[Federal Register Volume 60, Number 183 (Thursday, September 21, 1995)]
[Rules and Regulations]
[Pages 48890-48893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23352]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 184
[Docket No. 89G-0316]
Maltodextrin Derived From Potato Starch; Affirmation of GRAS
Status as Direct Human Food Ingredient
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is affirming that
maltodextrin derived from potato starch is generally recognized as safe
(GRAS) for use as a direct human food ingedient. This action is in
response to a petition filed by AVEBE America, Inc.
DATES: Effective September 21, 1995. 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 listed
in 21 CFR 184.1444, effective September 21, 1995.
FOR FURTHER INFORMATION CONTACT: Andrew D. Laumbach, Center for Food
Safety and Applied Nutrition (HFS-217), 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), AVEBE America, Inc., Princeton Corporate Center, 4
Independence Way, Princeton, NJ 08450, submitted a petition (GRASP
9G0353) proposing that maltodextrin derived from potato 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 August 31, 1989 (54 FR 36053), and gave interested parties
an opportunity to submit comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857. FDA received no comments in response to that
notice.
II. Standards for GRAS Affirmation
Pursuant to Sec. 170.30 (21 CFR 170.30), general recognition of
safety of food ingredients 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
[[Page 48891]]
1, 1958, through experience based on common use in food. 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 regulation, 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 of a
substance in food prior to January 1, 1958, may be determined without
the quantity or quality of scientific evidence required for approval of
a food additive regulation, and ordinarily is to be based upon
generally available data and information (Sec. 170.30(c)(1)).
III. Safety Evaluation
The petition by AVEBE America, Inc., argues that experience based
on common use in food prior to 1958 establishes that maltodextrin
derived from potato starch is GRAS. The petition contains documentation
that maltodextrin derived from potato starch was used in infant formula
prior to 1958. However, based upon an evaluation of the evidence
presented, the agency does not agree that the information in the
petition establishes that maltodextrin derived from potato starch was
in common use in food as defined in Sec. 170.3(f) (21 CFR 170.3(f)),
before 1958. However, the agency does conclude that the information
presented in the petition, together with other available information,
supports a determination that use of maltodextrin derived from potato
starch is GRAS based upon scientific procedures. Data in the petition,
along with other information in the agency's files, demonstrate that
potato starch is chemically equivalent to corn starch. Additionally,
the hydrolysis products made from these starch sources, including
maltodextrins, are essentially equivalent. Thus, maltodextrin derived
from potato starch is equivalent in all material respects to
maltodextrin derived from corn starch, which has been affirmed as GRAS
(Sec. 184.1444 (21 CFR 184.1444)).
1. Evidence of Uses in Food Prior to 1958
The agency has reviewed the information submitted by the petitioner
to support its assertion that maltodextrin derived from potato starch
was in common use in food prior to 1958 in Europe. ``Common use in
food'' means a substantial history of consumption of a substance for
food use by a significant number of consumers (Sec. 170.3(f)).
Information included in the petition documents that maltodextrin
derived from potato starch was first sold for use by infants and
children in Europe in 1935 (Ref. 1). One such product was produced by
enzyme hydrolysis of potato starch as described by a 1951 brochure
(Ref. 2), which is included in the petition. Additionally, in 1935, a
British patent specification was issued entitled ``Improved Process for
the Production of a Sugar Preparation from Starch, and for
Manufacturing a Milk Suitable for Infants'' (Ref. 3). The patent
specifically mentions potato starch as one of the alternate starting
materials (the others being starch from wheat, oats, or other cereals).
The benefits of maltodextrin and its uses as an ingredient in milk fed
to infants were also described in an article printed in Holland in 1942
(Ref. 4). In 1947, Campagne (Ref. 5) published a scientific explanation
of the function of maltodextrin-based products in the infant diet. The
diet described contained maltodextrin derived from potato starch.
The agency concludes that information presented in the petition
demonstrates that maltodextrin derived from potato starch was used in
infant formula prior to 1958. The agency does not agree, however, that
the evidence supports a finding of ``common'' use in food because the
totality of information shows that maltodextrin was used solely as an
ingredient in infant formulas. No evidence was presented to show that
the population at large used maltodextrin derived from potato starch in
the food supply. While the agency does not believe that maltodextrin
derived from potato starch was commonly used in food prior to 1958, its
historical use in infant formulas is evidence of general recognition of
safety because it represents documented experience in a particularly
sensitive segment of the population, namely, human infants.
2. Evidence of Chemical Equivalency of Potato Starch to Corn 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. 6). All food
starches, regardless of the plant source, are composed of chemically
equivalent polymeric forms of alpha-bond-linked glucose units (Ref. 7).
Starch consists of polymers of amylose and amylopectin polysaccharides
(Refs. 6 and 8). The relative proportions of amylose and amylopectin
are characteristic of the plant species from which the starch is
derived. Corn starch, for example, typically contains about 27 percent
by weight of amylose and 73 percent by weight of amylopectin, whereas
potato starch typically contains 22 percent amylose by weight and 78
percent amylopectin by weight (Refs. 8 and 9).
Because food starches derived from different plant sources are
equivalent in all material respects, 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.
(According to the petitioner, potato starch is being used to make
modified food starch.) In the Federal Register of April 1, 1985 (50 FR
12821) (Ref. 10), FDA published a proposal to find that the use of
potato starch (as well as several other starches) in food is GRAS. 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. 11). 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. 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. 7 and 12). 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 182.1866.)
Starch hydrolysates below 20 dextrose equivalents (D.E.) are
classified as maltodextrins (Refs. 13 and 14). Specifications for
maltodextrins are listed in the Food Chemicals Codex, 3d ed., 3d supp.
(1992) (Ref. 11).
[[Page 48892]]
Equivalent maltodextrin products result from equivalent hydrolysis of
edible starch sources (Ref. 15). Since corn starch and potato 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.
3. Corroborative Evidence of Chemical Equivalency
The petitioner has submitted data to demonstrate the equivalency
of maltodextrin derived from corn and potato starches, based upon their
dextrose equivalents (D.E.) (Refs. 16, 17, and 18). Hydrolysis of corn
starch or potato starch under similar conditions produces a
maltodextrin product with a D.E. of less than 20. The range of
carbohydrate composition (glucose, maltose, maltotriose, and
polysaccharides larger than maltotriose) in maltodextrins derived from
potato starch (Ref. 16) is virtually identical to that for
maltodextrins derived from corn starch (Refs. 15, and 16) at a D.E. of
less than 20. Also, based upon information submitted by the petitioner
and on information available in current scientific literature, FDA
believes that potato starch may be considered chemically similar to
corn starch in regard to amylose and amylopectin content (Refs. 6, 8,
9, 19, and 20).
4. Proposed Use in Food
Information supplied by the petitioner evidences that maltodextrin
derived from potato starch will be used as a replacement for
maltodextrin derived from corn starch in the same foods, at essentially
the same levels, and for the same technical effects that maltodextrin
derived from corn starch is now used (Ref. 21). The petitioner states
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 potato starch will be used
as a replacement for maltodextrin derived from corn starch, the
consumer exposure to maltodextrin is not expected to increase.
5. General Recognition of Safety
The agency has determined, based on the published literature, that
the safety of maltodextrin derived from potato starch is generally
recognized by food safety experts. Foremost in the support of safety is
published information that shows that corn starch and potato starch are
essentially equivalent, and therefore maltodextrin derived from potato
starch is equivalent to the maltodextrin derived from corn starch.
Thus, maltodextrin derived from potato starch presents no more of a
safety concern than maltodextrin derived from corn starch, which has
been affirmed as GRAS.
Additionally, based on published information in the petition,
maltodextrin derived from potato starch was extensively used in infant
formulas for over 20 years prior to 1958 (Refs. 1, 2, 3, 4, and 5), and
the agency is not aware of any reports of injuries or health risks
resulting from such use.
As a consequence of conclusions regarding safety, many countries,
including those represented by the European Starch Association (Ref.
14), recognize ``food starches,'' including potato starch, as a
suitable raw material for maltodextrin production. Furthermore, the
Joint Food and Agriculture Organization/World Health Organization (FAO/
WHO) Expert Committee on Food Additives (JECFA) (Refs. 22 and 23)
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 previously,
the agency has proposed to find that potato starch is GRAS.
The agency concurs that maltodextrin derived from potato starch is
chemically and functionally equivalent to maltodextrin derived from
corn starch (Ref. 15). No increase in exposure to maltodextrin would be
expected due to the substitution of one source for the other. Because
potato starch is already a significant constituent of the typical diet
(Ref. 24), the agency does not believe that there will be any
impurities in potato-derived maltodextrin that would cause a safety
concern (Refs. 15 and 25).
6. Specifications
The agency has reviewed the specifications for maltodextrin
published in the Food Chemicals Codex, 3d ed., 3d supp., p. 125, and
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
potato starch. Published elsewhere in this issue of the Federal
Register is a notice of proposed rulemaking to adopt these
specifications for maltodextrin derived from corn starch.
IV. Conclusions
The agency has evaluated the information in the petition, along
with other available data, and has reached the following conclusions:
(1) Potato starch is chemically equivalent to corn starch.
(2) Maltodextrin derived from potato starch is chemically
equivalent to maltodextrin derived from corn starch, which is currently
affirmed as GRAS for food use without restriction under Sec. 184.1444.
(3) Maltodextrin derived from potato starch has been used in
infant formula prior to 1958 with no reported adverse effects.
(4) When maltodextrin derived from potato starch is manufactured
as specified in Sec. 184.1444, there is general recognition among
qualified experts that its use 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 also concludes that
maltodextrin derived from potato starch is GRAS for use as a
replacement for maltodextrin derived from corn starch. Therefore, the
agency is affirming that maltodextrin derived from potato starch is
GRAS when used in accordance with good manufacturing practice (21 CFR
184.1(b)(1)).
V. Environmental Impact
The agency has determined under 21 CFR 25.24(b)(7) 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 of Impacts
FDA has examined the impacts of the 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). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive
[[Page 48893]]
Order. In addition, because the final rule is not a significant
regulatory action as defined by the Executive Order and therefore is
not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this rule requires no change in the current
industry practice concerning the manufacture and use of this
ingredient, the cost of compliance with this regulation is zero, and
the potential benefits of the rule include the wider use of this
substance to achieve the intended technical effects, the agency
certifies that the final rule will not have a significant economic
impact on a substantial number of small entities. Therefore, under the
Regulatory Flexibility Act, no further analysis is required.
VII. 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. ``Potato-Derived Maltodextrins for Infants and Toddlers,''
W. A. Scholten's Chemical Factories' Brochure, Avebe Foxhol, 1941.
2. ``The Double Triangle,'' 3d Annual, no. 36, W. A. Scholten's
Chemical and Potato Starch Factories and Meihuizen Boon's Factories,
Holland, pp. 1-10, June 21, 1951.
3. Patent Specification no. 435,034, ``Improved Process for the
Production of a Sugar Preparation from Starch, and for Manufacturing
a Milk Suitable for Infants,'' United Kingdom, 1935.
4. Kuyk, P. G., and K. Schots, ``For Infant and Toddler,'' in
``The Book of Foods and Allied Products and of Substitutes During
Wartime,'' 1942.
5. Campagne, J. vL., ``Feeding and Nutritional Derangements of
Infants,'' Scientific Publisher of the Amsterdam Book and Newspaper
Society, pp. 33, and 126-127, 1947.
6. Wolfram, M. L., and H. El Khadem, ``Chemical Evidence for
the Structure of Starch'' in ``Starch: Chemistry and Technology,''
R. L. Whistler, and E. F. Paschall, eds. Academic Press, Inc., New
York, pp. 251-278, 1965.
7. Schenck, F. W., and R. E. Hebeda, ``Starch Hydrolysis
Products: An Introduction and History'' in Starch Hydrolysis
Products, Worldwide Technology, Production, and Applications, F. W.
Schenk, and R. E. Hebeda, eds., VCH Publishers, Inc., New York, pp.
1-21, 1992.
8. ``Evaluation of the Health Aspects of Starches and Modified
Starches as Food Ingredients,'' Life Sciences Research Office,
Federation of American Societies for Experimental Biology, 1979.
9. Young, A. H., ``Fractionation of Starch'' in ``Starch,'' 2d
ed., R. L. Whistler, and E. F. Paschall, eds., Academic Press, Inc.,
New York, pp. 249-283, 1984.
10. ``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.
11. Food Chemicals Codex, 3d ed., 3d supp., p. 125, 1992.
12. Evans, R. B., and O. B. Wurzburg, ``Production and Use of
Starch Dextrins'' in Starch: Chemistry and Technology, vol. 2, R. L.
Whistler and E. F. Paschall, eds., Academic Press, Inc., New York,
pp. 253-278, 1967.
13. ``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.
14. ``Definition of Maltodextrin,'' European Starch
Associations, Circular Letter Stex 4/88, February 1988.
15. Memorandum dated September 11, 1989, from the Food and
Color Additives Review Section, FDA to the Direct Additives Branch,
FDA, ``Maltodextrin from Potatoes.''
16. ``Maltodextrins,'' Technical Bulletin No. 5.10.20.119EF,
AVEBE Veenddam-Holland, April 1987.
17. Letter plus attachments, in response to a letter of July
13, 1978, from George W. Irving of the Select Committee on GRAS
Substances, Federation of American Societies for Experimental
Biology, Bethesda, MD, to Corbin Miles, Food and Drug
Administration, Washington, DC, pp. 1-4, 1978.
18. ``Maltodextrins and Corn Syrup Solids,'' Technical
Bulletin, A. E. Staley Manufacturing Co., Decatur, IL, Bulletin,
July 1987.
19. Zuber, M. S., ``Genic Control of Starch Development'' in
``Starch: Chemistry and Technology,'' R. L. Whistler, and E. F.
Paschall, eds., Academic Press, Inc., New York, pp. 43-62, 1965.
20. Whistler, R. L., and J. R. Daniel, ``Starch,'' in Kirk-
Othmer's Encyclopedia of Chemical Technology, 3d ed., vol. 21, J.
Brown, C. I. Eastman, C. Galojuch, A. Klingsberg, and M. Wainwright,
eds., pp. 492-496, 1983.
21. ``Maltodextrin; Proposed Affirmation of GRAS Status as
Direct Human Food Ingredient,'' 47 FR 36443, August 20, 1982.
22. ``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. 13-14, 1970.
23. ``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.
24. ``Potato Facts,'' Economics Research Service, U.S.
Department of Agriculture, Fall/Winter, 1988/89.
25. Memorandum dated October 17, 1989, from the Additives
Evaluation Branch, FDA, to the Direct Additives Branch, FDA,
``Maltodextrin derived from potatoes.''
List of Subjects in 21 CFR Part 184
Food ingredients, 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 of the 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 184.1444 is amended by revising the second sentence in
paragraph (a) and by revising paragraph (b) 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 or potato starch with
safe and suitable acids and enzymes.
(b)(1) Maltodextrin derived from corn starch must be of a purity
suitable for its intended use.
(2) Maltodextrin derived from potato starch meets the
specifications of the Food Chemicals Codex, 3d ed., 3d supp. (1992), p.
125, which are 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 Office of the Federal Register, 800 North
Capital St. NW., suite 700, Washington, DC 20408, or at the Division of
Petition Control (HFS-217), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC
20204.
* * * * *
Dated: September 6, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-23352 Filed 9-20-95; 8:45 am]
BILLING CODE 4160-01-F
