博主观点  矢口否认欧洲食品安全局的权威性，肆意诋毁对塞拉利尼论文做出客观评估的专家是孟山都豢养的走狗，既是反转人士的“杀手锏”，也是他们的“软肋”！

翻译及校正完成时间：2012年10月7日17:15（引用请注明出处）

STATEMENT OF EFSA

欧洲食品安全局声明

Review of the Séralini et al. (2012) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and Chemical Toxicology 1

对塞拉利尼等（2012）发表于2012年9月19日《食品和化学毒物学》中关于用草甘膦配方及转基因玉米NK603对啮齿动物两年饲喂试验论文的评估

European Food Safety Authority2, 3

欧洲食品安全局（以下简称欧食安局）

European Food Safety Authority (EFSA), Parma, Italy

欧食安局（EFSA），意大利帕尔马

ABSTRACT
摘要

On 19 September 2012, Séralini et al. published online in the scientific journal Food and Chemical Toxicology a publication describing a 2-year feeding study in rats investigating the health effects of genetically modified (GM) maize NK603 with and without Roundup WeatherMAX® and Roundup® GT Plus alone (both are glyphosate-containing plant protection products). EFSA was requested by the European Commission to review this publication and to identify whether clarifications are needed from the authors. EFSA notes that the Séralini et al. (2012) study has unclear objectives and is inadequately reported in the publication, with many key details of the design, conduct and analysis being omitted. Without such details it is impossible to give weight to the results. Conclusions cannot be drawn on the difference in tumour incidence between the treatment groups on the basis of the design, the analysis and the results as reported in the Séralini et al. (2012) publication. In particular, Séralini et al. (2012) draw conclusions on the incidence of tumours based on 10 rats per treatment per sex which is an insufficient number of animals to distinguish between specific treatment effects and chance occurrences of tumours in rats. Considering that the study as reported in the Séralini et al. (2012) publication is of inadequate design, analysis and reporting, EFSA finds that it is of insufficient scientific quality for safety assessment. Therefore EFSA, concludes that the Séralini et al. study as reported in the 2012 publication does not impact the ongoing re-evaluation of glyphosate, and does not see a need to reopen the existing safety evaluation of maize NK603 and its related stacks. EFSA will give the authors of the Séralini et al. (2012) publication the opportunity to provide further information on their study to EFSA.
© European Food Safety Authority, 2012

2012年9月19日，塞拉利尼等在《食品与化学毒物学》科学杂志上在线发表一篇论文，报告了一项调查基因修饰玉米NK603联合或不联合农达（WeatherMax）及农达（GT Plus）单用（均含草甘膦的植物保护产品）健康效应的大鼠两年饲喂研究。欧食安局受欧盟委员会委托评估这篇论文，并确认是否有得到作者澄清的必要。欧食安局注意到，塞拉利尼等（2012）的研究对象不清楚，论文表述不恰当，许多关键的设计、操作和分析的细节被遗漏。如果没有这些细节，就不可能为全部结果添加砝码。从塞拉利尼等（2012）论文的设计、分析和结果，无法得出对照组和处理组在肿瘤发生率上有差异的结论。值得特别指出的是，塞拉利尼等（2012）论文中得出的结论仅仅基于每个处理每种性别10只大鼠的肿瘤发生率，而这样少的动物数量不足以区分大鼠肿瘤发生究竟源于特别处理还是机率。鉴于塞拉利尼等（2012）论文设计、分析和撰写不当，欧食安局认为其不具备安全评价应有的科学水平。因此，欧食安局做出如下结论：塞拉利尼等（2012）论文不影响正在进行中的对草甘膦的重新评价，也不认为有必要对NK603玉米品系及其相关的库存品重启已完成的安全评价。欧食安局会给塞拉利尼等（2012）论文的作者向欧食安局提供其进一步研究资料的机会。

Key words

关键词

Maize NK603, Roundup, glyphosate, experimental design, rat/rodent feeding study, toxicity, carcinogenicity

玉米NK603品系，农达，草甘膦，实验设计，大鼠/啮齿动物饲喂研究，毒性，致癌性

1 On request from European Commission Question No EFSA-Q-2012-00841, approved on 3 October 2012.

受欧盟委员会质询第EFSA-Q-2012-00841号文件委托，2012年10月3日批准。

2 Correspondence: sas@efsa.europa.eu

通讯信箱：sas@efsa.europa.eu

3 Acknowledgement: EFSA wishes to thank the following EFSA staff: Saghir Bashir, Per Bergman, Danièle Court Marques, Claudia Paoletti, Manuela Tiramani, Didier Verloo and Elisabeth Waigmann for the support provided to this scientific output. EFSA also thanks the peer reviewers of this statement Andrew Chesson (member of the GMO Panel) and Alberto Mantovani (member of the PPR panel).

欧食安局谨感谢下列欧食安局官员：Saghir Bashir, Per Bergman, Daniele Court Marques, Claudia Paoletti, Manuele Tiramani, Didier Verloo, Elisabeth Weigmann对此科学文件提供的支持。欧食安局也感谢该声明的两位同行评议人：Andrew Chesson（基因修饰生物部门成员）和Alberto Mantovani（植物产品监管部门成员）。

TABLE OF CONTENTS

目录

Abstract 摘要

Table of Contents 目录

Background as provided by the European Commission 欧盟委员会提供的背景资料

Terms of reference as provided by the European Commission 欧盟委员会提供的审查事项

EFSA’s approach to address the terms of reference 欧食安局处理审查事项的方法
1. Introduction 前言
2. Overview of the study as reported in the Séralini et al. (2012) 塞拉利尼等（2012）论文总览
3. Review of the Séralini et al.(2012) publication 塞拉利尼等（2012）论文评估
3.1. Study objectives 研究目的
3.2. Study Design 研究设计
3.3. Feed and Treatment Formulation 饲喂和处理配方
3.4. Statistical Methods 统计方法
3.5. Endpoint Reporting 终点报告
Conclusions 结论
Next steps 下一步
References 参考文献

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION

欧盟委员会提供的背景资料

On 19 September 2012, an article4 was published online in the scientific journal Food and Chemical Toxicology that described a 2-year rat feeding study investigating the health effects of genetically modified (GM) maize NK603 sprayed during growth with or without a Roundup® (glyphosate-containing plant protection product) and of Roundup® alone. The authors of the study conclude that low levels of glyphosate herbicide formulations, at concentrations well below officially set safe limits, induce severe hormone-dependent mammary, hepatic and kidney disturbances in rats. Similarly, they report disruption of biosynthetic pathways that may result from overexpression of the EPSPS transgene in the maize NK603. The authors suggest that such disruptions may have given rise to comparable pathologies that may be linked to abnormal or unbalanced phenolic acid metabolites or related compounds.

2012年9月19日，在学术杂志《食物与化学毒物学》上在线发表了一篇论文，描述了一项为期两年的大鼠饲喂试验，该实验调查了在生长过程中喷洒或不喷洒农达（含草甘膦的植物保护产品）以及农达单用的基因修饰玉米NK603的健康效应。该研究作者的结论是低水平（比官方设定安全限度还低的浓度）的草甘膦除草剂配方可在大鼠诱发严重的激素依赖性乳腺、肝脏和肾脏病变。同样，他们还报道了可能起因于玉米NK603中EPSPS转基因过度表达的生物化学途径的破坏。作者假设这种破坏作用可能引起与异常或不平衡酚酸代谢物或相关化合物有关的较大病变。

TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION

欧盟委员会提供的审查事项

EFSA received a mandate from DG SANCO on 26/09/2012 requesting to address the following terms of reference as a matter of urgency.

欧食安会于2012年9月26日来自DG SANCO的指令，要求紧急处理以下审查事项。

(A) Review the scientific publication

第一项：评估学术论文

(B) Ask any clarification needed to the authors

第二项：要求作者做出任何澄清的必要性

(C) Advise whether the publication contains new scientific elements that could lead EFSA to reconsider the outcome of its opinion on maize NK603 and its related stacks

第三项：论文是否包含新的科学要素可能导致欧食安局重新考虑其对NK603及其相关库存品的看法

(D) Take into consideration the assessment of Member States

第四项：考虑成员国的评估结论

(E) Take into consideration the assessment of the German authorities responsible for the evaluation of glyphosate

第五项：考虑德国负责草甘膦评价的机构的评估结论

EFSA’S APPROACH TO ADDRESS THE TERMS OF REFERENCE

欧食安局处理审查事项的方法

EFSA decided to address the terms of reference (ToR) in phases. This first EFSA statement addresses ToR A, B and C solely based on the study information available through the Séralini et al. (2012) publication.

欧食安局决定分阶段处理各个审查事项。第一份欧食安局声明基于塞拉利尼等（2012）论文中呈现的资讯，仅涉及前三项审查事项。

A second EFSA output will cover all the ToRs and will take into account any information received from the authors, the assessment activities from the Member States and the assessment of the German authorities responsible for the evaluation of glyphosate.

第二份欧食安局声明将涵括全部审查事项，还将纳入来自作者的任何资讯，来自各成员国的评价动态，来自负责草甘膦评价的德国有关机构的评估。

Following the publication of Séralini et al. (2012), EFSA set up an internal task force chaired by the Director of Regulated Products (REPRO) and composed of staff scientists with expertise in biostatistics, experimental design, mammalian toxicology, biotechnology, biochemistry, pesticide safety assessments and GMO safety assessments.

在塞拉利尼等（2012）论文发表后，欧食安局成立了一个内部工作小组，由监管产品部门负责人担任主席，成员包括本局精通生物统计学、实验设计、哺乳动物毒理学、生物技术、生物化学、杀虫剂安全评价和基因修饰生物安全评价的科学家。

The task force was mandated to draft this EFSA statement which has been peer reviewed by two experts from EFSA’s scientific panels.

该工作小组的职能是起草这份欧食安局声明，该声明由来自欧食安局科学部门的两位专家进行过同行评议。

1. Introduction

1、前言

The review presented in this statement is based solely on the details provided in the Séralini et al. (2012) publication since the complete study documentation is currently not available to EFSA. The Séralini et al. (2012) publication was reviewed taking into account good scientific practices such as internationally accepted reporting guidelines (Kilkenny 2010) and internationally agreed study guidelines (e.g. OECD guidelines for testing of chemicals5).

该声明中的评估仅基于塞拉利尼等（2012）论文中提供的细节，因为欧食安局尚未得到完整的研究治疗。对塞拉利尼等（2012）论文的评估时，考虑了优良学术规范，如国际接受的报告指南及国际认可的研究指南（如用于化学测定的OECD）。

The Kilkenny et al. (2010) ARRIVE (Animals in Research: Reporting In Vivo Experiments) Guidelines for Reporting Animal Research detail how to report animal experiments covering the following areas: abstract, background, ethical statement, study design, experimental procedures, experimental animals, housing and husbandry, sample size, allocating animals to experimental groups, experimental outcomes, statistical methods, baseline data, number (of animals) analysed, outcome estimation, adverse events, interpretation/scientific implications, generalisability/translation and funding.

克尔克里等（2010）ARRIVE（研究中的动物：报告活体实验）动物研究报告指南详细阐述了如何报告动物实验的方法，涵括下列内容：摘要、背景、伦理陈述、研究设计、试验程序、实验动物、饲养和耕种、样本大小、动物实验分组、实验结果、统计方法、基准数据、供分析的（动物）数量、结果估计、负面事件、解释或科学意义、普及性或翻译与资助。

2. Overview of the study as reported in Séralini et al. (2012)

2、塞拉利尼等（2012）论文总览

Séralini et al. (2012) report that the study followed 200 five-week old Virgin albino Sprague-Dawley rats over a period of two years. In total there were 100 female and 100 male rats used in this study. The rats were acclimatized for 20 days before they were randomly assigned on a weight basis into groups of 10 animals. Two rats of the same sex were housed together in a cage with a temperature of 22 3°C and humidity of 45-65%. The rats had free access to feed and water, and litter was replaced twice weekly. Animals were monitored twice weekly with regard to general observation and palpation of animals, recording of clinical signs, occurrence of tumours, food and water consumption, and individual body weights.

塞拉利尼等（2012）报道了两年期间跟踪研究200只5周龄幼龄白化SD大鼠的结果。该研究总共使用了100只雌鼠和100只雄鼠。基于体重随机编组的10只大鼠经过了20天的适应性饲养。同一性别的两只老鼠共用一个鼠笼，温度为22.3度，湿度为45-65%，自由取食和饮水。褥草每周更换两次。每周记录两次大鼠的下列情况：动物的一般观察和触摸、临床症状、肿瘤发生、饲料和饮水消耗、个体体重。

Forty-seven biochemical parameters (from blood and urine) were measured on 11 occasions. The first measurement was taken before the administration of treatment (baseline) and the following measurements were taken at months 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24. Anatomopathology parameters were collected from 36 organs. Animals were sacrificed during the study due to suffering or for ethical reasons, otherwise pathology examination was performed at the end of the study. Histological examination was performed on nine organs (brain, colon, heart, kidneys, liver, lungs, ovaries, spleen, testes).

47项生化参数（血液和尿）按11种情况进行了测定。第一项测定是在处理之前进行的（基准），后续测定分别在第1、2、3、6、9、12、15、18、21、24个月。解剖病理参数收集自36个器官。实验过程中，动物除因患病或伦理原因而被宰杀外，均在研究结束时进行病理学检查。组织学检测在9种器官（脑、肠、心、肾、肝、肺、卵巢、脾、睾丸）中进行。

The treatments studied are three levels of glyphosate tolerant maize NK603 (GMO in the diet at 11%, 22% and 33%) treated and untreated with Roundup WeatherMAX® during its cultivation, its closest isogenic non-GM maize (Control in the diet at 33%) and Roundup® GT Plus (glyphosate based formulation referred as Roundup (R) in Séralini et al. (2012) at three increasing doses in drinking water. For each sex there were 10 treatment groups, each consisting of 10 rats, as follows:

在塞拉利尼等（2012）论文中，各个处理分为3个耐草甘膦玉米NK603含量水平（11%、22%、33%转基因玉米），它们在栽培期间喷洒或不喷洒农达；农达以不同浓度溶于饮用水中；对照组是近等基因系（33%非转基因玉米）。每个性别由10个处理组构成，各有10只大鼠。

1. Control 33% maize（33%普通玉米，对照）
2. GMO 11% maize（11%转基因玉米）
3. GMO 22% maize（22%转基因玉米）
4. GMO 33% maize（33%转基因玉米）
5. GMO 11% maize +R（11%转基因玉米+农达）
6. GMO 22% maize +R（22%转基因玉米+农达）
7. GMO 33% maize +R（33%转基因玉米+农达）
8. R (A) (1.1 x 10-8% of R)（1.1X10-8%农达）
9. R (B) (0.09% of R)（0.09%农达）
10. R (C) (0.5% of R)（0.5%农达）

Séralini et al. (2012) report pathological effects, in particular an increased tumour incidence linked to treatment with maize NK603 and R in both sexes.

塞拉利尼等（2012）报告了病理学效应，尤其是发现雌雄鼠中肿瘤发生率的提高与NK603玉米品系和农达处理有关。

3、塞拉利尼等（2012）论文评估

In this section EFSA assesses the Séralini et al. (2012) publication, and highlights open issues that are usually addressed in a properly conducted, analysed and reported study.

3.1. Study objectives

3.1.研究目的

Assessment

评价

The study objectives are unclear in the Séralini et al. (2012) publication. The objectives are the questions that the study is designed to answer. These questions must be pre-specified as the design of the study, sample size calculation, statistical analysis, study conduct and reporting are dependent on these. Depending on the objectives of the study different weight is given to the results in the context of a safety assessment. Without clearly stating the study objectives it is difficult to determine whether the study design and sample size used are fit for purpose or indeed what that purpose is. International study guidelines are designed to meet specific objectives (e.g. OECD guidelines for chemical testing). If a specific guideline is chosen and followed then the objectives are inherently defined in the guideline. The study objectives need to be clearly stated a priori in the study protocol.

塞拉利尼等（2012）论文中研究目的不清楚。这些目的是实验设定要回答的问题。这些问题必须预先确定，因为研究设计、样本大小计算、统计分析、研究实施和撰写论文都要依靠它们。依据研究的目的，在安全评价的过程中，针对各种结果会给予不同的权重。如果没有清晰地指出研究的目的，则难以确定研究设计与样本大小是否适合其目的，也难以确定其目的究竟是什么。国际研究指南就是设计用来满足不同研究目的之需（如OECD指南专门用于化学测定）。如果选择并遵循一种专门的指南，那么研究目的就被指南确定下来。在实验开始之前，研究目的应清楚地在试验方案中表述出来。

3.2. Study Design

3.2.研究设计

Assessment

评价

Séralini et al. (2012) did not follow the internationally accepted protocols for sub-chronic, chronic toxicity and carcinogenicity studies (e.g. OECD 408, OECD 451, OECD 452 and OECD 453) currently recommended in the EU for food and feed safety assessment. Given that Séralini et al. (2012) conducted a two-year study, it is unclear why an OECD guideline suitable for a two-year chronic toxicity or carcinogenicity study (i.e. OECD 451, OECD 452 or OECD 453) was not adhered to.

塞拉利尼等（2012）没有遵循国际公认的亚慢性、慢性毒性及致癌性研究方案（如OECD 408、OECD 451、OECD 452、OECD 453），这些方案都是欧盟各国进行食品及饲喂安全评价的最新推荐方法。假定塞拉利尼等（2012）开展了两年的研究，不清楚他们为何不依据适合进行两年毒性及致癌性研究的OECD指南（如OECD 451、OECD 452、OECD453）。

The strain of rats chosen is known to be prone to development of tumours over their life (Dinse (2010), Brix (2005), Kaspareit (1999)). By conducting the experiment on this strain of rats over two years, which is approximately their life expectancy, the observed frequency of tumours is influenced by the natural occurence of tumours typical of this strain, regardless of any treatment. This is neither taken into account nor discussed in the Séralini et al. (2012) publication.

已知该大鼠品系在其生活史中易生肿瘤。用这个大鼠做两年以上（接近其期望寿命）的实验，不管何种处理方式，所观察到的肿瘤发生率都会受到该品系典型肿瘤自然发生率的影响。这在塞拉利尼等（2012）论文中既未考虑也未讨论。

The study design includes only one control group which is not suitable to serve as control for all the treatment groups. In particular, Séralini et al. (2012) claimed effects on the GMO 11%, GMO 11% +R, GMO 22% and GMO 22% +R without appropriate controls.

这项研究设计仅包含一个对照组，它不适合作为全部处理组的对照，特别是塞拉利尼等（2012）在未设适当对照的前提下主张11%转基因玉米、11%转基因玉米+农达、22%转基因玉米、22%转基因玉米+农达对大鼠健康的影响。

Séralini et al. (2012) draw conclusions on carcinogenicity by reporting on the incidence of tumours based on 10 rats per treatment per sex. There is a high probability that the Séralini et al. (2012) findings in relation to the tumour incidence are due to chance, given the low number of animals and the spontaneous occurrence of tumours in Sprague-Dawley rats. This is why relevant guidelines on carcinogenicity testing (i.e. OECD 451 and OECD 453) recommend using at least 50 rats per treatment per sex. Given the limited number of animals and the chosen study design, no conclusions on the relationship between treatment and tumour incidence can be drawn from the Séralini et al. (2012) publication.

塞拉利尼等（2012）通过报告基于每个处理每种性别10只大鼠的肿瘤发生率得出了致癌性结论。一种很大的可能性是，塞拉利尼等（2012）有关SD大鼠中肿瘤发生的发现是由于机遇，前提是动物数量太少，SD大鼠自发肿瘤发生率高。这就是为什么关于致癌性测定的相关指南（如OECD 451和OECD453）建议每个处理每个性别使用至少50只大鼠。在动物数量有限及实验设计欠佳的前提下，从塞拉利尼等（2012）论文不能得出的处理与肿瘤发生相互关系的结论。

There is no mention of any measures taken to reduce the risk of bias such as blinding. The biological relevance of the rat strain used should be justified with respect to the design choices. Suitable controls for all treatment groups are not present. The sample size (power) calculation is not presented hence it is not possible to assess if the study was sufficiently powered to meet the unclear objectives. Measures taken to reduce the risk of bias (e.g. blinding) are not reported.

未采取任何措施降低偏差的风险，如盲性设计。所采用的该大鼠品系的生物学关联性，应针对设计选择加以确定。对全部处理组的适当对照没有说明。样本大小（水平）计算未给出，因而不能评价该研究是否足以满足不清楚的研究目的。为减少偏差都说采取的措施（如盲性设计）也未报告。

3.3. Feed and Treatment Formulation

3.3.饲喂和处理配方

Assessment

评价

The publication states that “all feed formulations consisted in balanced diets, chemically measured as substantially equivalent except for the transgene”. However, no detailed information on either the composition of the various diets used in the experiment or the storage conditions of the feeds over the course of the two years is provided. The publication does not give any details regarding the possible presence of harmful substances such as mycotoxins in the feeds used in the study.

论文写道：“除转基因外，全部饲喂配方为平衡饲料，经化学测定为实质等同”。可是，无论是试验中采用的不同饲料的组成，还是两年实验过程中饲料的贮存条件均未提供。该论文也未给出实验所用饲料可能存在有害物质（如霉菌毒素）的任何详细资料。

Séralini et al. (2012) report only the application rate of the Roundup WeatherMAX® used to spray the plants and the concentration of the Roundup® GT Plus added to the rats’ drinking water. They state that the consumption was measured though it is not reported. Without this information it is not possible to estimate the exposure level. Furthermore, the level of residues of glyphosate and its metabolites on treated maize are not specified. Hence, their contribution to the reported findings cannot be assessed. In addition, information on other chemical contaminants e.g. other pesticides applied on the GM maize as well as on the isogenic non-GM control maize, is not provided.

塞拉利尼等（2012）仅报告了农达WeatherMax用于喷洒植物的用量比例和农达GT Plus添加到大鼠饮用水中的浓度。他们宣称曾测定过其消耗，但却未报告。没有这些资讯，不可能估计暴露水平。此外，草甘膦及其代谢物的残余水平也没有专门测定。因此，它们对所报告的发现的贡献无法评价。另外，关于其他化学污染物如喷洒在转基因玉米以及等基因非转基因玉米上的其他杀虫剂的资讯也未予提供。

The appropriateness and comparability of the diets cannot be assessed as critical information about their composition is not reported. The stability of the diets cannot be assessed as details of their storage conditions are not provided. It is impossible to evaluate whether or not there was any contamination of the diets, e.g. by mycotoxins, as it is not reported. The amount of residues of glyphosate and its metabolites in treated maize NK603 is not reported. The exposure to GMO, GMO +R and R cannot be evaluated since the food and water intakes of the GM- and R-treated groups, respectively, are not clearly reported. Suitability of the control cannot be determined because information on the possible exposure to other chemicals.

饲料是否适宜及能否比较，在未报告其组成等关键资讯时，是无法做出评价的。饲料的稳定性也不能评价，因为其贮存条件的细节未提供。不可能评价饲料中是否存在任何污染物，如霉菌毒素产生的污染物，因为它未提供。暴露于转基因玉米、转基因玉米+农达、农达难以评价，因为转基因玉米及农达相关处理组的饲料和饮水量并未清晰地予以报告。对照是否适当也不好判定，因为可能暴露与其他化学品的资讯缺如。

3.4. Statistical Methods

3.4.统计学方法

Assessment

评价

It is not reported if the statistical analyses were pre-specified in the protocol (i.e. prior to the start of the study) or in a statistical analysis plan prior to any access to the data. Summary statistics for all measured parameters (including biochemical and tumour related) by treatment group and sex are not presented.

该方案中或见到数据之前制定的统计分析计划中未报告统计学分析是否预先确定的（即在研究开始之前）。每个处理组及性别的全部测定参数（包括生化与肿瘤相关）未见列出。

Séralini et al. (2012) have chosen an unconventional statistical methodology to analyse the biochemical parameters instead of commonly used methods (e.g. analysis of variance). The methodology chosen does not allow for the estimation of the (unbiased) treatment effects and their associated variations.

塞拉利尼等（2012）选择了一个非常规的统计学方法分析生化参数，而不是采用一些常用的方法（如变异分析）。所选用的方法不能估计（无偏）处理效应及其相关变异。

Séralini et al. (2012) only present percentages and graphical summaries of the tumour incidences. There is no modelling-based analysis (e.g. time to event analysis) to estimate the (unbiased) treatment effects and their associated variations. For both types of analysis the issue of missing data and multiplicity should also be addressed.

塞拉利尼等（2012）仅给出肿瘤发生的百分率及简图。没有采用基于模型的分析（如时间-事件分析）来估计（无偏）处理效应及其相关变异。对于两种类型的分析，丢失数据与多重性等问题也应该说明。

It is not clear if the analysis presented is consistent with any pre-planned analyses. The reported analysis does not provide the following information needed to draw conclusions:
o A summary of drop outs and censoring (e.g. euthanised animals).
o Summary statistics for all measured parameters by treatment group (and sex).
o Unbiased treatment effect estimates (with confidence intervals) derived from an appropriate statistical analyses for the chosen design and endpoint. The issues of handling missing data and multiple testing (multiplicity) should be addressed.

不清楚给出的分析是否与任何预先计划的分析一致。报告的分析结果没有提供下结论所需的下列资讯：

中途退出与删改（如处死动物）的概要介绍；

处理组（和性别）的全部测定参数的统计学概要介绍；

来自选定设计与终点的适当统计学分析的无偏处理效应估计值（含置信区间）。处理丢失数据与多次测定（多重性）等问题也应予以说明。

3.5. Endpoint Reporting

3.5.终点报告

Assessment

评价

Far more endpoints (and measurement points thereof) than those reported in the publication were collected by Séralini et al. (2012). It is unclear why the publication does not report the complete set of samples collected and endpoints measured. Clinical observations other than tumours are selectively reported: in Table 2 of Séralini et al. (2012), a summary of the most frequent anatomical pathologies observed is presented; however a clear presentation of all the specific lesions occurring in the different organs, for each treatment group, is not provided. As for the carcinogenicity assessment, attention was mainly focused on the “largest palpable growths” with only mammary and pituitary tumours being mentioned for females and kidney and skin tumours for males. A detailed list of all tumour types per sex per group and notation of all histopathological lesions (including hyperplastic, pre-neoplastic and non-neoplastic) would be needed. All collected endpoints should be reported openly and transparently.

塞拉利尼等（2012）论文报道的结果绝非终点（也不是测定点）。不清楚为何论文不报告收集样本与测定终点的全部内容。肿瘤以外的临床观察是选择性报告的：在塞拉利尼等（2012）论文的表2中，只列出所观察到的最常见的解剖病理学变化，但却没有清楚地写明各个处理组中不同器官的全部特异性损伤。就致癌性评价而言，关注焦点主要集中在“最大可触摸生长物”，雌鼠只提到乳腺和垂体肿瘤，而雄鼠只提到肾脏和皮肤肿瘤。必须绘制一张详细的表格，把不同性别不同分组的全部肿瘤类型与全部组织病理学损伤（包括增生性、前肿瘤性和非肿瘤性）的说明都列出来。全部收集的终点数据的报告要公开和透明。

CONCLUSIONS

结论

EFSA notes that the study, as described in the Séralini et al. (2012) publication, is inadequately reported with many key details of the design, conduct, analysis and reporting being omitted. Without such details it is impossible to give weight to the subsequent results.
Conclusions cannot be drawn on the difference in tumour incidence between the treatment groups on the basis of the design, the analysis and the results as reported in the Séralini et al. (2012) publication. In particular, Séralini et al. (2012) draw conclusions on the incidence of tumours based on 10 rats per treatment per sex. This falls considerably short of the 50 rats per treatment per sex as recommended in the relevant international guidelines on carcinogenicity testing (i.e. OECD 451 and OECD 453). Given the spontaneous occurrence of tumours in Sprague-Dawley rats, the low number of rats reported in the Séralini et al. (2012) publication is insufficient to distinguish between specific treatment effects and chance occurrences of tumours in rats.
Considering that the study as reported in the Séralini et al. (2012) publication has unclear study objectives and given its inadequate design, analysis and reporting, EFSA finds that it is of insufficient scientific quality for safety assessments. Therefore EFSA, concludes that the Séralini et al. study as reported in the 2012 publication does not impact the ongoing re-evaluation of glyphosate, and does not see a need to reopen the existing safety evaluation of maize NK603 and its related stacks.

（见前面的翻译）

NEXT STEPS

下一步

To review the study in more detail, beyond what is reported in the Séralini et al. (2012) publication, access would need to be given to the study documentation and procedures followed, including the original study protocol, along with documentation on any planned or unplanned changes to it, the statistical analysis plan, the statistical report/analyses and the final full study report. Therefore, the authors will be made aware of the content of this EFSA statement and will be given the opportunity to submit information to EFSA.
A second EFSA output will cover all the ToR and will take into account any information received from the authors, the already ongoing assessment activities from the Member States (such as Belgium, France, Germany6 and The Netherlands7) and the assessment of the German authorities responsible for the evaluation of glyphosate.

为了更详细地评估此研究，不管塞拉利尼等（2012）论文报告了什么，必须跟踪该研究的实验资料和方法，包括原始实验记录，连同任何计划或未计划更改的资料、统计学分析计划、统计学报告或分析、最后的研究报告。因此，将向作者告知欧食安局声明的内容，并给予他们向欧食安局上交进一步研究资讯的机会。

欧食安局的第二份报告将会包括全部审查事项，并纳入来自作者的任何资讯，来自成员国（如比利时、法国、德国和荷兰）的已在进行中的评估动向，德国负责草甘膦评价的有关机构的评估结果。

REFERENCES

参考文献

Brix, A. E. et al. (2005). Incidences of selected lesions in control female Harlan Sprague-Dawley rats from two-year studies performed by the National Toxicology Program. Toxi-cologic Pathology 33 (4), 477-483.
Dinse, D. E. et al. (2010). Comparison of NTP historical control tumor incidence rates in female Harlan Sprague Dawley and Fischer 344/N rats. Toxicologic Pathology 38 (5), 765-775.
Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steeve Gress, Nicolas Defarge, Manuela Malatesta, Didier Hennequin, Joël Spiroux de Vendômois (2012) Long term toxicity of a Roundup herbicide
6 http://www.bfr.bund.de/cm/343/veroeffentlichung-von-seralini-et-al-zu-einer-fuetterungsstudie-an-ratten-mit-gentechnischveraendertem-mais-nk603-sowie-einer-glyphosathaltigen-formulierung.pdf
7 http://www.rijksoverheid.nl/bestanden/documenten-en-publicaties/notas/2012/10/03/advies-vwa-bij-onderzoek-naar-gezondheidsgevolgen-ggo-mais-en-roundup/advies-vwa-bij-onderzoek-naar-gezondheidsgevolgen-ggo-mais-en-roundup.pdf