[Federal Register: August 20, 2003 (Volume 68, Number 161)]
[Rules and Regulations]
[Page 50069-50073]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au03-12]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. 98F-0717]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Sucrose Oligoesters
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 sucrose oligoesters
(sucrose esters of fatty acids with an average degree of esterification
ranging from four to seven) as an emulsifier or stabilizer, at a level
not to exceed 2.0 percent, in chocolate and in butter-substitute
spreads. This action is in response to a petition filed by Mitsubishi
Chemical Corp.
[[Page 50070]]
DATES: This rule is effective August 20, 2003. Submit objections and
requests for a hearing by September 19, 2003. 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 certain
publications in new Sec. 172.869 (21 CFR 172.869), effective August
20, 2003.
ADDRESSES: Submit written objections and requests for a hearing to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Martha D. Peiperl, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3077.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of September 1, 1998
(63 FR 46465), FDA announced that a food additive petition (FAP 8A4610)
had been filed by Mitsubishi Chemical Corp., 5-2, Marunouchi 2-chome,
Chiyoda-Ku, Tokyo 100, Japan, proposing that the food additive
regulations be amended to provide for the safe use of sucrose esters of
fatty acids with an average degree of esterification ranging from four
to seven, as an emulsifier or stabilizer, at a level not to exceed 2.0
percent, in chocolate and in butter-substitute spreads. The petitioner
also proposed to adopt the name SOE as the common or usual name for
this additive.
The petitioner derived the name SOE as an acronym for sucrose
oligoesters. Mitsubishi requested the name SOE to differentiate this
additive from sucrose fatty acid esters (SFAE), listed under Sec.
172.859 (21 CFR 172.859), and olestra, listed under Sec. 172.867 (21
CFR 172.867).
The agency has reviewed the term sucrose oligoesters and finds it
to be an acceptable name to identify the petitioned substance.
Therefore, the agency agrees that the name sucrose oligoesters may be
used as the common or usual name for sucrose esters of fatty acids with
an average degree of esterification ranging from four to seven.
The agency has also considered the acronym SOE as an alternate name
for this ingredient. The agency has generally allowed an acronym to be
used as an alternate name for an ingredient in those cases where the
name of the ingredient is long and only after there has been sufficient
exposure to the acronym in conjunction with the established name to
allow consumers to recognize the acronym as an alternative to the
established name. For the subject petition, the agency believes that
neither the food industry nor the consumer is currently familiar with
the term SOE. Therefore, the agency is not adopting the acronym SOE as
an alternate name for sucrose oligoesters at this time.
Sucrose oligoesters consists of a mixture of sucrose fatty acid
esters, containing tetra-, penta-, hexa-, and hepta-esters
(representing not less than 50 percent of the total esters), mono-, di-
, and tri-esters (representing not greater than 45 percent of the total
esters), and octa-ester (representing not greater than 40 percent of
the total esters). The fatty acid moieties are derived from edible fats
and oils, predominantly C8 through C22 fatty acids. The proposed
additive, sucrose oligoesters, has a composition that overlaps that of
sucrose fatty acid esters, listed under Sec. 172.859, and olestra,
listed under Sec. 172.867. However, Sec. 172.859(b)(1) requires that
sucrose fatty acid esters contain a minimum of 80 percent of mono-, di-
, and tri-esters of sucrose and Sec. 172.867(b)(1) requires that
olestra contain a minimum of 97 percent of
octa-, hepta-, and hexa-esters of sucrose. The proposed additive is
thus mid-range between these two listed food additives in terms of the
average number of ester moieties on the sucrose backbone.
In support of the safety of the proposed use of sucrose
oligoesters, Mitsubishi submitted a combined chronic and
carcinogenicity study with a sucrose fatty acid ester blend of mono-
through penta-esters in male and female rats, as well as analytical
data on the percentages of mono- through octa-esters in both the
proposed additive and the fatty acid ester blend. Mitsubishi also
submitted a metabolism/pharmacokinetic study of \14\C-labeled sucrose
fatty acid esters in rats and several study reports and publications
previously considered by FDA during its safety reviews of sucrose fatty
acid esters and olestra.
As discussed in more detail in section II of this document, the
agency focused its safety evaluation on the exposure and the metabolic
fates of the tetra- penta-, and hexa-ester components of sucrose
oligoesters because FDA considered the other esters more fully in the
earlier decisions. The agency's safety determinations for the mono-,
di-, and tri-ester components (sucrose fatty acid esters (60 FR 44755,
August 29, 1995)) and for the hepta- and octa-ester components (olestra
(61 FR 3118, January 30, 1996)) remain unchanged.
II. Evaluation of Safety
In order to establish, with reasonable certainty, that this new
food additive is not harmful under its intended conditions of use, FDA
considered the probable human dietary exposure to the additive, the
available toxicological data on the additive, and the manufacturing
process for this additive.
A. Estimated Daily Intake for Sucrose Oligoesters and its Component
Esters
The petitioner provided information on both typical use levels and
maximum use levels. Absent specific information on typical use levels,
FDA bases its estimation of exposure to an additive on the maximum
possible use levels of the additive. FDA believes that typical use
levels are more appropriate for consideration of lifetime exposure
because a consumer is unlikely to consistently choose only those
products with the maximum levels of the additive. Furthermore, the
maximum level allowed may be higher than what is used in most foods.
Consistent with good manufacturing practices, products formulated with
the additive will contain the additive at a level no greater than that
needed to accomplish the intended technical effect. The petitioner has
provided information which indicates that the typical use level of the
additive in food products is 0.5 percent. Therefore, in estimating
probable daily intake for sucrose oligoesters, the agency used 0.5
percent as the level in foods consumed over a lifetime of exposure.
The agency has estimated that the mean lifetime-averaged daily
intake of sucrose oligoesters would be approximately 45 milligrams per
person per day (mg/p/day). FDA also estimated that an individual at the
90th percentile of consumption of food that would contain the additive
would have an exposure approximately two times the mean intake or 98
mg/p/day (Ref. 1).
Because the additive is a mixture and because the relevant safety
studies were conducted on mixtures with a variety of compositions, FDA
also examined the potential exposure to the component esters of sucrose
oligoesters. The agency evaluated data from approximately 50 batches of
the additive. Based on these data, the average percentages of the mono-
through octa-esters in the additive were calculated. These averages
were used in estimating exposure to the sucrose ester components of
sucrose oligoesters for the consumer at the 90th percentile. FDA
estimates exposure to these component esters to be 1.5 mg/p/day for the
mono-ester, 4.2 mg/p/day for the di-
[[Page 50071]]
ester, 10 mg/p/day for the tri-ester (or 16 mg/p/day for the mono-, di-
, and tri-esters combined), 14 mg/p/day for the tetra-ester, 19 mg/p/
day for the penta-ester, 23 mg/p/day for the hexa-ester, 20 mg/p/day
for the hepta-ester, and 9 mg/p/day for the octa-ester (Ref. 1).
B. Evaluation of Safety Studies
As mentioned in section II.A of this document, sucrose oligoesters
consist of a mixture of mono- to octa-esters, with most of the esters
ranging from four to seven fatty acids. The agency considered the
nature of the petitioned substance, its constituents and metabolites,
the currently approved uses of sucrose fatty acid esters and olestra,
available related toxicological data, and exposure estimates for the
individual sucrose fatty acid esters. Based on the totality of this
information, the agency finds that the previous safety assessments for
the mono-, di-, and tri-ester components and the hepta- and octa-ester
components of sucrose oligoesters made during reviews for SFAE (sucrose
fatty acid esters (60 FR 44755)) and olestra (olestra (61 FR 3118)),
respectively, are applicable for the petitioned use of this additive
(Ref. 2).
As stated previously, the estimated exposure to the combined mono-,
di-, and tri-ester components of sucrose oligoesters from the proposed
use is 16 mg/p/day. The agency finds that this estimated daily intake
to these three sucrose esters from the proposed use of sucrose
oligoesters and all approved uses of SFAE is less than the acceptable
daily intake (ADI) level that was established for SFAE (Ref. 3).
As further stated previously, the estimated exposure to the hepta-
ester from the proposed use of sucrose oligoesters is 20 mg/p/day and
the estimated exposure to the octa-ester is 9 mg/p/day. Exposure to the
hepta- and octa-esters from the proposed use of sucrose oligoesters
would be insignificant in comparison to the current estimated exposure
from olestra (20 mg/p/day v. 1,400 mg/p/day for the hepta-ester, and 9
mg/p/day v. 7,000 mg/p/day for the octa-ester) (Ref. 1 and 61 FR 3118).
In its review of the safety of the tetra-, penta-, and hexa-esters
of sucrose oligoesters, the agency considered the estimated exposures
to these ester components and other relevant information on sucrose
fatty acid esters, including pharmacokinetic studies. In particular,
the agency considered an absorption study of \14\C-labeled sucrose
polyester consisting of approximately 81 percent hexa- and lower esters
(predominately hexa- and penta-esters) in rats that was submitted with
the Olestra petition (FAP 7A3997). This study demonstrated that only a
small percentage (i.e. not more than 1.5 percent) of the administered
radiolabeled esters was absorbed and that the majority of the absorbed
radioactivity was found in expired air and urine. Additionally, interim
necropsies performed during the absorption study demonstrated that the
amount of radioactivity detected in tissues decreased rapidly over time
and therefore did not bioaccumulate. Because any increase in exposure
to the penta- and hexa-esters from the petitioned use of sucrose
oligoesters would be very small, and considering the totality of
evidence showing no toxicity from these esters, FDA has no safety
concerns from the potential intake of penta- and hexa-ester components
of sucrose oligoesters from this use (Refs. 4 and 5).
In its review of the safety of exposure to the tetra-ester
component of the subject additive, the agency considered a metabolism
study of \14\C-labeled sucrose esters of stearic acid in rats and a
combined chronic oral toxicity/carcinogenicity study of sucrose esters
of fatty acids in rats. Based on the comparison of an estimated ADI for
the tetra-ester of 110 mg/p/day from the oral toxicity study with a
highly conservative exposure estimate for the tetra ester of 26 mg/p/
day\1\ , the agency has no safety concerns regarding the potential
intake of sucrose tetra-ester in sucrose oligoesters from the
petitioned use (Refs. 1, 2, and 5).
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\1\Highly conservative estimates of exposures to the component
esters of the subject additive have been obtained by adding intakes
for 90th percentile eaters-only from the proposed use of SOE and the
regulated uses of SFAE and olestra.
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C. Specifications
In addition to specifications to ensure the identity of sucrose
oligoesters, the agency considered specifications for residual levels
of solvents and methanol. The additive is produced by
interesterification of sucrose with methyl esters of fatty acids
derived from edible fats and oils using the solvents dimethyl
sulfoxide, isobutyl alcohol, or other appropriate solvents. To ensure
removal of residual solvents and methanol from the methyl esters, the
petitioner proposed specification limits for residual levels of
dimethyl sulfoxide, isobutyl alcohol, and methanol. FDA has considered
the manufacturing process for this additive and has determined that
these specifications need to be included in the regulation.
III. Conclusion
Based on the totality of available information regarding the
subject sucrose esters and the absence of any observed toxicity, FDA
concludes that this additive is safe for its proposed use. Therefore,
the agency concludes that the food additive regulations should be
amended as set forth in this document. Because the foods described in
new Sec. 172.869(c) include foods subject to standards of identity,
the agency notes that the additive may not be used in a standardized
food unless permitted by the standard of identity. To ensure that only
a food grade product is used in food, the additive must meet the
specifications set forth in this document. The agency further concludes
that the name sucrose oligoesters is acceptable for use as the common
or usual name for the additive.
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 (see FOR FURTHER INFORMATION CONTACT). 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.
IV. Environmental Effects
The agency has previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 8A4610 (63 FR
46465). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
V. Paperwork Reduction Act 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VI. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum from DiNovi, Division of Biotechnology and GRAS
Notice Review, to Peiperl, Division of Petition Review, June 2,
2003.
2. Memorandum from Young, Division of Food Contact Substance
Notification Review,
[[Page 50072]]
to Peiperl, Division of Petition Review, March 8, 2002.
3. Memorandum from Bleiberg, Division of Health Effects
Evaluation, to Anderson, Division of Product Policy, November 4,
1993.
4. Memorandum from Young, Division of Food Contact Substance
Notification Review, to Peiperl, Division of Petition Review, July
18, 2002.
5. Memorandum from Young, Division of Food Contact Substance
Notification Review, to Peiperl, Division of Petition Review, June
3, 2003.
VII. Objections
Any person who will be adversely affected by this regulation may at
any time file with the Division of Dockets Management (see ADDRESSES)
written or electronic objections. 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 are to be submitted and are to 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 Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
List of Subjects in 21 CFR Part 172
Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.
0
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
0
1. The authority citation for 21 CFR part 172 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
0
2. Section 172.869 is added to subpart I to read as follows:
Sec. 172.869 Sucrose oligoesters.
Sucrose oligoesters, as identified in this section, may be safely
used in accordance with the following conditions:
(a) Sucrose oligoesters consist of mixtures of sucrose fatty acid
esters with an average degree of esterification ranging from four to
seven. It is produced by interesterification of sucrose with methyl
esters of fatty acids derived from edible fats and oils (including
hydrogenated fats and oils). The only solvents which may be used in the
preparation of sucrose oligoesters are dimethyl sulfoxide, isobutyl
alcohol, and those solvents generally recognized as safe in food.
(b) Sucrose oligoesters meet the specifications in the methods
listed in the table in this paragraph. The methods cited for
determining compliance with each specification are incorporated by
reference, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
of the methods may be examined at the Center for Food Safety and
Applied Nutrition's Library, room 1C-100, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or at the Office of the Federal Register, 800
North Capitol St. NW., suite 700, Washington, DC. Copies of the methods
are available from the sources listed in the table in this paragraph:
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Source for Obtaining
Specification Limit Method Cited Method
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(1) Sucrose esters.................. Not less than 90%...... ``Method for Analyzing Office of Food
the Purity of Sucrose Additive Safety,
Fatty Acid Esters,'' Center for Food
issued by Mitsubishi Safety and Applied
Chemical Corp., June 17, Nutrition (HFS-200),
1998. Food and Drug
Administration, 5100
Paint Branch Pkwy.,
College Park, MD
20740.
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(2) Mono-, di-, and tri-esters...... Not more than 45%...... ``Method for Measuring Do.
the Ester Distribution
of Sucrose
Oligoesters,'' issued by
Mitsubishi Chemical
Corp., June 17, 1998.
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(3) Tetra-, penta-, hexa-, and hepta- Not less than 50%...... Do. Do.
esters.
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(4) Octa-esters..................... Not more than 40%...... Do. Do.
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(5) Free Sucrose.................... Not more than 0.5%..... ``Free Sucrose Method,'' Do.
issued by Mitsubishi
Chemical Corp., June 17,
1998.
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(6) Acid Value...................... Not more than 4.0...... ``Acid Value,'' Appendix National Academy
VII, Method I Press, 2101
(Commercial Fatty Constitution Ave. NW,
Acids), in the Food Washington, DC 20418
Chemicals Codex, 4th ed. (Internet: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://(1996
), p. 820. www.nap.edu).
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(7) Residue on Ignition............. Not more than 0.7%..... ``Residue on Ignition, Do.
Appendix IIC, Method I,
in the Food Chemicals
Codex, 4th ed. (1996),
pp. 751-752, (using a 1-
gram sample).
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[[Page 50073]]
(8) Residual Methanol............... Not more than 10 Method listed in the Do.
milligrams/kilogram. monograph for ``Sucrose
Fatty Acid Esters'' in
the First Supplement to
the 4th ed. of the Food
Chemicals Codex (1997),
pp. 44-45.
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(9) Residual Dimethyl Sulfoxide..... Not more than 2.0 Do. Do.
milligrams/kilogram.
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(10) Residual Isobutyl Alcohol...... Not more than 10 Do. Do.
milligrams/kilogram.
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(11) Lead........................... Not more than 1.0 ``Atomic Absorption Do.
milligram/kilogram. Spectrophotometric
Graphite Furnace
Method,'' Method I, in
the Food Chemicals
Codex, 4th ed. (1996),
pp. 763-765.
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(c) The additive is used as an emulsifier (as defined in Sec.
170.3(o)(8) of this chapter) or stabilizer (as defined in Sec.
170.3(o)(28) of this chapter) in chocolate and in butter-substitute
spreads, at a level not to exceed 2.0 percent; except that the additive
may not be used in a standardized food unless permitted by the standard
of identity.
Dated: August 6, 2003.
L. Robert Lake,
Director, Office of Regulations and Policy, Center for Food Safety and
Applied Nutrition.
[FR Doc. 03-21270 Filed 8-19-03; 8:45 am]
BILLING CODE 4160-01-S