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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. 161

Total Petrochemicals & Refining USA, Inc.

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: Piperylene/2-methyl-2-butene copolymer resins (CAS Reg. No. 26813-14-9) and Piperylene/2-methyl-2-butene/α-methylstyrene terpolymer resins (CAS Reg. No. 62258-49-5), and as further described in the identity and manufacturing sections of the notification.
Notifier: Total Petrochemicals & Refining USA, Inc.
Manufacturer/Supplier: Total Petrochemicals & Refining USA, Inc.
Intended Use: As components of pressure-sensitive adhesives used as the food-contact surface of labels and tapes as provided in 21 CFR 175.125 Pressure-sensitive adhesives.
Limitations/Specifications*: The labels or tapes may be applied to poultry, dry food, processed, frozen, dried, or partially dehydrated fruits and vegetables, raw fruits, and raw vegetables. The tapes and labels will be used at room temperature or below. The maximum use level for either of the two food contact substances is 47.5 percent by weight of the final adhesive formulation.
Effective Date: Oct 2, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo