Sulfuryl fluoride is a new active substance for which, in accordance with Article 6(2) of Council Directive 91/414/EEC3, the United Kingdom received an application from Dow AgroSciences for inclusion in Annex I to Directive 91/414/EEC. Complying with Article 6 of Directive 91/414/EEC, the completeness of the dossier was evaluated and confirmed by Commission Decision 2003/305/EC4. Following the agreement between the Commission of the European Communities (hereafter referred to as ' the Commission') and the EFSA for the EFSA to organise a peer review of those new active substances for which the decision on the completeness of the dossier had been published after June 2002, the designated rapporteur Member State (RMS), the United Kingdom, made the report of its initial evaluation of the dossier on sulfuryl fluoride, hereafter referred to as the Draft Assessment Report (DAR), available on 29 October 2004. The peer review was initiated on 9 November 2004 by dispatching the DAR for consultation of the Member States and the applicant. Subsequently, the comments received on the DAR were examined by the RMS and the need for additional data was agreed in an evaluation meeting on 28 September 2005. Remaining issues as well as further data made available by the applicant upon request were evaluated in a series of scientific meetings with Member State experts in September 2006. A final discussion of the outcome of the consultation of experts took place with representatives from the Member States on 27 September 2007, leading to the conclusions as laid down in this report. The conclusion was reached on the basis of the evaluation of the representative uses as an insecticide, comprising application as a fumigant in food storage to control all life stages of arthropods (e.g. meal moth, flour and grain beetles) in emptied flour mills and empty grain storage facilities at maximum concentrations of 128 g/m(3) (CTP = 1500 (Concentration X Time Product)). Details of the applications and timings can be found in the list of end points. The uses submitted in the DAR on dried fruit and tree nut commodities were withdrawn by the applicant for the EU evaluation. The representative formulated product for the evaluation was 'ProFume', a gas (GA), registered under different trade names in Europe. The formulation contains 99.4% w/w sulfuryl fluoride pure (the technical active substance is the product). Analytical methodology is available for the determination of the active substance and the impurities in the technical material as manufactured and for the active substance in the formulation, which is in practice the technical material. Several methods are available to monitor the compounds given in the respective residue definitions for food of plant origin, in blood and urine, however additional data may be required after the finalization of the residue definitions in the different matrices. A data gap was identified for a method for residues in air. With regard to mammalian toxicity, sulfuryl fluoride has been classified (29th ATP, Commission Directive 2005/73/EC5) as T; R23 'Toxic by inhalation' based on reported deaths in humans. In addition, the experts' meeting proposed classification as T; R25 'Toxic if 'wallowed' and Xi; R37 'Irritating to the respiratory system'. It was also classified as Harmful; R48/20 'Danger of serious damage to health by prolonged exposure/ inhalation route'. The relevant short-term exposure No Observed Adverse Effect Levels (NOAELs) are 30 ppm in mice and rabbits, 20 ppm in dogs and 100 ppm in rats based on slight renal hyperplasia and mineralisation at 300 ppm. In rats and mice the longterm NOAEL is 20 ppm. Sulfuryl fluoride does not show any genotoxic or carcinogenic potential. It is not a reproductive or developmental toxicant. In multigeneration studies the parental NOAEL was 5 ppm while the NOAEL in offspring was 20 ppm based on reduced growth during lactation at 150 ppm. The lowest relevant developmental NOAEL is 75 ppm, from the rabbit study. The NOAEL for the acute study in rats is 300 ppm. The Acceptable Daily Intake (ADI) is 0.014 mg/kg bw/day, based on the long term toxicity study in rats, with a safety factor of 100. The Acute Reference Dose (ARfD) is 0.7 mg/kg bw and the Acceptable Operator Exposure Concentration (AOEC) resulted in 1 ppm. For the bystander exposure assessment, an AOEC of 3 ppm was set. The RMS proposed that operators introducing fumigant or carrying out tasks associated with the aeration procedure should wear suitable respiratory protective equipment. Based on the available data, a 10 metre exclusion zone around the fumigated structure was considered to protect unprotected persons (i.e. bystanders) from levels of sulfuryl fluoride above 3 ppm. Metabolism studies that address the nature of the residues on food commodities upon fumigation with sulfuryl fluoride were not submitted. Therefore it was discussed by experts whether the metabolism or mode of degradation, respectively, of sulfuryl fluoride in food and feed commodities was sufficiently addressed and whether there was satisfactory proof from the information and papers submitted, that the proposed breakdown mechanism is identical in all matrices as suggested by the applicant. The experts concluded that the available information is not sufficient to assess the involved reactions, to verify the reported results and to confirm that sulfuryl fluoride and free fluoride ion will be the only relevant residues the consumer may be exposed to. Therefore the consumer risk assessment, mainly with regard to the nature of the residue, cannot be finalised. Even though uses on the fumigation of food items (dried fruits, nuts) were withdrawn during the peer review procedure and only uses for structural treatments remain, 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 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. Sulfuryl fluoride is a gas under all environmental conditions (boiling point -54 degrees C). The vapour pressure is deemed to be high according to the available data. Potential degradation routes for sulfuryl fluoride were analysed in the DAR. All routes were considered negligible except the chemical hydrolysis that may occur in ocean waters. The initial assessment of the fate and behaviour of sulfuryl fluoride in the environment was based on a limited set of experimental data (essentially limited to the physical and chemical properties of the substance) and a number of assumptions and indirect information (such as production figures and atmospheric half-life) that were used as input parameters in the fugacity models employed for the assessment of the fate and behaviour of the substance at global scale. Assessment of the fate and behaviour of sulfuryl fluoride at the field scale level was not presented by the applicant in the initial submission. Also the fate and behaviour of hydrolysis transformation products was not addressed. A number of data gaps were identified in the early stages of the peer review to properly document the information used in the assessment. One of the key parameters used in the assessment is the atmospheric lifetime. The value used by the applicant was derived from a presumed monitored tropospheric concentration only available by a personal communication of one of the scientists involved. The experts' meeting considered that the data provided were not sufficiently documented for regulatory purposes and identified a data gap for the determination of atmospheric lifetime. At the experts' meetings (PRAPeR 02 and 03) on environmental fate and behaviour and ecotoxicology, respectively, the RMS was asked to undertake further assessments: in particular on wet deposition and the potential for contamination of soil and water by metabolites of sulfuryl fluoride; to evaluate field-scale PEC values in soil and surface water close to treated installations and revised fugacity modelling to calculate global-scale PECs in soil, water and air. Additional estimates were also requested for global warming potential (GWP), based on worst case atmospheric lifetime and anticipated sales volumes. These points have been largely addressed by the RMS in addendum 3 of May 2007 based on the information provided by the applicant. However, the assessment provided by the applicant and presented by the RMS in the addendum did not strictly follow the scenario approach proposed by the experts' meeting ( only lifetime of 4.5 yr was used and production figures were generally limited to historical records from 1992-2000) and did not take into consideration most recent information available at the time on the occurrence of sulfuryl fluoride in the atmosphere. This information is crucial since it supersedes the information used by the applicant to estimate the atmospheric lifetime of the substance on which most of the fate and behaviour assessment of sulfiryl fluoride is based. As a consequence, EFSA had redone parts of the modelling presented by the applicant and the RMS in addendum 3 of May 2007. The most relevant results are presented in the EFSA conclusion, and the background input parameters and calculations are documented in the EFSA addendum of July 2007. With respect to the field scale assessment, EFSA did a preliminary sensitivity analysis of the assumptions used in the field scale soil assessment (based on LEVEL I fugacity model) and added some considerations to address the transformation products of sulfuryl fluoride at field scale. Neither the RMS addendum 3 nor the EFSA addendum has been peer reviewed. A number of data gaps were identified during the peer review. The main areas of concern from the fate and behaviour point of view are the high uncertainty associated with the atmospheric lifetime (best available estimate was about 15 yr) and the intrinsic global warming potential that needed to be re-calculated. At the time of finalising this conclusion values previously estimated based on measurements of the AGAGE (Advanced Global Atmospheric Gases Experiment) network have been refined and a longer atmospheric lifetime than previously reported is recently quoted in the scientific literature (36 +/- 11 yr). Based on these recent data, a GWP of 4780 for the 100 years horizon has been published. Sulfuryl fluoride is very toxic to aquatic organisms. However, due to the specific use and the physicalchemical properties of the substance, exposure of non-target organisms is considered negligible and hence the risk to non-target organisms is considered to be low.
