“华中农业大学彭东海等人用转基因Bt制作的BMB696B粉剂持续口服14天急性与28天亚急性毒理学动物实验研究论文”是先正达向欧盟食品安全机构EFSA提交的转基因玉米MIR162“食用安全性”重要依据。“先正达转基因玉米MIR162表达的Vip3Aa20杀虫蛋白”与“转基因Bt制作的BMB696B粉剂”明显“实质不等同”,奥地利卫生部为此向欧洲食品安全机构提交的评审意见对先正达举证该项毒理学动物实验作为转基因玉米MIR162“食用安全性”依据的科学性与严谨性提出质疑。欧洲食品安全机构也确：“同意彭东海等人的研究论文不足以证实转基因玉米MIR162中表达的Vip3Aa20蛋白的安全性。”【评论：对张启发团队和中国农业大学食品科学与营养工程学院院长罗云波、黄昆仑教授对转基因Bt杀虫蛋白"灌胃一次观察七天毒理学试验"，奥地利卫生部不知会如何评价?】
Application EFSA-GMO-DE-2010-82 (Maize MIR162)
申请编号：EFSA-GMO-DE-2010-82(转基因玉米MIR162)
ANNEX G Comments and opinions submitted by MemberStates during the three-month consultation period
附件G 成员国在三个月咨询期内提交的评论与意见
http://registerofquestions.efsa.europa.eu/roqFrontend/?wicket:interface=:0:1:::
Austria Federal Ministry of Health
奥地利联邦卫生部
Regarding D, 07.08 Toxicology
关于D, 07.08毒理学
On the paperof Peng et al. 2007 (Appendix 36): Acute oral toxicity study: The authorsperformed an acute oral toxicity study employing fifty young adult (five tosix-week-old) Wistar (25 males and 25 females) rats. The animals received soliddiet and tap water ad libitum during the experiments. The test material,BMB696B powder preparation, was suspended in distilled water and administeredorally at doses of 500, 1250, 2500 and 5000 mg/kg bw by oral gavage. Controlgroups received distilled water instead. Consecutive observation period was 15days. No abnormal clinical signs or abnormal physiological activities werereported both in all verum groups and in the control. The body weights, bodyweight gains of the rats treated with the BMB696B powder preparation showed nosignificant changes compared with those of the control group. At necropsy, nogross histopathological alterations could be found in all tested animals and inthe control group. Therefore, the authors conclude that, since even the highdose of 5000 mg/kg bw did not induce any deaths or significant toxic symptomsin their study, the oral acute toxicity of BMB696B powder preparation could beconsidered as unclassified. The verbalisations of the authors were sometimesmisleading and only interpretable with in-depth knowledge of toxicological testprocedures (obviously because the English language is not the mother tongue ofthe authors).
(译注：华中农业大学)彭东海等2007年的论文(附件36)：急性毒理学研究：该项研究的们做了急性口服毒理学研究，使用五十只年轻的(5-6周年龄)Wistar(25只雄鼠与25只雌鼠)大鼠。实验期间，对这些动物服用了随意量固态饮食与自来水。试验材料，BMB696B粉状配制物，悬浮在蒸馏水中，以500、1250、2500与5000 mg/kg 体重剂量口服添喂。持续观察期为15天。对所有处理组与对照组都没有报告异常临床迹象或者异常生理活动。服用BMB696B配制物老鼠的体重、体重增加率，与对照组相比，没显示显著变化。验尸中，在所有试验动物与对照组中没能够发现任何总体组织病理学改变。该项研究的们因此结论，在他们的研究中，即便高剂量的5000mg/kg体重也未能诱发任何死亡或者显著毒性症状，BMB696B粉状配制物的口服剂型毒性可以考虑为不分类(无毒)。们的词汇有时造成误导，只有对毒理学试验程序深入知识才能解释(显然因为英文不是们的母语)。
No detaileddata were provided. Somewhat peculiar are the uncommonly small deviations inbody weights and body weight gains listed within all groups (partly only a fewpercents during the whole observation period).
该项研究没有提供详细数据。有点奇怪的是，所有组内都列出了身体重量和体重增长率非同寻常的小偏差(整个观察期间部分仅有百分之几)。
Subacute oraltoxicity study:
(该项研究包括的第二项)亚急性口服毒理学研究
The subacutetoxicity study involved oral administration of BMB696B powder preparation atdoses of 0, 200, 1000 and 5000 mg/kg bw per day given to both male and femaleWistar rats (six-week old, five animals per group) for 28 consecutive days. Thetest material was suspended in distilled water; the control received onlydistilled water.
亚急性毒理学研究涉及每天对雄性与雌性Wistar大鼠(6周年龄，每组5只)口服0、200、1000与5000 mg/kg体重剂量的BMB696B粉状配制物，连续28天。试验材料悬浮在蒸馏水中;对照组仅服用蒸馏水。
Except forsome minor non-dose-dependent clinical signs of single animals, noabnormalities and no obvious signs of toxicity or change in behaviouralpatterns or other physiological activities could be seen. Some haematologicaland blood chemistry values differed significantly from control in some verumgroups but the events were isolated and not dose-dependent. At autopsy,macroscopic observation of the organs did not show any change due to treatmentwith BMB696B powder preparation. Gross necropsy and pathological examination oftreated rats did not reveal any abnormality in morphology of lungs, heart,spleen, liver and kidney. Thus, the authors conclude that BMB696B administeredto rats even at a dose of 5000 mg/kg bw per day led to no significanttoxicological changes.
除了个别动物中某些次要的非剂量依赖临床信号，没有异常的与明显的毒性信号，也没看到行为变化或者其他的生理活动。在某些处理组中，某些血液学与血液化学指标值与对照组显著不同，但是这样的事件是孤立的与非剂量依赖。尸检中，对器官的宏观观察没有显示与服用BMB696B粉状配制物相关的任何改变。对处理组大鼠的尸体剖检总值和病理检查，没有揭示肺脏、心脏、脾脏、肝脏与肾脏任何形态学异常。该项研究的因此结论，即便每天服用5000 mg/kg体重的量也没有导致显著毒理学变化。
Based on theseresults, the no adverse effect level of the vip3Aa7 GM B. thuringiensis BMB696Bwould be higher than 5000 mg/kg bw per day. Therefore, they argue the vip3Aa7GM B. thuringiensis to be safe to rodents and could be considered as a safebio-pesticide for future use.
基于这些结果，vip3Aa7转基因Bt BMB696B的“没有危害影响水平”高于每天服用5000 mg/kg体重。因此，该项研究的们辩称vip3Aa7转基因Bt BMB696B对脊椎动物安全，也可以考虑为未来使用的安全的生物杀虫剂。
For thesubacute study some more data were provided than with the acute toxicity study,but likewise no details of important toxicological parameters, for instancelists of pathology/histopatholgy evaluations, were given.
对于亚急性研究，比急性毒性研究提供了一些更多的数据，但是与畸形毒性研究一样，没有提供重要毒理学指标的细节，例如没有给出病理学/病理变化评估。
[Appendix 36.
AdditionalInformation provided to Applications EFSA-GMO-DE-2009-66 and -67 for import anduse of genetically modified stacked Bt11 x MIR162 x MIR604 x GA21 maize andBt11 x MIR162 x GA21 maize under Regulation (EC) No 1829/2003, submitted on 16December 2009. Dossier EFSA/GMO/DE/2010/82.
法规(EC) No1829/2003项下2009年12月16日对进口与使用转基因多重基因Bt11 x MIR162x MIR604 x GA21玉米与Bt11 x MIR162 x GA21玉米申请EFSA-GMO-DE-2009-66 与-67对提交的进一步信息。档案EFSA/GMO/DE/2010/82。
Peng, D.,Chen, S., Ruan, L., Li, L., Yu, Z. und Sun, M. (2007). Safety assessment oftransgenic Bacillus thuringiensis with VIP insecticidal protein gene by feedingstudies. Food Chem Toxicol 45(7): 1179-1185.]
studies. FoodChem Toxicol 45(7): 1179-1185.]
彭东海、孙明等。通过喂养研究对VIP杀虫蛋白基因的转基因Bt的安全性评估。食物化学毒理学45(7):1179-1185。】
EFSA GMO PanelResponse:
欧洲食品安全机构转基因专家组的回应：
As furtherexplained in the scientific opinion the EFSA GMO Panel agrees with Austria onthe inadaquacy of the publication by Peng et al. to prove the safety of theVip3Aa20 expressed in maize MIR162. Therefore, the EFSA GMO Panel requested a28-day oral toxicity study in rodents with the purified Vip3Aa20 protein. Fordetails see section 5.1.3.2 of the scientific opinion.
如《科学意见》中进一步解释的那样，欧洲食品安全机构转基因专家组同意彭东海等人的研究论文不足以证实转基因玉米MIR162中表达的Vip3Aa20蛋白的安全性。欧洲食品安全机构转基因专家组因此要求进一步用纯Vip3Aa20蛋白对脊椎动物进行了一项28天口服毒理学研究。关于进一步细节，参看《科学意见》第5.1.3.2节。
奥地利卫生部揭转基因玉米MIR162大鼠90天试验恶性肿瘤
作为向欧洲食品安全机构(EFSA)提供转基因玉米MIR162“食用安全性”最为关键性依据，先正达提交了一篇未经同行审查也没公开发表的令人质疑《转基因玉米MIR162谷物90天全食品安全性老鼠试验》报告。奥地利卫生部揭露该篇毒理学试验报告暴露了以下严重问题:在喂养含10.0%转基因玉米MIR162阳性饮食的一只雄鼠的肾上腺中确诊了一个皮质腺瘤，在喂养含41.5%转基因玉米MIR162阴性对照非转基因玉米一只雌鼠的阴蒂腺还确证了一个腺瘤。在喂养41.5%转基因玉米MIR162阳性谷物试验组还早期记录了一只雌鼠肝恶性淋巴瘤。先正达强调：这些问题“在性质上具有自发性质而且与喂养的饮食中的转基因玉米MIR162谷物无关”予以排除!奥地利卫生部强调：“至于对转基因一般性应用而言，通常的预防性声明在这里也适用：鉴于给出的研究体系及其设计，对长期性(特别对食物而言)、生殖性或者发育性的影响，这些研究未能提供最终证据。”EFSA全然忽略奥地利卫生部提出的问题，反而武断决定：“依据适用的欧洲食品安全机构指导原则，...对于Vip3Aa20蛋白的长期性、生殖性与发育性影响的特定信息不再要求。”【评论：向先正达转基因玉米MIR162颁“安全证书”农业部必须公布“2011年指定农业部转基因生物食用安全监督检验测试中心(天津)进行MIR162玉米及常规对照玉米90天大鼠喂养试验”报告原件的扫描件!】
Application EFSA-GMO-DE-2010-82 (Maize MIR162)
申请编号：EFSA-GMO-DE-2010-82（转基因玉米MIR162）
ANNEX G Comments and opinions submitted by MemberStates during the three-month consultation period
附件G成员国在三个月咨询期内提交的评论与意见
http://registerofquestions.efsa.europa.eu/roqFrontend/?wicket:interface=:0:1:::
AustriaFederal Ministry of Health
奥地利联邦卫生部
Onthe 90-day whole food safety study (FROM CBI: Appendix 28 ):
关于90天全食品安全性研究(自CBI:附件28)
Itwas not confirmed analytically that the active principles could be actuallydetected in the diet. The investigators report that statistical evaluationallowing for pre-experimental body weight (adjusted means) indicated adjustedbody weights of females fed diet containing 41.5% Event MIR162 positive maizegrain having been occasionally statistically significantly lower than weightsof the corresponding control group, particularly during the latter part of thestudy. From the given data, only some increase in body weight of the femalehigh dose verum group could be verified.
未分析证实，饮食中实际上是否能检测到活性成分。调查者报告，统计学评价允许的试验前体重(经调整名义体重)显示，喂养含41.5%转基因玉米MIR162阳性饮食的雌鼠体重有时比对应对照组统计显著低，特别在试验的后期。从提供的数据看，仅高剂量组雌鼠中可以证明体重有某些增加。
Infemales, basophil count was statistically significantly lower for groups feddiets containing 10.0 and 41.5% Event MIR162 positive transgenic maize graincompared to the corresponding control groups. When the high control values wereexcluded the basophil count was no longer statistically significantly lower forthe group fed diet containing 41.5% Event MIR162 positive transgenic maizegrain. But it has to be mentioned that for the low dose verum group thedecreased basophil count remained statistically significant compared to thecorresponding control group, and with the high dose verum groupnon-significance as against the corresponding control group could only beachieved by deleting values of three (1/4) control animals. Moreover, a trendin the direction of decreased basophil counts within the verum groups stillremained. A decreased percentage of basophils may be due to an acute allergicreaction.
喂养10.0%与41.5%转基因玉米MIR162阳性处理组的雌鼠，与对应对照组比较，嗜碱细胞计数统计显著更低。高剂量对照值排除时，41.5%转基因玉米MIR162阳性处理组的嗜碱细胞计数就不再统计显著更低。但是应当提出，低剂量(10.0%)试验组嗜碱细胞计数统计显著低与对应对照组，而高剂量(41.5%)嗜碱细胞计数并不统计显著低与对应对照组仅能由于删除了对照组中三只鼠(1/4)的值。此外，处理组中嗜碱细胞计数减少的趋势依然存在。嗜碱细胞计数减少的百分百可能由于畸形过敏性反应。
At aninclusion level of 10.0% Event MIR162 positive transgenic maize grain, plasmaalkaline phosphatase was statistically significantly higher in males comparedto the corresponding control group. However, the difference did not remainstatistically significant after the exclusion of a single exceptionally highvalue. Apart from the fact that normally the deletion of "out-liers"leads to a "sharpening" of statistical significance(i.e.non-significant differences sometimes become significant because of thediminution of the standard deviation) and not vice versa, the seen effectposing no significance under isolated consideration gains in importance if theresults of the subacute study performed by Peng et al. (2007) are taken intoconsideration: the ALP (alkaline phosphatase) in 5000 mg/kg female group wassignificantly higher.
在含10.0%水平转基因玉米MIR162阳性中，与对应对照组相比，雄鼠中的碱性磷酸酶统计显著更高。然而，在排除单独一个特别高值以后，这种差别不再维持统计显著。除了正常地删除导致使统计显著“更突出”的“超出者”(即，减少标准偏差使非显著有时成为显著)，而非反之亦然，使所看到的影响在孤立考虑收益的重要性下没有意义，如果Penget al. (2007)进行的亚急性研究的结果考虑在内：5000mg/kg雌鼠组中的碱性磷酸酶(ALP)显著更高。
Twoinstances of benign tumours were observed. A cortical adenoma was diagnosed inthe adrenal gland of one male animal fed diet containing 10.0% Event MIR162positive maize grain, and an adenoma was also diagnosed in the clitoral glandof a female animal fed diet containing 41.5% Event MIR162 negative control,non-transgenic maize grain. One early case of malignant lymphoma involving onlythe liver was also recorded in one female animal fed diet containing 41.5%Event MIR162 positive maize grain. These tumours the authors considered to bespontaneous in nature and unrelated to the administration of Event MIR162 maizegrain in diets.
观察到两个良性肿瘤实例。在喂养含10.0%转基因玉米MIR162阳性饮食的一只雄鼠的肾上腺中确诊了一个皮质腺瘤，在喂养含41.5%转基因玉米MIR162阴性对照非转基因玉米顾问饮食的一只雌鼠的阴蒂腺还确证了一个腺瘤。在喂养41.5%转基因玉米MIR162阳性谷物试验组中早期还记录了一只雌鼠的肝恶性淋巴瘤。试验研究报告的们认为他们在性质上具有自发性质而且与喂养的饮食中的转基因玉米MIR162谷物无关。
[Appendix28.
[附件28.转基因
EventMIR162 maize grain 90 day whole food safety study in rats. DossierEFSA/GMO/DE/2010/82.
玉米MIR162谷物对大鼠的90天全食物安全性研究。文件编号：DossierEFSA/GMO/DE/2010/82.【注：未公开发布研究报告!】
Peng,D., Chen, S., Ruan, L., Li, L., Yu, Z. und Sun, M. (2007). Safety assessment oftransgenic Bacillus thuringiensis with VIP insecticidal protein gene by feedingstudies. Food Chem Toxicol 45(7): 1179-1185.]
彭东海、孙明等。通过喂养研究对VIP杀虫蛋白基因的转基因Bt的安全性评估。食物化学毒理学45(7):1179-1185。】
http://www.sciencedirect.com/science/article/pii/S0278691507000142
AustriaFederal Ministry of Health Conclusions:
奥地利联邦卫生部结论：
Foracute and subacute oral studies with rats fed the Vip3Aa protein, nosignificant toxicological effects up to 5000 mg/kg bw (the highest dose used)were reported by Peng et al. (2007).
用大鼠喂养Vip3Aa蛋白的急性与亚急性口服研究，Penget al. (2007)的研究论文宣称：一直到5000mg/kg体重(使用的最高剂量)都没有显著毒理学影响。
However,being a publication in a scientific journal, the paper of Peng et al. did notcontain detailed results in that extent of making verification or evaluation ofsomeone‟s own possible. Thus, detailed documentation and data would have to beprovided in order to make robust assessment on these toxicological parameters.
然而，作为在科学杂志上发表的文章，彭东海等人的论文没有达到使其他人可以验证或者评价的足够详尽结果。因而，需要提供详细的文件与数据以便能够对这些毒理学指标做出可靠的评估。
Withthe results of the 90-day study with the whole MIR 162 maize grain the studyauthors were seeing no deviations or pathological changes caused by theproduct.
鉴于转基因玉米MIR162全谷物90天研究的结果，该项研究的们看到MIR162玉米不造成任何偏差或者生理学改变。
Thisconclusion can be accepted in general with one exception, even thoughstatistically significant aberrations in the verum group are"smoothed" several times by omission of outlying values in thecontrol group or by comparison with the "historical control".
这个结论可以一般性的接受，但是有一个例外，即便通过排除对照组中的超量值或通过与“历史性对照”进行比较的方法对处理组中的畸变统计显著进行数次“平滑”处理。
Regardingthe basophil count in females, there was a trend in the direction of decreasecompared to the corresponding control groups.
关于雌鼠中的嗜碱细胞计数，与对应对照组相比，存在着减少倾向。
Adecreased percentage of basophils may be due to allergic reactibility.
嗜碱细胞计数百分百减少可能因为过敏性反应。
Regardingthe elevation of alkaline phosphatase, it was only sporadic, and no increase ofother organ (especially liver) damage indication enzymes (for instanceaminotransferases) could be seen.
关于碱性磷酸酶升高，它仅是零星的，而且未能看到其他器官(特别是肝脏)损伤指示酶(例如转氨酶)响应升高。
(FROMCBI: Appendix 28) Apart from the decreased basophil count with its possibleallergenic implication (which counts for even more, because the allergenicpotential or non-potential was elaborated only theoretically in another part ofthe dossier), from the given data no significant substantial detrimentaleffects caused by MIR162 maize or its active principle Vip3Aa protein could berecognised.
(从CBI：附录28)除了降低的嗜碱细胞计数及其可能的的致敏性关联(其计数意义更大，因为致敏性潜在或者不潜在仅作为理论可能性在档案另外一部分阐述)，从给出的数据来看，看不到可以承认的转基因玉米MIR162或其活性成分Vip3Aa蛋白造成显著实质性危害影响。
(FROM CBI: Appendix 28 ) As with applicationsof GMOs in general, the usual precautionary statement also applies in thiscase: With the given study batteries and designs, no final evidence is possiblewith reference to long-term (especially appropriate for foodstuffs),reproductive or developmental effects.
(从CBI：附录28)至于对转基因一般性应用而言，通常的预防性声明在这里也适用：鉴于给出的研究体系及其设计，对长期性(特别对食物而言)、生殖性或者发育性的影响，这些研究未能提供最终证据。
Increasedattention has to be paid to even very slight deviations from control groups indifferent parameters because of the very small concentrations/dosages of theactive principles which can be used. In addition, the general statements givenunder Applications for authorisation of genetically modified plants withcombined traits Bt11xMIR162xMIR604xGA21 and Bt11xMIR162xGA21 - according toSection D.7.8 EFSA GMO guidance document (EFSA 2006) and 7.2 of the UpdatedGuidance Document (EFSA 2008) for the Risk Assessment of Genetically ModifiedPlants and Derived Food and Feed, respectively - apply.
对于不同指标中与对照组相比的即便非常微小的偏差应当给予更多注意，因为所使用的活性物质的非常小浓度/剂量。此外，对于申请获得授权的Bt11xMIR162xMIR604xGA21与Bt11xMIR162xGA21多重形状转基因作物的总得声明 -- 依据欧洲食品安全机构转基因指导文件(EFSA2006)第D.7.8节，以及对转基因作物及其加工食品与饲料风险评估更新指导文件(EFSA2008)第7.2节，也适用。
[Appendix28.
[附录28.
EventMIR162 maize grain 90 day whole food safety study in rats. DossierEFSA/GMO/DE/2010/82.
转基因玉米MIR162谷物90天全食品安全性老鼠试验。档案EFSA/GMO/DE/2010/82
EFSA(2006). Guidance document of the Scientific Panel on Genetically ModifiedOrganisms for the risk assessment of genetically modified plants and derivedfood and feed. The EFSA Journal 99: 1-100. EFSA (2008).
欧洲食品安全机构(2006)。转基因生物科学专家组对转基因作物及其加工食品与饲料风险评估指导文件。欧洲食品安全机构杂志99：1-100.EFSA (2008)。
Updatedguidance document for the risk assessment of genetically modified plants andderived food and feed - draft document adopted in May 2008. The EFSA Journal727: 1-135.
对转基因作物及其加工食品与饲料风险评估更新指导文件 --2008年5月采纳的文件草案。欧洲食品安全机构杂志727：1-135.EFSA (2008)。
Peng,D., Chen, S., Ruan, L., Li, L., Yu, Z. und Sun, M. (2007). Safety assessment oftransgenic Bacillus thuringiensis with VIP insecticidal protein gene by feedingstudies. Food Chem Toxicol 45(7): 1179-1185.]
彭东海、孙明等。通过喂养研究对VIP杀虫蛋白基因的转基因Bt的安全性评估。食物化学毒理学45(7):1179-1185。】
http://www.sciencedirect.com/science/article/pii/S0278691507000142
欧洲食品安全机构(EFSA)对奥地利联邦卫生部质疑的回复：
Levelsof the newly expressed proteins in the diets are given in Appendix 28.1 (withinAppendix 28, page 952). The chemical composition of the diets is given inAppendix 1 within Appendix 28. The pedigree of the maize grain used toformulate the diets is given in Table 8 of the Technical dossier. Forassessment of the observations in the 90-day study see section 5.1.3.4 of theopinion.
附录28.1给出饮食中新表达的蛋白的水平(在附录28，第952页)。附录28中的附录1给出了饮食的化学成分。技术档案表8给出了用于配制饮食的玉米谷物品种。对90天研究中的观察的评估，参看《科学意见》第5.1.3.4节。
欧洲食品安全机构(EFSA)对奥地利联邦卫生部结论的回复：
Asfurther explained in the scientific opinion the EFSA GMO Panel agrees withAustria on the inadaquacy of the publication by Peng et al. to prove the safetyof the Vip3Aa20 expressed in maize MIR162. Therefore, the EFSA GMO Panelrequested a 28-day oral toxicity study in rodents with the purified Vip3Aa20protein. For details see section 5.1.3.2 of the scientific opinion.
如《科学意见》中进一步解释的那样，欧洲食品安全机构转基因生物转基因组同意奥地利提出的意见，即彭东海等人的试验研究论文不足以证实转基因玉米MIR162中表达的Vip3Aa20蛋白的安全性。欧洲食品安全机构转基因生物转基因组因此要求用纯Vip3Aa20蛋白对脊椎动物进行一项28天口服毒性研究。对于有关细节，参看《科学意见》第5.1.3.2节。
Forassessment of the observations in the 90-day study see section 5.1.3.4 in theopinion.
对90天研究观察的评估，参看《科学意见》第5.1.3.4节。
Comparativeanalyses established that no biologically relevant differences were identifiedin the compositional, agronomic or phenotypic characteristics of maize MIR162as compared with its conventional counterpart and that the composition of maizeMIR162 fell within the range of non-GM commercial varieties, except forexpressing the Vip3Aa20 and PMI proteins.
比较分析确立了转基因玉米MIR162，与其传统对应品种相比，在成分、农艺或表型特征方面，没有发现生物性相关差别，而且，转基因玉米MIR162的成分与非转基因商业品种的范围重叠，表达Vip3Aa20蛋白与PMI蛋白以外。
Basedon the compositional analysis and considering the outcomes of the 90-day ratand 42-day broiler feeding studies, no further animal safety studies arerequired in accordance with the EFSA guidance document. Furthermore, the informationprovided on the VIP protein includes a 28-day repeated dose toxicity study,which was performed on request of the EFSA GMO Panel, showed no indications ofadverse effects.
基于成分性分析以及考虑了90天大鼠研究与42天的肉鸡喂养研究的结果，依据欧洲食品安全指导文件不要求进一步的动物安全性研究。除此之外，对VIP蛋白提供的信息包括一项28天重复剂量毒理学研究，它是依据欧洲食品安全机构转基因生物专家组的要求进行的，表明没有危害性影响的迹象。
Inaccordance with applicable EFSA guidance the applicant submitted a 28-day oraltoxicity study with the Vip3Aa20 protein as additional information upon requestby the EFSA GMO Panel. Therefore, specific information regarding long-term,reproductive and developmental effects for Vip3Aa20 protein are not required.
依据适用的欧洲食品安全机构指导原则，作为额外信息，申请方已经提交了对Vip3Aa20蛋白进行的一项28天口服毒理学研究。因此，关于对于Vip3Aa20蛋白的长期性、生殖性与发育性影响的特定信息不再要求。
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