Evaluation of confirmatory data following the Article 12 MRL review and setting of an import tolerance for fluopyram in limes

Abstract

The applicant Bayer AG Crop Science Division submitted a request to the competent national authority in Germany to evaluate the confirmatory data for the active substance fluopyram that were identified in the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005. Within the same submission, the applicant also requested, in accordance with Article 6 of Regulation (EC) No 396/2005, to set an import tolerance for fluopyram in limes. To address the Article 12 data gaps, new residue trials on lemons, tomatoes, melons, escaroles, land cresses and leeks were submitted. The additional trials on grapefruits and oranges were included as well although not required. No new residue trials were submitted to support tentative MRLs for bananas, Chinese cabbage/pe-tsai, spinaches chards/beet leaves and globe artichokes. The new information provided, together with the assessment of alternative GAPs, enabled the derivation of revised MRLs. In the result of the assessment, the tentative MRLs were confirmed for grapefruits, oranges, lemons, mandarins, bananas and tomatoes. Moreover, lower MRLs were derived for spring onions, melons and watermelons, globe artichokes and leeks, while higher MRLs were derived for escaroles, land cresses and red mustards. In the absence of supporting data, and in line with the rotational crop assessment performed in the MRL review, an MRL of 0.15 mg/kg remains supported for Chinese cabbages/pe-tsai, spinaches and chards/beet leaves. The available residue data enabled the derivation, by extrapolation, of an import tolerance MRL of 0.9 mg/kg for limes. A revision of the consumer risk assessment for fluopyram was performed, and a consumer concern was not identified.