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Generally recognized as safe
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==Designation and list== A GRAS determination can be self-affirmed or the FDA can be notified of a determination of GRAS by qualified non-governmental experts: * '''Self-affirmed.''' The manufacturer of this chemical or substance had performed all necessary research, including the formation of an expert panel to review safety concerns, and is prepared to use these findings to defend its product's GRAS status. * '''FDA Response to GRAS notification.'''<ref name="fda"/> The manufacturer has performed all the aforementioned due diligence, and submitted a GRAS notification to inform the FDA of a determination that the use of a substance is GRAS. Following evaluation, the FDA provides three possible responses: 1. FDA does not question the basis for the notifier's GRAS determination,<ref name="fda"/> 2. the notification does not provide a sufficient basis for GRAS determination, or 3. the FDA has, at the notifier's request, ceased to evaluate the GRAS notice. {{as of|2021|January}} (beginning in 1998), 955 ingredient or food substances have been filed with the [[FDA]].<ref name="fda">{{cite web|url=https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices|title=List of GRAS Notices|publisher=US Food and Drug Administration|date=25 January 2021|access-date=30 January 2021}}</ref> These petitions, submitted by sponsors or manufacturers, are reviewed for the safety evidence contained in the document. FDA posts status of the review as either without further questions (as a position of "no objection") or the petition is withdrawn by the applicant.<ref name="fda"/> For substances used in food prior to January 1, 1958, a ''[[grandfather clause]]'' allows experience based on common use in food to be used in asserting an ingredient is safe under the conditions of their intended use.<ref name="gras-history">{{cite web |title=FDA's Approach to the GRAS Provision: A History of Processes |url=https://www.fda.gov/food/generally-recognized-safe-gras/fdas-approach-gras-provision-history-processes |archive-url=https://web.archive.org/web/20190612041606/https://www.fda.gov/food/generally-recognized-safe-gras/fdas-approach-gras-provision-history-processes |url-status=dead |archive-date=12 June 2019 |publisher=US Food and Drug Administration |access-date=30 January 2021 |date=4 January 2018}}</ref> The FDA can also explicitly withdraw the GRAS classification, as it did for [[trans fat]] in 2015.<ref name="Jalonik">{{cite news |last1=Jalonik |first1=Mary Clare |title=FDA tells food industry to phase out artificial trans fats |url=https://www.bostonglobe.com/business/2015/06/16/fda-tells-food-industry-phase-out-artificial-trans-fats/UAiibLOV27UY1iOWGQC4HJ/story.html |access-date=July 16, 2019 |work=Boston Globe |agency=Associated Press |date=June 16, 2015 |quote=To phase the fats out, the FDA made a preliminary determination in 2013 that partially hydrogenated oils no longer fall in the agency’s “generally recognized as safe” category, which covers thousands of additives that manufacturers can use in foods without FDA review. The agency made that decision final Tuesday, giving food companies until June 2018 to phase them out.}}</ref> ===List of GRAS notices=== The list of GRAS notices is updated approximately each month by the FDA.<ref name=fda/>
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