W.K., MAGAT, W.A., and HUBER, J. (1986) Informational regulation of consumer health risks: an empirical evaluation of hazard warnings. Rand Journal of Economics, 17, 351-365.

Vlscusl, W.K. (1994) Efficacy of labeling of foods and pharmaceuticals. Annual Review of Public Health, 15, 325-343.

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