{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is partially granting a petition submitted by the Breast Cancer Fund (now known as the Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids' Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff, by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. We are taking this action because, despite FDA's scientific analysis and determination that these substances do not pose a risk to public health under the conditions of their intended use, the petitioners provided data demonstrating that these additives induce cancer in laboratory animals, and, as a result of this finding in animals, FDA cannot as a matter of law maintain the listing of these synthetic flavoring substances in the food additive regulations. Because of evidence that benzophenone causes cancer in animals, FDA also is amending the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. FDA is denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. In addition, FDA is declining to act on the petitioners' request to issue a regulation to prohibit the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition.","action":"Final rule; notification of partial denial of petition.","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/2018/10/09/2018-21807.html","cfr_references":[{"chapter":null,"citation_url":null,"part":172,"title":21},{"chapter":null,"citation_url":null,"part":177,"title":21}],"citation":"83 FR 50490","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective October 9, 2018. See section IX for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by November 8, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-F-4317"],"dockets":[],"document_number":"2018-21807","effective_on":"2018-10-09","end_page":50503,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/10/09/2018-21807.xml","html_url":"https://www.federalregister.gov/documents/2018/10/09/2018-21807/food-additive-regulations-synthetic-flavoring-agents-and-adjuvants","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-21807?publication_date=2018-10-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-10-09/2018-21807/mods.xml","not_received_for_publication":null,"page_length":14,"page_views":{"count":55751,"last_updated":"2026-08-26 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-10-09/pdf/2018-21807.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-21807.pdf?1538743528","publication_date":"2018-10-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/10/09/2018-21807.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 17 Pyridine Final Toxicology Memo.TTyler.06.27.18 - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0076"},{"title":"Reference 16 MODE OF ACTION OF PULEGONE ON THE URINARY BLADDER OF F344 RATS (DA ROC - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0075"},{"title":"Reference 15 FAP 5A4810 Pulegone Final Toxicology Memo NA FINAL - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0074"},{"title":"Reference 14 2018 06 21 Myrcene Carcinogenic Final Tox Memo ATKhan - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0073"},{"title":"Reference 13 2018-06-21-Methyleugenol Carcinogenic Evaluation Tox memoFINAL - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0072"},{"title":"Reference 12 NTP Report on Carcinogens Background Document for Ethyl Acrylate Dockets - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0071"},{"title":"Reference 11 Ethyl Acrylate Carcinogenicity Review Memorandum Final 06_21_2018 (2) - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0070"},{"title":"Reference 10 Boobis 2006 IPCS MOA - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0069"},{"title":"Reference 9 Benzophenone Flavors  Review of the carcinogencity of benzophenone final 06_21_2018  - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0068"},{"title":"Reference  8 FEMA Response Package 041116_Redacted - re: Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","document_id":"FDA-2015-F-4317-0066"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-F-4317","supporting_documents_count":23,"docket_id":"FDA-2015-F-4317","regulation_id_number":null,"title":"Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids’ Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff; Filing of Food Additive Petition","checked_regulationsdotgov_at":"2018-11-18T10:05:30Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":50490,"subtype":null,"title":"Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants","toc_doc":"Synthetic Flavoring Agents and Adjuvants","toc_subject":"Food Additive Regulations:","topics":["Food additives","Food packaging","Reporting and recordkeeping requirements"],"type":"Rule","volume":83}