Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2456
KLK Kolb Specialties B.V.
KLK Tensachem S.A.
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-, C12-14-alkyl ethers, sodium salts (CAS Reg. No. 68891-38-3). |
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| Notifier: |
KLK Kolb Specialties B.V. KLK Tensachem S.A. |
| Manufacturer/Supplier: |
KLK Kolb Specialties B.V. KLK Tensachem S.A. |
| Intended Use: |
For use as an emulsifier in the production of:
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| Limitations/Specifications: |
1. 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. 2. The FCS may be used at a level not to exceed 0.7 percent by weight in adhesives complying with 21 CFR 175.105 and pressure-sensitive adhesives used as the food-contact surface of labels and/or tapes applied to food at temperatures not to exceed 120°F. 3. The FCS may be used at a level not to exceed 0.7 percent by weight in adhesives in laminate structures intended for use at temperatures of 250°F and above if the adhesive is separated from food by a functional barrier in compliance with 21 CFR 177.1390(c)(2)(ii). 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 9, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) |
| FDA Decision: | Categorical Exclusion Memo |
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