德国特殊医学用途配方食品的法规(欧盟199921EC指令的转换、执行和实施)

RegulationofDietaryfoodsfor

specialmedicalpurposesin

Germany德国特殊医学用途配方食品的法规Transposition,implementationandenforcementofEuropeanDirective

1999/21/EC欧盟1999/21/EC指令的转换、执行和实施FederalMinistryofFoodand

Agriculture联邦食品与农业部04.11.2014Folie

2→Cabinet-levelministryoftheFederalRepublicofGermany;联邦德国内阁级别机构→ThecurrentMinisterforFoodandAgricultureisChristianSchmidt

;现任食品与农业部部长Christian

Schmidt→HeadquartersarelocatedinBonnwithasecondofficein

Berlin;总部位于波恩，在柏林设立办事处→Department2:Nutrition,ProductSafety,Innovation2司：营养，食品安全，新技术→Division214:Specialfoods,FoodSupplements,Food

Additives214处：特殊食品，食品补充剂，食品添加剂16FederalStates(„Länder“)

with16个联邦州→theirowngovernmentsandparliaments;独立的州政府和议会→theirownstate

constitutions;独立的州宪法→differentsizes(400-70,000

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

million)常住人口数不同，在66-180万之间04.11.2014Folie

3TheFederalRepublicof

Germany联邦德国German

legislation联邦德国法律Federal

States(“Länder”)

联邦州European

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

law以食品和饲料法（LFGB）作为框架法Complementary

acts补充法案

Competentforenforcementoffoodcontrolandfoodcontrollegislation可以实施食品管制及其法规ControlsystemsareorganisedbyeachFederalStateunderitsownresponsibility各州独立施行控制体系04.11.2014Folie

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

Law”“通用食品法”

（EC）No.

178/2002SpecificRegulationsand

Directives专门的法规和指令OrdinanceonDietetic

Foodstuffs04.11.2014Folie

5膳食食品条例→Definesgeneralandspecificcompositionalandinformationrequirementsfor‘dietetic

foodstuffs’;定义一般和特殊成分的“膳食食品”

信息的要求→Requiresthatfoodslabeledasdieteticmustdiffersubstantiallyfrom‘regular

foods’;要求标签标示为“膳食类”的食品，必须与普通食品有显著区别→Directive1999/21/ECwas(interalia)transposedbythe

Ordinance;通过此法案将1999/21/EC指令转变为联邦性法规→NoadditionalspecificproductrelatedrequirementsforFSMPbeyondDirective

1999/21/EC.除了1999/21/EC指令,不需要其他特殊的产品相关要求AuthorizationrequirementforFSMPproduction

facilities04.11.2014Folie

6FSMP生产机构要求→ ProducersofFSMPrequireanofficialapproval(§11ofOrdinanceonDieteticFoodstuffs)FSMP生产商需要官方正式许可(§

11of

Ordinance

on

Dietetic

Foodstuffs)→ IssuedbythecompetentcontrolauthorityoftheFederalState

(Länder);由相关联邦州政府的主管部门签发→ Validforaparticularproduction

facility;只对提出申请的生产机构有效→ Unlimitedvaliditybutrevocableatanytime;无期限，但可随时撤销→ Demand:Presenceofexpertise(pharmacist,foodchemistor

chemist);需求：有相关专业人员（药剂师，食品化学，化学家）→ Demand:Proofofreliability(norepeatedviolationsofthefood

law);需求：证据可靠（无违反食品法）AuthorizationrequirementforFSMPproduction

facilities04.11.2014Folie

7FSMP生产机构要求→Demand:Presenceofappropriateequipmentforproperpreparation(esp.forprecisedosageandhomogeneous

mixing);要求：有适合的设备进行生产前的准备工作（尤其是精确的剂量和混合均匀）→Penaltiesforintentionallyviolationsof§11:Imprisonmentuptooneyearorafine;针对有意触犯

§11:

一年的监禁或是罚款→Penaltiesfornegligentviolationsof

§

11: finesupto20,000

Euro过失性触犯

§11：2万欧元的罚款→ImportersofFSMPneedacertificateofconformitywiththerelevantprovisionsoftheOrdinanceonDieteticFoodstuffsfromthecompetentauthorityofthecountryoforigin(§

11a).FSMP进口商需要提供原产国当地主管机构出具符合膳食食品法的证明Notificationrequirementsfor

FSMPFSMP通报要求→NotificationofFSMPisrequiredbyDirective1999/21/EC(Art.

5):1999/21/EC指令对通报的要求→GermanyhasimplementedtheobligationtonotifyFSMPintheOrdinanceonDieteticFoodstuffs(§

4a)德国实行在膳食食品条例中要求FSMP必须进行通报→Nopre-marketingauthorisationofFSMPin

Germany德国不需要上市前许可04.11.2014Folie

8Notificationof

FSMP04.11.2014Folie

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

;食品经销商需提交产品标签和通报单，通报单需包含生产商和公司详情(§4a膳食食品条例)→ThenotificationsystemisoperatedbytheFederalGovernmentasa“service”forthe

Länder;通报体系由联邦政府负责实施，作为各州的服务→Forofficialuseonly–nopublicaccess->login&

pw;仅官方内部使用，不向公众开放，需要密码登录→Technicallyrealisedbythepowerfulandflexibleopensourceweb-tool

“Alfresco”.技术上由高效灵活的开放性企业管理系统Alfresco实现Notificationsystemfor

FSMPFSMP通报系统04.11.2014Folie

10400350300250200150100500YearNumberofnotificationsofFoodsforSpecialMedicalPurposes(nutrionallycompleteand

incomplete)特殊医学用途食品的年通报量（全营养和非全营养配方食品）04.11.2014Folie

11Notificationprocedurefor

FSMPFSMP通报程序04.11.2014Folie

12PROs优点→Facilitatesanefficientofficialmonitoringofdietary

foodsforspecialmedical

purposes;利于有效监控FSMP→Putsonlyaverysmalladministrativeburden

forbusinesses;企业的行政负担非常小→Theflexibilityoftheproceduredoesnot

hinderinnovation.程序灵活，不阻碍创新Notificationprocedurefor

FSMP04.11.2014Folie

13FSMP通报程序CONs

缺点→Riskofoverwhelmingthefoodinspectionauthoritiesduetomissingofmedical

expertise;由于食品监测机构缺少专业医学人员，存在无法监管的风险→Theapplicationofastandardprior-authorisationprocedurewouldreducedifferentinterpretationandhenceensurebetterharmonisationacrossthe

EU;采用标准的预授权程序可以减少不同的解释，确保欧盟内协调一致→LegaldifficultiesinofficialsamplingatdistancesellingfromoutsideGermany(EUMemberStates/Third

Countries)在德国之外销售（欧盟成员国/

第三国）时官方采样存在法律困难Circumvention(‚Legislation

shopping‘)04.11.2014Folie

14规避→Voluntarynutritionandhealthclaimsrequireapre-authorisation(Regulationonclaims)thatwasrefusedinmanycasesduetoalackofscientificsubstantiation;普通食品的自愿营养和健康声称需要审批（声称方面的法规），而且很多情况下这些声称会因为缺乏科学证据而被拒绝的。→FlexibilityinthelegislationonnutritionallyincompleteFSMPisbeingmisusedtocircumventtheRegulationonnutritionandhealth

claims;非全营养配方FSPM产品在法规上的灵活性要求被滥用，用来规避营养和健康声称法规的要求→LegalDoctrine:‘Lexspecialisderogatlegi

generali’;法律条例：“特别法优于一般法”→Someoperatorsnotifya‘normal’foodasFSMPinordertobeabletousea‘dietetic’suitabilitystatement(mandatoryaccordingtothedieteticfoodlegislation).一些商家宣称”普通”食品为FSMP,

是为使用适用于“膳食类”食品的声明

（膳食食品法是强制的）FSMP

?04.11.2014Folie

15→Product

composition:产品成分：→Intended

use:用途Magnesium(250mg),VitaminE(200mg

α-TE)镁250mg，维生素E

(200mg

α-TE)„Forthedietarytreatmentofreducedbody‘sownresistance,particularlywithchronicfatiguethroughintakeofmagnesiumandvitamin

E”通过摄入镁和维生素E，作为降低机体的自身抵抗特别是慢性疲劳者膳食管理用Answer:答案：No!Theproductdoesnotdifferfromafoodsupplement(normal

food)!不！与食品补充剂（正常食品）没有差别！FSMP

?04.11.2014Folie

16→Product

composition:产品成分：→Intended

use:用途：Margarinewith83%

MCT含83%中链甘油三酯„ForthedietarymanagementofLCHAD(long-chain3-hydroxyacyl-coenzymeAdehydrogenase)fatmalabsorptionorother

conditionswherethereisaneedforsupplementationwithhighMCT/