|
Background
Following the outcome of the 1st technical meeting on E. sakazakii (FAO/WHO, 2004), and the ongoing efforts at the Codex Alimentarius level to reduce the risks posed by E. sakazakii, WHO issued two draft documents related to the preparation and handling of reconstituted infant formulae (WHO, 2006a, b):
- (a) short guideline for health-care settings and homes; and
- (b) longer version with more background information.
The recently published report of the FAO/WHO second technical meeting (FAO/WHO, 2006) outlines different preparation options which are based on the risk assessment model mandated by these two organizations. However, the above two drafts focus exclusively on the reconstitution of infant formula at over 70°C, while lower temperatures which have proven to avoid increased risk are not taken into account.
Below are the industry’s views and key messages on the current WHO guidelines in advance of their review by the Codex Committee on Food Hygiene.
Issues
Nutrients:
- Several organisations (i.e., the FDA (2002), ESPGHAN (2004) and AFSSA (2005)) have warned that reconstituting formula at over 70°C risks losing certain nutrients.
- The WHO’s view that vitamin loss can be compensated for by increasing the vitamin content in the manufacturing process does not take into account stringent national and international regulations and recommendations (including tolerances) governing the nutritional composition of infant formula. It also fails to address how overdosing should be dealt with given the different temperatures of reconstitution.
- Furthermore, the WHO guidelines neglect to consider nutrients other than vitamins. Reconstitution at over 70°C may also affect essential micronutrients such as amino acids, polyunsaturated fatty acids and other active ingredients. It may also lead to reactions causing blockage of lysine, precipitation of mineral salts or proteins, fat separation or the formation of unwanted components.
Active ingredients:
- Both FAO/WHO reports (2004, 2006) highlight new developments for enhancing product safety and minimising microbiological risks. For example, the use of probiotic strains have been shown to either significantly inhibit the growth of potentially harmful micro-organisms or avoid their adherence to intestinal mucosa (e.g. Collado et al., 2005).
- The current recommendations by the WHO would seriously affect such developments and potentially limit innovation in this field including the addition of enzymes, active proteins, etc. to infant formulae, as well as future innovations that might emerge from scientific and technological research.
Scalding:
- Internal and external burns and scalding of infants due to spilled hot water or ingestion of overly hot beverages can be severe and have long-term consequences. As such, they represent a major public health issue (e.g. Reig et al., 1993 and Jeffrey et al., 2000).
- Stating that burning and scalding can be solved by providing appropriate information is an oversimplification. Such incidents have been observed irrespective of warning and information provided to caregivers. The WHO’s recommendation of reconstituting at temperatures over 70°C is only likely to exacerbate the problem.
Other:
- While data on the killing rate of E. sakazakii has been established in laboratory experiments with inoculated samples, there is a significant risk that clumps and lumps will form at temperatures above 70°C. Under such circumstances vegetative cells entrapped in the dry powder will be protected by the low water activity instead of being killed as intended.
- While reconstitution at over 70°C kills vegetative micro-organisms, the high temperature will also activate spores of the natural flora contained in infant formula. This includes B. cereus which has not been properly taken into consideration as this micro-organism may also be naturally present at low levels. Such activation can lead to rapid growth, especially if storage and handling is performed under inappropriate conditions (Food Standards Australia and New Zealand, 2004).
Conclusions
- Reconstitution at over 70°C, as recommended by the WHO, has a number of drawbacks which have not been fully appreciated and which, while minimizing one problem, may increase other infant health risks.
- While occasional reconstitution at temperatures above 70°C may be acceptable and not lead to nutritional problems, its systematic application warrants a more thorough evaluation, by paediatricians and nutritionists, of its potential consequences and impact.
- As identified during the two FAO/WHO technical meetings, reconstitution, storage and handling play an important role in ensuring the safety of the reconstituted infant formula. It should however be recognised that no single measure will ensure complete safety.
- Recommending reconstitution exclusively at temperatures over 70°C does not give users and caregivers the correct message and does not reflect the extensive risk assessment models published by FAO/WHO (2006).
- Users would benefit more if the WHO were to develop guidelines based on existing risk assessments and risk models; and to highlight different options for those inclined toward alternative methods of reconstitution.
February 2007
|
|
