[Federal Register Volume 63, Number 58 (Thursday, March 26, 1998)]
[Rules and Regulations]
[Pages 14608-14611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7894]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 184
[Docket No. 91G-0451]
Direct Food Substances Affirmed as Generally Recognized as Safe;
Maltodextrin Derived From Rice Starch
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to affirm that maltodextrin derived from rice starch is
generally recognized as safe (GRAS). This action is in response to a
petition filed by Zumbro, Inc.
DATES: Effective March 26, 1998. 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 at 21
CFR 184.1444, effective March 26, 1998.
FOR FURTHER INFORMATION CONTACT: Andrew D. Laumbach, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3071.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with the procedures described in Sec. 170.35 (21 CFR
170.35), Zumbro, Inc., Rt. 1, Box 3, Hayfield, MN 55940, submitted a
petition (GRASP 2G0380) proposing that maltodextrin derived from rice
starch be affirmed as GRAS for use as a direct food ingredient.
FDA published a notice of filing of this petition in the Federal
Register of April 23, 1992 (57 FR 14839), 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 no comments in response to that
notice.
II. Standards for GRAS Affirmation
Under 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 food substances. 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, through
[[Page 14609]]
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 (21 CFR 170.30(b)). General recognition of
safety through experience based on common use of a substance 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)).
III. Safety Evaluation
FDA has evaluated the petition submitted by Zumbro, Inc., (GRASP
2G0380) on the basis of scientific procedures to determine whether the
use of maltodextrin derived from rice starch is GRAS. In addition to
evaluating the data in the petition, FDA also has considered published
articles in scientific journals along with other available information
in its review. The agency concludes, based upon scientific procedures,
that the information presented in the petition, and other published and
unpublished information, support a determination that the use of
maltodextrin derived from rice starch is GRAS.
Data in the petition, along with other information in the agency's
files, demonstrate that rice starch is chemically equivalent to corn
starch or potato starch. Additionally, the hydrolysis products made
from these starch sources, including maltodextrins, are essentially
equivalent. Thus, maltodextrin derived from rice starch is equivalent
in all material respects to maltodextrin derived from corn starch or
potato starch, both of which have been affirmed as GRAS (Sec. 184.1444
(21 CFR 184.1444)).
A. Evidence of Chemical Equivalency of Potato Starch and Corn Starch
to Rice Starch
Starch is the reserve carbohydrate in tubers such as potatoes, in
grains such as rice, corn, or barley, in seeds, and in many fruits. As
early as 1811, scientists had determined that food starches from
various plant sources were essentially equivalent (Ref. 1). All food
starches, regardless of the plant source, are composed of chemically
equivalent polymeric forms of alpha-bond-linked glucose units (Ref. 2).
Starch consists of polymers of amylose and amylopectin polysaccharides
(Refs. 1 and 3). The relative proportions of amylose and amylopectin
are characteristic of the plant species from which the starch is
derived (Refs. 3 and 4).
Because food starches derived from different plant sources are
equivalent in all material respects (Ref. 1), FDA's food additive
regulation for modified food starch (21 CFR 172.892) does not specify
that any particular source of food starch be used to manufacture the
additive. In the Federal Register of April 1, 1985 (50 FR 12821) (Ref.
5), FDA published a proposal to affirm that rice starch (as well as
several other starches) is GRAS for use in food. FDA has not issued a
final rule in that rulemaking. In addition, the Committee on Food
Chemicals Codex of the National Academy of Sciences has published a
monograph on maltodextrin stating that it may be obtained from any
edible starch (Ref. 6). Like FDA's food additive regulation for
modified food starch, the monograph does not require that the starch be
derived from any particular plant source.
Producing maltodextrin by the degradation of starch requires the
formation of intermediate breakdown products called dextrins, which
result from the partial hydrolysis of starch with mineral acids or
amylase (Refs. 2 and 7). Further hydrolysis of the starch dextrins
yields maltodextrins.
Dextrins are affirmed as GRAS under 21 CFR 184.1277 and can be
prepared by partially hydrolyzing the starch in corn, potato,
arrowroot, wheat, rice, or other starch sources. It has been common
industrial practice to use a wide variety of starch sources in
manufacturing commercial dextrin products (Refs. 2 and 7). During
digestion, acid and enzymatic processes in the stomach convert the
starch macromolecules to smaller molecules, such as maltodextrin, and
eventually to glucose. This digestion process is similar to the
commercial process used to produce glucose and fructose, which are GRAS
starch-based sweeteners presently used in foods (Ref. 7). (See corn
sugar, 21 CFR 184.1857; corn syrup, 21 CFR 184.1865; and high fructose
corn syrup, 21 CFR 184.1866).
Starch hydrolysates below 20 dextrose equivalents (D.E.) are
classified as maltodextrins (Refs. 8 and 9). Specifications for
maltodextrins are listed in the Food Chemicals Codex, 4th ed., (1996)
(Ref. 6). Equivalent maltodextrin products result from equivalent
hydrolysis of edible starch sources (Ref. 10). Because corn starch,
potato starch, and rice starch are essentially equivalent, the products
of hydrolysis, from simple glucose molecules to more complex starch
hydrolysates, such as dextrins and maltodextrins, are essentially
equivalent in terms of chemical, physical, and organoleptic properties.
B. Corroborative Evidence of Chemical Equivalency
The petitioner has submitted data to demonstrate the equivalency of
maltodextrin derived from rice starch with maltodextrin derived from
tapioca and potato starches, based upon chemical properties such as
dextrose equivalents (D.E.) and commercial uses (Refs. 11 and 12).
Additionally, the petitioner provided carbohyrate profiles for corn
maltodextrin and rice maltodextrin that demonstrate that the range of
carbohydrate composition in maltodextrins derived from corn starch is
virtually identical to that for maltodextrins derived from rice starch
(Ref. 13). Moreover, based upon information submitted by the petitioner
and on information available in the current scientific literature, FDA
concludes (Ref. 10) that rice starch may be considered chemically
equivalent to corn starch in regard to the content of the basic
chemical components of starch (i.e., amylose and amylopectin) (Refs. 1,
2, 3, 4, 7, 14, and 15).
C. Proposed Use in Food
Information supplied by the petitioner indicates that maltodextrin
derived from rice starch will be used as a replacement for maltodextrin
derived from corn starch or potato starch in the same foods, at
essentially the same levels, and for the same technical effects that
maltodextrin derived from corn starch or potato starch is now used
(Ref. 16). The petitioner indicates that maltodextrins are currently
used in a wide range of processed and convenience foods, principally as
a filler or carrier for flavorings and intensive sweeteners and as a
sweetness reducer or texture modifier. Because maltodextrin derived
from rice starch will be used as a replacement for maltodextrin derived
from corn starch or potato starch, the exposure of consumers to
maltodextrin is not expected to increase.
D. General Recognition of Safety
The agency has determined, based on published information, that
the safety of maltodextrin derived from rice starch is generally
recognized by food safety experts. Foremost in the support of safety is
published information that shows that corn starch, potato starch, and
rice starch are chemically equivalent, and therefore, maltodextrin
[[Page 14610]]
derived from rice starch is equivalent to the maltodextrin derived from
corn starch or potato starch. Thus, maltodextrin derived from rice
starch presents no more of a safety concern than maltodextrin derived
from corn starch or potato starch, both of which have been affirmed as
GRAS.
Moreover, many countries, including those represented by the
European Starch Association (Ref. 9), recognize ``food starches,''
including rice starch, as a suitable raw material for maltodextrin
production. Furthermore, the Food and Agriculture Organization/World
Health Organization and the Joint Expert Committee on Food Additives
(JECFA) (Refs. 17 and 18) recognizes maltodextrin as an intermediate
product in the production of enzyme-treated starches, a process that
JECFA has stated results in the production of normal (meaning safe)
food constituents. JECFA does not restrict the sources of food starches
used in the production of products such as maltodextrins. JECFA also
does not require toxicological testing of products such as
maltodextrins that are produced from enzyme-treated starches. Finally,
as noted in section III.A. of this document, the agency has proposed to
find that rice starch is GRAS (Ref. 5).
The agency concludes that maltodextrin derived from rice starch is
chemically and functionally equivalent to maltodextrin derived from
edible starch from other sources (Ref. 10). No increase in exposure to
maltodextrin would be expected due to the substitution of one source
for the other. Because rice starch is already a significant constituent
of the typical diet (Ref. 5), the agency does not believe that
consumption of maltodextrin derived from rice would cause a dietary
concern (Ref. 19).
E. Specifications
The agency has reviewed the specifications for maltodextrin
published in the Food Chemicals Codex, 4th ed. (1996), pp. 239 and 240,
and it finds that they are acceptable for maltodextrin derived from
edible starches. Therefore, the agency is adopting the specifications
for maltodextrin derived from edible starches for maltodextrin derived
from rice starch.
IV. Conclusions
The agency has evaluated the information in the petition, along
with other available data, and has reached the following conclusions:
(1) Rice starch is chemically equivalent to corn and potato starch.
(2) Maltodextrin derived from rice starch is chemically equivalent
to maltodextrin derived from corn starch and potato starch, both of
which are currently affirmed as GRAS for food use without restriction
under Sec. 184.1444.
(3) When maltodextrin derived from rice starch is manufactured
according to the methods specified in Sec. 184.1444, for corn and
potato starch, there is general recognition among qualified experts
that the use of maltodextrin derived from rice starch in food is safe.
Based upon the evaluation of published information, corroborated by
unpublished data and information, i.e., based upon scientific
procedures (Sec. 170.30(b)), the agency concludes that maltodextrin
derived from rice starch is GRAS for use as a replacement for
maltodextrin derived from corn or potato starch. Therefore, the agency
is affirming that maltodextrin derived from rice starch is GRAS when
used in accordance with good manufacturing practice (21 CFR
184.1(b)(1)).
V. Environmental Effects
The agency has determined under 21 CFR 25.32(f) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Analysis for Executive Order 12866
FDA has examined the impacts of this final rule under Executive
Order 12866. Executive Order 12866 directs agencies to assess the costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select the regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety effects; distributive impacts; and equity). According to
Executive Order 12866, a regulatory action is significant if it meets
any one of a number of specified 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 if it
raises novel legal or policy issues. FDA finds that this final rule is
not a significant regulatory action as defined by Executive Order
12866. In addition, the agency has determined that this final rule is
not a major rule for the purpose of congressional review.
The primary benefit of this action is to remove uncertainty about
the regulatory status of the petitioned substance. No compliance costs
are associated with this final rule because no new activity is required
and no current or future activity is prohibited by this rule.
VII. Regulatory Flexibility Analysis
FDA has examined the impact of this final rule under the Regulatory
Flexibility Act. The Regulatory Flexibility Act (5 U.S.C. 601-612)
requires Federal agencies to consider alternatives that would minimize
the economic impact of their regulations on small entities. FDA finds
that this final rule will not have a significant economic impact on a
substantial number of small entities.
No compliance costs are associated with this final rule because no
new activity is required and no current or future activity is
prohibited. Accordingly, under the Regulatory Flexibility Act, 5 U.S.C.
605(b), the agency certifies that this final rule will not have a
significant economic impact on a substantial number of small entities.
VIII. 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)).
IX. References
The following references have been placed on display at the Dockets
Management Branch (address above) and may be seen between 9 a.m. and 4
p.m., Monday through Friday.
1. Wolfrom, M. L., and H. El Khadem, ``Chemical Evidence for the
Structure of Starch,'' Starch: Chemistry and Technology, edited by
R. L. Whistler, and E. F. Paschall, Academic Press, Inc., New York,
pp. 251-278, 1965.
2. ``Starch Hydrolysis Products: An Introduction and History,''
Starch Hydrolysis Products, Worldwide Technology, Production, and
Applications, edited by F. W. Schenck and R. E. Hebeda, VCH
Publishers, Inc., New York, pp. 1-21, 1992.
3. ``Evaluation of the Health Aspects of Starch and Modified
Starches as Food Ingredients,'' Life Sciences Research Office,
Federation of American Societies for Experimental Biology, 1979.
4. Young, A. H., ``Fractionation of Starch,'' Starch, 2d ed.,
edited by R. L. Whistler, and E. F. Paschall, Academic Press, Inc.,
New York, pp. 249-283, 1984.
5. ``Unmodified Food Starches and Acid-Modified Starches;
Proposed Affirmation of GRAS Status as Direct and Indirect Human
Food Ingredients,'' 50 FR 12821, April 1, 1985.
[[Page 14611]]
6. Food Chemicals Codex, 4th ed., National Academy Press,
Washington, DC, pp. 239 and 240, 1996.
7. Evans, R. B., and O. B. Wurzburg, ``Production and Use of
Starch Dextrins,'' Starch: Chemistry and Technology, vol. 2, edited
by R. L. Whistler, and E. F. Paschall, Academic Press, Inc., New
York, pp. 253-278, 1967.
8. ``Food Additives and Contaminants Committee Report on
Modified Starches,'' United Kingdom Ministry of Agriculture,
Fisheries and Food, FAC/REP/31, Her Majesty's Stationery Office,
London, p. 5, 1980.
9. ``Definition of Maltodextrin,'' European Starch Associations,
Circular Letter Stex 4/88, February 1988.
10. Memorandum from the Chemistry Review Branch to the Direct
Additives Branch, ``Maltodextrin from Rice,'' dated January 13,
1997.
11. ``Paselli SA2,'' Technical Bulletin, No. 5.12.33.188EU,
AVEBE America, Inc., Princeton, NJ.
12. ``INSTANT N-OIL II,'' Techical Service Bulletin, No. 15889-
238, National Starch and Chemical Corp., Bridgewater, NJ.
13. Warthesen, J. J., ``Analysis of Saccharides in Low-Dextrose
Equivalent Starch Hydrolysates Using High-Performance Liquid
Chromatography,'' Cereal Chemistry. vol. 61, No. 2, pp. 194 and 195,
1984.
14. Zuber, M. S., ``Genic Control of Starch Development''
Starch: Chemistry and Technology, edited by R. L. Whistler and E. F.
Paschall, Academic Press, Inc., New York, pp. 45, 61-63, 1965.
15. Whistler, R. L., and J. R. Daniel, ``Starch,'' Kirk-Othmer's
Encyclopedia of Chemical Technology, 3d ed., vol. 21, edited by J.
Brown, C. I. Eastman, Galojuch, et al., John Wiley & Sons, New York,
pp. 492-507, 1983.
16. ``Maltodextrin; Proposed Affirmation of GRAS Status as
Direct Human Food Ingredient,'' 47 FR 36443, August 20, 1982.
17. ``Specifications for the Identity and Purity of Food
Additives and Their Toxicological Evaluation,'' FAO Nutrition
Meetings Report Series, No. 46 and WHO Technical Report Series, No.
445, pp. 13 and 14, 1970.
18. ``Toxicological Evaluation of Some Food Colours,
Emulsifiers, Stabilizers, Anti-Caking Agents, and Certain Other
Substances,'' FAO Nutrition Meetings Report Series, No. 46A, p. 62
and WHO/FOOD ADD./70.36, 1970.
19. Memorandum from the Additives Evaluation Branch, to the
Direct Additives Branch, ``GRP 2G0380-GRAS Affirmation Petition for
Maltodextrin Derived from Derived Rice: Division of Health Effects
Evaluation Review (DHEE; HFS-225),'' dated August 3, 1993.
List of Subjects in 21 CFR Part 184
Food additives, Incorporation by reference.
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: 21 U.S.C. 321, 342, 348, 371.
2. Section 184.1444 is amended by revising the second sentence in
paragraph (a) and by adding paragraph (b)(3) to read as follows:
Sec. 184.1444 Maltodextrin.
(a) * * * It is prepared as a white powder or concentrated solution
by partial hydrolysis of corn starch, potato starch, or rice starch
with safe and suitable acids and enzymes.
(b) * * *
(3) Maltodextrin derived from rice starch meets the specifications
of the Food Chemicals Codex, 4th ed. (1996), pp. 239 and 240, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. 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, 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.
* * * * *
Dated: March 3, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-7894 Filed 3-25-98; 8:45 am]
BILLING CODE 4160-01-F
