Outcome of the Public Consultation on the draft conclusions and recommendations on Threshold of Toxicological Concern (TTC) approach

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. Foramsulfuron 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), Finland, and co-rapporteur Member State (co-RMS), Slovakia, received an application from Bayer CropScience AG for the renewal of approval of the active substance foramsulfuron. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co-RMS, the European Commission and the European Food Safety Authority (EFSA) about the admissibility.

The RMS provided its initial evaluation of the dossier on foramsulfuron in the renewal assessment report (RAR), which was received by EFSA on 26 March 2015. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Bayer CropScience AG, for comments on 22 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 23 June 2015.

Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicant, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues and ecotoxicology.

In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether foramsulfuron 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.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of foramsulfuron as a herbicide on maize, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.

Sufficient efficacy data were provided to support the representative use.

In the area of identity, physical/chemical/technical properties and methods of analysis data gaps were identified for a method of analysis for AE F130619 in drinking water and for foramsulfuron in body fluids and tissues.

In the area of mammalian toxicology, two data gaps have been identified: the first one for further assessment of the toxicological relevance of the impurities in the technical specification, and the second one for further assessment of the toxicological properties of the metabolite AE F092944.

In the area of residues, data gaps have been identified for storage stability data in support of the residue trials, data to support the assumption that relevant residues of foramsulfuron will be negligible in pollen and bee products, and for the submission of publications identified as relevant in the public literature search. It is also requested that in view of the multiple possible sources of dietary exposure a comprehensive assessment of the metabolite AE F092944 – a common metabolite to a great number of pyrimidinylsulfonylurea herbicides – is made, including clarification with regard to the toxicological properties of AE F092944. The risk assessment has been conducted for foramsulfuron residues alone, and chronic exposure from the representative use in maize is well below 1% of the ADI.

The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level, with the notable exception that a data gap was identified for information on the effect of water treatment processes on the nature of residues of both the active substance and its identified metabolites potentially present in surface and groundwater, when surface water or groundwater are abstracted for drinking water. This gap leads to the consumer risk assessment from the consumption of drinking water being not finalised for all the representative uses. Another data gap was identified for reliable field DT50 and DT90 estimates from three different field trial sites for metabolite AE F092944.

A high risk to aquatic organisms was indicated in 4/8 FOCUS surface water scenarios for both uses. Risk mitigation measures were necessary to indicate a low risk to aquatic organisms for the remaining FOCUS surface water scenarios. As metabolite AE F130619 is of comparable toxicity to aquatic plants to foramsulfuron risk assessment considering combined exposure was considered necessary. However, the available assessment was not sufficient and therefore data gap and an issue that could not be finalised were identified. Using the EFSA (2013) guidance document, a low risk to honeybees (acute, chronic and larvae) was concluded for exposure to foramsulfuron via residues in nectar and pollen. No risk assessment was available to address the risk to honeybees from sublethal effects (HPG) (data gap), accumulative effects, consumption of contaminated water (data gap) and pertinent metabolites (data gap). A low risk was concluded for birds, wild mammals, non-target arthropods, soil organisms, non-target terrestrial plants (assuming risk mitigation measures) and sewage treatment organisms. Furthermore, a data gap was identified in the area of ecotoxicology for a detailed evaluation of the available search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites.

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• Source: EFSA scientific publications