News Brief
On 15 October 2025, the European Commission adopted Commission Implementing Regulation (EU) 2025/2068, officially renewing the approval of milbemectin in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. The decision extends the substance's approval period for 15 years, from November 16, 2025, to November 15, 2040.
Scientific Evaluation and Safety Conclusions
The renewal assessment was conducted in line with EU data requirements for active substances, involving an in‑depth evaluation by the European Food Safety Authority (EFSA). In its 2023 conclusion, EFSA confirmed that milbemectin meets the approval criteria under Article 4 of Regulation (EC) No 1107/2009. Notably, EFSA concluded that milbemectin does not meet the criteria for endocrine‑disrupting properties, either for humans or non‑target organisms.
The assessment also benefited from updated scientific methodologies, including advances in comparative metabolism and aquatic risk assessment—ensuring that all new insights were reflected in the Commission’s final decision.
Confirmatory Data Requirements
Furthermore, the regulation mandates the submission of additional confirmatory data by the applicant by November 5, 2027. This includes further toxicological studies to confirm the substance's genotoxic potential, comparative metabolism, and phototoxicity. Additionally, an updated and more comprehensive risk assessment for aquatic sediment organisms, based on specific OECD test guidelines, is required. Compliance with these data requirements is essential for the continued approval of milbemectin.
Risk Mitigation and Conditions of Use
Member States are required to take specific risk mitigation measures when authorising products containing milbemectin. These include safeguards to:
Protect operators and workers through the mandatory use of appropriate personal protective equipment;
Safeguard bees and other pollinators potentially exposed during flowering periods; and
Prevent off‑target drift into terrestrial and aquatic environments beyond the treated field.
The technical specification and purity of commercially manufactured milbemectin must also align with the criteria stated in the renewal report to maintain product consistency and risk predictability.
Regulatory Implications and Next Steps
Under the new regulation, the entry for milbemectin will be moved from Part A to Part B of the Annex to Implementing Regulation (EU) No 540/2011, reflecting its renewed approved status. This transition signifies that the substance has undergone a full re‑evaluation and continues to meet EU safety and efficacy standards.
For industry stakeholders, this renewal provides long‑term regulatory certainty until 2040 but also introduces additional responsibilities related to confirmatory data generation and implementation of enhanced environmental protection measures.
Outlook
The renewal of milbemectin highlights the EU’s ongoing commitment to a science‑based regulatory approach, ensuring both agricultural productivity and a high level of environmental and human health protection. It also exemplifies how evolving scientific knowledge can refine existing risk assessments and lead to more targeted regulatory actions.
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