[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
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.

------------------------------------------------------------------------
           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]