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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. 2006

DeLaval 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: An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), sulfuric acid (SA) (CAS reg. No. 7664-93-9), and 1-hydroxyethylidine-1,1- diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4).
Notifier: DeLaval Inc.
Manufacturer/Supplier: DeLaval Inc.
Intended Use: The FCS will be used as an antimicrobial agent for the commercial sterilization of aseptic, polymeric food packaging prior to filling, except for use of food packaging used in contact with infant formula or human milk. (see Limitations/Specifications).
Limitations/Specifications: The FCS may be applied as a spray only in the following applications:
  1. The FCS may be applied to polymeric bottles and closures without a rinse prior to filling with food and on the exterior of sealed polymeric food packaging without a rinse. The maximum at-use concentration of PAA, HP, and HEDP may not exceed 508 ppm, 2700 ppm, and 61 ppm, respectively.
  2. The FCS may be applied to polymeric containers and closures, drained, and the interior rinsed with potable water. The maximum at-use concentration of PAA, HP, and HEDP may not exceed 2030 ppm, 10,802 ppm, and 244 ppm, respectively.
  3. The FCS is not intended to be used on food packaging used in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Oct 23, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 224 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 135 kB)

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