• 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. 1967

Perstorp AB

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: 2,2‐bis((pentanoyloxy)methyl)propane‐1,3‐diyl dipentanoate (CAS Reg. No. 15834‐04‐5).
Notifier: Perstorp AB
Manufacturer/Supplier: Perstorp AB
Intended Use: As a plasticizer in polyvinyl chloride (PVC) polymers for use in:
(1) repeated‐use articles;

(2) as a coating or component of paper or paperboard;

(3) adhesives complying with 21 CFR 175.105; and

(4) pressure‐sensitive adhesives complying with 21 CFR 175.125.

The FCS is not intended for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS will be used at levels up to 31% in the PVC polymers. The FCS may be used in repeat-use food contact articles in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2. The FCS may be used as a component or coating of paper and paperboard in contact with Food Type VIII only and under Conditions of Use A through H. The FCS may be used in adhesives complying with 21 CFR 175.105 and pressure sensitive adhesives complying with 21 CFR 175.125 in contact with all food types. The finished food contact articles containing the FCS are 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: May 28, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF)
FDA Decision: Finding of No Significant Impact (FONSI)

679662  

-
-