欧盟NO6181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.docx
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欧盟NO6181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.docx
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欧盟NO6181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.
FortheCommission
MartinBANGEMANN
MemberoftheCommission
(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。
TABLEOFCONTENTS
Page
1.Introduction.4
2.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.11
NF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
Page
VIII.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.14
NF的營養資料
XII.MicrobiologicalinformationontheNF.14
NF的微生物資料
XIII.ToxicologicalinformationontheNF.14
NF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.17
TableII:
IndextostructuredschemestobefollowedforeachclassofNF.18
SchemesI-XIII.19
I.INTRODUCTION
Wheneverchangesaremadetothewayinwhichafoodisputonthemarket,producedorprocessedorusesnon-traditionalingredients,theimplicationsforconsumersafetyandnutritionalvaluewillrequireconsideration.Informationwillbeneededonanyissuerelatingtoboththeseaspects.Atpresent,theissueoffoodsafetyinrelationtonovelfoodsisunderconsiderationworld-wide.TheWorldHealthOrganization(WHO),theOrganizationforEconomicCooperationandDevelopment(OECD),andothernationalandinternationalbodieshaveaddressedbothgeneralandspecificaspectsrelevanttothewholesomenessofnovelfoods.Anumberofreportsoutlinethephilosophiesanddevelopmentsinthisfield(seereferences).
AspartofthedevelopmentofRegulation(EC)No258/97onNovelFoodsandNovelFoodIngredientstheEuropeanCommissionhasaskedtheScientificCommitteeforFood(SCF)todeveloprecommendationsconcerningthescientificaspectsof
I.theinformationnecessarytosupportanapplicationfortheplacingonthemarketofnovelfoodsandnovelfoodingredients;
II.thepresentationofsuchinformation;
III.thepreparationoftheinitialassessmentreports.
ThisreportcoverstaskI.
2.CATEGORIESOFNOVELFOODSANDNOVELFOODINGREDIENTSIDENTIFIEDINREGULATION(EC)No258/97
AccordingtoRegulation(EC)No258/97oftheEuropeanParliamentandoftheCouncilof27January1997concerningnovelfoodsandnovelfoodingredients
(1),Regulation(EC)No258/97willapplytotheplacingonthemarketoffoodsorfoodingredientswhichhavenothithertobeenusedforhumanconsumptiontoasignificantdegreewithintheCommunityandwhichfallunderthefollowingcategories:
(a)foodsandfoodingredientscontainingorconsistingofgeneticallymodifiedorganismswithinthemeaningofCouncilDirective90/220/EEC
(2);
(b)foodsandfoodingredientsproducedfrom,butnotcontaining,geneticallymodifiedorganisms;
(c)foodsandfoodingredientswithaneworintentionallymodifiedprimarymolecularstructure;
(d)foodsandfoodingredientsconsistingoforisolatedfrommicroorganisms,fungioralgae;
(e)foodsandfoodingredientsconsistingoforisolatedfromplantsandfoodingredientsisolatedfromanimals,exceptforfoodsandfoodingredientsobtainedbytraditionalpropagatingandbreedingpracticesandwhichhaveahistoryofsafefooduse;
(f)foodsandfoodingredientstowhichhasbeenappliedaproductionprocessnotcurrentlyused,wherethatprocessgivesrisetosignificantchangesinthecompositionorstructureofthefoodsorfoodingredientswhichaffecttheirnutritionalvalue,metabolismorthelevelofundesirablesubstances.
TheRegulationdoesnotapplyto:
foodadditivesfallingwithinthescopeofCouncilDirective89/107/EEC(3);flavouringsforuseinfoodstuffsfallingwithinthescopeofCouncilDirective88/388/EEC(4);orextractionsolventsusedintheproductionoffoodstuffsfallingwithinthescopeofCouncilDirective88/344/EEC(5).
3.KEYISSUESFORTHEASSESSMENTOFNOVELFOODSANDNOVELFOODINGREDIENTS(NF)
評估新型食品和新型食品配料(NF)的關鍵問題
3.1Generalconsiderations
一般狀況
Foodsareusuallycomplexmixturesofmacro-andmicroconstituentswhichprovideenergyandnutrientsandcontributetothewell-beingofhumans.Theyhavetraditionallybeenregardedasnatural,beneficialandnecessaryproductswhosesafetyandnutritionalvalueneednotbequestioned.
食物一般是由聚成分及微成分的複合物組成,提供能量及營養給人體。
這些被視為天然的,有益的和必要的產品是大家所認知不會懷疑他的安全性及營養價值
Regulatoryapproachestofoodsafetyhavereflectedthisattitudeandhavefocusedonfoodadditives,processingaidsandcontaminantsofnaturalorindustrialorigin.
食品安全監督管理辦法,反映關於食品添加劑,加工助劑和污染物或工業原料的影響。
Thus,foodshavenothithertobeensystematicallysubjectedtonutritionalortoxicologicalevaluation,exceptinrar
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