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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. 28

Asahi Chemical Industry Co.

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: Hydrogenated styrene-butadiene block copolymers modified with maleic anhydride such that the basic polymers are composed of : 18 to 40 percent by weight of units derived from styrene, 58 to 80 percent by weight of units derived from hydrogenated 1,3-butadiene and 0.1 to 2 percent by weight of units derived from maleic anhydride.
Notifier: Asahi Chemical Industry Co.
Manufacturer: Asahi Chemical Industry Co.
Intended Use: As a modifier (blending component) for polymers that are regulated in 21 CFR Part 177 or the subject of an effective notification.
Limitations/Specifications*: As a modifier (blending component) for polymers that are regulated in 21 CFR Part 177 or the subject of an effective notification at levels no greater than 10 weight-percent of the blend. The blend is intended for use as a component of articles that contact food of the types I, II, IVB, VI (<13% alcohol), VIIB and VIII under Conditions of Use A through H, as described in Tables 1 and 2. The subject copolymers shall conform to the following specifications based on the analytical methods in 21 CFR 177.1810(c): a minimum molecular weight of 25,000, complete solubility in toluene, glass transition points of -50°C (-58°F) to -20°C (-4°F) and 85°C (185°F) to 105°C (221°F), maximum extractable fraction of 0.010 mg/cm2 (0.06 mg/in2) of surface with testing at reflux temperature for 2 hr on a 0.071 cm (0.028 in) thick sample in distilled water, and maximum extractable fraction in 50 percent ethanol of 0.008 mg/cm2 (0.05 mg/in2) of surface with testing at 66°C (150°F) for 2 hr on a 0.071 cm (0.028 in) thick sample.
Effective Date: May 3, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (476 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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