The environmental risk assessment (ERA) of veterinary medicinal products (VMPs) has been a regulatory requirement in the European Union (EU) since 1993. However, in the last few years, the potential impact of human and veterinary medicines on the environment has become a growing concern worldwide. Indeed, the legal requirements for VMPs in the EU are changing. Regulation (EU) 2019/6, which will be applied from January 28, 2022, aims to update the regulatory framework for VMPs and replaces Directive 2001/82/EC. This paper analyzes the ability of both legislations to ensure a high level of protection of the environment while authorizing VMPs. Consideration is also given to the impact on administrative burdens in both the legislations. We conclude that the Regulation improves the Directive by reducing to a certain extent the regulatory burdens for the applicants and authorities. However, the knowledge of the environmental risks of all authorized VMPs and the consistency of the assessments remain quite similar between both legislations. Nevertheless, the new Regulation proposes to examine the feasibility and applicability of an assessment system based on the critical review of properties of the active substances (“monographs”) or other potential alternatives. With this in mind, two proposals (a basic and an enhanced approach) for developing a monograph system are presented and their main advantages and disadvantages are explored. Integr Environ Assess Manag 2021;17:1274–1285. © 2021 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC)

中文翻译：

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欧洲兽药立法：专论系统会改善环境风险评估吗？

自 1993 年以来，兽药产品 (VMP) 的环境风险评估 (ERA) 一直是欧盟 (EU) 的监管要求。 然而，在过去几年中，人类和兽药对环境的潜在影响已成为全球日益关注的问题。事实上，欧盟对 VMP 的法律要求正在发生变化。法规 (EU) 2019/6 将于 2022 年 1 月 28 日生效，旨在更新 VMP 的监管框架并取代指令 2001/82/EC。本文分析了这两项立法在授权 VMP 的同时确保高度保护环境的能力。两项立法还考虑了对行政负担的影响。我们的结论是，该法规通过在一定程度上减轻申请人和当局的监管负担来改进指令。然而，所有授权 VMP 的环境风险知识和评估的一致性在这两个立法之间仍然非常相似。尽管如此，新法规建议根据对活性物质（“专论”）或其他潜在替代品的特性的严格审查来审查评估系统的可行性和适用性。考虑到这一点，提出了开发专着系统的两个建议（基本方法和增强方法），并探讨了它们的主要优点和缺点。两项立法之间对所有授权 VMP 的环境风险的了解和评估的一致性仍然非常相似。尽管如此，新法规建议根据对活性物质（“专论”）或其他潜在替代品的特性的严格审查来审查评估系统的可行性和适用性。考虑到这一点，提出了开发专着系统的两个建议（基本方法和增强方法），并探讨了它们的主要优点和缺点。两项立法之间对所有授权 VMP 的环境风险的了解和评估的一致性仍然非常相似。尽管如此，新法规建议根据对活性物质（“专论”）或其他潜在替代品的特性的严格审查来审查评估系统的可行性和适用性。考虑到这一点，提出了开发专着系统的两个建议（基本方法和增强方法），并探讨了它们的主要优点和缺点。Integr Environ Assess Manag 2021；17:1274-1285。© 2021 作者。由 Wiley Periodicals LLC 代表环境毒理学与化学学会 (SETAC) 发布的综合环境评估和管理