[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36287-36290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17542]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 184
[Docket No. 88G-0388]
Direct Food Substances Affirmed as Generally Recognized as Safe;
Cocoa Butter Substitute Derived From High-Oleic Safflower or Sunflower
Oil
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to affirm that cocoa butter substitute manufactured from
high-oleic safflower or sunflower oil is generally recognized as safe
(GRAS). This action is in response to a petition filed by Fuji Oil Co.,
Ltd. (Fuji).
DATES: Effective July 10, 1996.
FOR FURTHER INFORMATION CONTACT: Nega Beru, Center for Food Safety and
Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St.
SW.,-Washington, DC 20204, 202-418-3097.
SUPPLEMENTARY INFORMATION:
I. Background-
In accordance with the procedures described in Sec. 170.35 (21 CFR
170.35), Fuji Oil Co., Ltd., 6-1, Hachiman-cho, Minami-ku, Osaka 542,
Japan, submitted a petition (GRASP 8G0348) requesting that
Sec. 184.1259 (21 CFR 184.1259) be amended to affirm that the use of
safflower or sunflower oil in the manufacture of cocoa butter
substitute is GRAS.
In the Federal Register of January 26, 1989 (54 FR 3853), FDA
published a notice of filing of Fuji's petition and gave interested
parties an opportunity to submit comments to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857. FDA received three comments in response to
that notice. These comments are discussed below.
In the filing notice, the agency gave notice that the petition had
requested that Sec. 184.1259 be amended to permit the use of safflower
or sunflower oil in the manufacture of cocoa butter substitute.
However, the petition requested, and the agency evaluated, the use of
high-oleic safflower or sunflower oil in the manufacture of cocoa
butter substitute. Therefore, because the filing notice did not make
clear that the proposed starting materials for the manufacture of the
petitioner's cocoa butter substitute are high-oleic rather than the
typical high-linoleic safflower and sunflower oils, the agency
published an amended filing notice in the Federal Register of April 28,
1995 (60 FR 20998), to give interested persons an opportunity to
comment with respect to the above-mentioned change. No comments were
received in response to the amended filing notice.
II. Standards for GRAS Affirmation
Pursuant to Sec. 170.30 (21 CFR 170.30), general recognition of
safety may be based only on the views of experts qualified by
scientific training and experience to evaluate the safety of substances
added to food. The basis of such views may be either: (1) Scientific
procedures, or (2) in the case of a substance used in food prior to
January 1, 1958, experience based on common use in food
(Sec. 170.30(a)). General recognition of safety based upon scientific
procedures requires the same quantity and quality of scientific
evidence as is required to obtain approval of a food additive and
ordinarily is to be based upon published studies, which may be
corroborated by unpublished studies and other data and information
(Sec. 170.30(b)). General recognition of safety through experience
based on common use in food prior to January 1, 1958, may be determined
without the quantity or quality of scientific procedures required for
approval of a food additive, and ordinarily is to be based upon
generally available data and information concerning the pre-1958
history of use of the substance in food (Sec. 170.30(c)(1)).
Cocoa butter substitute from high-oleic safflower or sunflower oil
was not used in food prior to 1958, and therefore cannot qualify for
GRAS status based on a history of common use in food (Sec. 170.30(c)).
Accordingly, FDA has evaluated the ingredient on the basis of
scientific procedures (Sec. 170.30(b)).
In evaluating this petition, the agency reviewed data and
information concerning: (1) The chemical composition of the cocoa
butter substitute; (2) the process used to manufacture it; (3) the
functional equivalence of the cocoa butter substitute to cocoa butter
substitute made from palm oil; (4) use of the cocoa butter substitute
in food; and (5) information regarding the safety of the cocoa butter
substitute.
III. Identity, Specifications, and Manufacturing Process
The common or usual name of the petitioned substance is ``cocoa
butter substitute primarily from high-oleic safflower or sunflower
oil.'' Its chemical name is 1,3-distearoyl-2-olein (CAS Reg. No. 2846-
04-0). The petitioner provided evidence to demonstrate that the
specifications for cocoa butter substitute primarily from high-oleic
safflower or sunflower oil conform to those for cocoa butter substitute
primarily from palm oil, 1-palmitoyl-2-oleoyl-3-stearin, which are set
forth in Sec. 184.1259(b)(1) through (b)(9).
Traditional safflower and sunflower oils typically contain high
levels of linoleic acid and low levels of oleic acid. However, in the
manufacture of its cocoa butter substitute, Fuji uses high-oleic acid-
containing safflower or sunflower oil. The high-oleic acid varieties of
safflower and sunflower were obtained through common breeding
techniques and are the subjects of several published articles (Refs. 1
through 7).
According to Fuji, its cocoa butter substitute is manufactured by
reacting ethyl stearate (obtained from food-grade stearic acid) with
high-oleic safflower oil or sunflower oil under nitrogen gas in the
presence of a catalyst (lipase enzyme preparation adsorbed onto
granular celite (diatomaceous earth)) at 37 to 47 deg.C for 48 hours.
After completion of the reaction, the catalyst
[[Page 36288]]
is removed by filtration. The remaining free fatty acids and ethyl
esters of fatty acids are distilled off at high temperature under
vacuum. The reaction product is fractionated with hexane to remove
high- and low-melting point fractions and refined by the ordinary
refining process for edible fats and oils (deacidification, bleaching,
deodorization).
IV. Functional Equivalence to Cocoa Butter Substitute Primarily
from Palm Oil
Cocoa butter substitutes have been described as nonhydrogenated
vegetable oils that contain a monounsaturated fatty acid at the 2
position and saturated fatty acids at the 1 and 3 positions (Ref. 8).
Cocoa butter substitute derived from palm oil is a mixture of
triglycerides containing oleic acid at the 2 position and saturated
fatty acids (mostly palmitic and stearic acids) at the 1 and 3
positions. Cocoa butter substitute from high-oleic safflower or
sunflower oil is a mixture of triglycerides containing oleic acid at
the 2 position and mostly stearic acid at the 1 and 3 positions.
Although the fatty acid composition of cocoa butter substitute
from high-oleic safflower or sunflower oil is different from that of
cocoa butter substitute derived from palm oil (higher in stearic acid
and lower in palmitic acid content), this difference in composition
does not affect the function of this cocoa butter substitute in food
(Ref. 9). The petitioner provided a published study by Feuge, et al.
(Ref. 10), who tested three mixtures (one consisting essentially of
oleopalmitostearin, another consisting essentially of oleostearin, and
a third consisting mostly of oleopalmitin) for their ability to
function as cocoa butter substitutes. The results showed that all three
products, when mixed with cocoa butter, had melting properties closely
resembling those of cocoa butter and therefore could be satisfactory
cocoa butter substitutes. Further, the petitioner stated that although
cocoa butter substitute from high-oleic safflower or sunflower oil by
itself can be used to make chocolate, it can also be blended with other
approved triglycerides to produce a cocoa butter substitute that is
similar in chemical composition to natural cocoa butter and to cocoa
butter substitute primarily from palm oil.
V. Use in Food
The petitioned use of the ingredient is in the following food
categories: confections and frostings as defined in Sec. 170.3(n)(9)
(21 CFR 170.3(n)(9)); in coatings of soft candy as defined in
Sec. 170.3(n)(38); and in sweet sauces and toppings as defined in
Sec. 170.3(n)(43). The petition proposes that use of the ingredient in
food be limited to levels consistent with current good manufacturing
practice (CGMP).
VI. Safety Information
The petition relies in part on the data developed to establish the
safety of cocoa butter substitute derived from palm oil. Section
184.1259 provides for the interesterification of partially saturated
1,2,3-triglycerides (derived from palm oil) with ethyl stearate in the
presence of a suitable lipase enzyme preparation. This is also used in
the manufacture of the cocoa butter substitute derived from high-oleic
safflower or sunflower oil.
Cocoa butter substitute made from high-oleic safflower or
sunflower oil consists predominantly of the triglyceride 1,3-
distearoyl-2-oleine. The components of this cocoa butter substitute are
glycerol and oleic and stearic acids. These components are naturally
found as part of glycerides, lipids, lipoproteins, and membranes of
both plants and animals. Moreover, they are the same fatty acids and
glycerol components as are found in a broad range of edible fats and
oils that are GRAS. The synthesis and metabolism of these substances
are well understood and are documented in biochemistry textbooks (for
example, Ref. 11).
The only difference between cocoa butter substitute derived from
high-oleic safflower or sunflower oil, on the one hand, and cocoa
butter substitute derived from palm oil, on the other hand, is a
difference in fatty acid composition, specifically, the ratio of
stearic acid to palmitic acid. The agency finds that this difference
does not pose a safety concern. Both of these fatty acids have been
safely consumed as common, naturally-occurring compounds in foods (Ref.
12), and the proposed use will not change dietary consumption
significantly. Therefore, the agency concludes that cocoa butter
substitute prepared from high-oleic safflower or sunflower oil is
equivalent to cocoa butter substitute prepared from palm oil with
respect to safety, provided it meets the specifications for the similar
palm oil-derived product.
Further, the petitioner submitted three published studies to
support its contention that cocoa butter substitute made from high-
oleic safflower or sunflower oil is safe (Refs. 13 through 15). The
studies included an acute oral toxicity study in rats, a subchronic
(90-day) oral toxicity study in rats, and a study to assess
mutagenicity in bacteria. The bacterial study showed that cocoa butter
substitute derived from high-oleic safflower or sunflower oil is not
mutagenic; no significant effects from consumption of the cocoa butter
substitute were found in the acute and subchronic toxicity studies.
VII. Response to Comments
FDA received three comments in response to the notice announcing
the filing of the petition. All of the comments supported the proposed
GRAS affirmation of cocoa butter substitute derived from high-oleic
safflower or sunflower oil.
Two comments stated that the GRAS affirmation regulation should
provide for the use of food-grade stearic acid as an alternative to
ethyl stearate as a starting material in manufacturing the petitioned
cocoa butter substitute. The comments asserted that it was common
industry practice to use both ethyl stearate and stearic acid in
interesterification reactions. In addition, the comments pointed out
that not only is stearic acid a natural metabolite, but food-grade
stearic acid is affirmed as GRAS (21 CFR 184.1090), and FDA permits the
use of stearic acid as a raw material to produce various substances
approved as food additives, including polysorbate 60, polysorbate 65,
sorbitan monostearate, and calcium stearoyl-2-lactylate (21 CFR
172.836, 172.838, 172.842, and 172.844, respectively). Moreover, the
comments asserted that stearic acid is a more desirable starting
material than ethyl stearate because an end product cocoa butter
substitute devoid of residual fatty acid ethyl esters can be produced.
The agency finds that, although the petitioner stated that ethyl
stearate would be used as a starting material in the
interesterification reaction during the manufacturing of its cocoa
butter substitute, it is also common industry practice to use stearic
acid in the manufacturing process (Ref. 16). Further, the agency notes
that ethyl stearate is itself made from the GRAS substance stearic
acid. In essence, direct use of stearic acid in the interesterification
reaction bypasses the intermediate step of first converting stearic
acid to ethyl stearate. The resulting cocoa butter substitute is the
same regardless of whether ethyl stearate or stearic acid is used in
the manufacturing process. Therefore, the agency agrees that the direct
use of stearic acid as a starting material, without first converting it
to ethyl stearate, does not affect the GRAS status of the petitioned
cocoa butter substitute. Moreover, the agency concludes that an
opportunity for public comment on the
[[Page 36289]]
direct use of stearic acid as a starting material is not necessary
because the two substances are so closely related. Therefore, in
amending Sec. 184.1259, the agency is including stearic acid as an
alternative raw material in the manufacture of cocoa butter substitute
from high-oleic safflower or sunflower oil.
One of the comments also stated that acetone should be allowed as
a solvent in the fractional crystallization of the petitioned cocoa
butter substitute during the manufacturing process and suggested a
residual acetone specification of not more than 5 parts per million.
The comment stated that acetone is a well-recognized solvent in the
edible oils industry and cited a number of FDA regulations that permit
its use as a solvent. Indeed, acetone is approved as an extractant for
annatto extract (21 CFR 73.30(a)(1)(ii)), as a diluent for color
additive mixtures made with D&C Red No. 39 (21 CFR 74.1339(a)(2)), as
an optional bleaching ingredient with flour (21 CFR 137.105(a)(6)), as
a processing solvent in the manufacture of the food additive N-acetyl-
L-methionine (21 CFR 172.372(a)(4)) and in the extraction of spice (21
CFR 173.210). The agency notes that the safety of the use of acetone as
a solvent is well recognized in the food oil industry. However, the
agency has no basis to set a specification for residual acetone because
it did not evaluate the use of acetone as a solvent in manufacturing
cocoa butter substitute. The agency also notes that, as always, any
residual solvent that becomes or may reasonably be expected to become a
functional component of food must be an approved food additive or GRAS
for use in that food.
The third comment consisted of a report by a panel of scientific
experts who evaluated evening primrose oil as a dietary supplement and
concluded that it was safe. The comment stated that the report on the
safety of evening primrose oil should aid FDA in determining the GRAS
status of Fuji's product because evening primrose oil is chemically
related to both safflower and sunflower oils in that the primary
constituent of all these oils is the GRAS substance linoleic acid. The
comment stated that it was submitted because FDA must consider
chemically and pharmacologically related substances in the diet when
considering the GRAS status of any substance (Sec. 170.3(i)(2)).
The safflower and sunflower oils the petitioner proposed to use as
raw material for the production of cocoa butter substitute are derived
from high-oleic variant seeds containing approximately 75 percent oleic
acid in their triglycerides instead of linoleic acid, which is the
major fatty acid in evening primrose oil and in oils derived from
traditional safflower and sunflower. Thus, the assertion that evening
primrose oil is similar to high-oleic safflower and sunflower oils
based on fatty acid content is erroneous.
More importantly, the petition does not seek to affirm the GRAS
status of safflower oil and sunflower oil, both of which are common
food items, but rather cocoa butter substitute derived by chemical
processes from high-oleic safflower or sunflower oil. For these
reasons, the agency finds this comment not relevant to the question of
whether cocoa butter substitute derived from high-oleic safflower or
sunflower oil is GRAS.
VIII. Conclusions
Based on the published literature about the petitioned cocoa
butter substitute and the data supporting the safety of cocoa butter
substitute from palm oil, corroborated by widely available information
about the safe consumption of glycerol and of oleic and stearic acids,
the agency concludes that cocoa butter substitute from high-oleic
safflower or sunflower oil is GRAS when used in accordance with CGMP
(21 CFR 184.1(b)(1)).
IX. Environmental Effects
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.
X. Analysis of Impacts
FDA has examined the impacts of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). According to Executive
Order 12866, a regulatory action is significant if it meets any one of
a number of specific conditions, including having an annual effect on
the economy of $100 million; adversely affecting in a material way a
sector of the economy, competition, or jobs; or raising novel legal or
policy issues. The Regulatory Flexibility Act requires agencies to
minimize the economic impact of their regulations on small businesses.
FDA finds that this final rule is not a significant regulatory
action as defined by Executive Order 12866. The rule does not raise
novel legal or policy issues. The compliance cost to firms currently in
the industry is zero because the rule prohibits no current activity.
Potential benefits of the rule include the wider use of this cocoa
butter substitute because of reduced uncertainty concerning its
regulatory status, and any resources saved by eliminating the need to
prepare further petitions to affirm the GRAS status of the use of this
cocoa butter substitute.
Finally, in compliance with the Regulatory Flexibility Act, FDA
certifies that the final rule will not have a significant economic
impact on a substantial number of small businesses. Therefore, under
the Regulatory Flexibility Act, no further analysis is required.
XI. Effective Date
As this rule recognizes an exemption from the food additive
definition in the Federal Food, Drug, and Cosmetic Act, and from the
approval requirements applicable to food additives, no delay in
effective date is required by the Administrative Procedure Act (5 U.S.C
553(d)). The rule will therefore be effective immediately (5 U.S.C.
553(d)(1)).
XII. References
The following references have 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. Winter, G., ``A New Safflower Oil with a Low Iodine Value,''
Nature, 179:582-583, 1957.
2. Knowles, P. F., A. B. Hill, and J. E. Ruckman, ``High Oleic
Acid Content in New Safflower, UC-1,'' California Agriculture, p.
15, 1965.
3. Fick, G. N., ``Genetics and Breeding of Sunflower,'' Journal
of the American Oil Chemists' Society, 60:1252-1253, 1983.
4. Purdy, R. H., ``Oxidative Stability of High Oleic Sunflower
and Safflower Oils,'' Journal of the American Oil Chemists' Society,
62:523-525, 1985.-
5. Smith, J. R., ``Safflower: Due for a Rebound,'' Journal of
the American Oil Chemists' Society, 62:1286-1291, 1985.
6. Purdy, R. H., ``High Oleic Sunflower: Physical and Chemical
Characteristics,'' Journal of the American Oil Chemists' Society,
63:1062-1066, 1986.
[[Page 36290]]
7. Anonymous, ``U. S. Sun Crop: Potential Still not Realized,''
Journal of the American Oil Chemists' Society, 63:1218-1224, 1986.
8. Faulkner, R. W., ``Cocoa Butter Equivalents are Truly
Specialty Vegetable Fats,'' The Manufacturing Confectioner, pp. 56-
61, 1981.
9. Memorandum from M. DiNovi, FDA to L. Lin, FDA, November 2,
1988.
10. Feuge, R. O. et al., ``Cocoa Butter-Like Fats from Domestic
Oils,'' Journal of the American Oil Chemists' Society, 35:194-199,
1958.
11. Lehninger, A. L., Principles of Biochemistry, Worth
Publishers, Inc., New York, NY, 1982.
12. Memorandum from J. C. Griffiths, FDA to L. Lin, FDA, July
14, 1989.
13. Shimoda, T. et al., ``Safety Studies of a Transesterified
Fat Produced by an Immobilized Lipase: I. Acute Oral Toxicity Study
in Rats,'' Journal of the American College of Toxicology, 13 (Suppl.
1):10-18, 1994.
14. Shimoda, T. et al., ``Safety Studies of a Transesterified
Fat Produced by an Immobilized Lipase: II. Subchronic Oral Toxicity
and Recovery Studies in Rats,'' Journal of the American College of
Toxicology, 13 (Suppl. 1):19-37, 1994.
15. Shimoda, T. et al., ``Safety Studies of a Transesterified
Fat Produced by an Immobilized Lipase: III. Bacterial Reversion
Test,'' Journal of the American College of Toxicology, 13 (Suppl.
1):38-45, 1994.
16. MacRae, A. R., ``Lipase-Catalysed Interesterification of
Oils and Fats,'' Journal of the American Oil Chemists' Society,
60:291-294, 1983.
List of Subjects in 21 CFR Part 184
Food ingredients.
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 184 is amended as follows:
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
1. The authority citation for 21 CFR part 184 continues to read as
follows:
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
2. Section 184.1259 is amended by revising the section heading and
paragraph (a) to read as follows:
Sec. 184.1259 Cocoa butter substitute.
(a) The common or usual name for the triglyceride 1-palmitoyl-2-
oleoyl-3-stearin is ``cocoa butter substitute primarily from palm
oil.'' The common or usual name for the triglyceride 1-3-distearoyl-2-
olein is ``cocoa butter substitute primarily from high-oleic safflower
or sunflower oil.''
(1) The ingredient 1-palmitoyl-2-oleoyl-3-stearin is manufactured
by:
(i) Directed esterification of fully saturated 1,3-diglycerides
(derived from palm oil) with the anhydride of food-grade oleic acid in
the presence of the catalyst trifluoromethane sulfonic acid
(Sec. 173.395 of this chapter), or
(ii) By interesterification of partially saturated 1,2,3-
triglycerides (derived from palm oil) with ethyl stearate in the
presence of a suitable lipase enzyme preparation that is either
generally recognized as safe (GRAS) or has food additive approval for
such use.
(2) The ingredient 1-3-distearoyl-2-olein is manufactured by
interesterification of partially unsaturated 1,2,3-triglycerides
(derived from high-oleic safflower or sunflower oil) with ethyl
stearate or stearic acid in the presence of a suitable lipase enzyme
preparation that is either GRAS or has food additive approval for such
use.
* * * * *
Dated: June 13, 1996.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 96-17542 Filed 7-9-96; 8:45 am]
BILLING CODE 4160-01-F
