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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. 107

Global Polyacetal Co., Ltd. and its affiliates

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: Polyethylene glycol (CAS Reg. No. 25322-68-3).
Notifier: Mitsubishi Engineering-Plastics Corp.
Manufacturer/Supplier: Global Polyacetal Co., Ltd. and its affiliates
Intended Use: As a lubricant in repeat-use polyoxymethylene copolymers as described in FCN 96 and 21 CFR 177.2470.
Limitations/Specifications: Polyethylene glycol (PEG) shall have a minimum number average molecular weight of 20,000. PEG will be used as a lubricant at a maximum level of 0.15 percent by weight of repeat use polyoxymethylene copolymer as described in FCN 000096 at temperatures not to exceed 250°F. Additionally, hydroquinone monomethyl ether may be used as a stabilizer in PEG at a maximum level of 1,000 ppm.
Effective Date: Nov 22, 2000
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*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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