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

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.

-----------------------------------------------------------------------

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