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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2016.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2016]
[CITE: 21CFR172.892]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart I--Multipurpose Additives

Sec. 172.892 Food starch-modified.

Food starch-modified as described in this section may be safely used in food. The quantity of any substance employed to effect such modification shall not exceed the amount reasonably required to accomplish the intended physical or technical effect, nor exceed any limitation prescribed. To insure safe use of the food starch-modified, the label of the food additive container shall bear the name of the additive "food starch-modified" in addition to other information required by the Act. Food starch may be modified by treatment prescribed as follows:

(a) Food starch may be acid-modified by treatment with hydrochloric acid or sulfuric acid or both.

(b) Food starch may be bleached by treatment with one or more of the following:

Limitations
Active oxygen obtained from hydrogen peroxide and/or peracetic acid, not to exceed 0.45 percent of active oxygen
Ammonium persulfate, not to exceed 0.075 percent and sulfur dioxide, not to exceed 0.05 percent
Chlorine, as calcium hypochlorite, not to exceed 0.036 percent of dry starchThe finished food starch-modified is limited to use only as a component of batter for commercially processed foods.
Chlorine, as sodium hypochlorite, not to exceed 0.0082 pound of chlorine per pound of dry starch
Potassium permanganate, not to exceed 0.2 percentResidual manganese (calculated as Mn), not to exceed 50 parts per million in food starch-modified.
Sodium chlorite, not to exceed 0.5 percent

(c) Food starch may be oxidized by treatment with chlorine, as sodium hypochlorite, not to exceed 0.055 pound of chlorine per pound of dry starch.

(d) Food starch may be esterified by treatment with one of the following:

Limitations
Acetic anhydrideAcetyl groups in food starch-modified not to exceed 2.5 percent.
Adipic anhydride, not to exceed 0.12 percent, and acetic anhydride Do.
Monosodium orthophosphateResidual phosphate in food starch-modified not to exceed 0.4 percent calculated as phosphorus.
1-Octenyl succinic anhydride, not to exceed 3 percent
1-Octenyl succinic anhydride, not to exceed 2 percent, and aluminum sulfate, not to exceed 2 percent
1-Octenyl succinic anhydride, not to exceed 3 percent, followed by treatment with a beta-amylase enzyme that is either an approved food additive of is generally recognized as safeLimited to use as a stabilizer or emulsifier in beverages and beverage bases as defined in 170.3(n)(3) of this chapter.
Phosphorus oxychloride, not to exceed 0.1 percent
Phosphorus oxychloride, not to exceed 0.1 percent, followed by either acetic anhydride, not to exceed 8 percent, or vinyl acetate, not to exceed 7.5 percentAcetyl groups in food starch-modified not to exceed 2.5 percent.
Sodium trimetaphosphateResidual phosphate in food starch-modified not to exceed 0.04 percent, calculated as phosphorus.
Sodium tripolyphosphate and sodium trimetaphosphateResidual phosphate in food starch-modified not to exceed 0.4 percent calculated as phosphorus.
Succinic anhydride, not to exceed 4 percent
Vinyl acetateAcetyl groups in food starch-modified not to exceed 2.5 percent.

(e) Food starch may be etherified by treatment with one of the following:

Limitations
Acrolein, not to exceed 0.6 percent
Epichlorohydrin, not to exceed 0.3 percent
Epichlorohydrin, not to exceed 0.1 percent, and propylene oxide, not to exceed 10 percent, added in combination or in any sequenceResidual propylene chlorohydrin not more than 5 parts per million in food starch-modified.
Epichlorohydrin, not to exceed 0.1 percent, followed by propylene oxide, not to exceed 25 percent Do.
Propylene oxide, not to exceed 25 percent Do.

(f) Food starch may be esterified and etherified by treatment with one of the following:

Limitations
Acrolein, not to exceed 0.6 percent and vinyl acetate, not to exceed 7.5 percentAcetyl groups in food starch-modified not to exceed 2.5 percent.
Epichlorohydrin, not to exceed 0.3 percent, and acetic anhydrideAcetyl groups in food starch-modified not to exceed 2.5 percent.
Epichlorohydrin, not to exceed 0.3 percent, and succinic anhydride, not to exceed 4 percent
Phosphorus oxychloride, not to exceed 0.1 percent, and propylene oxide, not to exceed 10 percentResidual propylene chlorohydrin not more than 5 parts per million in food starch-modified.

(g) Food starch may be modified by treatment with one of the following:

Limitations
Chlorine, as sodium hypochlorite, not to exceed 0.055 pound of chlorine per pound of dry starch; 0.45 percent of active oxygen obtained from hydrogen peroxide; and propylene oxide, not to exceed 25 percentResidual propylene chlorohydrin not more than 5 parts per million in food starch-modified.
Sodium hydroxide, not to exceed 1 percent

(h) Food starch may be modified by a combination of the treatments prescribed by paragraphs (a), (b), and/or (i) of this section and any one of the treatments prescribed by paragraph (c), (d), (e), (f), or (g) of this section, subject to any limitations prescribed by the paragraphs named.

(i) Food starch may be modified by treatment with the following enzymes:

Enzyme Limitations
Alpha-amylase (E.C. 3.2.1.1)The enzyme must be generally recognized as safe or approved as a food additive for this purpose. The resulting nonsweet nutritive saccharide polymer has a dextrose equivalent of less than 20.
Beta-amylase (E.C. 3.2.1.2)
Glucoamylase (E.C. 3.2.1.3)
Isoamylase (E.C. 3.2.1.68)
Pullulanase (E.C. 3.2.1.41)
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