Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications
  • Print
  • Share
  • E-mail
-

FCN No. 2403

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: Sodium sulfate salt of ethoxylated (7 moles of ethylene oxide) n- and isoundecyl alcohol (C11) (CAS Reg. No. 219756-63-5).
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: (1) acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard (2) adhesives, pressure-sensitive adhesives, and (3) adhesives used in laminate structures, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications:
  1. The FCS may be used at a level not to exceed 2.0 percent by weight of the acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard complying with 21 CFR 176.170 and 176.180 in contact with all food types.
  2. The FCS may be used at a level not to exceed 2.0 percent by weight in adhesives complying with 21 CFR Section 175.105 and pressure?sensitive adhesives complying with 21 CFR 175.125 at temperatures not to exceed 120°F.
  3. The FCS may be used at a level not to exceed 2.0 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 Section 177.1390(c)(2)(ii).

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: Mar 19, 2025
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.
-
-