EFSA has concluded that all existing maximum residue levels (MRLs) and Codex maximum residue limits (CXLs) for the pesticide clofentezine are supported by inadequate data, making the consumer risk assessment indicative only and requiring further consideration by risk managers. In a reasoned opinion published on 23 July 2026, the European Food Safety Authority found no consumer risk from the authorised uses and CXLs, with chronic exposure at up to 4% of the acceptable daily intake (ADI) for EU uses and up to 30% of the ADI when including CXLs. However, the assessment is limited because key data on the metabolite 2-chlorobenzonitrile (2-CBN) are missing, and the extraction efficiency of analytical methods in high-water and high-acid commodities has not been demonstrated.
The review was triggered by the non-renewal of clofentezine's approval in the EU, which expired on 1 January 2009 and was not renewed in 2023 after EFSA identified the substance as an endocrine disruptor under Regulation (EC) No 1107/2009. Since the active substance is no longer authorised in the EU, the MRL review focuses on import tolerances and CXLs. EFSA collected data from Member States and the UK starting in September 2024, with Spain as the rapporteur Member State submitting a Pesticide Residue Overview File in July 2025. A draft reasoned opinion was circulated in January 2026, and comments were discussed at a peer review experts' meeting in April 2026.
The residue definition for enforcement is proposed as clofentezine for fruit and leafy crops, while for risk assessment two separate definitions are set: clofentezine and 2-CBN. For livestock, the residue definition for enforcement is the sum of clofentezine and 4-hydroxy-clofentezine. Analytical methods are available for most matrices at a limit of quantification of 0.01 mg/kg, but for hops no specific method was submitted. The assessment is considered indicative because studies on the general toxicity and magnitude of 2-CBN in crops are pending. Risk managers must now decide whether to maintain or lower the existing MRLs and CXLs based on the limited data.
The opinion impacts EU importers and traders relying on clofentezine-treated commodities from third countries, as MRLs may be lowered if data gaps are not filled. EU consumers are not at risk according to the indicative assessment, but the uncertainty may prompt stricter limits. National authorities in Member States will need to consider enforcement challenges, particularly for hops and high-water-content commodities. The pesticide industry faces potential loss of market access for clofentezine residues unless additional data are submitted to support existing tolerances.