2022年整理—欧盟-NO618-1新型食品和新型食品配料和编制的初步评估报告根据法规

1、MISSION REMENDATION of 29 July 1997 concerning the scientific ects and the presentation of information necessary to sport applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assesent reports under Regulation (EC) No 258/97 of the Europe

2、an Parliament and of the Council (Text with EEA relevance) (97/618/EC)THE MISSION OF THE EUROPEAN MUNITIES,Having regard to the Treaty establishing the European munity,Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods a

3、nd novel food ingredients (1), and in particular Article 4 (4) thereof,Whereas, in order to protect public health, it is necessary that novel foods and novel food ingredients are subject to a single safety assesent through a munity procedure before they are placed on the market within the munity;Whe

4、reas remendations concerning the scientific ects of the information necessary to sport an application for the placing on the market of a novel food or a novel food ingredient will facilitate the task of economic operators in preparing su an application; whereas remendations concerning the presentati

5、on of su information and concerning the preparation of initial assesent reports by the petent food assesent bodies of the Member States will facilitate the evaluation of su applications;Whereas the Scientific mittee for Food has made remendations on the information necessary to sport su applications

6、, the presentation of that information and the preparation of initial assesent reports on those applications;Whereas experience in the assesent of novel foods and novel food ingredients is at present limited; whereas therefore any remendations in this area must be kept under constant review to take

7、account of new scientific information and the work of the relevant international organizations;Whereas the Member States have been consulted on this Remendation within the framework of the Standing mittee for Foodstuffs,HEREBY REMENDS THAT:1. When preparing applications for the placing on the market

8、 of novel foods and novel food ingredients, economic operators should follow the remendations concerning the scientific ects of the information necessary to sport su applications set out in the Annex, Part I.附錄 Part 1當準備進軍NF、NF成分到場經濟經營者(企業)應遵循科學方面提供必要的資料以支持這些應用2. Economic operators should ensure tha

9、t the information necessary to sport applications referred to in point 1 is presented in accordance with the remendations set out in the Annex, Part II.附錄 Part 2說明依第一點企業要保證支持申請的資料3. Member States should ensure that the initial assesent reports drawn by their petent food assesent bodies pursuant to A

10、rticle 6 (2) of Regulation (EC) No 258/97 are prepared in accordance with the remendations set out in the Annex, Part III.附錄 Part 3會員國的主單位依Article 6 (2) of Regulation (EC) No 258/97來要求各項最初的評估報告。Done at Brussels, 29 July 1997.For the missionMartin BANGEMANNMember of the mission(1) OJ L 43, 14. 2. 199

11、7, p. 1.ANNEX 附件PART I REMENDATIONS CONCERNING THE SCIENTIFIC ECTS OF INFORMATION NECESSARY TO SPORT APPLICATIONS FOR THE PLACING ON THE MARKET OF NOVEL FOODS AND NOVEL FOOD INGREDIENTS 附錄 Part 1關於支持新食物及其成份的場所需的科學資料建議。TABLE OF CONTENTS 1. Introduction . 42. Categories of novel foods and novel food i

12、ngredients identified in Regulation (EC) No 258/97 . 4依法規No 258/97定義NF及NF成分的分類3. Key issues for the assesent of novel foods and novel food ingredients (NF) . 5評估新型食品和新型食品配料NF的關鍵問題 3.1 General considerations . 5一般狀況3.2 Genetically modified organis (GMO) . 5基因生物3.3 Substantial equivalence . 5實質等同3.4 p

13、ositional analysis . 6成分分析3.5 Intake . 6吸收3.6 Nutritional considerations affecting toxicological testing in animals . 6動物性測試後的營養效應3.7 Toxicological requirements . 7性要求3.8 Implications of NF to human nutrition . 7關於NF對人體營養的含意3.9 Novel microorganis used in food . 7新型微生物在食物上的使用3.10 Allergenic potential

14、 . 8過敏的可能3.11 Assesent of marker genes . 8標記基因的評估4. Scientific classification of novel foods for the assesent of wholesomeness . 9科學對新型食品衛生評價的分類Class 1: Pure emicals or simple mixtures from non-GM sources . 9(非基因)物來源的純化學物或簡單的混何物Class 2: plex NF from non-GM sources . 9(非基因)物來源的NF複合物Class 3: GM plants

15、 and their products . 9基因植物與其產品Class 4: GM animals and their products . 10基因動物與其產品Class 5: GM microorganis and their products . 10基因微生物及其產品Class 6: Foods produced using a novel process . 10因新流程產生的食物5. Identification of essential information for assesent of wholesomeness . 10評估衛生安康資料的定義I. Specificati

16、on of the NF . 11NF的規格II. Effect of the production process applied to the NF . 11生產流程應用在NF上的效應III. History of the organi used as the source of the NF . 11生物使用在NF的歷史IV. Effect of the genetic modification on the properties of the host organi . 12基因改造的主機(母體)機體對性能的影響V. Genetic stability of the GMO used

17、as NF source . 13基因生物用於NF的基因穩定性VI. Specificity of expression of novel genetic material . 13新遺傳物質的特殊性VII. Transfer of genetic material from GMO . 13從基因物改良其基因體VIII. Ability of the GMM to survive in and colonize the human gut . 13基因物生存在人體腸道的才能IX. Anticipated intake/extent of use of the NF . 13預NF的攝入量/程

18、度上使用X. Information from previous human exposure to the NF or its source . 13以前人類接觸NF或其來源的資料XI. Nutritional information on the NF . 14NF的營養資料XII. Microbiological information on the NF . 14NF的微生物資料XIII. Toxicological information on the NF . 14NF的性資料6. Review of remendations . 15審查建議7. References . 15參

19、考資料8. Glossary . 16術語Table I: Association between the categorization in the munity Regulation on Novel Foods and Novel Food Ingredients and the SCF remendations . 17Table II: Index to structured semes to be followed for ea class of NF . 18Semes I-XIII . 19I. INTRODUCTION Whenever anges are made to t

20、he way in whi a food is put on the market, produced or processed or uses non-traditional ingredients, the implications for consumer safety and nutritional value will require consideration. Information will be needed on any issue relating to both these ects. At present, the issue of food safety in re

21、lation to novel foods is under consideration world-wide. The World Health Organization (WHO), the Organization for Economic Cooperation and Development (OECD), and other national and international bodies have addressed both general and specific ects relevant to the wholesomeness of novel foods. A nu

22、mber of reports outline the philosophies and developments in this field (see references).As part of the development of Regulation (EC) No 258/97 on Novel Foods and Novel Food Ingredients the European mission has asked the Scientific mittee for Food (SCF) to develop remendations concerning the scient

23、ific ects ofI. the information necessary to sport an application for the placing on the market of novel foods and novel food ingredients;II. the presentation of su information;III. the preparation of the initial assesent reports.This report covers task I.2. CATEGORIES OF NOVEL FOODS AND NOVEL FOOD I

24、NGREDIENTS IDENTIFIED IN REGULATION (EC) No 258/97 According to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), Regulation (EC) No 258/97 will apply to the placing on the market of foods or food ingredi

25、ents whi have not hitherto been used for human consumption to a significant degree within the munity and whi fall under the following categories:(a) foods and food ingredients containing or consisting of genetically modified organis within the meaning of Council Directive 90/220/EEC (2);(b) foods an

26、d food ingredients produced from, but not containing, genetically modified organis;(c) foods and food ingredients with a new or intentionally modified primary molecular structure;(d) foods and food ingredients consisting of or isolated from microorganis, fungi or algae;(e) foods and food ingredients

27、 consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating and breeding practices and whi have a history of safe food use;(f) foods and food ingredients to whi has been applied a production process not

28、currently used, where that process gives rise to significant anges in the position or structure of the foods or food ingredients whi affect their nutritional value, metaboli or the level of undesirable substances.The Regulation does not apply to: food additives falling within the scope of Council Di

29、rective /107/EEC (3); flavourings for use in foodstuffs falling within the scope of Council Directive 88/388/EEC (4); or extraction solvents used in the production of foodstuffs falling within the scope of Council Directive 88/344/EEC (5).3. KEY ISSUES FOR THE ASSESENT OF NOVEL FOODS AND NOVEL FOOD

30、INGREDIENTS (NF) 評估新型食品和新型食品配料NF的關鍵問題3.1 General considerations 一般狀況Foods are usually plex mixtures of macro- and micro constituents whi provide energy and nutrients and contribute to the well-being of humans. They have traditionally been regarded as natural, beneficial and necessary products whose

31、safety and nutritional value need not be questioned. 食物一般是由聚成分及微成分的複合物組成提供能量及營養給人體。這些被視為天然的有益的和必要的產品是大家所認知不會懷疑他的平安性及營養價值Regulatory approaes to food safety have reflected this attitude and have focused on food additives, processing aids and contaminants of natural or industrial origin. 食品平安監督理辦法反映關於食

32、品添加劑加工助劑和污染物或工業原料的影響。Thus, foods have not hitherto been systematically subjected to nutritional or toxicological evaluation, except in rare cases where acute toxic effects have been reported in humans (e.g. solanine, cyanogenic glycosides) or in those cases where animal studies or human experiences

33、have suggested adverse effects from raw food materials (e.g. raw soya flour). 因此食物尚未有系統關於營養及性評估。除了少數關於人體劇烈性的報導(如solanine, cyanogenic glycosides)或其他關於食物原料在人體及動物上負面效應案例出現。This is not to imply that nutritional evaluation of individual foods and of whole diets has not been performed, but that su nutriti

34、onal evaluations have not been used as a basis for a safety assesent of individual foods. 這並不意味著個別食品營養評價和整個飲食都尚未執行但這種營養評價沒有被用來作為一個基礎的平安評價單個食品On the other hand, food additives are not permitted in food unless they have been subjected to exhaustive toxicological evaluation.另依方面只有經過徹底性評估後食物添加劑才可以使用。Var

35、ious foods are known to contain toxic pounds, including mutagens and carcinogens. Some ronic diseases in humans have a dietary element in their etiology. Although it is agreed that some adverse effects of the diet on health are related to the pattern of nutrient intake, the exact meanis involved are

36、 not known. 各種食品中含有的有化合物包括誘變和致癌物質。一些慢性疾病其病因來自人類飲食的元素雖然大家同意一些在安康方面有害的飲食效果是與營養物攝取方式有關但是他的反應機制仍尚未明瞭It is possible that some ill health is due to ronic exposure to constituents of traditional foods. Until recently little attention has been given to this ect or to the possible role of modifiers of toxic

37、effects (e.g. anticarcinogens) naturally present in foods.這可能是一些疾病是由於長暴露於傳統食品的成分。直到最近有人注意這方面食品中自然存在給予可能的作用或性反應的改性劑如anticarcinogens。The assesent of the wholesomeness of foods including foods and food ingredients (NF) presents a number of scientific allenges. Conventional toxicological evaluation meth

38、ods cannot be applied to foods, because foods present particular difficulties not encountered with the testing of food additives and contaminants in vivo and in vitro. 關於食物(NF及NF成分)的衛生評估上要有許多對應的科學驗證。傳統的理學評估不能適用於食物因為食品在食品添加劑和體內和體外污染物測試上是很難表示出來。For example, the amount of food to be incorporated in the

39、 diet for animal feeding studies without perturbing its nutritional balance makes the use of conventional safety factors inappropriate for risk assesent and management for any product intended for use as a food or a major food ingredient. 如以食品的數量(結合不影響營養平衡的動物飼料研究)當成傳統平安因素判斷對於風險評估理是不合適的而且當成所有產品(食品或其成

40、份的使用)的理。Furthermore, traditional metabolic and pharmacokinetic studies are not directly applicable to plex emical mixtures like foods. The use of mutagencity and other in vitro tests for foods requires special teniques and cautious interpretation of the results.此外傳統的代謝和藥物動力學研究不能直接適用於複雜的化學混合物如食物。使用其他

41、的致突變性和體外試驗的食品需要特殊的技術和謹慎的解釋結果。Therefore, alternative approaes for the testing and assesent of the wholesomeness of foods and major food ingredients are needed. The ultimate strategy for bined nutritional-toxicological testing will extend from initial tests in vitro and in vivo studies in animal model

42、s to studies in humans if needed.因此其他對於食品及其主成分的衛生評估替代方案是必須的。如需要策略是結合營養-物測試從動物的體內體外實驗擴大到人體測試。3.2 Genetically Modified Organis (GMO) 基因生物Council Directives 90/219/EEC (6) and 90/220/EEC as amended by mission Directive 94/15/EC (7) set out the information requirements for the safety of the contained us

43、e of genetically modified microorganis (GMM) and the safety of the deliberate release of genetically modified organis (GMO), respectively. The requirements in these directives are also relevant to GMO covered by Regulation (EC) No 258/97 on Novel Foods and Novel Food Ingredients and fulfil basic inf

44、ormation requirements needed for the safety assesent of NF. The present remendations specifically focus on those ects relevant to human food safety issues.3.3 Substantial equivalence The concept of 'substantial equivalence has been introduced by WHO and OECD with particular reference to foods pr

45、oduced by modern biotenology. In the terminology of the OECD, the concept of substantial equivalence embodies the idea that existing organis used as foods or as food sources can serve as a basis for parison when assessing the safety of human consumption of a food or food ponent that has been modifie

46、d or is new. If a new food or food ponent is found to be substantially equivalent to an existing food or food ponent, it can be treated in the same manner with respect to safety, keeping in mind that establishment of substantial equivalence is not a safety or nutritional assesent in itself, but an a

47、pproa to pare a potential new food with its conventional counterpart.The application of the principle of substantial equivalence can be extended to the evaluation of foods from novel sources and processes. Substantially equivalent NF are thus parable, in terms of safety, to their conventional counte

48、rpart. Substantial equivalence may be established either for the whole food or food ponent including the introduced 'new ange, or it might be established for the food or food ponent except for the specific 'new ange introduced. If a NF has not been found to be substantially equivalent to an

49、existing food or food ponent, this does not imply that it is unsafe. It just indicates that su a NF should be evaluated on the basis of its unique position and properties.The establishment of substantial equivalence is an analytical exercise in the assesent of the relative wholesomeness of a NF pare

50、d to an existing food or food ponent. It contains a dynamic element, as the continuing modification of a food requires that the basis of parison will evolve in a way that the most recent NF is pared with an appropriate former NF and not necessarily with the most traditional counterpart.The parison m

51、ay be a simple task or be very lengthy depending on experience with and the nature of the NF under consideration. The tenical approa to establishing substantial equivalence will differ between whole animals, plants, microorganis, emical food ingredients and novel processes and is addressed in more d

52、etail under the different classes later in these remendations.3.4 positional analysis成分分析Analytical studies of the position of the NF are of crucial importance not only for the establishment of substantial equivalence but also as a prerequisite for nutritional and toxicological assesents. Methods ap

53、plied have to be standardized and validated to ensure quality and consistency of the data. The analyses and data presented should be based on sound scientific principles and should be tailored to the nature of the NF. Investigations should focus especially on the determination of the content of crit

54、ical nutrients (both macro- and micronutrients) and any critical toxicants and anti-nutritional factors whi might be either inherently present or process derived.3.5 Intake 吸收The consumption pattern may show a major ange when an NF is included in the diet and thus affects human nutritional status. A

55、s it may not be possible to predict su events, a surveillance programme should acpany the marketing of an NF. Su a programme should enpass information on anges in the conditions for processing and preparation as well as effects of possible replacement of other foods or food ponents of dietary import

56、ance. If surveillance reveals anges in those factors whi raise concerns regarding wholesomeness, a reappraisal of the acceptability of the NF would be required.3.6 Nutritional considerations affecting toxicological testing in animals In the overall evaluation it is of crucial importance to interpret

57、e carefully any adverse effects seen in animal studies and to distinguish between toxic effects and those due to nutritional imbalance in the experimental diet. Thus, nutritional and toxicological ects have to be closely integrated in the assesent of NF. Thorough knowledge of the nutritional propert

58、ies of the NF (e.g. energy value, protein content, and bioavailability of micronutrients) is needed as a prerequisite of the toxicological testing programme. In designing animal feeding studies, the um level of dietary incorporation aievable without causing nutritional imbalance should be the highest dose level, while the lowest dose level should be parable to its anticipated role in the human diet.If the predicted usage levels an