Evaluation of confirmatory data following the Article 12 MRL review for metalaxyl‐M.

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for metalaxyl‐M in the framework of the MRL review under Article 43 and Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps new data regarding analytical methods for enforcement (validation data for hops and cocoa beans, ILV for fat) and several residue trials data supporting adjusted GAPs for metalaxyl‐M on apples, pears, broccoli, cauliflower, herbs and edible flowers, soya beans and cocoa beans were submitted. Two data gaps concerning analytical methods for enforcement (validation data for hops and cocoa beans, ILV for fat) were considered satisfactorily addressed. However, the data gap on validation of the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock was not addressed. The data gap for residue trials supporting authorisations of metalaxyl‐M was partially addressed. The data gap for residue trials supporting authorisations of metalaxyl was not addressed. The new information provided may require a revision of the existing MRLs for several commodities of plant and animal origin. Further risk management considerations are required. [ABSTRACT FROM AUTHOR]