Follow up assessment of MRLs for the active substance iprodione. European Food Safety Authority (EFSA)

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1 Page 1 of 24 EFSA Journal TECHNICAL REPORT APPROVED: 27 March 2018 doi: /sp.efsa.2018.en-1404 Abstract Follow up assessment of MRLs for the active substance iprodione European Food Safety Authority (EFSA) The approval of iprodione was not renewed by Commission Implementing Regulation (EU) 2017/2091 and plant protection products containing iprodione have a grace period until 5 June As a consequence the European Commission needs to discuss with Member States the revision of existing MRLs (setting to the LOQ) and whether or not it would be appropriate to grant transitional measures for iprodione and for which commodities. The European Food Safety Authority (EFSA) was asked by the European Commission to provide a follow up assessment of MRLs for iprodione using the new toxicological reference values established in the Conclusions of the peer review in This information will support the European Commission and Member States to decide about transitional measures in which existing MRLs would be maintained for an extended period of time beyond the grace period of 5 June The current report concludes, taking into account the limitations and uncertainties of the assessment, that the use of existing MRLs leads to the exceedance of the acute reference dose for 27 unprocessed commodities and 11 processed commodities. Furthermore, the estimated long term dietary intake assessment shows an exceedance for the ADI. European Food Safety Authority, 2018 Keywords: iprodione, MRL, consumer exposure assessment, pesticide Requestor: European Commission Question number: EFSA Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Supporting publication 2018:EN-1404

2 EFSA Journal Page 2 of 24 Suggested citation: EFSA (European Food Safety Authority), Technical report on the follow up assessment of MRLs for the active substance iprodione. EFSA supporting publication 2018:EN pp. doi: /sp.efsa.2018.en 1404 ISSN: European Food Safety Authority, 2018 Reproduction is authorised provided the source is acknowledged. 2 EFSA Supporting publication 2018:EN-1404

3 Page 3 of 24 EFSA Journal Table of contents Abstract Introduction Background as provided by the requestor Terms of Reference as provided by the requestor Data and methodology Assessment Results for Scenario Results for Scenario Limitations of the assessment Uncertainties of the assessment Conclusion... 7 References... 8 Abbreviations... 9 Appendix A Input values for the exposure calculations Appendix B Pesticide Residue Intake Model (PRIMo) Appendix C Summary of available plant metabolism studies of iprodione (France, 2016) Appendix D Summary of available animal metabolism studies of iprodione (France, 2016) Appendix E Used compound codes EFSA Supporting publication 2018:EN-1404

4 EFSA Journal Page 4 of Introduction 1.1. Background as provided by the requestor The approval of iprodione was not renewed by Commission Implementing Regulation (EU) No 2017/ of 14 November As a consequence Member States have to revoke existing authorisations for plant protection products containing iprodione with the possibility to grant grace periods for sell off and use of existing stocks until 5 June 2018 at the latest. A draft proposal was prepared by the Commission services lowering the existing MRLs to the Limit of quantification (LOQ) to reflect this situation and a first discussion with Member States' experts took place in the Standing Committee on Plants, Animals, Food and Feed (PAFF) on February The discussion was very much focussed on whether or not it would be appropriate to grant transitional measures for iprodione and for which commodities this could be done. In the EFSA Conclusion on the peer review for iprodione (EFSA, 2016) new toxicological reference values were established. The ADI was lowered from 0.06 mg/kg bw to 0.02 mg/kg bw and a new Acute Reference Dose (ARfD) of 0.06 mg/kg bw was established which previously was not deemed necessary. An updated review report with the new endpoints has been presented to the Standing Committee on Plants, Animals, Food and Feed (PAFF) section pesticides legislation on 22 March 2018 for endorsement. For some representative uses the EFSA Conclusion of the peer review demonstrated that acute health concerns may exist. It is however not clear whether this is also the case for some of the other existing uses since the review of the existing MRLs for iprodione under Article 12(2) of Regulation (EC) No 396/2005 (EFSA, 2013) was carried out with the previous toxicological reference values Terms of Reference as provided by the requestor In order to enable the Commission to decide about transitional measures in which existing MRLs would be maintained for an extended period of time, EFSA was requested in accordance with Article 31 of Regulation (EC) No 178/2002 to provide an updated exposure assessment (screening exposure assessment) of iprodione using the new toxicological reference values established in the Conclusions of the peer review, to identify which MRLs are unlikely to present a risk to consumers. The new revision of the PRIMO model (PRIMO rev. 3) should be used for this task. As input parameters the data that were the basis for setting the MRLs in Regulation (EU) 2015/400 should be used. These data can be largely taken from the Art. 12 review on which the MRL Regulation was based, i.e. the residue definition for risk assessment and for enforcement, the supervised trial median residue (STMR) and highest residue (HR) data, as well as the JMPR data supporting Codex maximum residue limits that were considered safe for consumers and taken over into EU legislation. Should trial data not be available in specific cases, a worst case calculation with the existing MRL can be performed as long as this is clearly described. If further refinement of the exposure assessment is possible, e.g. by using processing factors, such refinements should be carried out. It was agreed with the requestor that a technical report containing the updated risk assessment should be provided by 31 March Commission Implementing Regulation (EU) 2017/2091 of 14 November 2017 concerning the non renewal of approval of the active substance iprodione, 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 Commission Implementing Regulation (EU) No 540/2011. OJ L 297, , p EFSA Supporting publication 2018:EN-1404

5 Page 5 of 24 EFSA Journal 2. Data and methodology EFSA performed a follow up assessment to the MRL review conducted in the framework of Article 12 of Regulation (EC) No 396/2005 (EFSA, 2013) of the MRLs for iprodione with the limitations highlighted under chapter 3.3: The calculations performed in this assessment are not reflecting the latest information available regarding iprodione and its metabolites (see also below Sections 3.3 Limitations of the assessment and 3.4 Uncertainties of the assessment). The follow up assessment was performed with revision 3 of the EFSA PRIMo (EFSA, 2018), using the new toxicological reference values established in the peer review (EFSA, 2016).The current assessment was performed with the residue definitions used previously in the framework of the MRL review of Article 12 of Regulation (EC) No 396/2005 (EFSA, 2013) (hereafter referred to as old residue definitions ) and does not consider the new residue definitions for risk assessment derived by the peer review (EFSA, 2016). Table 1 provides a comparison of the old and the new residue definitions for iprodione. Table 1: Comparison of residue definitions for iprodione Type of Commodity group Old residue definition New residue definition residue (EFSA, 2013) (EFSA, 2016) definition Enforcement All plant products Iprodione Iprodione All animal products Iprodione and all metabolites containing 3,5 dichloroaniline RP moiety, expressed as iprodione (a) Risk Plant products RAC: Iprodione (tentative) RAC and processed commodities: assessment (c) Processed commodities: inconclusive (b) Animal products Sum of iprodione and all Inconclusive (d) (kidney of metabolites containing the 3,5 mammalians and dichloroaniline or 3,5 dichloro 4 milk) hydroxyaniline moieties, expressed as iprodione (tentative) (b) Other animal Sum of iprodione and all products metabolites containing the 3,5 dichloroaniline moiety, expressed as iprodione (tentative) (b) 1. Sum of iprodione, RP and RP 32490, expressed as iprodione 2. Sum of 3,5 dichloroaniline and its conjugates expressed as 3,5 dichloroaniline (a) Existing EU MRLs for procymidone for animal commodities are currently established for vinclozolin, iprodione, procymidone, sum of compounds and all metabolites containing the 3,5 dichloroaniline moiety expressed as 3,5 dichloroaniline. (b) Lack of sufficient toxicological data for 3,5 dichloroaniline, suspected of greater toxicity than iprodione (c) Final expression is pending full elucidation of the genotoxic potential of metabolite RP and of any potential common effects of 3,5 dichloroaniline with iprodione, RP and RP (d) As for different toxicological profile and/or potency the expression of the compounds included in the old residue definition expression as common moiety was not considered appropriate The input values for the dietary exposure assessment were derived from the MRL review under Article 12 (EFSA, 2013), taking into account the MRLs set in Regulation (EU) 2015/400. Thus, crops for which EFSA derived an MRL proposal in the MRL review (EFSA, 2013) but where the proposed MRLs were not taken over in Regulation (EU) 2015/400, were excluded from the assessment (hazelnuts/cobnuts, celeriac, swedes, turnips, kales, kohlrabies, land cress, asparagus, fennels, artichokes, leeks, herbal infusion (dried flowers and leaves), spices (seeds, roots or rhizome), poultry muscle), assuming that the uses are no longer relevant or have been withdrawn in the meantime. 5 EFSA Supporting publication 2018:EN-1404

6 EFSA Journal Page 6 of 24 For crops, where residue trials reflecting the critical GAP were available, the derived supervised trial median residue (STMR) was used for the chronic risk assessment; in the acute risk assessment the highest residue (HR) value was used for case 2a/2b; for commodities that are usually bulked or blended (case 3 of ), the STMR was used. 2 For crops, where no supervised residue trials were available, the existing MRL was used as an input value in the chronic and acute risk assessment. The input values used are listed in Appendix A. No additional input parameters were included in the EFSA PRIMo revision 3 that would allow further refined calculations for unprocessed products (e.g. peeling factors, empirical variability factors). For processed products, the default processing factors implemented in the PRIMo tool were used (EFSA, 2018), except for wine, where an indicative processing factor derived in the framework of the MRL review (EFSA, 2013) was used. 3. Assessment EFSA calculated two scenarios: Scenario 1 was calculated including all risk assessment values listed in Appendix A. In Scenario 2, the commodities which lead to an exceedance of the ARfD in scenario 1 were excluded (these commodities are shaded in Appendix A in orange) 3.1. Results for Scenario 1 The assessment resulted in an exceedance of the ARfD for 27 unprocessed crops (i.e. table grapes, broccoli, lettuces, peaches, pears, apples, carrots, escaroles, blackberries, raspberries, head cabbages, tomatoes, sweet peppers, lemons, strawberries, kiwi fruit, cucumbers, melons, apricots, aubergines, watermelons, cherries, courgettes currants, plums, wine grapes and blueberries). The exceedance ranged from 1872% to 102% of the ARfD. For the remaining unprocessed products (see Appendix B) the short term exposure did not exceed the ARfD. The ARfD was exceeded for 11 processed commodities (boiled broccoli, boiled escaroles and endives, boiled head cabbages, currants juice, carrot juice, canned peach, grape juice, raspberry juice, boiled witloof, boiled pumpkin, boiled courgettes), ranging from 3282% to 100% of the ARfD. Using the indicative processing factor (0.29) derived for wine grape/wine during the MRL review (EFSA, 2013) wine does not exceed the ARfD (70%). The estimated long term dietary intake was in the range of 0% to 276% of the ADI; for three diets the long term exposure exceeded the ADI (i.e. NL toddler (276% of the ADI), DE child (184% of the ADI) and NL child (130% of the ADI). The main contributors to the overall chronic exposure were commodities, which exceeded the ARfD in the acute risk assessment (broccoli, apples and carrots). More detailed results of the assessment are presented in Appendix B Results for Scenario 2 Excluding the 27 commodities which lead to an exceedance of the ARfD in Scenario 1, the result of the chronic exposure calculation dropped below 100% of the ADI, ranging from 1% to 19%. The highest result for the chronic assessment in Scenario 2 were identified for the diet NL toddler with the three highest contributors being cattle milk and rice (6%), sugar beet roots (4%). The detailed results for the chronic and acute assessment are presented in Appendix B Limitations of the assessment The results of this assessment have the following main limitations due to the specific framing of the question by the requestor: 2 In the framework of the MRL review under Article 12, usually, the HR values are used for the acute risk assessment of commodities that are bulked or blended (case 3). Only if there is an exceedance of the ARfD, a refined calculation would be performed using the STMR values. 6 EFSA Supporting publication 2018:EN-1404

7 Page 7 of 24 EFSA Journal EFSA used the risk assessment values that reflect the tentative residue definitions derived in the MRL review for plant (RAC) and animal commodities (EFSA, 2013) and for processed commodities the same residue definition as C was used. The exposure calculations were not performed for the residue definitions derived in the framework of the peer review ( new residue definitions ). Metabolite RP was not taken into account under the current assessment. The peer review concluded that the genotoxic potential of metabolite RP could not be excluded (positive in vitro micronucleus (MN) test and equivocal/marginally positive in the in vivo MN test). This metabolite was observed in the plant metabolism studies in all matrices (see Appendix B) and in metabolism studies in goats and poultry, in tissues, milk and eggs (see Appendix D). No assessment was carried out for the metabolite 3,5 dichloroaniline. The likely greater toxicity of this metabolite compared to iprodione was flagged by the MRL review and finally confirmed by the Peer review (ADI: mg/kg bw per day ARfD: mg/kg bw per day), (EFSA, 2016). This metabolite was found in carrot, commodities of the group lettuce and other salad plants and in milk during animal metabolism studies (see Appendix D). It was also found in standard hydrolysis studies under conditions representative for sterilisation, specifically relevant to vegetable preserves (EFSA, 2013) Uncertainties of the assessment The results of this assessment have the following uncertainties Considering that the old residue definition for risk assessment for plant products comprises the parent compound only, and considering that metabolites RP and RP were identified in different plant matrices in metabolism studies in significant amounts (see Appendix B), the results of the follow up assessment are expected to underestimate the exposure, since the metabolites included in the new residue definitions are not covered. In the case of commodities where the follow up MRL assessment was performed with the MRL the discrepancy might be of less relevance, since the MRL is usually higher than the HR or the STMR. For animal products the follow up MRL assessment is expected to be more conservative compared to the new residue definition, because the old residue definition comprises compounds with the common moiety 3,5 dichloroanilin, which would also cover the metabolite RP and other metabolites with this common moiety. During the peer review a data gap for processing studies has been identified for the metabolite PR Thus, currently no information is available whether the metabolite is stable under processing or whether other, potentially toxicologically relevant degradation products are formed under processing. In the conclusion (EFSA, 2016) data gaps for toxicological studies on metabolites were identified including metabolites relevant for consumer exposure i.e. RP 25040, RP This means there is the possibility of underestimation of the exposure to relevant toxic metabolites. (see Appendix B and Appendix D 0). The refinement made in this report for wine is based on an indicative processing factor (EFSA, 2013) and is also affected by the data gap identified for processing studies. The degradation of iprodione to potentially toxic metabolites is not excluded. The effect of peeling and processing on the residue concentrations present in the edible part of the crops have not been taken into account, except the indicative processing factor for wine and for commodities where a default processing factor is implemented in PRIMo. 4. Conclusion and recommendations The current report concludes, taking into account the limitations and uncertainties of the assessment, that the use of existing EU MRLs leads to the exceedance of the acute reference dose for 27 unprocessed commodities and 11 processed commodities. Furthermore, the estimated long term dietary intake assessment shows an exceedance for the ADI. Accounting for the limitations outlined in section 3.3: 7 EFSA Supporting publication 2018:EN-1404

8 EFSA Journal Page 8 of 24 The uses where the ARfD is exceeded are not considered safe; furthermore the chronic exposure was above 100% of the ADI. EFSA performed a second scenario where these commodities leading to an exceedance of the ARfD were excluded. In this scenario, the indicative chronic exposure did not result in an exceedance of the ADI. However, in view of the limitations and uncertainties identified, the outcome of the assessment did not permit EFSA to advise that the residues in the remaining commodities are unlikely to present a risk to consumers. Moreover, EFSA would like to highlight that animals may be exposed to residues of iprodione and its metabolites via feed. Since currently no legal limits are established in the framework of Regulation (EC) No 396/2005 for products that are used exclusively for feed purpose, iprodione related residues in animal products may continue to occur, unless risk management measures are taken to ensure that animal feed does not contain iprodione related residues. References EFSA (European Food Safety Authority), Reasoned opinion on the review of the existing maximum residue levels (MRLs) for iprodione according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(10):3438, 94 pp. doi: /j.efsa EFSA (European Food Safety Authority), Conclusion on the peer review of the pesticide risk assessment of the active sub stance iprodione. EFSA Journal 2016;14(11):4609, 31 pp. doi: /j.efsa EFSA (European Food Safety Authority), Guidance document on the use of the EFSA Pesticide Residue Intake Model (EFSA PRIMo revision 3). EFSA Journal 2018;16(1):5147, 43 pp. doi: /j.efsa France, Renewal Draft Assessment Report (RAR) on iprodione prepared by the rapporteur Member State France in the framework of Regulation (EC) No 844/2012, October Available online: France, Revised renewal assessment report (RAR) on iprodione, August Available online: EFSA Supporting publication 2018:EN-1404

9 Page 9 of 24 EFSA Journal Abbreviations ADI acceptable daily intake ARfD acute reference dose CXL Codex maximum residue limit DALA Days after last application GAP good agricultural practice EU European Union HR highest residue LOQ limit of quantification MN micronucleus MRL maximum residue level MS Member State PAFF Standing Committee on Plants, Animals, Food and Feed PRIMo Pesticide Residue Intake Model RAC Raw agricultural commodity RMS rapporteur Member State STMR supervised trials median residue TRR Total radioactive residues 9 EFSA Supporting publication 2018:EN-1404

10 EFSA Journal Page 10 of 24 Appendix A Input values for the exposure calculations Table 1: Input values for the assessment Chronic risk assessment Acute risk assessment Code Commodity existing/ Source/ Input Comment Input Comment proposed MRL type of MRL value value (mg/kg ) Lemons (a)(e) 6 EU MRL 3.5 STMR RAC 3.8 HR RAC Almonds (e) 0.2 CXL (c) 0.05 STMR RAC 0.18 HR RAC Apples (a) (e) 6 EU MRL 0.95 STMR RAC 4.8 HR RAC Pears (a)(e) 6 EU MRL 0.95 STMR RAC 4.8 HR RAC Quinces (e) 5 CXL (d) 1.7 STMR RAC 2.4 HR RAC Medlar (e) 5 CXL (d) 1.7 STMR RAC 2.4 HR RAC Loquats/Japanese 5 CXL (d) 1.7 STMR RAC 2.4 HR RAC medlars (e) Apricots (a) (e) 6 EU MRL 1.8 STMR RAC 2.5 HR RAC Cherries (sweet) (a)(e) 10 CXL (c) 1.4 STMR RAC 6.5 HR RAC Peaches (a)(b)(e) 10 CXL (c) 2.9 STMR RAC 7.6 HR RAC Plums (a)(e)(e) 3 EU MRL 0.16 STMR RAC 1.45 HR RAC Table grapes (a)(e) 20 EU MRL 3.2 STMR RAC 15.4 HR RAC Wine grapes (a)(b)(e) 20 EU MRL 3.2 STMR RAC 15.4 HR RAC Strawberries (a)(e) 20 EU MRL 2.6 STMR RAC 12 HR RAC Blackberries (a)(e) 30 CXL (c) 9.45 STMR RAC 31 HR RAC Dewberries (e) 15 EU MRL 3.45 STMR RAC 7.7 HR RAC Raspberries (red (a) (b) and yellow) 30 CXL 9.45 STMR RAC 31 HR RAC (e) Blueberries (a) (e) 20 EU MRL 8.15 STMR RAC 9.25 HR RAC Cranberries (e) 20 EU MRL 8.15 STMR RAC 9.25 HR RAC Currants (red, black and white) (a) (b) 20 EU MRL 8.15 STMR RAC 9.25 HR RAC Gooseberries 20 EU MRL 8.15 STMR RAC 9.25 HR RAC (green, red and yellow) (e) Azarole/Mediteran 20 EU MRL 8.15 STMR RAC 9.25 HR RAC ean medlar (e) Kiwi fruits (green, 5 EU MRL 1.2 STMR RAC 2.4 HR RAC red, yellow) (a) (e) Potatoes (e) 0.05 EU MRL 0.05 STMR RAC 0.05 HR RAC Beetroots (e) 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC Carrots (a) (b) (e) 10 CXL (c) 5.6 STMR RAC 8 HR RAC Horseradishes (e) 0.06 EU MRL 0.05 STMR RAC HR RAC Parsnips (e) 0.5 EU MRL 0.14 STMR RAC 0.23 HR RAC Parsley 0.5 EU MRL 0.14 STMR RAC 0.23 HR RAC roots/hamburg roots parsley (e) Radishes (e) 0.6 EU MRL 0.18 STMR RAC 0.28 HR RAC Garlic (e) 0.4 EU MRL STMR RAC 0.14 HR RAC Onions (e) 0.2 EU MRL 0.02 STMR RAC 0.11 HR RAC Shallots (e) 0.2 EU MRL 0.02 STMR RAC 0.11 HR RAC 10 EFSA Supporting publication 2018:EN-1404

11 Page 11 of 24 EFSA Journal Code Commodity existing/ proposed MRL Spring onions/green onions and Welsh onions (e) Chronic risk assessment Acute risk assessment Source/ Input Comment Input Comment type of value value MRL (mg/kg ) 4 EU MRL 0.78 STMR RAC 1.87 HR RAC Tomatoes (a) (e) 5 CXL (c) 1.1 STMR RAC 4.2 HR RAC Sweet 7 EU MRL 2 STMR RAC 3.9 HR RAC peppers/bell (a) (e) peppers Aubergines/egg 6 EU MRL 1.5 STMR RAC 3.4 HR RAC plants (a) (e) Cucumbers (a) (e) 4 EU MRL 1.3 STMR RAC 1.7 HR RAC Gherkins (e) 4 EU MRL 1.3 STMR RAC 1.7 HR RAC Courgettes (a) (b) (e) 4 EU MRL 1.3 STMR RAC 1.7 HR RAC Melons (a) (e) 1.5 EU MRL 0.17 STMR RAC 0.68 HR RAC Pumpkins (b) (e) 1.5 EU MRL 0.17 STMR RAC 0.68 HR RAC Watermelons (a) (e) 1.5 EU MRL 0.17 STMR RAC 0.68 HR RAC Broccoli (a) (b) (e) 25 CXL (c) 25 STMR RAC 25 HR RAC Cauliflowers (e) 0.5 EU MRL 0.05 STMR RAC 0.33 HR RAC Brussels sprouts (e) 0.7 EU MRL 0.24 STMR RAC 0.27 HR RAC Head cabbages (a) 15 EU MRL 0.94 STMR RAC 5.9 HR RAC (b) (e) Chinese 0.7 EU MRL 0.05 STMR RAC 0.37 HR RAC cabbages/petsai Lamb's 20 EU MRL 4.9 STMR RAC 8.8 HR RAC lettuce/corn salads (e) Lettuces (a) (e) 25 CXL (c) 4.8 STMR RAC 22 HR RAC Escaroles/broadleaved endives (a) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC (b) (e) 8.8 HR RAC Cress and other 7 EU MRL 0.08 STMR RAC sprouts and shoots (e) Roman 20 EU MRL 4.9 STMR RAC rocket/rucola (e) Baby leaf crops 20 EU MRL 4.9 STMR RAC 8.8 HR RAC (including brassica species) (e) Spinaches 0.02 EU MRL 0.02 STMR RAC 0.02 HR RAC Chards/beet 0.02 EU MRL 0.02 STMR RAC 0.02 HR RAC leaves Witloofs/Belgian 3 EU MRL 0.91 STMR RAC 1.42 HR RAC endives (b) (e) Chervil (e) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC Chives (e) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC Celery leaves (e) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC Parsley (e) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC Sage (e) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC Rosemary (e) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC Thyme (e) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC Basil and edible flowers (e) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC 11 EFSA Supporting publication 2018:EN-1404

12 EFSA Journal Page 12 of 24 Chronic risk Acute risk assessment assessment Code Commodity existing/ Source/ Input Comment Input Comment proposed MRL type of MRL value value (mg/kg ) Laurel/bay 20 EU MRL 4.9 STMR RAC 8.8 HR RAC leaves (e) Tarragon (e) 20 EU MRL 4.9 STMR RAC 8.8 HR RAC Beans (with pods) 2 CXL 0.21 STMR RAC 1.3 HR RAC (e) Beans (without 0.08 EU MRL 0.02 STMR RAC 0.04 HR RAC pods) (e) Peas (with pods) 2 EU MRL 0.48 STMR RAC 0.9 HR RAC (e) Peas (without 0.3 EU MRL 0.3 STMR RAC 0.3 HR RAC pods) (e) Rhubarbs (e) 0.15 EU MRL 0.06 STMR RAC 0.08 HR RAC Beans (e) 0.4 EU MRL STMR RAC STMR RAC Lentils (e) 0.4 EU MRL STMR RAC STMR RAC Peas (e) 0.2 EU MRL STMR RAC STMR RAC Linseeds (e) 0.06 EU MRL 0.02 STMR RAC 0.02 STMR RAC Sunflower seeds (e) 0.5 CXL (d) STMR RAC STMR RAC Rapeseeds/canola 0.5 EU MRL 0.5 STMR RAC 0.5 STMR RAC seeds (e) Barley (e) 2 CXL (c) 0.4 STMR RAC 0.4 STMR RAC Rice (e) 10 CXL (c) 0.82 STMR RAC 0.82 STMR RAC Valerian root (e) 2 EU MRL 2 MRL 2 HR RAC Ginseng root (e) 2 EU MRL 2 MRL 2 HR RAC Sugar beet roots (e) 0.1 CXL 0.1 STMR RAC 0.1 HR RAC Swine: 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC Muscle/meat (f) Swine: Fat tissue (f) 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC Swine: Liver (f) 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC Swine: Kidney (f) 0.1 EU MRL 0.3 STMR RAC 0.3 HR RAC Bovine: 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC Muscle/meat (f) Bovine: Fat 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC tissue (f) Bovine: Liver (f) 0.2 EU MRL 0.12 STMR RAC 0.17 HR RAC Bovine: Kidney (f) 0.3 EU MRL 0.45 STMR RAC 0.63 HR RAC Sheep: 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC Muscle/meat (f) Sheep: Fat 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC tissue (f) Sheep: Liver (f) 0.2 EU MRL 0.12 STMR RAC 0.17 HR RAC Sheep: Kidney (f) 0.3 EU MRL 0.45 STMR RAC 0.63 HR RAC Goat: 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC Muscle/meat (f) Goat: Fat tissue (f) 0.1 EU MRL 0.1 STMR RAC 0.1 HR RAC Goat: Liver (f) 0.2 EU MRL 0.12 STMR RAC 0.17 HR RAC Goat: Kidney (f) 0.3 EU MRL 0.15 STMR RAC 0.21 HR RAC Poultry: Fat 0.2 EU MRL 0.1 STMR RAC 0.14 HR RAC tissue (f) Poultry: Liver (f) 1 EU MRL 0.11 STMR RAC 0.51 HR RAC Milk: Cattle (f) 0.1 EU MRL 0.02 STMR RAC 0.02 STMR RAC Milk: Sheep (f) 0.1 EU MRL 0.02 STMR RAC 0.02 STMR RAC 12 EFSA Supporting publication 2018:EN-1404

13 Page 13 of 24 EFSA Journal Code Commodity existing/ Source/ proposed type of MRL MRL Milk: Goat (f) Eggs: Chicken (f) Eggs: Duck (f) Eggs: Goose (f) Eggs: Quail (f) EU MRL EU MRL EU MRL EU MRL EU MRL Chronic risk Acute risk assessment assessment Input Comment Input Comment value value (mg/kg ) 0.02 STMR RAC 0.02 STMR RAC 0.1 MRL 0.1 HR RAC 0.1 MRL 0.1 HR RAC 0.1 MRL 0.1 HR RAC 0.1 MRL 0.1 HR RAC (a): Commodities (highlighted in orange) were excluded in Scenario 2, due to the exceedances of the ARfD noted in scenario 1 (b): Commodities (highlighted in orange) were excluded in Scenario 2, due to the exceedances of the ARfD for processed products noted in scenario 1 (c): MRL was derived from the CXL, which was considered not sufficiently supported by data but for which no risk to consumers was identified in 2013 (EFSA, 2013); in addition a GAP was available at EU level, which was also not fully supported by data, but which would have led to a lower tentative MRL. (d): MRL was derived from the CXL, which was considered not sufficiently supported by data but for which no risk to consumers was identified; there are no relevant authorisations or import tolerances reported at EU level (e): Information on storage stability, analytical methods, crop metabolism and residue trials were found to be unavailable (deadline for data submission ). (f): Information on analytical and/or confirmatory methods and a feeding study unavailable (deadline for data submission ) EFSA Supporting publication 2018:EN-1404

14 EFSA Journal Page 14 of 24 Appendix B Pesticide Residue Intake Model (PRIMo) Scenario 1 Comments: Iprodione LOQs range from: 0.01 to: 0.05 Toxicological reference values ADI (mg/kg bw/day): 0.02 ARfD (mg/kg bw): 0.06 Source of ADI: Year of evaluation: Source of ARfD: Year of evaluation: Input values Details - chronic risk Supplementary results - assessment chronic risk assessment Details - acute risk Details - acute risk assessment/children assessment/adults Refined calculation mode Chronic risk assessment: JMPR methodology (IEDI/TMDI) TMDI/NEDI/IEDI calculation (based on average food consumption) Calculated exposure (% of ADI) MS Diet No of diets exceeding the ADI : 3 Exposure resulting from MRLs set at commodities not the LOQ under assessment Expsoure Highest contributor to 2nd contributor to MS 3rd contributor to MS (in % of ADI) (in % of ADI) (Ig/kg bw per MS diet Commodity / diet Commodity / diet Commodity / day) (in % of ADI) group of commodities (in % of ADI) group of commodities (in % of ADI) group of commodities 276% NL toddler % Broccoli 51% Apples 30% Carrots 184% DE child % Apples 29% Carrots 22% Table grapes 130% NL child % Apples 17% Table grapes 15% Broccoli 98% IE adult % Broccoli 20% Wine grapes 9% Carrots 92% GEMS/Food G % Carrots 16% Wine grapes 8% Broccoli 92% PT general % Wine grapes 19% Carrots 5% Peaches 91% DK child % Carrots 11% Apples 11% Cucumbers 89% GEMS/Food G % Wine grapes 13% Carrots 6% Tomatoes 89% GEMS/Food G % Wine grapes 12% Carrots 9% Broccoli 89% GEMS/Food G % Tomatoes 17% Table grapes 6% Rice 86% RO general % Wine grapes 13% Carrots 11% Tomatoes 83% SE general % Carrots 10% Broccoli 10% Lettuces 83% GEMS/Food G % Wine grapes 12% Carrots 7% Tomatoes 79% FI 3 yr % Carrots 11% Broccoli 9% Raspberries (red and yellow) 79% DE women yr % Wine grapes 12% Apples 9% Carrots 76% FR toddler 2 3 yr % Carrots 15% Apples 14% Broccoli 73% DE general % Wine grapes 12% Apples 7% Carrots 72% GEMS/Food G % Lettuces 8% Carrots 8% Tomatoes 71% UK infant % Carrots 7% Apples 4% Milk: Cattle 70% FR infant % Carrots 17% Broccoli 8% Apples 68% FR child 3 15 yr % Carrots 8% Apples 6% Broccoli 65% UK toddler % Carrots 8% Apples 8% Broccoli 65% FR adult % Wine grapes 6% Carrots 4% Apples 58% NL general % Wine grapes 7% Broccoli 7% Apples 56% DK adult % Wine grapes 14% Carrots 5% Apples 54% FI 6 yr % Carrots 6% Raspberries (red and yellow) 5% Cucumbers 51% UK vegetarian % Wine grapes 11% Broccoli 6% Carrots 48% UK adult % Wine grapes 9% Broccoli 5% Carrots 47% ES adult % Lettuces 7% Wine grapes 4% Tomatoes 45% IT adult % Lettuces 6% Tomatoes 5% Peaches 44% IT toddler % Tomatoes 7% Lettuces 5% Carrots 43% ES child % Lettuces 5% Apples 5% Tomatoes 41% PL general % Apples 8% Carrots 5% Table grapes 38% FI adult % Carrots 5% Wine grapes 3% Lettuces 30% LT adult % Apples 5% Carrots 3% Tomatoes 20% IE child % Broccoli 5% Carrots 2% Apples Conclusion: The estimated TMDI/NEDI/IEDI was in the range of 0 % to % of the ADI. For 3 diet(s) the ADI is exceeded EFSA Supporting publication 2018:EN-1404

15 Page 15 of 24 EFSA Journal Acute risk assessment /children Acute risk assessment / adults / general population Details - acute risk assessment /children Details - acute risk assessment/adults The acute risk assessment is based on the ARfD. The calculation is based on the large portion of the most critical consumer group. Show results for all crops Unprocessed commodities Results for children No. of commodities for which ARfD/ADI is exceeded (): Results for adults No. of commodities for which ARfD/ADI is exceeded 25 (): 19 Highest % of ARfD/ADI Commodities Exposure (Ig/kg bw) Highest % of ARfD/ADI Commodities 1872% Table grapes 20 / % Broccoli 25 / % Broccoli 25 / % Table grapes 20 / % Lettuces 25 / % Wine grapes 20 / % Peaches 10 / % Lettuces 25 / % Pears 6 / % Blackberries 30 / % Apples 6 / % Head cabbages 15 / % Carrots 10 / % Escaroles/broad leaved 20 / % Escaroles/broad leaved 20 / % Raspberries (red and yellow) 30 / % Blackberries 30 / % Carrots 10 / % Raspberries (red and 30 / % Pears 6 / % Head cabbages 15 / % Peaches 10 / % Tomatoes 5 / % Apples 6 / % Sweet peppers/bell peppers 7 / % Strawberries 20 / % Lemons 6 / % Blueberries 20 / % Strawberries 20 / % Aubergines/egg plants 6 / % Kiwi fruits (green, red, 5 / % Tomatoes 5 / % Cucumbers 4 / % Cherries (sweet) 10 / % Melons 1.5 / % Sweet peppers/bell peppers 7 / % Apricots 6 / % Currants (red, black and 20 / % Aubergines/egg plants 6 / % Cucumbers 4 / % Watermelons 1.5 / % Gooseberries (green, red 20 / % Cherries (sweet) 10 / % Courgettes 4 / % Courgettes 4 / % Quinces 5 / % Currants (red, black and 20 / % Lemons 6 / % Plums 3 / % Kiwi fruits (green, red, 5 / % Quinces 5 / % Plums 3 / % Witloofs/Belgian endives 3 / % Watermelons 1.5 / % Gooseberries (green, red 20 / % Apricots 6 / % Blueberries 20 / % Melons 1.5 / % Medlar 5 / % Witloofs/Belgian endives 3 / % Spring onions/green onions 4 / % Lamb's lettuce/corn salads 20 / % Lamb's lettuce/corn salads 20 / % Medlar 5 / % Cranberries 20 / % Dewberries 15 / % Roman rocket/rucola 20 / % Parsley 20 / % Cauliflowers 0.5 / % Roman rocket/rucola 20 / % Pumpkins 1.5 / % Gherkins 4 / % Dewberries 15 / % Pumpkins 1.5 / % Chinese cabbages/pe tsai 0.7 / % Chinese cabbages/pe tsai 0.7 / % Beans (with pods) 2 / % Spring onions/green onions 4 / % Chervil 20 / % Poultry: Edible offals (other 1 / % Rice 10 / % Cauliflowers 0.5 / % Parsley 20 / % Rice 10 / % Azarole/Mediteranean 20 / % Parsnips 0.5 / % Parsnips 0.5 / % Radishes 0.6 / % Potatoes 0.05 / % Peas (with pods) 2 / % Chives 20 / % Poultry: Liver 1 / % Radishes 0.6 / % Parsley roots/hamburg roots 0.5 / % Sage 20 / % Barley 2 / % Basil and edible flowers 20 / % Sage 20 / % Gherkins 4 / % Onions 0.2 / % Beetroots 4.4 2% Chives 20 / % Peas (with pods) 2 / % Potatoes 0.05 / % Rhubarbs 0.15 / % Bovine: Kidney 0.3 / % Onions 0.2 / % Brussels sprouts 0.7 / % Milk: Cattle 0.1 / % Beetroots 1.2 4% Peas (without pods) 0.3 / % Valerian root 2 / % Bovine: Kidney 0.3 / % Valerian root 2 / % Brussels sprouts 0.7 / % Poultry: Muscle 1.2 4% Barley 2 / % Celery leaves 20 / % Bovine: Edible offals (other 0.3 / % Bovine: Edible offals (other 0.3 / % Poultry: Muscle/meat 1.7 2% Peas (without pods) 0.3 / % Celery leaves 20 / % Tarragon 20 / % Beans 0.4 / % Rosemary 20 / % Bovine: Liver 0.2 / % Rosemary 20 / % Eggs: Chicken 1.2 1% Rosemary 20 / % Swine: Muscle/meat 1.2 1% Rosemary 20 / % Parsley roots/hamburg 0.5 / % Milk: Cattle 0.1 / Exposure (Ig/kg bw) 15 EFSA Supporting publication 2018:EN-1404

16 EFSA Journal Page 16 of 24 Unprocessed commodities Results for children No. of commodities for which ARfD/ADI is exceeded (): 25 Highest % of ARfD/ADI Commodities 2% Swine: Muscle/meat 2% Parsley roots/hamburg 0.5 / % Bovine: Muscle/meat 1% Other farmed animals: 1% Rapeseeds/canola seeds 0.5 / 0.5 1% Equine: Muscle/meat 0.9% Poultry: Liver 1 / % Thyme 20 / % Lentils 0.4 / % Almonds 0.2 / % Garlic 0.4 / % Milk: Goat 0.1 / % Spinaches 0.02 / % Sheep: Muscle/meat 0.7% Valerian root 2 / 2 0.7% Valerian root 2 / 2 0.6% Swine: Kidney 0.1 / % Beans (without pods) 0.08 / % Chards/beet leaves 0.02 / % Swine: Edible offals (other 0.4% Rosemary 20 / % Peas 0.2 / % Bovine: Fat tissue 0.3% Sunflower seeds 0.5 / % Swine: Fat tissue 0.2% Swine: Liver 0.1% Laurel/bay leaves 20 / % Milk: Sheep 0.1 / % Shallots 0.2 / % Wine grapes 20 / % Linseeds 0.06 / % Horseradishes 0.06 / % Poultry: Fat tissue 0.2 / 0.14 Exposure (Ig/kg bw) Total number of commodities exceeding the ARfD/ADI in children and adult diets ( calculation) 25 Results for adults No. of commodities for which ARfD/ADI is exceeded (): 19 Highest % of ARfD/ADI Commodities 1% Rosemary 1% Milk: Cattle 1% Rhubarbs 1% Chervil 1% Bovine: Liver 1% Swine: Kidney 0.9% Bovine: Muscle 0.9% Other farmed animals: 0.9% Beans 0.8% Lentils 0.8% Equine: Muscle/meat 0.8% Sheep: Liver 0.8% Swine: Muscle/meat 0.7% Eggs: Chicken 0.7% Sheep: Muscle/meat 0.6% Horseradishes 0.6% Milk: Goat 0.5% Swine: Other products 0.5% Milk: Sheep 0.5% Shallots 0.4% Rapeseeds/canola seeds 0.4% Swine: Edible offals (other 0.4% Chards/beet leaves 0.3% Sheep: Edible offals (other 0.3% Swine: Fat tissue 0.3% Almonds 0.3% Beans (without pods) 0.3% Goat: Muscle 0.2% Swine: Liver 0.2% Eggs: Quail 0.2% Peas 0.2% Bovine: Fat tissue 0.2% Garlic 0.1% Spinaches 0.1% Sunflower seeds 0.1% Sheep: Kidney 0.08% Eggs: Goose 0.07% Poultry: Fat tissue 0.06% Purslanes 0.02% Linseeds 0.00% Beans (with pods) 20 / / / / / / / / / / / / / / / / / / / / / / / / / / / 1.3 Exposure (Ig/kg bw) Processed commodities Results for children No of processed commodities for which ARfD/ADI is exceeded (): Highest % of ARfD/ADI Results for adults No of processed commodities for which ARfD/ADI 11 is exceeded (): 5 Exposure Highest % of Exposure Processed commodities (Ig/kg bw) ARfD/ADI Processed commodities (Ig/kg bw) 3282% Broccoli / boiled 25 / % Broccoli / boiled 25 / % Escaroles/broad leaved endiv 20 / % Escaroles/broad leaved 20 / % Head cabbages / boiled 15 / % Currants (red, black and 20 / % Currants (red, black and whit 20 / % Peaches / canned 10 / % Carrots / juice 10 / % Wine grapes / juice 20 / % Peaches / canned 10 / % Carrots / canned 10 / % Wine grapes / juice 20 / % Wine grapes / wine 20 / % Raspberries / juice 30 / % Courgettes / boiled 4 / % Witloofs / boiled 3 / % Pumpkins / boiled 1.5 / % Pumpkins / boiled 1.5 / % Apples / juice 6 / % Courgettes / boiled 4 / % Witloofs / boiled 3 / % Apples / juice 6 / % Cauliflowers / boiled 0.5 / % Peaches / juice 10 / % Lemons / juice 6 / % Cranberries / juice 20 / % Cranberries / dried 20 / % Azarole (mediteranean medla 20 / % Table grapes / raisins 20 / % Gherkins / pickled 4 / % Head cabbages / canned 15 / % Blueberries / processed (not 20 / % Sugar beets (root) / sugar 0.1 / % Pears / juice 6 / % Tomatoes / sauce/puree 5 / % Cauliflowers / boiled 0.5 / % Rice / milling (polishing) 10 / % Kiwi fruits / juice 5 / % Peas (with pods) / boiled 2 / % Tomatoes / juice 5 / % Barley / beer 2 / % Beans (with pods) / boiled 2 / % Beetroots / boiled % Parsnips / boiled 0.5 / % Quinces / jam 5 / % Sugar beets (root) / sugar 0.1 / % Rhubarbs / sauce/puree 0.15 / % Lemons / jam 6 / % Onions / boiled 0.2 / % Quinces / jam 5 / % Peas (without pods) / boiled 0.3 / EFSA Supporting publication 2018:EN-1404

17 Page 17 of 24 EFSA Journal Processed commodities Results for children No of processed commodities for which ARfD/ADI is exceeded (): Highest % of ARfD/ADI Results for adults No of processed commodities for which ARfD/ADI 11 is exceeded (): 5 Highest % of ARfD/ADI Processed commodities Exposure (Ig/kg bw) Exposure Processed commodities (Ig/kg bw) 8% Rice / milling (polishing) 10 / % Shallots / boiled 0.2 / % Potatoes / fried 0.05 / % Beans / canned 0.4 / % Beetroots / boiled % Potatoes / dried (flakes) 0.05 / % Rhubarbs / sauce/puree 0.15 / % Chards/beet leaves / boiled 0.02 / % Potatoes / dried (flakes) 0.05 / % Beans (without pods) / boiled 0.08 / % Brussels sprouts / boiled 0.7 / % Spinaches / frozen 0.02 / % Peas (without pods) / canned 0.3 / % Potatoes / chips 0.05 / % Shallots / boiled 0.2 / % Peas / canned 0.2 / % Plums / juice 3 / % Purslanes / boiled 0.02 / % Barley / cooked 2 / % Valerian root / infusion 2 / % Rapeseeds / processed (not 0.5 / % Barley / milling (flour) 2 / % Spinaches / frozen 0.02 / % Lentils / boiled 0.4 / % Chards/beet leaves / boiled 0.02 / % Peas / canned 0.2 / % Sunflower seeds / oils 0.5 / Conclusion: The estimated short term intake () exceeded the toxicological reference value for 25 commodities. For processed commodities, the toxicological reference value was exceeded in one or several cases EFSA Supporting publication 2018:EN-1404

18 EFSA Journal Page 18 of 24 Appendix B Pesticide Residue Intake Model (PRIMo) Scenario 2 Comments: Iprodione LOQs range from: 0.01 to: 0.05 Toxicological reference values ADI (mg/kg bw/day): 0.02 ARfD (mg/kg bw): 0.06 Source of ADI: Year of evaluation: Source of ARfD: Year of evaluation: Input values Details - chronic risk Supplementary results - assessment chronic risk assessment Details - acute risk Details - acute risk assessment/children assessment/adults Refined calculation mode Chronic risk assessment: JMPR methodology (IEDI/TMDI) TMDI/NEDI/IEDI calculation (based on average food consumption) Calculated exposure (% of ADI) MS Diet No of diets exceeding the ADI : Exposure resulting from MRLs set at commodities not the LOQ under assessment Expsoure Highest contributor to 2nd contributor to MS 3rd contributor to MS (in % of ADI) (in % of ADI) (Ig/kg bw per MS diet Commodity / diet Commodity / diet Commodity / day) (in % of ADI) group of commodities (in % of ADI) group of commodities (in % of ADI) group of commodities 19% NL toddler % Milk: Cattle 3% Sugar beet roots 3% Rice 14% GEMS/Food G % Rice 1% Barley 1% Parsley 13% GEMS/Food G % Rice 0.8% Gherkins 0.7% Sugar beet roots 12% NL child % Sugar beet roots 2% Milk: Cattle 1% Rapeseeds/canola seeds 12% UK infant % Milk: Cattle 3% Rice 0.9% Peas (without pods) 12% GEMS/Food G % Barley 2% Lamb's lettuce/corn salads 1% Rice 12% FR toddler 2 3 yr % Milk: Cattle 2% Rice 1% Sugar beet roots 12% FR child 3 15 yr % Milk: Cattle 2% Sugar beet roots 2% Rice 11% DE child % Milk: Cattle 1% Rice 1.0% Other herbs 10% SE general % Bovine: Muscle/meat 2% Rice 1% Milk: Cattle 10% GEMS/Food G % Rice 1% Rapeseeds/canola seeds 1% Barley 10% GEMS/Food G % Barley 1% Rice 0.9% Potatoes 10% UK toddler % Rice 2% Milk: Cattle 2% Sugar beet roots 10% GEMS/Food G % Lamb's lettuce/corn salads 2% Barley 1% Rice 8% DE general % Sugar beet roots 1% Milk: Cattle 1% Barley 7% ES child % Rice 1% Milk: Cattle 0.7% Bovine: Muscle/meat 7% DE women yr % Sugar beet roots 1% Milk: Cattle 0.5% Lamb's lettuce/corn salads 7% NL general % Sugar beet roots 0.8% Milk: Cattle 0.7% Rapeseeds/canola seeds 7% IE adult % Rice 0.8% Basil and edible flowers 0.6% Potatoes 6% RO general % Milk: Cattle 1% Rice 0.9% Potatoes 6% DK child % Milk: Cattle 1% Rice 1% Swine: Muscle/meat 5% PT general % Rice 1% Potatoes 0.3% Peas (without pods) 5% FR infant % Milk: Cattle 0.7% Sugar beet roots 0.5% Beans (with pods) 5% ES adult % Rice 1.0% Barley 0.5% Milk: Cattle 5% FI 3 yr % Rice 1% Potatoes 0.5% Gooseberries (green, red and yellow) 4% FR adult % Rice 0.5% Lamb's lettuce/corn salads 0.4% Milk: Cattle 4% UK adult % Rice 0.3% Potatoes 0.3% Bovine: Muscle/meat 4% UK vegetarian % Rice 0.3% Potatoes 0.3% Milk: Cattle 3% FI 6 yr % Rice 1.0% Potatoes 0.1% Gooseberries (green, red and yellow) 3% LT adult % Rice 0.8% Potatoes 0.5% Swine: Muscle/meat 3% PL general % Gooseberries (green, red and yellow) 0.9% Potatoes 0.2% Celery leaves 3% IT adult % Other herbs 0.7% Rice 0.3% Parsley 3% IT toddler % Other herbs 0.8% Rice 0.2% Potatoes 3% DK adult % Milk: Cattle 0.4% Swine: Muscle/meat 0.3% Rice 2% IE child % Rice 0.4% Milk: Cattle 0.2% Potatoes 1% FI adult % Rice 0.3% Potatoes 0.2% Gooseberries (green, red and yellow) Conclusion: The estimated long term dietary intake (TMDI/NEDI/IEDI) was below the ADI. The long term intake of residues of Iprodione is unlikely to present a public health concern EFSA Supporting publication 2018:EN-1404

19 Page 19 of 24 EFSA Journal Acute risk assessment /children Acute risk assessment / adults / general population Details - acute risk assessment /children Details - acute risk assessment/adults The acute risk assessment is based on the ARfD. The calculation is based on the large portion of the most critical consumer group. Show results for all crops Unprocessed commodities Results for children No. of commodities for which ARfD/ADI is exceeded (): Highest % of ARfD/ADI Results for adults No. of commodities for which ARfD/ADI is exceeded (): Exposure Highest % of Commodities (Ig/kg bw) ARfD/ADI Commodities 98% Quinces 5 / % Gooseberries (green, red 20 / % Gooseberries (green, red 20 / % Quinces 5 / % Medlar 5 / % Lamb's lettuce/corn salads 20 / % Spring onions/green onions 4 / % Medlar 5 / % Lamb's lettuce/corn salads 20 / % Dewberries 15 / % Cranberries 20 / % Parsley 20 / % Roman rocket/rucola 20 / % Roman rocket/rucola 20 / % Cauliflowers 0.5 / % Gherkins 4 / % Dewberries 15 / % Chinese cabbages/pe tsai 0.7 / % Chinese cabbages/pe tsai 0.7 / % Spring onions/green onions 4 / % Beans (with pods) 2 / % Poultry: Edible offals (other 1 / % Chervil 20 / % Cauliflowers 0.5 / % Rice 10 / % Rice 10 / % Parsley 20 / % Parsnips 0.5 / % Azarole/Mediteranean 20 / % Radishes 0.6 / % Parsnips 0.5 / % Peas (with pods) 2 / % Potatoes 0.05 / % Poultry: Liver 1 / % Chives 20 / % Parsley roots/hamburg roots 0.5 / % Radishes 0.6 / % Barley 2 / % Sage 20 / % Sage 20 / % Basil and edible flowers 20 / % Onions 0.2 / % Gherkins 4 / % Chives 20 / % Beetroots 4.4 2% Potatoes 0.05 / % Peas (with pods) 2 / % Bovine: Kidney 0.3 / % Rhubarbs 0.15 / % Brussels sprouts 0.7 / % Onions 0.2 / % Beetroots 1.2 4% Milk: Cattle 0.1 / % Valerian root 2 / % Peas (without pods) 0.3 / % Valerian root 2 / % Bovine: Kidney 0.3 / % Poultry: Muscle 1.2 4% Brussels sprouts 0.7 / % Celery leaves 20 / % Barley 2 / % Bovine: Edible offals (other 0.3 / % Bovine: Edible offals (other 0.3 / % Peas (without pods) 0.3 / % Poultry: Muscle/meat 1.7 1% Tarragon 20 / % Celery leaves 20 / % Rosemary 20 / % Beans 0.4 / % Rosemary 20 / % Bovine: Liver 0.2 / % Rosemary 20 / % Eggs: Chicken 1.2 1% Rosemary 20 / % Swine: Muscle/meat 1.2 1% Milk: Cattle 0.1 / % Parsley roots/hamburg 0.5 / % Rhubarbs 0.15 / % Bovine: Muscle/meat % Chervil 20 / % Other farmed animals: % Bovine: Liver 0.2 / % Rapeseeds/canola seeds 0.5 / % Swine: Kidney 0.1 / % Equine: Muscle/meat % Bovine: Muscle % Poultry: Liver 1 / % Other farmed animals: % Thyme 20 / % Beans 0.4 / % Lentils 0.4 / % Lentils 0.4 / % Almonds 0.2 / % Equine: Muscle/meat % Garlic 0.4 / % Sheep: Liver 0.2 / % Milk: Goat 0.1 / % Swine: Muscle/meat % Spinaches 0.02 / % Eggs: Chicken % Sheep: Muscle/meat % Sheep: Muscle/meat % Valerian root 2 / % Horseradishes 0.06 / % Valerian root 2 / % Milk: Goat 0.1 / % Swine: Kidney 0.1 / % Swine: Other products % Beans (without pods) 0.08 / % Milk: Sheep 0.1 / % Chards/beet leaves 0.02 / % Shallots 0.2 / % Swine: Edible offals (other % Rapeseeds/canola seeds 0.5 / % Rosemary 20 / % Swine: Edible offals (other % Peas 0.2 / % Chards/beet leaves 0.02 / % Bovine: Fat tissue % Sheep: Edible offals (other 0.3 / % Sunflower seeds 0.5 / % Swine: Fat tissue % Swine: Fat tissue % Almonds 0.2 / % Swine: Liver % Beans (without pods) 0.08 / % Laurel/bay leaves 20 / % Goat: Muscle 0.16 Exposure (Ig/kg bw) 19 EFSA Supporting publication 2018:EN-1404

20 EFSA Journal Page 20 of 24 Unprocessed commodities Processed commodities Results for children No. of commodities for which ARfD/ADI is exceeded (): Highest % of ARfD/ADI Results for adults No. of commodities for which ARfD/ADI is exceeded (): Exposure Highest % of Commodities (Ig/kg bw) ARfD/ADI Commodities 0.1% Milk: Sheep 0.1 / % Swine: Liver % Shallots 0.2 / % Eggs: Quail % Linseeds 0.06 / % Peas 0.2 / % Horseradishes 0.06 / % Bovine: Fat tissue % Poultry: Fat tissue 0.2 / % Garlic 0.4 / % Spinaches 0.02 / % Sunflower seeds 0.5 / % Sheep: Kidney 0.3 / % Eggs: Goose % Poultry: Fat tissue 0.2 / % Purslanes 0.02 / % Linseeds 0.06 / % Beans (with pods) 2 / Total number of commodities exceeding the ARfD/ADI in children and adult diets ( calculation) Results for children No of processed commodities for which ARfD/ADI is exceeded (): Highest % of ARfD/ADI 1 Exposure (Ig/kg bw) Results for adults No of processed commodities for which ARfD/ADI is exceeded (): Exposure Highest % of Processed commodities (Ig/kg bw) ARfD/ADI Processed commodities 79% Cranberries / juice 20 / % Cauliflowers / boiled 0.5 / % Azarole (mediteranean medla 20 / % Cranberries / dried 20 / % Gherkins / pickled 4 / % Sugar beets (root) / sugar 0.1 / % Cauliflowers / boiled 0.5 / % Rice / milling (polishing) 10 / % Beans (with pods) / boiled 2 / % Peas (with pods) / boiled 2 / % Parsnips / boiled 0.5 / % Barley / beer 2 / % Sugar beets (root) / sugar 0.1 / % Beetroots / boiled 2.2 9% Quinces / jam 5 / % Quinces / jam 5 / % Rice / milling (polishing) 10 / % Rhubarbs / sauce/puree 0.15 / % Potatoes / fried 0.05 / % Onions / boiled 0.2 / % Beetroots / boiled 4.4 2% Peas (without pods) / boiled 0.3 / % Rhubarbs / sauce/puree 0.15 / % Shallots / boiled 0.2 / % Potatoes / dried (flakes) 0.05 / % Beans / canned 0.4 / % Brussels sprouts / boiled 0.7 / % Potatoes / dried (flakes) 0.05 / % Peas (without pods) / canned 0.3 / % Chards/beet leaves / boiled 0.02 / % Shallots / boiled 0.2 / % Beans (without pods) / boiled 0.08 / % Barley / cooked 2 / % Spinaches / frozen 0.02 / % Rapeseeds / processed (not 0.5 / % Potatoes / chips 0.05 / % Barley / milling (flour) 2 / % Peas / canned 0.2 / % Spinaches / frozen 0.02 / % Purslanes / boiled 0.02 / % Lentils / boiled 0.4 / % Valerian root / infusion 2 / % Chards/beet leaves / boiled 0.02 / % Peas / canned 0.2 / % Sunflower seeds / oils 0.5 / Exposure (Ig/kg bw) Conclusion: No exceedance of the toxicological reference value was identified for any unprocessed commodity. A short term intake of residues of Iprodione is unlikely to present a public health risk. For processed commodities, no exceedance of the ARfD/ADI was identified EFSA Supporting publication 2018:EN-1404

21 Page 21 of 24 EFSA Journal Appendix C Summary of available plant metabolism studies of iprodione (France, 2016) Table 2: Summary of available plant metabolism studies of iprodione Study Wheat 3(a) 1977 Strawberry (a) 1977 Peach 1981 Rate (kg/ha) 1x 1.0 1x 2.0 3x 1.1 1x x 1.1 2x 1.1 1x1.1 2x1.1 3x 1.1 4x 0.75 Rice Matrix Leaf+stem Ear Leaf Fruit Fruit Leaf Plant brown/ polished Plant Hay Hulls Root Top DALA TRR as parent equivalent Metabolites % TRR iprodione, parent nd RP nd RP nd traces RP RP RP RP RP M610F Others 2.9 Unidentified Unextracted total Highlighted values are above 10% of TRR Lettuce 1981 Rice 1983 Peanut 1983 Carrot 2012 a Trials with major shortcomings, data not relied on in Peer Review (EFSA, 2016) 21 EFSA Supporting publication 2018:EN-1404