FCN No. 2197

SK Functional Polymer S.A.S.

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: N,N'-dioleoylethylenediamine (CAS. Reg. No. 110-31-6).
• Notifier: SK Functional Polymer S.A.S.
• Manufacturer/Supplier: SK Functional Polymer S.A.S.
• Intended Use: As a release agent in authorized copolymers of ethylene and methyl acrylate, complying with 21 CFR 177.1340 (Ethylene-methyl acrylate copolymer resins), except for use in contact with infant formula and human milk (see Limitations/Specifications).
• Limitations/Specifications: For use at a level not to exceed 1,500 ppm in authorized treated copolymers. Treated copolymers may be used in:
  1. impact-modifier resins, where the treated copolymer comprises up to 20% of the resin in contact with all types of food under Conditions of Use A through H as described in Table 2, or
  2. multilayer laminated structures, where the treated copolymer comprises up to 1.2 mil (30 µm) of single-use, laminated food-contact articles for all types of food except type V (i.e., low moisture fats and oils) under Conditions of Use D through H.
  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 19, 2022
• National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 927 kB)
• FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 237 kB)

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*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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