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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. 110

INEOS USA LLC

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: Nitrile rubber-modified acrylonitrile-methyl acrylate copolymers (CAS Name: Polybutadiene-graft-poly(methyl acrylate-co-acrylonitrile), CAS Reg. No. 27012-62-0).
Notifier: INEOS USA LLC
Manufacturer: INEOS USA LLC
Intended Use: For use in fabricating beverage containers and in film or sheet packaging.
Limitations/Specifications*: Nitrile rubber-modified acrylonitrile-methyl acrylate copolymers consisting of 8 to 18 percent by weight of butadiene-acrylonitrile copolymers containing approximately 70 percent by weight of polymer units derived from butadiene intended for use in beverage containers (with the exception of containers for carbonated soft drinks and coffee substitutes) under Conditions of Use E and F as described in Table 2, and in food-contact film and sheet packaging under Conditions of Use D through G. 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°C, 27.5 pounds, 0.0824 inches diameter x 0.3145 inches length. Adjuvant substances permitted for use in copolymers complying with 21 CFR 177.1480 may be used in the subject copolymers.
Effective Date: Feb 17, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.60 MB)
FDA Decision: Finding of No Significant Impact (FONSI)
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