Chemistry, manufacturing and exposure assessments to support generally recognized as safe (GRAS) determinations

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Abstract

Identity, stability, purity, intended use levels in what foods and technical effects, and probable intake are among the key components in an assessment to support GRAS determinations. The specifications of identity of a food substance are an important component of the safety assessment as changes in the physical and chemical properties of a food substance can influence its technical effect in food and can influence its nutritional or toxicological properties of the food substance. Estimating exposure is a key determining step in the safety evaluation of a food substance. Intake assessment in GRAS determination is necessarily comprehensive based on cumulative exposure, i.e. proposed new uses plus background dietary exposure. Intake estimates for safety assurance in a GRAS determination also represent conservative overestimate of chronic exposure as they are based on 2-day average daily intake and the upper percentile (90th) intake among consumers. In contrast, in a nutrient assessment where realistic intake estimates are of interest, usual intake estimates are relied upon. It should also be noted that intake estimates for GRAS determinations are also more conservative than estimate of dietary exposure by EPA (FIFRA), where mean per capita are used to assess chronic exposure. Overall, for safety assurance, intake assessments in GRAS determinations are comprehensively cumulative and typically conservative overestimate of exposures.

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