[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Notices]
[Page 24856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006F-0059]


Danisco USA, Inc.; Filing of Food Additive Petition; Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is amending the filing 
notice for a food additive petition filed by Danisco USA, Inc., to 
indicate that the petition proposes to amend the food additive 
regulations at 21 CFR 172.841 by incorporating by reference the 
specifications for polydextrose in the 5th edition of the Food 
Chemicals Codex (FCC), 2003.

ADDRESSES: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul C. DeLeo, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1302.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of February 15, 2006 (71 FR 7975), FDA announced that a food 
additive petition (FAP 6A4763) had been filed by Danisco USA, Inc., 440 
Saw Mill River Rd., Ardsley, NY 10502-2605. 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 as a bulking 
agent, formulation aid, humectant, and texturizer in all foods, except 
meat and poultry. After publication of the filing notice, FDA learned 
that the petition also proposed to update Sec.  172.841 by 
incorporating by reference the specifications for polydextrose in the 
FCC, 5th ed., 2003. Currently, Sec.  172.841 incorporates by reference 
the specifications of FCC, 4th ed., 1996.
    The agency compared specifications in the monograph for 
polydextrose in the 4th and 5th editions of the FCC and found that the 
5th edition retains the lead limit of 0.5 milligram(mg)/ kilogram(kg), 
but no longer lists a specification limit of 5 mg/kg for heavy metals 
as lead. The 5th edition of the FCC eliminated the heavy metals as lead 
test from most monographs in favor of including individual 
specifications for relevant heavy metals. In addition, the 5th edition 
added a nickel specification of 2 mg/kg for hydrogenated polydextrose, 
as well as modified the pH specification of a 10 percent solution of 
untreated polydextrose from ``not less than 2.5'' (4th edition) to 
``between 2.5 and 7.0'' (5th edition). The name of the specification 
for 5-Hydroxymethylfurfural has also changed from ``5-
Hydroxymethylfurfural'' (4th edition) to ``5-Hydroxymethylfurfural and 
Related Compounds'' (5th edition), although the test and equation used 
to determine the level have remained the same. The agency has placed 
copies of the polydextrose monograph in the 4th and 5th editions of the 
FCC on public display at the Division of Dockets Management (see 
ADDRESSES) for public review.

    Dated: March 30, 2006.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. E6-6370 Filed 4-26-06; 8:45 am]
BILLING CODE 4160-01-S