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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. 2095

Milliken Chemical, Division of Milliken & Co

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: Bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, calcium salt (1:1), (1R,2R,3S,4S)-rel- (CAS Reg. No. 839683-04-4).
Notifier: Milliken Chemical, Division of Milliken & Co
Manufacturer/Supplier: Milliken Chemical, Division of Milliken & Co
Intended Use: As a nucleating agent in the manufacture of polyolefin food contact articles, except for use in contact with infant formula or human milk.
Limitations/Specifications: The FCS may be used at a level up to 0.25 weight percent in:
  1. high-density polyethylene and polypropylene in contact with all foods under Conditions of Use A through H, as described in Tables 1 and 2, respectively;
  2. low-density polyethylene and linear low-density polyethylene in contact with acidic foods under Conditions of Use A through H; and
  3. low-density polyethylene and linear low-density polyethylene in contact with aqueous, alcoholic and fatty foods under Conditions of Use B through H.
The FCS is not intended 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: Feb 13, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 749 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 141 kB)

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