Scientific support for preparing an EU position for the 45 th Session of the Codex Committee on Pesticide Residues (CCPR) 1

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1 EFSA Journal 2013;11(7):3312 SCIENTIFIC REPORT OF EFSA Scientific support for preparing an EU position for the 45 th Session of the Codex Committee on Pesticide Residues (CCPR) 1 European Food Safety Authority 2 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT In accordance with Article 43 of Regulation (EC) No 396/2005, EFSA received a request from the European Commission to provide support for the preparation of the EU position for the 45 th session of the Codex Committee on Pesticide Residues (CCPR). In 2012, JMPR evaluated 12 active substances regarding the setting of toxicological reference values to be used in consumer risk assessment, 7 new compounds (ametoctradin, chlorfenapyr, dinotefuran, fluxapyroxad, MCPA, picoxystrobin, sedaxane) and 4 part of periodic reevaluation (benzoate, fenpropathrin, fenvalerate, glufosinate-ammonium). Regarding the setting of Maximum Residue Limits (CXLs), JMPR assessed 26 substances (ametoctradin, azoxystrobin, buprofezin, carbofuran, chlorfenapyr, chlorothalonil, cycloxydim, cyfluthrin, cyromazine, dichlorvos, dicofol, dinotefuran, fenvalerate, fludioxonil, fluopyram, fluxapyroxad, glufosinate-ammonium, imidacloprid, MCPA, methoxyfenozide, penthiopyrad, phorate, picoxystrobin, sedaxane, spinetoram and trifloxystrobin). EFSA derived comments on the JMPR evaluations regarding the acceptability of the proposed draft Codex MRLs and the toxicological reference values. European Food Safety Authority, 2013 KEY WORDS Consumer risk assessment, toxicological evaluation, residue definitions, MRL setting, CCPR meeting On request from European Commission, Question No from EFSA-Q to EFSA-Q , approved 2 on 03 July Correspondence: pesticides.mrl@efsa.europa.eu Suggested citation: European Food Safety Authority, Scientific support for preparing an EU position for the 45th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2013;11(7):3312, 210 pp. doi: /j.efsa Available online: European Food Safety Authority, 2013

2 SUMMARY In preparation of the 45 th session of the Codex Committee on Pesticide Residues (CCPR meeting) the European Commission requested EFSA to provide comments on the recommendations of the 2012 Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and pesticide MRLs at step 3 and 6 of the Codex procedure. In 2012, JMPR evaluated 12 active substances regarding the setting of toxicological reference values to be used in consumer risk assessment, 7 new compounds (ametoctradin, chlorfenapyr, dinotefuran, fluxapyroxad, MCPA, picoxystrobin, sedaxane) and 4 part of periodic reevaluation (benzoate, fenpropathrin, fenvalerate, glufosinate-ammonium). EFSA compared the ADI and ARfD values derived at EU level and, in case differences were identified, EFSA provided further background information to explain the reasons for the differences. JMPR assessed 26 substances regarding the setting of Maximum Residue Limits (CXLs) (ametoctradin, azoxystrobin, buprofezin, carbofuran, chlorfenapyr, chlorothalonil, cycloxydim, cyfluthrin, cyromazine, dichlorvos, dicofol, dinotefuran, fenvalerate, fludioxonil, fluopyram, fluxapyroxad, glufosinate-ammonium, imidacloprid, MCPA, methoxyfenozide, penthiopyrad, phorate, picoxystrobin, sedaxane, spinetoram and trifloxystrobin). EFSA identified different conclusions regarding the setting toxicological reference values for fenbuconazole, ametoctradin, fenvalerate, glufosinate-ammonium, MCPA and picoxystrobin. Potential consumer concerns were identified for proposed draft Codex MRLs for dicofol, carbofuran, phorate, fenvalerate, imidacloprid, spinetoram and penthiopyrad. According to the EU policy for setting MRLs the data would not be sufficient in some cases where JMPR derived Codex MRL proposals. This finding refers to some of the proposed draft Codex MRLs for glufosinate-ammonium, spinetoram, ametoctradin and dinotefuran. Based on the dataset assessed by JMPR, different MRL levels would be derived at EU level for some of the Codex MRLs proposed for dichlorvos, glufosinate-ammonium cycloxydim, methoxyfenozide, trifloxystrobin, fluopyram, ametoctradin, penthiopyrad, dinotefuran and fluxapyroxad. EFSA identified concerns regarding the residue definitions derived by JMPR for dichlorvos, dicofol, chlorothalonil, phorate, fenvalerate, cyromazine, buprofezin, ametoctradin and MCPA. EFSA Journal 2013;11(7):3312 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background... 7 Terms of reference... 9 Assessment Introduction Comments on the JMPR follow-up evaluation with regard of specific concerns Acetamiprid (246) (R) Background information - Acetamiprid Chlorpyrifos-methyl (090) (R) Background information - Chlorpyrifos-methyl Dicamba (240) (T, R) Background information - Dicamba Diflubenzuron (130) (T, R) Background information - Diflubenzuron Indoxacarb (216) (R) Background information - Indoxacarb Isopyrazam (249) Background information - Isopyrazam Oxamyl (126) (R) Background information - Oxamyl Pyraclostrobin (210) (R) Saflufenacil (251) (R) Background information - Saflufenacil Residue definitions - Saflufenacil Spirotetramat (234) (R) Comments on the individual substances assessed by JMPR Dichlorvos (025) (R) Toxicological endpoints - Dichlorvos Residue definitions - Dichlorvos Codex MRL proposals - Dichlorvos Consumer risk assessment - Dichlorvos Dicofol (26) (T, R) Toxicological endpoints - Dicofol Residue definitions - Dicofol Codex MRL proposals - Dicofol Consumer risk assessment - Dicofol Chlorothalonil (81) (R) Toxicological endpoints - Chlorothalonil Residue definitions - Chlorothalonil Codex MRL proposals Chlorothalonil Consumer risk assessment - Chlorothalonil Carbofuran (96) (R) Toxicological endpoints - Carbofuran Residue definitions - Carbofuran Codex MRL proposals Carbofuran Consumer risk assessment - Carbofuran EFSA Journal 2013;11(7):3312 3

4 3.5. Phorate (112) (R) Toxicological endpoints - Phorate Residue definitions - Phorate Codex MRL proposals Phorate Consumer risk assessment - Phorate Fenvalerate (119) (T, R) Toxicological endpoints Fenvalerate Residue definitions - Fenvalerate Codex MRLs proposals - Fenvalerate Consumer risk assessment - Fenvalerate Cyfluthrin (157) (R) Toxicological endpoints - Cyfluthrin Residue definitions - Cyfluthrin Codex MRLs proposals Cyfluthrin Consumer risk assessment - Cyfluthrin Cyromazine (169) (R) Toxicological endpoints - Cyromazine Residue definitions - Cyromazine Codex MRLs proposals Cyromazine Consumer risk assessment - Cyromazine Bentazone (172) (T, periodic review) Toxicological endpoints - Bentazone Buprofezin (173) (R) Toxicological endpoints - Buprofezin Residue definitions - Buprofezin Codex MRL proposals Buprofezin Consumer risk assessment - Buprofezin Glufosinate-ammonium (175) (T, R) Toxicological endpoints - Glufosinate-ammonium Residue definitions - Glufosinate-ammonium Codex MRL proposals Glufosinate-ammonium Consumer risk assessment - Glufosinate-ammonium Cycloxydim (179) (R) Toxicological endpoints - Cycloxydim Residue definitions - Cycloxydim Codex MRL proposals Cycloxydim Consumer risk assessment - Cycloxydim Fenpropathrin (185) (R) Toxicological endpoints - Fenpropathrin Fenbuconazole (197) (T, periodic review) Toxicological endpoints - Fenbuconazole Imidacloprid (206) (R) Toxicological endpoints - Imidacloprid Residue definitions - Imidacloprid Codex MRL proposals Imidacloprid Consumer risk assessment - Imidacloprid Methoxyfenozide (209) (R) Toxicological endpoints - Methoxyfenozide Residue definitions - Methoxyfenozide Codex MRL proposals Methoxyfenozide Consumer risk assessment - Methoxyfenozide EFSA Journal 2013;11(7):3312 4

5 3.17. Fludioxonil (211) (R) Toxicological endpoints - Fludioxonil Residue definitions - Fludioxonil Codex MRL proposals Fludioxonil Consumer risk assessment - Fludioxonil Trifloxystrobin (213) (R) Toxicological endpoints - Trifloxystrobin Residue definitions - Trifloxystrobin Codex MRL proposals Trifloxystrobin Consumer risk assessment - Trifloxystrobin Azoxytrobin (229) (R) Toxicological endpoints - Azoxystrobin Residue definitions - Azoxystrobin Codex MRL proposals Azoxystrobin Consumer risk assessment - Azoxystrobin Spinetoram (233) (R) Toxicological endpoints - Spinetoram Residue definitions - Spinetoram Codex MRL proposals Spinetoram Consumer risk assessment - Spinetoram Fluopyram (243) (R) Toxicological endpoints - Fluopyram Residue definitions - Fluopyram Codex MRL proposals Fluopyram Consumer risk assessment - Fluopyram Penthiopyrad (253) ( R) Toxicological endpoints - Penthiopyrad Residue definitions - Penthiopyrad Codex MRL proposals - Penthiopyrad Consumer risk assessment Penthiopyrad Chlorfenapyr (254) (T, R) Toxicological endpoints - Chlorfenapyr Residue definitions - Chlorfenapyr Codex MRL proposals Chlorfenapyr Dinotefuran (255) (T, R) Toxicological endpoints - Dinotefuran Residue definitions - Dinotefuran Codex MRL proposals Dinotefuran Consumer risk assessment - Dinotefuran Fluxapyroxad (256) (T, R) Toxicological endpoints - Fluxapyroxad Residue definitions - Fluxapyroxad Codex MRL proposals Fluxapyroxad Consumer risk assessment - Fluxapyroxad MCPA (257) (T, R) Toxicological endpoints - MCPA Residue definitions - MCPA Codex MRL proposals MCPA Consumer risk assessment - MCPA Picoxystrobin (258) (T, R) Toxicological endpoints - Picoxystrobin EFSA Journal 2013;11(7):3312 5

6 Residue definitions - Picoxystrobin Codex MRL proposals Picoxystrobin Consumer risk assessment - Picoxystrobin Sedaxane (259) (T, R) Toxicological endpoints - Sedaxane Residue definitions - Sedaxane Codex MRL proposals Sedaxane Consumer risk assessment - Sedaxane Ametoctradin (260) (T, R) Toxicological endpoints - Ametoctradin Residue definitions - Ametoctradin Codex MRL proposals Ametoctradin Consumer risk assessment - Ametoctradin Conclusions and recommendations The proposed draft Codex MRL for leafy vegetables based on trials on mustard greens and spinach is not in line with the extrapolation rules discussed in the 2012 CCPR.References References Appendix A: Calculations of consumer exposure with Pesticide Residues Intake Model (PRIMo) Appendix B: Proposed draft Codex MRL derived by applying the proportionality principle Appendix C: Abbreviations EFSA Journal 2013;11(7):3312 6

7 BACKGROUND Manufacturers of pesticides submitted data to the JMPR (Joint Meeting on Pesticide Residues) for assessment with view of establishing new Codex maximum residue limits (CXLs). The recent JMPR evaluations of the toxicological data and the residue studies are summarised in the JMPR Report 2012 (WHO/FAO, 2012). It comprises 29 active substances, 3 of them (bentazone, fenpropathrin and fenbuconazole) were assessed to derive toxicological reference values only, 17 active substances were assessed in view of setting new CXLs and 9 active substances were assessed for both, toxicology and residues. In preparation of the 45 th session of the Codex Committee on Pesticide Residues (CCPR meeting) the European Commission requested EFSA on 25 January 2013 to review the JMPR evaluations of the active substances which will be discussed in the upcoming CCPR meeting in May 2013 and which are reported in the JMPR Report EFSA should provide comments regarding the acceptability of the proposed draft Codex MRLs and the toxicological reference values. The comments of EFSA will be considered to derive a common EU position for the Codex Committee on Pesticide Residues (CCPR) and to obtain an agreement of the Council before presenting the EU position in the CCPR. For 10 pesticides JMPR replied to specific concerns raised in the previous CCPR meeting. For reasons of transparency and traceability, EFSA has created separate questions for each of the active substances covered by the JMPR report in the EFSA Register of Questions with the following reference numbers and subjects: Question number Subject EFSA-Q EFSA-Q Acetamiprid- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns Ametoctradin- EFSA comments on toxicological reference values and draft CXLs evaluated by JMPR in 2012 EFSA-Q Azoxystrobin- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Bentazone- EFSA comments on toxicological reference value evaluated by JMPR in 2012 EFSA-Q Buprofezin- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Carbofuran- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Chlorfenapyr- EFSA comments on toxicological reference values and draft CXLs evaluated by JMPR in 2012 EFSA-Q Chlorothalonil- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Chlorpyrifos-methyl- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns EFSA-Q Cycloxydim- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Cyfluthrin- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Cyromazine- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Dicamba- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns EFSA-Q Dichlorvos- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Dicofol- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA Journal 2013;11(7):3312 7

8 Question number Subject EFSA-Q EFSA-Q EFSA-Q EFSA-Q EFSA-Q Diflubenzuron- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns Dinotefuran- EFSA comments on toxicological reference values and draft CXLs evaluated by JMPR in 2012 Fenbuconazole- EFSA comments on toxicological reference value evaluated by JMPR in 2012 Fenpropathrin- EFSA comments on toxicological reference value evaluated by JMPR in 2012 Fenvalerate- EFSA comments on toxicological reference value and CXLs evaluated by JMPR in 2012 EFSA-Q Fludioxonil- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Fluopyram- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q EFSA-Q Fluxapyroxad- EFSA comments on toxicological reference values and draft CXLs evaluated by JMPR in 2012 Glufosinate ammonium - EFSA comments on toxicological reference values and CXLs evaluated by JMPR in 2012 EFSA-Q Imidacloprid- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q EFSA-Q EFSA-Q Indoxacarb- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns Isopyrazam- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns MCPA- EFSA comments on toxicological reference values and draft CXLs evaluated by JMPR in 2012 EFSA-Q Methoxyfenozide- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Oxamyl- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns EFSA-Q Penthiopyrad- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Phorate - EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q EFSA-Q EFSA-Q EFSA-Q Picoxystrobin- EFSA comments on toxicological reference values and draft CXLs evaluated by JMPR in 2012 Pyraclostrobin- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns Saflufenacil- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns Sedaxane- EFSA comments on toxicological reference values and draft CXLs evaluated by JMPR in 2012 EFSA-Q Spinetoram- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA-Q Spirotetramat- EFSA comments on the JMPR follow-up evaluation with regard of specific concerns EFSA-Q Trifloxystrobin- EFSA comments on draft CXLs evaluated by JMPR in 2012 EFSA Journal 2013;11(7):3312 8

9 On 12 March 2013 the draft scientific report of EFSA was submitted for commenting to EU Member State experts and the European Commission for a Member State consultation. Comments were submitted by the Netherlands, Belgium, Germany and Sweden by 22 March 2013 and have been taken into account in the final report. TERMS OF REFERENCE The European Commission requested EFSA to prepare a contribution for the 45 th session of the Codex Committee on Pesticide Residues (CCPR) which will be held on 6 to 11 May 2013 in Beijing (China). For all active substances under discussion, EFSA provides background information regarding the status of the active substance at EU level (approval status of the active substance, availability of EFSA conclusions and availability of EFSA reasoned opinions on MRL applications or MRL review. In case new toxicological reference values were proposed by JMPR in the JMPR Report 2012, EFSA addresses the following questions: 1. Are the proposed toxicological reference values different from the agreed EU reference values? 2. What are the reasons for the differences? 3. Are the toxicological reference values proposed by JMPR acceptable? In case of the proposed draft Codex MRLs were derived by JMPR in the JMPR report 2012, EFSA provided responses on the following questions: 4. Are the residue definitions derived by JMPR comparable with the existing EU residue definitions? 5. Are the proposed draft Codex MRLs comparable with the residue levels? 6. Are the proposed draft Codex MRLs sufficiently supported by data? 7. Are the levels of the proposed draft Codex MRLs appropriate? 8. Are the proposed draft Codex MRLs safe for European consumers with regard to chronic and, where relevant, for acute exposure? EFSA agreed with the European Commission to respond to this request with a scientific report which will be adopted and published by 15 July EFSA Journal 2013;11(7):3312 9

10 ASSESSMENT 1. Introduction EFSA provides the requested background information regarding the toxicological reference values (question 1, 2 and 3 of the Terms of Reference) by comparing the assessments performed by JMPR with the assessments performed at EU level in the framework of the peer review under Regulation (EC) No 1107/ The sources of information used are the EFSA conclusions available for the active substances under consideration, the Review Reports, Draft Assessment Reports prepared by the Rapporteur Member States and other sources of information if available. For deriving the comments on question 4 (Are the residue definitions derived by JMPR comparable with the existing EU residue definitions?) and 5 (Are the proposed draft Codex MRLs comparable with the residue levels?), EFSA compared the levels of the proposed draft Codex MRLs and the enforcement residue definition derived by JMPR with the residue definition established in the EU legislation (Regulation (EC) No 396/ ) or the legislation under preparation. The EU residue definitions for risk assessment were retrieved from the EFSA conclusions, EFSA reasoned opinions on MRL review under Art. 12 of Regulation 396/2005 or, where these documents are not available, the reports prepared by the European Commission in the framework of the peer review of active substances or Member State evaluations in Draft Assessment Reports (DARs). For assessing whether the proposed draft Codex MRLs are sufficiently supported by data (question 6) EFSA took into account the currently valid EU guidance documents for consumer risk assessment and the agreed EU policies (EC, 1996, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2004, 2008, 2010, 2011 OECD 2011). It is noted that due to the different data requirements and policies in JMPR (FAO, 2009), the assessment of identical residue data sets submitted in support of a EU MRLs and CXLs request may result in different recommendations at EU level and by JMPR. In this report EFSA provides background information on the reasons for these differences. For calculating the numerical MRL value (question 7), EFSA used the same methodology as JMPR (OECD calculator). It is noted that some of the Codex MRL proposals were derived by applying the principle of proportionality. Since a final decision on the acceptability of the proportionality approach has not yet been taken at EU level, EFSA checked whether the criteria developed by JMPR in 2011 were met. Appendix B gives a summary of the findings of this compliance check to help risk managers to decide on the acceptability of the MRL proposals derived by JMPR. For the assessment of the safety of the proposed draft Codex MRLs (question 8), EFSA used the EFSA PRIMo rev. 2 (EFSA, 2007). For assessing the acute consumer risk, EFSA applied the standard EU methodology, including the agreed EU variability factors and the ARfD agreed at EU level. In those cases where a potential acute intake concern could not be excluded, EFSA calculated additional scenarios, aiming to provide risk managers with more information to decide on the acceptability of the proposed draft Codex MRL. For the assessment of the long-term consumer risk, EFSA calculated the exposure resulting from the existing EU MRLs, including the risk assessment values (HR or STMR, where appropriate) for the proposed draft Codex MRLs where the proposed draft Codex MRLs are higher than the existing EU MRLs. It is noted that this approach overestimates the actual exposure, because it is not likely that each food item consumed contains residues at the maximum level allowed in the European legislation. The contribution of the individual crops under consideration in the CCPR meeting was calculated separately. In case the first conservative risk assessment indicated a potential consumer health risk EFSA performed more refined intake 3 Regulation (EC) No 1107/2009 of 21 October OJ L 309, , p Regulation (EC) No 396/2005 of 23 February OJ L 70, , p EFSA Journal 2013;11(7):

11 calculations, using appropriate data from other sources (e.g. STMR values instead of the EU MRL where available). The exposure assessments are usually based on the EU toxicological reference values, unless it was concluded that the toxicological reference values derived by JMPR are preferable. For some active substances, the exposure is calculated for both options. For proposed draft Codex MRL for food of animal origin, EFSA focussed mainly on the consumer risk assessment and the validity of feeding studies and animal metabolism studies. For the CXLs for animal a full assessment of the expected dietary burden at EU level will not possible because relevant information may not be available to EFSA. 2. Comments on the JMPR follow-up evaluation with regard of specific concerns 2.1. Acetamiprid (246) (R) Concerns were raised by the EU delegation in the 44 th CCPR meeting as regards the proposed draft Codex MRLs for leafy vegetables (except spinach) because of acute intake concerns for scarole (166% of ARfD) 5. The EU delegation announced to submit a concern form and that the Member States would be asked to submit food consumption data to JMPR as soon as possible. The intake concerns were based on acute exposure calculations which were performed with the EFSA PRIMo revision 2; the most critical diet for scarole is Dutch diet for children. The consumption (97.5th percentile for Dutch children with a body weight of 17.1 kg) was reported as g /kg bw. The variability factor used for the exposure calculation was 5. According to the data submitted for the new revision of PRIMo, the most critical consumption data for scarole (without specification of processing) were reported for Belgian toddlers with a body weight of 17.8 kg: 8.03 g/kg body weight. The Dutch data also contained high amounts of scarole, split in several categories of processed scarole products; the highest was reported for cooked/boiled scarole ( g/kg body weight) for a child of 8-20 months and a mean body weight of 10.2 kg. With respect to the spinach proposed draft Codex MRL for which acute intake concerns were identified by JMPR for the South African children, the EU delegation did not object because the EU exposure calculation did not identify a consumer risk 6. JMPR now recommended maintaining the proposed MRL for spinach noting in a footnote the ARfD exceedance for spinach. JMPR was of the opinion that in cases where the ARfD is exceeded, additional considerations should be taken into account, such as the amount by which the ARfD is exceeded, the basis on which the ARfD had been established, likely conservatism and possible consequences and uncertainties in the estimate of intake. EFSA is of the opinion that as a matter of principle these considerations are not acceptable and are corroding the whole risk assessment concept. EFSA therefore would propose not to support the advancement of the proposed draft Codex MRL for spinach. 5 In the EFSA assessment, in addition concerns were raised for kale when using the exposure with the standard EU approach (VF 7) (128% of ARfD), but this crop was not mentioned in the EU common position. 6 It is noted that at EU level no variability factor is used for spinach, whereas in the calculations of the JMPR a variability factor of 3 was applied. EFSA Journal 2013;11(7):

12 Background information - Acetamiprid Acetamiprid was evaluated under Directive 91/414/EEC, repealed by Regulation (EC) No 1107/2009 with Greece as Rapporteur Member State. A decision to approve the active substance (Commission Directive 2004/99/EC 7 ) was taken in For acetamiprid no EFSA conclusion is available. The MRL review under the Article 10 of Regulation (EC) No 396/2005 is finished (EFSA, 2011b). The following toxicological reference values derived by EU level and by JMPR. Table 2-1: Comparison of toxicological reference values derived by JMPR and at EU level JMPR evaluation 2011 EU evaluation 2004 ADI mg/kg bw/day Value Study relied upon Safety factor Value Study relied upon Safety factor 0.07 mg/kg bw/day ARfD 0.1 mg/kg bw 0.1 mg/kg bw In the following table the residue definitions for risk assessment and enforcement purpose are compared. Table 2-2: Comparison of the residue definitions derived by JMPR and at EU level Acetamiprid group JMPR evaluation EU evaluation RD enf Plant Acetamiprid Acetamiprid RD RA Plant Acetamiprid Acetamiprid In the table below the proposed draft Codex MRLs are compared with the EU MRL. Table 3-1: Comparison of the proposed draft Codex MRLs derived by JMPR and EU MRLs Codex MRL proposal derived by JMPR 2012 Leafy vegetables (except spinach) Spinach 5 4 EU MRL/ EFSA 2011 Comment 7 Commission Directive 2004/99/EC of 1 October 2004, OJ L 309, , p. 6 8 EFSA Journal 2013;11(7):

13 2.2. Chlorpyrifos-methyl (090) (R) In 2009, JMPR derived draft Codex MRLs for wheat, barley and maize reflecting post harvest treatments (maximum residue level of 3 mg/kg, HR of 2.2 mg/kg and STMR of 2.1 mg/kg). Because of chronic intake concerns the proposal for maize was not advanced. Processing studies for maize would have been required to perform more refined intake calculations. The 2012 JMPR meeting received a new Spanish label indicating that the post- harvest use of chlorpyrifos-methyl is no longer recommended in maize. Thus, the proposal for maize is withdrawn by JMPR. The proposal is acceptable. However, it is recommended to reconsider the dietary burden calculation for livestock which was performed in 2009 including maize and the assessment of the CXLs for food of animal origin. The new situation might allow lowering the CXLs for animal Background information - Chlorpyrifos-methyl Chlorpyrifos-methyl was evaluated under Directive 91/414/EEC, repealed by Regulation (EC) No 1107/2009 with Spain as Rapporteur Member State. A decision to approve the active substance (Commission Directive 2005/72/EC 8 ) was taken in For chlorpyrifos-methyl no EFSA conclusion is available. The MRL review under the Article 12 of Regulation (EC) No 396/2005 is at stage 1 (data submitted for RO). The following toxicological reference values derived by EU level and by JMPR. Table 2-3: Comparison of toxicological reference values derived by JMPR and at EU level JMPR evaluation (ADI: 1992 reviewed in 2001) (ARfD: 2011) EU evaluation 2005 Value Study relied upon Safety factor Value Study relied upon Safety factor ADI mg/kg bw/day 2-year study of toxicity and carcinogenicity in rats mg/kg bw/day Rat, 2-years. 100 ARfD 0.1 mg/kg bw Single-dose study in human volunteers given mg/kg bw Acute and delayed neurotoxicity studies in rats 100 In the following table the residue definitions for risk assessment and enforcement purpose are compared. 8 Commision Directive 2005/72/EC of 21 October 2005, OJ L 279, , p EFSA Journal 2013;11(7):

14 Table 2-4: Comparison of the residue definitions derived by JMPR and at EU level Chlorpyrifosmethyl group JMPR evaluation EU evaluation RD enf Plant Chlorpyrifos- methyl The residue is fat soluble Chlorpyrifos-methyl, The residue is fat soluble. Animal RD RA Plant Animal Chlorpyrifos- methyl The residue is fat soluble Chlorpyrifos-methyl plus 3,5,6- trichloropyridinol (TCP) and its conjugates, expressed as chlorpyrifos-methyl. The residue is fat soluble Conclusion The EU residue definition for risk assessment established by Peer review in 2011 includes the 3,5,6- trichloropyridinol (TCP) and its conjugates. In the table below the proposed draft Codex MRLs under discussion are compared with the EU MRL. Table 3-2: Comparison of the proposed draft Codex MRLs derived by JMPR and EU MRLs Maize Codex MRL proposal derived by JMPR (Po), withdrawal EU MRL/ EFSA 2011 Comment 3/0.01* JMPR meeting decided to withdraw the CXL for maize because the long term dietary risk assessment indicates an exceedance of the ADI up to 140%, with maize accounting about 73% of the IEDI. In 2011 EFSA recommended the lowering to 0.01* mg/kg reflecting a SEU foliar use (EFSA, 2011c). EFSA Journal 2013;11(7):

15 2.3. Dicamba (240) (T, R) In the 44 th CCPR meeting, the EU raised concerns for the proposed draft Codex MRL for soya beans (dry) which was derived by using the proportionality concept. The compliance with the criteria for using the principles of proportionality was checked in detail and is reported in Appendix B. A concern form was submitted requesting clarifications of the scientific basis for the proposed draft Codex MRL, with particular considering the potential influence of pre-plant applications to the final residues. JMPR now confirmed the proposal, because the pre-plant application was found to be negligible. A final decision on the acceptability of the proportionality approach has not yet been taken at EU level Background information - Dicamba Dicamba was evaluated under Directive 91/414/EEC, repealed by Regulation (EC) No 1107/2009 with Denmark as Rapporteur Member State. A decision to approve the active substance (Commission Directive 2008/69/EC 9 ) was taken in For dicamba an EFSA conclusion is available. The MRL review under the Article 12 of Regulation (EC) No 396/2005 is at stage 1 (data submitted for RO). The following toxicological reference values derived by EU level and by JMPR. Table 2-5: Comparison of toxicological reference values derived by JMPR and at EU level JMPR evaluation 2011 EU evaluation 2008 ADI mg/kg bw/day Value Study relied upon Safety factor Value Study relied upon Safety factor 0.3 mg/kg bw/day ARfD 0.5 mg/kg bw 0.3 mg/kg bw In the following table the residue definitions for risk assessment and enforcement purpose are compared. Table 2-6: Comparison of the residue definitions derived by JMPR and at EU level Dicamba group JMPR evaluation 2010 EU evaluation RD enf Plant Dicamba Regulation (EC) No 396/2005: Dicamba. EFSA conclusion: Dicamba and its salts and conjugated dicamba expressed as dicamba. Animal Sum of dicamba and 3,6- dichlorosalicylic acid (DCSA) expressed as dicamba The residue is not fat soluble Dicamba and its salts and conjugated dicamba expressed as dicamba 9 Commission Directive 2008/69/EC of 1 July 2008, OJ L 172, , p EFSA Journal 2013;11(7):

16 Dicamba group JMPR evaluation 2010 EU evaluation RD RA Plant Sum of dicamba and 5-OH dicamba expressed as dicamba Dicamba and 5-OH-dicamba, free and conjugated Animal Sum of dicamba and 3,6- dichlorosalicylic acid (DCSA) expressed as dicamba The residue is not fat soluble Dicamba (free and conjugated) EFSA Journal 2013;11(7):

17 2.4. Diflubenzuron (130) (T, R) The EU raised a concern as regards the assessment of diflubenzuron since certain metabolites will be classified as carcinogenic and/or genotoxic. As the toxicological studies which were the basis of the EU concerns were not submitted to JMPR, no further assessment has been performed by JMPR. The studies and the outcome of the finalised EU evaluation will be submitted to JMPR for consideration at a future Joint meeting Background information - Diflubenzuron Diflubenzuron was evaluated under Directive 91/414/EEC, repealed by Regulation (EC) No 1107/2009 with Sweden as Rapporteur Member State. A decision not to approve the active substance (Commission Directive 2008/69/EC 10, amended by Commission Directive 2010/39/EC 11 ) was taken in A specific provision of the approval was that the notifier was requested to submit further studies (confirmatory data) on the potential genotoxicity of the impurity and metabolite 4- chloroaniline (PCA) by 30 June An EFSA conclusion on the peer review of the pesticide risk assessment for Diflubenzuron and of the confirmatory data is available (EFSA, 2012h). The MRL review under the Article 12 of Regulation (EC) No 396/2005 is at stage 0 (data pending). The following toxicological reference values derived by EU level and by JMPR. Table 2-7: Comparison of toxicological reference values derived by JMPR and at EU level JMPR evaluation 2001 Value Study relied upon Safety factor EU evaluation (EFSA, 2012h) Value Study relied upon Safety factor ADI mg/kg bw/day Rat, 2 year and 52 week mg/kg bw/day 1 year dog 100 ARfD n.n n.a In the peer review of diflubenzuron, EFSA noted the presence of PCA and the precursor CPU in the metabolic pathway in plants after metabolism studies in apples and mushrooms. In the following table the residue definitions for risk assessment and enforcement purpose are compared. Table 2-8: Comparison of the residue definitions derived by JMPR and at EU level Diflubenzuron group JMPR evaluation 2002 EU evaluation RD enf Plant Diflubenzuron Diflubenzuron 10 Commission Directive 2008/69/EC of 1 July 2008, OJ L 172, , p Commission Directive 2010/39/EU of 22 June 2010, OJ L 156, , p EFSA Journal 2013;11(7):

18 Diflubenzuron group JMPR evaluation 2002 EU evaluation Animal Diflubenzuron Sum of diflubenzuron and 4 chlorophenylurea expressed as diflubenzuron The residue is fat soluble The residue is fat soluble RD RA Plant Diflubenzuron For fruit crops after foliar application (provisional) (1) Diflubenzuron (2) Sum of 4-chlorophenylurea (CPU) + 4- chloroaniline (PCA) expressed as 4-chloroaniline; pending the finalisation of the toxicological evaluation of the metabolite CPU. For mushrooms after soil application (provisional) (1) Sum of diflubenzuron and 2,6-difluorobenzoic acid (DFBA) expressed as diflubenzuron (2) Sum of 4-chlorophenylurea (CPU) + 4- chloroaniline (PCA) expressed as 4-chloroaniline; pending the finalisation of the toxicological evaluation of the metabolite CPU. Animal Diflubenzuron The residue is fat soluble Provisional: 1) Diflubenzuron 2) Sum of 4-chlorophenylurea (CPU) + 4- chloroaniline (PCA) + 4-chloroacetanilide (PCAA) expressed as 4-chloroaniline; pending the finalisation of the toxicological evaluation of the metabolites CPU and PCAA. The residue is fat soluble. EFSA Journal 2013;11(7):

19 2.5. Indoxacarb (216) (R) In 2005 JMPR estimated a maximum residue level for lettuce, leaf at 15 mg/kg. The EU expressed acute dietary intake concerns for children. In 2011 JMPR assessed an alterative GAP (Spanish GAP) for which a proposed draft Codex MRL of 3 mg/kg was derived (HR 1.6 mg/kg, STMR 0.52 mg/kg). In 2012 JMPR presented the results of the risk assessment (30% of the ARfD) and proposed to withdraw the previous Codex MRL proposal of 15 mg/kg. The proposal to withdraw the draft Codex MRL which raised an acute intake concern is supported. EFSA confirms that for the alternative Codex MRL proposal of 3 mg/kg no consumer concern was identified at EU level for the reported HR of 1.6 mg/kg (34% of the EU ARfD) Background information - Indoxacarb Indoxacarb was evaluated under Directive 91/414/EEC, repealed by Regulation (EC) No 1107/2009 with the Netherlands as Rapporteur Member State. A decision to approve the active substance (Commission Directive 2006/10/EC 12 ) was taken in For indoxacarb no EFSA conclusion is available. The MRL review under the Article 12 of Regulation (EC) No 396/2005 is finished (EFSA, 2011f). The following toxicological reference values derived by EU level and by JMPR. Table 2-9: Comparison of toxicological reference values derived by JMPR and at EU level ADI ARfD JMPR evaluation (2005 for ADI; 2009 for ARfD) Value Study relied upon Safety factor mg/kg bw/day 0.1 mg/kg bw EU evaluation (EFSA 2011f) Value Study relied upon Safety factor mg/kg bw/day mg/kg bw In the following table the residue definitions for risk assessment and enforcement purpose are compared. Table 2-10: Comparison of the residue definitions derived by JMPR and at EU level Indoxocarb group JMPR evaluation 2007 EU evaluation RD enf Plant Sum of indoxacarb and its R enantiomer Sum of indoxacarb and its R isomer Animal Sum of indoxacarb and its R enantiomer and methyl 7-chloro-2,5-dihydro-2-[[[4- (trifluoromethoxy)phenyl]amino]carbonyl ]indeno[1,2-e][1,3,4]oxadiazine-4a(3h)- carboxylate, expressed as indoxacarb. The residue is fat soluble Sum of indoxacarb and its R isomer The residue is fat soluble 12 Commission Directive 2006/10/EC of 27 January 2006, OJ L 25, , p EFSA Journal 2013;11(7):

20 Indoxocarb group JMPR evaluation 2007 EU evaluation RD RA Plant Sum of indoxacarb and its R enantiomer Sum of indoxacarb and its R enantiomer Animal Sum of indoxacarb and its R enantiomer and methyl 7-chloro-2,5-dihydro-2-[[[4- (trifluoromethoxy)phenyl]amino]carbonyl ]indeno[1,2-e][1,3,4]oxadiazine-4a(3h)- carboxylate, expressed as indoxacarb Sum of indoxacarb and its R enantiomer The residue is fat soluble The residue is fat soluble Table 2-11: Comparison of proposed draft Codex MRL derived by JMPR and EU MRLs Codex MRL proposal derived by JMPR 2013 EU MRL /EFSA 2012 Lettuce, Leaf 3 1 lamb s lettuce (251010)/ 30 2 lettuce (251020) Comment The proposed draft Codex MRL is sufficiently supported by data (7 trials on head lettuce and 3 trials of open leave varieties). The result for the consumer risk assessment is presented in the Table below. Table 2-12: Summary of the consumer risk assessment for indoxacarb (for detailed calculation see Appendix A) Chronic risk Acute risk Conclusion No long-term consumer concern was identified (for a total ADI of 76%, contribution of lettuce is 4.6 % for ES adult diet) No acute consumer intake concerns identified (max. ARfD consumption calculated for lettuce is 34.4% of ARfD) The proposed draft Codex MRL for indoxacarb in lettuce is sufficiently supported by data with no consumer intake concerns identified. EFSA Journal 2013;11(7):

21 2.6. Isopyrazam (249) In 2012, the EU raised concerns regarding the ADI and ARfD derived by JMPR. After consideration of the data which were the basis of the toxicological reference values in the EU, JMPR confirmed the ADI and ARfD derived in Background information - Isopyrazam Isopyrazam is under evaluation according to Directive 91/414/EEC, repealed by Regulation (EC) No 1107/2009 with United Kingdom as Rapporteur Member State. A decision to approve the active substance (Commission Decision 2010/132/EC 13 - dossier complete) was not taken. An EFSA conclusion is available for this active substance (EFSA, 2012c). The following toxicological reference values derived by EU level and by JMPR. Table 2-13: Comparison of toxicological reference values derived by JMPR and at EU level JMPR evaluation 2011 EU evaluation/efsa, 2012c Value Study relied upon Safety factor Value Study relied upon Safety factor ADI mg/kg bw/day 2-yr rat mg/kg bw/day 2-yr rat 200 Comments ADI Derived from the NOAEL of 5.5 mg/kg bw/day in the 2 yr rat study on the basis of decreased body weight gain in females and foci of eosinophilic hepatocytes and clinical chemistry changes (triglycerides, bilirubin) of equivocal toxicological significance in both sexes at 27.6 mg/kg bw/day, supported by the NOAEL of 9.9 mg/kg bw/day in the mouse 80-week feeding study, based on periportal hepatocellular hypertrophy in females at 500 ppm (equal to 56.2 mg/kg bw/day). The margin between the maximum ADI and the LOAEL at mg/kg bw per day for uterine and liver tumours in female rats is approximately Derived from the LOAEL of of 5.5 mg/kg bw/day in the in 2 the yr rat 2 study yr rat on study the basis on the of liver basis centrilobular of liver hypertrophy centrilobular and hypertrophy vacuolation, and vacuolation, and bile and duct hyperplasia bile duct hyperplasia and fibrosis. and An fibrosis. increased An SF increased by 2 was used SF by as 2 based was used on a as LOAEL. based on a LOAEL. The ADI covers the a ratio syn/anti isomers up up to to 60:40 i.e. i.e. up up to 40% to 40% of the of more the more toxic anti toxic isomers anti and isomers applicable and is to applicable the metabolites to the CSCD metabolites , CSCD , and CSCD and CSCD ARfD Comments ARfD 0.3 mg/kg bw Rat, acute neurotoxicity study Derived from the NOAEL of 30 mg/kg bw in the rat acute neurotoxicity study, on the basis of nonspecific clinical signs of toxicity (weak appearance and decreased activity) at 250 mg/kg bw. The margin between the ARfD and the LOAEL at 500 mg/kg bw/day for teratogenic effects (microphthalmia) in rabbits is approximately mg/kg bw Rat, developmental toxicity study 100 Based on the maternal NOAEL of 20 mg/kg bw/day for reduced maternal body weight observed during the first days of dosing in the developmental toxicity study in rat. The ARfD covers the ratio syn/anti isomers up to 60:40 i.e. up to 40% of the more toxic anti isomers and is applicable to the metabolites CSCD , CSCD and CSCD Commission Decision: 2010/132/EC of 2 March 2010 OJ L 52, , p EFSA Journal 2013;11(7):

22 JMPR evaluation 2011 EU evaluation/efsa, 2012c Value Study relied upon Safety factor Value Study relied upon Safety factor Conclusion The derivation of the ADI was based on the same relevant study in the JMPR and EU evaluations, but the LOAEL of the study was defined differently; no NOAEL was identified by the EU evaluation resulting in the use of an increased SF of 200. The JMPR and EU evaluations based the ARfD on different studies and endpoints. In the following table the residue definitions for risk assessment and enforcement purpose are compared. Table 2-14: Comparison of the residue definitions derived by JMPR and at EU level Isopyrazam group JMPR evaluation EU evaluation EFSA 2012 RD enf Plant Isopyrazam (Sum of syn-isomer and anti-isomer) Isopyrazam (sum of isomers) Animal Isopyrazam (Sum of syn-isomer and anti-isomer) The residue is fat soluble Isopyrazam (sum of isomers) The residue is fat soluble RD RA Plant Sum of isopyrazam and 3- difluoromethyl-1-methyl-1h-pyrazole-4 carboxylic acid [9-(1-hydroxyl-1- methylethyl)-(1rs,4rs,9rs)-1,2,3,4- tetrahydro-1,4-methanonaphthalen-5- yl]amide expressed as isopyrazam Isopyrazam (sum of isomers) plus its metabolite CSCD [syn- hydroxyl isopyrazam] (free and conjugated), expressed as isopyrazam Animal Isopyrazam (Sum of syn-isomer and anti-isomer) The residue is fat soluble Isopyrazam (sum of isomers) plus all its metabolites containing the CSAA moiety [3-(difluromethyl)-1-methylpyrazole-4- methanoic acid] expressed as isopyrazam The residue is fat soluble EFSA Journal 2013;11(7):

23 2.7. Oxamyl (126) (R) JMPR 2012 did not derive Codex MRLs for citrus (drip irrigation treatment), cucumbers, summer squash, melons, peppers and tomatoes. A revision of the residue definition will be considered in the future. It is noted that at EU level the provisional residue definition proposed by EFSA in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 comprises parent compound only. However, EFSA was of the opinion that the use of oxamyl by drip irrigation in fruits and fruiting vegetables should be investigated by providing an additional metabolism study Background information - Oxamyl Oxamyl was evaluated under Directive 91/414/EEC, repealed by Regulation (EC) No 1107/2009 with Ireland as Rapporteur Member State. A decision to approve the active substance (Commission Directive 2006/16/EC 14 ) was taken in For oxamyl an EFSA conclusion is available (EFSA, 2005). The MRL review under the Article 12, of Regulation (EC) No 396/2005 is at stage 8 (finished RO) EFSA, 2010oxamyl art.12. The following toxicological reference values derived by EU level and by JMPR. Table 2-15: Comparison of toxicological reference values derived by JMPR and at EU level JMPR evaluation 2002 EU evaluation 2005 ADI mg/kg bw/day Value Study relied upon Safety factor Value Study relied upon Safety factor mg/kg bw/day. ARfD mg/kg bw 0.001mg/kg bw Table 2-16: Comparison of the residue definitions derived by JMPR and at EU level Oxamyl group JMPR evaluation 2007 EU evaluation (EFSA 2010) RD enf Plant Sum of oxamyl and oxamyl oxime expressed as oxamyl Oxamyl (provisional) Animal RD RA Plant Sum of oxamyl and oxamyl oxime expressed as oxamyl Oxamyl (provisional) Animal Sum of oxamyl and oxamyl oxime expressed as oxamyl Oxamyl Conclusion This residue definition for JMPR is different because, at the time of evaluation, these two compounds could not be differentiated from an analytical point of view (WHO/FAO, 2002) which is not the case in the present. 14 Commission Directive 2006/16/EC of 7 February 2006, OJ L 36, , p EFSA Journal 2013;11(7):

24 2.8. Pyraclostrobin (210) (R) JMPR derived a proposed draft Codex MRL for citrus oil, based on the processing study on orange oil which is extrapolated to all citrus fruit. The proposed draft Codex MRL of 10 mg/kg for citrus oil is acceptable. EFSA Journal 2013;11(7):

25 2.9. Saflufenacil (251) (R) Upon request of the manufacturer JMPR reassessed the trials for beans and peas (dry) and soya beans (dry) with view on deriving a group tolerance for pulses. JMPR confirmed that the data sets are sufficient and derived a proposed draft Codex MRL of 0.3 mg/kg. The recommendations for the individual CXLs for beans (0.3 mg/kg), peas (0.05 mg/kg) and soya beans (0.07 mg/kg) are withdrawn. An extrapolation from beans and peas (dry) to lentils is basically acceptable. However, the practice to set a group tolerance while sufficient data are available to establish separate CXLs at a lower level for peas and soya beans is questionable Background information - Saflufenacil Saflufenacil was never notified or authorised in Europe. There is no legislation available for this active substance. A reasoned opinion on MRLs setting under the Article 10 of Regulation (EC) No 396/2005 is finished (RO, EFSA 2012b). Concerns were identified with regard to the metabolite TFA. The applicability of the TTC approach is currently under consideration. The following toxicological reference values derived by EU level and by JMPR. Table 2-17: Comparison of toxicological reference values derived by JMPR and at EU level JMPR evaluation 2011 EU evaluation /EFSA, 2012b ADI mg/kg bw/day Value Study relied upon Safety factor Value Study relied upon Safety factor mg/kg bw/day ARfD n.n 0.05 mg/kg bw Residue definitions - Saflufenacil In the following table the residue definitions for risk assessment and enforcement purpose are compared. Table 2-18: Comparison of the residue definitions derived by JMPR and at EU level Saflufenacil group JMPR evaluation EU evaluation RD enf Plant Saflufenacil Sum of saflufenacil, M800H11 and M800H35, expressed as saflufenacil Animal Saflufenacil The residue is not fat soluble Saflufenacil RD RA Plant Saflufenacil Sum of saflufenacil, M800H11 and M800H35, expressed as saflufenacil Animal Saflufenacil The residue is not fat soluble Saflufenacil In the table below the proposed draft Codex MRL are compared with the EU MRL. EFSA Journal 2013;11(7):