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PAGEPAGE66I(Actswhosepublicationisobligatory)歐盟一般食品法Regulation(EC)No178/2002歐洲議會和歐盟理事會2002REGULATION(EC)No178/2002OFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof28January2002layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishingtheEuropeanFoodSafetyAuthorityandlayingdownproceduresinmattersoffoodsafety一、法規(guī)重點摘要:於2005年1月1日起一般食品法(178/2002號法規(guī)生效,並同時成立歐洲食品安全局(EuropeanFoodSfetyAuthority,EFSF),以協(xié)調(diào)各會員國執(zhí)行與食品安全有關(guān)之法規(guī),如食品之可追溯性、防止有害食品(含有害物質(zhì))進入市場、食品供應(yīng)鏈業(yè)者(含進出口商)之義務(wù)(包括配合實施歐盟食品及飼料快速警報系統(tǒng))、標示規(guī)範、不合符食品安全標準時須自市場撤回之規(guī)定。歐盟食物鏈及動物健康常務(wù)委員會(StandingCommitteeontheFoodChainandAnimalHealth)為協(xié)調(diào)各會員國執(zhí)行上述法規(guī)有關(guān)食品之可追溯性、防止有害食品進入市場、食品業(yè)者之義務(wù)及對進出口商之要求(178/2002號法規(guī)第11,12及16至20條)等一般原則及基本規(guī)範,已制定指導(dǎo)綱領(lǐng),並同時協(xié)助相關(guān)業(yè)者瞭解,以徹底落實相關(guān)規(guī)範。相關(guān)新規(guī)範將適用於所有食品、動物飼料、動物用藥、保育類植物、肥料以及所有食物鏈業(yè)者,包括農(nóng)場經(jīng)營、食品之加工、運輸、儲存、配送及零售等。另外,在標示規(guī)範方面,歐盟為在食物鏈建立可追溯性系統(tǒng),所有食品及飼料均須標示生產(chǎn)者之姓名、地址、產(chǎn)品名稱及交易日期,相關(guān)資料須保存至少5年,以供追查之需。該法規(guī)第18條雖未明確規(guī)範標示資料,惟基本上應(yīng)包括下列兩類資訊:(1)供應(yīng)商姓名地址及其供應(yīng)之產(chǎn)品名稱、銷售對象姓名地址及銷售產(chǎn)品名稱、交易或交貨日期。(2)產(chǎn)品之交易量、條碼、其他相關(guān)資訊(如定量包裝或散裝、水果或蔬菜種類、原料或加工產(chǎn)品)。該可追溯性法規(guī)(或標示規(guī)範)雖未強制要求第三國出口商配合執(zhí)行,惟輸入歐盟之進口產(chǎn)品須落實相關(guān)規(guī)定,為避免重新黏貼標示之困擾,歐盟進口商勢必將要求出口商配合實施。其他相關(guān)規(guī)定尚包括:(1)發(fā)現(xiàn)食品不符食品安全標準時要求自市場撤回之規(guī)定。(2)食品業(yè)者之義務(wù)【包括配合實施歐盟食品及飼料快速警報系統(tǒng)(RapidAlertSystemforFoodandFeed,RASFF)】。此外,協(xié)調(diào)歐盟各會員國之食品衛(wèi)生法(第852/2004號規(guī)定)將於2006年1月生效,其中有關(guān)動物用藥、保育類植物等相關(guān)規(guī)範亦須配合本項規(guī)定實施。THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,歐洲國會與歐盟市議會HavingregardtotheTreatyestablishingtheEuropeanCommunity,andinparticularArticles37,95,133andArticle152(4)(b)thereof,考慮歐盟建立的條約,尤其是其中的第37、95、133、及152(4)(b)條HavingregardtotheproposalfromtheCommission(1),HavingregardtotheopinionoftheEconomicandSocialCommittee(2),HavingregardtotheopinionoftheCommitteeoftheRegions(3),ActinginaccordancewiththeprocedurelaiddowninArticle251oftheTreaty(4),Whereas:然而(1)Thefreemovementofsafeandwholesomefoodisanessentialaspectoftheinternalmarketandcontributessignificantlytothehealthandwell-beingofcitizens,andtotheirsocialandeconomicinterests.食品安全的自由移動在內(nèi)部市場是重要的部分,且明顯對市民的健康、其社經(jīng)福利造成影響。(2)AhighlevelofprotectionofhumanlifeandhealthshouldbeassuredinthepursuitofCommunitypolicies.在執(zhí)行聯(lián)盟政策時,應(yīng)確保高度保護人類生命及健康。(3)ThefreemovementoffoodandfeedwithintheCommunitycanbeachievedonlyiffoodandfeedsafetyrequirementsdonotdiffersignificantlyfromMemberStatetoMemberState.在聯(lián)盟內(nèi)食品、飼料的自由移動可以達到,除了在會員國間食品與飼料安全要求沒有明顯不同。(4)Thereareimportantdifferencesinrelationtoconcepts,principlesandproceduresbetweenthefoodlawsoftheMemberStates.WhenMemberStatesadoptmeasuresgoverningfood,thesedifferencesmayimpedethefreemovementoffood,createunequalconditionsofcompetition,andmaytherebydirectlyaffectthefunctioningoftheinternalmarket.會員國之間的食品法律、原則、概念有明顯的差異。當會員國採用管理食品的措施時,這些差異可能會阻礙食品的自由流通,建立不平等的競爭情況,可能直接影響內(nèi)部市場的功能。(5)Accordingly,itisnecessarytoapproximatetheseconcepts,principlesandproceduressoastoformacommonbasisformeasuresgoverningfoodandfeedtakenintheMemberStatesandatCommunitylevel.Itishowevernecessarytoprovideforsufficienttimefortheadaptationofanyconflictingprovisionsinexistinglegislation,bothatnationalandCommunitylevel,andtoprovidethat,pendingsuchadaptation,therelevantlegislationbeappliedinthelightoftheprinciplessetoutinthepresentRegulation.於是,需要去瞭解這些概念、原則及程序,以便於建立在會員國及聯(lián)盟層級執(zhí)行食品及飼料一般基礎(chǔ)措施。然而,在現(xiàn)有的立法下,需要提供足夠的時間去採行受爭議的條款,且在採行期間,在現(xiàn)有法規(guī)的原則下,相關(guān)的立法可以被採用。(6)Waterisingesteddirectlyorindirectlylikeotherfoods,therebycontributingtotheoverallexposureofaconsumertoingestedsubstances,includingchemicalandmicrobiologicalcontaminants.However,asthequalityofwaterintendedforhumanconsumptionisalreadycontrolledbyCouncilDirectives80/778/EEC(5)and98/83/EC(6),itsufficestoconsiderwaterafterthepointofcompliancereferredtoinArticle6ofDirective98/83/EC.水是直接攝食或藉由食物攝食入,因此消費者有可能暴露在攝入的物質(zhì)包括化學或微生物污染物下。然而,飲用水的品質(zhì)已經(jīng)由決議80/778/EEC(5)與98/83/EC(6)管控,符合決議98/83/EC的水視為飲用水。(7)Withinthecontextoffoodlawitisappropriatetoincluderequirementsforfeed,includingitsproductionandusewherethatfeedisintendedforfood-producinganimals.Thisiswithoutprejudicetothesimilarrequirementswhichhavebeenappliedsofarandwhichwillbeappliedinthefutureinfeedlegislationapplicabletoallanimals,includingpets.在食品法令的範疇下,包括對飼料的要求。包括飼料的製造跟使用。其不違反現(xiàn)行之相關(guān)要求,且適用於未來的動物飼料的法律中。(8)TheCommunityhaschosenahighlevelofhealthprotectionasappropriateinthedevelopmentoffoodlaw,whichitappliesinanon-discriminatorymannerwhetherfoodorfeedistradedontheinternalmarketorinternationally.在建立食品法律時,歐盟已經(jīng)選擇健康的高標準。不論食品或飼料是在內(nèi)部市場或國際間流通。(9)Itisnecessarytoensurethatconsumers,otherstakeholdersandtradingpartnershaveconfidenceinthedecision-makingprocessesunderpinningfoodlaw,itsscientificbasisandthestructuresandindependenceoftheinstitutionsprotectinghealthandotherinterests.在食品法律的基礎(chǔ)下,需要確認消費者與業(yè)者在做決定時是有信心的,其科學基礎(chǔ)、結(jié)構(gòu)與保障健康及其他權(quán)益建立的獨立性。(10)Experiencehasshownthatitisnecessarytoadoptmeasuresaimedatguaranteeingthatunsafefoodisnotplacedonthemarketandatensuringthatsystemsexisttoidentifyandrespondtofoodsafetyproblemsinordertoensuretheproperfunctioningoftheinternalmarketandtoprotecthumanhealth.Similarissuesrelatingtofeedsafetyshouldbeaddressed.為了確保內(nèi)部市場的適當?shù)淖饔?,?jīng)驗已經(jīng)顯示採行保證不安全的食品不上市、辨識及反應(yīng)食品安全系統(tǒng)的措施是必要的。相關(guān)的飼料安全與相關(guān)的議題已經(jīng)被提出。(11)Inordertotakeasufficientlycomprehensiveandintegratedapproachtofoodsafety,thereshouldbeabroaddefinitionoffoodlawcoveringawiderangeofprovisionswithadirectorindirecteffectonthesafetyoffoodandfeed,includingprovisionsonmaterialsandarticlesincontactwithfood,animalfeedandotheragriculturalinputsatthelevelofprimaryproduction.為了對食品安全採取足夠、通盤的方法,應(yīng)要有廣泛的食品法令的定義,涵蓋直接或間接對飼料或食品的影響,包括材料的條款或與食品、動物飼料及其他農(nóng)產(chǎn)品輸入在初級生產(chǎn)的層級的相關(guān)法律。(12)Inordertoensurethesafetyoffood,itisnecessarytoconsiderallaspectsofthefoodproductionchainasacontinuumfromandincludingprimaryproductionandtheproductionofanimalfeeduptoandincludingsaleorsupplyoffoodtotheconsumerbecauseeachelementmayhaveapotentialimpactonfoodsafety.為了確認食品的安全性,需要考慮食品製造鏈的所有部份,做為初級生產(chǎn)、動物飼料的製造、販售、食品供給到消費者的連貫性。因為個階段可能有對食品安全的潛在衝擊。(13)Experiencehasshownthatforthisreasonitisnecessarytoconsidertheproduction,manufacture,transportanddistributionoffeedgiventofood-producinganimals,includingtheproductionofanimalswhichmaybeusedasfeedonfishfarms,sincetheinadvertentordeliberatecontaminationoffeed,andadulterationorfraudulentorotherbadpracticesinrelationtoit,maygiverisetoadirectorindirectimpactonfoodsafety.經(jīng)驗顯示這些原因需要去考慮飼料的生產(chǎn)、加工、運輸及配送,包括動物的製造準備用來做為養(yǎng)魚場的飼料,因為有意或無意的飼料污染、攙假或其他不好的相關(guān)案例,可能會產(chǎn)生直接或間接對食品安全的衝擊。(14)Forthesamereason,itisnecessarytoconsiderotherpracticesandagriculturalinputsatthelevelofprimaryproductionandtheirpotentialeffectontheoverallsafetyoffood.相同的理由,在初級生產(chǎn)的層級,需要考慮其他規(guī)範與農(nóng)產(chǎn)品的輸入及其他潛在食品安全性的影響。(15)Networkingoflaboratoriesofexcellence,atregionaland/orinterregionallevel,withtheaimofensuringcontinuousmonitoringoffoodsafety,couldplayanimportantroleinthepreventionofpotentialhealthrisksforcitizens.合格實驗室網(wǎng)絡(luò),在區(qū)域與/或區(qū)域間的層級,在確保食品安全的連續(xù)偵測下,可扮演對市民潛在健康危害的預(yù)防的角色。(16)MeasuresadoptedbytheMemberStatesandtheCommunitygoverningfoodandfeedshouldgenerallybebasedonriskanalysisexceptwherethisisnotappropriatetothecircumstancesorthenatureofthemeasure.Recoursetoariskanalysispriortotheadoptionofsuchmeasuresshouldfacilitatetheavoidanceofunjustifiedbarrierstothefreemovementoffoodstuffs.(17)Wherefoodlawisaimedatthereduction,eliminationoravoidanceofarisktohealth,thethreeinterconnectedcomponentsofriskanalysis-riskassessment,riskmanagement,andriskcommunication-provideasystematicmethodologyforthedeterminationofeffective,proportionateandtargetedmeasuresorotheractionstoprotecthealth.略(18)Inorderfortheretobeconfidenceinthescientificbasisforfoodlaw,riskassessmentsshouldbeundertakeninanindependent,objectiveandtransparentmanner,onthebasisoftheavailablescientificinformationanddata.為了對食品法律的科學基礎(chǔ)有信心,在現(xiàn)有的科學資訊及數(shù)據(jù)的基礎(chǔ)下,應(yīng)該以獨立、有目的且公開的態(tài)度執(zhí)行風險評估。(19)Itisrecognisedthatscientificriskassessmentalonecannot,insomecases,providealltheinformationonwhichariskmanagementdecisionshouldbebased,andthatotherfactorsrelevanttothematterunderconsiderationshouldlegitimatelybetakenintoaccountincludingsocietal,economic,traditional,ethicalandenvironmentalfactorsandthefeasibilityofcontrols.科學的風險評估是不能單獨進行的,在某些案例中,應(yīng)依所有提供的資訊做風險評估,考慮相關(guān)事件的其他因子應(yīng)該合法地,考慮包括社會、經(jīng)濟、傳統(tǒng)、道德及環(huán)境因子及管控的可行性。(20)TheprecautionaryprinciplehasbeeninvokedtoensurehealthprotectionintheCommunity,therebygivingrisetobarrierstothefreemovementoffoodorfeed.ThereforeitisnecessarytoadoptauniformbasisthroughouttheCommunityfortheuseofthisprinciple.已經(jīng)喚起預(yù)防原則去確保聯(lián)盟的健康保障,因此產(chǎn)生食品或飼料的自由移動屏障。因此使用此原則時,需要採用統(tǒng)一的基礎(chǔ)。(21)Inthosespecificcircumstanceswherearisktolifeorhealthexistsbutscientificuncertaintypersists,theprecautionaryprincipleprovidesamechanismfordeterminingriskmanagementmeasuresorotheractionsinordertoensurethehighlevelofhealthprotectionchosenintheCommunity.在這些特定的情況,生命或健康存在的風險存在,但是科學不確定度持續(xù),預(yù)防原則提供一機制去決定風險評估措施或其他行動,為了確保聯(lián)盟高度健康保護。(22)Foodsafetyandtheprotectionofconsumer'sinterestsisofincreasingconcerntothegeneralpublic,non-governmentalorganisations,professionalassociations,internationaltradingpartnersandtradeorganisations.Itisnecessarytoensurethatconsumerconfidenceandtheconfidenceoftradingpartnersissecuredthroughtheopenandtransparentdevelopmentoffoodlawandthroughpublicauthoritiestakingtheappropriatestepstoinformthepublicwheretherearereasonablegroundstosuspectthatafoodmaypresentarisktohealth.食品安全與消費者權(quán)益對一般公眾的關(guān)心、非政府組織的保護是高度關(guān)心的、專業(yè)的組織、國際貿(mào)易間的組織。需要去確認消費者的信賴度與業(yè)者的信賴度是安全的,經(jīng)由開放與公開食品法律發(fā)展,由公家機關(guān)採取適當?shù)某绦蛉ジ嬷蟊娪泻侠淼睦碛扇岩墒称房赡艽嬖趯】档奈:Α?23)ThesafetyandconfidenceofconsumerswithintheCommunity,andinthirdcountries,areofparamountimportance.TheCommunityisamajorglobaltraderinfoodandfeedand,inthiscontext,ithasenteredintointernationaltradeagreements,itcontributestothedevelopmentofinternationalstandardswhichunderpinfoodlaw,anditsupportstheprinciplesoffreetradeinsafefeedandsafe,wholesomefoodinanon-discriminatorymanner,followingfairandethicaltradingpractices.在聯(lián)盟內(nèi)消費者信心與安全,在第三國是很重要的。聯(lián)盟是食品與飼料的主要的全球貿(mào)易商,在此範圍內(nèi),已進入國際貿(mào)易協(xié)定,在食品法律的基礎(chǔ)下,其導(dǎo)致食品法律的發(fā)展、支持自由貿(mào)易在安全飼料、在非區(qū)別行為的所有食品,公正與種族貿(mào)易規(guī)範的原則。(24)Itisnecessarytoensurethatfoodandfeedexportedorre-exportedfromtheCommunitycomplieswithCommunitylawortherequirementssetupbytheimportingcountry.Inothercircumstances,foodandfeedcanonlybeexportedorre-exportediftheimportingcountryhasexpresslyagreed.However,itisnecessarytoensurethatevenwherethereisagreementoftheimportingcountry,foodinjurioustohealthorunsafefeedisnotexportedorre-exported.必須確認食品及飼料出國或再次從歐盟出口遵照聯(lián)盟或進口國建立的要求。在其他情況,如果進口國已經(jīng)表示同意,食品與飼料只可以被出口或再次出口。然而,需要確認有進口國的許可,傷害健康的食品或不安全的飼料不可出口或再次出口。(25)ItisnecessarytoestablishthegeneralprinciplesuponwhichfoodandfeedmaybetradedandtheobjectivesandprinciplesforthecontributionoftheCommunitytodevelopinginternationalstandardsandtradeagreements.在食品與飼料買賣下,需要建立一般原則及目標讓聯(lián)盟發(fā)展國際標準及貿(mào)易協(xié)定。(26)SomeMemberStateshaveadoptedhorizontallegislationonfoodsafetyimposing,inparticular,ageneralobligationoneconomicoperatorstomarketonlyfoodthatissafe.However,theseMemberStatesapplydifferentbasiccriteriaforestablishingwhetherafoodissafe.Giventhesedifferentapproaches,andintheabsenceofhorizontallegislationinotherMemberStates,barrierstotradeinfoodsareliabletoarise.Similarlysuchbarriersmayarisetotradeinfeed.在食品安全的前提下,一些會員國已經(jīng)採用水平立法,尤其對業(yè)者在市場的責任,只有食品是安全的。然而,這些會員國採用不同的基礎(chǔ)標準去建立是否食品是安全的。這些不同方法,在缺乏其他會員國的水平立法下,食品的貿(mào)易層障是容易發(fā)生的。同樣的,這些屏障也可能發(fā)生在飼料的貿(mào)易中。(27)Itisthereforenecessarytoestablishgeneralrequirementsforonlysafefoodandfeedtobeplacedonthemarket,toensurethattheinternalmarketinsuchproductsfunctionseffectively.因此只對上市的安全食品及飼料建立一般要求是必須的,去確認這些產(chǎn)品的功效在國內(nèi)市場是有效的。(28)Experiencehasshownthatthefunctioningoftheinternalmarketinfoodorfeedcanbejeopardisedwhereitisimpossibletotracefoodandfeed.Itisthereforenecessarytoestablishacomprehensivesystemoftraceabilitywithinfoodandfeedbusinessessothattargetedandaccuratewithdrawalscanbeundertakenorinformationgiventoconsumersorcontrolofficials,therebyavoidingthepotentialforunnecessarywiderdisruptionintheeventoffoodsafetyproblems.(29)Itisnecessarytoensurethatafoodorfeedbusinessincludinganimportercanidentifyatleastthebusinessfromwhichthefood,feed,animalorsubstancethatmaybeincorporatedintoafoodorfeedhasbeensupplied,toensurethatoninvestigation,traceabilitycanbeassuredatallstages.(30)Afoodbusinessoperatorisbestplacedtodeviseasafesystemforsupplyingfoodandensuringthatthefooditsuppliesissafe;thus,itshouldhaveprimarylegalresponsibilityforensuringfoodsafety.AlthoughthisprincipleexistsinsomeMemberStatesandareasoffoodlaw,inotherareasthisiseithernotexplicitorelseresponsibilityisassumedbythecompetentauthoritiesoftheMemberStatethroughthecontrolactivitiestheycarryout.SuchdisparitiesareliabletocreatebarrierstotradeanddistortcompetitionbetweenfoodbusinessoperatorsindifferentMemberStates.(31)Similarrequirementsshouldapplytofeedandfeedbusinessoperators.(32)ThescientificandtechnicalbasisofCommunitylegislationrelatingtothesafetyoffoodandfeedshouldcontributetotheachievementofahighlevelofhealthprotectionwithintheCommunity.TheCommunityshouldhaveaccesstohigh-quality,independentandefficientscientificandtechnicalsupport.(33)Thescientificandtechnicalissuesinrelationtofoodandfeedsafetyarebecomingincreasinglyimportantandcomplex.TheestablishmentofaEuropeanFoodSafetyAuthority,hereinafterreferredtoas‘theAuthority’,shouldreinforcethepresentsystemofscientificandtechnicalsupportwhichisnolongerabletorespondtoincreasingdemandsonit.(34)Pursuanttothegeneralprinciplesoffoodlaw,theAuthorityshouldtakeontheroleofanindependentscientificpointofreferenceinriskassessmentandinsodoingshouldassistinensuringthesmoothfunctioningoftheinternalmarket.Itmaybecalledupontogiveopinionsoncontentiousscientificissues,therebyenablingtheCommunityinstitutionsandMemberStatestotakeinformedriskmanagementdecisionsnecessarytoensurefoodandfeedsafetywhilsthelpingavoidthefragmentationoftheinternalmarketthroughtheadoptionofunjustifiedorunnecessaryobstaclestothefreemovementoffoodandfeed.(35)TheAuthorityshouldbeanindependentscientificsourceofadvice,informationandriskcommunicationinordertoimproveconsumerconfidence;nevertheless,inordertopromotecoherencebetweentheriskassessment,riskmanagementandriskcommunicationfunctions,thelinkbetweenriskassessorsandriskmanagersshouldbestrengthened.(36)TheAuthorityshouldprovideacomprehensiveindependentscientificviewofthesafetyandotheraspectsofthewholefoodandfeedsupplechains,whichimplieswide-rangingresponsibilitiesfortheAuthority.Theseshouldincludedissueshavingadirectorindirectimpactonthesafetyofthefoodandfeedsupplychains,animalhealthandwelfare,andplanthealth,However,itisnecessarytoensurethattheAuthorityfocusesonfoodsafety,soitsmissioninrelationtoanimalhealth,animalwelfareandplanthealthissuesthatarenotlinedtothesafetyofthefoodsupplechainshouldbelimitedtotheprovisionofscientificopinions.TheAuthority’smissionshouldalsocoverscientificadviseandscientificandtechnicalsupportonhumannutritioninrelationtocommunitylegislationandassistancetothecommissionatitsrequestoncommunicationlinkedtocommunityhealthprogrammes.(36)權(quán)責機關(guān)應(yīng)提供一有關(guān)安全和所有食品飼料供應(yīng)鏈之全面獨立科學見解,其表示權(quán)責機關(guān)多方面責任。這些應(yīng)包括有關(guān)直接或間接影響食品飼料鏈安全、動物健康及福利和植物健康之問題。但是,其應(yīng)確保權(quán)責機關(guān)專注於食品安全,所以,其關(guān)於動物健康、動物福利以及植物健康,但不屬於食品供應(yīng)鏈安全之任務(wù)應(yīng)限制於科學意見內(nèi)。權(quán)責機關(guān)之任務(wù)應(yīng)包括科學建議和科學、技術(shù)上關(guān)於人體營養(yǎng)之聯(lián)盟法規(guī)和在聯(lián)盟要求下對公共安全計畫溝通之幫助。(37)Sincesomeproductsauthorisedunderfoodlawsuchaspesticidesoradditivesinanimalfeedmayinvolveriskstotheenvironmentortothesafetyofworkers,someenvironmentalandworkerprotectionaspectsshouldalsobeassessedbytheAuthorityinaccordancewiththerelevantlegislation.(37)鑿於某些經(jīng)食品法批準之產(chǎn)品例如在動物飼料中之殺蟲劑或添加物可能有對環(huán)境或員工安全之風險,其環(huán)境及員工保護方面也應(yīng)被權(quán)責機關(guān)依去有關(guān)之法規(guī)進行評估。(38)Inordertoavoidduplicatedscientificassessmentsandrelatedscientificopinionsongeneticallymodifiedorganisms(GMOs),theAuthorityshouldalsoprovidescientificopinionsonproductsotherthanfoodandfeedrelatingtoGMOsasdefinedbyDirective2001/18/EC(1)andwithoutprejudicetotheproceduresestablishedtherein.(38)為了防止基因改造產(chǎn)品重複的科學評估和相關(guān)之科學意見,權(quán)責機關(guān)應(yīng)依據(jù)法令2001/18/EC(1)提供除了有關(guān)基因改造之飼料食品產(chǎn)品外的科學意見,並且不損害在其內(nèi)訂定之程序。(39)TheAuthorityshouldcontributethroughtheprovisionofsupportonscientificmatters,totheCommunity'sandMemberStates'roleinthedevelopmentandestablishmentofinternationalfoodsafetystandardsandtradeagreements.(39)權(quán)責機關(guān)應(yīng)在科學事件上經(jīng)由提供支持,對聯(lián)盟及會員國在國際食品安全標準及貿(mào)易協(xié)定建立和創(chuàng)建之角色有所貢獻。(40)TheconfidenceoftheCommunityinstitutions,thegeneralpublicandinterestedpartiesintheAuthorityisessential.Forthisreason,itisvitaltoensureitsindependence,highscientificquality,transparencyandefficiency.CooperationwithMemberStatesisalsoindispensable.(40)聯(lián)盟機構(gòu)一般大眾以及權(quán)責機關(guān)內(nèi)有興趣之第三機構(gòu)之信心是極重要的。為此目的,維持其獨立性高科學品質(zhì)透明度和有效性實不可或缺的。和其他會員國合作也是必須的。(41)TothateffecttheManagementBoardshouldbeappointedinsuchawayastosecurethehigheststandardofcompetence,abroadrangeofrelevantexpertise,forinstanceinmanagementandinpublicadministration,andthebroadestpossiblegeographicdistributionwithintheUnion.ThisshouldbefacilitatedbyarotationofthedifferentcountriesoforiginofthemembersoftheManagementBoardwithoutanypostbeingreservedfornationalsofanyspecificMemberState.(41)為此,管理會應(yīng)基於鞏固權(quán)責之最高標準,大範圍的相關(guān)專業(yè),例如是在管理方面和公共管理,以及在歐盟內(nèi)最廣擴之可能的地理分布。此管理可經(jīng)由沒有任何特一會員國經(jīng)營。並由管理會不同國家之成員的輪替管理。(42)TheAuthorityshouldhavethemeanstoperformallthetasksrequiredtoenableittocarryoutitsrole.(42)權(quán)責機關(guān)應(yīng)有完成所有必須之作業(yè)之法以能夠執(zhí)行其任務(wù)。(43)TheManagementBoardshouldhavethenecessaryrequestoncommunicationlinkedtoCommunityhealthpowerstoestablishthebudget,checkitsimplementation.,drawupinternalrules,adoptfinancialregulations,appointmembersoftheScientificPanelsandappointtheExecutiveDirector.(43)管理會應(yīng)在共同體衛(wèi)生權(quán)力之溝通上有必需的要求以建立其預(yù)算,檢查其執(zhí)行、建立內(nèi)部規(guī)定、通過經(jīng)濟法令、指定科學小組成員和執(zhí)行組長。(44)TheAuthorityshouldcooperatecloselywithcompetentbodiesintheMemberStatesifitistooperateeffectively.AnAdvisoryForumshouldbecreatedinordertoadvisetheExecutiveDirector,toconstituteamechanismofexchangeofinformation,andtoensureclosecooperationinparticularwithregardtothenetworkingsystem.Cooperationandappropriateexchangeofinformationshouldalsominimisethepotentialfordivergingscientificopinions.(44)權(quán)責機關(guān)如果要有效的執(zhí)行,應(yīng)和會員國之權(quán)責機構(gòu)密切的合作。一諮詢討論會應(yīng)被創(chuàng)建以建議其執(zhí)行組長建立資訊交換之程序並確保通系統(tǒng)的密切合作。(45)TheAuthorityshouldtakeovertheroleoftheScientificCommitteesattachedtotheCommissioninissuingscientificopinionsinitsfieldofcompetence.ItisnecessarytoreorganisetheseCommitteestoensuregreaterscientificconsistencyinrelationtothefoodsupplychainandtoenablethemtoworkmoreeffectively.AScientificCommitteeandPermanentScientificPanelsshouldthereforebesetupwithintheAuthoritytoprovidetheseopinions.(45)權(quán)責機關(guān)應(yīng)接管委員會之科學委員會在其權(quán)責內(nèi)發(fā)布之科學意見。重新組織這些委員是必須的以確保有關(guān)於食品供應(yīng)練更好的科學一致性以及使其能夠更有效的工作。應(yīng)因此在權(quán)責範圍內(nèi)建立一科學委員會和永久科學小組。(46)Inordertoguaranteeindependence,membersoftheScientificCommitteeandPanelsshouldbeindependentscientistsrecruitedonthebasisofanopenapplicationprocedure.(46)為了保證獨立性,科學委員會之成員和小組應(yīng)為公開徵招之獨立科學家。(47)TheAuthority'sroleasanindependentscientificpointofreferencemeansthatascientificopinionmayberequestednotonlybytheCommission,butalsobytheEuropeanParliamentandtheMemberStates.Inordertoensurethemanageabilityandconsistencyoftheprocessofscientificadvice,theAuthorityshouldbeabletorefuseoramendarequestprovidingjustificationforthisandonthebasisofpredeterminedcriteria.Stepsshouldalsobetakentohelpavoiddivergingscientificopinionsand,intheeventofdivergingscientificopinions.(48)TheAuthorityshouldalsobeabletocommissionscientificstudiesnecessaryfortheaccomplishmentofitsduties,whileensuringthatthelinksestablishedbyitwiththeCommissionandtheMemberStatespreventduplicationofeffort.ItshouldbedoneinanopenandtransparentfashionandtheAuthorityshouldtakeintoaccountexistingCommunityexpertiseandstructures.(49)ThelackofaneffectivesystemofcollectionandanalysisatCommunitylevelofdataonthefoodsupplychainisrecognisedasamajorshortcoming.AsystemforthecollectionandanalysisofrelevantdatainthefieldscoveredbytheAuthorityshouldthereforebesetup,intheformofanetworkcoordinatedbytheAuthority.AreviewofCommunitydatacollectionnetworksalreadyexistinginthefieldscoveredbytheAuthorityiscalledfor.(50)ImprovedidentificationofemergingrisksmayinthelongtermbeamajorpreventiveinstrumentatthedisposaloftheMemberStatesandtheCommunityintheexerciseofitspolicies.ItisthereforenecessarytoassigntotheAuthorityananticipatorytaskofcollectinginformationandexercisingvigilanceandprovidingevaluationofandinformationonemergingriskswithaviewtotheirprevention.(51)TheestablishmentoftheAuthorityshouldenableMemberStatestobecomemorecloselyinvolvedinscientificprocedures.ThereshouldthereforebeclosecooperationbetweentheAuthorityandtheMemberStatesforthispurpose.Inparticular,theAuthorityshouldbeabletoassigncertaintaskstoorganisationsintheMemberStates.(52)ItisnecessarytoensurethatabalanceisstruckbetweentheneedtousenationalorganisationstocarryouttasksfortheAuthorityandtheneedtoensureforthepurposesofoverallconsistencythatsuchtasksarecarriedoutinlinewiththecriteriaestablishedforsuchtasks.ExistingproceduresfortheallocationofscientifictaskstotheMemberStates,inparticularwithregardtotheevaluationofdossierspresentedbyindustryfortheauthorisationofcertainsubstances,productsorprocedures,shouldbere-examinedwithinayearwiththeobjectiveoftakingintoaccounttheestablishmentoftheAuthorityandthenewfacilitiesitoffers,theevaluationproceduresremainingatleastasstringentasbefore.(53)TheCommissionremainsfullyresponsibleforcommunicatingriskmanagementmeasures.TheappropriateinformationshouldthereforebeexchangedbetweentheAuthorityandtheCommission.ClosecooperationbetweentheAuthority,theCommissionandtheMemberStatesisalsonecessarytoensurethecoherenceoftheglobalcommunicationprocess.(54)TheindependenceoftheAuthorityanditsroleininformingthepublicmeanthatitshouldbeabletocommunicateautonomouslyinthefieldsfallingwithinitscompetence,itspurposebeingtoprovideobjective,reliableandeasilyunderstandableinformation.(55)AppropriatecooperationwiththeMemberStatesandotherinterestedpartiesisnecessaryinthespecificfieldofpublicinformationcampaignstotakeintoaccountanyregionalparametersandanycorrelationwithhealthpolicy.(56)Inadditiontoitsoperatingprinciplesbasedonindependenceandtransparency,theAuthorityshouldbeanorganisationopentocontactswithconsumersandotherinterestedgroups.(57)TheAuthorityshouldbefinancedbythegeneralbudgetoftheEuropeanUnion.However,inthelightofexperienceacquired,inparticularwithregardtotheprocessingofauthorisationdossierspresentedbyindustry,thepossibilityoffeesshouldbeexaminedwithinthreeyearsfollowingtheentryintoforceofthisRegulation.TheCommunitybudgetaryprocedureremainsapplicableasfarasanysubsidieschargeabletothegeneralbudgetoftheEuropeanUnionareconcerned.Moreover,theauditingofaccountsshouldbeundertakenbytheCourtofAuditors.(58)ItisnecessarytoallowfortheparticipationofEuropeancountrieswhicharenotmembersoftheEuropeanUnionandwhichhaveconcludedagreementsobligingthemtotransposeandimplementthebodyofCommunitylawinthefieldcoveredbythisRegulation.(59)AsystemforrapidalertalreadyexistsintheframeworkofCouncilDirective92/59/EECof29June1992ongeneralproductsafety(1).Thescopeoftheexistingsystemincludesfoodandindustrialproductsbutnotfeed.Recentfoodcriseshavedemonstratedtheneedtosetupanimprovedandbroadenedrapidalertsystemcoveringfoodandfeed.ThisrevisedsystemshouldbemanagedbytheCommissionandincludeasmembersofthenetworktheMemberStates,theCommissionandtheAuthority.ThesystemshouldnotcovertheCommunityarrangementsfortheearlyexchangeofinformationintheeventofaradiologicalemergencyasdefinedinCouncilDecision87/600/Euratom(2).(60)Recentfoodsafetyincidentshavedemonstratedtheneedtoestablishappropriatemeasuresinemergencysituationsensuringthatallfoods,whatevertheirtypeandorigin,andallfeedshouldbesubjecttocommonmeasuresintheeventofaseriousrisktohumanhealth,animalhealthortheenvironment.Suchacomprehensiveapproachtoemergencyfoodsafetymeasuresshouldalloweffectiveactiontobetakenandavoidartificialdisparitiesinthetreatmentofaseriousriskinrelationtofoodorfeed.(61)RecentfoodcriseshavealsoshownthebenefitstotheCommissionofhavingproperlyadapted,morerapidproceduresforcrisismanagement.Theseorganisationalproceduresshouldmakeitpossibletoimprovecoordinationofeffortandtodeterminethemosteffectivemeasuresonthebasisofthebestscientificinformation.Therefore,revisedproceduresshouldtakeintoaccounttheAuthority'sresponsibil
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