This paper provides a historical and legal perspective of EU regulation on genetically modified organisms (GMOs)—through its initial development to its current position—in view of major advancements of modern molecular biotechnologies used for agriculture. We argue that the emergence and development of EU regulation of GMOs were shaped by antecedent events, notably bovine spongiform encephalopathy (BSE) or ‘mad cow disease’ and the public fears that ensued around food safety. These regulatory emergencies were a key factor prompting national governments and EU institutions to work out the framework for the application of the precautionary principle to agricultural biotechnology. Moreover, while modern biotechnology techniques eliminate many of the perceived health and safety risks of earlier predecessors, the EU regulatory framework has been slow to keep up, lacking the proper regulatory tools that allow for a balanced policy approach towards the techniques underlying genome editing and synthetic biology. Difference in approaches to the regulation of GMOs between the EU and US, to a large extent, precipitated the transatlantic conflict over agricultural biotechnology. Specifically, a significant incompatibility between the application of the precautionary principle in the EU and the substantial equivalence in the US to assess GM food and feed risk was the main reason for the international trade dispute. The ruling of the Court of Justice of the European Union that genome editing techniques will not be warranted exemption from authorisation process suggests that EU policy on agricultural biotechnology is likely to remain stringent. This may complicate the progress of synthetic biology and render the EU vulnerable to future food security and economic contingencies.

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从“疯牛”危机到合成生物学：欧盟对转基因生物的监管超出欧洲范围的挑战

鉴于用于农业的现代分子生物技术的重大进步，本文提供了欧盟对转基因生物 (GMO) 监管的历史和法律视角——从最初的发展到现在的地位。我们认为，欧盟对转基因生物监管的出现和发展是由先前事件影响的，特别是牛海绵状脑病 (BSE) 或“疯牛病”以及随之而来的公众对食品安全的担忧。这些监管紧急情况是促使各国政府和欧盟机构制定将预防原则应用于农业生物技术的框架的关键因素。此外，虽然现代生物技术技术消除了早期前辈所认为的许多健康和安全风险，欧盟监管框架跟不上步伐，缺乏适当的监管工具，无法对基因组编辑和合成生物学的基础技术采取平衡的政策方法。欧盟和美国对转基因生物的监管方式不同，在很大程度上促成了跨大西洋农业生物技术冲突。具体而言，欧盟预防原则的应用与美国在评估转基因食品和饲料风险方面的实质等效之间存在重大不兼容，这是导致国际贸易争端的主要原因。欧盟法院关于基因组编辑技术不能免于授权程序的裁决表明欧盟对农业生物技术的政策可能会保持严格。