21/1/2015 CFR - Code of Federal Regulations Title 21

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CFRCodeofFederalRegulationsTitle21
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[CodeofFederalRegulations]
[Title21,Volume2]
[RevisedasofApril1,2014]
[CITE:21CFR110.110]

TITLE21FOODANDDRUGS
CHAPTERIFOODANDDRUGADMINISTRATION
DEPARTMENTOFHEALTHANDHUMANSERVICES
SUBCHAPTERBFOODFORHUMANCONSUMPTION
PART110CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,
PACKING,ORHOLDINGHUMANFOOD
SubpartGDefectActionLevels
Sec.110.110Naturalorunavoidabledefectsinfoodforhumanusethat
presentnohealthhazard.

(a)Somefoods,evenwhenproducedundercurrentgoodmanufacturing
practice,containnaturalorunavoidabledefectsthatatlowlevelsare
nothazardoustohealth.TheFoodandDrugAdministrationestablishes
maximumlevelsforthesedefectsinfoodsproducedundercurrentgood
manufacturingpracticeandusestheselevelsindecidingwhetherto
recommendregulatoryaction.
(b)Defectactionlevelsareestablishedforfoodswheneveritis
necessaryandfeasibletodoso.Theselevelsaresubjecttochange
uponthedevelopmentofnewtechnologyortheavailabilityofnew
information.
(c)Compliancewithdefectactionlevelsdoesnotexcuseviolationof
therequirementinsection402(a)(4)oftheactthatfoodnotbe
prepared,packed,orheldunderunsanitaryconditionsorthe
requirementsinthispartthatfoodmanufacturers,distributors,and
holdersshallobservecurrentgoodmanufacturingpractice.Evidence
indicatingthatsuchaviolationexistscausesthefoodtobe
adulteratedwithinthemeaningoftheact,eventhoughtheamountsof
naturalorunavoidabledefectsarelowerthanthecurrentlyestablished
defectactionlevels.Themanufacturer,distributor,andholderoffood
shallatalltimesutilizequalitycontroloperationsthatreduce
naturalorunavoidabledefectstothelowestlevelcurrentlyfeasible.
(d)Themixingofafoodcontainingdefectsabovethecurrentdefect
actionlevelwithanotherlotoffoodisnotpermittedandrendersthe
finalfoodadulteratedwithinthemeaningoftheact,regardlessofthe
defectlevelofthefinalfood.
(e)Acompilationofthecurrentdefectactionlevelsfornaturalor
unavoidabledefectsinfoodforhumanusethatpresentnohealthhazard
maybeobtaineduponrequestfromtheCenterforFoodSafetyand
AppliedNutrition(HFS565),FoodandDrugAdministration,5100Paint
BranchPkwy.,CollegePark,MD20740.
[51FR22475,June19,1986,asamendedat61FR14480,Apr.2,1996
66FR56035,Nov.6,2001]
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21/1/2015 CFR - Code of Federal Regulations Title 21

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