[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