[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1211]

[Page 241-242]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
 
Subpart B--Substances for Use as Basic Components of Single and Repeated 
                        Use Food Contact Surfaces
 
Sec. 177.1211  Cross-linked polyacrylate copolymers.

    Cross-linked polyacrylate copolymers identified in paragraph (a) of 
this section may be safely used as articles or components of articles 
intended for use in contact with food in accordance with the following 
prescribed conditions:
    (a) Identity. For the purpose of this section, the cross-linked 
polyacrylate copolymers consist of:
    (1) The grafted copolymer of cross-linked sodium polyacrylate 
identified as 2-propenoic acid, polymers with N,N-di-2-propenyl-2-
propen-1-amine and hydrolyzed polyvinyl acetate, sodium salts, graft 
(CAS Reg. No. 166164-74-5); or
    (2) 2-propenoic acid, polymer with 2-ethyl-2-(((1-oxo-2-
propenyl)oxy)methyl)-1,3-propanediyl di-2-propenoate and sodium 2-
propenoate (CAS Reg. No. 76774-25-9).
    (b) Adjuvants. The copolymers identified in paragraph (a) of this 
section may contain optional adjuvant substances required in the 
production of such copolymers. The optional adjuvant substances may 
include substances permitted for such use by regulations in parts 170 
through 179 of this chapter, substances generally recognized as safe in 
food, and substances used in accordance with a prior sanction or 
approval.
    (c) Extractives limitations. The copolymers identified in paragraph 
(a) of this section, in the finished form in which they will contact 
food, must yield low molecular weight (less than 1,000 Daltons) 
extractives of no more than 0.15 percent by weight of the total polymer 
when extracted with 0.2 percent by weight of aqueous sodium chloride 
solution at 20  deg.C for 24 hours. The low molecular weight extractives 
shall be determined using size exclusion chromatography or an equivalent 
method. When conducting the extraction test, the copolymer, with no 
other absorptive media, shall be confined either in a finished absorbent 
pad or in any suitable flexible porous article, (such as a ``tea bag'' 
or infuser), under an applied pressure of 0.15 pounds per square inch 
(for example, a 4x6 inch square pad is subjected to a 1.6 kilograms 
applied mass). The solvent used shall be at least 60 milliliters aqueous 
sodium chloride solution per gram of copolymer.
    (d) Conditions of use. The copolymers identified in paragraph (a)(1) 
of this section are limited to use as a fluid absorbent in food-contact 
materials used

[[Page 242]]

in the packaging of frozen or refrigerated poultry. The copolymers 
identified in paragraph (a)(2) of this section are limited to use as a 
fluid absorbent in food-contact materials used in the packaging of 
frozen or refrigerated meat and poultry.

[64 FR 28098, May 25, 1999, as amended at 65 FR 16817, Mar. 30, 2000]