• 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. 2023

Brüggemann Chemical US, Inc.

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: A mixture of 35-60 percent hydroxysulfinoacetic acid, disodium salt (CAS Reg. No. 223106-41-0), 10-60 percent hydroxysulfoacetic acid, disodium salt (CAS Reg. No. 29736-24-1), and 0-40 percent sodium sulfite (CAS Reg. No. 7757-83-7).
Notifier: Brüggemann Chemical US, Inc.
Manufacturer/Supplier: Brüggemann Chemical US, Inc.
Intended Use: As a reducing agent in emulsion polymerization redox catalyst systems. The produced polymers will be used as components of food contact articles, including for use in contact with infant formula and human milk.
Limitations/Specifications: The FCS will be used at a maximum level of 1.0 percent based on total monomer weight of polymers produced, unless otherwise specified below. The polymers produced using the FCS may contact all food types, including infant formula and human milk, under Conditions of Use A through H as described in Table 2 subject to any limitations on the use of such polymers under the 21 CFR regulations that provide for their intended use. The FCS may be used only in the production of: 1. Polymers to be used as components of pressure-sensitive adhesives complying with 21 CFR 175.125. 2. Acrylic latex polymers to be used as components of coatings complying with 21 CFR 175.300. Coatings that are formed from the acrylic latex polymers will have a maximum thickness of 9 microns. For such coatings intended for use in contact with infant formula or human milk, the FCS will be used at a maximum level of 0.5 percent based on total monomer weight of the acrylic latex polymers produced. 3. Polymers to be used as components of coatings for polyolefin films complying with 21 CFR 175.320. The coatings for polyolefin films will be applied at a maximum rate of 0.8 g/m2 of film. 4. Polymers to be used as components of coatings for polyester film wherein both the coating and the polyester film comply with regulations under 21 CFR that provide for their intended use. The coatings for polyester films will be applied at a maximum rate of 0.8 g/m2 of film.
Effective Date: Jan 22, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 685 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 118 kB)

2362  

-
-