Abstract
The European Commission requested EFSA to review the former EFSA/BIOHAZ opinion on microbiological risks in infant formulae and follow-on formulae. Particularly it was requested to provide a scientific opinion on the possible correlation between Enterobacteriaceae and Enterobacter sakazakii and Enterobacteriaceae and Salmonella in infant formulae as well as on the correlation between Enterobacteriaceae and Salmonella in follow-on formulae, in the light of new scientific data. The usefulness of Enterobacteriaceae as indicators for E. sakazakiiand Salmonella in powdered infant formulae and follow-on formulae was also requested if available scientific data do not indicate a clear correlation. The products of concern are powdered infant formulae and powdered follow-on formulae. Consideration of microbiological criteria is outside of the remit of this opinion. Enterobacter sakazakii and Salmonella, both in the family Enterobacteriaceae, are hazards that are occasionally present in powdered infant formulae and powdered follow-on formulae. Given that Salmonella and E. sakazakii are both members of the family Enterobacteriaceae, there is some relationship between the presence of E. sakazakii and Salmonella and the presence of Enterobacteriaceae. If E. sakazakii or Salmonella are present, Enterobacteriaceae should be found provided that the methods are equally sensitive. In some instances levels are so low that if E. sakazakii or Salmonella is detected, Enterobacteriaceae are not detected, just due to “chance”. However, the reverse is not inevitably true since the presence of Enterobacteriaceae does not necessarily mean the presence of Salmonella or E. sakazakii. Industry data from different companies showed that E. sakazakii / Enterobacteriaceae ratios range from 9 to 30%. A correlation between the prevalences of Enterobacteriaceae and that of E. sakazakii was observed in one plant but sufficient specific information was not available for the other plants. A correlation might be apparent according to the ecology of industrial units, with each unit having a characteristic ratio. The BIOHAZ Panel concluded that there is a relationship between the presence of Enterobacteriaceae and E. sakazakii in powdered infant formulae. No universal correlation can be established. There are indications that correlations could be established at individual plant level. It is not possible to establish a correlation between Enterobacteriaceae and Salmonella in infant formulae and in follow-on formulae and, because Salmonella is so rarely present, suitable data are not available. Industrial experience indicates that monitoring Enterobacteriaceae in the processing environment and in the product can be used to confirm the application of GMP/GHP and HACCP and would be expected to reduce the prevalence of E. sakazakii. The BIOHAZ Panel recommended that documented data ideally using standardized methods be accumulated (by industry, regulators, academia) testing for Enterobacteriaceae, Salmonella, and E. sakazakii in the same samples (ingredients, end-product and environmental) across the industry to explore correlations and their relevance in setting control measures
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