文档介绍：该【世卫标准美国FDA食品添加剂使用卫生标准】是由【泰山小桥流水】上传分享，文档一共【10】页，该文档可以免费在线阅读，需要了解更多关于【世卫标准美国FDA食品添加剂使用卫生标准】的内容，可以使用淘豆网的站内搜索功能，选择自己适合的文档，以下文字是截取该文章内的部分文字，如需要获得完整电子版，请下载此文档到您的设备，方便您编辑和打印。[CodeofFederalRegulations]
[Title21,Volume3]
[RevisedasofApril1,2006]
[CITE:21CFR171]
TITLE21--FOODANDDRUGS
CHAPTERI--FOODANDDRUGADMINISTRATION
DEPARTMENTOFHEALTHANDHUMANSERVICES
SUBCHAPTERB--FOODFORHUMANCONSUMPTION(CONTINUED)PART171FOODADDITIVEPETITIONS
SubpartA--GeneralProvisions
.
PetitionstobefiledwiththeCommissionerundertheprovisionsofsection409(b)oftheFederalFood,Drug,andCosmeticAct(theact)shallbesubmittedintriplicate
(quadruplicate,ifintendedusesincludeuseinmeat,meatfoodproduct,orpoultryproduct).Ifanypartofthematerialsubmittedisinaforeignlanguage,'spostofficeaddresstowhichpublishednoticesorordersissuedorobjectionsfiledpursuanttosection409oftheActmaybesent.
Pertinentinformationmaybeincorporatedin,andwillbeconsideredaspartof,,anyreferencetounpublishedinformationfurnishedbyapersonotherthantheapplicantwillnotbeconsideredunlessuseofsuchinformationisauthorizedinawrittenstatementsignedbythepersonwho
.
Petitionsshallincludethefollowingdataandbesubmittedinthefollowingform:(Date)
NameofpetitionerPost-officeaddressDate
Nameoffoodadditiveandproposeduse
______________________________________________________________
PetitionsControlBranch
FoodandDrugAdministration
DepartmentofHealthandHumanServices
Washington,DC20204.
DearSirs:
Theundersigned,_____submitsthispetitionpursuanttosection409(b)(1)oftheFederal
Food,Drug,andCosmeticActwithrespectto_____
(Nameofthefoodadditiveandproposeduse)
Attachedhereto,intriplicate(quadruplicate,ifintendedusesincludeuseinmeat,meatfoodproduct,orpoultryproduct),andconstitutingapartofthispetitionarethefollowing:
,includingchemicalidentityandcompositionofthefoodadditive,itsphysical,chemical,andbiologicalproperties,andspecificationsprescribingtheminimumcontentofthedesiredcomponent(s),astatementastothereasonswhyitisnotshouldbesubmitted.
Whenthechemicalidentityandcompositionofthefoodadditiveisnotknown,thepetitionshallcontaininformationinsufficientdetailtopermitevaluationregardingthemethodofmanufactureandtheanalyticalcontrolsusedduringthevariousstagesofmanufacturing,processing,.
Ifthefoodadditiveisamixtureofchemicals,thepetitionshallsupplyalistofallsubstancesusedinthesynthesis,extraction,orothermethodofpreparation,,,.
Ifthepetitionerdoesnothimselfperformallthemanufacturing,processing,andpackingoperationsforafoodadditive,thepetitionshallidentifyeachpersonwhowillperformapartofsuchoperationsanddesignatethepart.
Thepetitionshallincludestabilitydata,and,ifthedataindicatethatitisneededtoinsuretheidentity,strength,quality,orpurityoftheadditive,theexpirationdatethatwillbeemployed.
,togetherwithalldirections,recommendations,andsuggestionsregardingtheproposeduse,aswellasspecimensofthelabelingproposedforthefoodadditiveandanylabelingthatwillberequiredbyapplicableprovisionsoftheFederalFood,Drug,,thepetitionershallshowhowthismayoccurandwhatresiduesmayreasonablybeanticipated.
(Typewrittenorotherdraft-labelingcopywillbeacceptedforconsiderationofthepetition,providedastatementismadethatfinalprintedlabelingidenticalincontenttothedraftcopywillbesubmittedassoonasavailableandpriortothemarketingofthefoodadditive.)
(Ifthefoodadditiveisoneforwhichatolerancelimitationisrequiredtoassureitssafety,thelevelofuseproposedshouldbenohigherthantheamountreasonablyrequiredtoaccomplishtheintendedphysicalorothertechnicaleffect,eventhoughthesafetydatamaysupportahighertolerance.)
,ortoaffectthecharacteristics,directlyorindirectly,.
,processed,and/-controlpurposesandthatcanbeappliedwithconsistentresultsbyanyproperlyequippedandtrainedlaboratorypersonnel.
.
(
.)
,.
(c)(1)(A)oftheAct,.

.
Yoursverytruly,
Petitioner
By
(Indicateauthority)
Thepetitionerwillbenotifiedofthedateonwhichhispetitionisfiled;andanincompletepetition,oronethathasnotbeensubmittedintriplicate,.
Thepetitionmustbesignedbythepetitionerorbyhisattorneyoragent,or(ifacorporation)byanauthorizedofficial.
Thedataspecifiedundertheseveralletteredheadingsshouldbesubmittedonseparatesheetsorsetsofsheets,
anearlierapplication,,thepetitionermayrefertothemasterfileifandtotheextentheobtainsthemanufacturer'.
Apetitionshallberetainedbutshallnotbefiledifanyofthedataprescribedbysection409(b)oftheActarelackingorarenotsetforthsoastobereadilyunderstood.
(h)(1)Thefollowingdataandinformationinafoodadditivepetitionareavailableforpublicdisclosure,unlessextraordinarycircumstancesareshown,afterthenoticeoffiling
ofthepetitionispublishedintheFederalRegisteror,ifthepetitionisnotpromptlyfiledbecauseofdeficienciesinit,afterthepetitionerisinformedthatitwillnotbefiledbecauseofthedeficienciesinvolved:
Allsafetyandfunctionalitydataandinformationsubmittedwithorincorporatedbyreferenceinthepetition.
Aprotocolforatestorstudy,.
Adversereactionreports,productexperiencereports,consumercomplaints,andothersimilardataandinformation,afterdeletionof:
Namesandanyinformationthatwouldidentifythepersonusingtheproduct.
Namesandanyinformationthatwouldidentifyanythirdpartyinvolvedwiththereport,suchasaphysicianorhospitalorotherinstitution.
Alistofallingredientscontainedinafoodadditive,,andanotationshallbemadethatanysuchingredientlistisincomplete.
Anassaymethodorotheranalyticalmethod,.
Thefollowingdataandinformationinafoodadditivepetitionarenotavailableforpublicdisclosureunlesstheyhavebeenpreviouslydisclosedtothepublicasdefinedin
:
Manufacturingmethodsorprocesses,includingqualitycontrolprocedures.
Production,sales,distribution,andsimilardataandinformation,exceptthatany
compilationofsuchdataandinformationaggregatedandpreparedinawaythatdoesnotrevealdataorinformationwhichisnotavailableforpublicdisclosureunderthisprovisionisavailableforpublicdisclosure.
(iii)Quantitativeorsemiquantitativeformulas.
Allcorrespondenceandwrittensummariesoforaldiscussionsrelatingtoafood
additivepetitionareavailableforpublicdisclosureinaccordancewiththeprovisionsof
part20ofthischapterwhenthefoodadditiveregulationispublishedintheFederalRegister.
Forpurposesofthisregulation,safetyandfunctionalitydataincludeallstudiesandtestsofafoodadditiveonanimalsandhumansandallstudiesandtestsonafoodadditiveforidentity,stability,purity,potency,performance,andusefulness.
(i)(1)(i)Within15daysafterreceipt,theFoodandDrugAdministrationwillnotifythepetitioneroftheacceptanceornonacceptanceofapetition,andifnotaccepted,,thepetitionerwillbesentaletterstatingthisandthedateofthelettershallbecomethedateoffilingforthepurposesofsection409(b)(5)(FoodContactNotification(FCN))submittedundersection409(h)oftheactmaybeconvertedtoapetition,thewithdrawaldatefortheFCNwillbedeemedthedateofreceiptforthepetition.
Ifthepetitionerdesires,,,thepetitionshallbefiledandthepetitionersonotified.
Notwithstandingparagraph(i)(1)(ii)ofthissection,thepetitionshallnotbefiledif
theFoodandDrugAdministrationdeterminesthattheuseidentifiedinthepetitionshouldbethesubjectofanFCNundersection409(h)oftheactratherthanapetition.
TheCommissionerwillpublishintheFederalRegisterwithin30daysfromthedateoffilingofsuchpetition,anoticeofthefiling,thenameofthepetitioner,,thenoticeshallincludethenameofthemigratorysubstance,andwhereitisdifferentfromthatofoneoftheoriginalcomponents,thenameoftheparentcomponent,themaximumquantityofthemigratorysubstancethatisproposedforuseinfood,andthephysicalorothertechnicaleffect
whichthemigratorysubstanceoritsparentcom