The European Union is ushering in a structural overhaul of its agrochemical regulatory framework. Through a new work program established by Regulation (EU) 2024/1487, published on May 29, 2024, the EU will systematically evaluate and approve safeners and synergists as standalone substances.

This initiative marks a pivotal shift in the EU's regulatory philosophy. These components, historically assessed as part of a final plant protection product (PPP), must now undergo a separate, rigorous approval process. In the future, any safener or synergist that has not secured this independent authorization will be banned from use in PPPs sold on the EU market. While this presents a significant new compliance hurdle for global agrochemical companies, it also offers a strategic opportunity for proactive firms to build a competitive advantage by achieving early compliance.

Core of the New Regulation: A Shift from Bundled to Independent Assessment

The new framework fundamentally changes the rules of the game. Key elements include:

Mandatory Standalone Dossiers: The most profound change is the decoupling of safener and synergist evaluations from the PPPs they are used in. Companies must submit a complete, independent registration dossier for each substance. Only after a thorough scientific assessment and approval can the substance be legally used within the EU.

A Two-Step Application Timeline: The EU has established a strict, two-stage timeline for prospective applicants:

Step 1: Declaration of Interest (Deadline: June 19, 2025): Any company wishing to support a substance for evaluation must submit a notification to be included in the work program by this date. This step essentially reserves an "applicant" slot and is a prerequisite for formal submission.

Step 2: Full Dossier Submission (Deadline: June 19, 2028): Companies that have secured "applicant" status must then submit a complete technical dossier to the designated rapporteur Member State by this deadline.

Companies failing to meet the initial notification deadline will lose their right to apply independently. Their only recourse will be to collaborate with an existing applicant, typically by joining a consortium or task force to share data and costs.

Market Implications and Transitional Measures

To ensure a smooth market transition and mitigate the compliance burden, the regulation includes several practical provisions:

Transitional Period: For substances included in the work program, a review period of up to five years is granted. During this time, existing PPPs containing these safeners and synergists can continue to be sold, provided they hold a valid authorization in an EU Member State and comply with current regulations. This creates a crucial buffer for the industry to adapt.

Technical Equivalence (TE) Policy: The new framework includes a significant benefit for market access. Once a safener or synergist is officially approved, subsequent companies wishing to use it will not need to repeat the costly and time-consuming full registration process. Instead, they can apply for Technical Equivalence (TE), demonstrating that their source of the substance is chemically equivalent to the approved source. This pathway dramatically lowers the barrier to entry for other suppliers.

First List of Candidates Published

As the first concrete step in implementing this program, the European Commission has already published a draft Annex to Regulation (EU) 2024/1487, listing the initial candidates for evaluation. Following a public consultation period that concluded on July 8, 2024*, this list is expected to be formally adopted in the fourth quarter of 2025, officially kicking off the new era of independent assessment for these critical agrochemical components.