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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2371

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: Magnesium and zinc complexes with 10-40% hydroxy(sulfinato)acetate (CAS Reg. No. 743407-32-1), 20-60% hydroxy(sulfonato)acetate (CAS Reg. No. 5980-14-3), and 5-30% glyoxylate (CAS Reg. No. 298-12-4).
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, except for use in contact with infant formula and human milk (see Limitations/Specifications).
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, 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 in the production of polymer emulsions to be used as components of:
  1. Food?contact paper and paperboard complying with 21 CFR 176.170 or 176.180.
  2. Adhesives complying with 21 CFR 175.105.
  3. Pressure?sensitive adhesives complying with 21 CFR 175.125.
  4. Repeat use rubber articles complying with 21 CFR 177.2600.
  5. 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.
  6. 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.
  7. 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.
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: Aug 22, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 205 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 148 kB)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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