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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 2019.

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, 2019]
[CITE: 21CFR178.3520]



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 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

Subpart D--Certain Adjuvants and Production Aids

Sec. 178.3520 Industrial starch-modified.

Industrial starch-modified may be safely used as a component of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) Industrial starch-modified is identified as follows:

(1) A food starch-modified or starch or any combination thereof that has been modified by treatment with one of the reactants hereinafter specified, in an amount reasonably required to achieve the desired functional effect but in no event in excess of any limitation prescribed, with or without subsequent treatment as authorized in 172.892 of this chapter.

List of reactants Limitations
Ammonium persulfate, not to exceed 0.3 pct. or in alkaline starch not to exceed 0.6 pct.
(4-Chlorobutene-2) trimethylammonium chloride, not to exceed 5 pctIndustrial starch modified by this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging.
[beta]-Diethylaminoethyl chloride hydrochloride, not to exceed 4 pct
Dimethylaminoethyl methacrylate, not to exceed 3 pct
Dimethylol ethylene urea, not to exceed 0.375 pctIndustrial starch modified by this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging.
2,3-Epoxypropyltrimethylammonium chloride, not to exceed 5 pct
Ethylene oxide, not to exceed 3 pct of reacted ethylene oxide in finished product
Phosphoric acid, not to exceed 6 pct and urea, not to exceed 20 pctIndustrial starch modified by this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging and as surface sizing and coating for paper and paperboard that contact food only of Types IV-A, V, VII, VIII, and IX described in table 1 of 176.170(c) of this chapter.

(2) A starch irradiated under one of the following conditions to produce free radicals for subsequent graft polymerization with the reactants listed in this paragraph (a)(2):

(i) Radiation from a sealed cobalt 60 source, maximum absorbed dose not to exceed 5.0 megarads.

(ii) An electron beam source at a maximum energy of 7 million electron volts of ionizing radiation, maximum absorbed dose not to exceed 5.0 megarads.

List of reactants Limitations
Acrylamide and [2-(methacryloyloxy) ethyl]trimethylammonium methyl sulfate, such that the finished industrial starch-modified shall contain:For use only as a retention aid and dry strength agent employed before the sheet-forming operation in the manufacture of paper and paperboard intended to contact food, and used at a level not to exceed 0.25 pct by weight of the finished dry paper and paperboard fibers.
1. Not more than 60 weight percent vinyl copolymer (of which not more than 32 weight percent is [2-(methacryloyloxy)ethyl] trimethylammonium methyl sulfate)
2. Not more than 0.20 pct residual acrylamide
3. A minimum nitrogen content of 9.0 pct

(b) The following adjuvants may be used as surface-active agents in the processing of industrial starch-modified:

Polyethylene glycol (400) dilaurate.

Polyethylene glycol (400) monolaurate.

Polyoxyethylene (4) lauryl ether.

(c) To insure safe use of the industrial starch-modified, the label of the food additive container shall bear the name of the additive "industrial starch-modified," and in the instance of an industrial starch-modified which is limited with respect to conditions of use, the label of the food additive container shall contain a statement of such limited use.

[42 FR 14609, Mar. 15, 1977, as amended at 42 FR 49453, Sept. 27, 1977]

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