德國特殊醫(yī)學(xué)用途配方食品的法規(guī)(歐盟199921EC指令的轉(zhuǎn)換、執(zhí)行和實施)

RegulationofDietaryfoodsfor

specialmedicalpurposesin

Germany德國特殊醫(yī)學(xué)用途配方食品的法規(guī)Transposition,implementationandenforcementofEuropeanDirective

1999/21/EC歐盟1999/21/EC指令的轉(zhuǎn)換、執(zhí)行和實施FederalMinistryofFoodand

Agriculture聯(lián)邦食品與農(nóng)業(yè)部04.11.2014Folie

2→Cabinet-levelministryoftheFederalRepublicofGermany;聯(lián)邦德國內(nèi)閣級別機構(gòu)→ThecurrentMinisterforFoodandAgricultureisChristianSchmidt

;現(xiàn)任食品與農(nóng)業(yè)部部長Christian

Schmidt→HeadquartersarelocatedinBonnwithasecondofficein

Berlin;總部位于波恩，在柏林設(shè)立辦事處→Department2:Nutrition,ProductSafety,Innovation2司：營養(yǎng)，食品安全，新技術(shù)→Division214:Specialfoods,FoodSupplements,Food

Additives214處：特殊食品，食品補充劑，食品添加劑16FederalStates(?L?nder“)

with16個聯(lián)邦州→theirowngovernmentsandparliaments;獨立的州政府和議會→theirownstate

constitutions;獨立的州憲法→differentsizes(400-70,000

sqkm);各州的面積不同，400-7000平方公里→differentnumbersofinhabitants(660,000-18

million)常住人口數(shù)不同，在66-180萬之間04.11.2014Folie

3TheFederalRepublicof

Germany聯(lián)邦德國German

legislation聯(lián)邦德國法律Federal

States(“L?nder”)

聯(lián)邦州European

legislation歐盟法律FoodandFeedCode(Lebensmittel-undFuttermittelgesetzbuch,LFGB)asframework

law以食品和飼料法（LFGB）作為框架法Complementary

acts補充法案

Competentforenforcementoffoodcontrolandfoodcontrollegislation可以實施食品管制及其法規(guī)ControlsystemsareorganisedbyeachFederalStateunderitsownresponsibility各州獨立施行控制體系04.11.2014Folie

4Regulation(EC)No.178/2002“GeneralFood

Law”“通用食品法”

（EC）No.

178/2002SpecificRegulationsand

Directives專門的法規(guī)和指令OrdinanceonDietetic

Foodstuffs04.11.2014Folie

5膳食食品條例→Definesgeneralandspecificcompositionalandinformationrequirementsfor‘dietetic

foodstuffs’;定義一般和特殊成分的“膳食食品”

信息的要求→Requiresthatfoodslabeledasdieteticmustdiffersubstantiallyfrom‘regular

foods’;要求標簽標示為“膳食類”的食品，必須與普通食品有顯著區(qū)別→Directive1999/21/ECwas(interalia)transposedbythe

Ordinance;通過此法案將1999/21/EC指令轉(zhuǎn)變?yōu)槁?lián)邦性法規(guī)→NoadditionalspecificproductrelatedrequirementsforFSMPbeyondDirective

1999/21/EC.除了1999/21/EC指令,不需要其他特殊的產(chǎn)品相關(guān)要求AuthorizationrequirementforFSMPproduction

facilities04.11.2014Folie

6FSMP生產(chǎn)機構(gòu)要求→ ProducersofFSMPrequireanofficialapproval(§11ofOrdinanceonDieteticFoodstuffs)FSMP生產(chǎn)商需要官方正式許可(§

11of

Ordinance

on

Dietetic

Foodstuffs)→ IssuedbythecompetentcontrolauthorityoftheFederalState

(L?nder);由相關(guān)聯(lián)邦州政府的主管部門簽發(fā)→ Validforaparticularproduction

facility;只對提出申請的生產(chǎn)機構(gòu)有效→ Unlimitedvaliditybutrevocableatanytime;無期限，但可隨時撤銷→ Demand:Presenceofexpertise(pharmacist,foodchemistor

chemist);需求：有相關(guān)專業(yè)人員（藥劑師，食品化學(xué)，化學(xué)家）→ Demand:Proofofreliability(norepeatedviolationsofthefood

law);需求：證據(jù)可靠（無違反食品法）AuthorizationrequirementforFSMPproduction

facilities04.11.2014Folie

7FSMP生產(chǎn)機構(gòu)要求→Demand:Presenceofappropriateequipmentforproperpreparation(esp.forprecisedosageandhomogeneous

mixing);要求：有適合的設(shè)備進行生產(chǎn)前的準備工作（尤其是精確的劑量和混合均勻）→Penaltiesforintentionallyviolationsof§11:Imprisonmentuptooneyearorafine;針對有意觸犯

§11:

一年的監(jiān)禁或是罰款→Penaltiesfornegligentviolationsof

§

11: finesupto20,000

Euro過失性觸犯

§11：2萬歐元的罰款→ImportersofFSMPneedacertificateofconformitywiththerelevantprovisionsoftheOrdinanceonDieteticFoodstuffsfromthecompetentauthorityofthecountryoforigin(§

11a).FSMP進口商需要提供原產(chǎn)國當?shù)刂鞴軝C構(gòu)出具符合膳食食品法的證明Notificationrequirementsfor

FSMPFSMP通報要求→NotificationofFSMPisrequiredbyDirective1999/21/EC(Art.

5):1999/21/EC指令對通報的要求→GermanyhasimplementedtheobligationtonotifyFSMPintheOrdinanceonDieteticFoodstuffs(§

4a)德國實行在膳食食品條例中要求FSMP必須進行通報→Nopre-marketingauthorisationofFSMPin

Germany德國不需要上市前許可04.11.2014Folie

8Notificationof

FSMP04.11.2014Folie

9FSMP通報→Foodbusinessoperators(FBO)arerequiredtosubmittheproduct'slabelandanotificationformwithinformationabouttheproducerandcompanydetails(§4aOrdinanceonDieteticFoodstuffs)

;食品經(jīng)銷商需提交產(chǎn)品標簽和通報單，通報單需包含生產(chǎn)商和公司詳情(§4a膳食食品條例)→ThenotificationsystemisoperatedbytheFederalGovernmentasa“service”forthe

L?nder;通報體系由聯(lián)邦政府負責實施，作為各州的服務(wù)→Forofficialuseonly–nopublicaccess->login&

pw;僅官方內(nèi)部使用，不向公眾開放，需要密碼登錄→Technicallyrealisedbythepowerfulandflexibleopensourceweb-tool

“Alfresco”.技術(shù)上由高效靈活的開放性企業(yè)管理系統(tǒng)Alfresco實現(xiàn)Notificationsystemfor

FSMPFSMP通報系統(tǒng)04.11.2014Folie

10400350300250200150100500YearNumberofnotificationsofFoodsforSpecialMedicalPurposes(nutrionallycompleteand

incomplete)特殊醫(yī)學(xué)用途食品的年通報量（全營養(yǎng)和非全營養(yǎng)配方食品）04.11.2014Folie

11Notificationprocedurefor

FSMPFSMP通報程序04.11.2014Folie

12PROs優(yōu)點→Facilitatesanefficientofficialmonitoringofdietary

foodsforspecialmedical

purposes;利于有效監(jiān)控FSMP→Putsonlyaverysmalladministrativeburden

forbusinesses;企業(yè)的行政負擔非常小→Theflexibilityoftheproceduredoesnot

hinderinnovation.程序靈活，不阻礙創(chuàng)新Notificationprocedurefor

FSMP04.11.2014Folie

13FSMP通報程序CONs

缺點→Riskofoverwhelmingthefoodinspectionauthoritiesduetomissingofmedical

expertise;由于食品監(jiān)測機構(gòu)缺少專業(yè)醫(yī)學(xué)人員，存在無法監(jiān)管的風(fēng)險→Theapplicationofastandardprior-authorisationprocedurewouldreducedifferentinterpretationandhenceensurebetterharmonisationacrossthe

EU;采用標準的預(yù)授權(quán)程序可以減少不同的解釋，確保歐盟內(nèi)協(xié)調(diào)一致→LegaldifficultiesinofficialsamplingatdistancesellingfromoutsideGermany(EUMemberStates/Third

Countries)在德國之外銷售（歐盟成員國/

第三國）時官方采樣存在法律困難Circumvention(?Legislation

shopping‘)04.11.2014Folie

14規(guī)避→Voluntarynutritionandhealthclaimsrequireapre-authorisation(Regulationonclaims)thatwasrefusedinmanycasesduetoalackofscientificsubstantiation;普通食品的自愿營養(yǎng)和健康聲稱需要審批（聲稱方面的法規(guī)），而且很多情況下這些聲稱會因為缺乏科學(xué)證據(jù)而被拒絕的?！鶩lexibilityinthelegislationonnutritionallyincompleteFSMPisbeingmisusedtocircumventtheRegulationonnutritionandhealth

claims;非全營養(yǎng)配方FSPM產(chǎn)品在法規(guī)上的靈活性要求被濫用，用來規(guī)避營養(yǎng)和健康聲稱法規(guī)的要求→LegalDoctrine:‘Lexspecialisderogatlegi

generali’;法律條例：“特別法優(yōu)于一般法”→Someoperatorsnotifya‘normal’foodasFSMPinordertobeabletousea‘dietetic’suitabilitystatement(mandatoryaccordingtothedieteticfoodlegislation).一些商家宣稱”普通”食品為FSMP,

是為使用適用于“膳食類”食品的聲明

（膳食食品法是強制的）FSMP

?04.11.2014Folie

15→Product

composition:產(chǎn)品成分：→Intended

use:用途Magnesium(250mg),VitaminE(200mg

α-TE)鎂250mg，維生素E

(200mg

α-TE)?Forthedietarytreatmentofreducedbody‘sownresistance,particularlywithchronicfatiguethroughintakeofmagnesiumandvitamin

E”通過攝入鎂和維生素E，作為降低機體的自身抵抗特別是慢性疲勞者膳食管理用Answer:答案：No!Theproductdoesnotdifferfromafoodsupplement(normal

food)!不！與食品補充劑（正常食品）沒有差別！FSMP

?04.11.2014Folie

16→Product

composition:產(chǎn)品成分：→Intended

use:用途：Margarinewith83%

MCT含83%中鏈甘油三酯?ForthedietarymanagementofLCHAD(long-chain3-hydroxyacyl-coenzymeAdehydrogenase)fatmalabsorptionorother

conditionswherethereisaneedforsupplementationwithhighMCT/