On October 15, 2025, the Official Journal of the European Union published Commission Implementing Regulation (EU) 2025/2068, formally renewing the approval for the active substance milbemectin as a plant protection product. The valid approval period will extend from November 16, 2025, to November 15, 2040. This 15-year renewal period not only provides institutional guarantee for the stable application of milbemectin in agricultural production within the EU but also highlights the core principle of "taking scientific rigor as the foundation and flexible procedures as the supplement" in the EU's evaluation of pesticide active substances.

The approval and renewal process of milbemectin in the EU can be regarded as a typical case of pesticide regulation. As early as December 1, 2005, this substance was included in the EU's pesticide approval list, with an initial approval validity period until November 30, 2015. In accordance with the requirements of EU Regulation (EC) No 1107/2009 on pesticides, a comprehensive re-evaluation process was required upon expiration. Considering the complexity and time-consuming nature of scientific evaluation, the EU successively extended its temporary validity period to May 31, 2026, through documents such as Implementing Regulation (EU) 2025/99, reserving sufficient time for the complete evaluation process. This model of "temporary extension + comprehensive evaluation" not only prevents high-quality pesticide varieties from being hastily withdrawn from the market due to evaluation cycle issues but also ensures the adequacy of risk assessment, achieving a balance between regulatory rigor and industrial continuity.

This renewal evaluation was jointly led by Germany as the rapporteur member state and the Netherlands as the co-rapporteur member state, establishing a dual-country collaborative professional evaluation system. The evaluation team focused on the core concerns of pesticide safety management and conducted systematic demonstrations on key endpoints of milbemectin, including endocrine-disrupting properties, genotoxic potential, ecotoxicity, and metabolic behavior. As the authoritative institution in the field of food safety in the EU, the European Food Safety Authority (EFSA) took the lead in issuing scientific conclusions in July 2023, clearly stating that under the premise of complying with specific risk control conditions, plant protection products containing milbemectin can meet the approval standards specified in the regulations, providing key scientific support for the final renewal decision. This evaluation process fully reflects the core characteristics of the EU's pesticide evaluation, which is "based on scientific data and jointly supervised by multiple entities."

Long-term renewal does not mean unconditional approval; refined risk management measures constitute an important part of this approval. The EU clearly requires that when member states authorize relevant products, they must strictly implement four core conditions: first, standardize technical materials and product specifications to ensure batch consistency in commercial production and guarantee product quality stability from the source; second, strengthen the protection of operators, requiring the provision and standardized use of personal protective equipment to reduce occupational exposure risks; third, focus on controlling the impact on pollinators such as bees, especially avoiding exposure risks caused by application during the crop flowering period - this requirement echoes the EU's overall strategy for biodiversity conservation; fourth, implement comprehensive risk mitigation measures to strictly prevent pesticide drift from harming surrounding terrestrial and aquatic ecosystems. These targeted provisions establish a full-chain risk prevention and control system covering "production - application - environment."

To further consolidate the foundation of scientific evaluation, the EU has also set subsequent data supplementary requirements for applicants, clearly stipulating that four types of confirmatory research information must be submitted by November 5, 2027. Specifically, these include: confirming bone marrow exposure levels related to genotoxicity or aneuploid mutagenic potential through supplementary tests; conducting in vitro comparative metabolism studies in key species and comparing them with human metabolic conditions to provide a basis for cross-species risk assessment; carrying out targeted in vitro phototoxicity tests in the wavelength range of 290–700 nm; and updating the aquatic sediment organism risk assessment through OECD standard test methods in accordance with the latest EFSA guidelines.

From the perspective of industry impact, the long-term renewal approval of milbemectin has multiple positive implications. For manufacturing enterprises, the 15-year stable approval cycle has significantly reduced market uncertainty, providing long-term expectations for technological R&D, capacity layout, and market expansion; for agricultural producers, the continuous application of this efficient and low-toxicity active substance helps improve pest and disease control effects and ensure crop yield and quality; for the regulatory field, the closed-loop model of "scientific evaluation - conditional approval - dynamic monitoring" formed in this renewal process provides a reference model for the subsequent evaluation of other pesticide active substances.

Against the backdrop of increasingly strict global pesticide regulation and rising requirements for ecological protection, the case of milbemectin obtaining long-term renewal approval in the EU indicates that only by balancing scientific rigor and regulatory flexibility and achieving a balance between safety and effectiveness through full-chain risk management can the sustainable development of the pesticide industry be promoted, providing solid support for the coordinated development of agricultural production and ecological protection.