Simplification and the level of protection—primary law limits and legislative discretion in the Food and Feed Safety Omnibus

IF 7.1 3区 环境科学与生态学 Q1 ENVIRONMENTAL SCIENCES
Kim Teppe, Thomas Backhaus
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引用次数: 0

Abstract

Background

On 16 December 2025, under the label “Simplification Omnibus”, the European Commission tabled a legislative proposal (COM (2025) 1030 final) that simultaneously amends various legal acts in the area of food and pesticide law. As regards plant protection products, the proposal pursues four structural interventions. Three operate on the knowledge-input side of the risk-governance system: the conversion from time-limited to open-ended active substance approvals, the freezing of the state of knowledge underlying the active substance approval as the binding standard of review in the subsequent product authorisation procedure, and the introduction of deemed authorisation upon expiry of time limits. A fourth operates on the output side: the extension of grace periods, which allows substances whose approval has been withdrawn on health or environmental grounds to remain on the market for up to three further years. This contribution assesses these measures against primary law.

Results

Their cumulation structurally eliminates the dynamic updating of scientific knowledge required by the precautionary principle, without the proposal prescribing a functionally equivalent replacement system: the first three measures bar new risk knowledge from entering the assessment, while the extended grace periods prevent the system from acting on risk knowledge it has already confirmed. The proposal thus opens the regulatory loop at both ends. At the same time, the measures fail their own simplification objective: the reactive review system generates more administrative burden in any meaningful application than the application-driven renewal procedure, and deemed authorisation does not relieve administrations either, but compels them to maintain dedicated personnel capacities for keeping deadlines. The measures are therefore already questionable at the suitability stage of proportionality review. Deemed authorisation additionally constitutes a structural rupture with primary law, as it reverses the allocation of the burden of proof in risk authorisation law that the precautionary principle prescribes.

Conclusions

The contribution shows how the proposal could be developed in a manner compatible with primary law, and where the limits of reformability lie.

简化和保护水平——食品和饲料安全综合法案中的主要法律限制和立法自由裁量权
2025年12月16日,在“简化综合”标签下,欧盟委员会提交了一项立法提案(COM (2025) 1030 final),该提案同时修订了食品和农药法领域的各种法律行为。关于植物保护产品,该提案寻求四种结构性干预措施。其中三个是在风险治理系统的知识输入方面运作的:从有时限的原料药审批转变为开放式的原料药审批,冻结原料药审批的知识状态,作为后续产品批准程序中具有约束力的审查标准,以及在期限届满时引入视为授权。第四项措施涉及产出方面:延长宽限期,允许因健康或环境理由而撤销批准的物质再在市场上停留最多三年。这篇文章根据基本法律对这些措施进行了评估。结果它们的累积从结构上消除了预防原则所要求的科学知识的动态更新,而没有建议规定功能等效的替代系统:前三个措施禁止新的风险知识进入评估,而延长的宽限期则阻止系统对已经确认的风险知识采取行动。因此,该提案打开了两端的监管循环。与此同时,这些措施未能实现其本身的简化目标:在任何有意义的申请中,被动审查制度比申请驱动的续期程序产生了更多的行政负担,并且视为授权也没有减轻行政部门的负担,而是迫使他们保持专门的人员能力以遵守最后期限。因此,这些措施在相称性审查的适宜性阶段已经有问题。视同授权还构成与原始法的结构性断裂,因为它颠倒了预防原则规定的风险授权法中的举证责任分配。该贡献显示了该提案如何以与主要法律相容的方式发展,以及可改革性的限制所在。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Environmental Sciences Europe
Environmental Sciences Europe Environmental Science-Pollution
CiteScore
11.20
自引率
1.70%
发文量
110
审稿时长
13 weeks
期刊介绍: ESEU is an international journal, focusing primarily on Europe, with a broad scope covering all aspects of environmental sciences, including the main topic regulation. ESEU will discuss the entanglement between environmental sciences and regulation because, in recent years, there have been misunderstandings and even disagreement between stakeholders in these two areas. ESEU will help to improve the comprehension of issues between environmental sciences and regulation. ESEU will be an outlet from the German-speaking (DACH) countries to Europe and an inlet from Europe to the DACH countries regarding environmental sciences and regulation. Moreover, ESEU will facilitate the exchange of ideas and interaction between Europe and the DACH countries regarding environmental regulatory issues. Although Europe is at the center of ESEU, the journal will not exclude the rest of the world, because regulatory issues pertaining to environmental sciences can be fully seen only from a global perspective.
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