【文章內(nèi)容簡介】 t. 如以食品的數(shù)量(結(jié)合不影響營養(yǎng)平衡的動物飼料研究)當(dāng)成傳統(tǒng)平安因素判斷對於風(fēng)險(xiǎn)評估理是不合適的而且當(dāng)成所有產(chǎn)品(食品或其成份的使用)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(tǒng)的代謝和藥物動力學(xué)研究不能直接適用於複雜的化學(xué)混合物如食物。使用其他的致突變性和體外試驗(yàn)的食品需要特殊的技術(shù)和謹(jǐn)慎的解釋結(jié)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 nutritionaltoxicological testing will extend from initial tests in vitro and in vivo studies in animal models to studies in humans if needed.因此其他對於食品及其主成分的衛(wèi)生評估替代方案是必須的。如需要策略是結(jié)合營養(yǎng)物測試從動物的體內(nèi)體外實(shí)驗(yàn)擴(kuò)大到人體測試。 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 use 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 information requirements needed for the safety assesent of NF. The present remendations specifically focus on those ects relevant to human food safety issues. Substantial equivalence The concept of 39。substantial equivalence` has been introduced by WHO and OECD with particular reference to foods produced 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 modified 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 approa 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 counterpart. Substantial equivalence may be established either for the whole food or food ponent including the introduced 39。new` ange, or it might be established for the food or food ponent except for the specific 39。new` ange introduced. If a NF has not been found to be substantially equivalent to an 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 pared 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 may 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 detail under the different classes later in these remendations. 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 applied 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 critical nutrients (both macro and micronutrients) and any critical toxicants and antinutritional factors whi might be either inherently present or process derived. 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. As 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 importance. If surveillance reveals anges in those factors whi raise concerns regarding wholesomeness, a reappraisal of the acceptability of the NF would be required. Nutritional considerations affecting toxicological testing in animals In the overall evaluation it is of crucial importance to interprete 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 properties of the NF (. 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 and consumer intakes are likely to be high, the