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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. 1525

Trinseo 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: 2-Propenoic acid, butyl ester, polymer with 1,3-butadiene, ethenylbenzene and 2-propenenitrile (CAS Reg. No. 26657-42-1).
Notifier: Trinseo LLC
Manufacturer: Trinseo LLC
Intended Use: As articles or components of rigid and semirigid containers intended for repeat use.
Limitations/Specifications*: The polymer contains no more than 5 weight percent of 2-propenoic acid, butyl ester. The acrylonitrile monomer extraction for finished food-contact articles shall not exceed 0.003 milligram/square inch when extracted at a time equivalent to initial batch usage utilizing food-simulating solvents and temperatures appropriate to the intended conditions of use, per method described in 21 CFR 181.32(b) or equivalent. For use in repeat use articles used in contact with all types of food under Conditions of Use E through G, as described in Table 2. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Apr 18, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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