EUROPE – COM : Public Consultation on a draft regulation for the addition of unacceptable co-formulants
25 September 2025
EFSA has launched a public consultation up to 24 October 2025 on a draft protocol for the evaluation of emergency authorisations of insecticides and acaricides submitted under Article 53 of Regulation (CE) 1107/2009.
As a reminder, Article 53 allows Member States to respond to an emergency situation by authorising, by way of derogation and for a maximum of 120 days, the placing on the market of PPPs when there is no other available and suitable means of controlling a plant health hazard.
This protocol aims to :
- Standardise emergency authorisation assessment practices in Member States;
- Ensure that these authorisations remain exceptional and justified;
- Promote the transition to regular authorisation pathways;
- Improve transparency and efficiency of the decision-making process.
The protocol for the evaluation of emergency authorisations is based on a series of flowcharts, enabling the authorities to:
- Identify the phytosanitary threat justifying the application;
- Assess the hazard profile of the active substance and the risk associated with the pest;
- Examine the suitability of the proposed product for the application;
- Determine the availability and suitability of alternative solutions, chemical or otherwise;
- Verify the possibility of transitioning from emergency to regular authorisation;
- Define precise conditions of use (duration, areas, methods) for the product.
Furthermore, in the event of repeated authorisations, applicants must submit an action plan with a time frame indicating the steps to find long-term solutions.
Assessment grids are used to ‘rate’ alternative methods in terms of effectiveness, the time required to achieve this effectiveness, associated prerequisites, and feasibility, with examples. The combination of these four ratings determines whether an alternative method is eligible for controlling the identified phytosanitary threat.
In order to support Member States, work has begun compiling an inventory of alternative control methods covering the pests most frequently encountered in emergency authorisations within the EU.
In addition to the draft protocol, which is open for comments during the public consultation phase, EFSA has also provided three emergency authorization test cases, accompanied by literature research on available alternative methods
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