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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. 743

Croda Chemicals Europe

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: Mixture of saturated linear aliphatic esters produced from C12 - C18 alcohols and C12 - C18 fatty acids.
Notifier: Croda Chemicals Europe
Manufacturer: Croda Chemicals Europe
Intended Use: As a friction reduction additive in polyethylene terephthalate (PET) resins used in the production of containers and packaging films that may contact food.
Limitations/Specifications*: The finished PET resins may be used in contact with all Food Types under Conditions of Use E through G as described in Tables 1 and 2. The maximum use level of the FCS is 0.5 percent by weight in the final PET product.
Effective Date: Oct 2, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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