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 In this section:

        Food Ingredients & Packaging

Generally Recognized as Safe (GRAS)

                        
                


                GRAS Notice Inventory
          GRAS Substances (SCOGS) Database
          Microorganisms & Microbial-Derived Ingredients Used in Food (Partial List)
          Enzyme Preparations Used in Food (Partial List)
          Post-market Determinations that the Use of a Substance is Not GRAS Home
          Food
          Food Ingredients & Packaging
          Generally Recognized as Safe (GRAS)Food Ingredients & Packaging Generally Recognized as Safe (GRAS)
  	
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    Print"GRAS" is an acronym for the phrase **G**enerally **R**ecognized **A**s **S**afe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. General recognition of safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
	Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.Overview

About the GRAS Notification Program
	How FDA's GRAS Notification Program Works
	FDA's Approach to the GRAS Provision: A History of ProcessesGRAS Final Rule

Federal Register Notice – the GRAS Final Rule (81 FR 54960 – August 17, 2016)
	Federal Register Notice - the GRAS Proposal (62 FR 18937 - April 17, 1997)
	Federal Register Notice - Substances Generally Recognized as Safe; Reopening of the Comment Period (75 FR 81536 - Dec 28, 2010)Inventory for Human Food

GRAS Notice Inventory**Related Databases**

GRAS Substances (SCOGS) Database
	Microorganisms & Microbial-Derived Ingredients Used in Food (Partial List)
	Enzyme Preparations Used in Food (Partial List)Regulatory and Policy Guidance

Guidance for Industry: Best Practices for Convening a GRAS Panel
	Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act
	Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food
	Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives
	Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
	Providing Regulatory Submissions to OFAS
	CFSAN Online Submission Module (COSM)
	Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant FormulaScientific Guidance

Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices for Enzyme Preparations
	Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions
	Guidance for Industry: Estimating Dietary Intake of Substances in Food
	Guidance for Industry: Summary Table of Recommended Toxicological Testing for Additives Used in FoodRegulations

21 CFR 181 - Prior Sanctioned Food Ingredients
	21 CFR 182 - Substances GRAS in food
	21 CFR 184 - Substances Affirmed as GRAS in Food
	21 CFR 186 - Substances Affirmed as GRAS for Use in Food Packaging

                                                                                  Content current as of:
      10/17/2023
                  
                   
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Food & Color AdditivesGenerally Recognized as Safe (GRAS)                
                          

                        


                        GRAS Notice Inventory
          GRAS Substances (SCOGS) Database
          Microorganisms & Microbial-Derived Ingredients Used in Food (Partial List)
          Enzyme Preparations Used in Food (Partial List)
          Post-market Determinations that the Use of a Substance is Not GRAS
 
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