FIGURE D-1 Proposed process for evaluating the safety of ingredients new to infant formulas algorithm: Application by using the long-chain polyunsaturated fatty acid Generally Recognized as Safe (GRAS) Notifications 000041 and 000080 as a case study. An asterisk (*) along with the corresponding text underlined indicate steps that were either not apparent or not carried out within the GRAS notifications 000041 and 000080 provided to the committee. In-market assessment should be planned in conjunction with preclinical and clinical testing. This algorithm is modeled after the U.S. Generally Recognized as Safe Notification process; similar schemes can be adapted to other regulatory processes. = a state or condition, = a decision point, = an action, sidebar = an elaboration of recommendation or statement.

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