[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
