United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2018-02-09 article Part III Rules and Regulations D09002ee1c7f4aa1d D09002ee1c7f4b083 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status. 81 FR 54960 https://www.govinfo.gov/app/details/FR-2016-08-17/2016-19164 2016-19164 FR17AU16-10 RIN 0910-AH15 4164-01-P Docket No. FDA-1997-N-0020 (formerly 97N-0103) https://www.govinfo.gov/app/details/FR-2016-08-17/2016-19164 https://www.govinfo.gov/content/pkg/FR-2016-08-17/html/2016-19164.htm https://www.govinfo.gov/content/pkg/FR-2016-08-17/pdf/2016-19164.pdf Administrative Practice and Procedure Food Additives Food Packaging Confidential Business Information Courts Freedom of Information Government Employees Environmental Impact Statements Foreign Relations Reporting and Recordkeeping Requirements Animal Feeds Animal Foods 96 p. 54960 55055 81 FR 54960 Title 21 Part 170 21 CFR Part 170 Title 21 Part 184 21 CFR Part 184 Title 21 Part 186 21 CFR Part 186 Title 21 Part 20 21 CFR Part 20 Title 21 Part 25 21 CFR Part 25 Title 21 Part 570 21 CFR Part 570 RIN 0910-AH15 Substances Generally Recognized as Safe; Federal Register Vol. 81, Issue RULE 2016-19164 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-10-17 2016-10-17 Docket No. FDA-1997-N-0020 (formerly 97N-0103) 4164-01-P 2016-19164 Final rule.

The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.

This rule is effective October 17, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by October 17, 2016 (see section XXIX, the "Paperwork Reduction Act of 1995" section of this document). Regarding substances that would be used in human food: Paulette M. Gaynor, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740, 240-402-1192. Regarding substances that would be used in animal food: Geoffrey K. Wong, Center for Veterinary Medicine (HFV-224), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5838. Administrative Practice and Procedure Food Additives Food Packaging Confidential Business Information Courts Freedom of Information Government Employees Environmental Impact Statements Foreign Relations Reporting and Recordkeeping Requirements Animal Feeds Animal Foods Substances Generally Recognized as Safe , oira_submission@omb.eop.gov Dictionary.com ftp://ftp.fao.org/es/esn/food/biotechnology.pdf http://apps.who.int/iris/bitstream/10665/44065/9/WHO_EHC_240_9_eng_Chapter6.pdf http://dictionary.reference.com/browse/corroborate http://ilsina.org/our-work/food-safety/caffeine/ http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm441552.htm http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/GenerallyRecognizedasSafeGRASNotifications/ucm243845.htm http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm071977.pdf http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076880.pdf http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM350015.pdf http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM367746.pdf http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM401508.pdf http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm061846.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2006826.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2021277.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm217685.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm054658.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm074725.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm124917.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm230417.htm http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm300661.htm http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074482.htm http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074687.htm http://www.fda.gov/iceci/enforcementactions/warningletters/2010/ucm233990.htm http://www.fda.gov/iceci/enforcementactions/warningletters/2010/ucm234002.htm http://www.fda.gov/iceci/enforcementactions/warningletters/2010/ucm234023.htm http://www.fda.gov/iceci/enforcementactions/warningletters/2010/ucm234028.htm http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm http://www.fsis.usda.gov/wps/portal/informational/contactus http://www.gao.gov/new.items/d10246.pdf http://www.nationalacademies.org/hmd/Reports/2014/Caffeine-in-Food-and-Dietary-Supplements-Examining-Safety.aspx http://www.pewtrusts.org/∼/media/legacy/uploadedfiles/phg/content_level_pages/reports/foodadditivescapstonereportpdf.pdf http://www.plainlanguage.gov/whatisPL/govmandates/memo.cfm http://www.regulations.gov http://www.regulations.gov/docs/FactSheet_eRulemaking_Best_Practices.pdf http://www.ttb.gov/industry_circulars/archives/2010/10-08.html Regulations.gov Vol. 81, no. 159 Office of the Federal Register, National Archives and Records Administration 2016-08-17 continuing daily deposited born digital 405 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-08-17 P0b002ee1985ec261 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR17AU16 https://www.govinfo.gov/app/details/FR-2016-08-17 https://www.govinfo.gov/content/pkg/FR-2016-08-17/pdf/FR-2016-08-17.pdf https://www.govinfo.gov/content/pkg/FR-2016-08-17/xml/FR-2016-08-17.xml fdlp 54709 55104 DGPO 2018-02-09 2024-06-01 FR-2016-08-17 machine generated eng FR FR-2016-08-17 81 159