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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. 911

Ecolab, 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: 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 by weight), dimethyl succinate (up to 0.8 percent by weight), dimethyl adipate (68-76 percent by weight) and dimethyl glutarate (4-12 percent by weight).
Notifier: Ecolab, Inc.
Manufacturer: Ecolab, Inc.
Intended Use: As an antimicrobial additive that may be used alone or in combination with other processes in the commercial sterilization of polyethylene terephthalate bottles and polypropylene/polystyrene caps prior to filling.
Limitations/Specifications*: 1) The composition of the food-contact substance mixture will not exceed 6597 parts per million (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 solution may be applied to polyethylene terephthalate bottles and polypropylene/polystyrene cap packaging materials that are subsequently drained, rinsed with disinfected or sterile water, and drained again. 3) The sterilized packaging materials are limited to contact with the foods described in Title 21 CFR 170.3(n)(10), (31) and (33).
Effective Date: Oct 7, 2009
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.60 MB)
FDA Decision: Finding of No Significant Impact (FONSI)
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