[Federal Register Volume 60, Number 205 (Tuesday, October 24, 1995)]
[Rules and Regulations]
[Pages 54424-54425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26358]
-----------------------------------------------------------------------
[[Page 54425]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 172
[Docket No. 94F-0223]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Polydextrose
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 polydextrose
produced by using phosphoric acid. This action is in response to a
petition filed by A. E. Staley Manufacturing Co.
DATES: Effective October 24, 1995; written objections and requests for
a hearing by November 24, 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: Rosalie M. Angeles, Center for Food
Safety and Applied Nutrition (HFS-207), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3107.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of July 15, 1994 (59 FR 36204), FDA announced that a food
additive petition (FAP 4A4422) had been filed by A. E. Staley
Manufacturing Co., c/o P.O. Box 151, Decatur, IL 62525. The petition
proposed to amend the food additive regulations in Sec. 172.841
Polydextrose (21 CFR 172.841) to provide for the safe use of
polydextrose produced using phosphoric acid in place of citric acid.
The petition provided data that demonstrated that polydextrose
manufactured using phosphoric acid in place of citric acid is
equivalent to polydextrose produced in accordance with Sec. 172.841.
FDA further determined that the very low levels of residual phosphate
in polydextrose produced using phosphoric acid are both chemically and
toxicologically insignificant (Ref. 1). Therefore, based on its
evaluation of the data in the petition and other relevant material, FDA
concludes that the proposed food additive use is safe, and that the
regulation should be amended as set forth below.
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 (address above) by
appointment with the information contact person 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 November 24, 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. 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.
Reference
The following reference has 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. Memorandum from M. J. DiNovi, Chemistry Review Branch, CFSAN,
to R. M. Angeles, Novel Ingredients Branch, CFSAN, October 7, 1994.
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, 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 172.841 is amended by revising paragraph (a)(1) to read
as follows:
Sec. 172.841 Polydextrose.
* * * * *
(a)(1) Polydextrose (CAS Reg. No. 68424-04-4) is a partially
metabolizable water-soluble polymer prepared by the condensation of a
melt which consists either of approximately 89 percent D-glucose, 10
percent sorbitol, and 1 percent citric acid or of approximately 90
percent D-glucose, 10 percent sorbitol, and 0.1 percent phosphoric
acid, on a weight basis.
* * * * *
Dated: October 17, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-26358 Filed 10-23-95; 8:45 am]
BILLING CODE 4160-01-F