植物保护产品中活性物质的批准程序-对科学确定性的怀疑是争议的来源。以草甘膦为例的制度缺陷分析

Anna Gembicka, J. Farhan
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引用次数: 0

摘要

这篇文章的目的是检查关于在欧盟使用的植物保护产品的安全性的反复怀疑的原因。植物保护产品是一个特殊的监管对象。所有与之相关的标准都需要事先在精确科学领域进行深入的科学研究。在使用植物保护产品方面实现人类、动物和环境的充分安全不仅需要良好的法律,而且需要基于代表性研究和科学确定性的法律。考虑到上述情况,作者对第1107/2009号法规目的的实际实现进行了分析,即在植物保护产品中活性物质的批准程序中纳入科学研究,这似乎是造成重大社会疑虑的原因。首先介绍了植保产品原料药的审批程序,然后以草甘膦的审批为例,分析了审批程序中存在的主要缺陷。作者认为,文献综述的指导性文件应进行修订,以反映最佳的科学实践,并应执行其标准,特别是要确保文献综述的客观性不存在任何疑问。
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Approval procedure for active substances in plant protection products - doubts of scientific certainty as a source of controversy. Analysis of systemic imperfections on the example of glyphosate
The purpose of this article is to examine the causes of recurring doubts regarding the safety of plant protection products used in the European Union. Plant protection products are a particular subject of regulation. All standards concerning them require prior in-depth scientific research in the field of exact sciences. Achieving adequate safety of humans, animals and the environment in connection to the use of plant protection products requires not only good law, but a law based on representative research and scientific certainty. Bearing in mind the above, the authors undertook an analysis of what seems to be the cause of significant social doubts as to the actual achievement of the purposes of Regulation 1107/2009, i.e. inclusion of scientific research in the procedure of approval of active substances in plant protection products. First, the approval procedure for the active substance of the plant protection product was presented, and then the main shortcoming of the procedure was analyzed on the example of the approval of glyphosate. In the authors' opinion, guidance documents on literature review should be revised to reflect the best scientific practice, and their standards should be enforced, in particular, to ensure that there is no doubt about the objectivity of the literature review.
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26 weeks
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