ec1935_2004食品接觸類原料和制品(歐盟)1935_2004指令_中英文整理版

1、1REGULATION(EC)No19352004OFTHEEUROPEANPARLIAMENTOFTHECOUNCILof27October2004onmaterialsarticlesintendedtocomeintocontactwithfoodrepealingDirectives80590EEC89109EEC2004年10月27日發(fā)布關(guān)于食品接觸類原料和物料的歐日發(fā)布關(guān)于食品接觸類原料和物料的歐盟19352004指令，同時

2、撤銷原歐洲共同體指令，同時撤銷原歐洲共同體80590和89109指令指令THEEUROPEANPARLIAMENTTHECOUNCILOFTHEEUROPEANUNION歐洲議會與理事會HavingregardtotheTreatyestablishingtheEuropeanCommunityinparticularArticle95thereof注意到建立歐洲共同體的《條約》，特別是第95條Havingregardtotheprop

3、osalfromtheCommission注意到委員會的提案HavingregardtotheopinionoftheEuropeanEconomicSocialCommittee(1)注意到歐洲經(jīng)濟(jì)和社會委員會的意見（1）ActinginaccdancewiththeprocedurelaiddowninArticle251oftheTreaty(2)按照《條約》第251條規(guī)定的程序（2）Whereas:鑒于(1)CouncilDir

4、ective89109EECof21December1988ontheapproximationofthelawsoftheMemberStatesrelatingtomaterialsarticlesintendedtocomeintocontactwithfoodstuffs(3)establishedgeneralprinciplesfeliminatingthedifferencesbetweenthelawsoftheMemb

5、erStatesasregardsthosematerialsarticlesprovidedftheadoptionofimplementingdirectivesconcerningspecificgroupsofmaterialsarticles(specificdirectives).Thisapproachwassuccessfulshouldbecontinued.理事會1988年12月21日的指令89109EEC關(guān)于統(tǒng)一各

6、成員國材料和制品用于接觸食品的法律，為消除各成員國關(guān)于這些原料和物料制定的差異，以及為特定材料和物品（具體指令）提供通過執(zhí)行的指令而建立的一般原則。這種做法是成功的并會延續(xù)下去。(2)ThespecificdirectivesadoptedunderDirective89109EECingeneralcontainprovisionswhichleavelittleroomftheexerciseofdiscretionbytheMem

7、berStatesintheirtranspositionbesidesbeingsubjecttofrequentamendmentsrequiredtoadaptthemrapidlytotechnologicalprogress.Itshouldtherefebepossiblefsuchmeasurestotakethefmofregulationsdecisions.Atthesametimeitisappropriateto

8、includeanumberofadditionalsubjects.Directive89109EECshouldtherefebereplaced.具體通過89109EEC的指令一般來說囊括的規(guī)定都沒有空間讓成員國在法律移植上斟酌運用，除了遇到要求快速適應(yīng)技術(shù)上進(jìn)步的常見修正。因此，這應(yīng)當(dāng)可以采用相關(guān)方法決定規(guī)章或決議的形式。同時，添加額外的項目是可取的。89109EEC指令因此被取代。(3)Theprincipleunderlyi

9、ngthisRegulationisthatanymaterialarticleintendedtocomeintocontactdirectlyindirectlywithfoodmustbesufficientlyinerttoprecludesubstancesfrombeingtransferredtofoodinquantitieslargeenoughtoendangerhumanhealthtobringaboutanun

10、acceptablechangeinthecompositionofthefoodadeteriationinitsganolepticproperties.此規(guī)章的基本原則是任何用于直接或間接接觸食物原料或物件對于在傳輸一定數(shù)量食物過程中危害人類健康或者給食物結(jié)構(gòu)帶來不可接受的改變或者惡化其感官作用的物質(zhì)呈現(xiàn)充分的惰性反應(yīng)。(4)Newtypesofmaterialsarticlesdesignedtoactivelymaintain

11、improvetheconditionofthefood(activefoodcontactmaterialsarticles)arenotinertbytheirdesignunliketraditionalmaterialsarticlesintendedtocomeintocontactwithfood.Othertypesofnewmaterialsarticlesaredesignedtomonittheconditionof

12、thefood(intelligentfoodcontactmaterialsarticles).Boththesetypesofmaterialsarticlesmaybebroughtintocontactwithfood.Itistherefenecessaryfreasonsofclaritylegalcertaintyfactiveintelligentfoodcontactmaterialsarticlestobeinclu

13、dedinthescopeofthisRegulationthemainrequirementsftheirusetobeestablished.Furtherrequirementsshouldbestatedinspecificmeasurestoincludepositivelistsofauthizedsubstancesmaterialsarticleswhichshouldbeadoptedassoonaspossible.

14、所有旨在積極保持或提高食品（活性食品接觸的原料或物件）狀況的新款式的原料或物件在設(shè)計過程中必須呈現(xiàn)惰性，不同于以往新原料或物件會接觸到食物。其他新原料或物件需用于監(jiān)測食品（智能型食品接觸的原料或物件）狀況。這兩種原料或物件可能會接觸到食物。所以，出于明確原因和合法性，對于活性食品和智能型食品的接觸原料或物件都在此規(guī)章范圍內(nèi)，3arenotintendedtobeconsumedtogetherwithsuchfood.可能和食物一起使用

15、的組成部分覆蓋原料或涂料表層不適合這條規(guī)章的范圍。另一方面，這條規(guī)章應(yīng)該適用于那些非組成部分的且不一起消費使用的涂層原料如蓋住乳酪皮、預(yù)加工肉產(chǎn)品或者水果的涂料表層。(10)ItisnecessarytolaydownvarioustypesofrestrictionsconditionsftheuseofthematerialsarticlescoveredbythisRegulationthesubstancesusedinthei

16、rmanufacture.Itisappropriatetoestablishthoserestrictionsconditionsinspecificmeasureshavingregardtothetechnologicalacteristicsspecifictoeachgroupofmaterialsarticles.對此規(guī)章覆蓋的原料和物件的使用情況和其生產(chǎn)過程中使用的材料，制定不同類型限制和制約是非常必要的。對各組原料和物件

17、的具體關(guān)于技術(shù)性質(zhì)細(xì)節(jié)的措施建立限制條件是合適的。(11)PursuanttoRegulation(EC)No1782002oftheEuropeanParliamentoftheCouncilof28January2002layingdownthegeneralprinciplesrequirementsoffoodlawestablishingtheEuropeanFoodSafetyAuthitylayingdownprocedu

18、resinmattersoffoodsafety(1)theEuropeanFoodSafetyAuthity(theAuthity)shouldbeconsultedbefeprovisionsliabletoaffectpublichealthareadoptedunderspecificmeasures.(11)按照歐盟議會的(EC)No.1782002規(guī)章和2002年1月28日委員會擬定總則和食品法律的要求，建立歐洲食品安全局并

19、且對有關(guān)食品安全擬定程序(1)在具體措施下影響公眾健康的規(guī)定采用前，需要咨詢歐洲食品安全局的意見。(12)WhenspecificmeasuresincludealistofsubstancesauthizedwithintheCommunityfuseinthemanufactureofmaterialsarticlesintendedtocomeintocontactwithfoodthosesubstancesshouldunde

20、rgoasafetyassessmentpritotheirauthisation.ThesafetyassessmentauthisationofthosesubstancesshouldbewithoutprejudicetotherelevantrequirementsoftheCommunitylegislationconcerningtheregistrationevaluationauthizationrestriction

21、ofchemicals.當(dāng)具體措施包括用于生產(chǎn)接觸食品類的原料和物件的一系列社區(qū)授權(quán)物質(zhì)，這些物質(zhì)必須經(jīng)過安全評估階段才能獲得授權(quán)。這些物質(zhì)的安全評估和授權(quán)必須不影響共同體就注冊、評估、授權(quán)和化學(xué)限制的相關(guān)立法要求。(13)Differencesbetweennationallawsregulationsadministrativeprovisionsconcerningthesafetyassessmentauthisationofs

22、ubstancesusedinthemanufactureofmaterialsarticlesintendedtocomeintocontactwithfoodmayhinderthefreemovementofthosematerialsarticlescreatingconditionsofunequalunfaircompetition.Anauthisationprocedureshouldtherefebeestablish

23、edatCommunitylevel.IndertoensureharmonizedsafetyassessmentofthosesubstancestheAuthityshouldcarryoutsuchassessments.國家法律、規(guī)章和管理條例對在接觸食品的原料和物質(zhì)生產(chǎn)過程中所用的物質(zhì)的安全評估和授權(quán)的規(guī)定差別，會阻礙這些原料和物件的自由活動，產(chǎn)生不平等和不公平的競爭。因此審定程序須在社區(qū)水平上建立。為了保證這些物質(zhì)安全評估

24、協(xié)調(diào)，食品安全局須執(zhí)行這樣的評估。(14)ThesafetyassessmentofsubstancesshouldbefollowedbyariskmanagementdecisionastowhetherthosesubstancesshouldbeenteredonaCommunitylistofauthizedsubstances.物質(zhì)的安全評估必須遵循風(fēng)險管理決定，不管這些物質(zhì)是否列入社區(qū)授權(quán)目錄(15)Itisappropr

25、iatetoprovidefthepossibilityofanadministrativereviewofspecificactsomissionsonthepartoftheAuthityunderthisRegulation.ThisreviewshouldbewithoutprejudicetotheroleoftheAuthityasanindependentscientificpointofreferenceinriskas

26、sessment.就此規(guī)章下的安全局而言，為具體作為或不作為的，提供可能性管理檢閱是合適的。這種檢閱在風(fēng)險評估中作為獨立的科學(xué)參考點，對于安全局的角色不能有任何偏倚。(16)Labellingsupptsusersinthecrectuseofthematerialsarticles.Methodsusedfsuchlabellingmayvaryaccdingtotheuser.標(biāo)簽支持用戶正確使用原料和物件。標(biāo)簽的使用方法可以根據(jù)用

27、戶做相應(yīng)的改變。(17)CommissionDirective80590EEC(2)introducedasymbolthatmayaccompanymaterialsarticlesintendedtocomeintocontactwithfoodstuffs.ThissymbolshouldfreasonsofsimplicitybeincpatedinthisRegulation.委托指令的80590EEC(2)采用一種符號可以伴

28、隨接觸食品的原料和物件。這各符號出于簡化的原因，應(yīng)該被并入這條規(guī)章里。(18)Thetraceabilityofmaterialsarticlesintendedtocomeintocontactwithfoodshouldbeensuredatallstagesindertofacilitatecontroltherecallofdefectiveproductsconsumerinfmationtheattributionofres

29、ponsibility.Businessoperatsshouldatleastbeabletoidentifythebusinessesfromwhichtowhichthematerialsarticlesaresupplied.(1)OJL311.2.2002p.1.RegulationasamendedbyRegulation(EC)No16422003(OJL24529.9.2003p.4).(2)CommissionDire