Substances Generally Recognized as Safe (GRAS) Contents

5 conditions of use.17 The premarket review process begins when someone files a petition seeking FDA’s approval for use of an additive.18 The petition must include the identity of the additive, the proposed use, the intended technical effect, the method of analysis in food, and full reports of all safety studies.19 A specific clause in the statute, known as the Delaney Clause, further provides tha. [...] In response to this directive, the Agency announced a comprehensive review of the safety of each substance on the GRAS list.32 The original inventories emerged “without any detailed scientific assessment of the original safety data, much less of the data subsequently generated with constantly improving detection and safety assessment methods.”33 Thus, the purpose of the Agency’s review was to eval. [...] The agency emphasized that, in its view, “Congress intended the phrase ‘scientific procedures’ as used in section 201(s) of the act to have the same dimensions as the full reports of investigations required to prove the safety of a food additive under section 409 of the act.”47 Thus, the FDA concluded that GRAS determinations “require the same quantity and quality of scientific evidence as is requ. [...] The proposal’s notification process differs from the previous GAP process in that the notifier no longer must provide the detailed data and information that support the GRAS determination as part of the submission, and that FDA does not actually make a binding decision as to the GRAS status of the use of a substance in its response.72 Thus, unlike the GAP process, FDA does not assess the underlyin. [...] at 18,940 (“[A] GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use rather than on the basis of what the substance is or the types of data and information that are necessary to establish its safety.”).