Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition" (the guidance). This guidance provides information to industry on how to prepare a claim of categorical exclusion or an environmental assessment (EA) for submission to the Center for Food Safety and Applied Nutrition (CFSAN) in notifications for food contact substances, food additive petitions, color additive petitions, requests for exemption from regulation as a food additive, generally recognized as safe (GRAS) petitions, and petitions for certain food labeling regulations.