
[Federal Register Volume 77, Number 208 (Friday, October 26, 2012)]
[Proposed Rules]
[Pages 65340-65341]
From the Federal Register Online via the Government Printing 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


