The European Commission has issued Commission Implementing Regulation (EU) 2024/425, formally rejecting the approval of the active substance asulam-sodium for use in plant protection products across the European Union. This decision, effective from 22 February 2024, underscores the EU's steadfast commitment to safeguarding human health and the environment from potentially harmful substances.
The journey to this decision began on 19 December 2013, when UPL Europe Limited submitted an application for the approval of asulam-sodium. The application was initially processed by the United Kingdom as the rapporteur Member State, a role later assumed by France following the UK's notification of its intent to withdraw from the EU.
A comprehensive assessment led by the European Food Safety Authority (EFSA) included a rigorous evaluation of the substance's impact on human and animal health, as well as its environmental repercussions. Despite additional information provided by the applicant and an extensive peer review process, EFSA concluded that asulam-sodium poses a high long-term risk to birds and mammals, excluding small insectivorous mammals.
A pivotal aspect of the assessment was the evaluation of asulam-sodium's potential endocrine-disrupting properties, a criterion that came into sharper focus following the introduction of new scientific criteria by Commission Regulation (EU) 2018/605. Despite efforts by the applicant to address these concerns, the Commission determined that asulam-sodium could not be demonstrated to have negligible human exposure levels, nor could it be considered necessary to control a serious danger to plant health that could not be managed by other means, including non-chemical methods.
After careful consideration of the Authority's conclusions and the applicant's feedback, the Commission concluded that the concerns associated with asulam-sodium could not be satisfactorily addressed. Consequently, the approval criteria outlined in Regulation (EC) No 1107/2009 were deemed not satisfied.
In a final turn of events, the applicant withdrew its application for the approval of asulam-sodium on 6 October 2023. This withdrawal, however, does not preclude the possibility of a new application for asulam-sodium's approval in the future, subject to the stringent requirements of EU regulatory standards.
This regulation, set to be directly applicable in all Member States, reflects the EU's rigorous approach to the approval of active substances in plant protection products, prioritising the health of its citizens and the protection of the environment above all.
The European Commission has issued Commission Implementing Regulation (EU) 2024/425, formally rejecting the approval of the active substance asulam-sodium for use in plant protection products across the European Union. This decision, effective from 22 February 2024, underscores the EU's steadfast commitment to safeguarding human health and the environment from potentially harmful substances.
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