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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. 420

Perstorp Polyols, 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: 2-butyl-2-ethyl-1,3-propanediol (CAS Reg. No. 115-84-4).
Notifier: Perstorp Polyols, Inc.
Manufacturer: Perstorp Polyols, Inc.
Intended Use: As a polyol monomer in the synthesis of polyester resins used to produce coatings, specifically coating binder resins, for use as can coatings and adhesives for single use in food contact applications.
Limitations/Specifications*: 1. Polyester resins containing the food contact substance for use in can coatings, intended for single-use applications, may be used in contact with all food types except high-alcoholic (>15 percent alcohol) food as described in Table 1, under conditions of use A through H as described in Table 2. 2. Polyester resins containing the food contact substance for use in adhesives, intended for single use applications, may be used in contact with all food types as described in Table 1, under Conditions of Use A through H as described in Table 2.
Effective Date: Aug 4, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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