The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA’s scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for sulfuryl fluoride are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State the United Kingdom and presents EFSA’s scientific views and conclusions on the individual comments received.
Sulfuryl fluoride was included in Annex I to Directive 91/414/EEC on 1 November 2010 by Commission Directive 2010/38/EU, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. It was a specific provision of the approval that the applicant was required to submit to the European Commission further studies on the mill processing conditions necessary to ensure that residues of fluoride ion in flour, bran and grain do not exceed the natural background levels; on tropospheric concentrations of sulfuryl fluoride. Measured concentrations should be updated regularly. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air); and on estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario, with respect to the global warming potential (GWP) by 31 August 2012.
In accordance with the specific provision, the applicant, Dow AgroSciences, submitted an updated dossier in August 2012, which was evaluated by the designated rapporteur Member State (RMS), the United Kingdom, in the form of an addendum to the draft assessment report. In compliance with guidance document SANCO 5634/2009-rev.6.1, the RMS distributed the addendum to Member States, the applicant and EFSA for comments on 4 June 2015. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 4 September 2015. EFSA added its scientific views on the specific points raised during the commenting phase in column 4 of the reporting table.
The current report summarises the outcome of the consultation process organised by the RMS, the United Kingdom, and presents EFSA’s scientific views and conclusions on the individual comments received.
In the section on residues, several comments received indicate that there are doubts whether the confirmatory data requirement can be regarded as addressed by the current submission. It was expressed, that further considerations and discussions are probably necessary. The rapporteur Member State does not share the view of EFSA and the commenting Member States.
With respect to fate and behaviour, EFSA agrees with the RMS proposal that conditions set at the time of Annex I inclusion should be maintained. No precise data on emission (based on sulfuryl fluoride sales) have been provided by the applicant. Without having this information on a regular basis, it is not possible to obtain more precise calculations of atmospheric lifetime and global warming potential. The confirmatory data requirement cannot be considered fully addressed since further monitoring of atmospheric sulfuryl fluoride must be provided by the applicant to address its potential accumulation into the atmosphere and its effects as greenhouse gas.
Background documents are available in the Register of Questions