[Federal Register Volume 77, Number 208 (Friday, October 26, 2012)]
[Proposed Rules]
[Pages 65340-65341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26315]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2009-F-0303]
Ajinomoto Co., Inc.; Filing of Food Additive Petition; Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of petition.
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SUMMARY: The Food and Drug Administration (FDA) is amending the filing
notice for a food additive petition filed by Ajinomoto Co., Inc., to
indicate that the petitioned additive, N-[N-[3-(3-hydroxy-4-
methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1-methyl ester,
monohydrate (proposed additive name Advantame, CAS Reg. No. 714229-20-
6), is for use as a non-nutritive sweetener and flavor enhancer in
foods generally, except meat and poultry. The previous filing notice
indicated that the proposed additive was for use as a non-nutritive
sweetener
[[Page 65341]]
in tabletop applications and powdered beverage mixes.
DATES: Submit either electronic or written comments on the petitioner's
environmental assessment by November 26, 2012.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1264.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of July 21, 2009 (74 FR 35871), FDA announced that a food
additive petition (FAP 9A4778) had been filed by Ajinomoto, Co., Inc.,
c/o Ajinomoto Corporate Services LLC, 1120 Connecticut Ave. NW., Suite
1010, Washington, DC 20036 (now c/o Ajinomoto North America, Inc., 400
Kelby St., Fort Lee, NJ 07024). In the notice of filing, FDA announced
that the petitioner proposed that the food additive regulations in part
172 Food Additives Permitted for Direct Addition to Food for Human
Consumption (21 CFR part 172) be amended to provide for the safe use of
N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-
phenylalanine 1-methyl ester, monohydrate (CAS Reg. No. 714229-20-6) as
a non-nutritive sweetener in tabletop applications and powdered
beverage mixes. The petition was filed under section 409 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 348).
Subsequent to publication of the filing notice, Ajinomoto Co.,
Inc., amended its petition to provide for the safe use of N-[N-[3-(3-
hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1-
methyl ester, monohydrate as a non-nutritive sweetener and flavor
enhancer in foods generally, except meat and poultry. Therefore, FDA is
amending the filing notice of July 21, 2009, to indicate that the
petitioner has proposed that the food additive regulations in part 172
be amended to provide for the use of N-[N-[3-(3-hydroxy-4-
methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1-methyl ester,
monohydrate (proposed additive name Advantame, CAS Reg. No. 714229-20-
6), as a non-nutritive sweetener and flavor enhancer in foods
generally, except meat and poultry.
The potential environmental impact of this petition is being
reviewed. To encourage public participation consistent with regulation
issued under the National Environmental Policy Act (40 CFR 1501.4(b)),
the Agency is placing the environmental assessment submitted with the
petition that is the subject of this notice on public display at the
Division of Dockets Management (see DATES and ADDRESSES) for public
review and comment.
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. FDA will also place on public display any
amendments to, or comments on, the petitioner's environmental
assessment without further announcement in the Federal Register. If,
based on its review, the Agency finds that an environmental impact
statement is not required, and this petition results in a regulation,
the notice of availability of the Agency's finding of no significant
impact and the evidence supporting that finding will be published with
the regulation in the Federal Register in accordance with 21 CFR
25.51(b).
Dated: October 22, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2012-26315 Filed 10-25-12; 8:45 am]
BILLING CODE 4160-01-P