{"abstract":"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.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/08/17/2016-19164.html","cfr_references":[{"chapter":null,"citation_url":null,"part":20,"title":21},{"chapter":null,"citation_url":null,"part":25,"title":21},{"chapter":null,"citation_url":null,"part":170,"title":21},{"chapter":null,"citation_url":null,"part":184,"title":21},{"chapter":null,"citation_url":null,"part":186,"title":21},{"chapter":null,"citation_url":null,"part":570,"title":21}],"citation":"81 FR 54960","comment_url":null,"comments_close_on":"2016-10-17","correction_of":null,"corrections":["https://www.federalregister.gov/api/v1/documents/C1-2016-19164"],"dates":"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).","disposition_notes":null,"docket_ids":["Docket No. FDA-1997-N-0020 (formerly 97N-0103)"],"dockets":[{"supporting_documents":[{"title":"Reference 56-FDA-CVM-Guidance-GFI221-2015 re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0177"},{"title":"Reference 51-GRAS-FRIA-August2016 re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0172"},{"title":"Reference 38-FDA-Form-3667 re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0160"},{"title":"Reference 37-FDA-CFSAN-Guidance-Electronic-Submissions re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0159"},{"title":"Reference 33-FDA-CFSAN-Guidance-Enzymes re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0155"},{"title":"Reference 32-FDA-CFSAN-Guidance-Antimicrobial-Substances re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0154"},{"title":"Reference 26-Renwick-Food-Chem-Toxicology re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0149"},{"title":"Reference 17-ILSI-North America-Caffeine-Working-Group-accessed-06-08-2016 re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0140"},{"title":"Reference 12-FDA-2010-Warning Letter To Phusion Projects re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0135"},{"title":"Reference 11-FDA-2010-Warning Letter To New Century Brewing re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0134"}],"agency_name":"FDA","documents":[{"comment_count":6,"comment_start_date":"2016-08-17","updated_at":"2023-02-28T19:33:14.662-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-1997-N-0020-0126","allow_late_comments":null,"id":"FDA-1997-N-0020-0126","comment_end_date":"2016-10-18","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":115,"id":"FDA-1997-N-0020","title":"Substances Generally Recognized as Safe (GRAS) - Closed"}],"document_number":"2016-19164","effective_on":"2016-10-17","end_page":55055,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/08/17/2016-19164.xml","html_url":"https://www.federalregister.gov/documents/2016/08/17/2016-19164/substances-generally-recognized-as-safe","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-19164?publication_date=2016-08-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-08-17/2016-19164/mods.xml","not_received_for_publication":null,"page_length":96,"page_views":{"count":82030,"last_updated":"2026-05-23 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-17/pdf/2016-19164.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-19164.pdf?1471014925","publication_date":"2016-08-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/08/17/2016-19164.txt","regulation_id_number_info":{"0910-AH15":{"issue":"201604","html_url":"https://www.federalregister.gov/regulations/0910-AH15/substances-generally-recognized-as-safe","title":"Substances Generally Recognized as Safe","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AH15&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH15"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 56-FDA-CVM-Guidance-GFI221-2015 re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0177"},{"title":"Reference 51-GRAS-FRIA-August2016 re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0172"},{"title":"Reference 38-FDA-Form-3667 re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0160"},{"title":"Reference 37-FDA-CFSAN-Guidance-Electronic-Submissions re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0159"},{"title":"Reference 33-FDA-CFSAN-Guidance-Enzymes re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0155"},{"title":"Reference 32-FDA-CFSAN-Guidance-Antimicrobial-Substances re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0154"},{"title":"Reference 26-Renwick-Food-Chem-Toxicology re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0149"},{"title":"Reference 17-ILSI-North America-Caffeine-Working-Group-accessed-06-08-2016 re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0140"},{"title":"Reference 12-FDA-2010-Warning Letter To Phusion Projects re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0135"},{"title":"Reference 11-FDA-2010-Warning Letter To New Century Brewing re Substances Generally Recognized as Safe","document_id":"FDA-1997-N-0020-0134"}],"comments_count":6,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1997-N-0020","supporting_documents_count":115,"docket_id":"FDA-1997-N-0020","document_id":"FDA-1997-N-0020-0126","regulation_id_number":null,"title":"Substances Generally Recognized as Safe (GRAS) - Closed","checked_regulationsdotgov_at":"2023-03-01T00:33:13Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":54960,"subtype":null,"title":"Substances Generally Recognized as Safe","toc_doc":"Substances Generally Recognized as Safe","toc_subject":null,"topics":["Administrative practice and procedure","Animal feeds","Animal foods","Confidential business information","Courts","Environmental impact statements","Food additives","Food packaging","Foreign relations","Freedom of information","Government employees","Reporting and recordkeeping requirements"],"type":"Rule","volume":81}