• 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. 1410

Packaging, Transport and Logistic Center (ITENE)
BYK-Chemie GmbH

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: Hexadecyltrimethylammonium bromide modified montmorillonite organoclay.
Notifier: Packaging, Transport and Logistic Center (ITENE)
Manufacturer/Supplier: Packaging, Transport and Logistic Center (ITENE)
BYK-Chemie GmbH
Intended Use: As an additive in polylactic acid polymers (PLA), except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: Use in levels up to 5 percent by weight in PLA water bottles for contact with food type I, under Condition of Use E, as described in Tables 1 and 2, respectively. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Apr 30, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

2362  

-
-