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,BruceZhang张学华SHSGSHGLab,FoodContactMaterialGerneralIntroduction,食品接触材料介绍,Whatourproductsdotoourfood?我们的产品对食物有何影响?,FCMRegulationIntroduction食品接触材料法规介绍,TestMethodBasis测试基础,Whataffectchemicalmigration?什么因素影响测试结果?,FoodContactMaterialGerneralIntroduction与食品接触材料介绍,Whatourproductsdotoourfood?我们的产品对食物有何影响?,Foodandbeveragescanbeveryaggressiveproductsandmayinteractstronglywithmaterialsthattheytouch.食物和饮料有时候具有很强的“进攻性”,可以与食品接触材料发生强烈的作用。,*,Infact,nofoodcontactmaterialiscompletelyinertandsoitispossiblefortheirchemicalconstituentstomigrateintothepackagedfood.Metals,glass,ceramics,plastics,rubberandpapercanallreleaseminuteamountsoftheirchemicalconstituentswhentheytouchcertaintypesoffoods.实际上,没有材料是完全钝化的,总有可能材料中的物质迁移至食物中。金属、玻璃、陶瓷、塑料、橡胶、纸张可以释放微量的化学成份进入食物。,*1,Whatourproductsdotoourfood?我们的产品对食物有何影响?,Ceramicarticlesmayposearisktotheconsumerthroughheavymetalsusedintheglazingandcolouring.陶瓷通过其釉彩和着色剂对使用者产生威胁。,*,Whatourproductsdotoourfood?我们的产品对食物有何影响?,Inthe1980sitbecameevidentthatrubberteatsandsoothersmayreleasecarcinogenicnitrosamines,whicharereactionanddegradationproductsfromacceleratorsandstabilisersusedintherubber.上世纪80年代,有证据表明橡胶奶头和安抚奶嘴可以释放致癌的亚硝胺,它是橡胶引发剂和稳定剂反应和分解的产物。,*,Whatourproductsdotoourfood?我们的产品对食物有何影响?,Chemicalmigrationisalwaysundesirableandifnotcontrolleditcouldbehazardoustothehealthofconsumer.人们总不想材料中的化学物质进入食物当中,如果控制不当,将会对人体健康产生影响。,*2,Whatourproductsdotoourfood?我们的产品对食物有何影响?,Ithasbeenestimatedthattheper-capitauseofpackagingmaterialsforretailfoodstuffssoldintheEUcountriesisabout1200cm2perpersonperday.据估计,在欧洲每人每天食用的零售食物,与食物接触材料接触的面积大约为1200平方厘米。,*,Whatourproductsdotoourfood?我们的产品对食物有何影响?,Allpartiesinvolvedintheproduction,transport,sellingandconsumptionoffoodsneedtobeawareofthepotentialforchemicalmigrationandwaysofminimisingit.所有与食物的生产、运输、销售等相关的企业都需要意识到食品接触材料化学迁移的危害,都有义务尽量进少此类迁移。primarymanufacturersofrawmaterials,e.g.,polymerandpapermanufacturersconverterswhoturntherawmaterialintopackagingforfoodusevendorsofthematerials,e.g.,retailersofarticles,supplycompaniesusersofthematerialthefoodpackerfoodretailersenforcementauthoritiesconsumerswithrespecttotheproperusebothofpre-packagedfoodsandofmaterialsandarticlesusedinthehome.,*,Whatourproductsdotoourfood?我们的产品对食物有何影响?,LawStructure法规构架CommunitylegislationwhichisadoptedbytheEUandnationallegislationadoptedbytheMemberStates,soaRegulationisdirectlyapplicableineachMemberState.欧洲的颁布的法令,将在欧盟成员国中直接执行。Directiveshavetobetransposedintonationallawwithtranspositiontimesofupto18months.欧盟的指令,需要在欧盟成员国中转化本国的法律执行,并有最多为18个月的过渡期。,*,FCMRegulationIntroduction食品接触材料法规介绍,TheFrameworkRegulation(EC)No1935/2004setsoutthegeneralprinciplesthatapplytomaterialsincontactwithfood.欧盟法令(EC)No1935/2004是欧盟食品级接触材料所有指令的框架性法令,规定了食品级材料应该遵循的基本原则。Detailsforimplementingthesegeneralrulestakingaccountofthespecificrisksoftheindividualmaterialisgiveninthespecificlegislation.本法令的具体实施,要考虑到特定材料的特定风险,这些会在具体的指令中得以体现。,*,FCMRegulationIntroduction食品接触材料法规介绍,Thislistcomprises17differentmaterials.OnlyafewareyetcoveredbyspecificCommunitylegislation.本表罗列了17中不同的材料,只有一小部分被欧盟指令明确涵盖。,FCMRegulationIntroduction食品接触材料法规介绍,Communitylegislationwasintroducedtoharmonisenationallegislationandtoremovebarrierstotrade.制定这些指令是为了统一各成员国的立法,消除贸易障碍。MemberStateslegislationisbasedondifferentprinciplesandthiscanstillbeobservedinthoseareaswhicharenotyetcoveredbyCommunitylegislation.个成员国有不同的立法原则,这一点目前仍然能够在欧盟指令没有涵盖的领域可以看到。,*,FCMRegulationIntroduction食品接触材料法规介绍,Mostofthe25MemberStatesdonothavespecificnationalrules.大多数成员国没有自己特有的国家法律。NewerEUMemberStatesreplacedtheirnationallegislationwithCommunitylegislationbeforeaccessiontotheEU.欧盟新成员国在进入欧盟前,需要提前修改本国法律,以与欧盟指令一致。MemberStatesthatdonothavespecificnationallegislationonfoodcontactmaterialswillsometimesrefertootherMemberStateslegislation,suchasDutchwarenwetortheGermanrecommendations,whentestingforsafetycompliance.没有特有食品接触材料安全法律的成员国,通常会借鉴其他国家的食品接触材料安全法律。,*,FCMRegulationIntroduction食品接触材料法规介绍,FCMRegulationIntroduction食品接触材料法规介绍,FCMRegulationIntroduction食品接触材料法规介绍,FCMRegulationIntroduction食品接触材料法规介绍,Norway,IcelandandLiechtenstein,aspartoftheEuropeanEconomicArea(EEA),alsoapplytheCommunitylegislationwhilekeepingadditionalnationallegislation.SwitzerlandhasadoptedregulationscorrespondingtotheCommunitylegislation.挪威、冰岛、列支敦士登作为欧洲经济区的一部分,也采用欧盟的食品接触材料安全指令。,*,FCMRegulationIntroduction食品接触材料法规介绍,MemberStatesDuty成员国的义务MemberStateshavetheresponsibilityforenforcingtheCommunityandtheirownnationallegislationandmustmonitorthattherequirementsofthelegislationarefulfilledbythebusinessoperators(generalfoodlaw).成员国有责任执行欧盟的指令,并监控商业机构遵守食品接触材料安全要求。,*,FCMRegulationIntroduction食品接触材料法规介绍,MemberStateshavetolaydownacatalogueofsanctionsandmeasuresincludingdissuasivepenaltiesfornon-conformitywiththefoodlegislation.成员国必须制定一系列措施食品接触材料安全要求得以实施。ThemeasurestakenbyMemberStatesmayincludeprohibitingplacementonthemarket;theymayorderandmonitorwithdrawalofgoodsfromthemarket,recallanddestruction.Officialcontrolcancoverthefollowingactions:monitoring,surveillance,verification,audit,inspection,samplingandanalysis.这些措施包括禁止投放市场,成员国可能监控、责令停销问题产品,召回或者销毁它们。这些措施还包括监督、认可、检验、抽样、测试等。,*,FCMRegulationIntroduction食品接触材料法规介绍,Furthermoretheyhavetherighttodetainconsignmentsfromthirdcountries.海关也可扣押可疑货物。,*,FCMRegulationIntroduction食品接触材料法规介绍,WhenMemberStatestakemeasuresthataffectotherMemberStates,suchaswithdrawalfromthemarketwhenthearticleoriginatesfrom,orisdistributedto,anotherMemberState,theyshouldinformtheCommissionandtheotherMemberStatesviatheelectronicRapidAlertSystemforfeedandfood(RASFF).当一个成员国发生回收,应通报欧盟的快速警戒系统,本系统会通知其他各欧盟成员国。,*,FCMRegulationIntroduction食品接触材料法规介绍,*,Thismeanstheyhavetomakesurethatsubstancestheyuseinthefoodcontactmaterialareauthorised(ifpositivelistsexist)and/orarenottransferredintofoodinconcentrationsthatposeadangertohumanhealth.Theyhavetoconfirmthisinadeclarationofcompliance.以上措施表明,商家必须使用许可的材料,并保证材料不得迁移出对人体有害的化学物质。,FCMRegulationIntroduction食品接触材料法规介绍,*,Theconsumersshouldbeinformedon:消费者应被通知到:(i)thesuitabilityoftheproductforfoodcontact(tothispurposeasymbolrepresentingaglassandforkcanbeused);本产品适合与食物接触。(ii)thepersonresponsibleformanufactureorplacingonthemarketoftheproduct;商家负责人。(iii)instructionsforthesafeuseoftheproduct;产品安全使用说明。(iv)meansofidentificationoftheproductfortraceability.产品的识别的追溯。,FCMRegulationIntroduction食品接触材料法规介绍,*,Definitionsoftraceability追溯的定义。theabilitytogobackinthehistoryofafoodcontactmaterialorarticle,fromtheretailstagebacktothepointofitsmanufacturing,identifyingallappropriateinformation.,FCMRegulationIntroduction食品接触材料法规介绍,*,Obviously,traceabilitycanbeattainedonlyiftheidentificationelementsofeachoftheaboverawmaterialsareproperlyobtainedbytherelevantsuppliers,butthemostdifficultpartconsistsofthemanagementofsuchidentificationelementsinthevariousstepsofstorage,transformationandwarehousingoffinishedgoods.,FCMRegulationIntroduction食品接触材料法规介绍,2019/12/15,27,可编辑,*,WhatisFoodContactMaterial什么是食品接触材料?materialsthatarealreadyincontactwithfoodsuchasthepackagingofpre-packagedfood;materialsthatareintendedtocomeintocontactwithfood,suchascups,dishes,cutlery,foodpackagingnotyetinuse;materialsthatcanreasonablybeexpectedtobebroughtintocontactwithfoodsuchastablesurfacesinfoodpreparationareasortheinnerwallsandshelvesofarefrigerator;andmaterialsthatcanreasonablybeexpectedtotransfertheirconstituentstofoodsuchasacardboardboxaroundaplasticbagofcereals.,TestMethodBasis测试基础,*,Conventionaltestingfollowsthefollowingdiscretesteps:食品接触材料测试的几个步骤:1.Gatheringinformationaboutthecompositionofthematerial收集材料信息2.Selectrelevantlegislation筛选适合法规3.Checkwhethercompositionisinaccordancewiththelegislation检查成份是否和法规要求4.Performanceoftherelevanttests测试Besidescomplianceofaproductscompositionwithlegislation,oneneedstodemonstratethattheproductcomplieswiththelimitssetforoverallmigration,specificmigration,residualcontentandrequirements.,TestMethodBasis测试基础,*,PlasticsfoodcontactmaterialsandarticlesshouldcomplywithDirective2002/72/ECanditsamendmentsthatinclude:2002/72/EC的限制要求anoverallmigrationlimit(OML)specificmigrationlimits(SMLs)onmonomersspecificmigrationlimits(SMLs)onadditivescompositionallimits(QMs)onsomemonomers.,TestMethodBasis测试基础,TestMethodBasis测试基础,TestMethodBasis测试基础,TestMethodBasis测试基础,TestMethodBasis测试基础,TestMethodBasis测试基础,*,Fromtheavailabletoxicityandmigrationdata,aspecificmigrationlimit(SML)isderivedandseveralassumptionsaremade:基于已知的毒性和迁移数据,特殊迁移限值(SML)是通过下列假设制定的:1kgoffoodeateneveryday1kgoffoodcorrespondsto6dm2ofpackagingpackagingalwayscontainsthesubstancemigrationofthesubstanceatSMLconsumerbodyweightof60kg.,TestMethodBasis测试基础,*,Toavoidpossibleargumentsaboutwhatkindoffoodshouldbechosentoperformmigrationtesting,EUlegislatorshaveagreedonfourfoodsimulants,whichareabletomimicfoods:为防止关于食物类型的争论,欧盟规定了四种食物模拟液:SimulantA,water,mimickingaqueousfoodstuffsSimulantB,3%aceticacid,mimickingacidicfoodstuffsSimulantC,10%ethanol,mimickingalcoholicfoodstuffsSimulantD,oliveoil,oranotherapprovedoil,mimickingfattyfoodstuffs.,TestMethodBasis测试基础,TestMethodBasis测试基础,*,Directive85/572/EECdefineswhichsimulantsneedtobeusedtosimulatecertainfoods.Insomecasesitisnotpossibletouseoliveoilasafoodsimulantbecauseoftechnicalreasonsandalternativesimulantsmaybeusedlikeisooctaneand95%ethanol.85/572/EEC指令规定了模拟液。某些情况下,由于技术原因,不能使用橄榄油模拟液,这是可以使用替代液。,TestMethodBasis测试基础,*,Thereasonfordeterminingoverallmigrationisthatthefoodcontactmaterialmaybringaboutanunacceptablechangeinthecompositionofthefood(Article3oftheframeworkRegulation(EC)1935/2004).Themethodsofdeterminingtheoverallmigrationintotheaqueoussimulants(A,BandC)areasfollows:食品接触材料可能给食物的成份带来不可接受的变化,所以要进行全迁移测试,其步骤如下:Bringthefoodcontactmaterialincontactwiththesimulantforaselectedtimeandtemperature(seesection5.3.1).Separatethesamplefromthesimulantandevaporatethesimulant.Determinetheweightoftheresidueandcalculateoverallmigration.Asaconsequencevolatilechemicals,whichmigrate,arenotincludedintheoverallmigrationvaluefortheaqueoussimulants.,TestMethodBasis测试基础,*,Migrationtestinghastobeperformedunderworstforeseeablecontacttimeandtemperaturefortheenvisagedapplication.Along-termstorageatroomtemperatureis,forexample,representedbystoragefortendaysat40C.测试的条件,通常选择产品使用范围的上限。,TestMethodBasis测试基础,*3,Colourrelease颜色迁移Whenfoodisincontactwithfoodcontactmaterial,thecolourofthefoodcontactmaterialmustremainonthefoodcontactmaterialandmaynotcolourthefood.食品级材料与食物接触时,其颜色不得染污食物。,TestMethodBasis测试基础,*,Volatiles挥发性Forsiliconmaterialssomevolatilecomponentscanremaininthesiliconmaterialafterpolymerisation.Themethodofdeterminationis:对于硅胶类材料,一些挥发性成份会在硅胶合成后残留在材料中,测定的方法是:Preparethesiliconmaterial(cuttoprescribedsizes).Removewaterfromthesiliconmaterialusingwaterfreecalciumchloride.Determinetheweightofthesiliconmaterial.Exposethesiliconmaterialforacertaintimetoacertaintemperature.Determinetheweightofthesiliconmaterial.Calculatetheweightloss.,TestMethodBasis测试基础,Theseareexemplifiedbyhardmaterialssuchasmetals,glassandceramics.一些“硬质”材料具有此特点,比如金属、玻璃、陶瓷。,Whataffectchemicalmigration?什么因素影响测试结果?,Theseareexemplifiedbyplasticmaterialssuchasplastics,rubbersandelastomers.一些合成材料具有此特点,比如塑料、橡胶、弹性体等。,Whataffectchemicalmigration?什么因素影响测试结果?,Exemplifiedbypaperandboardmaterialswithaheterogeneous,opennetworkoffibreswithlargeairspacesorchannels.一些多孔的,具有网络纤维网络结构的材料有此特点,比如纸张。,Whataffectchemicalmigration?什么因素影响测试结果?,*,Themechanisticbasisofmigration化学迁移的原理Migrat
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