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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. 982

Croda International, Plc.

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 saturated, linear, aliphatic esters produced from C12 - C18 alcohols and C12 - C18 fatty acids.
Notifier: Croda Europe
Manufacturer: Croda International, Plc.
Intended Use: As a friction reduction additive in polyethylene terephthalate resins used in the production of containers and packaging films that may contact food.
Limitations/Specifications*: For use at levels not to exceed 0.5 percent by weight of single-, or repeat-use polyethylene terephthalate food-contact articles in contact with all food types, and under Conditions of Use A through H and J as described in Tables 1 and 2.
Effective Date: Jul 27, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo