歐盟特殊醫(yī)學(xué)用途配方食品(FSMPs)現(xiàn)有法規(guī)和未來挑戰(zhàn)

HealthandConsumersFoodsforSpecialMedicalPurposes(FSMPs)CurrentrulesintheEUandfuturechallenges歐盟特殊醫(yī)學(xué)用途配方食品(FSMPs)現(xiàn)有法規(guī)和未來挑戰(zhàn)BasilMathioudakisHeadof

UnitDirectorateGeneralforHealthand

ConsumersFSMPsForum,Beijing,October

20142Health

andLegalframeworkforFSMPsinthe

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

compositionalandlabelling

requirementsforFSMPsasdefinedintheDirectiveandpresentedas

suchFSMP要服從歐盟特殊醫(yī)學(xué)用途配方食品指令1999/21/EC

指令規(guī)定了如下FSMPs成分和標(biāo)簽的要求:'acategoryoffoodsforparticularnutritionalusesspeciallyprocessedorformulatedandintendedforthedietarymanagementofpatientsandtobeusedundermedical

supervision.Theyareintendedfortheexclusiveorpartialfeeding

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

achievedonlybymodificationofthenormaldiet,byotherfoodsforparticularnutritionaluses,orbyacombinationofthe

two'.一類滿足特殊營養(yǎng)使用的食品，經(jīng)過專門的加工或配制，用于病人的膳食管理，在醫(yī)生監(jiān)督下使用。FSMP可單獨(dú)食用或與其他食品配合食用，可用于進(jìn)食/消化/吸收/代謝或清除功能受限、障礙或紊亂而不能食用普通食品，或含有特定營養(yǎng)素，或產(chǎn)生某些代謝產(chǎn)物的食品，或者有疾病特異性營養(yǎng)素需求的人群，這些人群的膳食管理不能通過改變常規(guī)飲食，其他特定營養(yǎng)食品或兩者結(jié)合來實(shí)現(xiàn)。CommissionDirective1999/21/ECon

FSMPs歐盟FSMPs

1999/21/EC

指令3HealthandConsumersClassifies

FSMPs

into

three

categories

分為三類Nutritionallycompletefoods全營養(yǎng)配方食品Nutritionallycompletefoodswithanutrient-adapted

formulation特定疾病需要調(diào)整營養(yǎng)素的全營養(yǎng)配方食品Nutritionallyincomplete

foods非全營養(yǎng)配方食品IncludesFSMPsforinfants(0-12

months)包括0-12個月嬰兒的FSMPCommissionDirective1999/21/ECon

FSMPs4HealthandConsumersEnsures

flexibility

forcomposition

保證配方的靈活性Generalrequirementthatformulationisbasedonsoundmedicalandnutritionalprinciplesandtheproduct‘suseissafe,beneficialandeffectivebasedongenerallyacceptedscientific

evidence一般要求,配方要依據(jù)合理的醫(yī)學(xué)和營養(yǎng)原則,產(chǎn)品使用安全、益處和效果要根據(jù)通?？山邮艿目茖W(xué)依據(jù)Setsminandmaxamountsofmicronutrients(forFSMPsforadultsand

infants)對成人和嬰兒FSMPs,設(shè)定了微量營養(yǎng)素的最小和最大量RequiresFSMPsintendedforinfantstocomplywithcompositionalrequirementsforformulaeforhealthy

infants嬰兒的FSMPs要遵從健康嬰兒配方食品的營養(yǎng)成分要求Allowsderogationswhererequiredbytheintended

use特定使用情況下可以刪減CommissionDirective1999/21/ECon

FSMPs5HealthandConsumersEstablishesmandatorylabellingrequirements

including:設(shè)立強(qiáng)制標(biāo)簽要求，包括：Name

of

the

product

foreasy

identification

容易識別的產(chǎn)品名稱Nutrition

declaration

營養(yǎng)素含量Astatementthattheproductmustbeusedunder

medicalsupervision

標(biāo)簽必須標(biāo)示在醫(yī)務(wù)人員監(jiān)管下使用的警示語

Thestatement‘Forthedietarymanagement

of…’“為了……的膳食管理用”的聲明

Adescriptionofthepropertiesand/orcharacteristicsthatmaketheproductusefulinparticular,asthecasemaybe,relatingtothenutrientswhichhavebeenincreased,reduced,eliminatedorotherwisemodifiedandtherationaleoftheuseoftheproduct產(chǎn)品的性能和或特性的描述，尤其是在有關(guān)增加、減少、去掉或者改變的營養(yǎng)素和產(chǎn)品使用合理性Important:

重要的是Thestatement‘Forthedietarymanagement

of…’“為了……的膳食管理用”的聲明Adescriptionofthepropertiesand/orcharacteristicsthatmaketheproductusefulinparticular,asthecasemaybe,relatingtothenutrientswhichhavebeenincreased,reduced,eliminatedorotherwisemodifiedandtherationaleoftheuseofthe

product產(chǎn)品的性能和或特性的描述，尤其是在有關(guān)增加、減少、去掉或者改變的營養(yǎng)素和使用產(chǎn)品合理性的方面Thesestatementsaremandatory

notsubjecttoruleson

claims這些聲明是強(qiáng)制的

不受聲稱法規(guī)的約束Improperuseleadstoabuses(circumventionofrules)

importanceof

controls不恰當(dāng)使用導(dǎo)致濫用（規(guī)避原則）

監(jiān)控的重要性6HealthandConsumersHealth

and7ConsumersCommissionDirective1999/21/ECon

FSMPsForeseesanotificationprocedureatnationallevel(MemberStatesmayremoveitiftheyprovethatitisnotnecessary)需要在國家層面建立通報(bào)程序（如果成員國證明這不必要，可以去掉）Operatorssendafilled-inform&labelcopytoMemberStatecompetentauthority(e.g.MOH)atplacingonthe

market經(jīng)銷商在銷售時向成員國管理部門（如衛(wèi)生部）遞交填好的表格和標(biāo)簽MemberStatesareresponsibleforapplicationof

rules成員國負(fù)責(zé)制定申請的原則Noregistrationorpre-authorisation

required不需要注冊或上市前審批Note:Foodsfornormalconsumptionareinmostcasesplacedonthemarketwithout

notification提示：正常消費(fèi)的食品大多數(shù)情況市場銷售時不需要通報(bào)Exceptionoffoodsupplementsandfortified

foods食品補(bǔ)充劑和強(qiáng)化食品除外Other

relevant

rules

forFSMPs

其他相關(guān)規(guī)則8HealthandConsumersFSMPsarefoods

theyshouldalsocomplywithhorizontalrulesapplicabletofoodsingeneralsuch

as:FSMP是食品

也應(yīng)遵守通用的食品行業(yè)規(guī)則，如GeneralFoodLawProvisions(e.g.Regulation(EC)

No178/2002) 通用食品法規(guī)Rulesonadditives,

hygiene

and

others

添加劑、衛(wèi)生和其他法規(guī)EUlegislationdoesnotusuallysetrulesaboutthepoints

ofsaleof

foods歐盟法律通常不對食品零售點(diǎn)設(shè)定相關(guān)規(guī)定

EUDirective(since1999)hashadpositivepractical

experienceacrossMember

States歐盟指令在成員國已經(jīng)有良好的實(shí)踐經(jīng)驗(yàn)ThreeFSMPsub-categoriesarekeyfor

usage三個類別對使用很重要Flexibilityincompositionisessentialtakingintoaccountvarietyofmedicalconditionsanddifficultytokeepcriteriaupto

date考慮到不同醫(yī)療狀況和及時更新法規(guī)的難度，有必要在營養(yǎng)成分上保持靈活性Mandatorylabellingensuresappropriate

use標(biāo)簽強(qiáng)制標(biāo)示內(nèi)容能保證合理使用Nopre-authorisationfacilitatesproduct

development/innovation無需上市前審批有利于促進(jìn)產(chǎn)品研制/創(chuàng)新9HealthandConsumersKey

facts

重要事實(shí)Roleofhealthcareprofessionalsis

key醫(yī)務(wù)專業(yè)人員的作用是關(guān)鍵10HealthandConsumersProduct

development: FSMPsarecomplexproductsdevelopedinclosecooperationwithhealthcareprofessionalstocaterforspecificnutritionalneeds產(chǎn)品研發(fā)：FSMPs是復(fù)雜的產(chǎn)品，其研制需要醫(yī)務(wù)人員的合作來滿足特殊的營養(yǎng)需求Communication:Directdisseminationofusefulinformationshouldbepossibletohealthcare

professionals交流：可以直接宣傳有用的信息給專業(yè)醫(yī)務(wù)人員Productuse:theroleofhealthcareprofessionalsisveryimportantforthecorrectuseofthese

products產(chǎn)品使用：專業(yè)醫(yī)務(wù)人員對這類產(chǎn)品的正確使用非常重要Avoidingabuses:appropriateadvicefromhealthcareprofessionalsshouldcontributetoavoiding

abuses避免濫用：專業(yè)醫(yī)務(wù)人員的合理建議有助于避免濫用ChallengesforFSMPsinthe

EU11HealthandConsumers歐盟FSMPs的挑戰(zhàn)Afterimplementationofclaimslegislationincreasingnumberof

FSMPnotifications…

聲稱法規(guī)實(shí)施后

FSMP通報(bào)數(shù)量增加…withdoubts

ontheirappropriate

classification

對于合理分類存在疑問Some

examples

舉例Aconcentratedmixofglucosamine,chondroitinandhyaluronicacidforthe

dietarymanagementof

osteoarthritis氨基葡萄糖，硫酸軟骨素和透明質(zhì)酸的濃縮混合用于骨關(guān)節(jié)炎Acombinationofvitamins,minerals,choline,uridinemonophosphate,phospholipids

andomega-3fattyacidsforthedietarymanagementofearlyAlzheimer’s

disease維生素、礦物質(zhì)、膽堿、尿苷酸、磷脂和omega-3脂肪酸用于早期Alzheimer’s病Aconcentratedmixofmicro-organismsforthedietarymanagementofpatients

withchronicinflammatorybowel

disease微生物的濃縮混合用于慢性炎性腸病Acombinationofmineralsandcranberryextractforthedietarymanagementof

recurrentbladderinfections

(cystitis)礦物質(zhì)和蔓越莓提取物結(jié)合用于復(fù)發(fā)性膀胱感染（膀胱炎）HowwilltheEUreacttothese

challenges?12HealthandConsumers歐盟如何應(yīng)對這些挑戰(zhàn)？On-goingrevisionofexisting

rules(FSGRegulation(EU)No

609/2013)正在修訂現(xiàn)有法規(guī)（No

609/2013

特殊膳食用食品法規(guī)）Definitionwillremainthe

same定義保持不變Existingruleswillremainsimilar

BUT保持現(xiàn)有規(guī)定，但Howtoguaranteeflexibilitytoresponsible

operators…如何保證生產(chǎn)者的靈活性…Whilereducingriskfor

abuses?同時減少濫用的風(fēng)險(xiǎn)HowwilltheEUreacttothese

challenges?

EFSA‘s

role

will

be

key

歐洲食品安全局作用很關(guān)鍵HealthandConsumers13歐盟如何應(yīng)對這些挑戰(zhàn)？Appropriate

enforcement

of

rules

恰當(dāng)實(shí)施法規(guī)Member

States

asked

forguidance

to

help

them

成員國要求提供指導(dǎo)Preparation

byCOMis

on-going

COM正在進(jìn)行準(zhǔn)備工作Article

3

of

the

FSG

Regulation

(as

of20

July

2016)

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

acts:“為了保證法規(guī)執(zhí)行的一致性，歐盟委員會可以：whetheragivenfoodfallswithinthescopeofthis

Regulation;決定某一食物是否適用該法規(guī)towhichspecificcategoryoffood(…)agivenfood

belongs".決定某一食物所屬的類別”Someadviceforenforcement

authoritiesFSMPs用于疾病的膳食管理

這表示什么？Health

and

Consumers14執(zhí)法部門的建議FSMPdefinitioniskeyandallitselementsshouldbetakeninto

accountFSMP定義是關(guān)鍵，也要考慮其基本要素FSMPsarefoods,notmedicinalproducts(theyarenotintendedandshouldnotbepresentedforthetreatmentorcureofadisease)FSMP是食品，不是藥品（不能用于也不應(yīng)用于治療疾病）FSMPsaretobeusedundermedicalsupervision

thisdoesnotmeanthatinclusionofacorrespondingstatementonthelabelautomaticallyqualifiesaproduct

asFSMP要在醫(yī)生指導(dǎo)下使用

這不表示標(biāo)簽上包括相應(yīng)的聲明就被自動視為FSMPFSMPsareintendedforthedietarymanagementofdiseases/disorders/conditions

whatdoesthis

mean?FSMPsanddietarymanagementofdiseases/disorders/conditions15HealthandConsumersFSMP和疾病/紊亂的飲食管理Definition

定義FSMPsareintendedfortheexclusiveorpartialfeedingof

patients:FSMP可單獨(dú)或與其他食物配合使用：withalimited,impairedordisturbedcapacitytotake,digest,absorb,metaboliseorexcreteordinaryfoodstuffsorcertainnutrientscontainedthereinor

metabolites;攝入、消化、吸收、代謝或清除普通食物或某些營養(yǎng)素或代謝物的能力受限、受損或紊亂orwithothermedically-determinednutrientrequirements,whosedietarymanagementcannotbeachievedonlybymodificationofthenormaldiet,byotherfoodsforparticularnutritionaluses,orbyacombinationofthe

two或有其他疾病相關(guān)的營養(yǎng)素需要，膳食管理不能通過改變常規(guī)飲食、其他特定營養(yǎng)食品或兩者結(jié)合來實(shí)現(xiàn)Explanation

解釋FSMPsareintendedtofeedpatientsthat,becauseofa

particulardisease/disorder/condition:FSMP用于給處于特定疾病/紊亂狀態(tài)的病人提供食物eitherhaveproblemsinconsumingordinaryfoodstuffs

(includingfoodsupplements

/fortified

foods),

攝入普通食物（包括食物補(bǔ)充劑/強(qiáng)化食品）存在困難orhavespecificmedically-determinednutrientrequirementswhosedietarymanagementcannotbeachievedbymodifyingthenormaldiet(e.g.throughfoodsupplements/

fortifiedfoods)有特定的疾病相關(guān)的營養(yǎng)素需要，改變常規(guī)膳食（如食物補(bǔ)充劑/強(qiáng)化食品）不能實(shí)現(xiàn)Questionstoconsider,onacase-by-case

basis逐項(xiàng)需要考慮的問題16HealthandConsumersIsthedisease/disorder/condition

forwhichthespecificproductisintendedsufficiently

characterised?特殊產(chǎn)品適用的疾病是否特性充分？Isitscientificallydemonstratedthatpeoples