美国食品法上“公认安全”物质之认定标准

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1、上海交通大学硕士学位论文摘要细则中对“在食品中普遍使用”的地理限制，并将改后的规则保留至今；反映了国会、法院、行政机关对第201条（s）款理解的差异，以及法院在消除差异中的关键角色。国家标准和企业标准都是技术标准，“公认安全”法律标准是二者之间的界限。“公认安全”认定标准是该法律标准的构成要素。“公认安全”法律标准对审查我国的食品添加剂企业标准、合理划分国家标准与企业标准之间的界限具有借鉴意义。关键词：公认安全，食品添加剂，企业标准2万方数据上海交通大学硕士学位论文ABSTRACTTHENORMSFORGRASSUBSTANCEIN THEUSFOODLAWABSTRACTIna

2、ccordancewiththeFoodSafetyLaw,Chinawillsolelyestablishnationalstandardsfortheproductionoffoodadditives,whichprobablyresultsintheaverageuseoftheresourceofadministrationsupervision,thelackoftheinvestintheimportantfieldsoffoodsafety,andeventhebarrierforrapiddevelopmentofthefoodindustry.Therefore

3、,thefilingofenterprisestandardsforfoodadditivescouldbeimprovedbyreferencetoforeignexperience.IntheU.S.,“generallyrecognizedassafe”(GRAS)isalegalregimeoffoodsafetyprovidedin21U.S.C.§321(s),alegalstandardandakindoffood.TheGRASconceptcomesfromtheexceptionfromthefoodadditivedefinition.Ifanenterpr

4、iseshowsaparticularuseofanaddingfoodingredientisgenerallyrecognizedbyqualifiedexpertsassafe,theingredientconstitutestheGRASsubstance,whichcanbemarketedwithoutthe“nationalstandards”setbythegovernment.Generalrecognitionofsafetybyexpertsmaybebasedonscientificproceduresorexperiencebasedon1万方数据上海交

5、通大学硕士学位论文ABSTRACTcommonuseinfood.Thenotificationprocedurestartedin1997leadstotheoverexpansionoftheGRASsubstanceandseriouslyreducestheimplementationofthelegalnormsoffoodadditive.TheCocoRicocasecompliedinall-aroundmannerwiththenormsofdecidingGRASinprecedents,andinterpretedbythesenormstheGRASdou

6、ble-layerdeterminationstructureof21U.S.C.§321(s).TheFmalicaseanalyzedthelegislativeintentsof21U.S.C.§321(s)andpointedoutthatthecoreoftheGRASnormsisgeneralrecognitionofsafetybyexperts.Onthisground,thecourtreviewedtheFDA’sregulationof21U.S.C.§321(s)andheldthatthisregulationwasinvalid.Thiscasedi

7、rectlyledtotheFDAtoabolishthegeographicallimitto“commonuseinfood”inregulationsandthismodifiedruleretainssofar.ThiscasealsoreflectsthedifferentunderstandingoftheCongress,thecourtandtheagencyabout21U.S.C.§321(s),andthekeyrolethecourtplaysinelim