[Federal Register Volume 74, Number 46 (Wednesday, March 11, 2009)]
[Rules and Regulations]
[Page 10483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 73 and 101

[Docket No. FDA-1998-P-0032] (formerly Docket No. 1998P-0724)


Listing of Color Additives Exempt From Certification; Food, Drug, 
and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; 
Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of January 5, 2011, for the final rule that appeared in 
the Federal Register of January 5, 2009. The final rule amends the 
regulations 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.

DATES: The effective date of the final rule published on January 5, 
2009 (74 FR 207), amending 21 CFR 73.100, 73.2087, and 101.22, is 
confirmed: January 5, 2011.

FOR FURTHER INFORMATION CONTACT: James C. Wallwork, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1303.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 5, 2009 
(74 FR 207), FDA amended the color additive regulation in 21 CFR 73.100 
that permits the use of cochineal extract and carmine in foods by 
adding new paragraph (d)(2) to require that all foods (including 
butter, cheese, and ice cream) that contain cochineal extract or 
carmine specifically declare the presence of the color additive by its 
respective common or usual name, ``cochineal extract'' or ``carmine,'' 
in the ingredient statement of the food label. Because Sec.  101.22(k) 
(21 CFR 101.22(k)) allows any certification-exempt color additive to be 
declared with a general phrase, such as ``Artificial Color'' or 
``Artificial Color Added,'' rather than by its specific common or usual 
name, FDA amended Sec.  101.22(k) to disallow generic declaration of 
color additives for which individual declaration is required by 
applicable regulations in part 73 (21 CFR part 73).
    For cosmetic products, FDA amended the color additive regulation in 
Sec.  73.2087 (21 CFR 73.2087) permitting the use of carmine in 
cosmetics by revising paragraph (c) to require that cosmetics 
containing carmine that are not subject to the requirements of Sec.  
701.3 (21 CFR 701.3) specifically declare the presence of carmine 
prominently and conspicuously at least once in the labeling. This 
amendment covers all cosmetic products, including those cosmetics that 
are manufactured and sold for use only by professionals (e.g., makeup 
used in photography studios and by makeup artists for television, 
movie, and theater actors/actresses, products intended for use only by 
professionals in beauty salons, and camouflage makeup dispensed by 
physicians and aestheticians to clients with skin conditions such as 
scarring) and those cosmetics that are gifts or free samples. FDA also 
included in Sec.  73.2087, as an example, the following statement: 
``Contains carmine as a color additive.''
    FDA gave interested persons until February 4, 2009, to file 
objections or requests for a hearing. The agency received no objections 
or requests for a hearing on the final rule. Therefore, FDA finds that 
the effective date of the final rule that published in the Federal 
Register of January 5, 2009, should be confirmed.

List of Subjects

21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

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Therefore, under the Federal Food, Drug, and Cosmetic Act (15 U.S.C. 
1453, 1454, 1455; 21 U.S.C. 321, 331, 341, 342, 343, 348, 351, 352, 
355, 361, 362, 371, 379e; 42 U.S.C. 243, 264, 271) and under the 
authority delegated to the Commissioner of Food and Drugs (1410.10 of 
the FDA Staff Manual Guide) notice is given that no objections or 
requests for a hearing were filed in response to the January 5, 2009, 
final rule. Accordingly, the amendments issued thereby become effective 
January 5, 2011.

    Dated: March 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5286 Filed 3-10-09; 8:45 am]
BILLING CODE 4160-01-S