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U.S. Department of Health and Human Services

Cumulative Estimated Daily Intake (CEDI)
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FCN No. 2468

Valtris Specialty Chemicals

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 Assessment1.2 MB
FDA Decision: Finding of No Significant Impact (FONSI)231 kB

*Definitions

  • CAS Reg. No. (or other ID): Chemical Abstract Service (CAS) Registry Number© for the substance or a numerical code (other ID) assigned by CFSAN to those substances that do not have a CAS Registry Number (977nnn-nn-n or 809777nnn-nn-n series).
  • Substance: A name of the additive or impurity as recognized by CFSAN.
  • Calculation/Update Date: The date on which the CEDI was calculated or re-evaluated.
  • CDC: Cumulative Dietary Concentration (CDC, parts-per-billion, ppb)
  • CEDI: Cumulative Estimated Daily Intake (micrograms/kilogram body weight/person/day, µg/kg bw/d)
  • 21 CFR: The Code of Federal Regulations, Title 21 is the preferred reference to determine the regulatory status of Indirect Food Additives. Substances whose names appear in 21 CFR, parts 175-178 are authorized for specified intended users and conditions of use as stated in the regulation. Note that substances may appear in more than one regulation, or several times in the same regulation. Note that if a substance is mentioned in 21 CFR parts 175-178 and thus, is listed above, any other citations for the same substance in other sections of 21 CFR dealing with food additives (parts 1-199 inclusive) may also be cited.
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