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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. 2017

BASF Corporation

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: bis(hydrogenated palm-oil alkyl)hydroxy amines (CAS Reg. No. 1374859-51-4).
Notifier: BASF Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: As an antioxidant and/or stabilizer in olefin polymers complying with 21 CFR 177.1520(c); intended for single and repeat food contact use, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications:
  1. At levels not to exceed 0.1 percent by weight of polypropylene polymers complying with 21 CFR 177.1520(c), item 1.1, 1.2, 1.3, 3.1a (with density of 0.85- 0.91 gram per cubic centimeter), 3.2b, 3.4 and 3.5. The finished polymers may be used in contact with: (a) food types I, II, IV-B, VII-B and VIII described in Table 1, under Condition of Use A through H described in Table 2; (b) food types VI-A and VI-B described in Table 1, under Conditions of Use A through C described in Table 2; and food types III, IV-A, V, VI-C, VII-A, and IX described in Table 1, under Conditions of Use B through H described in Table 2.
  2. At levels not to exceed 0.1 percent by weight of high density polyethylene polymers and copolymers complying with 21 CFR 177.1520(c), item 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.6 (with a density not less than 0.94 gram per cubic centimeter) and 5. The finished polymers may be used in contact with food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H as described in Tables 1 and 2, and with food types III, IV-A, V, VI-C, VII-A and IX under Conditions of Use B through H as described in Tables 1 and 2.
  3. At levels not to exceed 0.1 percent by weight of polyethylene polymers and copolymers complying with 21 CFR 177.1520(c), item 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, and 3.6 (with a density less than 0.94 gram per cubic centimeter). The finished polymers may be used under Conditions of Use B through H described in Table 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: Mar 7, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 47 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 141 kB)

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