Commission Implementing Regulation (EU) No 844/2012 (hereinafter referred to as ‘the Regulation’) lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012. Isoxaflutole is one of the active substances listed in Regulation (EU) No 686/2012.
In accordance with Article 1 of the Regulation, the rapporteur Member State (RMS), Italy, and co-rapporteur Member State (co-RMS), Slovenia, received an application from Bayer Crop Science for the renewal of approval of the active substance isoxaflutole. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the RMS received an MRL application from Bayer Crop Science to set an import tolerance for the active substance isoxaflutole in soya bean grown in USA. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co-RMS (Slovenia), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.
The RMS provided its initial evaluation of the dossier on isoxaflutole in the renewal assessment report (RAR), which was received by EFSA on 28 January 2015. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Bayer Crop Science, for comments on 16 April 2015. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 17 June 2015.
Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicants and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour and ecotoxicology.
In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether isoxaflutole can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council and give a reasoned opinion concerning MRL applications as referred to in Article 10(1) of Regulation (EC) No 396/2005 as part of this conclusion.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of isoxaflutole as a herbicide on maize and sweet corn, as proposed by the applicant. The import tolerance was assessed for the use in soya bean grown in USA. Full details of the representative uses and the proposed MRLs can be found in Appendix A of this report.
The use of isoxaflutole according to the representative uses proposed at EU level results in a sufficient herbicidal efficacy against the target weeds.
In the area of identity, physical/chemical/technical properties and methods of analysis, data gaps were identified for monitoring analytical methods for plants and body fluids and tissues.
For mammalian toxicology, considering the harmonised classification of isoxaflutole for reproductive toxicity category 2 and the classification proposed by the peer review as carcinogen category 2, a critical area of concern was identified with regard to Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 interim provisions for active substances that shall be considered to have endocrine disruption properties. The RMS disagreed with the classification of isoxaflutole as carcinogen category 2. According to the current state of scientific knowledge, evidence of clear endocrine disrupting potential was not identified from the available studies and additional studies were not considered necessary.
The consumer risk assessment could not be finalised since the nature of RPA 203328 residues in processed commodities was not addressed. Also, the consumer risk assessment from consumption of drinking water could not be finalised whilst the nature of residues in drinking water following water treatment had not been addressed. Finally, a data gap was identified for the determination of the residues in pollen and bee products.
The applicant submitted an MRL application to set an import tolerance for the active substance isoxaflutole in soya bean grown in USA. However, this import tolerance request was not considered in the consumer risk assessment in addition to the representative uses since evidence of the registration of isoxaflutole for the use on soya bean in the country of origin was not available.
The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses, with the notable exception that information was not available regarding the effect of water treatment processes on the nature of residues that may be present in surface water and groundwater at the point of abstraction for drinking water purposes. This results in it not being possible to finalise the consumer exposure assessment. The available groundwater exposure assessment for these representative uses indicated that the herbicidally active and groundwater toxicologically relevant metabolite RPA 202248 would be expected to exceed the parametric drinking water limit of 0.1 µg/L in geoclimatic situations represented by more than half (5 out of 8) FOCUS groundwater scenarios. This has led to the identification of a critical area of concern.
In the area of ecotoxicology, data gaps have been identified regarding the risk assessments for mammals, aquatic organisms and bees. A high risk for long term dietary exposure for wild mammals was indicated for both representative uses.