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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 5


According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: Polybutadiene - graft - poly(methyl acrylate- co-acrylonitrile) (CAS Reg. No. 27012-62-0)
Manufacturer: INEOS USA LLC
Intended Use: Fabricating beverage containers
Limitations/Specifications*: Nitrile rubber modified acrylonitrile-methyl acrylate copolymers consist of 8 to 10.5 percent by weight of butadiene-acrylonitrile copolymers containing approximately 70 percent by weight of polymer units derived from butadiene. Adjuvant substances permitted for use in copolymers complying with 177.1480 may be used in the subject copolymers. The finished copolymers must meet any applicable specifications prescribed in 21 CFR 177.1480 and may be safely used as components of articles intended for food-contact use only under Conditions of Use E and F as described in Table 2. Paragraph 177.1480(d) not withstanding, the finished copolymers are authorized for use in fabricating bottles intended as containers for beverages as defined in 21 CFR 170.3(n)(3), (7) only under Conditions of Use E and F, (16), (35) and (36), with exception of soft drinks and coffee substitutes. The finished copolymers are to meet the following specifications: 1. residual acrylonitrile monomer content not more than 4 parts per million as determined by gas chromatography, 2. melt index in the range 2 to 6 grams per 10 minutes as determined by ASTM method D 1238-95 under the conditions 200 degrees C, 27.5 pounds, 0.0824 inches diameter x 0.3145 inches length.
Effective Date: Mar 14, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.70 MB)
FDA Decision: Finding of No Significant Impact (FONSI)