R.L. SMITH, J. DOULL, V.J. FERON, J.I. GOODMAN, I.C. MUNRO, P.M. NEWBERNE, P.S. PORTOGHESE, W.J. WADDELL, B.M. WAGNER, T.B. ADAMS,

M.M. MCGOWEN

In 1958, Congress enacted the Food Additives Amendment (FAA) to the Federal Food, Drug, and Cosmetics Act amid growing concern over the safety of substances added to foods. The FAA set forth standards and guidelines by which the safety of food additives must be established before they can be added to foods (FAA, 1958).

The FAA contained an exclusion provided by Congress for substances “generally recognized, by experts qualified by scientific training and experience to evaluate its safety, as havi…


Table 1—Steps for determining exposure to food using the DDA method

PCI = (kg/year)(109 μg/kg)

Table 2—Comparison of detailed dietary analysis (DDA), per capita intake × 10 (PCI × 10) and possible average daily intake (PADI) methods for exposure to flavoring agents through food intake

Table 3—Algorithm used for the full stochastic model for the estimation of exposure to flavoring substances. From Lambe (2000)

Table 4—Comparison of the use of theoretical added maximum daily intake (TAMDI), PCI × 10, and the full stochastic model (FSM) to estimate the intake of selected flavoring substances (μg/kg bw/day) and the probability that intakes along the distribution of FSM would exceed the TAMDI or PCI × 10 estimates (pFSM>).

Table 5—Primary names (in boldfaced capital letters, listed alphabetically) and synonyms (in lower case)

Table 5—Primary names (in boldfaced capital letters, listed alphabetically) and synonyms (in lower case)


Table 6—Use levels for new FEMA GRAS flavoring substances on which the FEMA Expert Panel based its judgments that the substances are generally recognized as safe (GRAS)

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