2010-7956. EMD Chemicals, Inc.; Withdrawal of Color Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of the remaining portion of a color additive petition (CAP 8C0262) proposing an amendment of the color additive regulations to provide for the safe use of composite pigments prepared from synthetic iron oxide, mica, and titanium dioxide to color food.

FOR FURTHER INFORMATION CONTACT:

Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1071.

SUPPLEMENTARY INFORMATION:

In a notice published in the Federal Register of September 25, 1998 (63 FR 51359), FDA announced that a color additive petition (CAP 8C0262) had been filed by EM Industries, Inc., 7 Skyline Dr., Hawthorne, NY 10532 (now EMD Chemicals, Inc.). The petition proposed to amend the color additive regulations in 21 CFR part 73 to provide for the safe use of synthetic iron oxide and mica to color food and to provide for the safe use of titanium dioxide to color food at levels higher than the current limit. At the time of filing of the petition, FDA considered the pigments that are the subjects of this petition to be color additive mixtures of synthetic iron oxide, mica, and titanium dioxide. After further review of the petition, the agency determined that these pigments are composite pigments, not color additive mixtures. Therefore, the agency published an amended filing notice in the Federal Register of June 21, 1999 (64 FR 33097), indicating that the petition proposed to amend the color additive regulations to provide for the safe use of composite pigments prepared from combinations of synthetic iron oxide, titanium dioxide, and mica to color food. FDA issued a partial response to the petition on June 2, 2006, permitting composite pigments prepared from mica and titanium dioxide to color cereals, confections and frostings, gelatin desserts, hard and soft candies, nutritional supplement tablets and gelatin capsules, and chewing gum (71 FR 31927). The remaining composite pigments containing synthetic iron oxide included in the petition remained under review. EMD Chemicals, Inc., has now withdrawn that remaining portion of the petition without prejudice to a future filing (21 CFR 71.6(c)(2)).

Dated: March 18, 2010.

Mitchell A. Cheeseman,

Acting Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.