Evaluation of confirmatory data following the Article 12 MRL review for fluroxypyr

fluroxypyr, confirmatory data, pesticide, MRL review, risk assessment
First published in the EFSA Journal
17 September 2019
20 August 2019
Reasoned Opinion


The applicant Dow AgroSciences submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for fluroxypyr in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a method of analysis for plant matrices, information on metabolism in onions, revised Good Agricultural Practices (GAPs) and reside trials on apples, onions and grass, argumentation regarding the efficiency of the hydrolysis step and information on storage stability in plant matrices and products of animal origin were submitted. A ruminant metabolism study with fluroxypyr‐meptyl was available and evaluated. Toxicological information on metabolites identified in the ruminant metabolism study (i.e. fluroxypyr pyridinol and its conjugates) is required to derive a final residue definition for livestock. EFSA recommends reconsideration of the existing MRLs for several plant and animal commodities.

European Food Safety Authority
pesticides.mrl [at] efsa.europa.eu
EFSA Journal 2019;17(9):5816
Question Number
On request from
European Commission

Background documents