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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. 793

ISOCHEM SA/Borealis Polyolefine GmbH

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: 1,5-Pentanedicarboxylic acid, calcium salt (CAS Reg. No. 19455-79-9).
Notifier: Borealis Polyolefine GmbH
Manufacturer: ISOCHEM SA/Borealis Polyolefine GmbH
Intended Use: The FCS will be used as a nucleating agent in the manufacture of polypropylene food-contact articles.
Limitations/Specifications*: The FCS will be used in the manufacture of single and repeat-use food contact articles at levels not to exceed 0.15 percent by weight of the finished food-contact article, in contact with all food types, and under Conditions of use A through H, as described in Table 2.
Effective Date: Apr 1, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo