{"abstract":"The Food and Drug Administration (FDA) is affirming that certain enzyme preparations derived from animal and plant sources are generally recognized as safe (GRAS) for use as direct food ingredients. This action is a partial response to a petition filed by the Ad Hoc Enzyme Technical Committee (now the Enzyme Technical Association). The following enzyme preparations derived from animal sources are affirmed as GRAS in this final rule: Catalase (bovine liver), animal lipase, pepsin, trypsin, and pancreatin (as a source of protease activity). The following enzyme preparations derived from plant sources are affirmed as GRAS in this final rule: Bromelain, ficin, and malt.","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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1995/06/26/95-15239.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"184","title":21}],"citation":"60 FR 32904","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective June 26, 1995. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication listed in 21 CFR 184.1024(b), 184.1034(b), 184.1316(b), 184.1415(b), 184.1443a(b), 184.1583(b), 184.1595(b), and 184.1914(b), effective June 26, 1995.","disposition_notes":null,"docket_ids":["Docket No. 84G-0257"],"dockets":[{"supporting_documents":[{"title":"Response of The Enzyme Technical Association to The Letter Dated June 26, 1986, of Dr. Lawrence J. Lin Regarding GRASP 3G0016 re Comment from  Enzyme Technical Association","document_id":"FDA-1984-G-0019-0176"},{"title":"Toxicological evaluation of some enzymes, modified starches\nand certain other substances re Letter from Wallerstein Company to FDA","document_id":"FDA-1984-G-0019-0175"},{"title":"Background Material re Enzyme Preparations from Animal and Plant Sources; Affirmation of GRAS Status As Direct Food Ingredients","document_id":"FDA-1984-G-0019-0174"},{"title":"Exhibit P: Acknowledgment of receipt from FDA to Enzyme Technical Association","document_id":"FDA-1984-G-0019-0173"},{"title":"The 1978 Enzyme Survey Summarized Data from National Research Council re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0172"},{"title":"Tab 5 Determining The Safety of Enzymes Used in Food Processing,  Department of Food Microbiology and Toxicology University of Wisconsin and Food Research Institute re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0171"},{"title":"Tab 4  Enzyme Survey, Quality Assurance and Regulatory Affairs, Biotechnology Group, Miles Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0170"},{"title":"Tab 3 Methods of Enzyme Manufacture, Director of Scientific Affairs Pfizer, Inc. and NOVO Biochemical Industry, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0169"},{"title":"Tab 2 General Discussion of Enzymes Dairyland Food Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0168"},{"title":"Tab 1 Introduction Biotechnology Group, Miles Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0167"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-08-03","updated_at":"2026-10-08T12:57:24.602-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1984-G-0019-0106","allow_late_comments":false,"id":"FDA-1984-G-0019-0106","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":18,"id":"FDA-1984-G-0019","title":"Affirmation of GRAS Status of Certain Enzymes - CLOSED"}],"document_number":"95-15239","effective_on":"1995-06-26","end_page":32912,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1995/06/26/95-15239/enzyme-preparations-from-animal-and-plant-sources-affirmation-of-gras-status-as-direct-food","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/95-15239?publication_date=1995-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1995-06-26/95-15239/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":160,"last_updated":"2026-10-24 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1995-06-26/pdf/95-15239.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1995-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1995/06/26/95-15239.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Response of The Enzyme Technical Association to The Letter Dated June 26, 1986, of Dr. Lawrence J. Lin Regarding GRASP 3G0016 re Comment from  Enzyme Technical Association","document_id":"FDA-1984-G-0019-0176"},{"title":"Toxicological evaluation of some enzymes, modified starches\nand certain other substances re Letter from Wallerstein Company to FDA","document_id":"FDA-1984-G-0019-0175"},{"title":"Background Material re Enzyme Preparations from Animal and Plant Sources; Affirmation of GRAS Status As Direct Food Ingredients","document_id":"FDA-1984-G-0019-0174"},{"title":"Exhibit P: Acknowledgment of receipt from FDA to Enzyme Technical Association","document_id":"FDA-1984-G-0019-0173"},{"title":"The 1978 Enzyme Survey Summarized Data from National Research Council re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0172"},{"title":"Tab 5 Determining The Safety of Enzymes Used in Food Processing,  Department of Food Microbiology and Toxicology University of Wisconsin and Food Research Institute re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0171"},{"title":"Tab 4  Enzyme Survey, Quality Assurance and Regulatory Affairs, Biotechnology Group, Miles Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0170"},{"title":"Tab 3 Methods of Enzyme Manufacture, Director of Scientific Affairs Pfizer, Inc. and NOVO Biochemical Industry, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0169"},{"title":"Tab 2 General Discussion of Enzymes Dairyland Food Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0168"},{"title":"Tab 1 Introduction Biotechnology Group, Miles Laboratories, Inc. re Comment from Enzyme Technical Association","document_id":"FDA-1984-G-0019-0167"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1984-G-0019","supporting_documents_count":18,"docket_id":"FDA-1984-G-0019","document_id":"FDA-1984-G-0019-0106","regulation_id_number":null,"title":"Affirmation of GRAS Status of Certain Enzymes - CLOSED","checked_regulationsdotgov_at":"2026-10-09T18:55:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":32904,"subtype":null,"title":"Enzyme Preparations From Animal and Plant Sources; Affirmation of Gras Status as Direct Food Ingredients","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":60}