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1. INTRODUCTION


Consistent with the need to provide safe feeding for all infants,[5] the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) convened a meeting on Enterobacter sakazakii and other microorganisms in powdered infant formula in WHO headquarters, Geneva, Switzerland from 2 to 5 February 2004. This meeting was part of the FAO/ WHO activities on the provision of scientific advice to Codex and to their member countries and was convened in response to a specific request for scientific advice on this issue from the Codex Committee on Food Hygiene (CCFH). The meeting was chaired by Dr John Cowden, Scottish Centre for Infection and Environmental Health. Dr Martin Cole, Food Science Australia served as rapporteur. A total of 16 experts from 12 countries participated in the meeting in their independent capacities and not as representatives of their governments, employers or institutions. There were also two representatives from the infant formula industry for the general exchange of information only; they did not participate in the final drafting of conclusions or recommendations.

The meeting was supported by a number of background papers on the epidemiological and microbiological issues related to microorganisms in powdered infant formula, industry practices in the production of these products, the variety of products and their preparation for consumption (Appendix A). Prior to the meeting, a short electronic discussion group was organized to consider possible approaches for assessing the risk posed by pathogens in powdered infant formula; the outcome of this discussion acted as support material to this meeting. The electronic discussion was convened by the Director of the WHO Collaborating Centre for Risk Assessment of Pathogens in Food and Water in the Netherlands and included meeting participants with experience in that area. A number of other papers and relevant data submitted in response to an FAO/WHO public call for data were also considered during the deliberations of the meeting (Appendix B).

1.1 Background and objectives

The issue of pathogens and in particular E. sakazakii in infant formula was brought to the attention of the 35th session of the Codex Committee on Food Hygiene (CCFH) by the United States of America. In raising this issue the United States had also prepared a risk profile of E. sakazakii in powdered infant formula for consideration by the committee. At the same time the 24th session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) requested that the CCFH revise the Recommended International Code of Hygienic Practices for Foods for Infants and Children (CAC, 1979) in order to address concerns raised by pathogens that may be present in infant formula. As a result, the 35th session of the CCFH established a drafting group to initiate the revision of this code. The committee noted that as well as E. sakazakii there were a number of other pathogens of concern that may be present in powdered infant formula, such as Clostridium botulinum, Staphylococcus aureus and other Enterobacteriaceae that may need to be considered when revising the code. In reviewing the risk profile on E. sakazakii in powdered infant formula, the committee was of the opinion that it could be improved by incorporating information from other sources such as industry. However, it was also recognized that there are still many data gaps in relation to E. sakazakii in powdered infant formula. The committee thus requested FAO and WHO to convene at the earliest opportunity an expert meeting on pathogens of concern in powdered infant formula, including Enterobacter sakazakii and Clostridium botulinum.

In the interim, the risk profile prepared for the CCFH[6] has been updated to include additional information. It provides background information on the epidemiology of food safety concerns associated with powdered infant formula. In addition to E. sakazakii, it addresses other Enterobacteriaceae, including Salmonella, as well as staphylococci and clostridia. Consideration is also given to the manufacture and use of powdered infant formula. The unique issues associated with underweight infants and infants in neonatal intensive care units are outlined. Other issues that are raised include the use of powdered infant formula for babies born to HIV-positive mothers and those issues facing developing countries, such as the availability of potable water.

Canada is leading the drafting group working on the revision of the Codex Code of Hygienic Practices for Foods for Infants and Children (CAC, 1979). This Codex drafting group is examining the code to determine its adequacy, to establish the need for additional guidance and to identify specific issues related to powdered infant formula that should be included. This includes identifying the most relevant pathogenic and opportunistic microorganisms and providing guidance on these within the code.

The objective of the requested expert meeting was not clearly defined by the CCFH, although the need for additional information on E. sakazakii was made clear. However, as E. sakazakii and other microorganisms consumed in powdered infant formula affect a susceptible population group in neonates and infants and can cause severe and life-threatening conditions, there is a need to manage this risk. In keeping with the principles recommended for the effective interaction between risk managers and risk assessors (FAO/WHO, 2002), FAO and WHO liaised with the two aforementioned groups to ensure complementarity to the ongoing work and to assure that they provided the required scientific advice.

The objectives of the meeting were the following:

This report summarizes the deliberations, findings and conclusions of the meeting.


[5] As a global public health recommendation, infants should be exclusively breastfed for the first 6 months of life to achieve optimal growth, development and health. Thereafter, to meet their evolving nutritional requirements, infants should receive nutritionally adequate and safe complementary foods while breastfeeding continues until up to 2 years of age or beyond. Infants who are not breastfed require a suitable breastmilk substitute, for example an infant formula prepared in accordance with applicable Codex Alimentarius standards. Information provided in this connection to mothers and other family members who need to use it should include adequate instructions for appropriate preparation and information concerning the health hazards of inappropriate preparation and use (WHO, 2002).
[6] Currently available at ftp://ftp.fao.org/codex/ccfh36/fh04_12e.pdf.

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