EC193食品接触类原料和制品欧盟193指令中英文整理版.docx
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EC193食品接触类原料和制品欧盟193指令中英文整理版
REGULATION(EC)No1935/2004OFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of27October2004
onmaterialsandarticlesintendedtocomeintocontactwithfoodandrepealingDirectives80/590/EECand89/109/EEC
2004年10月27日发布关于食品接触类原料和物料的欧盟1935/2004指令,同时撤销原欧洲共同体80/590和89/109指令
THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEAN
UNION,欧洲议会与理事会
HavingregardtotheTreatyestablishingtheEuropeanCommunity,
andinparticularArticle95thereof,
注意到建立欧洲共同体的《条约》,特别是第95条
HavingregardtotheproposalfromtheCommission,
注意到委员会的提案
HavingregardtotheopinionoftheEuropeanEconomicand
SocialCommittee
(1),
注意到欧洲经济和社会委员会的意见
(1)
ActinginaccordancewiththeprocedurelaiddowninArticle251
oftheTreaty
(2),
按照《条约》第251条规定的程序
(2)
Whereas:
鉴于
(1)CouncilDirective89/109/EECof21December1988ontheapproximationofthelawsoftheMemberStatesrelatingtomaterialsandarticlesintendedtocomeintocontactwithfoodstuffs(3)establishedgeneralprinciplesforeliminatingthedifferencesbetweenthelawsoftheMemberStatesasregardsthosematerialsandarticlesandprovidedfortheadoptionofimplementingdirectivesconcerningspecificgroupsofmaterialsandarticles(specificdirectives).Thisapproachwassuccessfulandshouldbecontinued.
理事会1988年12月21日的指令89/109/EEC关于统一各成员国材料和制品用于接触食品的法律,为消除各成员国关于这些原料和物料制定的差异,以及为特定材料和物品(具体指令)提供通过执行的指令而建立的一般原则。
这种做法是成功的并会延续下去。
(2)ThespecificdirectivesadoptedunderDirective89/109/EECingeneralcontainprovisionswhichleavelittleroomfortheexerciseofdiscretionbytheMember
Statesintheirtranspositionbesidesbeingsubjecttofrequentamendmentsrequiredtoadaptthemrapidlytotechnologicalprogress.Itshouldthereforebepossibleforsuchmeasurestotaketheformofregulationsordecisions.Atthesametimeitisappropriatetoincludeanumberofadditionalsubjects.Directive89/109/EECshouldthereforebereplaced.
具体通过89/109/EEC的指令一般来说囊括的规定都没有空间让成员国在法律移植上斟酌运用,除了遇到要求快速适应技术上进步的常见修正。
因此,这应当可以采用相关方法决定规章或决议的形式。
同时,添加额外的项目是可取的。
89/109/EEC指令因此被取代。
(3)TheprincipleunderlyingthisRegulationisthatanymaterialorarticleintendedtocomeintocontactdirectlyorindirectlywithfoodmustbesufficientlyinerttoprecludesubstancesfrombeingtransferredtofoodinquantitieslargeenoughtoendangerhumanhealthortobringaboutanunacceptablechangeinthecompositionofthefoodoradeteriorationinitsorganolepticproperties.
此规章的基本原则是任何用于直接或间接接触食物原料或物件对于在传输一定数量食物过程中危害人类健康或者给食物结构带来不可接受的改变或者恶化其感官作用的物质呈现充分的惰性反应。
(4)Newtypesofmaterialsandarticlesdesignedtoactivelymaintainorimprovetheconditionofthefood(activefoodcontactmaterialsandarticles)arenotinertbytheirdesign,unliketraditionalmaterialsandarticlesintendedtocomeintocontactwithfood.Othertypesofnewmaterialsandarticlesaredesignedtomonitortheconditionofthefood(intelligentfoodcontactmaterialsandarticles).Boththesetypesofmaterialsandarticlesmaybebroughtintocontactwithfood.Itisthereforenecessary,forreasonsofclarityandlegalcertainty,foractiveandintelligentfoodcontactmaterialsandarticlestobeincludedinthescopeofthisRegulationandthemainrequirementsfortheirusetobeestablished.Furtherrequirementsshouldbestatedinspecificmeasures,toincludepositivelistsofauthorizedsubstancesand/ormaterialsandarticles,whichshouldbeadoptedassoonaspossible.
所有旨在积极保持或提高食品(活性食品接触的原料或物件)状况的新款式的原料或物件在设计过程中必须呈现惰性,不同于以往新原料或物件会接触到食物。
其他新原料或物件需用于监测食品(智能型食品接触的原料或物件)状况。
这两种原料或物件可能会接触到食物。
所以,出于明确原因和合法性,对于活性食品和智能型食品的接触原料或物件都在此规章范围内,以及它们使用的主要要求也有明确规定。
那些尽快被采用的进一步要求包括授权物质和原料或物件的准许进口货单将规定在具体措施中。
(5)Activefoodcontactmaterialsandarticlesaredesignedtodeliberatelyincorporate‘active’componentsintendedtobereleasedintothefoodortoabsorbsubstancesfromthefood.Theyshouldbedistinguishedfrommaterialsandarticleswhicharetraditionallyusedtoreleasetheirnaturalingredientsintospecifictypesoffoodduringtheprocessoftheirmanufacture,suchaswoodenbarrels.
活性食品接触的原料或物件旨在有意的吸收释放到食物中的“活性”成分或者从食物中吸收物质。
它们在生产过程中,如木桶的生产,必须区分那些传统用于释放天然配料到具体食物中的原料与物件。
(6)ActivefoodcontactmaterialsandarticlesmaychangethecompositionortheorganolepticpropertiesofthefoodonlyifthechangescomplywiththeCommunityprovisionsapplicabletofood,suchastheprovisionsofDirective89/107/EEC(4)onfoodadditives.Inparticular,substancessuchasfoodadditivesdeliberatelyincorporatedintocertainactivefoodcontactmaterialsandarticlesforreleaseintopackagedfoodsortheenvironmentsurroundingsuchfoods,shouldbeauthorisedundertherelevantCommunityprovisionsapplicabletofoodandalsobesubjecttootherruleswhichwillbeestablishedinaspecificmeasure.
活性食品接触的原料或物件当且只有符合食品的社区规定,如89/107/EEC(4)指令中的食品规定,才可以改变其成分或感官特性。
特别是某些特定的活性食品的食品添加剂所接触的原料和物件释放到包装上或周围的环境等,应当授权于相应的食品社区规定同时要遵循即将成立的具体措施规定。
(1)OJC117,30.4.2004,p.1.
(2)OpinionoftheEuropeanParliamentof31March2004(notyetpublishedintheOfficialJournal)andCouncilDecisionof14October2004.
2004年3月31日的欧盟议会意见(还没在官方期刊出版)和2004年10月14日理事会决议
(3)OJL40,11.2.1989,p.38.DirectiveasamendedbyRegulation(EC)No1882/2003oftheEuropeanParliamentandoftheCouncil(OJL284,31.10.2003,p.1)
指令由欧盟议会和理事会的1882/2003规章修改
.(4)CouncilDirective89/107/EECof21December1988ontheapproximationofthelawsoftheMemberStatesconcerningfoodadditivesauthorisedforuseinfoodstuffsintendedforhumanconsumption(OJL40,11.2.1989,p.27).DirectiveaslastamendedbyRegulation(EC)No1882/2003.L338/4ENOfficialJournaloftheEuropeanUnion13.11.2004
理事会1988年12月21日的指令89/109/EEC关于统一各成员国授权使用添加剂的法律(OJL40,11.2.1989,p.27)。
指令最后由13.11.2004官方期刊的No1882/2003.L338/4规章修正
Inaddition,adequatelabellingorinformationshouldsupportusersinthesafeandcorrectuseofactivematerialsandarticlesincompliancewiththefoodlegislation,includingtheprovisionsonfoodlabelling.
除此以外,提供充足的满足食品法规的标签或者信息支持用户处于安全和活性原料和物件的正确使用
(7)Activeandintelligentfoodcontactmaterialsandarticlesshouldnotchangethecompositionortheorganolepticpropertiesoffoodorgiveinformationabouttheconditionofthefoodthatcouldmisleadconsumers.Forexample,activefoodcontactmaterialsandarticlesshouldnotreleaseorabsorbsubstancessuchasaldehydesoraminesinordertomaskanincipientspoilageofthefood.Suchchangeswhichcouldmanipulatesignsofspoilagecouldmisleadtheconsumerandtheyshouldthereforenotbeallowed.
活跃性和智能型的食品触点原料和物件不应该改变其组成或者食品的感官特性或者给关于能误导消费者食品状态的信息。
例如,活跃性食品触点原料和物件不应该释放或者吸收像乙醛或者胺那样的物质从而为了掩饰食品的开始变化。
这样能操纵变质迹象的变化能误导消费者,因此不被允许。
Similarly,activefoodcontactmaterialsandarticleswhichproducecolourchangestothefoodthatgivethewronginformationconcerningtheconditionofthefoodcouldmisleadtheconsumerandthereforeshouldnotbeallowedeither.
与此类似,活性食品触点原料和物件换乘错了信息关于食品的状态可能误导消费者的给的食品,因此也不被允许。
(8)AnymaterialorarticleintendedtocomeintocontactwithfoodwhichisplacedonthemarketshouldcomplywiththerequirementsofthisRegulation.Nevertheless,materialsandarticlessuppliedasantiquesshouldbeexcludedastheyareavailableinrestrictedquantitiesandtheircontactwithfoodisthereforelimited.
所有要接触食品的原料或物件在投入市场前需要符合这条规章的要求。
虽然如此,视为古董的原料或物件排除在一定限制数量内是被允许的情况,因此接触食品也是被限制的。
(9)CoveringorcoatingmaterialsformingpartofthefoodandpossiblybeingconsumedwithitshouldnotfallwithinthescopeofthisRegulation.Ontheotherhand,thisRegulationshouldapplytocoveringorcoatingmaterialswhichcovercheeserinds,preparedmeatproductsorfruitbutwhichdonotformpartoffoodandarenotintendedtobeconsumedtogetherwithsuchfood.
可能和食物一起使用的组成部分覆盖原料或涂料表层不适合这条规章的范围。
另一方面,这条规章应该适用于那些非组成部分的且不一起消费使用的涂层原料如盖住乳酪皮、预加工肉产品或者水果的涂料表层。
(10)ItisnecessarytolaydownvarioustypesofrestrictionsandconditionsfortheuseofthematerialsandarticlescoveredbythisRegulationandthesubstancesusedintheirmanufacture.Itisappropriatetoestablishthoserestrictionsandconditionsinspecificmeasureshavingregardtothetechnologicalcharacteristicsspecifictoeachgroupofmaterialsandarticles.
对此规章覆盖的原料和物件的使用情况和其生产过程中使用的材料,制定不同类型限制和制约是非常必要的。
对各组原料和物件的具体关于技术性质细节的措施建立限制条件是合适的。
(11)PursuanttoRegulation(EC)No178/2002oftheEuropeanParliamentandoftheCouncilof28January2002layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishingtheEuropeanFoodSafetyAuthorityandlayingdownproceduresinmattersoffoodsafety
(1),theEuropeanFoodSafetyAuthority(theAuthority)shouldbeconsultedbeforeprovisionsliabletoaffectpublichealthareadoptedunderspecificmeasures.
(11)按照欧盟议会的(EC)No.178/2002规章和2002年1月28日委员会拟定总则和食品法律的要求,建立欧洲食品安全局并且对有关食品安全拟定程序
(1),在具体措施下影响公众健康的规定采用前,需要咨询欧洲食品安全局的意见。
(12)WhenspecificmeasuresincludealistofsubstancesauthorizedwithintheCommunityforuseinthemanufactureofmaterialsandarticlesintendedtocomeintocontactwithfood,thosesubstancesshouldundergoasafetyassessmentpriortotheirauthorisation.ThesafetyassessmentandauthorisationofthosesubstancesshouldbewithoutprejudicetotherelevantrequirementsoftheCommunitylegislationconcerningtheregistration,evaluation,authorizationandrestrictionofchemicals.
当具体措施包括用于生产接触食品类的原料和物件的一系列社区授权物质,这些物质必须经过安全评估阶段才能获得授权。
这些物质的安全评估和授权必须不影响共同体就注册、评估、授权和化学限制的相关立法要求。
(13)Differencesbetweennationallaws,regulationsandadministrativeprovisionsconcerningthesafetyassessmentandauthorisationofsubstancesusedinthemanufactureofmaterialsandarticlesintendedtocomeintocontactwithfoodmayhinderthefreemovementofthosematerialsandarticles,creatingconditionsofunequalandunfaircompetition.AnauthorisationprocedureshouldthereforebeestablishedatCommunitylev