Inventory of Effective Food Contact Substance (FCS) Notifications
FCN No. 806
Mitsui Chemicals, Inc.
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:||Ethylene/1-butene copolymer (CAS Reg. No. 25087-34-7).|
|Notifier:||Mitsui Chemicals, Inc.|
|Manufacturer/Supplier:||Mitsui Chemicals, Inc.|
|Intended Use:||As a component of articles used in contact with all types of food.|
|Limitations/Specifications*:||Ethylene-butene copolymers may contain up to 34 weight percent polymer units derived from 1-butene, and have a density of not less than 0.86 g/cm3 and melt flow rate (190oC) of no more than 50g/10 min. For use as a component of articles in contact with all food under Conditions of Use B through H, as described in Table 2. Adjuvant substances permitted for use in olefin copolymers complying with 21 CFR 177.1520 (c), item 3.1 may be used in the subject copolymers, provided that the limitations on the use of the adjuvant substances are met.|
|Effective Date:||Jun 4, 2008|
|National Environmental Policy Act (NEPA)** Submission:||Categorical Exclusion 25.32(j) and Environmental Assessment (436 kB)|
|FDA Decision:||Categorical Exclusion Memo/Finding of No Significant Impact (FONSI)|