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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. 1570

Mitsubishi Corporation Plastics Ltd.

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: Amorphous hydrogenated carbon coating produced from acetylene as the carbon source in a radio-frequency plasma as described in the notification.
Notifier: Mitsubishi Corporation Plastics Ltd.
Manufacturer/Supplier: Mitsubishi Corporation Plastics Ltd.
Intended Use: As a coating on the interior of plastic containers used in single-use food-contact applications, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The amorphous hydrogenated carbon coating is intended for use at a thickness not to exceed 0.10 microns and may be used with all food types, except for infant formula and breast milk, under Conditions of Use B through H, as described in Table 2. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Oct 16, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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