The European Food Safety Authority was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of isoxaflutole as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, in accordance with Article 4 (7) This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.Evaluation of data on isoxaflutole to control a serious danger to plant health The European Food Safety Authority (EFSA) finalised the conclusion on the peer review of the pesticide risk assessment of isoxaflutole in February 2016 (EFSA, 2016a). Furthermore, EFSA finalised the peer review in light of negligible exposure data in February 2017 (EFSA, 2017a).In 2016, during the peer review, EFSA proposed to classify isoxaflutole as carcinogenic category 2 (C2) and considering the harmonised classification as toxic for reproduction category 2 (R2) (EFSA, 2016a). A critical area of concern was identified with regard to the approval criteria of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 interim provisions for active substances that shall be considered to have endocrine disrupting properties.The applicant Bayer Crop Science requested derogation in accordance with the provisions of Article 4(7) of Regulation (EU) No 1107/2009, submitting evidence regarding the necessity of isoxaflutole to control a serious danger to plant health which cannot be contained by other available means. In January 2016, the European Commission requested EFSA to provide scientific assistance as regards the consideration of evidence that the application of an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including nonchemical methods. In order to address this request, EFSA set up a working group (WG) to develop a specific methodology for the assessment of herbicide active substance (a.s.). The protocol on the methodology was published on 2 August 2016 (EFSA, 2016b).Subsequently, the applicant was requested by the European Commission to re-submit the data following the methodology developed by EFSA. On 15 December 2016, EFSA received the updated dossier provided by the applicant, consisting of a data collection set and a report (Bayer, 2016). The applicant, included claims that the use of isoxaflutole is considered essential in accordance with Article 4(7) of Regulation (EC) No 1107/2009 in relation to the uses authorised in 17 Member States (MS).As following step, EFSA launched a commenting phase in January-March 2017 asking all MS to confirm that the uses for which the applicant requested Article 4(7) derogat...
