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FoodContactMaterialGerneralIntroduction食品接觸材料介紹Whatourproductsdotoourfood?

我們的產(chǎn)品對食物有何影響?FCMRegulationIntroduction食品接觸材料法規(guī)介紹TestMethodBasis測試根底Whataffectchemicalmigration?什么因素影響測試結(jié)果?Foodandbeveragescanbeveryaggressiveproductsandmayinteractstronglywithmaterialsthattheytouch.食物和飲料有時候具有很強的“進攻性〞,可以與食品接觸材料發(fā)生強烈的作用。*Infact,nofoodcontactmaterialiscompletelyinertandsoitispossiblefortheirchemicalconstituentsto‘migrate’intothepackagedfood.Metals,glass,ceramics,plastics,rubberandpapercanallreleaseminuteamountsoftheirchemicalconstituentswhentheytouchcertaintypesoffoods.實際上,沒有材料是完全鈍化的,總有可能材料中的物質(zhì)遷移至食物中。金屬、玻璃、陶瓷、塑料、橡膠、紙張可以釋放微量的化學成份進入食物。*1Ceramicarticlesmayposearisktotheconsumerthroughheavymetalsusedintheglazingandcolouring.陶瓷通過其釉彩和著色劑對使用者產(chǎn)生威脅。*Inthe1980sitbecameevidentthatrubberteatsandsoothersmayreleasecarcinogenicnitrosamines,whicharereactionanddegradationproductsfromacceleratorsandstabilisersusedintherubber.上世紀80年代,有證據(jù)說明橡膠奶頭和安撫奶嘴可以釋放致癌的亞硝胺,它是橡膠引發(fā)劑和穩(wěn)定劑反響和分解的產(chǎn)物。*Chemicalmigrationisalwaysundesirableandifnotcontrolleditcouldbehazardoustothehealthofconsumer.人們總不想材料中的化學物質(zhì)進入食物當中,如果控制不當,將會對人體健康產(chǎn)生影響。*2Ithasbeenestimatedthattheper-capitauseofpackagingmaterialsforretailfoodstuffssoldintheEUcountriesisabout1200cm2perpersonperday.據(jù)估計,在歐洲每人每天食用的零售食物,與食物接觸材料接觸的面積大約為1200平方厘米。*Allpartiesinvolvedintheproduction,transport,sellingandconsumptionoffoodsneedtobeawareofthepotentialforchemicalmigrationandwaysofminimisingit.所有與食物的生產(chǎn)、運輸、銷售等相關(guān)的企業(yè)都需要意識到食品接觸材料化學遷移的危害,都有義務(wù)盡量進少此類遷移。primarymanufacturersofrawmaterials,e.g.,polymerandpapermanufacturersconverterswhoturntherawmaterialintopackagingforfoodusevendorsofthematerials,e.g.,retailersofarticles,supplycompaniesusersofthematerial–thefoodpackerfoodretailersenforcementauthoritiesconsumers–withrespecttotheproperusebothofpre-packagedfoodsandofmaterialsandarticlesusedinthehome.*LawStructure法規(guī)構(gòu)架CommunitylegislationwhichisadoptedbytheEUandnationallegislationadoptedbytheMemberStates,soaRegulationisdirectlyapplicableineachMemberState.歐洲的公布的法令,將在歐盟成員國中直接執(zhí)行。Directiveshavetobetransposedintonationallawwithtranspositiontimesofupto18months.歐盟的指令,需要在歐盟成員國中轉(zhuǎn)化本國的法律執(zhí)行,并有最多為18個月的過渡期。*TheFrameworkRegulation(EC)No1935/2004setsoutthegeneralprinciplesthatapplytomaterialsincontactwithfood.歐盟法令(EC)No1935/2004是歐盟食品級接觸材料所有指令的框架性法令,規(guī)定了食品級材料應(yīng)該遵循的根本原那么。Detailsforimplementingthesegeneralrulestakingaccountofthespecificrisksoftheindividualmaterialisgiveninthespecificlegislation.本法令的具體實施,要考慮到特定材料的特定風險,這些會在具體的指令中得以表達。*Thislistcomprises17differentmaterials.OnlyafewareyetcoveredbyspecificCommunitylegislation.本表羅列了17中不同的材料,只有一小局部被歐盟指令明確涵蓋。Communitylegislationwasintroducedtoharmonisenationallegislationandtoremovebarrierstotrade.制定這些指令是為了統(tǒng)一各成員國的立法,消除貿(mào)易障礙。MemberStateslegislationisbasedondifferentprinciplesandthiscanstillbeobservedinthoseareaswhicharenotyetcoveredbyCommunitylegislation.個成員國有不同的立法原那么,這一點目前仍然能夠在歐盟指令沒有涵蓋的領(lǐng)域可以看到。*Mostofthe25MemberStatesdonothavespecificnationalrules.大多數(shù)成員國沒有自己特有的國家法律。NewerEUMemberStatesreplacedtheirnationallegislationwithCommunitylegislationbeforeaccessiontotheEU.歐盟新成員國在進入歐盟前,需要提前修改本國法律,以與歐盟指令一致。MemberStatesthatdonothavespecificnationallegislationonfoodcontactmaterialswillsometimesrefertootherMemberStates’legislation,suchasDutchwarenwetortheGermanrecommendations,whentestingforsafetycompliance.沒有特有食品接觸材料平安法律的成員國,通常會借鑒其他國家的食品接觸材料平安法律。*Norway,IcelandandLiechtenstein,aspartoftheEuropeanEconomicArea(EEA),alsoapplytheCommunitylegislationwhilekeepingadditionalnationallegislation.SwitzerlandhasadoptedregulationscorrespondingtotheCommunitylegislation.挪威、冰島、列支敦士登作為歐洲經(jīng)濟區(qū)的一局部,也采用歐盟的食品接觸材料平安指令。*MemberStatesDuty成員國的義務(wù)MemberStateshavetheresponsibilityforenforcingtheCommunityandtheirownnationallegislationandmustmonitorthattherequirementsofthelegislationarefulfilledbythebusinessoperators(generalfoodlaw).成員國有責任執(zhí)行歐盟的指令,并監(jiān)控商業(yè)機構(gòu)遵守食品接觸材料平安要求。*MemberStateshavetolaydownacatalogueofsanctionsandmeasuresincludingdissuasivepenaltiesfornon-conformitywiththefoodlegislation.成員國必須制定一系列措施食品接觸材料平安要求得以實施。ThemeasurestakenbyMemberStatesmayincludeprohibitingplacementonthemarket;theymayorderandmonitorwithdrawalofgoodsfromthemarket,recallanddestruction.Officialcontrolcancoverthefollowingactions:monitoring,surveillance,verification,audit,inspection,samplingandanalysis.這些措施包括禁止投放市場,成員國可能監(jiān)控、責令停銷問題產(chǎn)品,召回或者銷毀它們。這些措施還包括監(jiān)督、認可、檢驗、抽樣、測試等。*Furthermoretheyhavetherighttodetainconsignmentsfromthirdcountries.海關(guān)也可扣押可疑貨物。*WhenMemberStatestakemeasuresthataffectotherMemberStates,suchaswithdrawalfromthemarketwhenthearticleoriginatesfrom,orisdistributedto,anotherMemberState,theyshouldinformtheCommissionandtheotherMemberStatesviatheelectronicRapidAlertSystemforfeedandfood(RASFF).當一個成員國發(fā)生回收,應(yīng)通報歐盟的快速警戒系統(tǒng),本系統(tǒng)會通知其他各歐盟成員國。**Thismeanstheyhavetomakesurethatsubstancestheyuseinthefoodcontactmaterialareauthorised(ifpositivelistsexist)and/orarenottransferredintofoodinconcentrationsthatposeadangertohumanhealth.Theyhavetoconfirmthisinadeclarationofcompliance.以上措施說明,商家必須使用許可的材料,并保證材料不得遷移出對人體有害的化學物質(zhì)。*Theconsumersshouldbeinformedon:消費者應(yīng)被通知到:(i)thesuitabilityoftheproductforfoodcontact(tothispurposeasymbolrepresentingaglassandforkcanbeused);本產(chǎn)品適合與食物接觸。(ii)thepersonresponsibleformanufactureorplacingonthemarketoftheproduct;商家負責人。(iii)instructionsforthesafeuseoftheproduct;產(chǎn)品平安使用說明。(iv)meansofidentificationoftheproductfortraceability.產(chǎn)品的識別的追溯。*Definitionsoftraceability追溯的定義?!畉heabilitytogobackinthehistoryofafoodcontactmaterialorarticle,fromtheretailstagebacktothepointofitsmanufacturing,identifyingallappropriateinformation.’*Obviously,traceabilitycanbeattainedonlyiftheidentificationelementsofeachoftheaboverawmaterialsareproperlyobtainedbytherelevantsuppliers,butthemostdifficultpartconsistsofthemanagementofsuchidentificationelementsinthevariousstepsofstorage,transformationandwarehousingoffinishedgoods.*WhatisFoodContactMaterial

什么是食品接觸材料?materialsthatarealreadyincontactwithfoodsuchasthepackagingofpre-packagedfood;materialsthatareintendedtocomeintocontactwithfood,suchascups,dishes,cutlery,foodpackagingnotyetinuse;materialsthatcanreasonablybeexpectedtobebroughtintocontactwithfoodsuchastablesurfacesinfoodpreparationareasortheinnerwallsandshelvesofarefrigerator;andmaterialsthatcanreasonablybeexpectedtotransfertheirconstituentstofoodsuchasacardboardboxaroundaplasticbagofcereals.*Conventionaltestingfollowsthefollowingdiscretesteps:

食品接觸材料測試的幾個步驟:1.Gatheringinformationaboutthecompositionofthematerial

收集材料信息2.Selectrelevantlegislation

篩選適合法規(guī)3.Checkwhethercompositionisinaccordancewiththelegislation

檢查成份是否和法規(guī)要求4.Performanceoftherelevanttests

測試Besidescomplianceofaproduct’scompositionwithlegislation,oneneedstodemonstratethattheproductcomplieswiththelimitssetforoverallmigration,specificmigration,residualcontentandrequirements.TestMethodBasis測試根底*

PlasticsfoodcontactmaterialsandarticlesshouldcomplywithDirective2002/72/ECanditsamendmentsthatinclude:

2002/72/EC的限制要求anoverallmigrationlimit(OML)specificmigrationlimits(SMLs)onmonomersspecificmigrationlimits(SMLs)onadditivescompositionallimits(QMs)onsomemonomers.TestMethodBasis測試根底*Fromtheavailabletoxicityandmigrationdata,aspecificmigrationlimit(SML)isderivedandseveralassumptionsaremade:基于的毒性和遷移數(shù)據(jù),特殊遷移限值(SML)是通過以下假設(shè)制定的:1kgoffoodeateneveryday1kgoffoodcorrespondsto6dm2ofpackagingpackagingalwayscontainsthesubstancemigrationofthesubstanceatSMLconsumerbodyweightof60kg.*Toavoidpossibleargumentsaboutwhatkindoffoodshouldbechosentoperformmigrationtesting,EUlegislatorshaveagreedonfourfoodsimulants,whichareabletomimicfoods:為防止關(guān)于食物類型的爭論,歐盟規(guī)定了四種食物模擬液:SimulantA,water,mimickingaqueousfoodstuffsSimulantB,3%aceticacid,mimickingacidicfoodstuffsSimulantC,10%ethanol,mimickingalcoholicfoodstuffsSimulantD,oliveoil,oranotherapprovedoil,mimickingfattyfoodstuffs.*Directive85/572/EECdefineswhichsimulantsneedtobeusedtosimulatecertainfoods.Insomecasesitisnotpossibletouseoliveoilasafoodsimulantbecauseoftechnicalreasonsandalternativesimulantsmaybeusedlikeisooctaneand95%ethanol.

85/572/EEC指令規(guī)定了模擬液。某些情況下,由于技術(shù)原因,不能使用橄欖油模擬液,這是可以使用替代液。*Thereasonfordeterminingoverallmigrationisthatthefoodcontactmaterialmaybringaboutanunacceptablechangeinthecompositionofthefood(Article3oftheframeworkRegulation(EC)1935/2004).Themethodsofdeterminingtheoverallmigrationintotheaqueoussimulants(A,BandC)areasfollows:

食品接觸材料可能給食物的成份帶來不可接受的變化,所以要進行全遷移測試,其步驟如下:Bringthefoodcontactmaterialincontactwiththesimulantforaselectedtimeandtemperature(seesection5.3.1).Separatethesamplefromthesimulantandevaporatethesimulant.Determinetheweightoftheresidueandcalculateoverallmigration.Asaconsequencevolatilechemicals,whichmigrate,arenotincludedintheoverallmigrationvaluefortheaqueoussimulants.*Migrationtestinghastobeperformedunderworstforeseeablecontacttimeandtemperaturefortheenvisagedapplication.Along-termstorageatroomtemperatureis,forexample,representedbystoragefortendaysat40∞C.測試的條件,通常選擇產(chǎn)品使用范圍的上限。*3Colourrelease

顏色遷移Whenfoodisincontactwithfoodcontactmaterial,thecolourofthefoodcontactmaterialmustremainonthefoodcontactmaterialandmaynotcolourthefood.

食品級材料與食物接觸時,其顏色不得染污食物。*Volatiles

揮發(fā)性Forsiliconmaterialssomevolatilecomponentscanremaininthesiliconmaterialafterpolymerisation.Themethodofdeterminationis:

對于硅膠類材料,一些揮發(fā)性成份會在硅膠合成后殘留在材料中,測定的方法是:Preparethesiliconmaterial(cuttoprescribedsizes).Removewaterfromthesiliconmaterialusingwaterfreecalciumchloride.Determinetheweightofthesiliconmaterial.Exposethesiliconmaterialforacertaintimetoacertaintemperature.Determinetheweightofthesiliconmaterial.Calculatetheweightloss.Theseareexemplifiedby‘hard’materialssuchasmetals,glassandceramics.一些“硬質(zhì)〞材料具有此特點,比方金屬、玻璃、陶瓷。Whataffectchemicalmigration?什么因素影響測試結(jié)果?Theseareexemplifiedby‘plastic’materialssuchasplastics,rubbersandelastomers.一些合成材料具有此特點,比方塑料、橡膠、彈性體等。Exemplifiedbypaperandboardmaterialswithaheterogeneous,open

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