美国FDA的食品添加剂使用卫生标准Word格式.docx

美国FDA的食品添加剂使用卫生标准Word格式.docx

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21CFR171]

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION

DEPARTMENTOFHEALTHANDHUMANSERVICES

SUBCHAPTERB--FOODFORHUMANCONSUMPTION（CONTINUED）PART171FOODADDITIVEPETITIONS

SubpartA--GeneralProvisions

Sec.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）

Nameofpetitioner

Post-officeaddress

Date

Nameoffoodadditiveandproposeduse

______________________________________________________________

PetitionsControlBranch

FoodandDrugAdministration

DepartmentofHealthandHumanServices

Washington,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.Thesedatashouldincludeinformationinsufficientdetailtopermitevaluationwithcontroldata.

D.Adescriptionofpracticablemethodstodeterminetheamountofthefoodadditiveintheraw,processed,and/orfinishedfoodandofanysubstanceformedinoronsuchfoodbecauseofitsuse.Thetestproposedshallbeonethatcanbeusedforfood-controlpurposesandthatcanbeappliedwithconsistentresultsbyanyproperlyequippedandtrainedlaboratorypersonnel.

E.Fullreportsofinvestigationsmadewithrespecttothesafetyofthefoodadditive.

（Apetitionmayberegardedasincompleteunlessitincludesfullreportsofadequatetestsreasonablyapplicabletoshowwhetherornotthefoodadditivewillbesafeforitsintendeduse.Thereportsordinarilyshouldincludedetaileddataderivedfromappropriateanimalandotherbiologicalexperimentsinwhichthemethodsusedandtheresultsobtainedareclearlysetforth.Thepetitionshallnotomitwithoutexplanationanyreportsofinvestigationsthatwouldbiasanevaluationofthesafetyofthefoodadditive.）

F.Proposedtolerancesforthefoodadditive,iftolerancesarerequiredinordertoinsureitssafety.Apetitionermayincludeaproposedregulation.

G.Ifsubmittingpetitiontomodifyanexistingregulationissuedpursuanttosection409（c）

（1）（A）oftheAct,fullinformationoneachproposedchangethatistobemadeintheoriginalregulationmustbesubmitted.Thepetitionmayomitstatementsmadeintheoriginalpetitionconcerningwhichnochangeisproposed.Asupplementalpetitionmustbesubmittedforanychangebeyondthevariationsprovidedforintheoriginalpetitionandtheregulationissuedonthebasisoftheoriginalpetition.

H.Thepetitionerisrequiredtosubmiteitheraclaimforcategoricalexclusionunder25.30or25.32ofthischapteroranenvironmentalassessmentunder25.40ofthischapter.

Yoursverytruly,

Petitioner

By

（Indicateauthority）

（d）Thepetitionerwillbenotifiedofthedateonwhichhispetitionisfiled;

andanincompletepetition,oronethathasnotbeensubmittedintriplicate,willusuallyberetainedbutnotfiledasapetitionundersection409oftheAct.Thepetitionerwillbenotifiedinwhatrespectshispetitionisincomplete.

（e）Thepetitionmustbesignedbythepetitionerorbyhisattorneyoragent,or（ifacorporation）byanauthorizedofficial.

（f）Thedataspecifiedundertheseveralletteredheadingsshouldbesubmittedonseparatesheetsorsetsofsheets,suitablyidentified.Ifsuchdatahavealreadybeensubmittedwithanearlierapplication,thepresentpetitionmayincorporateitbyspecificreferencetotheearlier.Ifpartofthedatahavebeensubmittedbythemanufacturerofthefoodadditiveasamasterfile,thepetitionermayrefertothemasterfileifandtotheextentheobtainsthemanufacturer'

swrittenpermissiontodoso.Themanufacturermayauthorizespecificreferencetothedatawithoutdisclosuretothepetitioner.Nothinghereinshallpreventreferencetopublisheddata.

（g）Apetitionshallberetainedbutshallnotbefiledifanyofthedataprescribedbysection409（b）oftheActarelackingorarenotsetforthsoastobereadilyunderstood.

（h）

（1）Thefollowingdataandinformationinafoodadditivepetitionareavailableforpublicdisclosure,unlessextraordinarycircumstancesareshown,afterthenoticeoffilingofthepetitionispublishedintheFederalRegisteror,ifthepetitionisnotpromptlyfiledbecauseofdeficienciesinit,afterthepetitionerisinformedthatitwillnotbefiledbecauseofthedeficienciesinvolved:

（i）Allsafetyandfunctionalitydataandinformationsubmittedwithorincorporatedbyreferenceinthepetition.

（ii）Aprotocolforatestorstudy,unlessitisshowntofallwithintheexemptionestablishedfortradesecretsandconfidentialcommercialinformationin20.61ofthischapter.

（iii）Adversereactionreports,productexperiencereports,consumercomplaints,andothersimilardata