减少食品掺假-脆弱性评估.pdf

Mitigation of Food Adulteration Fraud Through Vulnerability Assessment减少食品掺假 脆弱性评估Wei Zhu,Ph.D.朱炜博士朱炜博士Director，Global Center of Excellence for Food总监全球食品卓越中心总监全球食品卓越中心US Pharmacopeia美国药典委员会美国药典委员会USPsFood:Ingredients食品原料食品原料通过提供公共标准及其它相关项目以确保药品与食品的质量与安全，促进全人类的健康。FoodChemicalsCodex(FCC)食品化学法典食品化学法典Compendiumoftestingstandardsandspecificationsforfoodingredients检测标准与规格的法典USP Testingphilosophy检测的原则Characterizewhatafoodingredientshouldbe(Integrity)确定食品原料本身具有的特性；Excludematerialsthathavebeeneconomicallymotivatedadulterated(Fraud):排除替代,稀释，更换等掺假Compendium standard Is the ingredient what it purports to be Help prevent substitutionPurity/AssayIs enough of the ingredient presentHelp prevent dilutionAuthenticity Canitbeverified Helpmaintaintheintegrityofsupplychain AidsproductssafetyIdentity Set minimum quality specificationHelp prevent EMA(fraud)4Thepublicstandardsettingprocess公共标准建立流程公共标准建立流程Transparent and science-based mechanism to develop new and revised quality standards透明的基于科学的机制，来开发和修改质量标准透明的基于科学的机制，来开发和修改质量标准Processdrivenbystakeholders(mostlyindustry)流程由利益相关者驱动（主要是工业界）流程由利益相关者驱动（主要是工业界）Process open to public input流程向公众开放接受公众意见流程向公众开放接受公众意见Approval by independent,volunteer scientific expert committee由独立的，志愿者科学专家委员会批准由独立的，志愿者科学专家委员会批准FoodFraud:GlobalProblem食品掺假：全球问题食品掺假：全球问题ConsequencesofFoodFraud食品掺假的后果食品掺假的后果Always:Cheatsconsumers总是：欺骗消费者Whendiscovered:Significantcostsforfoodproducers;Erodesconsumerconfidence被发现：食品制造者重大的代价；损坏消费者的信任Gonewrong:Introducesfoodsafetyhazards导致食品安全危险FoodFraudIsHardtoPredict预知食品掺假的困难预知食品掺假的困难Criminal“designs”adulterant to evade existing QA system罪犯“设计”掺假来规避现行质量体系QA system reacts by developing new tests质量体系开发新测试来应对Industryandregulatorsalikeneedawaytopredictfoodfraudandapplyriskbasedprevention工业界和监管者等需要预知食品掺假的途径，实行基于风险的预防RealityforIndustryandRegulators工业界和监管现状工业界和监管现状Whereto聚焦哪里?AdvancesTowardsPrevention预防 前进“Neitherawisemannorabravemanliesdownonthetracksofhistorytowaitforthetrainofthefuturetorunoverhim.”DwightD.Eisenhower智者和勇者都不会躺在历史的轨道上等待未来的列车压碎他们。-德怀特戴维艾森豪威尔Aim:Guidancetohelporganizationsdeveloptheirownactionorientedfraudmitigationsystemtoidentifyriskiestingredientsanddevelopappropriatecontrolplan帮助识别风险最高的原料，来开发特有的适合的控制体系Focus:Ingredients;EMA专注于食品成分和EMAAvailableforFreeat:www.foodfraud.orgPublished:Sept.1,2015,FCC9,3rdSupplement2015年九月一日出版,FCC9第3增补版USPGuidanceonFoodFraudMitigationUSP 指导原则：减少食品掺假USP 指导原则：减少食品掺假USPFoodFraudMitigationGuidanceApproach减少食品掺假途径减少食品掺假途径1.Contributingfactorsassessment脆弱性的贡献2.Impactsassessment影响评估3.Combining1&2结合1&24.Mitigationstrategydevelopment开发控制策略VulnerabilitiesCharacterization脆弱性评估Ingredient by ingredient.逐一成分Step1:ContributingFactors步骤1：影响因素步骤1：影响因素Step1:ContributingFactors步骤1：影响因素步骤1：影响因素Step1:ContributingFactors步骤1：影响因素步骤1：影响因素Susceptibility ofTestMethodstofood FraudSimpleNotvariable2strongtests(IRandHPLC)CompositionalDifficultiesTestingPowerIngredientHighPurityReb.AVulnerabilityPomegranateJuiceComplexVariable2weaktest(%BrixandHuntercolor)FCC9 2SStep1:ContributingFactors步骤1：影响因素步骤1：影响因素Food Fraud History食品掺假的历史食品掺假的历史www.foodfraud.orgSince2012,thefirstpublicdatabaseonfoodfraud开始于2012，也是唯一的公共数据库开始于2012，也是唯一的公共数据库2,000+records2000+记录 Fraudhistory掺假历史 Potentialhazards潜在危险 Analyticalmethod分析方法Melamineadulteratedproteinrichingredients(1980s)inItalyAdulterationofspiceswithleadchromateinIndiaDilutionofmilkpowderswithmaltodextrininS.AmericaReplacementofmilkfatwithvegetableoilinS.AmericaNextStepsforFood Fraud Database食品掺假Significantupgradeplannedfor2016andbeyond2016年计划重大升级Newcustomizabledashboardinterfacewithdataanalytics新可定制的控制面板界面及数据分析Addinginformationonpotentialsafetyissuesforadulterants增加掺假导致的潜在安全问题的信息Geospatial surveillanceinformation地理空间 监控信息Newrecordtypesandfields新记录与领域Step1:ContributingFactors步骤步骤1：影响因素：影响因素Step2:ImpactsAssessment步骤2：影响评估步骤2：影响评估Identifyknownandpotentialadulterants识别已知与潜在掺假Step 2Step 1Step3:OverallFraudVulnerabilitiesCharacterization步骤 3:总体掺假脆弱性评估步骤 3:总体掺假脆弱性评估Example:Hypothetical举例：假设Maltodextrin 麦芽糊精Step 2Step 1Step3:OverallFraudVulnerabilitiesCharacterization步骤 3:总体掺假脆弱性评估步骤 3:总体掺假脆弱性评估Example:Hypothetical举例：假设Spice调味品Step4:DevelopingaMitigationStrategy步骤4：开发控制策略步骤4：开发控制策略Question:Aremytheidentifiedvulnerabilitiesacceptable?Ifnot,howdoIpreventorcontrolthem?识别的脆弱性能接受吗?怎样防止或控制？WhyUSPsSolution?Integratedsolution LinkagetoUSPfoodfrauddatabase UseofFCCstandardsascontrolmeasures IndustryfriendlyDevelopedbyindependentvolunteerexpertfromindustry(andregulators)forindustry Testedbyacoalitionofmultinationalindustryexpertstoensurepracticalityandcompatibility OpenandtransparentstandardssettingprocessforPubliccomments USPcommitmenttosupportcapacitybuildingandtrainingUpcomingUSPEventsonAdulterationUSP掺假研讨USP掺假研讨USP-Rockville,MDTraining course on USP Food Fraud Mitigation:Dec.2,2015Workshop on Food and Supplement Adulteration:Dec.3-4,2015 Collaborative Research Projects合作科研项目合作科研项目 Submit entries for the USP Food Fraud Database向USP食品掺假数据库提供信息向USP食品掺假数据库提供信息 Volunteer for a USP Expert Committee or PanelUSP 专家委员会或专家小组的志愿者USP 专家委员会或专家小组的志愿者 New monographs,standards,toolsFormal submission to USP向向USP正式提交各论，标准，工具各论，标准，工具All suggestions WELCOME!欢迎建议！26OpportunitiestoWorkTogether共同协作USPFoodIngredientExpertCommitteeUSP食品添加剂专家委员会USP ExpertPanelonFoodIngredients IntentionalAdulterantsUSP食品原料掺假专家小组