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Chapter 9 : Regulatory Aspects
The International Commission on Microbiological Specifications for Foods (ICMSF) has been requested to contribute by proposing risk-based microbiological criteria as one of the control measures, and the proposal currently annexed in the revised draft code is presented in this chapter. The main stumbling blocks identified during the preparation of the initial drafts certainly is the scope of the new code, i.e., the types of products to be included in relation to the existing definitions of infants and the definitions of infant formulae, which may vary depending on the country. The European Commission has, established microbiological criteria for formulae for special medical purposes and for infant formulae that include two food safety parameters (Salmonella and E. sakazakii), with detection of other Enterobacteriaceae as a process hygiene parameter. The importance of the adherence to good hygiene practices during preparation has been stressed in all assessments performed. While the establishment of microbiological criteria has progressed rapidly and has led to the creation and even the implementation of very similar stringent criteria throughout the world, the establishment of guidelines for the safe preparation, handling, and storage of infant feeds has lagged behind. It is evident that, as far as regulatory approaches to control E. sakazakii are concerned, a multipronged approach is the best one. This will require continued cooperation and collaboration between hospitals, industry, and governments.