歐盟一般食品法Regulation-(EC)-No-178-2002中文翻譯

PAGEPAGE66I(Actswhosepublicationisobligatory)歐盟一般食品法Regulation(EC)No178/2002歐洲議會(huì)和歐盟理事會(huì)2002REGULATION(EC)No178/2002OFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof28January2002layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishingtheEuropeanFoodSafetyAuthorityandlayingdownproceduresinmattersoffoodsafety一、法規(guī)重點(diǎn)摘要：於2005年1月1日起一般食品法(178/2002號(hào)法規(guī)生效，並同時(shí)成立歐洲食品安全局(EuropeanFoodSfetyAuthority,EFSF)，以協(xié)調(diào)各會(huì)員國(guó)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(jìn)入市場(chǎng)、食品供應(yīng)鏈業(yè)者（含進(jìn)出口商）之義務(wù)（包括配合實(shí)施歐盟食品及飼料快速警報(bào)系統(tǒng)）、標(biāo)示規(guī)範(fàn)、不合符食品安全標(biāo)準(zhǔn)時(shí)須自市場(chǎng)撤回之規(guī)定。歐盟食物鏈及動(dòng)物健康常務(wù)委員會(huì)（StandingCommitteeontheFoodChainandAnimalHealth）為協(xié)調(diào)各會(huì)員國(guó)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(jìn)入市場(chǎng)、食品業(yè)者之義務(wù)及對(duì)進(jìn)出口商之要求（178/2002號(hào)法規(guī)第11,12及16至20條）等一般原則及基本規(guī)範(fàn)，已制定指導(dǎo)綱領(lǐng)，並同時(shí)協(xié)助相關(guān)業(yè)者瞭解，以徹底落實(shí)相關(guān)規(guī)範(fàn)。相關(guān)新規(guī)範(fàn)將適用於所有食品、動(dòng)物飼料、動(dòng)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(chǎng)經(jīng)營(yíng)、食品之加工、運(yùn)輸、儲(chǔ)存、配送及零售等。另外，在標(biāo)示規(guī)範(fàn)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(biāo)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(fàn)標(biāo)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(duì)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(biāo)示規(guī)範(fàn)）雖未強(qiáng)制要求第三國(guó)出口商配合執(zhí)行，惟輸入歐盟之進(jìn)口產(chǎn)品須落實(shí)相關(guān)規(guī)定，為避免重新黏貼標(biāo)示之困擾，歐盟進(jìn)口商勢(shì)必將要求出口商配合實(shí)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(biāo)準(zhǔn)時(shí)要求自市場(chǎng)撤回之規(guī)定。（2）食品業(yè)者之義務(wù)【包括配合實(shí)施歐盟食品及飼料快速警報(bào)系統(tǒng)（RapidAlertSystemforFoodandFeed,RASFF）】。此外，協(xié)調(diào)歐盟各會(huì)員國(guó)之食品衛(wèi)生法(第852/2004號(hào)規(guī)定)將於2006年1月生效，其中有關(guān)動(dòng)物用藥、保育類植物等相關(guān)規(guī)範(fàn)亦須配合本項(xiàng)規(guī)定實(shí)施。THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,歐洲國(guó)會(huì)與歐盟市議會(huì)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(dòng)在內(nèi)部市場(chǎng)是重要的部分，且明顯對(duì)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(shí)，應(yīng)確保高度保護(hù)人類生命及健康。(3)ThefreemovementoffoodandfeedwithintheCommunitycanbeachievedonlyiffoodandfeedsafetyrequirementsdonotdiffersignificantlyfromMemberStatetoMemberState.在聯(lián)盟內(nèi)食品、飼料的自由移動(dòng)可以達(dá)到，除了在會(huì)員國(guó)間食品與飼料安全要求沒(méi)有明顯不同。(4)Thereareimportantdifferencesinrelationtoconcepts,principlesandproceduresbetweenthefoodlawsoftheMemberStates.WhenMemberStatesadoptmeasuresgoverningfood,thesedifferencesmayimpedethefreemovementoffood,createunequalconditionsofcompetition,andmaytherebydirectlyaffectthefunctioningoftheinternalmarket.會(huì)員國(guó)之間的食品法律、原則、概念有明顯的差異。當(dāng)會(huì)員國(guó)採(cǎi)用管理食品的措施時(shí)，這些差異可能會(huì)阻礙食品的自由流通，建立不平等的競(jìng)爭(zhēng)情況，可能直接影響內(nèi)部市場(chǎng)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(huì)員國(guó)及聯(lián)盟層級(jí)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(shí)間去採(cǎi)行受爭(zhēng)議的條款，且在採(cǎi)行期間，在現(xiàn)有法規(guī)的原則下，相關(guān)的立法可以被採(cǎi)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(fèi)者有可能暴露在攝入的物質(zhì)包括化學(xué)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(fàn)疇下，包括對(duì)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(lái)的動(dòng)物飼料的法律中。(8)TheCommunityhaschosenahighlevelofhealthprotectionasappropriateinthedevelopmentoffoodlaw,whichitappliesinanon-discriminatorymannerwhetherfoodorfeedistradedontheinternalmarketorinternationally.在建立食品法律時(shí)，歐盟已經(jīng)選擇健康的高標(biāo)準(zhǔn)。不論食品或飼料是在內(nèi)部市場(chǎng)或國(guó)際間流通。(9)Itisnecessarytoensurethatconsumers,otherstakeholdersandtradingpartnershaveconfidenceinthedecision-makingprocessesunderpinningfoodlaw,itsscientificbasisandthestructuresandindependenceoftheinstitutionsprotectinghealthandotherinterests.在食品法律的基礎(chǔ)下，需要確認(rèn)消費(fèi)者與業(yè)者在做決定時(shí)是有信心的，其科學(xué)基礎(chǔ)、結(jié)構(gòu)與保障健康及其他權(quán)益建立的獨(dú)立性。(10)Experiencehasshownthatitisnecessarytoadoptmeasuresaimedatguaranteeingthatunsafefoodisnotplacedonthemarketandatensuringthatsystemsexisttoidentifyandrespondtofoodsafetyproblemsinordertoensuretheproperfunctioningoftheinternalmarketandtoprotecthumanhealth.Similarissuesrelatingtofeedsafetyshouldbeaddressed.為了確保內(nèi)部市場(chǎng)的適當(dāng)?shù)淖饔茫?jīng)驗(yàn)已經(jīng)顯示採(cǎi)行保證不安全的食品不上市、辨識(shí)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(duì)食品安全採(cǎi)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(duì)飼料或食品的影響，包括材料的條款或與食品、動(dòng)物飼料及其他農(nóng)產(chǎn)品輸入在初級(jí)生產(chǎn)的層級(jí)的相關(guān)法律。(12)Inordertoensurethesafetyoffood,itisnecessarytoconsiderallaspectsofthefoodproductionchainasacontinuumfromandincludingprimaryproductionandtheproductionofanimalfeeduptoandincludingsaleorsupplyoffoodtotheconsumerbecauseeachelementmayhaveapotentialimpactonfoodsafety.為了確認(rèn)食品的安全性，需要考慮食品製造鏈的所有部份，做為初級(jí)生產(chǎn)、動(dòng)物飼料的製造、販?zhǔn)邸⑹称饭┙o到消費(fèi)者的連貫性。因?yàn)閭€(gè)階段可能有對(duì)食品安全的潛在衝擊。(13)Experiencehasshownthatforthisreasonitisnecessarytoconsidertheproduction,manufacture,transportanddistributionoffeedgiventofood-producinganimals,includingtheproductionofanimalswhichmaybeusedasfeedonfishfarms,sincetheinadvertentordeliberatecontaminationoffeed,andadulterationorfraudulentorotherbadpracticesinrelationtoit,maygiverisetoadirectorindirectimpactonfoodsafety.經(jīng)驗(yàn)顯示這些原因需要去考慮飼料的生產(chǎn)、加工、運(yùn)輸及配送，包括動(dòng)物的製造準(zhǔn)備用來(lái)做為養(yǎng)魚場(chǎng)的飼料，因?yàn)橛幸饣驘o(wú)意的飼料污染、攙假或其他不好的相關(guān)案例，可能會(huì)產(chǎn)生直接或間接對(duì)食品安全的衝擊。(14)Forthesamereason,itisnecessarytoconsiderotherpracticesandagriculturalinputsatthelevelofprimaryproductionandtheirpotentialeffectontheoverallsafetyoffood.相同的理由，在初級(jí)生產(chǎn)的層級(jí)，需要考慮其他規(guī)範(fàn)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(shí)驗(yàn)室網(wǎng)絡(luò)，在區(qū)域與/或區(qū)域間的層級(jí)，在確保食品安全的連續(xù)偵測(cè)下，可扮演對(duì)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(duì)食品法律的科學(xué)基礎(chǔ)有信心，在現(xiàn)有的科學(xué)資訊及數(shù)據(jù)的基礎(chǔ)下，應(yīng)該以獨(dú)立、有目的且公開(kāi)的態(tài)度執(zhí)行風(fēng)險(xiǎn)評(píng)估。(19)Itisrecognisedthatscientificriskassessmentalonecannot,insomecases,providealltheinformationonwhichariskmanagementdecisionshouldbebased,andthatotherfactorsrelevanttothematterunderconsiderationshouldlegitimatelybetakenintoaccountincludingsocietal,economic,traditional,ethicalandenvironmentalfactorsandthefeasibilityofcontrols.科學(xué)的風(fēng)險(xiǎn)評(píng)估是不能單獨(dú)進(jìn)行的，在某些案例中，應(yīng)依所有提供的資訊做風(fēng)險(xiǎn)評(píng)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(huì)、經(jīng)濟(jì)、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(dòng)屏障。因此使用此原則時(shí)，需要採(cǎi)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(fēng)險(xiǎn)存在，但是科學(xué)不確定度持續(xù)，預(yù)防原則提供一機(jī)制去決定風(fēng)險(xiǎn)評(píng)估措施或其他行動(dòng)，為了確保聯(lián)盟高度健康保護(hù)。(22)Foodsafetyandtheprotectionofconsumer'sinterestsisofincreasingconcerntothegeneralpublic,non-governmentalorganisations,professionalassociations,internationaltradingpartnersandtradeorganisations.Itisnecessarytoensurethatconsumerconfidenceandtheconfidenceoftradingpartnersissecuredthroughtheopenandtransparentdevelopmentoffoodlawandthroughpublicauthoritiestakingtheappropriatestepstoinformthepublicwheretherearereasonablegroundstosuspectthatafoodmaypresentarisktohealth.食品安全與消費(fèi)者權(quán)益對(duì)一般公眾的關(guān)心、非政府組織的保護(hù)是高度關(guān)心的、專業(yè)的組織、國(guó)際貿(mào)易間的組織。需要去確認(rèn)消費(fèi)者的信賴度與業(yè)者的信賴度是安全的，經(jīng)由開(kāi)放與公開(kāi)食品法律發(fā)展，由公家機(jī)關(guān)採(cǎi)取適當(dāng)?shù)某绦蛉ジ嬷蟊娪泻侠淼睦碛扇岩墒称房赡艽嬖趯?duì)健康的危害。(23)ThesafetyandconfidenceofconsumerswithintheCommunity,andinthirdcountries,areofparamountimportance.TheCommunityisamajorglobaltraderinfoodandfeedand,inthiscontext,ithasenteredintointernationaltradeagreements,itcontributestothedevelopmentofinternationalstandardswhichunderpinfoodlaw,anditsupportstheprinciplesoffreetradeinsafefeedandsafe,wholesomefoodinanon-discriminatorymanner,followingfairandethicaltradingpractices.在聯(lián)盟內(nèi)消費(fèi)者信心與安全，在第三國(guó)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(fàn)圍內(nèi)，已進(jìn)入國(guó)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(fàn)的原則。(24)Itisnecessarytoensurethatfoodandfeedexportedorre-exportedfromtheCommunitycomplieswithCommunitylawortherequirementssetupbytheimportingcountry.Inothercircumstances,foodandfeedcanonlybeexportedorre-exportediftheimportingcountryhasexpresslyagreed.However,itisnecessarytoensurethatevenwherethereisagreementoftheimportingcountry,foodinjurioustohealthorunsafefeedisnotexportedorre-exported.必須確認(rèn)食品及飼料出國(guó)或再次從歐盟出口遵照聯(lián)盟或進(jìn)口國(guó)建立的要求。在其他情況，如果進(jìn)口國(guó)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(rèn)有進(jìn)口國(guó)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(biāo)讓聯(lián)盟發(fā)展國(guó)際標(biāo)準(zhǔn)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(huì)員國(guó)已經(jīng)採(cǎi)用水平立法，尤其對(duì)業(yè)者在市場(chǎng)的責(zé)任，只有食品是安全的。然而，這些會(huì)員國(guó)採(cǎi)用不同的基礎(chǔ)標(biāo)準(zhǔn)去建立是否食品是安全的。這些不同方法，在缺乏其他會(huì)員國(guó)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(duì)上市的安全食品及飼料建立一般要求是必須的，去確認(rèn)這些產(chǎn)品的功效在國(guó)內(nèi)市場(chǎng)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(zé)機(jī)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(dú)立科學(xué)見(jiàn)解，其表示權(quán)責(zé)機(jī)關(guān)多方面責(zé)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(dòng)物健康及福利和植物健康之問(wèn)題。但是，其應(yīng)確保權(quán)責(zé)機(jī)關(guān)專注於食品安全，所以，其關(guān)於動(dòng)物健康、動(dòng)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(xué)意見(jiàn)內(nèi)。權(quán)責(zé)機(jī)關(guān)之任務(wù)應(yīng)包括科學(xué)建議和科學(xué)、技術(shù)上關(guān)於人體營(yíng)養(yǎng)之聯(lián)盟法規(guī)和在聯(lián)盟要求下對(duì)公共安全計(jì)畫溝通之幫助。(37)Sincesomeproductsauthorisedunderfoodlawsuchaspesticidesoradditivesinanimalfeedmayinvolveriskstotheenvironmentortothesafetyofworkers,someenvironmentalandworkerprotectionaspectsshouldalsobeassessedbytheAuthorityinaccordancewiththerelevantlegislation.(37)鑿於某些經(jīng)食品法批準(zhǔn)之產(chǎn)品例如在動(dòng)物飼料中之殺蟲劑或添加物可能有對(duì)環(huán)境或員工安全之風(fēng)險(xiǎn)，其環(huán)境及員工保護(hù)方面也應(yīng)被權(quán)責(zé)機(jī)關(guān)依去有關(guān)之法規(guī)進(jìn)行評(píng)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(xué)評(píng)估和相關(guān)之科學(xué)意見(jiàn)，權(quán)責(zé)機(jī)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(xué)意見(jiàn)，並且不損害在其內(nèi)訂定之程序。(39)TheAuthorityshouldcontributethroughtheprovisionofsupportonscientificmatters,totheCommunity'sandMemberStates'roleinthedevelopmentandestablishmentofinternationalfoodsafetystandardsandtradeagreements.(39)權(quán)責(zé)機(jī)關(guān)應(yīng)在科學(xué)事件上經(jīng)由提供支持，對(duì)聯(lián)盟及會(huì)員國(guó)在國(guó)際食品安全標(biāo)準(zhǔn)及貿(mào)易協(xié)定建立和創(chuàng)建之角色有所貢獻(xiàn)。(40)TheconfidenceoftheCommunityinstitutions,thegeneralpublicandinterestedpartiesintheAuthorityisessential.Forthisreason,itisvitaltoensureitsindependence,highscientificquality,transparencyandefficiency.CooperationwithMemberStatesisalsoindispensable.(40)聯(lián)盟機(jī)構(gòu)一般大眾以及權(quán)責(zé)機(jī)關(guān)內(nèi)有興趣之第三機(jī)構(gòu)之信心是極重要的。為此目的，維持其獨(dú)立性高科學(xué)品質(zhì)透明度和有效性實(shí)不可或缺的。和其他會(huì)員國(guó)合作也是必須的。(41)TothateffecttheManagementBoardshouldbeappointedinsuchawayastosecurethehigheststandardofcompetence,abroadrangeofrelevantexpertise,forinstanceinmanagementandinpublicadministration,andthebroadestpossiblegeographicdistributionwithintheUnion.ThisshouldbefacilitatedbyarotationofthedifferentcountriesoforiginofthemembersoftheManagementBoardwithoutanypostbeingreservedfornationalsofanyspecificMemberState.(41)為此，管理會(huì)應(yīng)基於鞏固權(quán)責(zé)之最高標(biāo)準(zhǔn)，大範(fàn)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(kuò)之可能的地理分布。此管理可經(jīng)由沒(méi)有任何特一會(huì)員國(guó)經(jīng)營(yíng)。並由管理會(huì)不同國(guó)家之成員的輪替管理。(42)TheAuthorityshouldhavethemeanstoperformallthetasksrequiredtoenableittocarryoutitsrole.(42)權(quán)責(zé)機(jī)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(huì)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(guò)經(jīng)濟(jì)法令、指定科學(xué)小組成員和執(zhí)行組長(zhǎng)。(44)TheAuthorityshouldcooperatecloselywithcompetentbodiesintheMemberStatesifitistooperateeffectively.AnAdvisoryForumshouldbecreatedinordertoadvisetheExecutiveDirector,toconstituteamechanismofexchangeofinformation,andtoensureclosecooperationinparticularwithregardtothenetworkingsystem.Cooperationandappropriateexchangeofinformationshouldalsominimisethepotentialfordivergingscientificopinions.(44)權(quán)責(zé)機(jī)關(guān)如果要有效的執(zhí)行，應(yīng)和會(huì)員國(guó)之權(quán)責(zé)機(jī)構(gòu)密切的合作。一諮詢討論會(huì)應(yīng)被創(chuàng)建以建議其執(zhí)行組長(zhǎng)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(zé)機(jī)關(guān)應(yīng)接管委員會(huì)之科學(xué)委員會(huì)在其權(quán)責(zé)內(nèi)發(fā)布之科學(xué)意見(jiàn)。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(xué)一致性以及使其能夠更有效的工作。應(yīng)因此在權(quán)責(zé)範(fàn)圍內(nèi)建立一科學(xué)委員會(huì)和永久科學(xué)小組。(46)Inordertoguaranteeindependence,membersoftheScientificCommitteeandPanelsshouldbeindependentscientistsrecruitedonthebasisofanopenapplicationprocedure.(46)為了保證獨(dú)立性，科學(xué)委員會(huì)之成員和小組應(yīng)為公開(kāi)徵招之獨(dú)立科學(xué)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