21 CFR § 177.1211 - Cross-linked polyacrylate copolymers.

§ 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 °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 4 × 6 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 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]