Conclusion on the peer review of the pesticide risk assessment of the active substance triasulfuron 1

Transcription

1 EFSA Journal 2015;13(1):3958 CONCLUSION ON PESTICIDE PEER REVIEW Conclusion on the peer review of the pesticide risk assessment of the active substance triasulfuron 1 ABSTRACT European Food Safety Authority 2 European Food Safety Authority (EFSA), Parma, Italy The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France and the co-rapporteur Member State Denmark for the pesticide active substance triasulfuron are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative use of triasulfuron as a herbicide on winter cereals. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. European Food Safety Authority, 2015 KEY WORDS triasulfuron, peer review, risk assessment, pesticide, herbicide 1 On request from the European Commission, Question No EFSA-Q , approved on 12 December Correspondence: pesticides.peerreview@efsa.europa.eu Suggested citation: EFSA (European Food Safety Authority), Conclusion on the peer review of the pesticide risk assessment of the active substance triasulfuron. EFSA Journal 2015;13(1):3958, 78 pp. doi: /j.efsa Available online: European Food Safety Authority, 2015

2 SUMMARY Commission Regulation (EU) No 1141/2010, as amended by Commission Implementing Regulation (EU) No 380/2013, (hereinafter referred to as the Regulation ) lays down the procedure for the renewal of the approval of a second group of active substances and establishes the list of those substances. Triasulfuron is one of the active substances listed in the Regulation. The rapporteur Member State provided its initial evaluation of the dossier on triasulfuron in the Renewal Assessment Report (RAR), which was received by the EFSA on 14 October The evaluation of the dossier took place in collaboration with the co-rms Denmark. The peer review was initiated on 28 October 2013 by dispatching the RAR for consultation of the Member States and the applicant Syngenta Ltd. Following consideration of the comments received on the RAR, it was concluded that EFSA should conduct an expert consultation in the areas of mammalian toxicology, fate and behaviour and ecotoxicology and EFSA should adopt a conclusion on whether triasulfuron can be expected to meet the conditions provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and the Council. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of triasulfuron as a herbicide on winter cereals as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report. In the area of Identity, physical/chemical/technical properties and methods of analysis data gaps were identified for various properties of the active substance as well as for tank cleaning procedures. In the mammalian toxicology area, a major concern is represented by the impossibility of setting reference values due to inconclusive genotoxicity assessment (for both triasulfuron and the groundwater metabolite/impurity triazine amine CGA a data gap was set) and consequently to perform the non-dietary risk assessment. In the area of residues and consumer exposure no data gaps were identified however, as no reference values were set a consumer risk assessment could not be conducted. The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses. These assessments identify the critical area of concern that, there is a high potential for 80 th percentile annual average recharge concentrations leaching below 1m depth to be above the parametric drinking water limit of 0.1 µg/l for the parent active substance triasulfuron, in geoclimatic situations that are represented by 8 out of 9 FOCUS groundwater scenarios. The metabolite triazine amine (CGA150829) also indicated a high potential for groundwater exposure above the parametric drinking water limit of 0.1 µg/l in geoclimatic situations represented by the Thiva FOCUS groundwater scenario. This is considered an assessment not finalised, whilst information is outstanding to confirm the relevance (or not) of triazine amine (CGA150829). A critical area of concern was identified as a high risk to aquatic plants from exposure to triasulfuron was indicated for 8/9 FOCUS surface water scenarios even when risk mitigation measures are accounted for. Under acidic conditions, a high risk is indicated in all FOCUS scenarios. A low risk to non-target terrestrial plants was concluded when risk mitigation measures are considered. A low risk to all other groups of non-target organisms was concluded. EFSA Journal 2015;13(1):3958 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Background... 4 The active substance and the formulated product... 6 Conclusions of the evaluation Identity, physical/chemical/technical properties and methods of analysis Mammalian toxicity Residues Environmental fate and behaviour Ecotoxicology Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental compartments Soil Ground water Surface water and sediment Air List of studies to be generated, still ongoing or available but not peer reviewed Particular conditions proposed to be taken into account to manage the risk(s) identified Concerns Issues that could not be finalised Critical areas of concern Overview of the concerns identified for each representative use considered References Appendices Abbreviations EFSA Journal 2015;13(1):3958 3

4 BACKGROUND Commission Regulation (EU) No 1141/ as amended by Commission Implementing Regulation (EU) No 380/ (hereinafter referred to as the Regulation ) lays down the detailed rules for the procedure of the renewal of the approval of a second group of active substances. This regulates for the European Food Safety Authority (EFSA) the procedure for organising the consultation of Member States and the applicant for comments on the initial evaluation in the Renewal Assessment Report (RAR) provided by the rapporteur Member State (RMS), and the organisation of an expert consultation, where appropriate. In accordance with Article 16 of the Regulation, if mandated, EFSA is required to adopt a conclusion on whether the active substance is expected to meet the conditions provided for in Article 4 of Regulation (EC) No 1107/2009 within 6 months from the receipt of the mandate, subject to an extension of up to 9 months where additional information is required to be submitted by the applicant(s) in accordance with Article 16(3). In accordance with Article 4 of the Regulation France (hereinafter referred to as the RMS ) received an application from Syngenta Ltd for the renewal of approval of the active substance triasulfuron. Complying with Article 11 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the Commission and EFSA about the admissibility. The RMS provided its initial evaluation of the dossier on triasulfuron in the RAR, which was received by the EFSA on 14 October 2013 (France, 2013). The evaluation of the dossier took place in collaboration with the co-rms Denmark. The peer review was initiated on 28 October 2013 by dispatching the RAR to Member States and the applicant Syngenta Ltd. for consultation and comments. In addition, the EFSA conducted a public consultation on the RAR. The comments received were collated by the EFSA and forwarded to the RMS for compilation and evaluation in the format of a Reporting Table. The applicant was invited to respond to the comments in column 3 of the Reporting Table. The comments and the applicant s response were evaluated by the RMS in column 3. The need for expert consultation and the necessity for additional information to be submitted by the applicant in accordance with Article 16(3) of the Regulation were considered in a telephone conference between the EFSA, the RMS, and the European Commission on 27 February On the basis of the comments received, the applicant s response to the comments and the RMS s evaluation thereof it was concluded that additional information should be requested from the applicant and the EFSA should organise an expert consultation in the areas of mammalian toxicology, fate and behaviour and ecotoxicology.according to Art. 16(2) of the Regulation t decided to consult the EFSA. The mandate was received on 3 March The outcome of the telephone conference, together with EFSA s further consideration of the comments is reflected in the conclusions set out in column 4 of the Reporting Table. All points that were identified as unresolved at the end of the comment evaluation phase and which required further consideration, including those issues to be considered in an expert consultation, and the additional information to be submitted by the applicant, were compiled by the EFSA in the format of an Evaluation Table. The conclusions arising from the consideration by the EFSA, and as appropriate by the RMS, of the points identified in the Evaluation Table, together with the outcome of the expert consultation where this took place, were reported in the final column of the Evaluation Table. 3 Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances. OJ L 322, , p Commission Implementing Regulation (EU) No 380/2013 of 25 April 2013 amending Regulation (EU) No 1141/2010 as regards the submission of the supplementary complete dossier to the Authority, the other Member States and the Commission. OJ L 116, , p. 4 EFSA Journal 2015;13(1):3958 4

5 A final consultation on the conclusions arising from the peer review of the risk assessment took place with Member States via a written procedure in November/December This conclusion report summarises the outcome of the peer review of the risk assessment on the active substance and the representative formulation evaluated on the basis of the representative uses as a herbicide on winter cereals as proposed by the applicant. A list of the relevant end points for the active substance as well as the formulation is provided in Appendix A. In addition, a key supporting document to this conclusion is the Peer Review Report, which is a compilation of the documentation developed to evaluate and address all issues raised in the peer review, from the initial commenting phase to the conclusion. The Peer Review Report (EFSA, 2014) comprises the following documents, in which all views expressed during the course of the peer review, including minority views, can be found: the comments received on the RAR, the Reporting Table (27 February 2014), the Evaluation Table (10 December 2014) the report(s) of the scientific consultation with Member State experts (where relevant), the comments received on the assessment of the additional information (where relevant), the comments received on the draft EFSA conclusion. Given the importance of the RAR including its addendum (compiled version of November 2014 containing all individually submitted addenda (France 2014)) and the Peer Review Report, both documents are considered respectively as background documents A and B to this conclusion. It is recommended that this conclusion report and its background documents would not be accepted to support any registration outside the EU for which the applicant has not demonstrated to have regulatory access to the information on which this conclusion report is based. EFSA Journal 2015;13(1):3958 5

6 THE ACTIVE SUBSTANCE AND THE FORMULATED PRODUCT Triasulfuron is the ISO common name for 1-[2-(2-chloroethoxy)phenylsulfonyl]-3-(4-methoxy-6- methyl-1,3,5-triazin-2-yl)urea (IUPAC). The representative formulated product for the evaluation was LOGRAN 20WG a water dispersible granule (WG) containing 200 g/kg triasulfuron. The representative uses evaluated comprise outdoor foliar spraying against dicot. weeds in winter cereals Full details of the GAP can be found in the list of end points in Appendix A. It was indicated that a literature search for the active substance had been performed in relation to mammalian toxicity (section 2) and environmental fate and behaviour (section 4). However, a literature search was not provided for the identified metabolites of triasulfuron. Furthermore, a literature search performed in relation to the other sections was not available. Consequently, a data gap was identified for an updated systematic review of the available peer reviewed scientific literature covering both the active substance and its metabolites dealing with side-effects on health, the environment and non-target species.(see section 7). CONCLUSIONS OF THE EVALUATION 1. Identity, physical/chemical/technical properties and methods of analysis The following guidance documents were followed in the production of this conclusion: SANCO/3030/99 rev.4 (European Commission, 2000), SANCO/10597/2003 rev (European Commission, 2012), and SANCO/825/00 rev. 8.1 (European Commission, 2010). The minimum purity of the active substance as manufactured is 940 g/kg. The decision on whether there are relevant impurities is open. The main data regarding the identity of triasulfuron and its physical and chemical properties are given in Appendix A. The data for the following points were considered incomplete and a data gap is identified, melting point, appearance, dissociation constant, flammability, explosive and oxidizing properties, partition coefficient n-octanol/water, relative density, solubility in water, solubility in organic solvents and vapour pressure of the active substance. The information given on the effectiveness of tank cleaning was also incomplete and a data gap was identified. HPLC-UV methods were available to analyse for the active substance in the technical material and formulated product. LC-MS/MS methods were available for plants, soil water and air. A method of analysis for products of animal origin was provided but is not necessary as no MRLs are proposed. The active substance is not classified as a Health Hazard under the CLP Regulation and therefore a method of analysis is not required for body fluids and tissues. 2. Mammalian toxicity The following guidance documents were followed in the production of this conclusion: SANCO/221/2000 rev final (European Commission, 2003), SANCO/222/2000 rev. 7 (European Commission, 2004) and SANCO/10597/2003 rev (European Commission, 2012). Triasulfuron was discussed in the Pesticides Peer Review expert meeting 118 held in September The batches used for toxicity testing contained a higher number of impurities compared to the new proposed specifications. However, waiting for clarifications on the genotoxic potential of the active EFSA Journal 2015;13(1):3958 6

7 substance triasulfuron (see below), which could be in relation to the presence of impurity CGA which was tested at lower levels than the specified ones, the compliance of the batches tested in the mammalian toxicology data package to the newly proposed specification remains to be confirmed. Triasulfuron is rapidly and almost completely absorbed after oral administration; it is uniformly distributed and extensively excreted. It is not acutely toxic via oral, dermal and inhalation routes. The relevant short term toxicity No Observed Adverse Effect Level (NOAEL) is 14.5 mg/kg bw per day based on kidney effects in the rat (atrophy, basophilia, chronic inflammation and hyperplasia), whereas the long term toxicity NOAEL of 1.2 mg/kg bw per day was established based on liver effects in the mouse study (liver centrilobular degeneration/hepatocytomegaly; in rats the NOAEL was 32.1 mg/kg bw per day based on decreased body weight). Triasulfuron did not show any carcinogenic potential; it was negative in the bacterial reverse mutation assay and the mouse lymphoma mutagenicity assay. However, it was found to be clastogenic in vitro after 24h exposure in the absence of metabolic activation. Regarding the impurity profile of the new batch proposed by the applicant, a single impurity tested at the level mg/kg showed positive in clastogenicity in vitro and negative in vivo but it is doubted whether the bone marrow was reached (toxicokinetics data was not available on the impurity); the same applies to the new batch of triasulfuron as a whole that was tested in in vivo micronucleus assay. Based on the uncertainty on the impurity and on the new batch a Comet assay performed with the representative specification with the highest amount of the impurity of potential clastogenic concern should be performed (following the EFSA opinion, EFSA SC, 2011, and the OECD guideline No 489 In vivo mammalian alkaline comet assay, OECD, 2014). Triasulfuron did not show reproductive toxicity effects in the rat (parental, reproductive and offspring NOAEL 50 mg/kg bw per day) and showed decreased foetal weights and delayed ossification at maternally toxic doses in the rabbit (relevant maternal and developmental toxicity NOAEL 100 mg/kg bw per day and 240 mg/kg bw per day, respectively). Based on the open issue on the clastogenic potential of triasulfuron, EFSA considers that it is not possible to set reference values. Therefore EFSA concludes that a risk assessment for dietary and non-dietary exposure cannot be performed. Groundwater metabolite SYN has been subjected to a battery of genotoxicity tests, the results of which indicated it is non-relevant according to the guidance document on relevance of groundwater metabolites. Groundwater metabolite triazine amine (CGA150829) is also an impurity and it was shown to be harmful if swallowed, of low acute toxicity by dermal and inhalation routes, and a skin sensitiser. The potential genotoxicity of CGA was tested in a battery of studies which showed that CGA is positive in vitro and negative in vivo, but it is doubted whether the bone marrow was reached (ADME data was not available on CGA150829). A data gap for the relevance of this metabolite was identified. Regarding the interim provisions of Regulation (EC) No. 1107/2009 for the consideration of potential endocrine disrupting properties, triasulfuron is not classified or proposed to be classified as toxic for reproduction category 2. With regard to the scientific risk assessment, the most frequently occurring tumours were noted in the endocrine tissues and mammary gland. No investigations have been provided to clarify a possible endocrine-mediated mode of action of triasulfuron. In particular, the Level 2 tests, currently indicated in the OECD Conceptual Framework (OECD, 2012), and analysed in the EFSA Scientific Committee Opinion on the hazard assessment of endocrine disruptors (EFSA SC, 2013), are missing (namely oestrogen receptor (ER) and androgen receptor (AR) binding assays, the ER 3transactivation assay (OECD TG 455), the steroidogenesis assay (OECD TG 456) and the aromatase assay, a test for ER agonists and antagonists (OECD TG 457) and assays for thyroid hormone-mediated modalities (though not yet validated)). Therefore, a data gap is identified for investigation of potential endocrine-mediated effects of triasulfuron (see also section 5). 3. Residues The assessment in the residue section below is based on the guidance documents listed in the document 1607/VI/97 rev.2 (European Commission, 1999), and the JMPR recommendations on livestock burden calculations stated in the 2004 and 2007 JMPR reports (JMPR, 2004, 2007). EFSA Journal 2015;13(1):3958 7

8 Primary crop metabolism was investigated for cereals following a broadcast spray application of triasulfuron to wheat. This study indicated that the triasulfuron is degraded, but that there are no metabolites at significant amounts in the study conducted that are of relevance to the GAP. Consequently, the residue definition for enforcement and risk assessment in cereals, covering the authorized uses, is defined as triasulfuron only. Regarding the magnitude of residues in primary crops, a sufficient number of trials complying with the GAP were reported for barley, oats, rye and wheat. Freezer storage stability data were provided that supports the residue trials. A metabolism study is available to address the potential for residues to occur in rotational crops. Upon identification of the residues, the metabolites CGA (triazine amine) and CGA were the major metabolites and present at significant proportions at all PBI. Due to the low levels of individual component residues (< 0.01 mg/kg), it can be concluded that no significant residues will occur in rotational crops. However it is noted, that the data gap for the genotoxic potential of the metabolite CGA (see section 7), even if it is present at levels < 0.01 mg/kg, may trigger the need for further consideration. Studies on the nature and magnitude of residues in commodities of animal origin are not required, following the estimation of the dietary burden arising from the representative uses of triasulfuron. Metabolism data are available for goat and hens and confirm an expectation of insignificant residues. This was also confirmed by animal feeding studies. Since residues in cereal grain do not exceed 0.1 mg/kg processing studies are not required. However four balance processing studies were conducted for the production of oat flakes from grain. Residue levels were below the LOQ (<0.02 mg/kg) in the unprocessed grain and no analyses were completed for the processed commodities to determine Triasulfuron residue levels. A consumer risk assessment cannot be conducted as reference values have not been set (see section 2). 4. Environmental fate and behaviour Triasulfuron was discussed at the Pesticides Peer Review expert meeting 117 in September In soil laboratory incubations under aerobic conditions in the dark, triasulfuron exhibited moderate to medium persistence, forming the major (>10% applied radioactivity (AR)) metabolites triazine amine (CGA150829, max. 27 % AR), CGA (max. 23 % AR) and SYN (max. 17 % AR), which exhibited low to very high, low to moderate and moderate to high persistence, respectively. Mineralisation of the triazinyl and phenyl ring 14 C radiolabels to carbon dioxide accounted for 9-13 % AR after 120 days. The formation of unextractable residues (not extracted by methanol / water buffered with phosphate) for these radiolabels accounted for % AR after 120 days. In a laboratory moist soil photolysis experiment triasulfuron degraded faster than in the dark controls, forming the major metabolite SYN (max. 29 % AR), which exhibited moderate to medium persistence in dark aerobic soil incubations. Triasulfuron and SYN exhibited very high mobility in soil. Triazine amine (CGA150829) exhibited very high to medium soil mobility, CGA exhibited very high to high mobility and SYN exhibited high soil mobility. It was concluded that the adsorption of these compounds was not ph dependent. In field dissipation studies carried out at 5 sites in Germany and 2 in France (spray application to the soil surface on bare soil plots in late spring) where assessment concluded the trials and kinetic fitting could be considered reliable, triasulfuron exhibited moderate persistence on the basis of the dissipationt 50/90 values that were estimated as triggering endpoints as defined by FOCUS (2006) kinetics guidance. These dissipation endpoints would be expected to include photolysis at the soil surface. Sample analyses were only carried out for the parent triasulfuron. Field study DT 50 values were also normalised to FOCUS reference conditions (20 C and PF2 soil moisture) using the time step normalisation procedure in accordance with FOCUS (2006) guidance (excepting the FR2 trial site where errors had been made in the normalisation procedure) with surface process losses including photolysis being excluded using the 10mm rainfall criterion to estimate degradationt 50 values as set out in EFSA PPR EFSA Journal 2015;13(1):3958 8

9 (2010) guidance. The experts at the Pesticides Peer Review 117 meeting agreed that only 3 of the available field studies could be considered to provide robust degradationt 50 endpoints that might be used in FOCUS modelling. If a correct time step normalisation and subsequent evaluation according to EFSA PPR (2010) guidance was provided for the FR2 trial site, it might be that a robust 4 th value would be available. This missing assessment for the FR2 trial site is identified as a data gap in section 7 of this conclusion. In laboratory incubations in dark aerobic natural sediment water systems, triasulfuron exhibited medium to high persistence, forming the major metabolite CGA (max % AR in water). The unextractable sediment fraction (not extracted by methanol / water buffered with phosphate) was a sink for the triazinyl and phenyl ring 14 C radiolabels, accounting for 7 10 % AR at study end (100 days). Mineralisation of these radiolabels accounted for only % AR at the end of the study. In a laboratory sterile aqueous photolysis experiment triasulfuron was transformed to the major metabolite SYN (max. 12.9% AR). The necessary surface water and sediment exposure assessments (Predicted environmental concentrations (PEC) calculations) were carried out for the metabolites triazine amine (CGA150829), CGA195660, SYN and SYN546832, using the FOCUS (FOCUS, 2001) step 1 and step 2 approach (version 2.1 of the Steps 1-2 in FOCUS calculator). For the active substance triasulfuron, appropriate step 3 (FOCUS, 2001) and step 4 calculations were available 5. The step 4 calculations appropriately followed the FOCUS (FOCUS, 2007) guidance, with no-spray drift buffer zones of up to 30 m being implemented for the drainage scenarios (representing a % spray drift reduction), and combined no-spray buffer zones with vegetative buffer strips of up to 20 m (representing a % spray drift reduction and reducing solute flux in run-off by 80 % and erosion flux in run-off by 95%) being implemented for the run-off scenarios. The SWAN tool (version 1.1) was appropriately used to implement these mitigation measures in the simulations. However, risk managers and others may wish to note that whilst run-off mitigation is included in the step 4 calculations available, the FOCUS (FOCUS, 2007) report acknowledges that for substances with K Foc < 2000 ml/g (i.e. triasulfuron), the general applicability and effectiveness of run-off mitigation measures had been less clearly demonstrated in the available scientific literature, than for more strongly adsorbed compounds. The necessary groundwater exposure assessments were appropriately carried out using FOCUS (FOCUS, 2009) scenarios and the models PEARL and PELMO for the active substance triasulfuron and its metabolites triazine amine (CGA150829), CGA195660, SYN and SYN Geomean laboratory degradationt50 values were used as input in all this modelling. As only 3 robust field degradationt50 values were available for parent triasulfuron a longest field value would need to be used in modelling with this field dataset, which returns a value comparable to the geomean laboratory value currently used. The provision of a fourth field value (identified as a data gap in section 7) might allow a geomean field value to be selected or result in the field values being added to the laboratory values, before calculating a geomean, when selecting modelling input in any future groundwater exposure assessment. The available reliable groundwater modelling identifies that for the representative uses being assessed for triasulfuron, there is a high potential for 80 th percentile annual average recharge concentrations leaching below 1m depth to be above the parametric drinking water limit of 0.1 µg/l. It is concluded that this potential is high in geoclimatic situations that are represented by 8 out of 9 FOCUS groundwater scenarios. Only in the geoclimatic situations represented by the Sevilla scenario, might the potential for groundwater exposure by parent triasulfuron be expected to be low. The modelling also indicated a high potential for groundwater exposure above the parametric drinking water limit of 0.1 µg/l for the metabolite SYN in geoclimatic situations represented by 5 out of 9 FOCUS groundwater scenarios with concentrations estimated to be in the range µg/L. However this metabolite was concluded to be nonrelevant (see sections 2 and 6). Finally the modelling also indicated a high potential for 80 th percentile annual average recharge concentrations leaching below 1m depth to be above the parametric drinking 5 Simulations correctly utilised the agreed Q10 of 2.58 (following EFSA, 2007) and Walker equation coefficient of Simulations complied with EFSA, 2004 and correctly utilised the agreed Q10 of 2.58 (following EFSA, 2007) and Walker equation coefficient of 0.7 EFSA Journal 2015;13(1):3958 9

10 water limit of 0.1 µg/l for the metabolite triazine amine (CGA150829) in geoclimatic situations represented by the Thiva FOCUS groundwater scenario, with a concentration estimated to 0.114µg/L. The relevance assessment of groundwater metabolite CGA was not finalised whilst there are still questions over the results of some genotoxicity investigations where this metabolite was dosed (see section 2). The PEC in soil, surface water, sediment, and groundwater covering the representative uses assessed can be found in Appendix A of this conclusion. 5. Ecotoxicology The risk assessment was based on the following documents: European Commission (2002a, 2002b), SETAC (2001), and EFSA (2009). Triasulfuron was discussed at the Pesticides Peer Review meeting 119 (23-25 September 2014). On the basis of the available data and assessments, a low acute and long-term risk to birds and wild mammals from the representative use of triasulfuron was concluded. Suitable data demonstrating the toxicity of triasulfuron to aquatic organisms were available. On the basis of the risk assessment using FOCUS step 1 exposure estimates a low acute and chronic risk to fish, aquatic invertebrates and algae was concluded. Studies investigating the toxicity of triasulfuron to Lemna gibba were available and were discussed at the Pesticides Peer Review meeting 119. The available studies were considered to have a number of weaknesses; nevertheless, the experts agreed that they were sufficient to derive toxicity endpoints for risk assessment. The endpoints from the available studies differed by approximately a factor of five. The experts concluded that this was likely to be due to the different ph level of the test solutions used in the studies. The study performed under acidic conditions (ph at study initiation) gave the lower endpoint. In some circumstances, acidic conditions can be found in agricultural water bodies (Brock et al. (2010)). It was agreed that the risk assessment should be performed using both of the available toxicity endpoints. On the basis of this risk assessment, for alkaline conditions, a high risk to aquatic plants was indicated for 8/9 FOCUS water scenarios even when risk mitigation measures are accounted for. Using the lower endpoint, representative of acidic water, all FOCUS water scenarios indicated a high risk to aquatic plants. Consequentially, a high risk to aquatic plants from the representative use of triasulfuron was concluded. A low risk to aquatic organisms from the metabolites CGA150829, CGA195660, SYN and SYN was concluded. The available data and risk assessments were suitable to conclude a low risk to honeybees and nontarget arthropods. A low risk to earthworms, soil macroorganisms and soil microorganisms was concluded for the active substance and metabolites CGA150829, CGA195660, SYN and SYN The available risk assessment for non-target terrestrial plants indicated a high risk. However, when risk mitigation measures (5 m non-sprayed buffer zone) are taken into account, a low risk was indicated. A low risk to sewage treatment organisms was also concluded. For the ecotoxicological assessments, no studies were available to address the potential endocrine activity of triasulfuron. Pending on the outcome of the data gap in section 2, further ecotoxicological tests might be necessary to address the potential endocrine disrupting properties of triasulfuron. EFSA Journal 2015;13(1):

11 6. Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental compartments 6.1. Soil Compound (name and/or code) Triasulfuron Triazine amine (CGA150829) CGA SYN SYN Persistence Moderate to medium persistence Biphasic kinetics DT days (DT days, 20ºC, pf2 soil moisture) European field dissipation studies biphasic kinetics DT days (DT days) low to very high persistence SFO DT 50 7->1000 days and biphasic kinetics DT days (DT >1000 days), (20ºC 40% to 50% MWHC or pf2 soil moisture) low to moderate persistence SFO DT >30.9 days (20ºC, PF2 soil moisture) moderate to high persistence SFO DT days and biphasic kinetics DT days (DT days), (20ºC, pf2 soil moisture) Moderate to medium persistence SFO DT days and biphasic kinetics DT days (DT days), (20ºC, pf2 soil moisture) Ecotoxicology Low risk to soil dwelling organisms. Low risk to soil dwelling organisms. Low risk to soil dwelling organisms. Low risk to soil dwelling organisms. Low risk to soil dwelling organisms. EFSA Journal 2015;13(1):

12 6.2. Ground water Compound (name and/or code) Mobility in soil >0.1 μg/l 1m depth for the representative uses (at least one FOCUS scenario or relevant lysimeter) Pesticidal activity Toxicological relevance Ecotoxicological activity Triasulfuron Very high mobility K Foc 7-25 ml/g Yes at 8 out of 9 FOCUS groundwater scenarios Yes Yes Yes Triazine amine (CGA150829) Very high to medium mobility K Foc ml/g Yes at 1 out of 9 FOCUS scenarios with the concentration being 0.114µg/L No data. Data gap. To be defined depending on the genotoxicity of triasulfuron and Triazine amine (CGA150829) (Data gaps) No CGA Very high to high mobility K Foc ml/g No No data. Assessment not triggered No data Assessment not triggered No SYN High mobility K Foc ml/g No No No data Assessment not triggered No SYN Very high mobility K Foc 3-14 ml/g Yes at 5 out of 9 FOCUS scenarios with concentrations being µg/L No No (no genotoxicity potential) No EFSA Journal 2015;13(1):

13 6.3. Surface water and sediment Compound (name and/or code) Triasulfuron (water & sediment) Triazine amine (CGA150829) (water & sediment) CGA (water only) SYN (water only) SYN (water only) Ecotoxicology High risk to aquatic plants in 8/9 FOCUS surface water scenarios. Under acidic conditions, a high risk to aquatic plants is indicated in all FOCUS surface water scenarios. A low risk to fish, aquatic invertebrates and algae was indicated. Low risk to aquatic organisms. Low risk to aquatic organisms. Low risk to aquatic organisms. Low risk to aquatic organisms Air Compound (name and/or code) Triasulfuron Toxicology Not acutely toxic via inhalation; LC 50 > 5.2µg/L EFSA Journal 2015;13(1):

14 7. List of studies to be generated, still ongoing or available but not peer reviewed This is a list of data gaps identified during the peer review process, including those areas where a study may have been made available during the peer review process but not considered for procedural reasons (without prejudice to the provisions of Article 56 of Regulation (EC) No 1107/2009 concerning information on potentially harmful effects). An updated search of the scientific peer-reviewed open literature covering both triasulfuron and its metabolites, dealing with side-effects on health, the environment and non-target species, published within the last 10 years before the date of submission of the dossier. (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown). Melting point, appearance, dissociation constant, flammability, explosive and oxidizing properties, partition coefficient n-octanol/water, relative density, solubility in water, solubility in organic solvents and vapour pressure of the active substance (relevant for all representative uses evaluated; some reliable information may be contained in the dossier, but a transparent evaluation of the information available has not been provided by the RMS; see section 1) Data supporting the tank cleaning procedure (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see section 1) A Comet assay with multi-organ approach following the EFSA opinion 2011 and the OECD guideline No 489 In vivo mammalian alkaline comet assay adopted in September 2014; the representative specification should be used with the highest amount of the impurity of potential clastogenic concern (CGA ) (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see section 2) The relevance of the groundwater metabolite CGA (including clarification on the genotoxic potential) needs to be addressed. (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see section 2) Investigation of potential endocrine-mediated effects of triasulfuron (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see section 2 and 5) An acceptable time step normalisation for the field soil dissipation trial site FR2 was not available, there being significant errors in the normalisation that had been provided (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see section 4) Further information to address the risk to aquatic plants (relevant for all representative uses; submission date proposed by the applicant: unknown; see section 5). Assessment of the biological/pesticidal activity of groundwater metabolite CGA (relevant for all representative uses evaluated; submission date proposed by the applicant: unknown; see section 6). 8. Particular conditions proposed to be taken into account to manage the risk(s) identified Under alkaline conditions, a low risk to aquatic plants is indicated in situations only represented by the FOCUS surface water scenario D6 provided that risk mitigation measures equivalent to a 30 m non-sprayed buffer zone are used. Risk mitigation measures such as a 5 m non-sprayed buffer zone are required to protect non-target terrestrial plants. EFSA Journal 2015;13(1):

15 9. Concerns 9.1. Issues that could not be finalised An issue is listed as an issue that could not be finalised where there is not enough information available to perform an assessment, even at the lowest tier level, for the representative uses in line with the Uniform Principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in Commission Regulation (EU) No 546/ and where the issue is of such importance that it could, when finalised, become a concern (which would also be listed as a critical area of concern if it is of relevance to all representative uses). An issue is also listed as an issue that could not be finalised where the available information is considered insufficient to conclude on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of the Regulation. 1. There is a high potential for 80 th percentile annual average recharge concentrations leaching below 1m depth to be above the parametric drinking water limit of 0.1 µg/l for the metabolite triazine amine (CGA150829), in geoclimatic situations that are represented by 1 out of 9 FOCUS groundwater scenarios. The groundwater non relevance assessments for this metabolite could not be finalised with the available toxicological effects and pesticidal activity information Critical areas of concern An issue is listed as a critical area of concern where there is enough information available to perform an assessment for the representative uses in line with the Uniform Principles in accordance with Article 29(6) of Regulation (EC) No. 1107/2009 and as set out in Commission Regulation (EU) No 546/2011, and where this assessment does not permit to conclude that for at least one of the representative uses it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater or any unacceptable influence on the environment. An issue is also listed as a critical area of concern where the assessment at a higher tier level could not be finalised due to a lack of information, and where the assessment performed at the lower tier level does not permit to conclude that for at least one of the representative uses it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater or any unacceptable influence on the environment. An issue is also listed as a critical area of concern the active substance is not expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/ The compliance of the batches tested in the mammalian toxicology data package to the newly proposed specification. 3. The consumer and the non-dietary risk assessments cannot be conducted as toxicological reference values have not been set. 4. Health based reference values could not be set based on the incomplete genotoxicity assessment 5. There is a high potential for 80 th percentile annual average recharge concentrations leaching below 1m depth to be above the parametric drinking water limit of 0.1 µg/l for the parent active substance triasulfuron, in geoclimatic situations that are represented by 8 out of 9 FOCUS groundwater scenarios. 7 Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, , p EFSA Journal 2015;13(1):

16 6. A high risk to aquatic plants was indicated for the representative use Overview of the concerns identified for each representative use considered (If a particular condition proposed to be taken into account to manage an identified risk, as listed in section 8, has been evaluated as being effective, then risk identified is not indicated in this table.) All columns are grey as the toxicological reference values needed for the risk assessment could not be set 4 and the batches tested in the toxicological studies do not comply with the newly proposed specification. Representative use Operator risk Worker risk Bystander risk Consumer risk Risk to wild non target terrestrial vertebrates Risk to wild non target terrestrial organisms other than vertebrates Risk to aquatic organisms Groundwater exposure active substance Groundwater exposure metabolites Comments/Remarks Winter cereals Risk identified Assessment not finalised X 3 Risk identified Assessment not finalised X 3 Risk identified Assessment not finalised X 3 Risk identified Assessment not finalised X 3 Risk identified Assessment not finalised Risk identified Assessment not finalised Risk identified Assessment not finalised 8/9 FOCUS scenarios 6 (alkaline conditions) 9/9 FOCUS scenarios 6 (acidic conditions) Legal parametric value breached 8/9 FOCUS scenarios 5 Assessment not finalised Legal parametric value breached (a) Parametric value of 10µg/L (b) breached Assessment not finalised 1/9 FOCUS scenarios 3 CGA The superscript numbers in this table relate to the numbered points indicated in Sections 9.1 and 9.2. Where there is no superscript number see Sections 2 to 6 for further information. (a): When the consideration for classification made in the context of this evaluation under Regulation (EC) No 1107/2009 is confirmed under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December. (b): Value for non-relevant metabolites prescribed in SANCO/221/2000-rev 10-final, European Commission, EFSA Journal 2015;13(1):

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