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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. 1963

Peter Greven GmbH & Co. KG

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: Fatty acids, C14-C20, esters with pentaerythritol (CAS Reg. No. 68440-28-8).
Notifier: Peter Greven GmbH & Co. KG
Manufacturer/Supplier: Peter Greven GmbH & Co. KG
Intended Use: As a processing agent in the production of poly(ethylene terephthalate) (PET) and poly(butylene terephthalate) (PBT) polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS may be used at a level up to 2% by weight of the finished PET and PBT polymers in contact with food under Conditions of Use B through H, as described in Table 2. 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: May 28, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

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