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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. 2110

DIC 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: Reaction product of the three substances:
  1. Coconut oil polymer with ethylene glycol, glycerol, and phthalic anhydride (CAS Reg. No. 68413-10-5);
  2. 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- polymer with bis(isocyanatomethyl)benzene (CAS Reg. No. 51852-81-4); and
  3. 1-Propanamine 3-(triethoxysilyl)- (CAS Reg. No. 919-30-2).
Notifier: DIC Corporation
Manufacturer/Supplier: DIC Corporation
Intended Use: As a coating on poly(ethylene terephthalate) (PET) food packaging films, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The coating may be used at a thickness of up to 0.3 grams per square meter on PET that contacts all types of food under Conditions of Use A through H 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: Apr 15, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
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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