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Habitat loss and fragmentation due to agricultural expansion and pesticide use are primary drivers of biodiversity decline. The United Nation (UN) “Decade on Ecosystem Restoration” (2021–2030) and the European Green Deal’s “Farm-to-Fork” strategy aim to address these issues by promoting sustainable food production and reducing pesticide use. Among the most promising new generation of pest control technologies, RNA interference (RNAi) offers target-specific pest control by causing the silencing of specific genes in pests, potentially reducing harm to non-target organisms (NTOs). In December 2023, the US-Environmental Protection Agency (US-EPA)’s approval of the first sprayable double-stranded (dsRNA)-based plant protection product (PPP), Ledprona, against the Colorado potato beetle, marks a significant advancement in the diffusion of the technology. RNAi can be implemented through host-induced gene silencing (HIGS), spray-induced gene silencing (SIGS), and engineered microorganisms or viruses. HIGS involves genetically modified plants (GMPs) expressing dsRNAs, while SIGS involves direct application of dsRNA on plants. Field release of GMPs in the European Union (EU) is regulated according to Directive 2001/18/EC and 2018/350. The development of SIGS in the EU requires to meet the same data requirements as chemical PPPs as these are not yet defined for products with this new mechanism of action. The authorization process involves thorough risk assessments firstly of the active substance and therefore of the specific PPP. The process is led by the European Food Safety Authority (EFSA) and Member States and aims at ensuring safety for human health and the environment. dsRNA molecules are naturally occurring and generally considered safe for mammals due to biological barriers that prevent their uptake. Various formulation strategies, including nanocarriers and chemical modifications, enhance the stability and effectiveness of dsRNA-based PPPs. These formulations must comply with regulations to avoid harmful co-formulants and ensure environmental safety and human health.

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Regulatory Landscape Surrounding Approval and Authorisation of dsRNA-Based Plant Protection Products in Europe

  • 章节

  • 发表日期：

    2025年

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  • Achim Gathman,
  • Eve Veromann,
  • Guy Smagghe,
  • Salvatore Arpaia

摘要

Habitat loss and fragmentation due to agricultural expansion and pesticide use are primary drivers of biodiversity decline. The United Nation (UN) “Decade on Ecosystem Restoration” (2021–2030) and the European Green Deal’s “Farm-to-Fork” strategy aim to address these issues by promoting sustainable food production and reducing pesticide use. Among the most promising new generation of pest control technologies, RNA interference (RNAi) offers target-specific pest control by causing the silencing of specific genes in pests, potentially reducing harm to non-target organisms (NTOs). In December 2023, the US-Environmental Protection Agency (US-EPA)’s approval of the first sprayable double-stranded (dsRNA)-based plant protection product (PPP), Ledprona, against the Colorado potato beetle, marks a significant advancement in the diffusion of the technology. RNAi can be implemented through host-induced gene silencing (HIGS), spray-induced gene silencing (SIGS), and engineered microorganisms or viruses. HIGS involves genetically modified plants (GMPs) expressing dsRNAs, while SIGS involves direct application of dsRNA on plants. Field release of GMPs in the European Union (EU) is regulated according to Directive 2001/18/EC and 2018/350. The development of SIGS in the EU requires to meet the same data requirements as chemical PPPs as these are not yet defined for products with this new mechanism of action. The authorization process involves thorough risk assessments firstly of the active substance and therefore of the specific PPP. The process is led by the European Food Safety Authority (EFSA) and Member States and aims at ensuring safety for human health and the environment. dsRNA molecules are naturally occurring and generally considered safe for mammals due to biological barriers that prevent their uptake. Various formulation strategies, including nanocarriers and chemical modifications, enhance the stability and effectiveness of dsRNA-based PPPs. These formulations must comply with regulations to avoid harmful co-formulants and ensure environmental safety and human health.