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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. 2028

BASF SE 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: Polyurethane resins (CAS Reg. No. 89097-02-9) derived from the reaction of diphenylmethane diisocyanate with 1,3-propanediol and polytetramethylene ether glycol.
Notifier: BASF SE and its affiliates
Manufacturer/Supplier: BASF SE and its affiliates
Intended Use: For repeated use applications, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used as a component of molded articles used in food processing equipment only such as conveyor belts, hoses, and tubing intended to contact all food types under all Conditions of Use as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Feb 12, 2020
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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