Fluoride Action Network

EU: Sulfuryl fluoride. Technical report on the outcome of the consultation on the risk assessment

Source: European Food Safety Authority | October 13th, 2015
Location: European Union
Industry type: Pesticides

Title of report: Technical report on the outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfuryl fluoride in light of confirmatory data.

Unlike the U.S., where sulfuryl fluoride fumigation is used directly on all post-harvest food stored in warehouses and mills, it was approved for use in the EU as a structural fumigant in empty grain stores and flour mills. As noted in a 2010 EFSA report (Conclusion on the peer review of the pesticide risk assessment of the active substance sulfuryl fluoride): “… there is still the potential for consumer exposure to inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Available data show that high fluoride residue levels in flour and bran occurred after the production in a treated mill structure had been taken up again. Therefore measures to avoid contaminated cereal products getting into the food chain are necessary if, in practice, contamination cannot be avoided. The RMS [rapporteur Member State] suggested separate MRLs for fluoride ion  should be proposed based on background levels. However, there are currently no agreed acceptable fluoride background levels in food products in the EU and therefore the allocation of an adequate MRL for fluoride might be difficult. Any higher MRL than at natural background levels would trigger a consumer exposure and risk assessment. It is noted that such assessment will also need to consider other sources of fluoride exposure.”

Summary: 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/m 3 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 accu

– END –

Some comments:

EFSA: RMS has thoroughly summarized and discussed new available data on  atmospheric monitoring of sulfuryl fluoride.  Available data seems to confirm  atmospheric lifetime of sulfuryl fluoride falls in the upper limit of those already  considered in sulfuryl fluoride EU evaluation as plant protection active substance (DAR, Addendum and EFSA conclusion), being expected to be ca 36 years. However, uncertainty associated to this estimations remains high, since the  amount of  emissions is not known with precision. As a matter of fact, the most relevant  information is that concentration of sulfuryl fluoride in the troposphere, being still low (in the range of 2 pptv) has continued to increase since its approval for uses as  pesticide in EU.  The intrinsic global warming potential of sulfuryl fluoride has been also confirmed by recent data and assessments (including  IPCC reports). In conclusion EFSA agrees with the RMS proposal that conditions set at the time of  Annex I inclusion should be maintained (eg. updated data on monitoring of sulfuryl  fluoride in the atmosphere needs to be provided regularly by the notifier in order to have more precise estimations of atmospheric lifetime and GWP). Also critical areas of concern and issues that could not  be finalized at the time of publishing EFSA conclusion of sulfuryl fluoride can still be considered to be critical areas of concern  and open issues. No precise data on emission (based on sulfuryl fluoride sales) has yet been provided by the applicant (not even under the confidentiality clause). Without having this information in a regular basis, it is not possible to obtain more precise calculations of atmospheric lifetime and GWP. Applicant claimed that a plateau of emissions will be reached by 2015; however, there is no data that can allow to independently confirm this. On the contrary, it may be expected that emissions will keep increasing as long as new authorizations for sulfuryl fluoride are granted (in terms of uses and geographically).