• 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. 1408

Pall Corporation

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: Copolymer of polyethylene glycol dimethacrylate, trimethylolpropane trimethacrylate and 2-hydroxyethyl methacrylate.
Notifier: Smithers Pira
Manufacturer/Supplier: Pall Corporation
Intended Use: For use as a repeated use microbial filter intended to clarify water, except for use in packaging of infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used in a membrane cartridge for filtration of water. The membrane cartridge is to be manufactured and used as specified in the submission. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Apr 17, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

2362  

-
-