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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. 2468

Valtris Specialty Chemicals

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: 1,4-bis(2-ethylhexyl) benzenedicarboxylate (CAS Reg. No. 6422-86-2).
Notifier: Valtris Specialty Chemicals
Manufacturer/Supplier: Valtris Specialty Chemicals
Intended Use: As a component of:
  1. nitrile rubber.
  2. plasticized vinyl chloride formulations.
  3. paper or paperboard or coatings of such paper and paperboard.
  4. adhesives.
  5. pressure sensitive adhesives in contact with food.

The FCS is not for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used:
  1. as a plasticizer at levels up to 15 percent by weight in repeated-use nitrile rubber articles in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.
  2. at levels not to exceed 55 percent by weight of finished plasticized vinyl chloride polymer formulations used in repeated-use applications in contact with all food types at temperatures not to exceed 100°C.
  3. as a component of paper or paperboard, or coatings for such paper and paperboard intended for use in contact with dry foods with no free surface fats or oil in compliance with 21 CFR 176.180.
  4. as a component of adhesives complying with the provisions of 21 CFR 175.105.
  5. as a component of pressure sensitive adhesives complying with the provisions of 21 CFR 175.125.
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 25, 2026
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*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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