In a ruling on 25 July 2018, the Court of Justice of the European Union concluded that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs in the sense of Directive 2001/18, and that organisms obtained by means of techniques/methods of directed mutagenesis are not excluded from the scope of the Directive. Following the ruling, there has been much debate about the possible wider implications of the ruling. In October 2019, the Council of the European Union requested the European Commission to submit, in light of the CJEU ruling, a study regarding the status of novel genomic techniques under Union Law. For the purpose of the study, the Commission initiated stakeholder consultations early in 2020. Those consultations focused on the technical status of novel genomic techniques.

This article aims to contribute to the discussion on the legal status of organisms developed through novel genomic techniques, by offering some historical background to the negotiations on the European Union (EU) GMO Directives as well as a technical context to some of the terms in the Directive, and by analysing the ruling. The article advances that (i) the conclusion that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs under the Directive means that the resulting organisms must comply with the GMO definition, ie the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination; (ii) the conclusion that organisms obtained by means of techniques/methods of directed mutagenesis were not intended to be excluded from the scope of the Directive is not inconsistent with the negotiation history of the Directive; (iii) whether an organism falls under the description of “obtained by means of techniques/methods of directed mutagenesis” depends on whether the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination. Finally, the article offers an analysis of the EU GMO definition, concluding that for an organism to be a GMO in the sense of the Directive, the technique used, as well as the genetic alterations of the resulting organism, must be considered.

在 2018 年 7 月 25 日的一项裁决中，欧盟法院得出结论，通过诱变技术/方法获得的生物体构成指令 2001/18 意义上的转基因生物，并且通过以下技术/方法获得的生物体定向诱变不排除在指令范围之外。裁决发布后，人们就该裁决可能产生的更广泛影响展开了很多辩论。2019 年 10 月，欧盟理事会要求欧盟委员会根据 CJEU 的裁决提交一份关于欧盟法律下新型基因组技术现状的研究。出于这项研究的目的，委员会于 2020 年初启动了利益相关者磋商。这些磋商的重点是新型基因组技术的技术状况。

本文旨在通过为欧盟 (EU) 转基因生物指令的谈判提供一些历史背景以及一些条款的技术背景，为通过新型基因组技术开发的生物体的法律地位的讨论做出贡献。指令，并通过分析裁定。该文章提出，(i) 通过诱变技术/方法获得的生物体构成该指令下的转基因生物的结论意味着由此产生的生物体必须符合转基因生物体的定义，即所得生物体的遗传物质已在某种程度上被改变交配和/或自然重组不会自然发生的方式；(ii) 通过定向诱变技术/方法获得的生物体不打算被排除在指令范围之外的结论与指令的谈判历史并不矛盾；(iii) 生物体是否属于“通过定向诱变技术/方法获得”的描述取决于所得生物体的遗传物质是否以非通过交配和/或自然发生的方式发生改变重组。最后，文章对欧盟转基因生物定义进行了分析，得出的结论是，要使生物体成为指令意义上的转基因生物体，必须考虑所使用的技术以及由此产生的生物体的遗传改变。(iii) 生物体是否属于“通过定向诱变技术/方法获得”的描述取决于所得生物体的遗传物质是否以非通过交配和/或自然发生的方式发生改变重组。最后，文章对欧盟转基因生物定义进行了分析，得出的结论是，要使生物体成为指令意义上的转基因生物体，必须考虑所使用的技术以及由此产生的生物体的遗传改变。(iii) 生物体是否属于“通过定向诱变技术/方法获得”的描述取决于所得生物体的遗传物质是否以非通过交配和/或自然发生的方式发生改变重组。最后，文章对欧盟转基因生物定义进行了分析，得出的结论是，要使生物体成为指令意义上的转基因生物体，必须考虑所使用的技术以及由此产生的生物体的遗传改变。