[Federal Register Volume 61, Number 126 (Friday, June 28, 1996)]
[Rules and Regulations]
[Pages 33654-33656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 94F-0405]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Aspartame

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 aspartame as a 
general purpose sweetener. This action is in response to a petition by 
the NutraSweet Co., and will simplify the existing regulation by 
replacing most of the 23 currently listed uses of aspartame with a 
single use category for food.

DATES: The regulation is effective June 28, 1996. Submit written 
objections and requests for a hearing by July 29, 1996. The Director of 
the Office of the Federal Register approves the incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a 
certain publication in 21 CFR 172.804(c)(2), effective June 28, 1996.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
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.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of December 8, 1994 (59 FR 63368), FDA announced that a food 
additive petition (FAP 5A4439) had been filed by the NutraSweet Co., 
1751 Lake Cook Rd., Deerfield, IL 60015-5239, proposing that the food 
additive regulations be amended in Sec. 172.804 Aspartame (21 CFR 
172.804) to provide for the safe use of aspartame as a general purpose 
sweetener.

I. Background

    Aspartame is currently approved for use in a large number of 
processed foods under Sec. 172.804 (21 CFR 172.804) (20 permitted uses 
as a sweetener and 3 permitted uses as a flavor enhancer). The 
regulation has resulted from the approval of 27 separate food additive 
petitions (FAP's).
    The acceptable daily intake (ADI) of 50 milligrams per kilogram 
body weight per day (mg/kg/day) was established for aspartame as a 
result of the agency's review of FAP 2A3661, which requested use of 
aspartame in carbonated beverages (48 FR 31376, July 8, 1983). The ADI 
is the level of consumption that has been determined to be safe for 
human consumption every day over an entire lifetime. The agency's 
review of all petitions submitted subsequent to aspartame's approval in 
carbonated beverages involved primarily: (1) An assessment of the 
estimated exposure from each additional use; and (2) a determination of 
whether the cumulative estimated exposure, including the newly 
requested use, would cause the acceptable daily intakes for aspartame 
and for its major breakdown product, diketopiperazine (DKP), to be 
exceeded over a lifetime by individuals consuming aspartame at the 90th 
percentile level. The 90th percentile intake (which represents high 
exposure) is the level of consumption at which 90 percent of the 
population (a selected population subgroup) consumes the ingredient at 
or below the indicated value.
    NutraSweet is now requesting that the aspartame regulation be 
amended to allow its use as a general purpose sweetener at levels 
determined by current good manufacturing practice (CGMP). FDA's CGMP 
regulation for food additives requires, among other things, that the 
level of an additive used in food not be higher than that level 
required to accomplish the intended functional effect (21 CFR 
172.5(a)(1)). This level has not, in general, been set by the agency 
except when there appears to be a specific need to do so. In the case 
of the agency's review of FAP 7A4044, which requested the use of 
aspartame in baked goods and baking mixes, the maximum level of use of 
aspartame that would be consistent with CGMP was set at 0.5 percent by 
weight of ready-to-bake products or of finished formulations prior to 
baking. In that decision, the agency imposed a use limit that can be 
verified by an analytical method that is incorporated by reference into 
the regulation. That requirement is maintained in this regulation. For 
all other uses of aspartame the agency has determined that CGMP levels 
of use need not be specified.
    The practical effect of the amendment requested in the current 
petition would be to simplify the existing regulation in Sec. 172.804 
by replacing most of the 23 currently listed uses of aspartame with a 
single use category for food. As discussed below, the permitted uses of 
aspartame are sufficiently broad that including any additional category 
not allowed by the current regulation will not cause human exposure to 
change significantly.

II. Petition for Use of Aspartame as a General Purpose Sweetener

    To support the proposed amendment, NutraSweet has submitted a 
summary of postmarket aspartame intake surveys performed by the Market 
Research Corp. of America (MRCA) between 1984 and 1992. These surveys 
(which measure the actual amount of aspartame consumed by individuals) 
track the quantity of aspartame-sweetened foods that are consumed over 
a 2-week period. According to the July 1991 to June 1992 survey, the 
intake of aspartame for individuals who consume aspartame at the 90th 
percentile (``eaters only'') is 3.0 mg/kg/day (6 percent of the ADI) 
for the ``all ages'' population group and is 5.2 mg/kg/day (10.4 
percent of the ADI) for children in the 0-month to 5-year-old subgroups 
(the groups that consume the highest amounts of aspartame per kg of 
body weight). NutraSweet states in the petition that aspartame intake 
from the potential new uses is not expected to significantly increase 
aspartame consumption above current levels. This is because: (1) Its 
intake from the major use category (e.g., beverages) has stabilized and 
the potential new uses will have, at most, a minor effect on total 
consumption; and (2) the permitted uses of competing high-intensity 
sweeteners continue to be broadened.

III. Exposure Estimates

    The agency focused its safety evaluation on whether human exposure 
to aspartame as a general purpose sweetener would exceed the ADI of 50 
mg/kg/day; and whether human exposure to DKP, the aspartame 
decomposition product, would exceed the ADI of 30 mg/kg/day (Ref. 1).

A. Aspartame

    In the Commissioner's 1981 decision to approve aspartame (46 FR 
38285, July 24, 1981), several methods were described for projecting 
the level of

[[Page 33655]]

aspartame consumption. In one method the agency estimated that if 
aspartame replaced all sucrose in the diet of an average 60 kg 
individual, the aspartame consumption would be approximately 8.3 mg/kg/
day. In the petition, Nutrasweet projects an aspartame intake of 8.1 
mg/kg/day for all age groups when used as a general purpose sweetener.
    The agency has reassessed the anticipated exposure to aspartame in 
light of all the evidence gained since the earlier approval. Assuming 
that all sucrose added to food would be replaced by aspartame, the 
agency estimates that the daily intake would be 8.7 mg/kg/day. Use of 
other approaches to estimate consumption also results in consistent 
intake estimates that are far below the ADI (Ref. 1). This shows that 
high levels of aspartame intake derived for different age groups are 
unlikely to exceed the ADI if used in food with no limitations other 
than CGMP.

B. DKP

    Aspartame can partially decompose to yield DKP in certain food 
products when they are heated or stored for prolonged periods of time. 
FDA has previously set an ADI for DKP of 30 mg/kg/day (48 FR 31376, 
July 8, 1983). In order to derive a conservative exposure to DKP, FDA 
used the highest exposure estimate derived for aspartame (based on the 
assumption that all sugars added to food would be replaced with 
aspartame). This DKP exposure estimate does not exceed 10 percent of 
the ADI for all age groups and does not exceed 16 percent for the 0- to 
5-year-old age group (Ref. 1) These estimates show that the ADI for DKP 
will not be exceeded when aspartame is used as a general purpose 
sweetener.

IV. Comment

    The agency received one comment in response to the filing notice of 
December 8, 1994, from the McNeil Specialty Products Co. (Ref. 2). This 
comment raised two points, each of which is addressed below.
    The first point raised by the comment was that the filing notice 
failed to specify that the agency was soliciting comments on the entire 
petition, not just on the environmental assessment. The comment 
suggested that the entire petition should be made available at the 
Dockets Management Branch and that a separate notice should be 
published in the Federal Register explicitly requesting comments on all 
aspects of the petition.
    Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 348(b)(5)), FDA is required to announce the filing 
of a food additive petition. Although public notice of a petition is 
required, the act is silent with respect to public comment on a 
petition.
    Historically, FDA has not placed food additive petitions on public 
display when a notice of filing is published and knows of no reason why 
such public display should be required. The agency considers comments 
received consistent with their relevance to the petitioned action. 
Information from the petition can be obtained through a request made 
under the Freedom of Information Act consistent with 21 CFR part 20.
    The second point raised by the comment was that the petition lacks 
information required under Sec. 171.1(c) (21 CFR 171.1(c)) on the 
amount of the additive proposed for use, appropriate functionality data 
to support the additional use categories requested, and methods to 
determine the level of the additive in food. It is further noted in the 
comment that if such information exists in other petitions, 
Sec. 171.1(b) allows the petitioner to reference, rather than resubmit, 
such information. The comment points to: (1) Data establishing 
functionality and appropriate use levels and analytical techniques for 
the newly-requested approvals are not present in the current petition 
and (2) the petitioner had not specifically referenced such data; thus, 
the petition does not comply with the requirements found in 
Sec. 171.1(c). Therefore, the comment contends that the petition is 
deficient and should not have been accepted for filing, and should be 
amended accordingly prior to the agency taking final action.
    The agency disagrees with the contention that the petition lacks 
information required under Sec. 171.1(c). As stated above in section I. 
of this document, aspartame has been previously approved for use as a 
sweetener in a large number of processed foods. These various approvals 
have resulted from the agency's consideration of 27 separate food 
additive petitions. The approved uses of aspartame span a wide range of 
food matrices and include products which are stored under a wide 
variety of conditions. Data establishing the functionality and 
stability of aspartame, and descriptions of methods for detecting 
aspartame in a wide variety of food products, are contained in either 
the 27 petitions or in several Food Master Files established for 
aspartame by the agency. Much of this information has been discussed in 
previous Federal Register documents.
    Further, all of these petitions are specifically referenced in FAP 
5A4439. Therefore, the statement made in the comment that these 
petitions are not specifically referenced in the subject petition is 
factually incorrect.

V. Conclusions

    FDA has calculated exposure estimates to aspartame under the 
assumption that the sweetener would be used in food with no limits 
other than CGMP. Having considered the results of these exposure 
estimates, which were made using extremely conservative assumptions 
(such as, that aspartame would replace all sugars added to food), the 
agency concludes that the use of aspartame as a general purpose 
sweetener will not cause the ADI for aspartame to be exceeded. The 
agency has estimated exposure to DKP (the major decomposition product 
of aspartame) and concludes that the ADI for DKP will also not be 
exceeded by its use as a general purpose sweetener. Based on these 
evaluations, the agency further concludes that the use of aspartame as 
a general purpose sweetener, subject only to CGMP conditions of use 
(including a specific CGMP level of use of 0.5 percent in baked goods 
and baking mixes), is safe and that the regulation for aspartame should 
be amended in Sec. 172.804(c) as set forth below. In addition, 
Sec. 172.804(b) is amended to conform to the requirement of providing 
three addresses for methods that are incorporated by reference, one 
where the method may be obtained and two where it may be examined by 
the public.
    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 by appointment with the 
information contact person listed above. As provided in Sec. 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.

[[Page 33656]]

    Any person who will be adversely affected by this regulation may at 
any time on or before July 29, 1996, 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.

VI. References

     The following information 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 the Chemistry Review Branch, FDA, to the 
Novel Ingredients Branch, FDA; March 8, 1994.
    2. Comment from the McNeil Specialty Products Co., January 6, 
1995.

List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, 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 172.804 is amended by revising the introductory text, 
the second sentence of paragraph (b), and paragraph c; by removing 
paragraph (d) and redesignating paragraphs (e) and (f) as paragraphs 
(d) and (e) to read as follows:


Sec. 172.804  Aspartame.

    The food additive aspartame may be safely used in food in 
accordance with good manufacturing practice as a sweetening agent and a 
flavor enhancer in foods for which standards of identity established 
under section 401 of the act do not preclude such use under the 
following conditions:
* * * * *
    (b) *  *  * Copies are available from the National Academy Press, 
2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at 
the Center for Food Safety and Applied Nutrition's Library, Food And 
Drug Administration, 200 C St. SW., rm. 3321, Washington, DC, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (c)(1) When aspartame is used as a sugar substitute tablet for 
sweetening hot beverages, including coffee and tea, L-leucine may be 
used as a lubricant in the manufacture of such tablets at a level not 
to exceed 3.5 percent of the weight of the tablet.
    (2) When aspartame is used in baked goods and baking mixes, the 
amount of the additive is not to exceed 0.5 percent by weight of ready-
to-bake products or of finished formulations prior to baking. Generally 
recognized as safe (GRAS) ingredients or food additives approved for 
use in baked goods shall be used in combination with aspartame to 
ensure its functionality as a sweetener in the final baked product. The 
level of aspartame used in these products is determined by an 
analytical method entitled ``Analytical Method for the Determination of 
Aspartame and Diketopiperazine in Baked Goods and Baking Mixes,'' 
October 8, 1992, which was developed by the Nutrasweet Co. Copies are 
available from the Office of Premarket Approval (HFS-200), Center for 
Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 
or are available for inspection at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 200 C St. 
SW., rm. 3321, Washington, DC 20204, and the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
* * * * *

    Dated: June 18, 1996.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 96-16522 Filed 6-27-96; 8:45 am]
BILLING CODE 4160-01-F