We identify the origins, and key characteristics, of the current regulatory framework for genetically modified organisms (GMOs) in the European Union (EU). We focus on the approach of the European Food Safety Authority (EFSA) to assessing GMO risks to public and environmental health. An historical account informs our critical appraisal of the current practices of EFSA’s GMO panel, and helps to explain how and why it fails to satisfy the objectives of the EU’s GMO legislation. While those legislative texts set appropriate objectives, their concrete implementation has fallen far short of the legislative goals. EFSA’s prevailing approach to GM crop and food risk assessment starts from what it terms a ‘comparative safety assessment’. Those comparisons require the scrutiny of sets of molecular, chemical and phenotypic data from GM plants and non-GM varieties (many of which may be only remotely related to the GM variety). Those data are, however, inadequate for predicting adverse biological, toxicological and ecological effects. EFSA’s ‘comparative safety assessments’ draw over-optimistic conclusions from too little data from too few studies. When GM products are deemed to have passed a ‘comparative safety assessment’, EFSA has interpreted that as grounds for conducting only very narrowly circumscribed risk assessments, which have not required meaningful data from studies of ecological or eco-toxicological impacts. This is a reductionist approach to risk assessment, when a more inclusive and comprehensive approach, which we outline, is scientifically available, and also more likely to meet the specified legislative aims. Instead, however, the reductionist choice is systematically applied, but never justified nor acknowledged as such. Indeed, it is concealed, by EFSA and by its main policy client the European Commission, as if it were only for specialist expert scientific deliberation. Thus, key questions that sound scientific assessments should ask about potential harm are not even posed, let alone answered—or at least, they are ‘answered’ only by default, given that the implicit burden of proof requires harm to be demonstrated. Furthermore, and a key point of this paper, we show how the problematic features of EFSA’s approach have been premised on a set of evaluative policy judgements, rather than purely scientific considerations. Responsibility for selecting how EFSA frames its scientific approach should however lie with European Commission risk managers, and not with EFSA. These problems might have been and could be avoided if explicit commitments entered into by the EU at the Codex Alimentarius Commission were implemented by the European Commission and EFSA were instructed accordingly.

我们确定了欧盟（EU）当前的转基因生物（GMO）监管框架的起源和关键特征。我们专注于欧洲食品安全局（EFSA）评估转基因生物对公众和环境健康的风险的方法。历史记录有助于我们对EFSA GMO专家组的当前做法进行严格评估，并有助于解释其如何以及为什么不能满足欧盟GMO立法的目标。这些立法文本虽然设定了适当的目标，但其具体实施却远远没有达到立法目标。EFSA普遍采用的转基因作物和食品风险评估方法始于所谓的“比较安全性评估”。这些比较需要对分子集进行仔细检查，来自转基因植物和非转基因品种的化学和表型数据（其中许多可能仅与转基因品种遥相关）。然而，这些数据不足以预测不利的生物学，毒理学和生态学影响。EFSA的“比较安全性评估”从太少的研究中得出的太少的数据得出了过于乐观的结论。当转基因产品被认为已通过“比较安全性评估”时，欧洲食品安全局将其解释为仅进行非常狭义的风险评估的依据，而风险评估并不需要生态或生态毒理学影响研究的有意义数据。如果我们概述了一种更具包容性和综合性的方法，并且在科学上可用，并且也更有可能达到指定的立法目标，则这是一种简化的风险评估方法。但是，还原主义者的选择是系统地应用的，但从来没有这样的理由或承认。的确，EFSA及其主要政策客户欧洲委员会对其进行了隐瞒，就好像它仅用于专家科学审议一样。因此，健全的科学评估应询问的有关潜在危害的关键问题甚至都没有提出，更不用说回答了，或者至少，鉴于隐含的举证责任要求证明损害，这些问题只有在默认情况下才得到“回答”。此外，也是本文的重点，我们展示了EFSA方法的问题特征是如何基于一系列评估性政策判断而非纯粹的科学考虑的前提下得出的。但是，选择EFSA如何构建其科学方法的责任应由欧洲委员会风险管理人员负责，而不是EFSA。