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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. 145

ColorMatrix Group 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: Ethylene phthalate polymers identified in 21 CFR 177.1630(e)(4)(i) and 177.1630(e)(4)(ii), items 2 and 3, 177.1637 and FCN numbers 4, 13, 14, and 135 modified with 1,2,4,5-benzenetetracarboxylic dianhydride (pyromellitic dianhydride (PMDA)) (CAS Reg. No. 89-32-7).
Notifier: ColorMatrix Group Inc.
Manufacturer/Supplier: ColorMatrix Group Inc.
Intended Use: As a component of ethylene phthalate polymers complying with 21 CFR 177.1630(e)(4)(i) and in 177.1630(e)(4)(ii), items 2 and 3, and FCN Numbers 4, 13, 14, and 135, and ethylene naphthalate polymers complying with 21 CFR 177.1637.
Limitations/Specifications*: The level of PMDA in finished articles and films manufactured from the subject modified polyesters may not exceed 0.1 weight percent. Such articles and films may be used in contact with aqueous, acidic and low-alcohol food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H, as described in Table 2. The finished PMDA modified polyesters must meet any specifications applicable to the unmodified polyester that is appropriate to its intended use. Adjuvant substances permitted for use in ethylene phthalate polymers complying with 21 CFR 177.1630, or ethylene naphthalate polymers complying with 21 CFR 177.1637 may be used in the pyromellitic dianhydride modified copolymers subject to any limitations in the regulation or notification authorizing the use of the adjuvant substance.
Effective Date: Jul 31, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)