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 2018_register executive 2018-10-06 article Rules and Regulations D09002ee1c7e05470 D09002ee1c7e056d5 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, 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. 83 FR 50490 https://www.govinfo.gov/app/details/FR-2018-10-09/2018-21807 2018-21807 fr09oc18-7 4164-01-P Docket No. FDA-2015-F-4317 https://www.govinfo.gov/app/details/FR-2018-10-09/2018-21807 https://www.govinfo.gov/content/pkg/FR-2018-10-09/html/2018-21807.htm https://www.govinfo.gov/content/pkg/FR-2018-10-09/pdf/2018-21807.pdf Food Additives Reporting and Recordkeeping Requirements Food Packaging 14 p. 50490 50503 83 FR 50490 Title 21 Part 172 21 CFR Part 172 Title 21 Part 177 21 CFR Part 177 Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants; Federal Register Vol. 83, Issue RULE 2018-21807 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2018-10-09 2018-11-08 Docket No. FDA-2015-F-4317 4164-01-P 2018-21807 Final rule; notification of partial denial of petition.

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.

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. Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1071. Food Additives Reporting and Recordkeeping Requirements Food Packaging Food Additive Regulations: Synthetic Flavoring Agents and Adjuvants , http://www.inchem.org/documents/ehc/ehc/ehc240_index.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 83, no. 195 Office of the Federal Register, National Archives and Records Administration 2018-10-09 continuing daily deposited born digital 337 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-10-09 P0b002ee19d38627a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr09oc18 https://www.govinfo.gov/app/details/FR-2018-10-09 https://www.govinfo.gov/content/pkg/FR-2018-10-09/pdf/FR-2018-10-09.pdf https://www.govinfo.gov/content/pkg/FR-2018-10-09/xml/FR-2018-10-09.xml fdlp 50475 50801 DGPO 2018-10-06 2024-06-01 FR-2018-10-09 machine generated eng FR FR-2018-10-09 83 195