Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products
The EU is updating data requirements for active substances in plant protection products, raising safety standards and regulatory expectations.
The European Commission has approved Allium fistulosum, commonly known as Welsh onion, as a basic substance for plant protection use under Regulation (EU) 2024/2878, effective 1 December 2024. This decision allows processed Allium fistulosum extracts to be utilised as bactericides, primarily in soil treatments for tomato cultivation.
The European Commission formalised the approval of processed Allium fistulosum on 8 November 2024, specifying its role as a bactericide for soil treatment in both open fields and permanent greenhouses before tomato planting. This approval, aligned with Regulation (EC) No 1107/2009 on plant protection products, marks a significant step in integrating natural substances within plant protection practices across the EU.
EFSA Review and Approval Process
The Commission’s decision followed a thorough review process initiated in March 2021 by the Institut Technique de l’Agriculture Biologique, which submitted Allium fistulosum for consideration. The European Food Safety Authority (EFSA) completed a comprehensive technical report in October 2023, confirming the plant’s safety profile and effectiveness as a bactericide. EFSA’s findings indicated that processed Allium fistulosum poses no risks of endocrine disruption, neurotoxicity, or immunotoxicity.
Approval Conditions and Usage Guidelines
In its processed form, Allium fistulosum will be regulated for compliance with food safety standards, including those outlined in Regulation (EC) No 178/2002. The regulation specifies two acceptable forms for application: as a water extract or as fresh, chopped plant material. Under the guidance of Annex I and Annex II of the new regulation, users are required to follow specific conditions for safe and effective application.
Amendments to Regulation 540/2011
As part of the approval, the EU has updated Implementing Regulation 540/2011 to include Allium fistulosum, processed, in its list of approved basic substances. This amendment will facilitate broader acceptance and standardisation of the substance for agricultural use.
This decision reflects the EU’s commitment to sustainable agricultural practices and the use of natural alternatives in plant protection. With its entry into force on 1 December 2024, this regulation introduces new options for organic and sustainable agriculture across Member States.
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