欧盟特殊医学用途配方食品(FSMPs)现有法规和未来挑战

HealthandConsumersFoodsforSpecialMedicalPurposes(FSMPs)CurrentrulesintheEUandfuturechallenges欧盟特殊医学用途配方食品(FSMPs)现有法规和未来挑战BasilMathioudakisHeadof

UnitDirectorateGeneralforHealthand

ConsumersFSMPsForum,Beijing,October

20142Health

andLegalframeworkforFSMPsinthe

EUConsumers欧盟FSMPs法律框架FSMPsaresubjectto:CommissionDirective1999/21/ECondietaryfoodsforspecialmedicalpurposes

compositionalandlabelling

requirementsforFSMPsasdefinedintheDirectiveandpresentedas

suchFSMP要服从欧盟特殊医学用途配方食品指令1999/21/EC

指令规定了如下FSMPs成分和标签的要求:'acategoryoffoodsforparticularnutritionalusesspeciallyprocessedorformulatedandintendedforthedietarymanagementofpatientsandtobeusedundermedical

supervision.Theyareintendedfortheexclusiveorpartialfeeding

ofpatientswithalimited,impairedordisturbedcapacitytotake,digest,absorb,metaboliseorexcreteordinaryfoodstuffsorcertainnutrientscontainedthereinormetabolites,orwithothermedically-determinednutrientrequirements,whosedietarymanagementcannotbe

achievedonlybymodificationofthenormaldiet,byotherfoodsforparticularnutritionaluses,orbyacombinationofthe

two'.一类满足特殊营养使用的食品，经过专门的加工或配制，用于病人的膳食管理，在医生监督下使用。FSMP可单独食用或与其他食品配合食用，可用于进食/消化/吸收/代谢或清除功能受限、障碍或紊乱而不能食用普通食品，或含有特定营养素，或产生某些代谢产物的食品，或者有疾病特异性营养素需求的人群，这些人群的膳食管理不能通过改变常规饮食，其他特定营养食品或两者结合来实现。CommissionDirective1999/21/ECon

FSMPs欧盟FSMPs

1999/21/EC

指令3HealthandConsumersClassifies

FSMPs

into

three

categories

分为三类Nutritionallycompletefoods全营养配方食品Nutritionallycompletefoodswithanutrient-adapted

formulation特定疾病需要调整营养素的全营养配方食品Nutritionallyincomplete

foods非全营养配方食品IncludesFSMPsforinfants(0-12

months)包括0-12个月婴儿的FSMPCommissionDirective1999/21/ECon

FSMPs4HealthandConsumersEnsures

flexibility

forcomposition

保证配方的灵活性Generalrequirementthatformulationisbasedonsoundmedicalandnutritionalprinciplesandtheproduct‘suseissafe,beneficialandeffectivebasedongenerallyacceptedscientific

evidence一般要求,配方要依据合理的医学和营养原则,产品使用安全、益处和效果要根据通常可接受的科学依据Setsminandmaxamountsofmicronutrients(forFSMPsforadultsand

infants)对成人和婴儿FSMPs,设定了微量营养素的最小和最大量RequiresFSMPsintendedforinfantstocomplywithcompositionalrequirementsforformulaeforhealthy

infants婴儿的FSMPs要遵从健康婴儿配方食品的营养成分要求Allowsderogationswhererequiredbytheintended

use特定使用情况下可以删减CommissionDirective1999/21/ECon

FSMPs5HealthandConsumersEstablishesmandatorylabellingrequirements

including:设立强制标签要求，包括：Name

of

the

product

foreasy

identification

容易识别的产品名称Nutrition

declaration

营养素含量Astatementthattheproductmustbeusedunder

medicalsupervision

标签必须标示在医务人员监管下使用的警示语

Thestatement‘Forthedietarymanagement

of…’“为了……的膳食管理用”的声明

Adescriptionofthepropertiesand/orcharacteristicsthatmaketheproductusefulinparticular,asthecasemaybe,relatingtothenutrientswhichhavebeenincreased,reduced,eliminatedorotherwisemodifiedandtherationaleoftheuseoftheproduct产品的性能和或特性的描述，尤其是在有关增加、减少、去掉或者改变的营养素和产品使用合理性Important:

重要的是Thestatement‘Forthedietarymanagement

of…’“为了……的膳食管理用”的声明Adescriptionofthepropertiesand/orcharacteristicsthatmaketheproductusefulinparticular,asthecasemaybe,relatingtothenutrientswhichhavebeenincreased,reduced,eliminatedorotherwisemodifiedandtherationaleoftheuseofthe

product产品的性能和或特性的描述，尤其是在有关增加、减少、去掉或者改变的营养素和使用产品合理性的方面Thesestatementsaremandatory

notsubjecttoruleson

claims这些声明是强制的

不受声称法规的约束Improperuseleadstoabuses(circumventionofrules)

importanceof

controls不恰当使用导致滥用（规避原则）

监控的重要性6HealthandConsumersHealth

and7ConsumersCommissionDirective1999/21/ECon

FSMPsForeseesanotificationprocedureatnationallevel(MemberStatesmayremoveitiftheyprovethatitisnotnecessary)需要在国家层面建立通报程序（如果成员国证明这不必要，可以去掉）Operatorssendafilled-inform&labelcopytoMemberStatecompetentauthority(e.g.MOH)atplacingonthe

market经销商在销售时向成员国管理部门（如卫生部）递交填好的表格和标签MemberStatesareresponsibleforapplicationof

rules成员国负责制定申请的原则Noregistrationorpre-authorisation

required不需要注册或上市前审批Note:Foodsfornormalconsumptionareinmostcasesplacedonthemarketwithout

notification提示：正常消费的食品大多数情况市场销售时不需要通报Exceptionoffoodsupplementsandfortified

foods食品补充剂和强化食品除外Other

relevant

rules

forFSMPs

其他相关规则8HealthandConsumersFSMPsarefoods

theyshouldalsocomplywithhorizontalrulesapplicabletofoodsingeneralsuch

as:FSMP是食品

也应遵守通用的食品行业规则，如GeneralFoodLawProvisions(e.g.Regulation(EC)

No178/2002) 通用食品法规Rulesonadditives,

hygiene

and

others

添加剂、卫生和其他法规EUlegislationdoesnotusuallysetrulesaboutthepoints

ofsaleof

foods欧盟法律通常不对食品零售点设定相关规定

EUDirective(since1999)hashadpositivepractical

experienceacrossMember

States欧盟指令在成员国已经有良好的实践经验ThreeFSMPsub-categoriesarekeyfor

usage三个类别对使用很重要Flexibilityincompositionisessentialtakingintoaccountvarietyofmedicalconditionsanddifficultytokeepcriteriaupto

date考虑到不同医疗状况和及时更新法规的难度，有必要在营养成分上保持灵活性Mandatorylabellingensuresappropriate

use标签强制标示内容能保证合理使用Nopre-authorisationfacilitatesproduct

development/innovation无需上市前审批有利于促进产品研制/创新9HealthandConsumersKey

facts

重要事实Roleofhealthcareprofessionalsis

key医务专业人员的作用是关键10HealthandConsumersProduct

development: FSMPsarecomplexproductsdevelopedinclosecooperationwithhealthcareprofessionalstocaterforspecificnutritionalneeds产品研发：FSMPs是复杂的产品，其研制需要医务人员的合作来满足特殊的营养需求Communication:Directdisseminationofusefulinformationshouldbepossibletohealthcare

professionals交流：可以直接宣传有用的信息给专业医务人员Productuse:theroleofhealthcareprofessionalsisveryimportantforthecorrectuseofthese

products产品使用：专业医务人员对这类产品的正确使用非常重要Avoidingabuses:appropriateadvicefromhealthcareprofessionalsshouldcontributetoavoiding

abuses避免滥用：专业医务人员的合理建议有助于避免滥用ChallengesforFSMPsinthe

EU11HealthandConsumers欧盟FSMPs的挑战Afterimplementationofclaimslegislationincreasingnumberof

FSMPnotifications…

声称法规实施后

FSMP通报数量增加…withdoubts

ontheirappropriate

classification

对于合理分类存在疑问Some

examples

举例Aconcentratedmixofglucosamine,chondroitinandhyaluronicacidforthe

dietarymanagementof

osteoarthritis氨基葡萄糖，硫酸软骨素和透明质酸的浓缩混合用于骨关节炎Acombinationofvitamins,minerals,choline,uridinemonophosphate,phospholipids

andomega-3fattyacidsforthedietarymanagementofearlyAlzheimer’s

disease维生素、矿物质、胆碱、尿苷酸、磷脂和omega-3脂肪酸用于早期Alzheimer’s病Aconcentratedmixofmicro-organismsforthedietarymanagementofpatients

withchronicinflammatorybowel

disease微生物的浓缩混合用于慢性炎性肠病Acombinationofmineralsandcranberryextractforthedietarymanagementof

recurrentbladderinfections

(cystitis)矿物质和蔓越莓提取物结合用于复发性膀胱感染（膀胱炎）HowwilltheEUreacttothese

challenges?12HealthandConsumers欧盟如何应对这些挑战？On-goingrevisionofexisting

rules(FSGRegulation(EU)No

609/2013)正在修订现有法规（No

609/2013

特殊膳食用食品法规）Definitionwillremainthe

same定义保持不变Existingruleswillremainsimilar

BUT保持现有规定，但Howtoguaranteeflexibilitytoresponsible

operators…如何保证生产者的灵活性…Whilereducingriskfor

abuses?同时减少滥用的风险HowwilltheEUreacttothese

challenges?

EFSA‘s

role

will

be

key

欧洲食品安全局作用很关键HealthandConsumers13欧盟如何应对这些挑战？Appropriate

enforcement

of

rules

恰当实施法规Member

States

asked

forguidance

to

help

them

成员国要求提供指导Preparation

byCOMis

on-going

COM正在进行准备工作Article

3

of

the

FSG

Regulation

(as

of20

July

2016)

特殊膳食用食品法规（FSG）法规第三章"InordertoensuretheuniformimplementationofthisRegulation,theCommissionmaydecide,bymeansofimplementing

acts:“为了保证法规执行的一致性，欧盟委员会可以：whetheragivenfoodfallswithinthescopeofthis

Regulation;决定某一食物是否适用该法规towhichspecificcategoryoffood(…)agivenfood

belongs".决定某一食物所属的类别”Someadviceforenforcement

authoritiesFSMPs用于疾病的膳食管理

这表示什么？Health

and

Consumers14执法部门的建议FSMPdefinitioniskeyandallitselementsshouldbetakeninto

accountFSMP定义是关键，也要考虑其基本要素FSMPsarefoods,notmedicinalproducts(theyarenotintendedandshouldnotbepresentedforthetreatmentorcureofadisease)FSMP是食品，不是药品（不能用于也不应用于治疗疾病）FSMPsaretobeusedundermedicalsupervision

thisdoesnotmeanthatinclusionofacorrespondingstatementonthelabelautomaticallyqualifiesaproduct

asFSMP要在医生指导下使用

这不表示标签上包括相应的声明就被自动视为FSMPFSMPsareintendedforthedietarymanagementofdiseases/disorders/conditions

whatdoesthis

mean?FSMPsanddietarymanagementofdiseases/disorders/conditions15HealthandConsumersFSMP和疾病/紊乱的饮食管理Definition

定义FSMPsareintendedfortheexclusiveorpartialfeedingof

patients:FSMP可单独或与其他食物配合使用：withalimited,impairedordisturbedcapacitytotake,digest,absorb,metaboliseorexcreteordinaryfoodstuffsorcertainnutrientscontainedthereinor

metabolites;摄入、消化、吸收、代谢或清除普通食物或某些营养素或代谢物的能力受限、受损或紊乱orwithothermedically-determinednutrientrequirements,whosedietarymanagementcannotbeachievedonlybymodificationofthenormaldiet,byotherfoodsforparticularnutritionaluses,orbyacombinationofthe

two或有其他疾病相关的营养素需要，膳食管理不能通过改变常规饮食、其他特定营养食品或两者结合来实现Explanation

解释FSMPsareintendedtofeedpatientsthat,becauseofa

particulardisease/disorder/condition:FSMP用于给处于特定疾病/紊乱状态的病人提供食物eitherhaveproblemsinconsumingordinaryfoodstuffs

(includingfoodsupplements

/fortified

foods),

摄入普通食物（包括食物补充剂/强化食品）存在困难orhavespecificmedically-determinednutrientrequirementswhosedietarymanagementcannotbeachievedbymodifyingthenormaldiet(e.g.throughfoodsupplements/

fortifiedfoods)有特定的疾病相关的营养素需要，改变常规膳食（如食物补充剂/强化食品）不能实现Questionstoconsider,onacase-by-case

basis逐项需要考虑的问题16HealthandConsumersIsthedisease/disorder/condition

forwhichthespecificproductisintendedsufficiently

characterised?特殊产品适用的疾病是否特性充分？Isitscientificallydemonstratedthatpeoples