DEFINING SAFETY FOR INFANTS

The committee structured this report so that the first three chapters provide the background information and rationale for the report. Chapter 2 reviews the parameters considered by the committee when defining safety and how to approach it from a practical, theoretical, and statistical point of view. Chapter 3 compares the biological and behavioral advantages of human milk with infant formulas and reviews how infant formulas were developed to meet the biological advantages of human milk. 

A wide variety of packaging (cans, bottles, composite canisters, pouches) is currently used for infant formulas, and current regulations define methods to assure safety and bioavailability. If new ingredients require novel package forms, the safety assessment must account for this. 

Currently clinical trials for infant formulas with added new ingredients, although recommended, are not required by FDA, and the manufacturer decides when and if clinical trials are needed. The required tests focus on nutrient requirements, and only in cases of minor changes to the formulation can the manufacturer request a waiver of the tests requirements. Flowever in the proposed rule (Section 106.3(o), subpart E, Quality Factors for Infant Formulas ), quality factors are defined in terms of growth and development of the infant and therefore would require clinical trials as evidence of normal growth. The committee recommends that those clinical trials that address safety of the ingredient, metabolites, and matrix be included as part of the submission (see Figure 4-1, Box 5). 

In foods processed for safety, such as pasteurised milk, cooked meat products, dried infant formulae and similar products, Enterobacteriaceae are the most appropriate indicator organisms They are more accurately defined in the taxonomic sense and as a rule are more numerous than the coli-aerogenes group, which was and still is in use for the same purpose. Their more precise taxonomic definition leads to considerably better reproducibility than when the coli-aerogenes group as presently ill-defined " " is used . This is a tremendous advantage in the case of foods entering international trade. 

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