欧盟-NO618-1新型食品和新型食品配料和编制的初步评估报告根据法规

COMMISSIONRECOMMENDATIONof29July1997concerningthescientificaspectsandthepresentationofinformationnecessarytosupportapplicationsfortheplacingonthemarketofnovelfoodsandnovelfoodingredientsandthepreparationofinitialassessmentreportsunderRegulation(EC)No258/97oftheEuropeanParliamentandoftheCouncil(TextwithEEArelevance)(97/618/EC)THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanCommunity,HavingregardtoRegulation(EC)No258/97oftheEuropeanParliamentandoftheCouncilof27January1997concerningnovelfoodsandnovelfoodingredients(1),andinparticularArticle4(4)thereof,Whereas,inordertoprotectpublichealth,itisnecessarythatnovelfoodsandnovelfoodingredientsaresubjecttoasinglesafetyassessmentthroughaCommunityprocedurebeforetheyareplacedonthemarketwithintheCommunity;Whereasrecommendationsconcerningthescientificaspectsoftheinformationnecessarytosupportanapplicationfortheplacingonthemarketofanovelfoodoranovelfoodingredientwillfacilitatethetaskofeconomicoperatorsinpreparingsuchanapplication;whereasrecommendationsconcerningthepresentationofsuchinformationandconcerningthepreparationofinitialassessmentreportsbythecompetentfoodassessmentbodiesoftheMemberStateswillfacilitatetheevaluationofsuchapplications;WhereastheScientificCommitteeforFoodhasmaderecommendationsontheinformationnecessarytosupportsuchapplications,thepresentationofthatinformationandthepreparationofinitialassessmentreportsonthoseapplications;Whereasexperienceintheassessmentofnovelfoodsandnovelfoodingredientsisatpresentlimited;whereasthereforeanyrecommendationsinthisareamustbekeptunderconstantreviewtotakeaccountofnewscientificinformationandtheworkoftherelevantinternationalorganizations;WhereastheMemberStateshavebeenconsultedonthisRecommendationwithintheframeworkoftheStandingCommitteeforFoodstuffs,HEREBYRECOMMENDSTHAT:1.Whenpreparingapplicationsfortheplacingonthemarketofnovelfoodsandnovelfoodingredients,economicoperatorsshouldfollowtherecommendationsconcerningthescientificaspectsoftheinformationnecessarytosupportsuchapplicationssetoutintheAnnex,PartI.附錄Part1，當準備進軍NF、NF成分到市場，經濟經營者(企業)應遵循科學方面提供必要的資料，以支持這些應用2.Economicoperatorsshouldensurethattheinformationnecessarytosupportapplicationsreferredtoinpoint1ispresentedinaccordancewiththerecommendationssetoutintheAnnex,PartII.附錄Part2，說明依第一點，企業要保證支持申請文件的資料3.MemberStatesshouldensurethattheinitialassessmentreportsdrawnupbytheircompetentfoodassessmentbodiespursuanttoArticle6(2)ofRegulation(EC)No258/97arepreparedinaccordancewiththerecommendationssetoutintheAnnex,PartIII.附錄Part3，會員國的主管單位依Article6(2)ofRegulation(EC)No258/97來要求各項最初的評估報告。DoneatBrussels,29July1997.FortheCommissionMartinBANGEMANNMemberoftheCommission(1)OJL43,14.2.1997,p.1.ANNEX附件PARTIRECOMMENDATIONSCONCERNINGTHESCIENTIFICASPECTSOFINFORMATIONNECESSARYTOSUPPORTAPPLICATIONSFORTHEPLACINGONTHEMARKETOFNOVELFOODSANDNOVELFOODINGREDIENTS附錄Part1，關於支持新食物及其成份的市場所需的科學資料建議。TABLEOFCONTENTSPage1.Introduction.42.CategoriesofnovelfoodsandnovelfoodingredientsidentifiedinRegulation(EC)No258/97.4依法規No258/97，定義NF及NF成分的分類3.Keyissuesfortheassessmentofnovelfoodsandnovelfoodingredients(NF).5評估新型食品和新型食品配料（NF）的關鍵問題3.1Generalconsiderations.5一般狀況3.2Geneticallymodifiedorganisms(GMO).5基因生物3.3Substantialequivalence.5實質等同3.4Compositionalanalysis.6成分分析3.5Intake.6吸收3.6Nutritionalconsiderationsaffectingtoxicologicaltestinginanimals.6動物毒性測試後的營養效應3.7Toxicologicalrequirements.7毒性要求3.8ImplicationsofNFtohumannutrition.7關於NF對人體營養的含意3.9Novelmicroorganismsusedinfood.7新型微生物在食物上的使用3.10Allergenicpotential.8過敏的可能3.11Assessmentofmarkergenes.8標記基因的評估4.Scientificclassificationofnovelfoodsfortheassessmentofwholesomeness.9科學對新型食品衛生評價的分類Class1:Purechemicalsorsimplemixturesfromnon-GMsources.9(非基因)物來源的純化學物或簡單的混何物Class2:ComplexNFfromnon-GMsources.9(非基因)物來源的NF複合物Class3:GMplantsandtheirproducts.9基因植物與其產品Class4:GManimalsandtheirproducts.10基因動物與其產品Class5:GMmicroorganismsandtheirproducts.10基因微生物及其產品Class6:Foodsproducedusinganovelprocess.10因新流程產生的食物5.Identificationofessentialinformationforassessmentofwholesomeness.10評估衛生健康資料的定義I.SpecificationoftheNF.11NF的規格II.EffectoftheproductionprocessappliedtotheNF.11生產流程應用在NF上的效應III.HistoryoftheorganismusedasthesourceoftheNF.11生物使用在NF的歷史IV.Effectofthegeneticmodificationonthepropertiesofthehostorganism.12基因改造的主機(母體)機體對性能的影響V.GeneticstabilityoftheGMOusedasNFsource.13基因生物用於NF的基因穩定性VI.Specificityofexpressionofnovelgeneticmaterial.13新遺傳物質的特殊性VII.TransferofgeneticmaterialfromGMO.13從基因物改良其基因體PageVIII.AbilityoftheGMMtosurviveinandcolonizethehumangut.13基因物生存在人體腸道的能力IX.Anticipatedintake/extentofuseoftheNF.13預期NF的攝入量/程度上使用X.InformationfromprevioushumanexposuretotheNForitssource.13以前人類接觸NF或其來源的資料XI.NutritionalinformationontheNF.14NF的營養資料XII.MicrobiologicalinformationontheNF.14NF的微生物資料XIII.ToxicologicalinformationontheNF.14NF的毒性資料6.Reviewofrecommendations.15審查建議7.References.15參考資料8.Glossary.16術語TableI:AssociationbetweenthecategorizationintheCommunityRegulationonNovelFoodsandNovelFoodIngredientsandtheSCFrecommendations.17TableII:IndextostructuredschemestobefollowedforeachclassofNF.18S