EU approves Mitsui Chemicals' fungicide penthiopyrad

The European Commission has proposed to approve Mitsui Chemicals’ fungicide penthiopyrad under the EU plant protection regulation (1107/2009). It will be formally included in Annex I on May 1, 2014 and will expire on April 30, 2024.

The Commission requires that member states shall pay particular attention to the protection of operators and workers; the risk to aquatic and soil organisms; the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; the level of residues in rotational crops following consecutive application of the active substance over several years.

In addition, the applicant is required to submit confirmatory information as regards:

(1) the non-relevance of metabolite M11 (3-methyl-1-{3-[(1-methyl-3- trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2- yl}pentanoic acid) for groundwater with the exception of evidence related to the risk of carcinogenicity, which is dependent on the classification of the parent and specified separately at (3) below; (2) the toxicological profile and the reference values of the metabolite PAM; (3) the relevance of the metabolites M11 (3-methyl-1-{3-[(1-methyl-3- trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2- yl}pentanoic acid), DM-PCA (3-trifluoromethyl-1H-pyrazole-4- carboxylic acid), PAM (1-methyl-3-trifluoromethyl-1H-pyrazole-4- carboxamide) and PCA (1-methyl-3-trifluoromethyl-1H-pyrazole-4- carboxylic acid) and their risk to contaminate groundwater, if penthiopyrad is classified under Regulation (EC) No 1272/2008 as carcinogenic cat. 2.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) and (2) by 30 April 2016 and the information set out in point (3) within six months from the notification of the classification decision concerning penthiopyrad.