[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3520]
[Page 412-413]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS--Table of Contents
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 Sec.
172.892 of this chapter.
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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 Industrial starch modified by
chloride, not to exceed 5 pct. 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 Industrial starch modified by
0.375 pct. 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 Industrial starch modified by
and urea, not to exceed 20 pct. 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 Sec.
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) For use only as a retention aid
ethyl]trimethylammonium methyl and dry strength agent
sulfate, such that the finished employed before the sheet-
industrial starch-modified shall forming operation in the
contain: 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).
[[Page 413]]
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]
Additives that reference this regulation: |
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