Renewal of approval of the active substance isoxaflutole

(1)

Commission Directive 2003/68/EC (2) included isoxaflutole as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance isoxaflutole as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 July 2019.

(4)

An application for the renewal of the approval of isoxaflutole was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 28 January 2015.

(7)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)

On 18 February 2016, the Authority communicated to the Commission its conclusion (6) on whether isoxaflutole can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented an initial draft renewal report for isoxaflutole to the Standing Committee on Plants, Animals, Food and Feed on 12 July 2016.

(9)

As regards the new criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (7), which became applicable on 10 November 2018, the conclusion of the Authority infers that while no specific studies were available for non-target organisms, it is highly unlikely that isoxaflutole is an endocrine disrupter based on the scientific evidence and that no additional studies are considered necessary. Thus, the Commission considers that isoxaflutole is not to be considered as having endocrine disrupting properties.

(10)

It has been established with respect to one or more representative uses of at least one plant protection product containing isoxaflutole that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(11)

The risk assessment for the renewal of the approval of isoxaflutole is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing isoxaflutole may be authorised. It is therefore appropriate not to maintain the restriction to use as a herbicide. It is therefore appropriate to renew the approval of isoxaflutole.

(12)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

(13)

The Commission considers that isoxaflutole does not have endocrine disrupting properties based on the available scientific information summarised in the conclusion of the Authority. However, in order to increase the confidence in this conclusion, the applicant should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 and in accordance with the guidance for the identification of endocrine disruptors (8).

(14)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(15)

This Regulation should apply from the day after the date of expiry of the approval of the active substance isoxaflutole.

(16)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,