The European Unionan Food Safety Authority (EFSA) has issued a positive scientific assessment regarding proposed changes to maximum residue levels (MRLs) for the fungicidal active substance prothioconazole in a range of agricultural commodities.
The assessment follows an application submitted by Sipcam Oxon SpA under Article 6 of Regulation (EC) No 396/2005 to the competent national authority in Greece. The request sought to modify existing MRLs for prothioconazole in several crops.
Crops Covered by the Application
Based on the data submitted, EFSA confirmed that sufficient information was available to derive MRL proposals for:
Pome fruits
Apricots
Cherries
Plums
Cucurbits with edible peel
Cucurbits with inedible peel
Rice
Analytical and Enforcement Aspects
EFSA confirmed that:
Adequate analytical enforcement methods are available for all relevant plant matrices.
Residues of prothioconazole can be reliably controlled at a validated limit of quantification (LOQ) of 0.01 mg/kg, ensuring effective regulatory monitoring.
Consumer Risk Assessment
EFSA conducted both short-term (acute) and long-term (chronic) dietary exposure assessments, taking into account:
Residues of prothioconazole
Relevant triazole derivative metabolites (TDMs)
The intended agricultural practices reported by the applicant
Based on the risk assessment outcomes, EFSA concluded that:
Consumer exposure is unlikely to pose a risk to human health
Both acute and chronic intake estimates remain within toxicological reference values
Regulatory Implications
The EFSA opinion provides the scientific basis for the European Unionan Commission and Member States to proceed with the proposed MRL amendments. Once adopted, the revised MRLs will be incorporated into Annexes of Regulation (EC) No 396/2005, supporting continued use of prothioconazole in the assessed crops while maintaining a high level of consumer protection.