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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. 670

Ecolab, Incorporated

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 peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidine-1,1-diphosphonic acid, with or without an optional adjuvant system composed of a mixture dimethyl sebacate (up to 20 percent), dimethyl succinate (up to 0.8 percent), dimethyl adipate (68-76 percent) and dimethyl glutarate (4-12 percent).
Notifier: Ecolab, Incorporated
Manufacturer: Ecolab, Incorporated
Intended Use: As an antimicrobial additive that may be used alone or in combination with other processes in the commercial sterilization of polyethylene terephthalate and high density polyethylene food packaging prior to filling.
Limitations/Specifications*: 1. The composition of the food-contact substance mixture will not exceed 1 percent (by weight) 1-hydroxyethylidine-1,1-diphosphonic acid with or without 1500 parts per million (by weight) of the sum components of the adjuvant solution. 2. The surfaces of the polyethylene terephthalate and high density polyethylene packaging will be drained, rinsed, and drained again following the application of the food-contact substance mixture. 3. Packaging treated with the food-contact substance mixture is limited to contact with low acid foods as defined in 21 CFR 113.3(n) and described in 21 CFR 170.3(n)(3),(7),(l0),(31),(33), and (35).
Effective Date: Jan 30, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.15 MB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement