FDA 21CFR Part110

FDA 21CFR Part110

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时间:2019-08-04

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1、Title21,Volume2][RevisedasofApril1,2011][CITE:21CFR110]TITLE21--FOODANDDRUGSCHAPTERI--FOODANDDRUGADMINISTRATIONDEPARTMENTOFHEALTHANDHUMANSERVICESSUBCHAPTERB--FOODFORHUMANCONSUMPTION PART110CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PACKING,ORHOLDI

2、NGHUMANFOOD SubpartA--GeneralProvisionsSec.110.3Definitions.Thedefinitionsandinterpretationsoftermsinsection201oftheFederalFood,Drug,andCosmeticAct(theact)areapplicabletosuchtermswhenusedinthispart.Thefollowingdefinitionsshallalsoapply:(a)Acidfoodsorac

3、idifiedfoodsmeansfoodsthathaveanequilibriumpHof4.6orbelow.(b)Adequatemeansthatwhichisneededtoaccomplishtheintendedpurposeinkeepingwithgoodpublichealthpractice.(c)Battermeansasemifluidsubstance,usuallycomposedofflourandotheringredients,intowhichprincipa

4、lcomponentsoffoodaredippedorwithwhichtheyarecoated,orwhichmaybeuseddirectlytoformbakeryfoods.(d)Blanching,exceptfortreenutsandpeanuts,meansaprepackagingheattreatmentoffoodstuffsforasufficienttimeandatasufficienttemperaturetopartiallyorcompletelyinactiv

5、atethenaturallyoccurringenzymesandtoeffectotherphysicalorbiochemicalchangesinthefood.(e)Criticalcontrolpointmeansapointinafoodprocesswherethereisahighprobabilitythatimpropercontrolmaycause,allow,orcontributetoahazardortofilthinthefinalfoodordecompositi

6、onofthefinalfood.(f)Foodmeansfoodasdefinedinsection201(f)oftheactandincludesrawmaterialsandingredients.(g)Food-contactsurfacesarethosesurfacesthatcontacthumanfoodandthosesurfacesfromwhichdrainageontothefoodorontosurfacesthatcontactthefoodordinarilyoccu

7、rsduringthenormalcourseofoperations."Food-contactsurfaces"includesutensilsandfood-contactsurfacesofequipment.(h)Lotmeansthefoodproducedduringaperiodoftimeindicatedbyaspecificcode.(i)Microorganismsmeansyeasts,molds,bacteria,andvirusesandincludes,butisno

8、tlimitedto,specieshavingpublichealthsignificance.Theterm"undesirablemicroorganisms"includesthosemicroorganismsthatareofpublichealthsignificance,thatsubjectfoodtodecomposition,thatindicatethatfoodiscontaminatedwithfilth,orthatotherwisema

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