Abstract

Contrary to popular belief, approval of a natural food ingredient may not be as simple a process as one might think. In fact, unless an ingredient had a history of use in food prior to January 1, 1958, or the substance was deemed safe by scientific procedures, the ingredient must be determined Generally Recognized As Safe (GRAS) or be classified as a food additive. Furthermore, approval for one use (such as a flavor) does not constitute approval for any other use. This chapter will detail the history of GRAS in the U.S.: the challenges FDA faced prior to 1958, the scientific procedures accepted by FDA in a GRAS petition, the importance of an exposure analysis in determining GRAS, and who may be considered as an expert.

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