按：欧盟议会67位议员2016年1月28日联署给欧洲委员会负责健康与食品安全的委员Vytenis Andriukaitis的公开信，要求禁止重新批准草甘膦：1）对欧盟EFSA与德国BfR重新批准草甘膦除草剂的程序缺乏透明性与严重的健康担心；2）欧盟EFSA与德国BfR作为安全评估结论核心基础的主要研究皆是草甘膦生产企业自己做的从来没有发表至今对IARC与公众保密的动物试验报告；3）这些研究报告的安全评估皆是对单一成分草甘膦原药动物试验，而非对完整配方草甘膦除草剂动物试验；4）欧盟EFSA与德国BfR对草甘膦的安全评估忽视科学试验证实草甘膦配方除草剂在人类细胞系中是内分泌干扰剂；5）强烈要求公布从来未公开发表至今对公众保密的产业界自己的所有研究，而且不仅公布它们的摘要，而且公布这些研究其作者们的姓名与利益冲突声明，以便对这些研究进行独立评估! 全世界见证欧洲食品安全机构（EFSA）与世界卫生组织国际癌症研究机构（IARC）之间对于世界最广泛使用的草甘膦除草剂致癌性的重大科学争议：国际癌症研究机构（IARC）2015年3月结论草甘膦是可能的人类致癌物（类别2A）；欧洲食品安全机构（EFSA），基于报告员成员国德国联邦风险评估所（BfR）提出的重新评估报告，2015年11月结论草甘膦“不看来对人类构成致癌风险而且证据不支持对其致癌潜在能力的分类”。对草甘膦是否致癌正确分类至关重要，因为涉及重要的监管后果。
MEPsCall on EU Commissioner to Stop Re-Approval of Glyphosate Herbicides over Health Concerns
欧盟议会议员们就健康担心呼吁停止再批准草甘膦除草剂
http://sustainablepulse.com/2016/01/28/meps-call-on-eu-health-commissioner-to-cancel-re-approval-of-glyphosate/#.VqrdOvml_mO
来源：Posted on Jan 28 2016 - 7:39pm by Sustainable Pulse
《可持续脉搏》网站发表日期：2016年1月28日
Source/原载： www.michele-rivasi.eu
Sixty-seven Members of the European Parliament (MEPs) have written a letter Thursday to the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, to request for the re-approval of glyphosate, the most widely used herbicide in the World, to be stopped due to a lack of transparency in the re-approval process as well as serious health concerns.
欧盟议会67位议员2016年1月28日联署写信给欧洲委员会负责健康与食品安全的委员Vytenis Andriukaitis，要求禁止重新批准草甘膦，世界使用最广泛的除草剂，原因是重新批准程序缺乏透明性以及严重的健康担心。
欧盟议会67位议员要求禁止重新批准草甘膦除草剂公开信
草甘膦除草剂：终极杀戮剂!
Brussels, 28 January 2016
布鲁塞尔，2016年1月28日
Dear Commissioner Andriukaitis,
尊敬的委员Andriukaitis
We, Members of the European Parliament from different political groups, are very concerned by the ongoing re-approval process of glyphosate, the active substance in the most widely used herbicide.
我们，来自不同政治团体的欧洲议员，对正在进行的世界最广泛使用除草剂活性成分草甘膦的重新批准程序深感担心。
We currently witness a major scientific controversy between the European Food Safety Agency (EFSA) and the International Agency for Research on Cancer of the World Health Organisation (IARC) with regard to the carcinogenicity of glyphosate.
我们目前正在见证欧洲食品安全机构（EFSA）与世界卫生组织国际癌症研究机构（IARC）之间对于草甘膦致癌性的重大科学争议。
While IARC had concluded in March 2015 that glyphosate is a probable human carcinogen (category 2A), the EFSA peer review, based on the renewal assessment report by the rapporteur Member State (BfR), concluded in November 2015 that glyphosate is « unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential ». Proper classification is crucial as it entails important regulatory consequences.
尽管国际癌症研究机构（IARC）2015年3月结论草甘膦是可能的人类致癌物（类别2A），欧洲食品安全机构（EFSA），基于报告员成员国德国联邦风险评估所（BfR）提出的重新评估报告，2015年11月结论草甘膦“不看来对人类构成致癌风险而且证据不支持对其致癌潜在能力的分类”。正确的分类至关重要的，因为它涉及重要的监管后果。
We do not have the necessary technical expertise to properly assess the detailed scientific arguments brought forward by either side with regard to the classification of glyphosate. However, we consider that there are some overarching problems that urgently need to be addressed.
我们不具有适当评估任何一方提出有关草甘膦分类详细科学论证的必要技术专长。然而，我们认为，存在着必须紧急对待的某些首要问题。
According to EFSA, there are two key issues that explain the different conclusions:
依据欧洲食品安全机构（EFSA），有两项可以解释这两项不同结论的关键性因素：
a) the number of studies assessed [published vs. unpublished],
a) 双方评估的研究的数量【出版过的相对于未出版过的研究】,
b) the object of the studies assessed [active substance vs. plant protection products].
b) 这些研究评估的对象【活性物质相对于植物保护产品】。
With regard to the first point, EFSA stated that its « evaluation considered a large body of evidence, including a number of studies not assessed by the IARC which is one of the reasons for reaching different conclusions » (EFSA news story, 12 November 2015).
针对第一点，欧洲食品安全机构（EFSA）声称他们的“评价考虑了大量的证据，包括国际癌症研究机构没有评估的相当数量研究，是得出不同结论原因之一”（EFSA新闻故事，2015年11月12日）。
In a detailed response to an open letter sent by MEPs and MPs on 20 October 2015, EFSA gives further indications: « Based on a comprehensive genotoxicity data package on the active substance glyphosate, and considering a weight of evidence approach on all available data, it is concluded that glyphosate is unlikely to be genotoxic in vivo and does not require hazard classification regarding mutagenicity according to the CLP Regulation. It is noted that unpublished studies that were the core basis of the peer review evaluation were not available to the IARC experts as reported in the IARC monograph 112 on glyphosate (IARC, 2015)[own emphasis added]. »
回复一批欧盟议员和国会议员2015年10月20日公开信的详细答复中，欧洲食品安全机构（EFSA）给了进一步的表达：“基于对于活性物质草甘膦综合性基因毒性数据资料，同时考虑对可以获得的所有资料的证据权重，结论草甘膦不看来在体内致基因毒性，而且，依据《欧盟物质和混合物的分类、标签和包装法规》（CLP）不要求做风险分类。还应注意到未出版的研究构成同行审查评估的核心依据，国际癌症研究机构专家看不到这些未出版的研究，如国际癌症研究机构专家对草甘膦的国际癌症研究机构专著112（参考文献：IARC, 2015）报告的那样。”
In other words, unpublished studies seen by EFSA were not only the core basis of the peer review, but based on a weight of evidence approach, these unpublished studies trumped the published studies used by IARC and thus led to an opposite conclusion.
换句话，欧洲食品安全机构（EFSA）看到的未出版的研究，不仅构成同行审查核心基础，而且基于某种证据权重分析方法，（国际癌症研究机构专家看不到的）这些未发表的研究“战胜了”国际癌症研究机构使用的已发表的研究，造成相反的结论。
We are deeply concerned about such an intransparent weight of evidence approach, based on which positive findings (in published studies) are outweighed by referring to negative findings (in unpublished studies). This does not create a level playing field, does not allow for independent scrutiny, and as a result inevitably questions the work of EFSA.
我们对这样一种不透明的证据权重衡量方法深感担心：这样的方法中，（公开发表的研究中）肯定性发现反而被（未发表的研究中）否定性发现抵消掉。这种做法不是创造公平竞争的环境，不允许独立审查，这也对欧洲食品安全机构（EFSA）的工作提出不可避免的问题。
We therefore call on you to demand the publication of all the studies which were used by the BfR and EFSA to assess glyphosate and not only their summaries, including names of the authors and declarations of conflicts of interests, so that these studies can be independently assessed.
我们因此呼吁你们要求公布德国联邦风险评估所（BfR）与欧洲食品安全机构（EFSA）使用的所有研究，而且不仅公布它们的摘要，而且公布这些研究其作者们的姓名与利益冲突声明，以便对这些研究进行独立评估。
With regard to the second point, EFSA has recently gone on record that its task would be to assess the active substance, not the formulated product (Huffington Post, 21 January 2016).
对于第二点，欧洲食品安全机构（EFSA）最近已经正式明确其任务是评估（草甘膦除草剂的）活性物质，而不是评估（草甘膦除草剂）配方产品（赫芬顿邮报，2016年1月21日报道）。
While it is correct that the authorisation of the diverse formulated plant protection products is the responsibility of Member States, EFSA also has key obligations in that regard.
虽然授权批准多样化植物保护产品确实是成员国的责任，欧洲食品安全机构（EFSA）对此也承担关键性责任。
According to Article 4(5) of Regulation (EC) No 1107/2009, for approval of an active substance, the approval criteria shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. It is thus clear that EFSA also needs to assess at least one plant protection product against the approval criteria, and in that respect pay full attention to all relevant data, including epidemiological one.
依据欧盟法规(EC) No 1107/2009第4条(5)款，批准一种活性物质时，
批准标准被视为令人满意时，包括含这种活性物质的至少一个或多个有代表性的植物保护产品的令人满意评估。因而非常清楚，，欧洲食品安全机构（EFSA）还必须依据批准标准评估至少一个或多个有代表性的植物保护产品，而且在这种情况下，对所有相关资料，包括流行病学资料，给予充分考虑。
The EFSA statement referred to above raises important questions with regard to the compliance of EFSA’s peer review with Article 4(5).
欧洲食品安全机构（EFSA）就此的说法，对欧洲食品安全机构（EFSA）的同行审查是否符合上述法令第4条(5)，提出了重要的问题。
Moreover, EFSA admitted that a number of published studies performed with glyphosate based formulations of unknown composition gave positive results when tested in vitro and in vivo.
此外，欧洲食品安全机构（EFSA）承认，对不知成分草甘膦为基础配方进行的数项公开发表的研究，在活体内与试管中试验时提供了正向结果。
EFSA furthermore acknowledged that POE-tallowamine is one of the co-formulants that is known to be used in some glyphosate-based formulations, and that « this co-formulant has been shown to be more toxic than the active substance glyphosate on several toxicological endpoints, namely acute, short term, reproductive and developmental toxicity, further to equivocal evidence of DNA damage in vitro at high doses ». However, according to EFSA, POE-tallowamine is not present in the representative formulation.
欧洲食品安全机构（EFSA）进一步确认，“乙氧化（牛脂烷基）胺”（POEA）是某些草甘膦为基础的除草剂配方中夫辅佐剂，而且“这种辅佐剂已知，对数项毒理学端点，包括急性、短期、生殖与发育毒性，其毒性超过活性物质草甘膦，除此还在试管中高剂量试验中发生模糊的DNA损伤。
We are very concerned that an applicant may get approval of an active substance based on one plant protection product alone, especially when many different formulations are placed on the market, most likely choosing a formulation with the least harmful co-formulants, despite the wide use of such highly problematic co-formulants such as POE-tallowamine.
我们非常担心草甘膦除草剂的申请方可能基于仅仅一种植物保护产品获得批准，特别在市场中销售多种不同配方的产品时，他们最有可能选择含最少辅佐剂的一种配方，尽管这种有问题的辅佐剂 “乙氧化（牛脂烷基）胺”（POEA）在许多草甘膦除草剂产品中广泛使用。
EFSA concluded that the toxicity of formulations and in particular their genotoxic potential should be further considered and addressed, leaving that task to Member States.
欧洲食品安全机构（EFSA）结论说，配方的毒性，特别它们的基因毒性潜在能力，应当进一步考虑与应对，将这个任务留给各成员国。
However, given the hazards shown by formulations, and in particular by POE-tallowamine, and without prejudice to our concerns with regard to the carcinogenic properties of glyphosate as found by IARC, it seems that Member States are not properly applying Article 4(3) of Regulation (EC) No 1107/2009.
然而，考虑到有关配方已经表明的风险，特别含辅佐剂POEA配方表明的风险，即便不考虑我们对于国际癌症研究机构（IARC）发现草甘膦的致癌性质的担心，看来各成员国并没有适当应用欧盟法规(EC) No 1107/2009第4条（3）款。
We would therefore like to know whether you consider that EFSA complied with Article 4(5) and whether it assessed the most relevant plant protection product in that context, and how you want to ensure that Member States properly apply the provisions of the Regulation, and in particular its Article 4(3) with regard to the authorisation of plant protection products.
我们因此希望知道您是否考虑欧洲食品安全机构（EFSA）符合第4章（5）碘的要求，而且他们是否在这种情况下对最相关的植物保护产品进行了评估，以及您如何确保成员国们正确应用领导该法规的条款，以及在批准植物保护产品时如何特别营养该法规第4条（3）款的规定。
Finally, we are greatly concerned that glyphosate may be reapproved prior to the adoption of scientific criteria for the determination of endocrine disrupters. Glyphosate-based formulations have been found to be endocrine disrupters in human cell lines (see Gasnier et al., Toxicology, 21 August 2009).
最后，我们极为担心对于确定内分泌干扰剂的科学标准采纳之前就可能重新批准草甘膦。草甘膦为基础的除草剂配方已经在人类细胞系中发现是内分泌干扰剂(参考科学文献Gasnier et al.，毒理学，2009年8月21日）。
In the absence of proper scientific criteria, EFSA only assessed glyphosate against the interim criteria for endocrine disrupters, yet stated that an endocrine-mediated mode of action could not be ruled out in the context of possible adverse effects on reproduction.
缺乏合适的科学标准情况下，欧洲食品安全机构（EFSA）仅仅依据草甘膦对临时内分泌干扰剂的标准评估了草甘膦，然而他们声称，在对于生殖可能的负面影响环境下，内分泌介导作用方式不能排除。
As you know, the Commission was obliged to present scientific criteria by 14 December 2013, but failed to do so. An analogous obligation is laid down in the Biocides Regulation EU (No) 528/2012. In this context, the General Court declared on 16 December 2015 that the Commission has breached EU law by failing to adopt delegated acts as regards the specification of the scientific criteria for the determination of the endocrine-disrupting properties.
如您所知，欧洲委员会本来承担责任在2013年12月14日提出内分泌干扰剂的科学标准，但是未能实现。生物杀灭剂法规EU (No) 528/2012也规定了欧洲委员会类似的责任。在这种情景下，欧盟一般法院2015年12月16日宣布：欧洲委员会已经违反欧盟法律，因为它未能就履行它受委托的行为按时确定内分泌干扰性质的科学标准。
In conclusion, we urge you to refrain from re-approving glyphosate as long as
作为结论，我们催促您在下述情况下避免重新批准草甘膦：
• key studies used for the assessment remain confidential or unpublished,
• 用于评估的关键研究继续保密或者没有发表，
• glyphosate-containing formulations are not properly and fully assessed,
• 含草甘膦的配方还没有进行合适的与充分的评估，
• the Commission has not adopted specific scientific criteria for the determination of endocrine-disrupting properties.
• 欧洲委员会对确定内分泌干扰性质还没有才能特定的科学标准。
Yours sincerely,
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