美国FDA的食品添加剂使用卫生标准

[CodeofFederalRegulations][Title21,Volume3][RevisedasofApril1,2006][CITE:21CFR171]TITLE21--FOODANDDRUGSCHAPTERI--FOODANDDRUGADMINISTRATIONDEPARTMENTOFHEALTHANDHUMANSERVICESSUBCHAPTERB--FOODFORHUMANCONSUMPTION(CONTINUED)PART171FOODADDITIVEPETITIONSSubpartA--GeneralProvisionsSec.171.1Petitions.(a)PetitionstobefiledwiththeCommissionerundertheprovisionsofsection409(b)oftheFederalFood,Drug,andCosmeticAct(theact)shallbesubmittedintriplicate(quadruplicate,ifintendedusesincludeuseinmeat,meatfoodproduct,orpoultryproduct).Ifanypartofthematerialsubmittedisinaforeignlanguage,itshallbeaccompaniedbyanaccurateandcompleteEnglishtranslation.Thepetitionshallstatepetitioner'spostofficeaddresstowhichpublishednoticesorordersissuedorobjectionsfiledpursuanttosection409oftheActmaybesent.(b)Pertinentinformationmaybeincorporatedin,andwillbeconsideredaspartof,apetitiononthebasisofspecificreferencetosuchinformationsubmittedtoandretainedinthefilesoftheFoodandDrugAdministration.However,anyreferencetounpublishedinformationfurnishedbyapersonotherthantheapplicantwillnotbeconsideredunlessuseofsuchinformationisauthorizedinawrittenstatementsignedbythepersonwhosubmittedit.Anyreferencetopublishedinformationofferedinsupportofafoodadditivepetitionshouldbeaccompaniedbyreprintsorphotostaticcopiesofsuchreferences.(c)Petitionsshallincludethefollowingdataandbesubmittedinthefollowingform:(Date)NameofpetitionerPost-officeaddressDateNameoffoodadditiveandproposeduse______________________________________________________________PetitionsControlBranchFoodandDrugAdministrationDepartmentofHealthandHumanServicesWashington,DC20204.DearSirs:Theundersigned,_____submitsthispetitionpursuanttosection409(b)(1)oftheFederalFood,Drug,andCosmeticActwithrespectto_____(Nameofthefoodadditiveandproposeduse)Attachedhereto,intriplicate(quadruplicate,ifintendedusesincludeuseinmeat,meatfoodproduct,orpoultryproduct),andconstitutingapartofthispetitionarethefollowing:A.Thenameandallpertinentinformationconcerningthefoodadditive,includingchemicalidentityandcompositionofthefoodadditive,itsphysical,chemical,andbiologicalproperties,andspecificationsprescribingtheminimumcontentofthedesiredcomponent(s)andidentifyingandlimitingthereactionbyproductsandotherimpurities.Wheresuchinformationisnotavailable,astatementastothereasonswhyitisnotshouldbesubmitted.Whenthechemicalidentityandcompositionofthefoodadditiveisnotknown,thepetitionshallcontaininformationinsufficientdetailtopermitevaluationregardingthemethodofmanufactureandtheanalyticalcontrolsusedduringthevariousstagesofmanufacturing,processing,orpackingofthefoodadditivewhicharereliedupontoestablishthatitisasubstanceofreproduciblecomposition.Alternativemethodsandcontrolsandvariationsinmethodsandcontrolswithinreasonablelimitsthatdonotaffectthecharacteristicsofthesubstanceorthereliabilityofthecontrolsmaybespecified.Ifthefoodadditiveisamixtureofchemicals,thepetitionshallsupplyalistofallsubstancesusedinthesynthesis,extraction,orothermethodofpreparation,regardlessofwhethertheyundergochemicalchangeintheprocess.EachsubstanceshouldbeidentifiedbyitscommonEnglishnameandcompletechemicalname,usingstructuralformulaswhennecessaryforspecificidentification.Ifanyproprietarypreparationisusedasacomponent,theproprietarynameshouldbefollowedbyacompletequantitativestatementofcomposition.Reasonablealternativesforanylistedsubstancemaybespecified.Ifthepetitionerdoesnothimselfperformallthemanufacturing,processing,andpackingoperationsforafoodadditive,thepetitionshallidentifyeachpersonwhowillperformapartofsuchoperationsanddesignatethepart.Thepetitionshallincludestabilitydata,and,ifthedataindicatethatitisneededtoinsuretheidentity,strength,quality,orpurityoftheadditive,theexpirationdatethatwillbeemployed.B.Theamountofthefoodadditiveproposedforuseandthepurposesforwhichitisproposed,togetherwithalldirections,recommendations,andsuggestionsregardingtheproposeduse,aswellasspecimensofthelabelingproposedforthefoodadditiveandanylabelingthatwillberequiredbyapplicableprovisionsoftheFederalFood,Drug,andCosmeticActonthefinishedfoodbyreasonoftheuseofthefoodadditive.Iftheadditiveresultsormayreasonablybeexpectedtoresultfromtheuseofpackagingmaterial,thepetitionershallshowhowthismayoccurandwhatresiduesmayreasonablybeanticipated.(Typewrittenorotherdraft-labelingcopywillbeacceptedforconsiderationofthepetition,providedastatementismadethatfinalprintedlabelingidenticalincontenttothedraftcopywillbesubmittedassoonasavailableandpriortothemarketingofthefoodadditive.)(Ifthefoodadditiveisoneforwhichatolerancelimitationisrequiredtoassureitssafety,thelevelofuseproposedshouldbenohigherthantheamountreasonablyrequiredtoaccomplishtheintendedphysicalorothertechnicaleffect,eventhoughthesafetydatamaysupportahighertolerance.)C.Dataestablishingthatthefoodadditivewillhavetheintendedphysicalorothertechnicaleffectorthatitmayreasonablybeexpectedtobecomeacomponent,ortoaffectthecharacteristics,directlyorindirectly,offoodandtheamountnecessarytoaccomplishthis.Thesedatashouldincludeinformationinsufficientdetailtopermitevalu