Food additives: Sucralose,
[Federal Register: August 12, 1999 (Volume 64, Number 155)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. 99F-0001]
Food Additives Permitted for Direct Addition to Food for Human Consumption; Sucralose
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of sucralose as a general purpose sweetener for food. This action is in response to a petition filedby McNeil Specialty Products Co.
DATES: This regulation is effective August 12, 1999; written objections and requests for a hearing by September 13, 1999.
ADDRESSES: Written objections may be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Blondell Anderson, Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3106.
In a notice published in the Federal Register on January 11, 1999 (64 FR 1634), FDA announced that a food additive petition (FAP 8A4624) had been filedby McNeil Specialty Products, Co., 501 George St., New Brunswick, NJ 08903-2400. The petition proposed that the food additive regulations be amended at Sec. 172.831 (21 CFR 172.831) to expand the permitted uses of sucralose to allow for use as a general purpose sweetener in food. FDA previously approved sucralose for use in 15 food categories under Sec. 172.831 (64 FR 16417, April 3, 1998).
Sucralose is a disaccharide that is made from sucrose in a five- step process that selectively substitutes three atoms of chlorine for three hydroxyl groups in the sugar molecule. It is a free-flowing, white crystalline solid, product at an approximate purity of 98 percent, that is soluble in water and stable both in crystalline form and in most aqueous solutions. The sweetness intensity for sucralose in 320 to 1,000 times that of sucrose, depending on the food application.
Hydrolysis of sucralose may occur under conditions of prolonged storage at elevated temperatures in highly acidic aqueous food products. The hydrolysis products are the monosaccharides, 4-chloro-4- deoxy-galactose (4-CG) and 1,6-dichloro-1,6-dideoxyfructose (1,6-DCF).
Evaluation of Safety
In support of safety for the proposed expanded uses of sucralose, the petitioner referenced the toxicological safety data base submitted in food additive petition (FAP) 9A3987 that established the safety of the currently approved uses. Also referenced were the identity, manufacturing process, and specifications for the sweetener. In the new petition (FAP 8A4624), the petitioner submitted data concerning: (1) Use and typical use levels; (2) self-limiting levels; (3) proof of technical effect; (4) exposure; (5) stability; and (6) analysis in foods for both sucralose and its potential hydrolysis products.
In order to determine whether sucralose can be safety used as a general
purpose sweetener, the agency reevaluated the currently established acceptable daily intake (ADI) for sucralose, 5 milligrams per kilogram body weight per day (mg/kg bw/d) (Ref. 1) and determined that this ADI is still appropriate (Ref. 2). FDA also estimated new daily intakes (EDI) for the 90th percentile consumer of sucralose to include the expanded uses. The new EDI was derived from projections based on the amount of sucralose that may be used in the currently regulated food categories, the proposed food categories, and on data regarding the consumption levels of these particular foods. Based upon the data in the petition and other information, the agency established a no effect level (NOEL) for the hydrolysis products of sucralose at 30 mg/kg bw/d (Ref. 2).
To aid in the establishment of new exposure estimates for sucralose and its hydrolysis products, the petitioner submitted a Market Research Corporation of America (MRCA) report that addresses foods in which sucralose may be used and an updated report on the potential exposure for the hydrolysis products. From this information, the agency has determined that based on the expanded uses, the cumulative exposure to sucralose could increase to 2.4 mg/kg bw/d and the cumulative exposure to its hydrolysis products to 0.007 mg/kg bw/d (Ref. 3). The agency concludes: Exposure to sucralose will remain below the previously established ADI of 5.0 mg/kg bw/d for sucralose, and exposure to the hydrolysis products will remain far below the no effect level of 30 mg/ kg bw/d (Refs. 2 and 3).
From the review of all the information available on sucralose and its hydrolysis products, the agency concludes that sucralose may be safely used as a sweetener in food generally (Refs. 2 and 3).
In accordance with Sec. 171.1(h) (21 CFR 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 carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.
Paperwork Reduction Act 1995
This final rule contains no collection 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 September 13, 1999, file with the Dockets Management Branch (address above) written objections thereto. Each objection shall be separately numbered, and each numbered objection shall specify with particularly 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 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 objections 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.
The following references have been placed on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
Addendum memorandum from Whiteside, Scientific Support Branch, FDA, to Anderson, Novel Ingredients Branch, FDA, November 13, 1997.
Memorandum from Whiteside, Division of Health Effects Evaluation, FDA, to Anderson, Regulatory Policy Branch, February 25, 1999.
Memorandum from DiNovi, Division Product Manufacture and Use, FDA, to Anderson, Division of Product Policy, FDA, October 22, 1998.
List of Subjects in 21 CFR Part 172
Food additives, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 172 is amended as follows:
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
The authority citation for 21 CFR part 172 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
Section 172.831 is amended by removing the introductory paragraph and by revising paragraph (c) to read as follows:
Sec. 172.831 Sucralose.
* * * * *
(c)The additive may be used as a sweetener in foods generally, in accordance with current good manufacturing practice in an amount not to exceed that reasonably required to accomplish the intended effect. * * * * *
Dated: August 5, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy.
[FR Doc. 99-20888Filed8-11-99; 8:45 am]
BILLING CODE 4160-01-F