The safety evaluation of pesticides in the European Union (EU) relies to a large extent on toxicity studies commissioned and funded by the industry. The herbicide glyphosate and four of its salts are currently under evaluation for renewed market approval in the EU. The safety documentation submitted by the applicant companies does not include any animal study regarding developmental neurotoxicity (DNT) that is compliant with test guidelines. For a fifth salt, not included in the present application for re-approval, such a DNT study was sponsored by one of the applicant companies in 2001. That study shows an effect of that form of glyphosate on a neurobehavioural function, motor activity, in rat offspring at a dose previously not known to cause adverse effects. Counter to regulatory requirements, these effects were apparently not communicated to authorities in EU countries where that form of glyphosate was authorised at that time. That DNT study may also be relevant for the ongoing assessment of glyphosate but was not included in the present or previous applications for re-approval. In this commentary, we highlight that it is the responsibility of the industry to evaluate and ensure the safety of their products, taking all available scientific knowledge into account. We argue that the legal obligation for industry to submit all potentially relevant data to EU authorities is clear and far-reaching, but that these obligations were not fulfilled in this case. We claim that authorities cannot reliably pursue a high level of protection of human health, if potentially relevant evidence is withheld from them. We suggest that a retrospective cross-check of lists of studies performed by test laboratories against studies submitted to regulatory authorities should be performed, in order to investigate the completeness of data submitted to authorities. We further suggest that future toxicity studies should be commissioned by authorities rather than by companies, to improve the authorities’ oversight over existing data and to prevent that economic conflicts of interest affect the reporting of study results and conclusions.

中文翻译：

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你不知道的事情仍然会伤害你——在欧盟农药法规中漏报

欧盟 (EU) 农药的安全性评估在很大程度上依赖于该行业委托和资助的毒性研究。除草剂草甘膦及其四种盐类目前正在评估中，以便在欧盟重新获得市场批准。申请公司提交的安全文件不包括任何符合测试指南的关于发育神经毒性（DNT）的动物研究。对于第五种盐，未包括在本申请重新批准的申请中，此类 DNT 研究由一家申请公司于 2001 年赞助。该研究显示了该形式的草甘膦对神经行为功能、运动活动的影响，在大鼠后代的剂量以前不知道会引起不良反应。违反监管要求，这些影响显然没有传达给当时批准这种形式的草甘膦的欧盟国家的当局。该 DNT 研究也可能与正在进行的草甘膦评估相关，但未包含在当前或以前的重新批准申请中。在本评论中，我们强调行业有责任评估和确保其产品的安全性，同时考虑到所有可用的科学知识。我们认为，行业向欧盟当局提交所有潜在相关数据的法律义务是明确而深远的，但在本案中这些义务并未得到履行。我们声称，如果不向他们提供潜在的相关证据，当局就无法可靠地追求高水平的人类健康保护。我们建议对测试实验室进行的研究列表与提交给监管机构的研究进行回顾性交叉检查，以调查提交给监管机构的数据的完整性。我们进一步建议，未来的毒性研究应由当局而非公司委托，以改善当局对现有数据的监督，并防止经济利益冲突影响研究结果和结论的报告。