[Federal Register Volume 60, Number 167 (Tuesday, August 29, 1995)]
[Rules and Regulations]
[Pages 44755-44756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21378]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket Nos. 89F-0400, 89F-0508, and 92F-0163]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Sucrose Fatty Acid Esters

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 sucrose fatty acid 
esters as emulsifiers, stabilizers, and texturizers in chewing gum, 
confections, and frostings; texturizers in surimi-based fabricated 
seafood products; and emulsifiers in coffee and tea beverages with 
added dairy ingredients and/or dairy product analogues. This action is 
in response to petitions filed by the Nebraska Department of Economic 
Development and Mitsubishi Kasei Corp.

DATES: Effective August 29, 1995; written objections and requests for a 
hearing by September 28, 1995.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
    Blondell Anderson, Center for Food Safety and Applied Nutrition 
(HFS-207), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 202-418-3106, or
    Dennis M. Keefe, Center for Food Safety and Applied Nutrition (HFS-
206), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 202-418-3102.

SUPPLEMENTARY INFORMATION: In notices published in the Federal 
Registers of October 24, 1989 (54 FR 43338), January 10, 1990 (55 FR 
908), and May 13, 1992 (57 FR 20495), FDA announced that food additive 
petitions (FAP 9A4166, FAP 0A4183, and FAP 2A4321, respectively) had 
been filed by the Nebraska Department of Economic Development, 301 
Centennial Mall South, Lincoln, NE 68509 (FAP 9A4166), and Mitsubishi 
Kasei Corp., 5-2, Marunouchi 2-Chome, Chiyoda-ku, Japan (FAP 0A4183 and 
FAP 2A4321), proposing that Sec. 172.859 Sucrose fatty acid esters (21 
CFR 172.859) be amended to provide for the safe use of sucrose fatty 
acid esters as emulsifiers, stabilizers, and texturizers in chewing 
gum, confections and frostings; as texturizers in surimi-based 
fabricated seafood products; and as emulsifiers in coffee and tea 
beverages.
    FDA has evaluated data in these petitions and concludes from all 
the available data that there is a reasonable certainty that the 
proposed uses are safe. In reaching this conclusion, the agency has 
among other things, calculated the estimated daily intake from the 
proposed uses and all previously approved uses of sucrose fatty acid 
esters (Ref. 1). The agency has also calculated from toxicological 
information the acceptable daily intake level of sucrose fatty acid 
esters (Ref. 2). The agency finds that the estimated daily intake from 
the proposed uses and all approved uses is less than the estimated 
acceptable daily intake level. Thus, the agency concludes that the food 
additive regulations should be amended as set forth below.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petitions 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petitions are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with one of 
the information contact persons listed above. As provided in 21 CFR 
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.
    Any person who will be adversely affected by this regulation may at 
any time on or before September 28, 1995, file with the Dockets 
Management Branch (address above) written objections 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. 

[[Page 44756]]
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 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.

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. DiNovi, M., Memorandum to L. Tarantino, May 23, 1995.
    2. Bleiberg, M., Memorandum to B. Anderson et al., November 4, 
1993.

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 and 
redelegated to the Director of the Center for Food Safety and Applied 
Nutrition, 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: Secs. 201, 401, 402, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 
379e).

    2. Section 172.859 is amended by revising paragraphs (c)(1) and 
(c)(2) to read as follows:


Sec. 172.859  Sucrose fatty acid esters.

* * * * *
    (c) * * *
    (1) As emulsifiers as defined in Sec. 170.3(o)(8) of this chapter, 
or as stabilizers as defined in Sec. 170.3(o)(28) of this chapter, in 
baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this 
chapter, in chewing gum as defined in Sec. 170.3(n)(6) of this chapter, 
in coffee and tea beverages with added dairy ingredients and/or dairy 
product analogues, in confections and frostings as defined in 
Sec. 170.3(n)(9) of this chapter, in dairy product analogues as defined 
in Sec. 170.3(n)(10) of this chapter, in frozen dairy desserts and 
mixes as defined in Sec. 170.3(n)(20) of this chapter, and in whipped 
milk products.
    (2) As texturizers as defined in Sec. 170.3(o)(32) of this chapter 
in biscuit mixes, in chewing gum as defined in Sec. 170.3(n)(6) of this 
chapter, in confections and frostings as defined in Sec. 170.3(n)(9) of 
this chapter, and in surimi-based fabricated seafood products.
* * * * *

    Dated: August 8, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-21378 Filed 8-28-95; 8:45 am]
BILLING CODE 4160-01-F