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欧盟饲料安全保障体系及进口产品管理FAMI-QS秘书长(EUfeedsafetyassurancesystemandmanagementofimportedproducts)Dr.DidierJansSecretaryGeneralFEFANA•TheEUAssociationofSpecialityFeedIngredients/欧盟特殊饲料原料协会•FeedAdditivesandFunctionalingredients/饲料添加剂和功能性原料•Premixturesandmixturesoffunctionalingredients/预混料和功能性原料混合物•Producersandtraders27EuropeanUnioncountries100companies/欧盟27国的生产商和贸易商100家•Linkindustry/EUauthorities/与行业及欧盟当局紧密联系•Regulatoryandenforcementactivitiesforindustry/帮助行业进行监督和执法活动TheAssociation协会介绍Startingyear20042004年建立Spin-offprojectwithinFEFANAFEFANA旗下的项目ManagesalltheactivitiesrelatedtoFAMI-QScertification管理涉及FAMI-QS认证的所有活动FacilitatestheInternationalTradeforSpecialtyFeedIngredientsandtheirMixtures促进特殊饲料原料及其混合物的国际贸易MadefromtheIndustryfortheIndustry来自行业，服务于行业3•Placinganadditive/importedadditiveontheEuropeanMarket/向欧盟市场投放添加剂/进口添加剂•Re-authorisationsandimplications/再批准及其影响•FAMI-QS/EUFeedSafetyAssuranceSystem/FAMI-QS/欧盟饲料安全保障体系Plan计划PlacingandAdditive/importedadditiveontheEUmarket向欧盟市场投放添加剂/进口添加剂•Pre-marketauthorisation/投放市场前批准•Positivelistofauthorisedadditives/被批准添加剂的肯定列表•Holder/non-holderspecific/持有者/非持有者特定•Includesidentityandconditionsofuse/包括特性和使用条件•Listavailableat/列表可在下面网址获得•NofundamentaldistinctionbetweenEUandthirdcountryoperators(viarepresentativeinEU)/欧盟和第三国经营者（通过在欧盟内的代表）没有本质区别•FeedAdditivealreadyauthorized(Register)/已获得批准（注册）的饲料添加剂–“Non-holder”Approval(identicalidentityanduse)/“非持有者”批准（相同的特性和用途）–“Holder-Specific”Approval/“持有者-特定”批准–Attentiontransitionregime/re-authorisation/注意过渡期限要求/再批准•FeedAdditivenotalreadyauthorized/otherapplication没有获得批准/申请的添加剂Pre-marketingauthorizationneeded/需要投放市场前批准•Regulation1831/2003onFeedAdditives1831/2003饲料添加剂法规CanagivenadditivegoonEUmarket?一个添加剂是否可以进入欧盟市场？CanagivencompanyplacethisadditiveonEUmarket?一个公司是否可以投放添加剂到欧盟市场？•Ifitisauthorised(Register)如果该添加剂被批准（注册）•Iftheadditiveitplacesonthemarketfulfilsallthecriteriaoftheauthorisation如果该添加剂在市场上的投放满足批准的所有标准•Ifitisregistered/authorisedbycompetentauthorityforthiscategoryofadditives/activities如果是被主管当局按照此添加剂类别/活动进行注册/批准•Regulation183/2005onFeedHygieneFAMI-QS183/2005饲料卫生法规FAMI-QSFeedAdditivesRe-authorisationprocess饲料添加剂再批准过程•AllAdditivesmustbeauthorisedunder1831/2003所有添加剂必须基于1831/2003进行批准•Re-authorisationofca.3000additives大约3000种添加剂的再批准•Somewillnotbere-authorised(AnnexIIRegister)某些添加剂不会被再批准（附件II列表）•Processgoingonsince2004再批准过程从2004年开始•Evaluationstage评估阶段•Productidentityandconditionsofusebeingmodified产品特性和使用条件的修改9FAMI-QSCode:ToolfortheimplementationofEUlegislationFAMI-QS规范：贯彻欧盟法规的工具10食品安全法通则饲料添加剂饲料卫生食品&饲料控制FAMI-QSrecognitionunderFHRFAMI-QS在饲料卫生法规下的认可•FAMI-QSsubmittedforrecognitionunderArt22ofFeedHygieneRegulation(CommunityGuides)/FAMI-QS提交了基于饲料卫生法规（欧盟指南）第22条的认可申请•AssessmentandevaluationbyStandingCommittee–nationalexpertspanel/常务委员会-国家专家组进行评定和评估•Extensiveconsultationstakeholders-interestedparties/广泛的征求股东-利益相关方的意见•PublicconsultationonSANCOwebpage/在SANCO（健康和消费者保护总署）网站上公开征求意见FormaladoptionattheStandingCommitteemeetingof29January2007在2007年1月29日的常务委员会会议上正式通过12FAMI-QSScopeFAMI-QS范围SpecialtyFeedIngredientsandMixturesSpecialtyFeedIngredientsFeedAdditivesFunctionalFeedIngredientsMixturesPremixturesSpecialtyComplementaryFeedSpecialtyComplementaryDieteticFeed特殊饲料原料及混合物特殊饲料原料混合物饲料添加剂功能性饲料原料预混合饲料特殊补充饲料特殊营养性补充饲料14FAMI-QSSystemFAMI-QS体系SafetyandQualityManagementSystemsinclude质量安全管理体系包括FAMI-QSSafetyaspects:安全方面PRP(GMP)+HACCP前提方案（GMP）+HACCPandQualityaspects:质量方面•company-internalrequirements,企业的内部要求•legal/mandatoryrequirements,法规强制要求•customerrequirements顾客要求•managementresponsibility管理职责SafetyaspectsarebasedonEULegislation安全方面是基于欧盟法规WhatFAMI-QSis….FAMI-QS是什么…EuropeanCodeofPracticeforFeedAdditiveandPremixtureOperators欧洲饲料添加剂和预混料经营者操作规范•1Introduction介绍•2Scope范围•3Termsanddefinitions术语和定义•4ManagementSystem(MS)管理体系•5ManagementResponsibility管理职责•6Resourcemanagement资源管理•7Productrealisation产品实现•8SystemReview体系评审•9Controlofnon-conformingproducts不合格产品控制•10Statisticaltechniques统计技术17WhocangrantFAMI-QSCertificate由谁授予FAMI-QS证书WhograntsaFAMI-QScertificate?由谁授予FAMI-QS证书？•Accreditedandlicensedcertificationbodiesonly/只能由被认可和批准的认证机构•License-ApprovalisprovidedbytheFAMI-QSorganisation/批准-由FAMI-QS提供批准–Licencerelationship/批准关系–Listofapprovedcertificationbodies/被批准认证机构列表•CertificationBodyisresponsibleforcertificationprocess(planning,audit,decision)/认证机构负责认证过程（计划、审核、决定）OurPartnersCertificationBodies与我们合作的认证机构InternationalTradeChallenges国际贸易挑战CanFAMI-QScertificationbethesolution?FAMI-QS认证能否成为一个解决办法？2021Weaknessesinthepublicgovernance公共管理上的失败ComplexityoftheGlobalSupplyChain全球供应链的复杂性ResponsibilitiesforFeedSafetyfromCompetentAuthoritiestoOperators主管当局对经营者在饲料安全方面的责任DifferentRegulatoryBackground不同的法规背景DifferentCulturalEnvironment不同文化环境InternationalTradeChallenges国际贸易挑战LargeScaleTraceability大范围的溯源FairPlay/公平竞争BuildingConfidenceInitiativeHarmonizationImprovementConnectionCommunicationCredibilityMonitoring22一致性改进建立自信联系沟通可信性监测主动CompetentAuthorities/主管当局Industry/行业NationalAssociation/国家协会ConnectionIntegrityProgramme/诚信项目Accre