世卫标准美国FDA的食品添加剂使用卫生标准docx.docx

世卫标准美国FDA的食品添加剂使用卫生标准docx.docx

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世卫标准美国FDA的食品添加剂使用卫生标准docx

[CodeofFederalRegulations]

[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