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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. 49

Unitika Ltd.

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: Nylon 6 polymers produced using benzoic acid as a blocking agent.
Notifier: Unitika Ltd.
Manufacturer/Supplier: Unitika Ltd.
Intended Use: The Nylon 6 polymers would be used for food-contact applications as described in 21 CFR 177.1500(b)(6.1) and (6.2).
Limitations/Specifications: Maximum use level of 0.15 percent by weight of benzoic acid in the finished polymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H, as described in Table 2. The finished Nylon 6 polymers must meet the applicable specifications prescribed in 21 CFR 177.1500(b) when tested by the methods described in 21 CFR 177.1500(c).
Effective Date: Jun 9, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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