2.1 Microbial risks of powdered infant milk formula
According to the current WHO feeding recommendations for developed countries, newborns should
exclusively be breastfed within the first 4 to 6 month of their life [2]. Breast-feeding is the best and most
natural way to nourish a baby. It is valuable in a nutritional context because breast milk provides the
adequate content of nutrients to meet the newborns’ requirements for growth and development[3].
Epidemiologic evidence suggests that breastfeeding protects infants against several diseases such as
gastrointestinal and respiratory infection[2]. In cases when mothers cannot or do not want to breast-feed
their children, a wide range of powdered infant milk formulas are commercially available. Powdered
infant milk formulas, however, cannot be produced and packed sterile. It can contain low numbers of
microorganisms, such as Enterobacter sakazakii (E. sakazakii), that can lead to foodborne diseases and
serious health hazard to infants. E. sakazakii has a ubiquitous character. It is difficult to control because it
is widespread and can be found in all environments. There is currently still a lack of knowledge regarding
many aspects of E. sakazakii. More research is needed on its dose/response relationship in humans, the
specific virulence mechanism, and the sources and vehicle of infection[4]. E. sakazakii has been found in
various types of food, but only powdered infant milk formula has been linked to outbreaks of infection[5].
The occurrence of this pathogen in infant milk formula is especially dangerous for premature infants
and newborns with low birth weight ( ≤ 2,000 g). Immuno-compromised infants and those who are
medically debilitated are more likely to be susceptible to infections. E. sakazakii can cause neonatal
sepsis, bacterial meningitis, and neonatal necrotizing enterocolitis, an inflammatory disease of the gut that
can lead to death. The mortality rate for meningitis is 20 to 50 %. Children who survive often suffer from
severe neurological disorders[1,5]. Between 1961 and 2003, 48 cases of E. sakazakii induced infections
among infants were reported. According to the U.S. FoodNet 2002 survey, the infection rate with this
pathogen in infants under 1 year of age is 1 per 100,000 infants. Among low-birth-weight newborns,
however, the infection rate is 8.7 per 100,000. Consequently, not the frequency but the severity of the
disease is a matter of concern[5]. The WHO, however, states that there might be a significant
underreporting of this disease in all countries[6]. Adults with infections have milder outcomes whereas the
elderly like the very young are particularly at risk[5, 7].
2.2 Marketing of breast-milk substitutes
Powdered infant milk formula is not just a food. It is a substitute for a natural product. Even if breast
milk is today regarded as being superior to breast-milk substitutes, it is not always possible to breast-feed
a baby. Mothers have biological, social, or economic reasons why they decide or have to decide not to
breast-feed (e.g., have to take medical drugs, have physical problems, have or want to go back to work).
The efforts of companies to increase the demand for breast-milk substitutes led to the “International Code
of Marketing of Breast-milk Substitutes” adopted on May 21, 1981[8]. The code has been controversially
discussed before and after its implementation. See Greer (1990) for a more detailed discussion on the pros
and cons. The code’s aim was to provide infants with safe and adequate nutrition [9]. If it is necessary to
feed breast-milk substitutes, they should be used properly by giving adequate information and through
appropriate marketing and distribution. From its inception, the code defined and regulated many aspects
of the marketing of breast-milk substitutes, e.g. its definition “[...] any food being marketed or otherwise
presented as a partial or total replacement for breast milk, whether or not suitable for that purpose” ([10], p.
8). The Code also requires that the words "Important Notice" or their equivalent have to be on the
packaging as well as the statement of the superiority of breastfeeding, a statement that the product should
be used only on the advice of a health worker as to the need for its use and the proper method of use,
instructions for appropriate preparation, and a warning against the health hazards of inappropriate
preparation[10]. It is, however, not specified that the product is not sterile. Hence, there is no assurance that
the product contains no pathogens that can cause adverse health effects. A quality assurance label could
help provide additional information to overcome this information asymmetry. It could also signify that
powdered infant milk formulas are not sterile and the labeled product is relatively safer compared to
others. This would enable the consumer or the purchaser, respectively, to make an informed decision
when purchasing powdered infant milk formula.