[Federal Register: August 12, 1999 (Volume 64, Number 155)]
[Rules and Regulations]
[Page 43908-43909]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au99-5]

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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.

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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 filed by 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.

SUPPLEMENTARY INFORMATION:

I. Introduction

    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 filed by 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).

II. Identity

    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).

III. 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

[[Page 43909]]

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).

IV. Conclusions

    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.

V. Environmental

    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.

VI. 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.

VII. Objections

    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.

VIII. References

    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.
    1. Addendum memorandum from Whiteside, Scientific Support Branch,
FDA, to Anderson, Novel Ingredients Branch, FDA, November 13, 1997.
    2. Memorandum from Whiteside, Division of Health Effects
Evaluation, FDA, to Anderson, Regulatory Policy Branch, February 25,
1999.
    3. 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

    1. The authority citation for 21 CFR part 172 continues to read as
follows:

    Authority:  21 U.S.C. 321, 341, 342, 348, 371, 379e.

    2. 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. 99-20888 Filed 8-11-99; 8:45 am]
BILLING CODE 4160-01-F