世卫标准美国FDA的食品添加剂使用卫生标准docxWord文档格式.docx
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世卫标准美国FDA的食品添加剂使用卫生标准docxWord文档格式.docx
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[Title21,Volume3]
[RevisedasofApril1,2006]
[CITE:
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,anyreferencetounpublishedinformationfurnishedbyapersonotherthantheapplicantwillnotbeconsideredunlessuseofsuchinformationisauthorizedinawrittenstatementsignedbythepersonwho
submittedit.Anyreferencetopublishedinformationofferedinsupportofafoodadditivepetitionshouldbeaccompaniedbyreprintsorphotostaticcopiesofsuchreferences.
(c)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:
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,the
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