Note from Fluoride Action Network
The brain is the main target of Sulfuryl fluoride.
Review of the existing maximum residue levels for sulfuryl fluoride according to Article 12 of Regulation (EC) No 396/2005
According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sulfuryl fluoride. To assess the occurrence of sulfuryl fluoride and fluoride ion residues in plants, processed commodities and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRLs were calculated, but a consumer risk assessment could be carried out for sulfuryl fluoride only. Although no apparent risk to consumers was identified for sulfuryl fluoride, a standard consumer risk assessment to fluoride ion could not be performed, lacking information on the toxicological reference values for fluoride. Hence, an ‘overall’ consumer risk assessment could not be performed, only tentative MRLs proposal could be derived and measures for reduction of the consumer exposure should also be considered. Nevertheless, considering that fluoride ion is naturally occurring in food of plant and animal origin, EFSA performed an indicative calculation of the consumer exposure to estimate whether the uses currently authorised will contribute significantly to the overall consumer exposure to fluoride.
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.
As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, the European Food Safety Authority (EFSA) is required to provide a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance in compliance with Article 12(1) of the aforementioned regulation.
As the basis for the MRL review, on 18 March 2019, EFSA initiated the collection of data for this active substance. In a first step, Member States and the United Kingdom were invited to submit by 17 April 2019 their national Good Agricultural Practices (GAPs) in a standardised way, in the format of specific GAP forms, allowing the designated rapporteur Member State, Austria, to identify the critical GAPs in the format of a specific GAP overview file. Subsequently, Member States were requested to provide residue data supporting the critical GAPs, within a period of 1 month, by 8 September 2019. On the basis of all the data submitted by Member States, the United Kingdom and by the European Union Reference Laboratories for Pesticides Residues (EURLs), EFSA asked the rapporteur Member State (RMS) to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report, together with Pesticide Residues Intake Model (PRIMo) calculations and an updated GAP overview file were provided by the RMS to EFSA on 12 December 2019. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS, if any, has been compiled in the completeness check report.
Based on the information provided by the RMS, Member States, the United Kingdom and the EURLs, and taking into account the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the MRLs established by the Codex Alimentarius Commission, EFSA prepared in May 2020 a draft reasoned opinion, which was circulated to Member States and EURLs for consultation via a written procedure. All comments received by 22 June 2020 were evaluated by EFSA. As comments received triggered significant modifications of the assessment, the revised reasoned opinion was further circulated for a second commenting via a written procedure. The additional comments received by 27 November 2020 were evaluated by EFSA and considered during the finalisation of the reasoned opinion. The following conclusions are derived.
The nature of sulfuryl fluoride in plant commodities was not investigated in metabolism studies. Instead, information from public literature on the mode of degradation of sulfuryl fluoride in several food commodities was available. However, this information was considered not sufficient to fully elucidate the nature of the residues expected in food matrices upon fumigation. Tentative residue definitions for enforcement and risk assessment were proposed, i.e. sulfuryl fluoride and fluoride ion expressed individually. Depending on the results of the additional studies elucidating the nature of residues in unprocessed products, further information might be required also for processed products (investigation of hydrolytic stability of metabolites identified in treated products); hence, the residue definitions for processed products are also set on a tentative basis. Since sulfuryl fluoride is authorised only as fumigation on the interior of buildings, studies on rotational crops are not relevant.
Fully validated analytical methods are available for the enforcement of the proposed residue definitions in high oil and dry matrices but also in dried fruits at the limits of quantification (LOQs) of 0.004–0.01 mg/kg for sulfuryl fluoride and 0.05–5 mg/kg for fluoride ion. Analytical methods for the enforcement of fluoride ion in acidic and high-water content commodities, in tea, coffee beans, herbal infusions, carobs, hops and spices are not available. According to the EURLs, an LOQ of 0.005 mg/kg for sulfuryl fluoride is achievable in high water, high oil, dry matrices and tea by using a single residue method. An analytical method for the enforcement of fluoride ion is currently not available to the EURLs. An analytical method for the enforcement of the proposed residue definitions in cocoa beans is not available and is still required.
The data from the available residue trials are considered sufficient to calculate MRL and risk assessment values for the first residue definition (i.e. sulfuryl fluoride) for all commodities under evaluation.
As regards the second residue definition (fluoride ion), EFSA considered the results of the trials and the information on the background levels of fluoride naturally occurring in plant commodities. Based on the available data, it was possible to calculate MRL and risk assessment values for all plant commodities, except for dry pulses, oilseeds, oil fruits, coffee beans, carobs, hops, spices and sugar plants for which no information on the background levels nor residue trials were available.
EFSA calculated MRL recommendations for raisins and cereals milling products for further risk management considerations, noting that according to Regulation (EC) No 396/2005, the setting of MRLs is not foreseen for processed products.
Considering the data gaps related to the nature of residues in the treated crops and to sufficiently validated analytical methods for enforcement in cocoa beans, in acidic and high-water content commodities, in tea and in herbal infusions, the missing residue trials on cereals and raisins and pending more detailed information on the residue study on cocoa beans and on the background levels, all calculated MRLs should be considered tentative only.
Sulfuryl fluoride is authorised for use on cereals that might be fed to livestock. Nevertheless, considering that the authorised use is on empty stores and mills and the risk mitigation currently in place, livestock are not expected to be exposed to residues of sulfuryl fluoride and fluoride ion above the LOQ or above the background levels. Therefore, there is no need to further investigate residues in livestock. Regarding background concentrations from other sources than the authorised uses, data from the scientific opinion of the Panel on Dietetic Products, Nutrition and Allergies on fluoride were considered to derive MRLs for animal commodities. Nevertheless, these MRLs should be considered tentative only and should be confirmed by more detailed information on the background levels. Moreover, an analytical method for the enforcement of fluoride ion in animal commodities is not available.
Chronic and acute exposure calculations for all crops reported in the framework of this review were performed using revision 3.1 of the EFSA PRIMo for both sulfuryl fluoride and fluoride ion.
The exposure values calculated were compared with the toxicological reference values for sulfuryl fluoride, derived by EFSA. The highest chronic exposure was calculated for IE adult, representing 4% of the acceptable daily intake (ADI) and the highest acute exposure was calculated for pistachios, representing 4% of the acute reference dose (ARfD). Apart for the MRLs evaluated in the framework of this review, internationally recommended codex maximum residue limits (CXLs) have also been established for sulfuryl fluoride. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out. The highest chronic exposure represented 4% of the ADI (IE adults) and the highest acute exposure amounted to 5% of the ARfD (coconuts).
For fluoride ion, a standard consumer risk assessment could not be performed, lacking information on the toxicological reference values. Nevertheless, considering that fluoride ion is naturally occurring in food of plant and animal origin, EFSA performed an indicative calculation of the consumer exposure to estimate whether the uses currently authorised will contribute significantly to the overall consumer exposure to fluoride ion. According to these indicative calculations, the contribution from the authorised uses and CXLs to the overall fluoride exposure is low (except for the uses on cereals assessed by the JMPR). Nevertheless, an ‘overall’ conclusive consumer exposure assessment for the uses under consideration could not be performed, pending additional information on the toxicological profile of fluoride ion and comprehensive data on background levels for fluoride ion in plant and animal products.
… Only uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures may be authorised insofar:
- these structures are empty; or
- where food or feed commodities are present in a fumigated facility, the users and the food business operators ensure that only the food or feed commodities compliant with the existing maximum residue levels for sulfuryl fluoride and fluoride ion set by Regulation (EC) No 396/2005 of the European Parliament and of the Council may enter the food and feed chain; to this purpose, the users and the food business operators shall fully implement measures equivalent to the HACCP principles as laid down in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council; in particular, the users shall identify the critical control point at which control is essential to prevent maximum residue levels to be exceeded, and establish and implement effective monitoring procedures at that critical control point.