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 2009_register executive 2010-09-23 article Rules and Regulations D09002ee1c8078659 D09002ee1c80786ce 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) is revising its requirements for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract- containing food and carmine-containing food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This action also responds to a citizen petition submitted by the Center for Science in the Public Interest (CSPI). 74 FR 207 https://www.govinfo.gov/app/details/FR-2009-01-05/E8-31253 E8-31253 fr05ja09-5 RIN 0910-AF12 4160-01-S Docket No. FDA-1998-P-0032 https://www.govinfo.gov/app/details/FR-2009-01-05/E8-31253 https://www.govinfo.gov/content/pkg/FR-2009-01-05/html/E8-31253.htm https://www.govinfo.gov/content/pkg/FR-2009-01-05/pdf/E8-31253.pdf Food Labeling Nutrition Reporting and Recordkeeping Requirements Color Additives Cosmetics Drugs Medical Devices 11 p. 207 217 74 FR 207 Title 21 Part 101 21 CFR Part 101 Title 21 Part 73 21 CFR Part 73 RIN 0910-AF12 Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Federal Register Vol. 74, Issue RULE E8-31253 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2011-01-05 2009-02-04 Docket No. FDA-1998-P-0032 4160-01-S E8-31253 Final rule.

The Food and Drug Administration (FDA) is revising its requirements for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract- containing food and carmine-containing food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This action also responds to a citizen petition submitted by the Center for Science in the Public Interest (CSPI).

This regulation is effective January 5, 2011. All affected products initially introduced or initially delivered for introduction into interstate commerce on or after this date shall fully comply, except as to any provisions that may be stayed by the filing of proper objections. Voluntary compliance with this final regulation, including making any required labeling changes, may begin immediately. Submit written or electronic objections and requests for hearing by February 4, 2009. See section IX of the SUPPLEMENTARY INFORMATION section of this document for information on filing of objections. Mical Honigfort, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1278. Food Labeling Nutrition Reporting and Recordkeeping Requirements Color Additives Cosmetics Drugs Medical Devices Listing of Color Additives Exempt From Certification: Food, Drug, and Cosmetic Labeling; Cochineal Extract and Carmine Declaration, http://www.regulations.gov Vol. 74, no. 2 Office of the Federal Register, National Archives and Records Administration 2009-01-05 continuing daily deposited born digital 198 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2009-01-05 P0b002ee1809a3bcb 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05ja09 https://www.govinfo.gov/app/details/FR-2009-01-05 https://www.govinfo.gov/content/pkg/FR-2009-01-05/pdf/FR-2009-01-05.pdf https://www.govinfo.gov/content/pkg/FR-2009-01-05/xml/FR-2009-01-05.xml fdlp 201 391 DGPO 2010-09-23 2024-06-05 FR-2009-01-05 machine generated eng FR FR-2009-01-05 74 2