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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. 1067

Mitsui Chemicals, Inc. and Johoku Chemical Co., 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: 2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane, 3,9-bis(isodecyloxy)- (CAS Reg. No. 26544-27-4).
Notifier: Mitsui Chemicals, Inc. and Johoku Chemical Co., Ltd.
Manufacturer: Mitsui Chemicals, Inc. and Johoku Chemical Co., Ltd.
Intended Use: As an antioxidant in food-contact adhesives.
Limitations/Specifications*: For use at a level not to exceed 100 parts per million by weight of the finished adhesive. The FCS may be used in finished adhesives in contact with all food types under Conditions of Use A through H and J, as described in Table 2.
Effective Date: May 5, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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