Source: https://www.federalregister.gov/documents/2006/06/02/E6-8575/listing-of-color-additives-exempt-from-certification-mica-based-pearlescent-pigments
Timestamp: 2017-05-29 17:14:18
Document Index: 720094958

Matched Legal Cases: ['§\u200973', '§\u200973', 'art 73', '§\u200971', '§\u200971', '§\u200971', 'art2', '§\u200973', '§\u200970']

A Rule by the Food and Drug Administration on 06/02/2006
31927-31929
E6-8575
https://www.federalregister.gov/d/E6-8575
In a final rule published in the Federal Register of October 24, 2002 (67 FR 65311), the agency listed the color additives based on titanium or iron salts and mica platelets for use in contact lenses in § 73.3128 (21 CFR 73.3128). In the same final rule, the agency collectively identified these color additives as mica-based pearlescent pigments. In addition, in the Federal Register of July 22, 2005 (70 FR 42271), the agency published a final rule to amend the color additive regulations to provide for the use of mica-based pearlescent pigments as color additives, in amounts up to 3 percent by weight, in ingested drugs by adding § 73.1128 (21 CFR 73.1128). To be consistent with these actions, the agency is using the same name for the color additive that is the subject of the present rule.
Based on the data and information in the petition and other relevant material, FDA concludes that the petitioned use of mica-based pearlescent pigments prepared from titanium salts and mica to color food is safe. The agency further concludes that the additive will achieve its intended technical effect, and is suitable for use in coloring food. The agency also concludes that 21 CFR part 73 of the color additive regulations should be amended as set forth in this document. In addition, based upon the factors listed in § 71.20(b) (21 CFR 71.20(b)), the agency concludes that certification of these titanium dioxide-coated mica-based pearlescent pigments is not necessary for the protection of the public health.
In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the Start Printed Page 31929petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT). As provided in § 71.15, the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.
Start Amendment PartTherefore, under the Federal Food, Drug, and Cosmetic Act (the act) and under the authority delegated to the Commissioner of Food and Drugs, End Amendment Part
Start Amendment Part2. Section 73.350 is added to subpart A to read as follows:End Amendment Part
(a) Identity. (1) The color additive is formed by depositing titanium salts onto mica, followed by heating to produce titanium dioxide on mica. Mica used to manufacture the color additive shall conform in identity to the requirements of § 73.1496(a)(1).
(d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.