Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for cyflumetofen in light of confirmatory data

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1 TECHNICAL REPORT APPROVED: 11 February 2016 PUBLISHED: 25 February 2016 Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for cyflumetofen in light of confirmatory data Abstract European Food Safety Authority (EFSA) 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 cyflumetofen are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State the Netherlands and presents EFSA s scientific views and conclusions on the individual comments received. European Food Safety Authority, 2016 Key words: cyflumetofen, peer review, confirmatory data, risk assessment, pesticide, acaricide Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.peerreview@efsa.europa.eu EFSA Supporting publication 2016:EN-997

2 Suggested citation: EFSA (European Food Safety Authority), Technical report on the outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for cyflumetofen in light of confirmatory data. EFSA supporting publication 2016:EN pp. European Food Safety Authority, 2016 Reproduction is authorised provided the source is acknowledged. 2 EFSA Supporting publication 2016:EN-997

3 Summary Cyflumetofen was approved on 1 June 2013 by Commission Implementing Regulation (EU) No 22/2013 as an active substance in accordance with Regulation (EC) No 1107/2009. It was a specific provision of the approval that the applicant was required to submit to the European Commission further studies on (a) the possible mutagenic potential of the metabolite B3 (2-(trifluoromethyl) benzamide), by excluding an in vivo relevance of observed in vitro effects via an appropriate test protocol; (b) additional information to establish an ARfD for metabolite B3; and (c) further ecotoxicological studies and assessments for aquatic vertebrates that cover their full life-cycle by 31 May In accordance with the specific provision, the applicant, WIL Research, on behalf of OAT Agrio Co. Ltd., submitted an updated dossier in April 2015, which was evaluated by the designated rapporteur Member State (RMS), the Netherlands, 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 6 October The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 18 January A second addendum to the draft assessment report was also prepared by the RMS. 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 Netherlands, and presents EFSA s scientific views and conclusions on the individual comments received. In the area of mammalian toxicology EFSA would recommend further discussion on the toxicological relevance assessment of the groundwater metabolite B3. This includes discussion on the results of the Comet assays on which further details were requested by Member States, the relevant NOAEL in the sub-acute toxicity study and the setting of consumer reference values since the metabolite exceeds 0.75 µg/l and consumer risk assessment is triggered. In addition, considering confirmatory data triggered by ecotoxicology EFSA would also recommend further discussion on the endocrine disruption potential of cyflumetofen based on new provided mechanistic data and the new high dose 2-year rat cancer study. In the area of environmental fate and behaviour, updated PECs GW have been provided. Assessment of relevance of metabolite B3 is confirmed. Since metabolite B3 is expected to exceed 0.75 µg/l in a significant number of scenarios, the consumer exposure to metabolite B3 via drinking water has to be assessed. However, since the toxicological profile of this metabolite could not be addressed, a consumer risk assessment cannot be performed at this stage. In relation to the ecotoxicological assessment, a peer review is recommended to consider the need for a fish-full life-cycle study for addressing the chronic risk assessment to fish, pending on the outcome of the discussion on endocrine disruption in mammals. 3 EFSA Supporting publication 2016:EN-997

4 Table of contents Abstract... 1 Summary Introduction Background and Terms of Reference as provided by the requestor Interpretation of the Terms of Reference Assessment... 6 Documentation provided to EFSA... 6 References... 6 Abbreviations... 7 Appendix A Collation of comments from Member States, applicant and EFSA on the pesticide risk assessment for the active substance cyflumetofen in light of confirmatory data and the conclusions drawn by EFSA on the specific points raised... 8 Appendix B Used compound code(s) EFSA Supporting publication 2016:EN-997

5 1. Introduction 1.1. Background and Terms of Reference as provided by the requestor Cyflumetofen was approved on 1 June 2013 by Commission Implementing Regulation (EU) No 22/ as an active substance in accordance with Regulation (EC) No 1107/ EFSA previously finalised a Conclusion on this active substance on 16 December 2011 in the (EFSA, 2011). It was a specific provision of the approval that the applicant was required to submit to the European Commission further studies on: the possible mutagenic potential of the metabolite B3 (2-(trifluoromethyl) benzamide), by excluding an in vivo relevance of observed in vitro effects via an appropriate test protocol; additional information to establish an ARfD for metabolite B3; further ecotoxicological studies and assessments for aquatic vertebrates that cover their full life-cycle. The deadline for the additional studies was 31 May In accordance with the specific provision, the applicant, WIL Research, on behalf of OAT Agrio Co. Ltd., submitted an updated dossier in April 2015, which was evaluated by the designated rapporteur Member State (RMS), the Netherlands, in the form of an addendum to the draft assessment report (vol. 3) (Netherlands, 2015). In compliance with guidance document SANCO 5634/2009-rev.6.1 (European Commission, 2013), the RMS distributed the addendum to Member States, the applicant and EFSA for comments on 6 October The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 18 January A second addendum to the draft assessment report (vol. 3) was also prepared by the RMS (Netherlands, 2016a). 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 Netherlands, and presents EFSA s scientific views and conclusions on the individual comments received Interpretation of the Terms of Reference On 22 December 2014 the European Commission requested EFSA to provide scientific assistance with respect to the risk assessment of confirmatory data following approval of an active substance in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. EFSA s scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the risk assessment of confirmatory data for cyflumetofen are presented. To this end, a technical report containing the finalised reporting table is being prepared by EFSA. The deadline for providing the finalised report is 16 February On the basis of the reporting table, the European Commission may decide to further consult EFSA to conduct a full or focused peer review and to provide its conclusions on certain specific points. 1 Commission Implementing Regulation (EU) No 22/2013 of 15 January 2013 approving the active substance cyflumetofen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. OJ L 11, , p Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, , p EFSA Supporting publication 2016:EN-997

6 2. Assessment The comments received on the pesticide risk assessment for the active substance cyflumetofen in light of confirmatory data and the conclusions drawn by the EFSA are presented in the format of a reporting table. The comments received are summarised in column 2 of the reporting table. The RMS considerations of the comments are provided in column 3, while EFSA s scientific views and conclusions are outlined in column 4 of the table. The finalised reporting table is provided in Appendix A of this report. Documentation provided to EFSA 1. Netherlands, Addendum to the assessment report (vol. 3) on cyflumetofen, confirmatory data, October Available online: 2. Netherlands, 2016a. Addendum to the assessment report (vol. 3) on cyflumetofen, confirmatory data, January Available online: 3. Netherlands, 2016b. Reporting table, comments on the pesticide risk assessment for cyflumetofen in light of confirmatory data, January References ACD/Labs 2015 Release, Advanced Chemistry Development, Inc., Toronto, ON, Canada, ECHA (European Chemicals Agency), Guidance on the Application of the CLP Criteria; Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. Version 4.1, June Reference: ECHA-15-G-05-EN; ISBN: ; available online: EFSA (European Food Safety Authority), 2012a. Conclusion on the peer review of the pesticide risk assessment of the active substance cyflumetofen. EFSA Journal 2012;10(1):2504. [77 pp.] doi: /j.efsa EFSA (European Food Safety Authority), 2012b. Peer review report to the conclusion regarding the peer review of the pesticide risk assessment of the active substance cyflumetofen. Available online: European Commission, Guidance document on aquatic ecotoxicology under Council Directive 91/414/EEC. SANCO/3268/2001-rev. 4 (final), 17 October European Commission, Guidance document on assessment of the relevance of metabolites in groundwater of substances regulated under Council Directive 91/414/EEC. SANCO/221/2000-rev. 10 (final), 25 February European Commission, Review Report for the active substance cyflumetofen finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 20 November 2012 in view of the inclusion of cyflumetofen as active substances in accordance with Regulation (EC) No 1107/2009. European Commission, Guidance document on the procedures for submission and assessment of confirmatory information following approval of an active substance in accordance with Regulation (EC) No 1107/2009. SANCO 5634/2009-rev EFSA Supporting publication 2016:EN-997

7 Abbreviations a.s. ADI CLP DAR GAP DG SANCO DT 50 ECHA EFSA EU FOCUS HCD LOAEL MoA MS NOAEL PEC OECD PEC gw PEC sed PEC soil PEC sw active substance acceptable daily intake classification, labelling and packaging draft assessment report good agricultural practice European Commission Directorate General Health and Consumers period required for 50 % dissipation (define method of estimation) European Chemicals Agency European Food Safety Authority European Union Forum for the Co-ordination of Pesticide Fate Models and their Use historical control data lowest observable adverse effect level mode of action Member State no observed adverse effect level predicted environmental concentration Organisation for Economic Co-operation and Development predicted environmental concentration in groundwater predicted environmental concentration in sediment predicted environmental concentration in soil predicted environmental concentration in surface water ppm parts per million (10 6 ) PRIMo SD SF RMS TK TMDI Pesticide Residue Intake Model standard deviation safety factor rapporteur Member State technical concentrate theoretical maximum daily intake 7 EFSA Supporting publication 2016:EN-997

8 Appendix A Collation of comments from Member States, applicant and EFSA on the pesticide risk assessment for the active substance cyflumetofen in light of confirmatory data and the conclusions drawn by EFSA on the specific points raised 2. Effects on human and animal health Toxicological data on metabolites No. Column 1 Reference to addendum to assessment report 2(1) Vol. 3, B6.8.3, Studies on endocrine disruption Column 2 Comments from Member States / applicant / EFSA Notifier: The RMS points out that the effects seen in the in vitro steroidogenesis assay in H295R cells, i.e. decreased levels of testosterone and increased levels of estradiol are of biological significance in vivo based on the observed increase in Leydig cell tumours (LCT) in Fisher F344 rats. This view is not supported since Fisher F344 rats are not a suitable model to study formation of LCT. Column 3 Evaluation by rapporteur Member State NL: noted. However, RMS is still of the opinion that relevance for humans cannot be excluded. Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data Peer Review Proposed. The endocrine disruption potential of cyflumetofen should be further discussed based on new mechanistic data and the new high dose 2-year rat cancer study where Leydig cell tumours were observed. In order to help the discussion EFSA would propose to the RMS to summarise the results of the new high dose 2-year rat cancer study in B.6 and not in B.9. 2(2) Vol 3, B6,, 2015, Comet assay AT: Does RMS maybe has the explanation why this second Comet assay has been conducted in 2015, since there was already one test conducted in NL: the applicant has not clearly indicated this, however, the 2012 study was not performed under GLP while the 2015 study was performed under GLP. Peer Review Proposed. The results of the Comet assays on metabolite B-3 should be further discussed since further details on the studies were requested by Member States. 2(3) Vol 3, B6, 2015, Comet assay AT: In 2015 a Comet assay in vivo has been repeated ( 2015). The results were partially positive and dose response has been observed, however, it was argued that the positive findings were still within the HCD which had a NL: Noted. See 2(2). 8 EFSA Supporting publication 2016:EN-997

9 2(4) Vol. 3 B6.8.1 Metabolite Re. No / B-3 Study 3: Comet assay, 2015 very wide range. General remark, no action needed by the RMS: In vivo Comet assay has not been usually applied for testing plant protection actives and experiences with this test might be limited. A general question is, how to interpret the data if HCD has such a wide range, and how to integrate this test for regulatory purposes. FR: At the 24-hour harvest, a statistically significant and dose-related increase in % tail DNA was observed in liver and stomach. This increase was not considered as biologically relevant by the RMS based on the historical control data. Nevertheless, as stated in the OECD guideline, Different tissues and different species, as well as different vehicles and routes of administrations, may give different negative control % tail DNA values. And ( ) a test chemical is considered to be clearly positive if: ( ) c) any of the results are outside the distribution of the historical negative control data for a given species, vehicle, route, tissue, and number of administrations. However, studies included in the HCD were performed using several types of vehicles and several routes of administration. The number of administrations is not mentioned. Furthermore, organs were harvested approximately 3 hours after the last dose for studies included in HCD, whereas in the study conducted on the metabolite, the statistically significant and dose-related increase in % tail DNA was observed after a harvest time of 24 hours after treatment. Therefore, relevant HCD (same vehicle, same route of administration, same NL: After the commenting phase, the applicant provided a detailed evaluation of the historical control data. This was included in the addendum. This detailed evaluation showed that there was no statistical significance between the different dosing regimens. Furthermore, HCD were given for each individual vehicle. The results found in the study are within the HCD given for the vehicle used (corn oil). RMS considers this detailed evaluation of the historical control data sufficient. In addition, the first Comet assay (2012) was clearly negative supporting the conclusion that there was no treatment related increase in DNA damage. Overall, we conclude that B3 is negative in the in vivo comet assay. See 2(2). 9 EFSA Supporting publication 2016:EN-997

10 number of administration) has to be provided in order to conclude on the outcome of this assay. 2(5) Vol. 3, B.6.8.1, toxicity studies on metabolite Re. No / B-3, oral 28-day in rats 2(6) Vol. 3, B.6.8.1, toxicity studies on metabolite Re. No / B-3, Comet assays EFSA: It is noted that body weight gain were reduced not only at the top dose level but also at 300 ppm in males. Some organ weights were significantly (>10% and dose-response related) increased already at the low dose level: increased relative epididymides, kidneys and testes weight. The changes in epididymides and testes weight should be taken into consideration when establishing the NOAEL of the study. As no other toxicological study, such as developmental or reproductive toxicity were performed with B3, the relevance of these organ weight changes cannot be dismissed. Please indicate the corresponding daily intake of the higher dose levels (300 and 1200 ppm) used in the study to ease the information regarding the comparative toxicity with the parent compound cyflumetofen. EFSA: it is agreed that the negative results obtained in both Comet assays outweigh the positive results obtained in the TK in vitro gene mutation assay in absence of metabolic activation. NL: indeed at 300 ppm there is a significant change in the overall body weight gain (-16.5%). This finding was added to the text. For the relative epididymides, kidney and testes weights in males, they were indeed already altered >10% at 75 ppm compared to the control. However, histopathological evaluation showed kidney results that are not considered relevant to humans. No histopathological changes were observed in epididymides or testes (control and high dose were examined), therefore these nonsignificant changes in relative organ weight are not considered for the setting of the NOAEL. RMS still considers the low dose (75 ppm = 6.1 mg/kg bw/day) as a NOAEL. The mean daily intake of test substance was already given in the text: 6.1, 24.1 and 85.3 mg/kg bw/day in males for the 75, 300 and 1200 ppm doses; 6.2, 23.9 and 88.2 mg/kg bw/day in females for the 75, 300 and 1200 ppm doses. RMS: Noted. See 2(3). 2(7) Vol. 3, B.6.8.1, toxicity EFSA: EFSA considers that a LOAEL of 6.1 NL: RMS still considers the low dose of 6.1 See 2(5). Peer Review Proposed. The toxicological profile of B-3, including the NOAEL in the 28-day study on B-3 and the setting of consumer reference values should be further discussed EFSA Supporting publication 2016:EN-997

11 studies on metabolite Re. No / B-3, ADI 2(8) Vol. 3, B.6.8.3, Studies on endocrine disruption 2(9) Vol. 3, Annex B (AS) Addendum on Confirmatory Data B.6.8.3, Studies on endocrine disruption, Study 5 H295R steroidogenesis assay is obtained from the 28-day study in rats; the ADI for B3 should be lowered by a proposed additional uncertainty factor of 2. This would result in an ADI of mg/kg bw per day for the metabolite B3. EFSA: We agree with the RMS conclusion that cyflumetofen showed to have an influence in the steroidogenesis pathway. On this basis, the carcinogenic potential of cyflumetofen may have to be revised considering the increased incidence of Leydig cell tumours found in the 2-year rat study. Furthermore, this may indicate a plausible endocrine mediated MoA for the increased incidence of delay in sexual maturation observed in females in the 2-generation reproduction toxicity study in rats. It is noted that this issue is not part of the mammalian toxicology confirmatory data requirements; it may however have an impact on the confirmatory data for the ecotoxicology section. DE: The increase in estradiol and the decrease in testosterone production in the H395R steroidogenesis assay with cyflumetofen are noted. The results should be seen in relationship to the findings in the long-term rat study (such as testes tumours) and in the 2- generation study in rats (such as delayed sexual development, hormonal changes). In summary, a possible hormone mediated mechanism leading to adverse effects observed in intact organism (rats) cannot be excluded. mg/kg bw/day to be a NOAEL. NL: Agreed, the results might lead to a need to reconsider the carcinogenic potential of cyflumetofen. However, as the confirmatory data requirement was not set for the mammalian toxicology section (but for the ecotox section), RMS has not further considered this for mammalian tox. The need to classify for carcinogenicity will be addressed in the CLH proposal to ECHA. NL: noted. The results of the long-term rat study and 2-generation study were discussed, however in the addendum for the ecotoxicology section since the confirmatory data requirement was set for ecotox and not mammalian tox. See 2(1) See 2(1) 11 EFSA Supporting publication 2016:EN-997

12 2(10) Vol. 3, Annex B (AS) Addendum on Confirmatory Data B Toxicity studies of metabolites and relevant impurities Study 2 Comet assay and Study 3 Comet assay DE: RMS, please report, whether the laboratories demonstrated proficiency to conduct the comet assay and proficiency for the evaluated tissues. RMS, please report, whether the laboratories demonstrated that the method was under control e.g., with control charts (OECD TG 489, para 21). The selection criteria for the assessed tissues are unclear. RMS, please clarify. NL: the first comet assay ( 2012) was not performed under GLP. However, this lab was involved in the validation process of the in vivo Comet assay, led by JaCVAM. The laboratory that performed the second Comet assay ( 2015) was in compliance with GLP during inspections for the area of expertise of mutagenicity. Furthermore, this lab was involved in the validation process of the in vivo Comet assay. Based on the provided data, the lab that performed the second Comet assay ( 2015) seems to be under control for this method. As for the selection criteria for the assessed tissues: in both studies liver and stomach were assessed. These tissues have been most extensively studied with the in vivo Comet assay, for instance in the validation trial (JaCVAM). Furthermore, in the study report the following was stated: Stomach was chosen as representative organ for possible effects at the site-of-first contact. Liver was found to be the main target organ for B3 in a 28-day study in Wistar rats. This information has now been added to the addendum. See 2(2). 2(11) Vol. 3, Annex B (AS) Addendum on Confirmatory Data B Toxicity studies of metabolites and relevant impurities Study 2 Comet assay DE: A reduction in DNA migration can be a sign for DNA crosslinking potential. Slight decreases in DNA migration (% tail DNA) were seen in the study by but were not further taken into account. RMS, please amend accordingly. NL: As OECD 489 indicates, this test is not appropriate for detecting crosslinking agents. Therefore, this is not the primary purpose of this assay. See 2(2) EFSA Supporting publication 2016:EN-997

13 2(12) Vol. 3, Annex B (AS) Addendum on Confirmatory Data B Toxicity studies of metabolites and relevant impurities Study 3 Comet assay 2(13) Vol. 3, Annex B (AS) Addendum on Confirmatory Data B Toxicity studies of metabolites and relevant impurities Study 1 Oral 28-day study DE: In liver and stomach a significantly increased trend and significant increases in % tail DNA were reported in the 24h experiment. No historical control data (HCD) ranges for the 24h experiments were provided (only for the 3h experiments). In stomach an increased dose response and doubling in % tail DNA were reported in the 3-4h experiment, albeit reaching the upper range of HCD (mean+sd). RMS, a more detailed presentation of histological data (in a Table) would help to clarify possible impact of cytotoxicity on the apparent increases of DNA damage. The Addendum indicates that similar (or at least no higher) levels of toxicity were reported for the treated groups than for positive control groups; which would speak against excessive levels of toxicity. Currently, it seems that more criteria point to a positive call of the results than those indicating a negative result. In summary, a more detailed evaluation of the data is necessary, before concluding whether metabolite B-3 is devoid of any genotoxic potential in vivo. RMS, please amend accordingly. DE: RMS, please provide an evaluation whether the results in the 28-day rat study might trigger classification with STOT-RE. NL: For the comment regarding HCD: see response to comment 2(4). The applicant provided new tables describing the histopathological findings in liver and stomach. These were added to the addendum (Tables , and ). NL: the metabolite is not a substance that should be classified according to CLP (not a substance that will be placed on the market). Furthermore, in the SANCO/221/2000 document, metabolites are considered relevant when classified as toxic or very toxic, or when reproductive toxicity or carcinogenicity are a problem. See 2(2). See 2(5) EFSA Supporting publication 2016:EN-997

14 The data on the parent and metabolite B3 indicate that this metabolite is not relevant according to stages 2 and 3 of step 3 in the GD and a metabolite specific ADI has been established. RMS does not consider it necessary to further discuss a possible STOT-RE classification for this metabolite. 2(14) Vol. 3, Annex B (AS) Addendum on Confirmatory Data B Toxicity studies of metabolites and relevant impurities Study 1 Oral 28-day study (ADI for B-3) 2(15) Vol. 3, B.6, Derivation of the ADI DE: RMS proposed an ADI for metabolite B-3 based on a 28-day rat study and a SF of 600. It is noted that Sanco/221/2000 rev.10- final (GD on relevance of groundwater metabolites) recommends a SF of 1000 when the ADI is based on a 90-day study. RMS, please add a sound justification for the selection of the SF. AT: The RMS agreed with the proposal of the applicant to add an additional SF of 6 for duration of exposure. We are wondering if this additional safety factor also covers the very tiny database for B3 (only 28-days study available), keeping in mind that B3 is more acutely and subacutely toxic than the parent. By using an additional SF of 10 (1000 in sum), the ADI would be mg/kg bw/d NL: after reconsideration, RMS has decided to change the safety factor to 1000 in compliance with the SANCO GD. This results in an ADI for metabolite B3 of mg/kg bw/day. The addenda for mammalian toxicology and for fate were adjusted accordingly. See 2(5). NL: see reply to comment 2(14). See 2(5) EFSA Supporting publication 2016:EN-997

15 4. Environmental fate and behaviour PEC in surface water and ground water No. Column 1 Reference to addendum to assessment report 4(1) Vol 3. Annex CP9, pages (relevant metabolites assessment) 4(2) Vol. 3, Annex CP9 Addendum on confirmatory data. Column 2 Comments from Member States / applicant / EFSA Applicant: From the text and the data in the table, it is clear that metabolite B-3 is not biologically active. However, below Table 2 it is concluded that B-3 is biologically active. This is considered a typing error. Please rephrase: Conclusion: Metabolite B-3 is not biologically active. EFSA: The information presented is an update of the PEC GW calculated for metabolite B3 with end points agreed for parent compound during the peer review. These new calculations do not specifically form part of the confirmatory data requested by the Commission but is relevant to have a fully updated assessment. These update calculations confirm the need to assess the toxicological relevance of groundwater metabolite B3 that exceeds 0.1 µg/l in the majority of uses and scenarios simulated. Levels of this metabolite are also expected to exceed 0.75 µg/l in a significant number of scenarios. The new calculations confirm the need for the confirmatory data requested on metabolite B3. Column 3 Evaluation by rapporteur Member State NL: indeed this is a typo. This is revised. No further action needed. NL: agree with EFSA that the new calculations also indicate that the metabolite B3 exceeds 0.1 µg/l. Please note that the highest predicted concentration was observed in the assessment underlying the original inclusion. No further action needed. Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data Addressed. Typo corrected in updated assessment. Addressed Updated PECs GW have been provided. Assessment of relevance of metabolite B3 is confirmed (to be addressed in toxicology, residues and ecotoxicology sections). Since metabolite B3 is expected to exceed 0.75 µg/l in a significant number of scenarios, the consumer exposure to metabolite B3 via drinking water has to be assessed. However, since the toxicological profile of this metabolite could not be addressed (see point 2(5)), a consumer risk assessment cannot be performed at this stage EFSA Supporting publication 2016:EN-997

16 5. Ecotoxicology Aquatic organisms No. Column 1 Reference to addendum to assessment report 5(1) Confirmatory data addendum, B.9, Ecotoxicology, B , Chronic toxicity to fish ELS study by (2011) 5(2) Vol 3, B, , study IIA /01 ( 2010) Column 2 Comments from Member States / applicant / EFSA EFSA: It is appreciated that the study and the RMS has given careful consideration to the problems caused by the low water solubility. The measured concentrations on day 22 were 148% of the nominal and vastly exceeded the water solubility of the test substance. It was suggested that this may have been due to aeration of the test systems causing organic matter with adsorbed test material to become suspended. It is therefore questionable whether this value should have been used in the calculation of the mean measured concentrations which were used to express the endpoint. Applicant: RMS states that the NOEC of the study would be <11 µg a.s./l when using data from the pooled controls. However, as the study is rejected, deriving a NOEC from this study is not relevant. 5(3) STUDY IIA /01 AT: The discussion of the effects on survival is not completely clear. It is stated that no dose response effect was noted, but a clear effect seems to be there for survival of eggs and larvae after 31 days (Table B ). The lack of dose response should also not be considered to fully reject the study, Column 3 Evaluation by rapporteur Member State RMS: Even if this value is removed, the mean measured concentration only very slightly changes (to 26.6 µg/l). The risk assessment would still pass with a relatively high margin of safety. The RMS does not consider it necessary to adjust this, but if it is considered vital we will do so. RMS: Agreed. The NOEC is irrelevant. RMS: Table B is a bit misleading, because it is as per the study report, i.e. using only the solvent control as the control for statistical comparison, the RMS finds that the pooled control (solvent and blank) should be used to evaluate differences from control, particularly in this case when there is no statistical difference Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data Addressed. It is considered that it would be more appropriate to remove the measured concentrations which exceeded the water solubility in the calculation of the exposure value. However, this does not affect the overall conclusion of the study i.e. that there were no effects at the tested concentration which should be regarded as close to the water saturation level. Ideally a footnote could be added to the LoEP to indicate that the quantified endpoint is not completely reliable. Addressed. The RMS did not consider the fish ELS study by 2010 to be reliable for risk assessment. The endpoint was not included in the updated LoEP. Addressed. The RMS did not consider the fish ELS study by 2010 to be reliable for risk assessment. The endpoint was not included in the updated LoEP. There were various reasons for not considering the study to be reliable EFSA Supporting publication 2016:EN-997

17 5(4) Confirmatory data addendum, B.9, Ecotoxicology, B , Chronic toxicity to fish ELS study by (2010) 5(5) Vol. 3, B.9.2.2, Risk assessment for aquatic vertebrates 5(6) Confirmatory data addendum, B.9, Ecotoxicology, B.9.2.2, Statement from the applicant regarding the potential for endocrine effects in mammals especially as effects are indicate at concentrations lower than in the other study. EFSA: The concerns of the RMS regarding the reliability of this study are agreed. Furthermore, it seems that the solvent control (and test item) resulted in an earlier time of hatching. Perhaps the problems in this study related to the use of a solvent which is not recommended (nor is it excluded) by the OECD 210 test guideline. Applicant: RMS states that According to the interim criteria, cyflumetofen is not considered to be an endocrine disruptor. Cyflumetofen has been submitted under regulation 91/414 and should not be assessed under the criteria provided in regulation 1107/2009 EFSA: It should be noted that the assessment of cyflumetofen was under the previous Council Directive 91/414/EEC. Therefore, there was no need to consider the hazard criteria for endocrine disruption as required under Regulation 11017/2009. According to SANCO/3268/2002 (EC, 2002), when there are indications of endocrine mediated effects the toxicology studies then the need for a fish-full life cycle study should be considered as shorter studies may not cover all potential effects caused by endocrine disruption. In relation to the applicants statement regarding ED in mammals, EFSA has the between the two control groups themselves. When this is done, effects are seen at all doses, but not in a dosedependent manner (as stated in the comments of the RMS in the study evaluation). RMS: Indeed, it is possible that the solvent resulted in problems in the test. Addressed. RMS: See comment 5(6). See comment 5(6). RMS: (i) (ii) We agree that these criteria do not pertain to this assessment per se. The criteria were used in the absence of other criteria. However, SANCO/3268/2002 specifies only that a fish full life cycle test might be considered, not that it is required. The RMS agreed that it was impossible to rule out steroidogenic effects which could be human relevant. These were not reproduction relevant in any tested species The RMS did not consider the fish ELS study by 2010 to be reliable for risk assessment. The endpoint was not included in the updated LoEP. Refer to 2(1) where this issue is proposed for peer review EFSA Supporting publication 2016:EN-997

18 5(7) Vol. 3, B.9.2.2, Risk assessment for aquatic vertebrates following comments (please note that these only relate to the need for a FFLC and not for a mammalian toxicology assessment): i) The interim criteria under 1107/2009 for the assessment of ED in mammals is not considered appropriate for consideration of the need for a FFLC study. ii) Overall, it is not agreed that the data do not indicate possible endocrine mediated effects in mammals i.e. due to the delay in sexual maturation. Applicant: RMS has included a discussion regarding human relevance of Leydig cell tumors in F344 rats. A detailed explanation why this finding is of no relevance is included in a comment on Vol. 3, B6.8.3 above. Moreover, as cancer is not a relevant endpoint for the ecotoxicological risk assessment, assessment of human relevance of LCT should not be included in the section on risk assessment for aquatic vertebrates. The RMS is requested to remove this part from B.9 and refer to B (8) Vol 3, B Applicant: in the inserted statement, in paragraph 3.1 parts of the text were removed (strikethrough). However, it is not clear why some of the sentences were not removed as no reasoning was given on the removal of the sentences. The applicant is of opinion that in the context of EDSP discussion, the outcome of 2-generation studies data is relevant. The RMS is requested to (actually, only seen in rats) and were at relatively high doses. RMS: We agree that cancer is not a relevant ecotoxicological endpoint; the relevance of Leydig cell tumors in F344 rats to the ecotoxicology section is mainly concerning the mechanism of action of the Leydig cell tumor (LCT) formation in rats. As the underlying mechanisms of action of LCT may be (are often) related to the endocrine system, and since the potential interaction of cyflumetofen with the endocrine system is the question, the RMS considers the discussion relevant in the context of both mammalian and eco toxicology. RMS: These adjustments were made in the interest of clarity as to from whom the information and conclusions came and to minimize repetitiveness. We have re-placed it, with the note that it is a statement of the applicant and not a conclusion of the Ctgb. See comment 5(6). Addressed. The RMS provided clarification EFSA Supporting publication 2016:EN-997

19 5(9) Confirmatory data addendum, B.9, Ecotoxicology, B.9.2.2, 4.2 Exposure data provide a clarification why some sentences were removed. EFSA: It is correct that the geomean of the whole system DT 50 values are 1.32 days. However, to consider the need for a chronic fish risk assessment according to SANCO/3268/2002 (EC, 2002) indicates in the case of multiple applications (i.e. the representative use of cyflumetofen) then it should be demonstrated that prolonged exposure will not occur. It is expected that this would be done using FOCUS surface water exposure profiles. However, as only FOCUS step 2 modelling is available, no profiles were generated. It is therefore considered that it has not been demonstrated that there will not be prolonged exposure to cyflumetofen. Care should also be taken in the cases where long-term effects could be caused by short-term exposure which may be the case for potential endocrine disrupters. RMS: We agree that long-term exposure is not necessary/relevant for endocrine-mediated effects. Our discussion over the exposure profile addresses the question of whether chronic toxicity testing in fish is triggered according to the Guidance or regulation. We have adjusted our comments on the statement of the applicant to reflect this. Further, it should be noted that although only FOCUS Step 2 modelling was presented in the Fate section (since Step 3 was not required to finalize the risk assessment), Focus Step 3 modelling data was presented in Ikemi (2014), which was submitted as part of the confirmatory data packet. Details of the simulation with the D1 scenario are available in the statement of Ikemi (2014). This scenario showed one of the highest PIEC values of µg/l. Based on the short DT 50 in water/sediment, prolonged exposure will only be relevant if significant amounts of substance enter the water body between applications. Hence this will only occur if there are substantial contributions of the drainage or run-off route. Drainage and run-off are not relevant for this substance and hence exposure levels between applications (spray drift events) will be negligible. The disappearance of the substance after the peaks is regulated by the DT 50 system that has been introduced to the model (and by the other processes sorption to sediment, dispersion, dilution). Detailed PEC sw calculations for D1 (ditch with drainage) are available in Appendix IV of the Ikemi et al report have been analysed by RMS. This concerns a single EFSA agrees that in the case of cyflumetofen the spray drift entry route will be driving the exposure due to its strong adsorption to soil and relatively low persistence in soil. However, taking into account the number of applications (4) and the relative short interval between them (7 d), it may be expected that, in the worst case D1 scenario, calculated exposure will be continuously within the range from 0.1 µg/l to 1.6 µg/l (calculated using as basis the pattern provided for a single application) over the 30 d period after the first application, with four acute exposure events (between µg/l). In relation to the DT 50, whereas the geometric mean is used for the PEC exposure calculations, triggering values are usually based on worst case measured values. In this case, a DT 50 whole system = 12.4 d in one of the two water/sediment systems is observed, which clearly exceeds the trigger of 2 d proposed in the guidance EFSA Supporting publication 2016:EN-997

20 application. The dominant entry route is via spray drift and not via any of the soil routes. This means that small deviations in input values regarding degradation in soil compared to the final endpoint are not critical. PEC values in the ditch over time are influenced by degradation/sorption as well as dilution/dispersion. No full exposure profile is available however the actual concentrations over time show the following pattern: Actual concentrations in water layer in μg.l-1 * * Global max Aug :00 * PEC 1 day Aug :00 * PEC 2 days Aug :00 * PEC 4 days Aug :00 * PEC 7 days Aug :00 * PEC 14 days Aug :00 * PEC 21 days Aug :00 * PEC 28 days Sep :00 * PEC 42 days Sep :00 * PEC 50 days Sep :00 * PEC 100 days Nov :00 * EFSA Supporting publication 2016:EN-997

21 From the decline over time it can be seen that the dissipation over time occurs very quickly. The derivation of a DT 50 from the observed concentrations is complicated by the fact that multiple processes occur simultaneously and/or consecutively: sorption to sediment, degradation, dispersion, dilution. Hence a kinetic fit following one of the kinetic models is not considered appropriate (and also not relevant for the question of prolonged exposure when actually is meant if multiple entry routes create a continuous exposure). For multiple applications limited results are available consisting of global maxima, TWA4days, TWA21days and TWA28days. See Appendix 3 of the Ikemi report. Table 1-4 and 1-8 reflect the PEC sw after multiple applications in two different periods. When TWA4 days results are compared with global maxima it becomes clear that the average concentration over 4 days is always less than half the maximum PEC (pond scenarios) and often very much lower (stream and ditch scenarios). This indicates a rapid decline and sustains the notion that long-term exposure is not relevant. 5(12) Confirmatory data addendum, B.9, Ecotoxicology, B.9.2.2, Conclusion on the need for a FFLC study EFSA: No FFLC study was submitted as part of the confirmatory data. The applicant submitted argumentation as to why such as study was not considered necessary, in response to those points: v) It is not agreed that it clear that there are no indications of endocrine effects in RMS: (1) We agree that there are possible indications of a steroidogenesis/leydig cell abnormality/delayed puberty MoA based upon the available data. However, we also note that the in vivo data was far from conclusive, based on the very marginal changes that were seen; (2) We disagree. It has been Peer review proposed It is noted that a fish-early life-stage study was made available in the confirmatory data assessment; there were no effects at the water saturation level. However, this study only covers development and does not cover reproduction. Using the proposed endpoint a low chronic risk to fish was indicated EFSA Supporting publication 2016:EN-997

22 the mammalian data (see comment (4) in mamtox above). ii) It is not agreed that it has been demonstrated that there will not be prolonged exposure to fish and therefore no chronic risk assessment is triggered (see separate comment). iii) It is agreed there were no effects observed in the fish ELS study ( 2011), the short-term (8 day) fish toxicity study and the observed effect on growth in the fish juvenile study. iv) It is also noted that the chronic fish risk assessment, using the endpoint from the ELS study, passes at FOCUS step 1. This infers some margin of safety in the risk assessment. v) It is also considered that any further vertebrate testing should be carefully considered (possibly taking in to account what would be required for a hazard assessment under 1107/2009). Overall, it is not agreed that the need for a FFLC study has been fully clarified in the confirmatory data assessment. demonstrated that there will not be prolonged exposure to fish based upon the DT 50 in water, and the DisT 50 in water. We do not consider the Focus Step 3 profiles to be necessary considering the very quick degradation/dissipation in water. Please see our response in the comment 5(9); (3) Noted. (4) Noted. (5) In the interest of minimizing vertebrate testing, it should be noted that the level at which receptor activation was seen in the in vitro receptor assay was equivalent to 2237 μg/l, which is significantly higher than the expected exposure for fish, either chronically or acutely. In addition, the levels at which potential delayed puberty were seen only in rats at levels of 10 mg/kg bw/d. Overall, the question that must be answered as regards chronic toxicity to fish is whether there is likely to be chronic exposure (triggering chronic toxicity testing), and/or whether the evidence of endocrine disruption from the mammalian toxicology section indicates population/reproduction relevant effects on the endocrine system at a reasonably similar exposure level as expected based on the exposure profile for the active substance and requested uses (we note that point 2 is also true for other organisms, such as birds or amphibians). The RMS has shown that (1) the PECs and properties of cyflumetofen mean that no chronic exposure is expected and (2) the However, it is further noted that, the representative uses include 4 applications (7 day interval between applications) prolonged exposure cannot be excluded (albeit at concentrations which are low relative to the maximum PEC value) (see response to 5(11)). Therefore, the need for a fish-full life-cycle study should be further considered for addressing the chronic risk assessment to fish, pending on the outcome of the discussion on endocrine disruption in mammals, proposed in the mammalian toxicology section (5(2)) EFSA Supporting publication 2016:EN-997

23 level at which (minor and not reproductively-relevant) effects were seen in vivo (rats only) and in vitro, are around 10000x and 2000x higher than the highest expected maximum Step 3 PEC (1.397 μg/l). Based upon these data we consider it logical to conclude that it is highly unlikely that any population relevant effects at all will occur from the exposure in question. Further testing in fish would therefore be unnecessary. 5(13) Addendum confirmatory information Vol. 3 B.9 DE: In our opinion the provided data do not fulfil the requirements set by the approval regulation. There it is stated that: The applicant shall submit confirmatory information as regards (c) further ecotoxicological studies and assessments for aquatic vertebrates that cover the full life-cycle for cyflumetofen. The provided data do not cover the full life-cycle of the fish in any way. The full life-cycle data was required in order to exclude an endocrine potential of the as. With the data provided it is not possible to exclude an endocrine potential or to draw any conclusion on that. The studies are not informative concerning the ability of the fish to reproduce. In our opinion the notifier should in order to avoid going straight to FLC testing provide data according to OECD 229 and 230 (screening assay and short term repro assay). RMS: Noted. We agree that the specific possible MoA for cyflumetofen is not covered by the current chronic fish studies, as the period of sexual development is not investigated in the current ELS studies, nor in the previous studies (juvenile growth and OECD 212). We adjusted the confirmatory data addendum to reflect this. We do not consider OECD 230 to be relevant, as it is intended to provide information on potential mechanisms of action for ED in fish (estrogenic and/or androgenic activity or aromatase inhibition specifically, which were already shown to be irrelevant in the in vitro assays) and does not provide a relevant endpoint for risk assessment. We do not find that this study would provide more information that is already provided by the mammalian toxicology and in vitro study packet. OECD 229 is also intended as a screening assay, developed to determine if a compound may be endocrine active in sexually maturing fish, rather than a test to determine a population-relevant endpoint for chronic risk assessment. Again, we do not find that better or more useful data would be derived from these studies than already exists in the current data packet. For See comment 5(12) EFSA Supporting publication 2016:EN-997

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