Recently, the European Food Safety Authority (EFSA) officially released a draft methodology for the evaluation of emergency authorizations for insecticides and acaricides, comprehensively regulating the application process for "emergency authorizations" stipulated in Article 53 of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. This policy adjustment will profoundly impact the market access and operations of pesticide enterprises in the EU, and relevant entities must pay close attention and proactively plan response strategies.

Policy Background: Abuse of Emergency Authorizations Drives Demand for Standardization

According to Article 53 of the EU Pesticide Regulation, when a Member State faces an sudden plant health crisis with no effective control measures available, it may approve an emergency marketing authorization for plant protection products for a maximum period of 120 days. In recent years, affected by multiple factors such as the frequent occurrence of extreme weather, the rising number of newly invasive pests, and the annual increase in banned pesticide substances, some EU Member States have increasingly resorted to the emergency authorization mechanism. This not only involves the temporary reuse of banned pesticides but also the emergency trial of unapproved pesticides.

However, due to the lack of unified evaluation standards, significant differences exist among EU Member States in terms of the duration of emergency authorization reviews, data submission requirements, and the identification of exemption grounds. This regulatory fragmentation has not only intensified trade barriers within the EU and increased the compliance costs for enterprises but also posed potential risks to human health and the ecological environment due to the temporary use of certain high-risk pesticides. To address these issues, the European Commission entrusted EFSA to develop a unified evaluation framework, aiming to standardize the application scenarios of emergency authorizations, ensure they are only used as exceptional cases, improve decision-making efficiency, reduce regulatory differences among Member States, and gradually reduce reliance on the emergency authorization mechanism. It is worth noting that the current draft focuses solely on insecticides and acaricides, with subsequent expansion to other pesticide categories such as fungicides and herbicides.

Core Content of the Draft: Six Key Evaluation Stages + Rigorous Transition Requirements

The draft establishes a core evaluation system for emergency authorization applications through a flowchart, with regulatory authorities conducting reviews around the following key stages:

The specificity and urgency of the pest threat targeted by the application;

The hazard characteristics of the product's active substances and the level of risk associated with the pest;

The suitability and control effectiveness of the applied product for the target pest;

The availability and scientific validity of alternative data;

The feasibility of converting the product to full registration;

Specific restrictive clauses such as the product's usage period, applicable area, and application methods.

For repeated applications for emergency authorizations, the draft sets strict rigid constraints: if an enterprise reapplies for the same product to control the same pest, it must submit a "structured action plan" detailing specific steps and timelines for transitioning to full registration, mutual recognition among regions, or alternative Integrated Pest Management (IPM) solutions. In principle, enterprises must complete the transition within five years; otherwise, their subsequent emergency authorization applications for the same product-pest combination will no longer be accepted. For applications related to minor crops or low-economic-value pests, the transition period may be appropriately extended, but sufficient scientific justification must be provided, and progress reports must be submitted annually.

Industry Impact and Future Outlook: Accelerated Green Transition, Clearer Compliance Thresholds

The introduction of EFSA's draft strengthens the principle of prudent use of emergency authorizations through standardized evaluation processes, which will drive the EU pesticide market to accelerate the phase-out of high-risk traditional pesticides and create broader market space for green pest control technologies such as biopesticides, pheromones, and physical barriers. Additionally, the draft's recognition of "field experience + expert judgment" as legitimate forms of efficacy data is expected to reduce the upfront compliance costs for small and medium-sized enterprises (SMEs) entering the EU market, enhancing flexibility in market access.

The draft is expected to be officially implemented in the second quarter of 2026, leaving less than two years of preparation time for relevant enterprises. For pesticide enterprises planning to enter or already operating in the EU market, it is crucial to closely monitor policy developments and proactively sort out product layouts: on the one hand, they must improve data reserves in accordance with the draft requirements to ensure application materials meet unified standards; on the other hand, they need to formulate clear transition strategies. In particular, products relying on emergency authorizations should accelerate the process of full registration or seek green alternative solutions to avoid disruptions to market access due to policy implementation.

This standardized reform of the EU's pesticide emergency authorization mechanism is not only an inevitable requirement to address environmental and health risks but also an important measure to promote the green and sustainable development of agriculture. In the future, with the full implementation of the policy, the EU pesticide market will usher in a more transparent and unified regulatory environment, and enterprises that proactively layout compliance and transformation are expected to seize opportunities in market competition.