Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2450
Pilot Chemical Co.
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: | Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C12-16-alkyl ethers, sodium salts (CAS Reg. No. 161074-78-8). |
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| Notifier: | Pilot Chemical Co. |
| Manufacturer/Supplier: | Pilot Chemical Co. |
| Intended Use: | For use as an emulsifier in the production of acrylic and modified acrylic polymers, styrene-acrylic copolymers, and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used at levels not to exceed 2.0 percent by weight of acrylic and modified acrylic polymers, styrene-acrylic copolymers, and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard complying with 21 CFR 176.170 and 176.180. The FCS is not for use in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the FCN. |
| Effective Date: | Oct 4, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) |
| FDA Decision: | Categorical Exclusion Memo |
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