Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers

In a notice published in the Federal Register of October 6, 1998 (63 FR 53679), FDA announced that a food additive petition (FAP 8B4626) had been filed by BASF Corp., 3000 Continental Dr. North, Mt. Olive, NJ 07828-1234. The petition proposed to amend the food additive regulations in Sec. 178.3297 Colorants for polymers (21 CFR 178.3297) to provide for the safe use of anthra(2,1,9- def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone (C.I. Pigment Violet 29) as a colorant for polymers intended for use in contact with food. FDA has evaluated data in the petition and other relevant material. Based on this information, the agency concludes that the proposed use of the additive as a colorant for all polymers intended for use in contact with food is safe and that the additive will have the intended technical effect. Therefore, the regulations in Sec. 178.3297 should be amended as set forth below. In accordance with Sec. 171.1(h) (21CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in Sec. 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection. The agency has previously considered the potential environmental effects of this rule as announced in the notice of filing for the petition. No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required. This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. Any person who will be adversely affected by this regulation may at any time on or before June 17, 1999 file with the Dockets Management Branch (address above) a written objection thereto. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents shall be submitted and shall be identified with the docket number found in brackets in the heading of this document. Any objection received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 178 is amended as follows:

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e. 2. Section 178.3297 is amended in the table in paragraph (e), by alphabetically adding an entry for anthra(2,1,9-def:6,5,10- d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone (C.I. Pigment Violet 29) under the headings ``Substances'' and ``Limitations'' to read as follows:

Sec. 178.3297 Colorants for polymers.

* * * * * (e) * * *

------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ * * * * * * * Anthra(2,1,9-def:6,5,10- For use at levels not to exceed 1% d'e'f')diisoquinoline- by weight of polymers. The 1,3,8,10(2H,9H)-tetrone (C.I. finished articles are to contact Pigment Violet 29; CAS Reg. No. 81- food only under conditions of use 33-4) B through H as described in Table 2 of Sec. 176.170(c) of this chapter. * * * * * * * ------------------------------------------------------------------------

Dated: May 5, 1999. L. Robert Lake, Director, Office of Policy, Planning and Strategic Initiatives, Center for Food Safety and Applied Nutrition. [FR Doc. 99-12396 Filed 5-17-99 8:45 am] BILLING CODE 4160-01-F