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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. 146

Basell Polyolefins N.V.

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: Poly-1-butene polymers (CAS Reg. No. 009003-28-5) and butene/ethylene copolymers (CAS Reg. No. 25087-34-7) as identified in 21 CFR 177.1570(a).
Notifier: Basell Polyolefins N.V.
Manufacturer: Basell Polyolefins N.V.
Intended Use: As articles or components of articles intended to contact food.
Limitations/Specifications*: 1. The finished polymers shall have no more than 100 mg/kg residual tertiary butyl alcohol. 2. The finished polymers, complying with all of the specifications of 21 CFR 177.1570(b)(1), may be used in contact with all types of food under Conditions of Use A through H, as described in Table 2. Such polymers shall yield maximum extractables not to exceed 0.8 percent by weight of the polymer when film samples 0.1 to 0.2 millimeters (0.004 to 0.008) in thickness are extracted for 6 hours with refluxing 95 percent ethanol in a soxhlet extractor. 3. The finished polymers, complying with the specifications of 21 CFR 177.1570(b)(1)(i) and (iii), may be used in contact with all types of food under Conditions of Use B through H, as described in Table 2, provided the polymers have an intrinsic viscosity less than 3.2 as determined by ASTM Method D1601-78, "Standard Test Method for Dilute Solution Viscosity of Ethylene Polymers"; a Brookfield viscosity at 176.6°C (350°F) greater than 10,000 centipoises as determined by ASTM Method D 1084-63 (Reapproved 1981), "Standard Test Methods for Viscosity of Adhesives"' and a melt index of 0.1 to 240 as determined by ASTM Method D1238-85, Condition E, "Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer." (In the event of a conflict between the melt index and viscosity measurements, which may occur with high melt index polymers, compliance will be determined by the Brookfield viscosity alone.) Such polymers shall yield maximum extractables not to exceed 2.0 percent by weight of the polymer when film samples 0.1 to 0.2 millimeters (0.004 to 0.008) in thickness are extracted for 6 hours with refluxing 95 percent ethanol in a soxhlet extractor.
Effective Date: Aug 2, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (424 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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