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==Regulation in the United States == The United States Food and Drug Administration defines a food additive as "any substance the intended use of which results or may reasonably be expected to result directly or indirectly in its becoming a component or otherwise affecting the characteristics of any food".<ref name=fda-how/><ref name=fda-cons/> For a novel food additive to be approved, a food additive approval petition must be submitted to the FDA.<ref name="fda-guide">{{cite web |title=Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process |url=https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-about-food-additive-or-color-additive-petition-process |publisher=US Food and Drug Administration |access-date=4 January 2025 |date=20 September 2018}}</ref> The identity of the ingredient, the proposed use in the food system, the technical effect of the ingredient, a method of analysis for the ingredient in foods, information on the manufacturing process, and full safety reports must be defined in a food additive petition.<ref name=fda-guide/><ref name=fda-cons/> The FDA evaluates the chemical composition of the ingredient, the quantities that would be typically consumed, acute and chronic health impacts, and other safety factors.<ref name=fda-guide/><ref name=fda-cons/> The FDA reviews the petition prior to market approval of the additive.<ref name=fda-guide/>
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