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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. 801

 
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Food Contact Substance:  Peroxyacetic acid (CAS Reg. No. 79-21-0), solution containing 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4).
 
Notifier:  FMC Corporation
 
Manufacturer:  FMC Corporation
 
Intended Use:  The FCS will be used to treat food-contact surfaces of plastic containers and their enclosures to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR Part 113 or as an antimicrobial on packaging for any acidic food. The peroxyacetic acid PAA solutions will contain equilibrium concentrations of peroxyacetic acid, hydrogen peroxide (CAS Reg. No. 7722-84-l), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and water.
 
Effective Date:  05/01/2008
 
Limitations/Specifications:  The targeted PAA concentration for treatment solutions applied to containers/closures is 4000 ppm or less. Treatment solution need not be rinsed from container/closure surfaces prior to introduction of food provided that the maximum application rate in terms of milliliters of treatment solution per ounce of container capacity does not exceed the value determined by dividing the PAA concentration of the treatment solution (expressed in parts per million) into an empirically determined constant value of 70 and no recycle of PAA or more concentrated makeup to the feed tank is allowed. If treatment solution is applied at a rate exceeding the amount determined by dividing the PAA concentration of the treatment solution (expressed in parts per million) into an empirically determined constant value of 70, or if PAA solution with a concentration of greater than 4000 ppm PAA is added to the treatment solution reservoir as makeup, treatment solution must be drained from the container surface and rinsed with sufficient water to achieve a theoretical 60-fold dilution of the treatment solution residue (assumed to be 1 mg/cm2, on the interior container surface following draining).
 
Environmental Impact Decisions:  Environmental Decisions Site
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