1、COMMISSION RECOMMENDATION of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97

2、of the European Parliament and of the Council (Text with EEA relevance) (97/618/EC)THE COMMMISSIION OFF THE EUROPPEAN CCOMMUNNITIESS,Having regarrd to the TTreatyy estaablishhing tthe Euuropeaan Commmunitty,Having regarrd to Regullationn (EC) No 2258/977 of tthe Euuropeaan Parrliameent annd of the C

3、Counciil of 27 Jaanuaryy 19977 conccerninng novvel fooods aand noovel ffood iingreddientss (1), and in paarticuular AArticlle 4 (4) thhereoff,Whereass, in orderr to pprotecct pubblic hhealthh, it is neecessaary thhat noovel ffoods and nnovel food ingreedientts aree subjject tto a ssinglee safeety as

4、ssessmment tthrouggh a CCommunnity pproceddure bbeforee theyy are placeed on the mmarkett withhin thhe Commmunitty;Whereass recoommenddationns conncerniing thhe sciientiffic asspectss of tthe innformaation necesssary to suupportt an aappliccationn for the pplacinng on the mmarkett of aa noveel foood

5、 or a novvel foood inngrediient wwill ffaciliitate the ttask oof ecoonomicc operratorss in ppreparring ssuch aan appplicattion; whereeas reecommeendatiions cconcerrning the ppresenntatioon of such inforrmatioon andd conccerninng thee prepparatiion off inittial aassesssment reporrts byy the compeeten

6、t food assesssmentt bodiies off the Membeer Staates wwill ffaciliitate the eevaluaation of suuch appplicaationss;Whereass the Scienntificc Commmitteee for Food has mmade rrecommmendattions on thhe infformattion nnecesssary tto suppport such appliicatioons, tthe prresenttationn of tthat iinformmation

7、n and the ppreparrationn of iinitiaal asssessmeent reeportss on tthose appliicatioons;Whereass expeeriencce in the aassesssment of noovel ffoods and nnovel food ingreedientts is at prresentt limiited; whereeas thherefoore anny reccommenndatioons inn thiss areaa mustt be kkept uunder consttant rrevie

8、ww to ttake aaccounnt of new sscienttific inforrmatioon andd the work of thhe rellevantt inteernatiional organnizatiions;Whereass the Membeer Staates hhave bbeen cconsullted oon thiis Reccommenndatioon witthin tthe frramewoork off the Standding CCommitttee ffor Fooodstuuffs,HEREBY RECOMMMENDSS THATT

9、:1. Whenn prepparingg appllicatiions ffor thhe plaacing on thhe marrket oof novvel fooods aand noovel ffood iingreddientss, ecoonomicc operratorss shouuld foollow the rrecommmendattions conceerningg the scienntificc aspeects oof thee infoormatiion neecessaary too suppport ssuch aappliccationns sett

10、out in thhe Annnex, PPart II.附錄 Partt 1，當準備進軍軍NF、NF成成分到市場，經濟經營者(企企業)應遵循科學學方面提供必必要的資料，以以支持這些應應用2. Econnomic operaators shoulld enssure tthat tthe innformaation necesssary to suupportt appllicatiions rreferrred too in ppoint 1 is preseented in acccordaance wwith tthe reecommeendatiions sset ouut in th

11、e AAnnex, Partt II.附錄 Partt 2，說明依第一一點，企業要保證證支持申請文文件的資料3. Membber Sttates shoulld enssure tthat tthe innitiall asseessmennt repports drawnn up bby theeir coompeteent foood asssessmment bbodiess purssuant to Arrticlee 6 (22) of Regullationn (EC) No 2258/977 are prepaared iin acccordannce wiith thhe re

12、ccommenndatioons seet outt in tthe Annnex, Part III.附錄 Partt 3，會員員國的主管單單位依Artticle 6 (2) of RRegulaation (EC) No 2558/97來來要求各項最最初的評估報報告。Done att Brusssels, 29 JJuly 11997.For thee CommmissioonMartin BANGEEMANNMember of thhe Commmissiion(1) OJ L 43, 14. 2. 19997, pp. 1.ANNEX 附件PART I RECOMMMENDAATION

13、SS CONCCERNINNG THEE SCIEENTIFIIC ASPPECTS OF INNFORMAATION NECESSSARY TO SUUPPORTT APPLLICATIIONS FFOR THHE PLAACING ON THHE MARRKET OOF NOVVEL FOOODS AAND NOOVEL FFOOD IINGREDDIENTSS 附錄 Partt 1，關於支持新食食物及其成份份的市場所需需的科學資料料建議。TABLE OOF CONNTENTSS Page1. Intrroducttion . 42. Cateegoriees of novell food

14、ds andd noveel foood inggredieents iidentiified in Reegulattion (EC) NNo 2588/97 . 4依法規No 2258/977，定義NFF及NF成分分的分類3. Key issuees forr the assesssmentt of nnovel foodss and novell foodd ingrrediennts (NNF) . 5評估新型食品和和新型食品配配料（NF）的關鍵鍵問題 3.1 Genneral consiiderattions . 5一般狀況3.2 Genneticaally mmodifiied o

15、rrganissms (GGMO) . 5基因生物3.3 Subbstanttial eequivaalencee . 5實質等同3.4 Commposittionall anallysis . 6成分分析3.5 Inttake . 6吸收3.6 Nuttritioonal cconsidderatiions aaffectting ttoxicoologiccal teestingg in aanimalls . 66動物毒性測試後後的營養效應應3.7 Toxxicoloogicall requuiremeents . 7毒性要求3.8 Impplicattions of NFF to hh

16、uman nutriition . 7關於NF對人體體營養的含意意3.9 Novvel miicroorrganissms ussed inn foodd . 7新型微生物在食食物上的使用用3.10 Alllergeenic ppotenttial . 8過敏的可能3.11 Asssessmment oof marrker ggenes . 8標記基因的評估估4. Scieentifiic claassifiicatioon of novell foodds forr the assesssmentt of wwholessomeneess . 9科學對新型食品品衛生評價的的分類Class 1

17、1: Purre cheemicalls or simplle mixxturess fromm non-GM soourcess . 9(非基因)物來來源的純化學學物或簡單的的混何物Class 22: Commplex NF frrom noon-GM sourcces . 9(非基因)物來來源的NF複合物Class 33: GM plantts andd theiir prooductss . 9基因植物與其產產品Class 44: GM animaals annd theeir prroductts . 110基因動物與其產產品Class 55: GM microoorgannisms

18、and ttheir produucts . 10基因微生物及其其產品Class 66: Fooods prroduceed usiing a novell proccess . 10因新流程產生的的食物5. Idenntificcationn of eessenttial iinformmationn for assesssmentt of wwholessomeneess . 10評估衛生健康資資料的定義I. Speccificaation of thhe NF . 11NF的規格II. Efffect oof thee prodductioon proocess appliied too

19、 the NF . 111生產流程應用在在NF上的效應應III. Hiistoryy of tthe orrganissm useed as the ssourcee of tthe NFF . 111生物使用在NFF的歷史IV. Efffect oof thee geneetic mmodifiicatioon on the pproperrties of thhe hosst orgganismm . 122基因改造的主機機(母體)機體對性能能的影響V. Geneetic sstabillity oof thee GMO used as NFF sourrce . 13基因生物用於NNF的

20、基因穩穩定性VI. Speecificcity oof exppressiion off noveel gennetic materrial . 13新遺傳物質的特特殊性VII. Trransfeer of genettic maateriaal froom GMOO . 133從基因物改良其其基因體PageVIII. AAbilitty of the GGMM too survvive iin andd coloonize the hhuman gut . 13基因物生存在人人體腸道的能能力IX. Antticipaated iintakee/exteent off use of thhe

21、NF . 13預期NF的攝入入量/程度上使用X. Infoormatiion frrom prreviouus humman exxposurre to the NNF or its ssourcee . 133以前人類接觸NNF或其來源源的資料XI. Nuttritioonal iinformmationn on tthe NFF . 144NF的營養資料料XII. Miicrobiiologiical iinformmationn on tthe NFF . 144NF的微生物資資料XIII. TToxicoologiccal innformaation on thhe NF . 14NF

22、的毒性資料料6. Reviiew off recoommenddationns . 115審查建議7. Refeerencees . 115參考資料8. Glosssary . 16術語Table II: Asssociattion bbetweeen thee cateegorizzationn in tthe Coommuniity Reegulattion oon Novvel Fooods aand Noovel FFood IIngreddientss and the SSCF reecommeendatiions . 17Table III: Inndex tto strructu

23、rred scchemess to bbe folllowedd for each classs of NNF . 118Schemess I-XIIII . 19I. INTRRODUCTTION Wheneveer chaanges are mmade tto thee way in whhich aa foodd is pput onn the markeet, prroduceed or proceessed or usses noon-traaditioonal iingreddientss, thee impllicatiions ffor coonsumeer saffety a

24、and nuutritiional valuee willl requuire cconsidderatiion. IInformmationn willl be nneededd on aany isssue rrelatiing too bothh thesse asppects. At ppresennt, thhe isssue off foodd safeety inn relaation to noovel ffoods is unnder cconsidderatiion woorld-wwide. The WWorld Healtth Orgganizaation (WHO),

25、 thee Orgaanizattion ffor Ecconomiic Coooperattion aand Deeveloppment (OECDD), annd othher naationaal andd inteernatiional bodiees havve adddresseed botth genneral and sspeciffic asspectss releevant to thhe whoolesommenesss of nnovel foodss. A nnumberr of rreportts outtline the pphilossophiees andd

26、deveelopmeents iin thiis fieeld (ssee reeferennces).As partt of tthe deeveloppment of Reegulattion (EC) NNo 2588/97 oon Novvel Fooods aand Noovel FFood IIngreddientss the Europpean CCommisssion has aasked the SScienttific Commiittee for FFood (SCF) to deevelopp recoommenddationns conncerniing thhe s

27、ciientiffic asspectss ofI. the inforrmatioon neccessarry to suppoort ann appllicatiion foor thee placcing oon thee markket off noveel fooods annd novvel foood inngrediients;II. thee pressentattion oof succh infformattion;III. thhe preeparattion oof thee inittial aassesssment reporrts.This reeport co

28、verrs tassk I.2. CATEEGORIEES OF NOVELL FOODDS ANDD NOVEEL FOOOD INGGREDIEENTS IIDENTIIFIED IN REEGULATTION (EC) NNo 2588/97 Accordiing too Reguulatioon (ECC) No 258/997 of the EEuropeean Paarliamment aand off the Counccil off 27 JJanuarry 19997 conncerniing noovel ffoods and nnovel food ingreedient

29、ts (1), Reggulatiion (EEC) Noo 258/97 wiill appply tto thee placcing oon thee markket off foodds or food ingreedientts whiich haave noot hitthertoo beenn usedd for humann conssumptiion too a siignifiicant degreee witthin tthe Coommuniity annd whiich faall unnder tthe foollowiing caategorries:(a) foo

30、ods annd foood inggredieents ccontaiining or coonsistting oof genneticaally mmodifiied orrganissms wiithin the mmeaninng of Counccil Diirectiive 900/220/EEC (2);(b) fooods annd foood inggredieents pproducced frrom, bbut noot conntainiing, ggenetiicallyy modiified organnisms;(c) fooods annd foood ing

31、gredieents wwith aa new or inntentiionallly moddifiedd primmary mmolecuular sstructture;(d) fooods annd foood inggredieents cconsissting of orr isollated from microoorgannisms, funggi or algaee;(e) fooods annd foood inggredieents cconsissting of orr isollated from plantts andd foodd ingrrediennts is

32、solateed froom aniimals, exceept foor fooods annd foood inggredieents oobtainned byy tradditionnal prropagaating and bbreediing prracticces annd whiich haave a histoory off safee foodd use;(f) fooods annd foood inggredieents tto whiich haas beeen appplied a prooductiion prrocesss not curreently used

33、, wherre thaat proocess givess risee to ssignifficantt channges iin thee comppositiion orr struucturee of tthe fooods oor foood inggredieents wwhich affecct theeir nuutritiional valuee, mettaboliism orr the levell of uundesiirablee subsstancees.The Reggulatiion dooes noot appply too: foood addditive

34、es fallling withiin thee scoppe of Counccil Diirectiive 899/107/EEC (3); fflavouuringss for use iin fooodstufffs faallingg withhin thhe scoope off Counncil DDirecttive 888/3888/EEC (4); or exxtracttion ssolvennts ussed inn the produuctionn of ffoodsttuffs falliing wiithin the sscope of Coouncill Dir

35、eectivee 88/3344/EEEC (5).3. KEY ISSUEES FORR THE ASSESSSMENTT OF NNOVEL FOODSS AND NOVELL FOODD INGRREDIENNTS (NNF) 評估新型食品和和新型食品配配料（NF）的關鍵鍵問題3.1 Genneral consiiderattions 一般狀況Foods aare ussuallyy compplex mmixturres off macrro- annd miccro coonstittuentss whicch proovide energgy andd nutrrientss an

36、d contrributee to tthe weell-beeing oof hummans. They have tradiitionaally bbeen rregardded ass natuural, benefficiall and necesssary produucts wwhose safetty andd nutrritionnal vaalue nneed nnot bee quesstioneed. 食物一般是由聚聚成分及微成成分的複合物物組成，提供供能量及營養養給人體。這這些被視為天天然的，有益益的和必要的的產品是大家家所認知不會會懷疑他的安安全性及營養養價值Regu

37、lattory aapproaaches to foood saafety have refleected this attittude aand haave foocusedd on ffood aadditiives, proceessingg aidss and contaaminannts off natuural oor inddustriial orrigin. 食品安全監督管管理辦法，反反映關於食品品添加劑，加加工助劑和污污染物或工業業原料的影響響。Thus, ffoods have not hhitherrto beeen syystemaaticallly suubjectt

38、ed too nutrritionnal orr toxiicologgical evaluuationn, exccept iin rarre casses whhere aacute toxicc effeects hhave bbeen rreportted inn humaans (ee.g. ssolaniine, cyannogeniic glyycosiddes) oor in thosee casees wheere annimal studiies orr humaan expperiennces hhave ssuggessted aadversse efffects fr

39、om raw ffood mmateriials (e.g. raw ssoya fflour). 因此，食物尚未未有系統關於於營養及毒性性評估。除了了少數關於人人體劇烈毒性性的報導(如如solannine, cyanoogenicc glyccosidees)或其他他關於食物原原料在人體及及動物上負面面效應案例出出現。This iss not to immply tthat nnutrittionall evalluatioon of indivviduall foodds andd of wwhole dietss has not bbeen pperforrmed, but tthat

40、ssuch nnutrittionall evalluatioons haave noot beeen useed as a bassis foor a ssafetyy asseessmennt of indivviduall foodds. 這並不意味著個個別食品營養養評價和整個個飲食都尚未未執行，但這這種營養評價價沒有被用來來作為一個基基礎的安全評評價單個食品品On the otherr handd, foood addditivees aree not permiitted in foood unnless they have been subjeected to exxhaustti

41、ve ttoxicoologiccal evvaluattion.另依方面，只有有經過徹底毒毒性評估後，食食物添加劑才才可以使用。Variouss foodds aree knowwn to contaain tooxic ccompouunds, incluuding mutaggens aand caarcinoogens. Somee chroonic ddiseasses inn humaans haave a dietaary ellementt in ttheir etiollogy. Althoough iit is agreeed thaat somme advverse ef

42、feccts off the diet on heealth are rrelateed to the ppatterrn of nutriient iintakee, thee exacct mecchanissms innvolveed aree not knownn. 各種食品中含有有已知的有毒毒化合物，包包括誘變和致致癌物質。一些慢性疾病，其其病因來自人人類飲食的元元素雖然大家同意一一些在健康方方面有害的飲飲食效果是與與營養物攝取取方式有關，但但是他的反應應機制仍尚未未明瞭It is ppossibble thhat soome illl heaalth iis duee to cch

43、roniic expposuree to cconstiituentts of tradiitionaal fooods. UUntil recenntly llittlee atteentionn has been givenn to tthis aaspectt or tto thee posssible role of moodifieers off toxiic efffects (e.g. antiicarciinogenns) naaturallly prresentt in ffoods.這可能是一些疾疾病是由於長長期暴露於傳傳統食品的成成分。直到最近有人注注意這方面，食品中自然

44、然存在給予可可能的作用或或毒性反應的的改性劑（如如anticcarcinnogenss）。The asssessmeent off the wholeesomenness oof fooods inncludiing fooods aand foood inngrediients (NF) preseents aa numbber off scieentifiic chaallengges. CConvenntionaal toxxicoloogicall evalluatioon metthods cannoot be appliied too foodds, beecausee foodd

45、s preesent partiicularr diffficultties nnot enncounttered with the ttestinng of food addittives and ccontamminantts in vivo and iin vittro. 關於食物(NFF及NF成分)的衛生評估估上，要有許許多對應的科科學驗證。傳統的毒理學評評估方法不能能適用於食物物，因為食品品在食品添加加劑和體內和和體外污染物物測試上是很很難表示出來來。For exaample, the amounnt of food to bee incoorporaated iin thee di

46、ett for animaal feeeding studiies wiithoutt pertturbinng itss nutrritionnal baalancee makees thee use of coonventtionall safeety faactorss inappproprriate for rrisk aassesssment and mmanageement for aany prroductt inteended for uuse ass a foood orr a maajor ffood iingreddient. 如，以食品的數量(結合不影響響營養均衡的的動

47、物飼料研研究)當成傳統安安全因素判斷斷對於風險評評估管理是不不合適的，而而且當成所有有產品(食品品或其成份的的使用)的管管理。Furtherrmore, tradditionnal meetabollic annd phaarmacookinettic sttudiess are not ddirecttly appplicaable tto commplex chemiical mmixturres liike fooods. The uuse off mutaagenciity annd othher inn vitrro tessts foor fooods reequirees spe

48、ecial technniquess and cautiious iinterppretattion oof thee resuults.此外，傳統的代代謝和藥物動動力學研究，不不能直接適用用於複雜的化化學混合物，如如食物。使用其他的致突突變性和體外外試驗的食品品需要特殊的的技術和謹慎慎的解釋結果果。Therefoore, aalternnativee apprroachees forr the testiing annd asssessmeent off the wholeesomenness oof fooods annd majjor foood inngrediients are nn

49、eededd. Thee ultiimate strattegy ffor coombineed nuttritioonal-ttoxicoologiccal teestingg willl exteend frrom innitiall testts in vitroo and in viivo sttudiess in aanimall modeels too studdies iin hummans iif neeeded.因此，其他對於於食品及其主主成分的衛生生評估替代方方案是必須的的。如需要，最好策略是結合合營養-毒物物測試從動物物的體內體外外實驗，擴大大到人體測試試。3.2 Gen

50、neticaally MModifiied Orrganissms (GGMO) 基基因生物Councill Direectivees 90/219/EEEC (66) andd 90/2220/EEEC as amendded byy Commmissioon Dirrectivve 94/15/ECC (7) set oout thhe infformattion rrequirrementts forr the safetty of the ccontaiined uuse off geneeticallly moodifieed miccroorgganismms (GMMM) ann

51、d thee safeety off the delibberatee releease oof genneticaally mmodifiied orrganissms (GGMO), respeectiveely. TThe reequireementss in tthese direcctivess are also relevvant tto GMOO coveered bby Reggulatiion (EEC) Noo 258/97 onn Noveel Fooods annd Novvel Foood Inngrediients and ffulfill basiic inffo

52、rmattion rrequirrementts neeeded ffor thhe saffety aassesssment of NFF. Thee pressent rrecommmendattions speciificallly foocus oon thoose asspectss releevant to huuman ffood ssafetyy issuues.3.3 Subbstanttial eequivaalencee The conncept of ssubstaantiall equiivalennce hhas beeen inntroduuced bby WHO

53、O and OECD with partiicularr refeerencee to ffoods produuced bby moddern bbiotecchnoloogy. IIn thee termminoloogy off the OECD, the conceept off subsstantiial eqquivallence emboddies tthe iddea thhat exxistinng orgganismms useed as foodss or aas foood souurces can sserve as a basiss for compaarisonn

54、 whenn asseessingg the safetty of humann conssumptiion off a foood orr foodd compponentt thatt has been modiffied oor is new. If a new ffood oor foood commponennt is foundd to bbe subbstanttiallyy equiivalennt to an exxistinng foood or food compoonent, it ccan bee treaated iin thee samee mannner wii

55、th reespectt to ssafetyy, keeeping in miind thhat esstabliishmennt of substtantiaal equuivaleence iis nott a saafety or nuutritiional assesssmentt in iitselff, butt an aapproaach too comppare aa poteentiall new food with its cconvenntionaal couunterppart.The appplicattion oof thee prinnciplee of ssu

56、bstaantiall equiivalennce caan be extennded tto thee evalluatioon of foodss fromm noveel souurces and pprocessses. Substtantiaally eequivaalent NF arre thuus commparabble, iin terrms off safeety, tto theeir coonventtionall counnterpaart. SSubstaantiall equiivalennce maay be estabblisheed eitther ffo

57、r thhe whoole foood orr foodd compponentt inclludingg the introoducedd neww chaange, or itt mighht be estabblisheed forr the food or foood coomponeent exxcept for tthe sppecifiic neew chhange introoducedd. If a NF has nnot beeen foound tto be substtantiaally eequivaalent to ann exissting food or foo

58、od coomponeent, tthis ddoes nnot immply tthat iit is unsaffe. Itt justt indiicatess thatt suchh a NFF shouuld bee evalluatedd on tthe baasis oof itss uniqque coomposiition and pproperrties.The esttablisshmentt of ssubstaantiall equiivalennce iss an aanalyttical exerccise iin thee asseessmennt of the

59、 rrelatiive whholesoomenesss of a NF compaared tto an existting ffood oor foood commponennt. Itt conttains a dynnamic elemeent, aas thee conttinuinng moddificaation of a food requiires tthat tthe baasis oof commparisson wiill evvolve in a way tthat tthe moost reecent NF iss comppared with an appprop

60、rriate formeer NF and nnot neecessaarily with the mmost ttradittionall counnterpaart.The commparisson maay be a simmple ttask oor be very lengtthy deependiing uppon exxperieence wwith aand thhe natture oof thee NF uunder consiiderattion. The ttechniical aapproaach too estaablishhing ssubstaantiall e