REASONED OPINION. European Food Safety Authority 2, 3. European Food Safety Authority (EFSA), Parma, Italy

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1 EFSA Journal 215;13(3):45 REASONED OPINION Reasoned opinion on the review of the existing maximum residue levels (MRLs) for fenpropimorph according to Article 12 of Regulation (EC) No 396/25 1 ABSTRACT European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy According to Article 12 of Regulation (EC) No 396/25, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance fenpropimorph. In order to assess the occurrence of fenpropimorph residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible chronic/acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. European Food Safety Authority, 215 KEY WORDS fenpropimorph, MRL review, Regulation (EC) No 396/25, consumer risk assessment, morpholine, fungicide 1 On request from EFSA, Question No EFSA-Q , approved on 13 March Correspondence: pesticides.mrl@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the rapporteur Member State, Germany, for the preparatory work on this scientific output. Suggested citation: EFSA (European Food Safety Authority), 215. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for fenpropimorph according to Article 12 of Regulation (EC) No 396/25. EFSA Journal 215;13(3):45, 66 pp. doi:1.293/j.efsa Available online: European Food Safety Authority, 215

2 SUMMARY Fenpropimorph was included in Annex I to Directive 91/414/EEC on 1 May 29, which is after the entry into force of Regulation (EC) No 396/25 on 2 September 28. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Germany, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The requested information was submitted to EFSA on 13 October 21 and, after having considered several comments made by EFSA, the RMS provided on 19 December 213 a revised PROFile and evaluation report. Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS, EFSA issued on 15 September 214 a draft reasoned opinion that was circulated to Member States experts for consultation. Comments received by 17 November 214 were considered in the finalisation of this reasoned opinion. The following conclusions are derived. The toxicological profile of fenpropimorph was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at.3 mg/kg bw per d and.3 mg/kg bw, respectively. The metabolism of fenpropimorph was considered as sufficiently investigated in spring wheat (cereals), sugar beet (root and tuber vegetables) and in banana (fruit crops) following foliar application. The residue definition for enforcement is set as fenpropimorph only. For risk assessment, since the metabolites fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6- dimethylmorpholine (BF 421-1) were recovered in significant amounts in wheat straw and sugar beet leaves, the residue definition is proposed as the sum of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1), expressed as fenpropimorph. A conversion factor for risk assessment of 5 derived from the metabolism studies was applied to cereal straw and sugar beet leaves. The same conversion factor was applied on strawberries, cane fruit, other small fruit and berries crops, leek and hops on a tentative basis since residue trials on these crops complying with the residue definition for risk assessment were not provided and the available metabolism studies were not considered representative for the crops. A conversion factor of 1 was agreed for bananas, cereal grains and root and tuber vegetables based on the metabolism data. Validated analytical methods for enforcement of the proposed residue definition are available. A fully validated analytical method for hops is still required. The methods are not stereoselective. Regarding the magnitude of residues in primary crops, the available residues data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for strawberries, cane fruit, other small fruit and berries crops, and sugar and fodder beets where available residues trials only allowed deriving a tentative MRL, and for leek and hops where the available data were insufficient to derive MRLs. Storage stability data for acidic commodities were also found to be missing. Hydrolysis studies demonstrated that processing by pasteurisation, baking/brewing/boiling and sterilisation is not expected to have a significant impact on the stability of fenpropimorph in matrices of plant origin. The relevant residue for enforcement and risk assessment in processed commodities is therefore expected to be the same as for primary crops. Robust processing factors for enforcement and risk assessment were derived for peeled banana, wholemeal wheat flour and bread, barley brewing malt, beer and oat flakes. Further processing studies are not required in this case as they are not expected to affect the outcome of the risk assessment. However, if more robust processing factors were to be required by risk managers, in particular for enforcement purposes, additional processing studies would be needed. EFSA Journal 215;13(3):45 2

3 The metabolic pathway of fenpropimorph in rotational crops was considered as sufficiently investigated and was found to be similar to that observed in primary crops and a specific residue definition for rotational crops is not deemed necessary. In view of the high persistence of fenpropimorph, rotational crop field trials on cereals, leafy and root vegetables conducted at a dose rate covering the long-term plateau concentration of fenpropimorph in soil and addressing the magnitude of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1) in the edible parts of the rotational crops are required. Livestock metabolism studies were submitted. The general metabolic pathways in rodents and ruminants were found to be comparable; the findings in ruminants can therefore be extrapolated to pigs. The residue definition for enforcement and risk assessment are set as the sum of fenpropimorph and fenpropimorph carboxylic acid (BF. A ruminant feeding study permitted to derive MRLs in ruminants and pigs. A poultry feeding study is not available and is not triggered. MRLs for poultry matrices can therefore be established at the LOQ of the method. Validated analytical methods for enforcement of the proposed residue definition are available but are not stereoselective. Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRLs for an indicative calculation. The highest chronic exposure represented 26 % of the ADI (French toddlers) and an exceedance of the ARfD was identified for leek (983 %), strawberries (251 %), bovine liver (132 %), bananas (129 %) and blackberries (17 %). A second exposure calculation was therefore performed, assuming that livestock was not fed with sugar/fodder beet leaves, excluding the uses on leek, strawberries and blackberries and considering that import of bananas would be limited to bananas that were bagged prior to treatment. The residue trials on bagged bananas were also considered as a fallback position. In this case, the highest chronic exposure represented 43 % of the ADI (UK toddlers) and the highest acute exposure amounted to 68 % of the ARfD (bovine liver). Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for fenpropimorph. Additional assessment of the consumer exposure, considering these CXLs, was therefore carried out. The highest chronic exposure was calculated for UK toddlers, representing 47 % of the ADI and an exceedance of the ARfD was identified for the existing CXL in banana (129 % of the ARfD). A second intake calculation was therefore conducted, excluding the CXL on banana for which an acute intake exceedance was observed. The highest chronic exposure declined to 43 % of the ADI for UK toddlers; the highest acute exposure was calculated for bovine liver (68 % of the ARfD). Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/25. MRL recommendations were derived in compliance with the decision tree reported in Appendix D of the reasoned opinion (see summary table). All MRL values listed as Recommended in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation. However, the remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). Indeed, some tentative MRLs or existing EU MRLs still need to be confirmed by the following data: a fully validated analytical method for the determination of fenpropimorph residues in hops; residue trials supporting authorisations on cane fruit (except blackberries), berries and small fruits (currants, blueberries, cranberries, gooseberries) and hops conducted in accordance with the residue definition for enforcement and risk assessment; 8 residue trials on sugar beet compliant with the northern outdoor GAP and 2 additional residue trials compliant with the southern outdoor GAP; EFSA Journal 215;13(3):45 3

4 storage stability data in acidic matrices covering the maximum storage period of the residue trials samples on strawberries, cane fruit and other small fruit and berries crops. EFSA also identified the following data gap which is not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations: 8 residue trials on oats compliant with the Belgian GAP; rotational crops field trials on cereals, leafy and root vegetables conducted at a dose rate covering the long-term plateau concentration of fenpropimorph in soil and addressing the magnitude of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6- dimethylmorpholine (BF 421-1) in the edible parts of the rotational crops. If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level. Member States are in any case recommended to pay particular attention to the possible occurrence of residues in rotational crops It is also highlighted that MRLs for commodities of animal origin are based on the assumption that sugar/fodder beet leaves in northern and southern Europe would not be fed to livestock because livestock commodities from animals exposed to these feed items may lead to exceedances of the ARfD for the final consumer. Therefore, Member States should consider defining restrictions to avoid exposure of livestock to these feed items or, if such restriction is not considered feasible, withdrawal of the authorisations on sugar and fodder beets. Since an acute dietary risk cannot be excluded for strawberries, leek and blackberries, Member States should also consider withdrawing authorisations in these crops, unless GAP-compliant residue trials investigating residues according to both enforcement and risk assessment residue definitions are provided for refinement of the exposure calculations. Furthermore, it is important to note that the import tolerance on bananas is derived from trials where bananas were bagged prior to treatment. Import of bananas that were not bagged prior to treatment may therefore lead to an exceedance of the proposed MRL and pose an acute dietary risk to European consumers. EFSA also emphasises that the above assessment does not consider the possible impact of plant and livestock metabolism on the isomer ratio of fenpropimorph and further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available. SUMMARY TABLE Code number Commodity Existing EU MRL Existing CXL MRL Enforcement residue definition (existing): fenpropimorph Enforcement residue definition (proposed): fenpropimorph Outcome of the review Comment 152 Strawberries Further consideration needed (a) 1531 Blackberries Further consideration needed (a) 1532 Dewberries Further consideration needed (b) 1533 Raspberries Further consideration needed (b) 1541 Blueberries Further consideration needed (b) EFSA Journal 215;13(3):45 4

5 Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 1542 Cranberries Further consideration needed (b) 1543 Currants (red, black and white) Further consideration needed (b) 1544 Gooseberries Further consideration needed (b) 1632 Banana Recommended (c) 2132 Carrots.5* -.4 Recommended (d) 214 Horseradish.5* -.4 Recommended (d) 2136 Parsnips.5* -.4 Recommended (d) 2137 Parsley root.5* -.4 Recommended (d) 2139 Salsifies.5* -.4 Recommended (d) 276 Leek Further consideration needed (e) 51 Barley Recommended (f) 55 Oats Recommended (f) 57 Rye Recommended (f) 59 Wheat Recommended (f) 7 Hops (dried) 1-1 Further consideration needed (g) 91 Sugar beet (root).1*.5.15 Further consideration needed (h) - Other products of plant origin See App. C1 - - Further consideration needed (i) Enforcement residue definition (existing): fenpropimorph carboxylic acid (BF 421-2), expressed as fenpropimorph Enforcement residue definition (proposed): sum of fenpropimorph and fenpropimorph carboxylic acid (BF (fat soluble) 1111 Swine muscle.2*.2.2 Recommended (j) 1112 Swine fat.1*.1.1* Recommended (k) 1113 Swine liver Recommended (j) 1114 Swine kidney.5*.5.5 Recommended (j) 1121 Bovine muscle.2*.2.15 Recommended (k) 1122 Bovine fat.1*.1.2 Recommended (k) 1123 Bovine liver Recommended (k) 1124 Bovine kidney.5*.5.5 Recommended (k) 1131 Sheep muscle.2*.2.15 Recommended (k) 1132 Sheep fat.1*.1.2 Recommended (k) 1133 Sheep liver Recommended (k) 1134 Sheep kidney.5*.5.5 Recommended (k) 1141 Goat muscle.2*.2.15 Recommended (k) 1142 Goat fat.1*.1.2 Recommended (k) 1143 Goat liver.5*.3 3 Recommended (k) EFSA Journal 215;13(3):45 5

6 Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 1144 Goat kidney.1*.5.5 Recommended (k) 1161 Poultry muscle.1*.1*.1* Recommended (k) 1162 Poultry fat.1*.1*.1* Recommended (k) 1163 Poultry liver.1*.1*.1* Recommended (k) 121 Cattle milk.1*.1.15 Recommended (k) 122 Sheep milk.1*.1.15 Recommended (k) 123 Goat milk.1*.1.15 Recommended (k) 13 Birds' eggs.1*.1*.1* Recommended (k) - Other products of animal origin See App. C1 - - Further consideration needed (i) (*): Indicates that the MRL is set at the limit of analytical quantification.. (a): GAP evaluated at EU level is not fully supported by data and a risk to consumers cannot be excluded; no CXL is available. Either a specific LOQ or the default MRL of.1 mg/kg may be considered (combination D-I in Appendix D). (b): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; no CXL is available (combination E-I in Appendix D). (c): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; CXL is higher, supported by data but a risk to consumers cannot be excluded (combination G-VI in Appendix D). (d): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; no CXL is available (combination G-I in Appendix D). (e): GAP evaluated at EU level is not supported by data and a risk to consumers cannot be excluded for the existing EU MRL; no CXL is available. Either a specific LOQ or the default MRL of.1 mg/kg may be considered (combination B-I in Appendix D). (f): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; CXL is higher but it is not sufficiently supported by data and a risk to consumers cannot be excluded (combination G-IV in Appendix D). (g): GAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL; no CXL is available (combination C-I in Appendix D). (h): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; existing CXL is covered by the tentative MRL (combination E-III in Appendix D). (i): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either a specific LOQ or the default MRL of.1 mg/kg may be considered (combination A-I in Appendix D). (j): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified; GAP evaluated at EU level, which is also fully supported by data, leads to a lower MRL (combination G-VII in Appendix D). (k): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; existing CXL is covered by the recommended MRL (combination G-III in Appendix D). EFSA Journal 215;13(3):45 6

7 TABLE OF CONTENTS Abstract... 1 Summary... 2 Background... 8 Terms of reference... 9 The active substance and its use pattern... 9 Assessment Methods of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues Nature and magnitude of residues in plant Primary crops Rotational crops Nature and magnitude of residues in livestock Dietary burden of livestock Nature of residues Magnitude of residues Consumer risk assessment Consumer risk assessment without consideration of the existing CXLs Consumer risk assessment with consideration of the existing CXLs Conclusions and recommendations Documentation provided to EFSA References Appendix A Good Agricultural Practices (GAPs) Appendix B Pesticide Residues Intake Model (PRIMo) Appendix C Existing EU maximum residue limits (MRLs) and Codex Limits (CXLs) Appendix D Decision tree for deriving MRL recommendations Appendix E List of metabolites and related structural formula Abbreviations EFSA Journal 215;13(3):45 7

8 BACKGROUND Regulation (EC) No 396/25 4 establishes the rules governing the setting and the review of pesticide MRLs at European level. Article 12(1) of that regulation stipulates that EFSA shall provide within 12 months from the date of the inclusion of an active substance in Annex I to Directive 91/414/EEC 5 a reasoned opinion on the review of the existing MRLs for that active substance. As fenpropimorph was included in Annex I to the above mentioned directive on 1 May 29, EFSA initiated the review of all existing MRLs for that active substance and a task with the reference number EFSA-Q was included in the EFSA Register of Questions. According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC. It should be noted, however, that in the framework of Directive 91/414/EEC only a few representative uses are evaluated, while MRLs set out in Regulation (EC) No 396/25 should accommodate all uses authorised within the EU, and uses authorised in third countries that have a significant impact on international trade. The information included in the assessment report prepared under Directive 91/414/EEC is therefore insufficient for the assessment of all existing MRLs for a given active substance. In order to gain an overview of the pesticide residues data that have been considered for the setting of the existing MRLs, EFSA developed the Pesticide Residues Overview File (PROFile). The PROFile is an inventory of all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance. This includes data on: the nature and magnitude of residues in primary crops; the nature and magnitude of residues in processed commodities; the nature and magnitude of residues in rotational crops; the nature and magnitude of residues in livestock commodities and; the analytical methods for enforcement of the proposed MRLs. Germany, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for fenpropimorph and to prepare a supporting evaluation report. The requested information was submitted to EFSA on 13 October 21 and subsequently checked for completeness. On 19 December 213, after having clarified some issues with EFSA, the RMS provided a revised PROFile and updated evaluation report. A draft reasoned opinion was issued by EFSA on 15 September 214 and submitted to Member States (MS) for commenting. All MS comments received by 17 November 214 were considered by EFSA in the finalisation of the reasoned opinion. 4 Regulation (EC) No 396/25 of the European Parliament and of the Council of 23 February 25 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 7, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 23, , p EFSA Journal 215;13(3):45 8

9 TERMS OF REFERENCE According to Article 12 of Regulation (EC) No 396/25, EFSA shall provide a reasoned opinion on: the inclusion of the active substance in Annex IV to the Regulation, when appropriate; the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation; the inclusion of the recommended MRLs in Annex II or III to the Regulation; the setting of specific processing factors as referred to in Article 2(2) of the Regulation. THE ACTIVE SUBSTANCE AND ITS USE PATTERN Fenpropimorph is the ISO common name for cis-4-[(rs)-3-(4-tert-butylphenyl)-2-methylpropyl]-2,6- dimethylmorpholine (IUPAC). CH 3 H 3 C C N O CH 3 MW: 33.5 Fenpropimorph is a systemic fungicide belonging to the morpholine compounds. The active substance inhibits the formation of appressoria and haustoria and controls mycelial growth and sporulation. Fenpropimorph is used to control a range of fungal diseases. Fenpropimorph was evaluated in the framework of Directive 91/414/EEC with Germany being the designated rapporteur Member State (RMS). The representative uses supported for the peer review process were foliar spray applications on cereals (barley, oats, wheat, rye, triticale), sugar beet and sunflower in northern and southern Europe. Following the peer review, which was carried out by EFSA, a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 28/17/EC, 6 which entered into force on 1 May 29. According to Regulation (EU) No 54/211, 7 fenpropimorph is deemed to have been approved under Regulation (EC) No 117/29. 8 This approval is restricted to uses as fungicide only. The EU MRLs for fenpropimorph are established in Annexes II and IIIB of Regulation (EC) No 396/25. Since the entry into force of that regulation, EFSA also recommended the modification of the existing MRLs for barley, oats, rye, wheat and for commodities of animal origin (EFSA, 213) which are not yet legally implemented. All existing EU MRLs, which are established for the parent compound only for commodities of plant origin and for ) expressed as fenpropimorph for commodities of animal origin are summarised in Appendix C.1 to this document. CXLs for fenpropimorph were also established by the Codex Alimentarius Commission 6 Commission Directive 28/17/EC of 25 November 28 amending Council Directive 91/414/EEC to include abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as active substances. OJ L 316, , p Commission Implementing Regulation (EU) No 54/211 of 25 May 211 implementing Regulation (EC) No 117/29 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, , p Regulation (EC) No 117/29 of the European Parliament and of the Council of 21 October 29 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ 39, , p BF 421-2: 2-methyl-2-{4-[2-methyl-3-(cis-2,6-dimethylmorpholin-4-yl)propyl]phenyl}propionic acid; see Appendix E EFSA Journal 215;13(3):45 9

10 and are reported in Appendix C.2 to this reasoned opinion. These CXLs refer to the same residue definitions as those defined at EU level. For the purpose of this MRL review, the critical uses of fenpropimorph currently authorised within the EU as well as uses authorised in third countries that might have a significant impact on international trade, have been collected by the RMS and reported in the PROFile. Additional GAPs reported during the consultation of Member States were also considered (see Appendix A). According to all GAPs reported, fenpropimorph is authorised in northern and southern Europe for foliar application in several berries, banana, several root and tuber vegetables, leek, cereals, sugar beet, fodder beet and hops, only under outdoor conditions. ASSESSMENT EFSA bases its assessment on the PROFile submitted by the RMS, the evaluation report accompanying the PROFile (Germany, 213), the conclusion on the peer review of the pesticide risk assessment of the active substance fenpropimorph (EFSA, 28), the JMPR Evaluation reports (FAO, 1995, 1999), the previous reasoned opinion on fenpropimorph (EFSA, 213) as well as the evaluation reports submitted during the consultation of Member States (France, 214; Germany,214a, 214b; Netherlands, 214; United Kingdom, 214). The assessment is performed in accordance with the legal provisions of the Uniform Principles for Evaluation and Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/211 1 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (EC, 1996, 1997a-g, 2, 21a,b, 211 and OECD, 211). 1. Methods of analysis 1.1. Methods for enforcement of residues in food of plant origin During the peer review under Directive 91/414/EEC, an analytical method using LC-MS/MS was evaluated and validated for the determination of fenpropimorph residues in plant matrices with an LOQ of.5 mg/kg in high water content (wheat forage), high oil content (sunflower seed), acidic (oranges) and dry (wheat grain) commodities and in straw (Germany, 25; EFSA, 28). The method was validated for only one mass transition and cannot be considered as highly specific according to the current guidance document on analytical methods (EC, 21b). Moreover, an ILV is not available. In addition, a multi-residue GC-MS analytical method (DFG S19) was also evaluated and validated for the determination of fenpropimorph residues in plant matrices with an LOQ of.1 mg/kg in high water content (tomato), acidic (lemon) and dry (wheat grain) commodities and with an LOQ of.2 mg/kg in high oil content matrices (rape seed) using one fragment ion for quantification (Germany, 28; EFSA, 28). However, since no validation data were provided for the 2 additional fragment ions, this method cannot be accepted as a confirmatory method. Moreover, an ILV is not available. A further analytical method using LC-MS/MS and confirmed by the validation of a second mass transition was evaluated and fully validated for the determination of fenpropimorph residues in high water content (wheat plant, lettuce, onion, tomato), in high oil content (rape seed), in acidic (lemon) and in dry (wheat grain) commodities with an LOQ of.1 mg/kg (Germany, 214b). Also for this method an ILV is not available. The multi-residue QuEChERS method in combination with HPLC-MS/MS, as described by CEN (28b), is also validated for analysis of parent fenpropimorph with an LOQ of.1 mg/kg in acidic, high water content and dry commodities (see Table 1-1). 1 Commission Regulation (EU) No 546/211 of 1 June 211 implementing Regulation (EC) No 117/29 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, , p EFSA Journal 215;13(3):45 1

11 Table 1-1: Recovery data for the analysis of fenpropimorph in different crop groups using the QuEChERS method in combination with LC-MS/MS (CEN, 28b). Commodity group Spiking levels Recoveries Mean (%) RSD (%) n No of labs Acidic (lemon, orange) Dry (wheat flour) High water (cucumber) Hence it is concluded that fenpropimorph can be enforced in food of plant origin with an LOQ of.1 mg/kg in high water content, acidic and dry commodities. However, a fully validated analytical method for hops is still required. The available methods are not stereoselective Methods for enforcement of residues in food of animal origin During the peer review under Directive 91/414/EEC, an analytical method using HPLC-UV, confirmed by LC-MS in all matrices except in liver and kidney, and its ILV were evaluated and validated for the determination of fenpropimorph carboxylic acid (BF 421-2) in food of animal origin with an LOQ of.1 mg/kg in muscle, liver, kidney and eggs and with an LOQ of.2 mg/kg in milk (Germany, 25). However, the method was not validated in fat. During the peer review under Directive 91/414/EEC, an analytical method using HPLC-MS/MS, confirmed by the validation of a second mass transition, and its ILV were evaluated and validated for the determination of fenpropimorph and its metabolite fenpropimorph carboxylic acid (BF 421-2) in food of animal origin with an LOQ of.5 mg/kg per analyte in muscle, fat, liver, kidney and eggs and with an LOQ of.1 mg/l per analyte in milk (Germany, 28; EFSA, 28). Hence it is concluded that fenpropimorph and its metabolite fenpropimorph carboxylic acid (BF 421-2) can be enforced in food of animal origin with an LOQ of.5 mg/kg per analyte in muscle, fat, liver, kidney and eggs and with an LOQ of.1 mg/l per analyte in milk. The available methods are not stereoselective. 2. Mammalian toxicology The toxicological assessment of fenpropimorph was peer reviewed under Directive 91/414/EEC and toxicological reference values were established by EFSA (28). These toxicological reference values are summarised in Table 2-1. Table 2-1: Overview of the toxicological reference values Fenpropimorph Source Year Value Study relied upon Safety factor ADI EFSA 28.3 mg/kg bw per d Rat, 2-year study 1 ARfD EFSA 28.3 mg/kg bw Rabbit, developmental study 5 (a) (a): Usual safety factor of 1 with an additional safety factor of 5 which gives a margin of safety of 1 with respect to the most critical teratogenic effects that were observed. EFSA Journal 215;13(3):45 11

12 3. Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues Metabolism of fenpropimorph was investigated for foliar application on cereals (spring wheat), on fruits and fruiting vegetables (banana) and on root and tuber vegetables (sugar beet), using [U- 14 C- phenyl]- and [2,6-14 C-morpholine]-labelled fenpropimorph (Germany, 25, 28; EFSA, 28). The characteristics of these studies are summarised in Table 3-1. Table 3-1: Summary of available metabolism studies in plants Group Crop Label position Fruits and fruiting vegetables Root and tuber vegetables Cereals Banana U- 14 C- phenyl and 2,6-14 C- morpholine Sugar beet U- 14 C- phenyl and 2,6-14 C- morpholine Spring wheat U- 14 C- phenyl and 2,6-14 C- morpholine Method, F or G (a) Foliar spray, F Foliar spray, G Foliar spray, F Application and sampling details Rate (kg a.s./ha) (a): Outdoor/field application (F) or glasshouse/protected/indoor application (G) No Sampling (DAT) (fruits, leaves).75 1 (immature plants), 112 (leaves, roots) (forage), 49 (straw, grain) Remarks Time interval: 14, 51 and 12 days. 2 batches of tests respectively on the protected and unprotected banana bunches Wheat forage was sampled 25 days after the first of the 2 applications and dried to hay. In spring wheat, total radioactive residues accounted for mg eq/kg in hay, mg eq/kg in straw and mg eq/kg in grain for the phenyl and morpholine labelling forms. A similar metabolic pattern was depicted using the 2 labelling forms of fenpropimorph. The parent compound remained a significant constituent of the total residues in cereal hay (34.3 % TRR-16.5 mg/kg), in straw (7.8 % TRR-1.13 mg/kg) and in grain (16.4 % TRR-.21 mg/kg). The compound BF , mainly under its conjugated form, was also identified at significant proportions in cereal hay ( % TRR), in straw ( % TRR) and in grain ( % TRR). In addition, regarding the morpholine labelling, the intact 2,6-dimethylmorpholine (BF 421-1) 12 compound resulting from the cleavage of the parent molecule was recovered in cereal hay and straw (up to 6.5 % TRR 1.53 mg eq/kg) and also in grain but at a trace level (.6 % TRR-.2 mg/kg). Other minor compounds structurally related to the parent compound and present mainly under their conjugated form were also formed in all matrices but at a proportion each below 1 % TRR. EFSA highlighted that only 35 % and 15 % of the total residues were extracted in wheat grain respectively for the phenyl and the 11 BF 421-1: 4-{3-[4-(2-hydroxy-1,1-dimethyl)ethylphenyl]-2-methylpropyl}-cis-2,6-dimethylmorpholine; see Appendix E 12 BF 421-1: cis-2,6-dimethylmorpholine; see Appendix E EFSA Journal 215;13(3):45 12

13 morpholine labelling forms but further characterization of the non-extractable residues showed that the major part of the radioactivity was incorporated into natural plant constituents (sugars). The same metabolic pathway as observed in cereals was depicted in the sugar beet leaves and roots. The total residues amounted to mg eq/kg in the leaves and mg eq/kg in the roots for the phenyl and morpholine label forms, respectively. Fenpropimorph was found to be a predominant compound of the total residues in roots (33.5 % TRR -.9 mg eq/kg and 17.4 % TRR-.7 mg eq/kg, respectively) and in leaves (4.5 % TRR-.43 mg eq/kg and 19 % TRR-.97 mg eq/kg, respectively). For the phenyl labelling treated roots, the fenpropimorph alcohol (BF 421-1) and compound BF , mainly under their conjugated form, were detected at levels of 15.3 % (.4 mg eq/kg) and 1.3 % TRR (.3 mg eq/kg), respectively whilst for the leaves, metabolites BF 421-1, BF and BF were also present under their conjugated form and exceeded 1 % of the total residues. Cleavage of the parent compound did not occur in the roots whereas 2,6-dimethylmorpholine was detected in the leaves at a level of 1.2 % TRR (.46 mg eq/kg). The total radioactive residues in unprotected ripe banana amounted to.94 mg eq/kg and.61 mg eq/kg, respectively for the phenyl and morpholine labelling forms. The parent fenpropimorph was recovered at a level of 3.2 % of TRR (morpholine label) and 35 % of TRR (phenyl label), respectively. No further metabolite was identified. The resulting fragments of the degradation of the morpholine moiety were shown to be preferentially involved in the anabolic pathway such as sugars biosynthesis during ripening. The metabolism of fenpropimorph was considered as sufficiently investigated in spring wheat (cereals), sugar beet (root and tuber vegetables) and banana (fruit crops) following foliar application. The metabolic pathway was similar and consists of 2 main routes: Oxidation of the tertiary butyl group of the phenyl ring followed by further glucosylation; Oxidative opening of the morpholine ring and cleavage of the parent molecule between the morpholine ring and its methylpropyl side chain. The metabolites BF and BF are major rat metabolites and their toxicity is therefore covered by the toxicological properties of the parent compound. The other plant metabolites were shown to be structurally related to the parent compound and resulted from metabolic pathways that are similar to those observed in the rat. It is therefore assumed that these metabolites are of no higher or different toxicity compared to the parent compound. Based on the metabolic pattern of fenpropimorph depicted in primary crops, the residue definition for enforcement is set as fenpropimorph only. For risk assessment, since the metabolites BF (free and conjugated) and BF were recovered in significant amounts in wheat straw and sugar beet leaves, the residue definition is proposed as the sum of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1), expressed as fenpropimorph in order to consider the potential contribution of these metabolites to the overall toxicological burden. Validated analytical methods for enforcement of the proposed residue definition are available for all crop commodities, except for hops (see also section 1.1). In addition, EFSA emphasises that the above studies do not investigate the possible impact of plant metabolism on the isomer ratio of fenpropimorph and further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available. Meanwhile, since the available analytical methods are not stereoselective, the proposed 13 BF 421-2: 2-{4-[(2RS)-3-{[(2RS)-2-hydroxypropyl]amino}-2-methylpropyl]phenyl}-2-methylpropan-1-ol; see Appendix E 14 BF : 2-(4-{(2RS)-3-[(2RS,6RS)-2,6-dimethyl-4-oxidomorpholin-4-yl]-2-methylpropyl}phenyl)-2-methylpropyl D- glucopyranoside; see Appendix E EFSA Journal 215;13(3):45 13

14 residue definitions for enforcement and risk assessment are derived for the sum of the R- and S- isomers Magnitude of residues According to the RMS, the active substance fenpropimorph is authorised in northern and southern Europe for foliar application in several berries, banana, several root and tuber vegetables, leek, cereals, sugar beet, fodder beet and hops, only under outdoor conditions (see Appendix A). To assess the magnitude of fenpropimorph residues resulting from these GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Germany, 213), including residue trials evaluated in the framework of the peer review (Germany, 28; EFSA, 28) or in the framework of a previous MRL application (EFSA, 213) and additional data submitted during the consultation of Member States (France, 214; Germany, 214a; United Kingdom, 214). All available residue trials that comply with the authorised GAPs are summarised in Table 3-2. It is highlighted that none of the available trials investigated residues according to the residue definition for risk assessment. However, a conversion factor for risk assessment of 5 derived from the metabolism studies was applied to cereal straw and beet leaves. For root and tuber vegetables, and cereals grains no conversion factor was considered necessary because the metabolites included in the risk assessment residue definition were either encountered at a very low concentration or not detected. Approaches for these crops were already agreed upon during the peer review. For bananas, EFSA proposes to rely on the available metabolism study to conclude that no conversion factor for risk assessment is necessary. In contrast, for strawberries, cane fruit (raspberries, dewberries, blackberries), other small fruit and berries (currants, blueberries, cranberries, gooseberries), leek and hops, the available metabolism studies were not considered representative to derive robust conversion factor for risk assessment. Therefore, the highest observed conversion factor of 5 was applied for these crops on a tentative basis. The number of residue trials and extrapolations were also evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (EC, 211). A sufficient number of trials complying with the GAPs were available on banana, carrots (extrapolated to horseradish, parsnips, parsley root, salsifies), barley (extrapolated to oats) and wheat (extrapolated to rye) to derive MRL and risk assessment values. The following considerations were also made by EFSA: Strawberries, cane fruit (raspberries, dewberries, blackberries) and other small fruit and berries (currants, blueberries, cranberries, gooseberries): available residues trials were considered sufficient to derive tentative MRL and risk assessment values (also considering a tentative conversion factor of 5 for risk assessment, see above). However, a complete set of trials compliant with the supported GAPs and investigating residues according to the residue definitions for enforcement and risk assessment are still required. Banana: Although the reported residue trials were conducted with 4 instead of 5 applications, the first application is expected to occur at a very early stage and will therefore have a negligible impact on the final residue level. The residue trials on whole fruit, bagged and unbagged were reported and MRL and risk assessment values can be derived. Leek: No residue trials complying with the northern outdoor GAP are available. Considering that it is a major crop in northern Europe, 8 residue trials compliant with the northern outdoor GAP are required. Meanwhile, neither MRL nor risk assessment values can be derived. Oats: It is noted that a more critical GAP is authorised in Belgium (2 x 75 g a.s./ha, 28 d PHI but is not supported by residue data. Although adequate MRLs can be derived from the Swedish GAP, 8 residue trials compliant with the Belgian GAP are in principle still required. EFSA Journal 215;13(3):45 14

15 Wheat: The number of residue trials supporting the southern outdoor GAP is not compliant with the data requirements for this major crop (4 trials instead of 8). However, based on the magnitude of the residues in grain and straw from the residue trials compliant with the northern outdoor zone, it can be concluded that the southern outdoor GAP is not expected to be more critical. Appropriate MRL and risk assessment values can be derived from the northern outdoor residue data. Sugar and fodder beet: Residue trials compliant with the northern outdoor GAP were not provided but 4 overdosed residue trials conducted with 1 application at 75 g a.s./ha and a 28 d PHI were considered on a tentative basis. Furthermore, the number of residue trials supporting the southern outdoor GAP (for sugar beet only) is not compliant with the data requirements (6 trials instead of 8). Although tentative MRL and risk assessment values can be derived from the northern residue data, 8 residue trials on sugar beet compliant with the northern outdoor GAP and 2 additional residue trials compliant with the southern outdoor GAP are still required, with a possible extrapolation to fodder beet for the northern outdoor zone only. Hops: No residue trial was provided to support the northern outdoor GAP. Since hops are a minor crop in the northern outdoor zone, 4 GAP-compliant residue trials are required. Meanwhile, neither MRL nor risk assessment values can be derived. The potential degradation of residues during storage of the residue trials samples was also assessed. In the framework of the peer review, storage stability of fenpropimorph was demonstrated for a period of 24 months at -2 C in commodities with high water content (banana, sugar beet root), high oil content (sunflower seed), dry commodities (wheat grain) and in straw (Germany, 28; EFSA, 28). No storage stability data were reported for acidic commodities and are requested to cover the maximum storage time interval of the residue trials samples of strawberries, cane fruit and small fruit and berries. According to the RMS, most of the residue trial samples reported in the PROFile on banana, cereals and sugar beet was stored in compliance with the storage conditions reported above. Although the storage conditions for the residue trials on carrots and for some residue trials on wheat and barley were not reported by the RMS, it is assumed that storage periods longer than 24 months are not expected in practice. Degradation of residues during storage of the trial samples is therefore not expected for these crops. In contrast, the acceptability of the residue trials provided on strawberries, cane fruit and other small fruit and berries will be reconsidered pending on the outcome of the requested storage stability data in acidic commodities. Consequently, the available residues data are considered sufficient to derive MRL proposals as well as risk assessment values for all crops under evaluation, except for strawberries, cane fruit, other small fruit and berries, and sugar and fodder beet where tentative MRLs are derived, and for leek and hops where the available data were insufficient to derive tentative MRLs (see also Table 3-2). Where several uses are authorised for one commodity, the final MRL proposal was derived from the most critical use and indicated in bold in Table 3-2. Tentative MRLs were also derived for feed crops (cereal straw, sugar/fodder beet leaves) in view of the future need to set MRLs in feed items. EFSA Journal 215;13(3):45 15

16 Table 3-2: Overview of the available residue trials data Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement Risk assessment Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Residue definition for enforcement: fenpropimorph Residue definition for risk assessment: sum of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1), expressed as fenpropimorph Strawberries NEU Outdoor.17;.237;.247;.25;.37;.641;.778;.965 Blackberries Dewberries Raspberries Blueberries Cranberries Currants (red and white) Gooseberries NEU Outdoor.71;.94;.158;.163;.253;.346;.59;.6 NEU Outdoor.283;.292;.292; (e) (tentative) (e) (tentative) (e) (tentative) 5 (f) GAP-compliant residue trials (United Kingdom, 214). MRL OECD =1.65 R ber =1.49 R max = (f) GAP-compliant residue trials (United Kingdom, 214). MRL OECD =1.13 R ber =1.6 R max =.96 5 (f) GAP-compliant residue trials (United Kingdom, 214). MRL OECD =.89 R ber =.62 R max =.37 EFSA Journal 215;13(3):45 16

17 Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement Risk assessment Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Bananas Carrots Horseradish Parsnips Parsley root Salsifies Import (VE) Outdoor (unbagged) Outdoor (bagged).1;.12;.16;.26;.32;.36;.43;.65;.7;.75; 1.2; <.5;.13;.16;.17;.31; (g) GAP-compliant residue trials (Germany, 213, 214a). MRL OECD =2.22 R ber =1.48 R max = (g) GAP-compliant residue trials (Germany, 213, 214a). MRL OECD =.59 R ber =.34 R max =.44 NEU Outdoor 7 <.3; (g) GAP-compliant residue trials (United Kingdom, 214). MRL OECD =.4 R ber =.6 R max =.3 Leek NEU Outdoor No trials available. EFSA Journal 215;13(3):45 17

18 Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement Risk assessment Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Barley, oats grain Barley, oats straw NEU Outdoor.1; 2.2;.4; 4 <.5; 2.5;.6; 2.9;.1; 2.11; 3.13;.16;.22;.24;.27 SEU Outdoor <.1; 2.1; 4.2; 2.3; 2 <.5;.67;.68 NEU Outdoor.2;.4; 2.7;.8;.13; 2.14;.17;.53;.66;.68;.76; 1.2; 1.29; 2 1.3; 1.7; 1.71; 1.8; 2.5; 3.25; 3.9 SEU Outdoor.4; 2 <.5; 2.8; 2.1; 2.14; 2.15;.162;.28; (g) GAP-compliant residue trials on barley with a possible extrapolation to oats (Germany, 28, 213). The NEU GAP on oats is not properly reported (growth stage at application is not defined). MRL OECD =.38 R ber =.26 R max = (g) GAP-compliant residue trials on barley with a possible extrapolation to oats (Germany, 28, 213). MRL OECD =.11 R ber =.1 R max = (tentative) (tentative) 5 (g) GAP-compliant residue trials on barley with a possible extrapolation to oats (Germany, 28, 213). MRL OECD =5.33 R ber =3.4 R max = (g) GAP-compliant residue trials on barley with a possible extrapolation to oats (Germany, 28, 213). MRL OECD =.53 R ber =.31 R max =.4 EFSA Journal 215;13(3):45 18

19 Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement Risk assessment Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Wheat, rye grain Wheat, rye straw NEU Outdoor 5 <.1;.1; 2.2; 11 <.5;.5; 2.6;.7; 2.8; (g) GAP-compliant residue trials on wheat with a possible extrapolation to rye (Germany, 28, 213). MRL OECD =.14 R ber =.1 R max =.1 SEU Outdoor <.1; 2.2; (g) GAP-compliant residue trials on wheat with a possible extrapolation to rye (Germany, 28, 213). MRL OECD =.7 R ber =.7 R max =.9 NEU Outdoor 2.7;.11;.14;.17;.19;.21;.26;.27; 2.29;.3;.33;.48;.92; 1.1; 1.57; 1.6; 2.9; 2.8; 2.86; 3.28; 2 3.6; 3.82; (tentative) SEU Outdoor.12;.24;.34; (tentative) 5 (g) GAP-compliant residue trials on wheat with a possible extrapolation to rye (Germany, 28, 213). MRL OECD =7.9 R ber =5.63 R max = (g) GAP-compliant residue trials on wheat with a possible extrapolation to rye (Germany, 28, 213). MRL OECD =.87 R ber =.86 R max =1.3 Hops NEU Outdoor No GAP-compliant residue trials (United Kingdom, 214). EFSA Journal 215;13(3):45 19

20 Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement Risk assessment Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Sugar and fodder beet root NEU Outdoor 3 <.1; (h) SEU Outdoor <.1; <.1;.3; <.5; <.5;.27 (tentative) (h) (tentative) 1 (g) Overdosed residue trials conducted at 1 75 g a.s./ha, PHI: 28 days (Germany, 213; France, 214). MRL OECD =.12 R ber =.1 R max =.15 1 (g) GAP-compliant residue trials on sugar beet (Germany, 28, 213; France, 214); not authorised for use on fodder beet in SEU. MRL OECD =.1 R ber =.1 R max =.1 EFSA Journal 215;13(3):45 2

21 Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement Risk assessment Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Sugar and fodder beet leaves NEU Outdoor.11;.15;.33; (h) SEU Outdoor.22;.79;.93; 1.; 1.1; 1.2 (tentative) (h) (tentative) 5 (g) Overdosed residue trials conducted at 1 75 g a.s./ha, PHI: 28 days (Germany, 213; France, 214). MRL OECD =.88 R ber =.83 R max =1.5 5 (g) GAP-compliant residue trials on sugar beet (Germany, 28, 213; France, 214); not authorised for use on fodder beet in SEU. MRL OECD =2.63 R ber =2.25 R max =2.18 (a): NEU (Northern and Central Europe), SEU (Southern Europe and Mediterranean), EU (i.e. outdoor use) or Import (country code) (EC, 211). (b): Median value of the individual trial results according to the enforcement residue definition. (c): Highest value of the individual trial results according to the enforcement residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial and was tentatively derived from the metabolism studies on cereals and sugar beet. (e): Storage stability data in acidic commodities are required covering the maximum storage time period of these residue trials samples on strawberries, cane fruit and other small fruit and berries crops. (f) A default conversion factor for risk assessment of 5 was tentatively applied to these crops. Residue trials on these crops conducted in compliance with the residue definition for risk assessment are required. (g): Adequate conversion factors for risk assessment were derived from the available metabolism studies (see body text). (h): GAP-compliant residue trials on sugar beet root and leaves are required. (*): Indicates that the MRL is set at the limit of analytical quantification. EFSA Journal 215;13(3):45 21

22 Effect of industrial processing and/or household preparation The effect of processing on the nature of fenpropimorph was investigated in the framework of the peer review. Studies were conducted simulating representative hydrolytic conditions for pasteurisation (2 minutes at 9 C, ph 4), boiling/brewing/baking (6 minutes at 1 C, ph 5) and sterilisation (2 minutes at 12 C, ph 6). From these studies, it was concluded that processing under the above conditions is not expected to have a significant impact on the composition of residues in matrices of plant origin (Germany, 28; EFSA, 28). The relevant residue for enforcement and risk assessment in processed commodities is therefore expected to be the same as for primary crops. Studies investigating the magnitude of residues in processed commodities of banana, wheat, barley and oats were also reported (Germany, 28, 213; 214a; EFSA, 28). An overview of all available processing studies is available in Table 3-3. Robust processing factors for enforcement and risk assessment were derived for peeled banana (bagged and unbagged), wheat wholemeal flour and bread, barley brewing malt, beer and oats flakes. No robust processing factor for enforcement and risk assessment could be derived for barley pot/pearl and wheat white flour because of the high variability of the individual results which did not allow drawing a reliable conclusion whether an increased or reduced residue concentration is expected in these processed products. Furthermore, the processing factor derived for wheat/rye bran should be regarded as indicative only as it was not supported by a sufficient number of studies (a minimum of 3 studies are required). These processing factors reported in Table 3-3 should therefore be considered as indicative only. Nevertheless, further processing studies are not required in this case as they are not expected to affect the outcome of the risk assessment. If more robust processing factors were to be required by risk managers, in particular for enforcement purposes, additional processing studies would be needed. Table 3-3: Overview of the available processing studies Processed commodity Number of studies Median PF (a) Median CF (b) Comments Enforcement residue definition : fenpropimorph Processing factors recommended (sufficiently supported by data) Banana, peeled Data for bagged and unbagged bananas were pooled because they were not significantly different (Germany, 213, 214a) Barley, brewing malt (EFSA, 28; Germany, 28) Barley, beer 4 <.21 1 (EFSA, 28; Germany, 28) Oats, flakes (EFSA, 28; Germany, 28) Wheat, wholemeal flour (EFSA, 28; Germany, 28) Wheat, wholemeal bread (EFSA, 28; Germany, 28) Indicative processing factors (limited data set or high variability in the results) Barley, pot/pearl (EFSA, 28; Germany, 28) Wheat, white flour (EFSA, 28; Germany, 28) Wheat, bran (EFSA, 28; Germany, 28) Rye, bran Extrapolated from the wheat study (EFSA, 28; Germany, 28) EFSA Journal 215;13(3):45 22

23 (a): The median processing factor is obtained by calculating the median of the individual processing factors of each processing study. (b): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors of each processing study Rotational crops Preliminary considerations All crops under consideration, except bananas, may be grown in rotation. According to the soil degradation studies evaluated in the framework of the peer review, DT 9 values of fenpropimorph are expected to range between days which is higher than the trigger value of 1 days (EFSA, 28). The major soil metabolite fenpropimorph carboxylic acid (BF 421-2) was demonstrated to be of low persistence (DT 5 : days). According to the European guidelines on rotational crops (EC, 1997b), further investigation of residues in rotational crops is relevant Nature of residues The metabolism of fenpropimorph in rotational crops (lettuce, radish, wheat) has been evaluated (Germany, 25; EFSA, 28). A confined rotational crop study was conducted with [U- 14 C-phenyl] and [2,6-14 C-morpholine]-labelled fenpropimorph and investigated the nature of residues at different plant back intervals (PBIs). The characteristics of these studies are summarised in Table 3-4. Table 3-4: Summary of available metabolism studies in rotational crops Crop group Leafy vegetables Root and tuber vegetables Crop Label position Lettuce U- 14 C- phenyl and 2,6-14 C- morpholine Radish U- 14 C- phenyl and 2,6-14 C- morpholine Cereals Wheat U- 14 C- phenyl and 2,6-14 C- morpholine Method, F or G (a) Bare soil application, G Bare soil application, G Bare soil application, G Application and sampling details Rate (kg a.s./ha) Sowing intervals (DAT) 1.5 3, 12, , 12, , 12, 365 (a): Outdoor/field application (F) or glasshouse/protected/indoor application (G) n.r.: Not reported Harvest Intervals (DAT) n.r. n.r. n.r. Remarks The aged soil was mixed with untreated soil for ploughing Crop interception: % The total radioactive residues recovered in succeeding crops at the 3d PBI accounted for mg eq/kg in lettuce, mg eq/kg in radish root and mg eq/kg in wheat straw for the phenyl and morpholine labelling forms, respectively. These residue levels declined with subsequent plant back intervals of 12 and 365 days. In wheat grain, the total residue levels amounted to mg eq/kg at the 3d PBI for both labels and increased in the samples at the 12d PBI ( mg eq/kg) followed by a significant decline at the 365d PBI ( mg eq/kg). No rationale was provided to explain these results since the total residue levels in soil following application decreased uniformly with the soil ageing period. For both labelling forms, parent fenpropimorph was shown to be extensively metabolised in all edible parts of the succeeding crops EFSA Journal 215;13(3):45 23

24 and was detected at significant proportions only in lettuce at the 3d and 365d PBI (22.7 % -.15 mg/kg and 29.4 % TRR - <.1 mg/kg, respectively) and in radish root at 3d PBI (up to 15.4 % TRR.7 mg/kg) for the phenyl labelling form. In the phenyl-labelled treated crops, the metabolite BF was found to be a predominant compound of the total residues in lettuce (19 % TRR -.13 mg eq/kg) and under its free and conjugated form in wheat straw (61 % TRR.338 mg eq/kg) at the 3d PBI. In the morpholine-labelled treated crops, 2,6-dimethylmorpholine (BF 421-1) was found to be the major compound of the total residues in lettuce (43 % TRR.89 mg eq/kg) and in wheat straw (37.3 % TRR mg eq/kg) at all plant back intervals and in radish root (12.2 % TRR -.12 mg eq/kg) and in wheat grain (1.2 % TRR.15 mg eq/kg) at the 3d PBI. For both labelling forms, the major part of the radioactivity was shown to be incorporated into natural compounds of the plants (sugars) with up to 72.6 % of total residues in wheat grain. The metabolic pathway of fenpropimorph in the edible parts of the rotational crops was considered as sufficiently investigated and was found to be similar to that observed in primary crops and a specific residue definition for rotational crops is not deemed necessary Magnitude of residues Although it can be anticipated lower residue levels in rotational crops under practical conditions assuming interception of the applied substance by the treated crops, EFSA is of the opinion that rotational crops field trials should be provided since fenpropimorph may accumulate in soil following successive years of application in view of its high persistence. A data gap was therefore identified to provide rotational crops field trials on cereals, leafy and root vegetables conducted at a dose rate covering the long-term plateau concentration of fenpropimorph in soil and addressing the magnitude of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1) in the edible parts of the rotational crops. Meanwhile, Member States are recommended to pay particular attention to the possible occurrence of residues in rotational crops Nature and magnitude of residues in livestock Dietary burden of livestock Fenpropimorph is authorised for use on several crops that might be fed to livestock. The median and maximum dietary burdens were therefore calculated for different groups of livestock using the agreed European methodology (EC, 1996). The input values for all relevant commodities have been selected according to the recommendations of JMPR (FAO, 29) and are summarised in Table 3-5. For cereal bran, the indicative processing factor derived under section has been included in the calculation. Table 3-5: Input values for the dietary burden calculation Commodity Median dietary burden Maximum dietary burden Input value Comment Input value Comment Risk assessment residue definition: sum of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1), expressed as fenpropimorph Barley & oats grain.9 Median residue.9 Median residue Barley & oats straw 3.4 Median residue CF 19.5 Highest residue CF Wheat & rye grain.5 Median residue.5 Median residue Wheat & rye straw 2.3 Median residue CF 21.5 Highest residue CF Wheat & rye bran.235 Median residue PF.235 Median residue PF Fodder beet root.1 Median residue.6 Highest residue EFSA Journal 215;13(3):45 24

25 Commodity Median dietary burden Maximum dietary burden Input value Comment Input value Comment Fodder beet leaves 1.2 Median residue CF 2.2 Highest residue CF Sugar beet root.3 Median residue.6 Highest residue Sugar beet leaves 4.9 Median residue CF 6. Highest residue CF The results of the calculations are reported in Table 3-6. The calculated dietary burdens for all groups of livestock were found to exceed the trigger value of.1 mg/kg DM. Further investigation of residues is therefore required in all commodities of animal origin. Table 3-6: Results of the dietary burden calculation Median dietary burden (mg/kg bw per d) Maximum dietary burden (mg/kg bw per d) Highest contributing commodity Max dietary burden (mg/kg DM) Trigger exceeded (Y/N) Risk assessment residue definition: sum of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1), expressed as fenpropimorph Dairy ruminants Sugar beet leaves Y Meat ruminants Wheat straw Y Poultry.6.8 Barley grain.13 Y Pigs Sugar beet leaves 9.59 Y Nature of residues The nature of fenpropimorph residues in commodities of animal origin was investigated in the framework of Directive 91/414/EEC (EFSA, 28). Reported metabolism studies include one study in lactating goats and one study in laying hens using [U- 14 C-phenyl] and [2,6-14 C-morpholine]-labelled fenpropimorph. The characteristics of these studies are summarised in Table 3-7. Table 3-7: Summary of available metabolism studies in livestock Group Species Label position Lactating ruminants Laying poultry (a): 23 hours after last dose Goat U- 14 C- phenyl and 2,6-14 C- morpholine Hens U- 14 C- phenyl and 2,6-14 C- morpholine No of animal Application details Rate (mg/kg bw per d) Duration (days) Commodity Sample details Time 7 Milk Twice daily Urine and faeces Tissues Daily At sacrifice (a) 1 Eggs Twice daily Excreta Tissues Daily At sacrifice (a) EFSA Journal 215;13(3):45 25

26 Lactating cows were dosed with mg/kg bw per d of fenpropimorph, corresponding to approximately 1 and.6 times the exposure of dairy and meat ruminants, respectively. The study demonstrated that transfer of residues to milk and tissues was minor as fenpropimorph was rapidly absorbed and excreted mainly unchanged in the excreta (56 % 78 % of the total dose) whilst in milk and tissues, only up to 1.23 % and.3 % of the administered radioactivity were recovered for both labellings. The highest residue levels were found in liver ( mg eq/kg), in kidney ( mg eq/kg) and in fat ( mg eq/kg) whereas the total radioactive residues were recovered at lower levels in muscle ( mg eq/kg) and in milk ( mg eq/kg). For the phenyl and morpholine labelling forms, fenpropimorph was recovered at low proportions in milk (1 % TRR and 1.4 % TRR, respectively) and in tissues (up to 15 % TRR in fat and kidney). By far the fenpropimorph carboxylic acid derivative (BF 421-2) constituted the most predominant compound of the total residues in milk (up to 26.8 % TRR) and in all tissues (up to 4 % TRR in kidney and 78.6 % TRR in muscle for the phenyl label and up to 33.5 % TRR in fat and 57 % TRR in liver for the morpholine label, respectively). The metabolite BF under its glucoside conjugated form was recovered at significant amounts in fat only for both labels (14.4 % TRR.28 mg eq/kg and 15.4 % TRR.37 mg eq/kg, respectively) and was not detected or at a trace level in the other matrices (<.1 mg eq/kg). The metabolite BF was also found to be a major compound of the total residues in kidney only for the phenyl and morpholine labels (41 % TRR.63 mg eq/kg and 21 % TRR.54 mg eq/kg, respectively) whilst it was detected below 1 % TRR (<.5 mg eq/kg) in the other matrices. The metabolites resulting from the cleavage of the morpholine ring of the parent molecule were either not detected or recovered at a trace level (<.1 mg eq/kg) and were shown to be further metabolised and incorporated into endogenous compounds (fatty acids, amino acids). Laying hens were dosed with.81 mg/kg bw per d of fenpropimorph, corresponding to approximately 115 times the exposure estimated for poultry. The parent compound was rapidly absorbed and almost completely excreted mainly unchanged in the excreta (84.9 % -18 % of the total dose) whilst in eggs, up to 1.65 % of the total dose was recovered. For both labellings, the highest residue levels were observed in liver ( mg eq/kg), in fat ( mg eq/kg) and in eggs ( mg eq/kg) and to a minor extend in muscle ( mg eq/kg). All the identified metabolites were expected at a trace level (<.1 mg eq/kg) at the calculated dietary burden. Similar routes of degradation of fenpropimorph as in ruminants were also observed in the poultry matrices but with a significant amount of radioactivity that was incorporated into endogenous lipids (45.5 % TRR in eggs and 79.5 % TRR in fat, for both labels). The main routes of degradation of fenpropimorph in ruminants and poultry consisted of hydroxylation of the tert-butyl moiety (BF 421-1) followed by oxidation to the carboxylated tert-butyl moiety (BF 421-2) and hydroxylation of the dimethylmorpholine ring (BF 421-3). Compound BF was further metabolised by hydrolysis of the dimethylmorpholine ring followed by successive degradation of the side chains that lead to the formation of small polar compounds entering the anabolic reactions such as fatty acids and amino acids biosynthesis. A minor degradation pathway of the parent compound was the cleavage between the methylpropyl group and either the morpholine group (BF 421-1) or the phenyl group (minor metabolites BF and BF ). All identified metabolites in ruminants and poultry matrices, which may be present at levels exceeding.1 mg/kg at the calculated dietary burden, were also encountered in the rat metabolism. These are therefore not considered to be of any toxicological concern compared to the parent compound. Moreover, since the general metabolic pathways in rodents and ruminants were found to be comparable, the metabolic pattern of fenpropimorph in ruminants can be extrapolated to pigs. From the metabolism data, EFSA proposes to derive the residue definition for enforcement and risk assessment in products of animal origin as the sum of fenpropimorph and fenpropimorph carboxylic 15 BF 421-3: 2-(4-{(2RS)-3-[(2R,6R)-2-(hydroxymethyl)-6-methylmorpholin-4-yl]-2-methylpropyl}phenyl)-2-methylpro panoic acid; see Appendix E 16 BF : 4-(2-carboxypropan-2-yl)benzoic acid; see Appendix E 17 BF : 4-(1-hydroxy-2-methylpropan-2-yl)benzoic acid; see Appendix E EFSA Journal 215;13(3):45 26

27 acid (BF, as it was originally agreed by the peer review. Regarding the residue definition for risk assessment, the potential inclusion of metabolites BF (under its glucoside conjugated form) and BF 421-3, recovered respectively in fat and in kidney, was also envisaged. However, since there is no significant contribution of ruminant fat and kidney residues to the overall dietary intake, it can reasonably be assumed that the non-inclusion of these metabolites in the residue definition for risk assessment will have a limited impact on the consumer margin of safety. Since the metabolism studies indicated that the magnitude of residues of fenpropimorph and fenpropimorph carboxylic acid (BF 421-2) were higher in fat compared to fat free muscle and the log Pow value for fenpropimorph was 4.1, the residue is considered fat soluble (EFSA, 28). In addition, EFSA emphasises that the above studies do not investigate the possible impact of livestock metabolism on the isomer ratio of fenpropimorph and further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available. Meanwhile, since the available analytical methods are not stereoselective, the proposed residue definitions for enforcement and risk assessment are derived for the sum of the R- and S- isomers Magnitude of residues During the peer review under Directive 91/414/EEC, the magnitude of the sum of fenpropimorph and fenpropimorph carboxylic acid residues in ruminants was investigated in a feeding study with lactating cows (Germany, 28; EFSA, 28). Four groups of lactating cows, each consisting of three animals were dosed for 28 consecutive days with fenpropimorph and fenpropimorph carboxylic acid at levels of (control), 2.17, 6.54 and 21.7 mg/kg in the diet (equivalent to,.7,.21 and.73 mg/kg bw per d). The samples were analysed in accordance with the proposed residue definition for enforcement and risk assessment. Results of the ruminant livestock feeding study are summarised in Table 3-8. In milk, a plateau level was reached after 3-5 days of exposure depending on the dosing group. The storage stability of fenpropimorph carboxylic acid residues in animal products was evaluated under the peer review of Directive 91/414/EEC (Germany, 28; EFSA, 28). These data demonstrated the stability of fenpropimorph carboxylic acid residues under frozen conditions (-2 C) in milk and kidney for 8 months, in muscle for 5 months, in fat for 9 months, in liver for 1 months and covered the storage time conditions of the samples from the livestock feeding study. Further storage stability data on fenpropimorph and fenpropimorph carboxylic acid residues were provided for milk and ruminant tissues over a frozen storage period of 29 months at -2 C but were corrected for procedural recoveries (Germany, 213). Consequently, the available data are considered sufficient for deriving MRLs in milk, ruminants and pigs. These MRLs were derived in compliance with the latest recommendations on this matter (FAO, 29) and are summarised in Table 3-8. Significant residues in milk, ruminants and pigs tissues are expected and MRLs for these commodities can be proposed. A poultry feeding study is not available and is not triggered. Indeed, based on the metabolism data, no residues of fenpropimorph and fenpropimorph carboxylic acid are expected in eggs and tissues above the LOQ of the method at the calculated dietary burden. MRLs and risk assessment values for the relevant commodities in poultry can therefore be established at the LOQ of the method respectively for fenpropimorph and fenpropimorph carboxylic acid. EFSA Journal 215;13(3):45 27

28 Table 3-8: Overview of the values derived from the livestock feeding studies Commodity Dietary burden Results of the livestock feeding study Median residue No Result for enf. Result for RA (b) Med. (mg/kg bw per d) Max. (mg/kg bw per d) Dose Level (mg/kg bw per d) (a) Mean Max. Mean Max. Highest residue (c) MRL proposal Proposed enforcement and risk assessment residue definition: sum of fenpropimorph and fenpropimorph carboxylic acid (BF (sum of isomers) Pig muscle (f) Pig fat (f) Pig liver (f) Pig kidney (f) CF for RA (d) EFSA Journal 215;13(3):45 28

29 Commodity Dietary burden Results of the livestock feeding study Median residue No Result for enf. Result for RA (b) Med. (mg/kg bw per d) Max. (mg/kg bw per d) Dose Level (mg/kg bw per d) (a) Mean Max. Mean Max. Highest residue (c) MRL proposal Ruminant muscle Ruminant fat Ruminant liver Ruminant kidney Milk (e) n.a..6 (e) n.a (e) n.a..16 (e) n.a (e) n.a..5 (e) n.a. n.a.: Not applicable only the mean values are considered for calculating MRLs in milk (a): Based on a 55 kg animal consuming 2 kg feed DM/day. (b): Median residue value according to the enforcement residue definition, derived by interpolation/extrapolation from the feeding study for the median dietary burden (FAO, 29). (c): Highest residue value (tissues) or mean residue value (milk) according to the enforcement residue definition, derived by interpolation/extrapolation of the maximum dietary burden between the relevant feeding groups of the study (FAO, 29). (d): The median conversion factor for enforcement to risk assessment. (e): Mean residue level from day 1 until day 28 (3 cows, 1 sampling days except for the medium dosing group, where a cow was sacrificed on day 18). (f): Although the feeding study results originate from the ruminant study, the MRL and risk assessment values are based on the calculated dietary burden for pigs. (*): Indicates that the MRL is set at the limit of analytical quantification. CF for RA (d) EFSA Journal 215;13(3):45 29

30 4. Consumer risk assessment In the framework of this review, only the uses of fenpropimorph reported by the RMS in Appendix A were considered, however the use of fenpropimorph was previously also assessed by the JMPR (FAO, 1995, 1999). The CXLs, resulting from these assessments by JMPR and adopted by the CAC, are now international recommendations that need to be considered by European risk managers when establishing MRLs. In order to facilitate consideration of these CXLs by risk managers, the consumer exposure was calculated both with and without consideration of the existing CXLs (see Appendix C.2) Consumer risk assessment without consideration of the existing CXLs Chronic and acute exposure calculations for all crops reported in the framework of this review were performed using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) (EFSA, 27). Input values for the exposure calculations were derived in compliance with Appendix D and are summarised in Table 4-1. The tentative median and highest residue values selected for chronic and acute intake calculations are based on the residue levels in the raw agricultural commodities reported in section 3, except for bananas where the median and highest residues were multiplied by the peeling factor derived in section For those commodities where data were insufficient to derive an MRL in section 3, EFSA considered the existing EU MRL multiplied by the highest observed conversion factor of 5 for an indicative calculation. The contribution of other commodities, for which no GAP was reported in the framework of this review, was not included in the calculation. It is also noted that for the refinement of the acute risk assessment in raspberry juice, EFSA used the median residue level in raspberries (multiplied by the tentative conversion factor) which is in line with the international recommendations for acute risk assessment of processed bulked products. Table 4-1: Input values for the consumer risk assessment (without consideration of CXLs) Commodity Chronic risk assessment Acute risk assessment Input value Comment Input value Comment Risk assessment residue definition: sum of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1), expressed as fenpropimorph Strawberries 1.55 Median residue CF 4.83 Highest residue CF (tentative) (a) (tentative) (a) Blackberries Dewberries Raspberries Blueberries Cranberries Currants (red and white) Gooseberries 1.4 Median residue CF 3. Highest residue CF (tentative) (a) (tentative) (a) 1.46 Median residue CF 1.59 Highest residue CF (tentative) (a) (tentative) (a) Bananas.13 Median residue PF.462 Highest residue PF (unbagged) (b) (unbagged) (b).17 Median residue PF.129 Highest residue PF (bagged) (b) (bagged) (b) EFSA Journal 215;13(3):45 3

31 Carrot Horseradish Parsnips Parsley root Salsifies Mallow root Commodity Chronic risk assessment Acute risk assessment Input value Comment Input value Comment.3 Median residue (b).32 Highest residue (b) Leek 5 EU MRL 5 (c) 5 EU MRL 5 (c) Barley grain.9 Median residue (b).27 Highest residue (b) Oats grain.9 Median residue (b).27 Highest residue (b) Wheat grain.5 Median residue (b).9 Highest residue (b) Rye grain.5 Median residue (b).9 Highest residue (b) Hops 5 EU MRL 5 (c) 5 EU MRL 5 (c) Sugar beet root.3 Median residue.6 Highest residue (tentative) (a) (tentative) (a) Risk assessment residue definition: sum of fenpropimorph and fenpropimorph carboxylic acid (BF 421-2), expressed as fenpropimorph Swine meat.77.8 Median muscle Highest muscle +.2 Median fat (d).2 Highest fat (d) Swine fat.91 Median residue (d).113 Highest residue (d) Swine liver 1.33 Median residue (d) Highest residue (d) Swine kidney.259 Median residue (d).31 Highest residue (d) Ruminant meat Median muscle Highest muscle +.2 Median fat (d).2 Highest fat (d) Ruminant fat.142 Median residue (d).38 Highest residue (d) Ruminant liver Median residue (d) 4.96 Highest residue (d) Ruminant kidney.375 Median residue (d).769 Highest residue (d) Poultry meat.1* Median residue (d).1* Highest residue (d) Poultry fat.1* Median residue (d).1* Highest residue (d) Poultry liver.1* Median residue (d).1* Highest residue (d) Ruminant milk.26 Median residue (d).41 Highest residue (d) Bird s eggs.1* Median residue (d).1* Highest residue (d) (*): Indicates that the input value is proposed at the limit of analytical quantification. (a): Use reported by the RMS is not fully supported by data but the risk assessment values derived in section 3 are used for indicative exposure calculations. (b): At least one relevant GAP reported by the RMS is fully supported by data for this commodity; the risk assessment values derived in section 3 are used for the exposure calculations. (c): Use reported by the RMS is not supported by data; the existing EU MRL multiplied by the highest conversion factor for risk assessment is used for indicative exposure calculations. (d): Dietary burden relevant to this commodity of animal origin, resulting from the GAPs reported by the RMS, is fully supported by data; the risk assessment values derived in section 3 are used for the exposure calculations. The calculated exposures were compared with the toxicological reference values derived for fenpropimorph (see Table 2-1); detailed results of the calculations are presented as EU scenario 1 in EFSA Journal 215;13(3):45 31

32 Appendix B.1. The highest chronic exposure was calculated for the French toddler, representing 26 % of the ADI with leek being the major contributor to the chronic dietary intake (12 % ADI). With regard to the acute exposure, however, an exceedance of the ARfD was identified for leek, strawberries, bovine liver, unbagged bananas and blackberries, representing 983 %, 251 %, 132 %, 129 % and 17 % of the ARfD, respectively. In order to address the chronic intake concerns (milk products contributing significantly to the chronic exposure) and the exceedance of the ARfD observed for bovine liver, EFSA investigated the possibility to reduce the dietary burden of livestock. As sugar beet leaves was generally identified as a major contributor to the dietary intake for ruminants and pigs, EFSA assessed the impact of not feeding livestock with sugar/fodder beet leaves (both in northern and southern Europe). Assuming this restriction, new risk assessment values and MRLs for animal products were derived; they are summarised in Table 4-2. Table 4-2: Results of the new dietary burden calculation (without consideration of sugar/fodder beet leaves (NEU/SEU)) and new values derived from the livestock feeding studies Median dietary burden (mg/kg bw per d) Maximum dietary burden (mg/kg bw per d) Median residue (a) Highest residue (b) MRL proposal Enforcement and risk assessment residue definition: sum of fenpropimorph and fenpropimorph carboxylic acid (BF Pig muscle * Pig fat.1.1.1* Pig liver Pig kidney Ruminant muscle Ruminant fat Ruminant liver Ruminant kidney Milk (*): Indicates that the MRL is set at the limit of analytical quantification. (a): Median residue value according to the enforcement residue definition, derived by interpolation/extrapolation from the feeding study for the median dietary burden (FAO, 29). (b): Highest residue value (tissues, eggs) or mean residue value (milk) according to the enforcement residue definition, derived by interpolation/extrapolation of the maximum dietary burden between the relevant feeding groups of the study (FAO, 29). Hence a second exposure calculation was performed, assuming that livestock was not fed with sugar/fodder beet leaves, excluding the uses on leek, strawberries and blackberries and considering that import of bananas would be limited to bananas that were bagged prior to treatment. According to the results of this second calculation (see Appendix B.2 EU scenario 2), the highest chronic exposure declined to 43 % of the ADI for UK toddlers; the highest acute exposure is then calculated for bovine liver, representing 68 % of the ARfD. Based on the above calculations, EFSA concludes that the use of fenpropimorph on crops fully supported by data (footnote a in Table 4-1), is acceptable with regard to consumer exposure. For the other crops under assessment, major uncertainties remain due to the data gaps identified in section 3, but considering tentative MRLs or existing EU MRLs in the exposure calculation did not indicate a risk to consumers provided that the use of fenpropimorph is withdrawn on strawberries, blackberries and leek and that import of bananas is restricted to those bananas that were bagged prior to treatment. EFSA Journal 215;13(3):45 32

33 For commodities of animal origin, the proposed MRLs did not indicate a risk to consumers provided that risk managers would be in a position to implement a restriction in order not to feed livestock with treated sugar/fodder beet leaves (both in northern and southern Europe) Consumer risk assessment with consideration of the existing CXLs In order to include the CXLs in the calculations of the consumer exposure, all data relevant to the consumer exposure assessment have been collected from JMPR evaluations and reported in Appendix C.2 to this document. These CXLs were compared with the EU MRL proposals in compliance with Appendix D and input values resulting from this comparison are summarised in Table 4-3. For products of animal origin, it is noted that when including the CXLs in the EU risk assessment, there is no need to consider the CXLs that have been established for horses and other farm animals because there are no agreed extrapolations for these commodities of animal origin at EU level (except for pigs). It is also noted that the CXL proposals were derived according to the enforcement residue definition set by the JMPR as fenpropimorph carboxylic acid (BF 421-2), only. However, based on the livestock metabolism data (see section ), the expected residue overestimation is assumed to be of minor relevance when the MRL proposals are derived according to the enforcement residue definition agreed by the peer review. Furthermore, EFSA highlights that although the CXLs derived on cereals grain were shown to be higher compared to the proposed EU MRLs, the CXLs for animal commodities (ruminants in particular) are around one order of magnitude lower than the proposed EU MRLs, which were mainly driven by the residue levels observed in cereals. EFSA is therefore uncertain that the occurrence of residues in ruminants has been adequately assessed by the JMPR. In view of the acute intake concern that was already identified considering the European authorizations (bovine liver), EFSA is of the opinion that the CXLs on cereals grain should not be included in the overall dietary intake risk assessment. Table 4-3: Input values for the consumer risk assessment (with consideration of CXLs) Commodity Chronic risk assessment Acute risk assessment Input value Comment Input value Comment Risk assessment residue definition: sum of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1), expressed as fenpropimorph Dewberries Raspberries Blueberries Cranberries Currants (red and white) Gooseberries 1.4 Median residue CF 3. Highest residue CF (tentative) (a) (tentative) (a) 1.46 Median residue CF 1.59 Highest residue CF (tentative) (a) (tentative) (a) Bananas.13 Median residue PF.46 Highest residue PF (CXL) (e) (CXL) (e) Carrots Horseradish Parsnips Parsley root Salsifies.3 Median residue (b).32 Highest residue (b) Barley grain.9 Median residue (b).27 Highest residue (b) Oats grain.9 Median residue (b).27 Highest residue (b) EFSA Journal 215;13(3):45 33

34 Commodity Chronic risk assessment Acute risk assessment Input value Comment Input value Comment Wheat grain.5 Median residue (b).9 Highest residue (b) Rye grain.5 Median residue (b).9 Highest residue (b) Hops 5 EU MRL 5 (c) 5 EU MRL 5 (c) Sugar beet root.3 Median residue.6 Highest residue (tentative) (a) (tentative) (a) Risk assessment residue definition: sum of fenpropimorph and fenpropimorph carboxylic acid (BF 421-2), expressed as fenpropimorph Swine meat.9 Median residue (CXL) (e).12 Highest residue (CXL) (e) Swine fat.1* Median residue (d).1* Highest residue (d) Swine liver.22 Median residue (CXL) (e).28 Highest residue (CXL) (e) Swine kidney.26 Median residue (CXL) (e).33 Highest residue (CXL) (e) Ruminant muscle.33.8 Median muscle Highest muscle +.2 Median fat (d).2 Highest fat (d) Ruminant fat.34 Median residue (d).162 Highest residue (d) Ruminant liver.51 Median residue (d) Highest residue (d) Ruminant kidney.94 Median residue (d).42 Highest residue (d) Poultry meat.1* Median residue (d).1* Highest residue (d) Poultry fat.1* Median residue (d).1* Highest residue (d) Poultry liver.1* Median residue (d).1* Highest residue (d) Ruminant milk.3 Median residue (d).14 Highest residue (d) Bird s eggs.1* Median residue (d).1* Highest residue (d) (*): Indicates that the input value is proposed at the limit of analytical quantification. (a): Use reported by the RMS is not fully supported by data but the risk assessment values derived in section 3 are used for indicative exposure calculations. (b): At least one relevant GAP reported by the RMS is fully supported by data for this commodity; the risk assessment values derived in section 3 are used for the exposure calculations. (c): Use reported by the RMS is not supported by data; the existing EU MRL multiplied by the highest conversion factor for risk assessment is used for indicative exposure calculations. (d): Dietary burden relevant to this commodity of animal origin, resulting from the GAPs reported by the RMS, is fully supported by data; the risk assessment values derived in section 3 are used for the exposure calculations. (e): CXL is supported by data; the corresponding risk assessment values are used for the exposure calculations. Chronic and acute exposure calculations were also performed using revision 2 of the EFSA PRIMo and calculated exposures were compared with the toxicological reference values derived for fenpropimorph (see Table 2-1); detailed results of the calculations are presented as EU/Codex scenario 1, in Appendix B.3. The highest chronic exposure was calculated for UK toddlers, representing 47 % of the ADI. With regard to the acute exposure, an exceedance of the ARfD was identified for banana, representing 129 % of the ARfD. A second intake calculation was therefore performed, excluding the CXL on banana. According to the results of this second calculation (see Appendix B.4 EU/Codex scenario 2), the highest chronic exposure declined to 43 % of the ADI for UK toddlers; the highest acute exposure is then calculated for bovine liver, representing 68 % of the ARfD. Based on the above calculations, EFSA concludes that the CXLs supported by data (footnote e in Table 4-3) are not expected to be of concern for European consumers, except for cereal grains (barley, oats, wheat, rye) and banana. EFSA Journal 215;13(3):45 34

35 EFSA emphasises that the above assessment does not consider the possible impact of plant and livestock metabolism on the isomer ratio of fenpropimorph and further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available. CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The toxicological profile of fenpropimorph was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at.3 mg/kg bw per d and.3 mg/kg bw, respectively. The metabolism of fenpropimorph was considered as sufficiently investigated in spring wheat (cereals), sugar beet (root and tuber vegetables) and in banana (fruit crops) following foliar application. The residue definition for enforcement is set as fenpropimorph only. For risk assessment, since the metabolites fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6- dimethylmorpholine (BF 421-1) were recovered in significant amounts in wheat straw and sugar beet leaves, the residue definition is proposed as the sum of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1), expressed as fenpropimorph. A conversion factor for risk assessment of 5 derived from the metabolism studies was applied to cereal straw and sugar beet leaves. The same conversion factor was applied on strawberries, cane fruit, other small fruit and berries crops, leek and hops on a tentative basis since residue trials on these crops complying with the residue definition for risk assessment were not provided and the available metabolism studies were not considered representative for the crops. A conversion factor of 1 was agreed for bananas, cereal grains and root and tuber vegetables based on the metabolism data. Validated analytical methods for enforcement of the proposed residue definition are available. A fully validated analytical method for hops is still required. The methods are not stereoselective. Regarding the magnitude of residues in primary crops, the available residues data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for strawberries, cane fruit, other small fruit and berries crops, and sugar and fodder beets where available residues trials only allowed deriving a tentative MRL, and for leek and hops where the available data were insufficient to derive MRLs. Storage stability data for acidic commodities were also found to be missing. Hydrolysis studies demonstrated that processing by pasteurisation, baking/brewing/boiling and sterilisation is not expected to have a significant impact on the stability of fenpropimorph in matrices of plant origin. The relevant residue for enforcement and risk assessment in processed commodities is therefore expected to be the same as for primary crops. Robust processing factors for enforcement and risk assessment were derived for peeled banana, wholemeal wheat flour and bread, barley brewing malt, beer and oat flakes. Further processing studies are not required in this case as they are not expected to affect the outcome of the risk assessment. However, if more robust processing factors were to be required by risk managers, in particular for enforcement purposes, additional processing studies would be needed. The metabolic pathway of fenpropimorph in rotational crops was considered as sufficiently investigated and was found to be similar to that observed in primary crops and a specific residue definition for rotational crops is not deemed necessary. In view of the high persistence of fenpropimorph, rotational crop field trials on cereals, leafy and root vegetables conducted at a dose rate covering the long-term plateau concentration of fenpropimorph in soil and addressing the magnitude of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6-dimethylmorpholine (BF 421-1) in the edible parts of the rotational crops are required. EFSA Journal 215;13(3):45 35

36 Livestock metabolism studies were submitted. The general metabolic pathways in rodents and ruminants were found to be comparable; the findings in ruminants can therefore be extrapolated to pigs. The residue definition for enforcement and risk assessment are set as the sum of fenpropimorph and fenpropimorph carboxylic acid (BF. A ruminant feeding study permitted to derive MRLs in ruminants and pigs. A poultry feeding study is not available and is not triggered. MRLs for poultry matrices can therefore be established at the LOQ of the method. Validated analytical methods for enforcement of the proposed residue definition are available but are not stereoselective. Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRLs for an indicative calculation. The highest chronic exposure represented 26 % of the ADI (French toddlers) and an exceedance of the ARfD was identified for leek (983 %), strawberries (251 %), bovine liver (132 %), bananas (129 %) and blackberries (17 %). A second exposure calculation was therefore performed, assuming that livestock was not fed with sugar/fodder beet leaves, excluding the uses on leek, strawberries and blackberries and considering that import of bananas would be limited to bananas that were bagged prior to treatment. The residue trials on bagged bananas were also considered as a fallback position. In this case, the highest chronic exposure represented 43 % of the ADI (UK toddlers) and the highest acute exposure amounted to 68 % of the ARfD (bovine liver). Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for fenpropimorph. Additional assessment of the consumer exposure, considering these CXLs, was therefore carried out. The highest chronic exposure was calculated for UK toddlers, representing 47 % of the ADI and an exceedance of the ARfD was identified for the existing CXL in banana (129 % of the ARfD). A second intake calculation was therefore conducted, excluding the CXL on banana for which an acute intake exceedance was observed. The highest chronic exposure declined to 43 % of the ADI for UK toddlers; the highest acute exposure was calculated for bovine liver (68 % of the ARfD). RECOMMENDATIONS Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/25. MRL recommendations were derived in compliance with the decision tree reported in Appendix D of the reasoned opinion (see summary table). All MRL values listed as Recommended in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation. However, the remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). Indeed, some tentative MRLs or existing EU MRLs still need to be confirmed by the following data: a fully validated analytical method for the determination of fenpropimorph residues in hops; residue trials supporting authorisations on cane fruit (except blackberries), berries and small fruits (currants, blueberries, cranberries, gooseberries) and hops conducted in accordance with the residue definition for enforcement and risk assessment; 8 residue trials on sugar beet compliant with the northern outdoor GAP and 2 additional residue trials compliant with the southern outdoor GAP; storage stability data in acidic matrices covering the maximum storage period of the residue trials samples on strawberries, cane fruit and other small fruit and berries crops. EFSA also identified the following data gap which is not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations: EFSA Journal 215;13(3):45 36

37 8 residue trials on oats compliant with the Belgian GAP; rotational crops field trials on cereals, leafy and root vegetables conducted at a dose rate covering the long-term plateau concentration of fenpropimorph in soil and addressing the magnitude of fenpropimorph, fenpropimorph alcohol (BF 421-1, free and conjugated) and 2,6- dimethylmorpholine (BF 421-1) in the edible parts of the rotational crops. If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level. Member States are in any case recommended to pay particular attention to the possible occurrence of residues in rotational crops It is also highlighted that MRLs for commodities of animal origin are based on the assumption that sugar/fodder beet leaves in northern and southern Europe would not be fed to livestock because livestock commodities from animals exposed to these feed items may lead to exceedances of the ARfD for the final consumer. Therefore, Member States should consider defining restrictions to avoid exposure of livestock to these feed items or, if such restriction is not considered feasible, withdrawal of the authorisations on sugar and fodder beets. Since an acute dietary risk cannot be excluded for strawberries, leek and blackberries, Member States should also consider withdrawing authorisations in these crops, unless GAP-compliant residue trials investigating residues according to both enforcement and risk assessment residue definitions are provided for refinement of the exposure calculations. Furthermore, it is important to note that the import tolerance on bananas is derived from trials where bananas were bagged prior to treatment. Import of bananas that were not bagged prior to treatment may therefore lead to an exceedance of the proposed MRL and pose an acute dietary risk to European consumers. EFSA also emphasises that the above assessment does not consider the possible impact of plant and livestock metabolism on the isomer ratio of fenpropimorph and further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available. SUMMARY TABLE Code number Commodity Existing EU MRL Existing CXL MRL Enforcement residue definition (existing): fenpropimorph Enforcement residue definition (proposed): fenpropimorph Outcome of the review Comment 152 Strawberries Further consideration needed (a) 1531 Blackberries Further consideration needed (a) 1532 Dewberries Further consideration needed (b) 1533 Raspberries Further consideration needed (b) 1541 Blueberries Further consideration needed (b) 1542 Cranberries Further consideration needed (b) 1543 Currants (red, black and white) Further consideration needed (b) 1544 Gooseberries Further consideration needed (b) 1632 Banana Recommended (c) EFSA Journal 215;13(3):45 37

38 Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 2132 Carrots.5* -.4 Recommended (d) 214 Horseradish.5* -.4 Recommended (d) 2136 Parsnips.5* -.4 Recommended (d) 2137 Parsley root.5* -.4 Recommended (d) 2139 Salsifies.5* -.4 Recommended (d) 276 Leek Further consideration needed (e) 51 Barley Recommended (f) 55 Oats Recommended (f) 57 Rye Recommended (f) 59 Wheat Recommended (f) 7 Hops (dried) 1-1 Further consideration needed (g) 91 Sugar beet (root).1*.5.15 Further consideration needed (h) - Other products of plant origin See App. C1 - - Further consideration needed (i) Enforcement residue definition (existing): fenpropimorph carboxylic acid (BF 421-2), expressed as fenpropimorph Enforcement residue definition (proposed): sum of fenpropimorph and fenpropimorph carboxylic acid (BF (fat soluble) 1111 Swine muscle.2*.2.2 Recommended (j) 1112 Swine fat.1*.1.1* Recommended (k) 1113 Swine liver Recommended (j) 1114 Swine kidney.5*.5.5 Recommended (j) 1121 Bovine muscle.2*.2.15 Recommended (k) 1122 Bovine fat.1*.1.2 Recommended (k) 1123 Bovine liver Recommended (k) 1124 Bovine kidney.5*.5.5 Recommended (k) 1131 Sheep muscle.2*.2.15 Recommended (k) 1132 Sheep fat.1*.1.2 Recommended (k) 1133 Sheep liver Recommended (k) 1134 Sheep kidney.5*.5.5 Recommended (k) 1141 Goat muscle.2*.2.15 Recommended (k) 1142 Goat fat.1*.1.2 Recommended (k) 1143 Goat liver.5*.3 3 Recommended (k) 1144 Goat kidney.1*.5.5 Recommended (k) 1161 Poultry muscle.1*.1*.1* Recommended (k) 1162 Poultry fat.1*.1*.1* Recommended (k) 1163 Poultry liver.1*.1*.1* Recommended (k) 121 Cattle milk.1*.1.15 Recommended (k) EFSA Journal 215;13(3):45 38

39 Code number Commodity Existing EU MRL Existing CXL MRL Outcome of the review Comment 122 Sheep milk.1*.1.15 Recommended (k) 123 Goat milk.1*.1.15 Recommended (k) 13 Birds' eggs.1*.1*.1* Recommended (k) - Other products of animal origin See App. C1 - - Further consideration needed (i) (*): Indicates that the MRL is set at the limit of analytical quantification.. (a): GAP evaluated at EU level is not fully supported by data and a risk to consumers cannot be excluded; no CXL is available. Either a specific LOQ or the default MRL of.1 mg/kg may be considered (combination D-I in Appendix D). (b): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; no CXL is available (combination E-I in Appendix D). (c): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; CXL is higher, supported by data but a risk to consumers cannot be excluded (combination G-VI in Appendix D). (d): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; no CXL is available (combination G-I in Appendix D). (e): GAP evaluated at EU level is not supported by data and a risk to consumers cannot be excluded for the existing EU MRL; no CXL is available. Either a specific LOQ or the default MRL of.1 mg/kg may be considered (combination B-I in Appendix D). (f): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; CXL is higher but it is not sufficiently supported by data and a risk to consumers cannot be excluded (combination G-IV in Appendix D). (g): GAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL; no CXL is available (combination C-I in Appendix D). (h): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; existing CXL is covered by the tentative MRL (combination E-III in Appendix D). (i): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either a specific LOQ or the default MRL of.1 mg/kg may be considered (combination A-I in Appendix D). (j): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified; GAP evaluated at EU level, which is also fully supported by data, leads to a lower MRL (combination G-VII in Appendix D). (k): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; existing CXL is covered by the recommended MRL (combination G-III in Appendix D). DOCUMENTATION PROVIDED TO EFSA 1. Pesticide Residues Overview File (PROFile) on fenpropimorph prepared by the rapporteur Member State Germany in the framework of Article 12 of Regulation (EC) No 396/25. Submitted to EFSA on 13 October 21. Last updated on 19 December 213. REFERENCES CEN (European Committee for Standardization), 28b. Foods of plant origin - Determination of pesticide residues using GC-MS and/or LC-MS/MS following acetonitrile extraction/partitioning and clean-up by dispersive SPE. QuEChERS-method. EN 15662, November 28. EC (European Commission), Appendix G. Livestock Feeding Studies. 731/VI/95 rev.4. EC (European Commission), 1997a. Appendix A. Metabolism and distribution in plants. 728/IV/95- rev.3. EC (European Commission), 1997b. Appendix B. General recommendations for the design, preparation and realization of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 9/642/EEC. 729/VI/95-rev.6. EC (European Commission), 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. EFSA Journal 215;13(3):45 39

40 EC (European Commission), 1997d. Appendix E. Processing studies. 735/VI/95-rev.5. EC (European Commission), 1997e. Appendix F. Metabolism and distribution in domestic animals. 73/VI/95-rev.3. EC (European Commission), 1997f. Appendix H. Storage stability of residue samples. 732/VI/95- rev.5. EC (European Commission), 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 739/VI/95. As amended by the document: classes to be used for the setting of EU pesticide maximum residue levels (MRLs). SANCO 1634/21. EC (European Commission), 2. Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414. SANCO/329/99-rev.4. EC (European Commission), 21a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 1634/21 Rev., finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of March 21. EC (European Commission), 21b. Residue analytical methods. For post-registration control. SANCO/825/-rev.8-1. EC (European Commission), 211. Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. EFSA (European Food Safety Authority), 27. Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs according to Regulation (EC) No 396/25 on Maximum Residue Levels of Pesticides in Food and Feed of Plant and Animal Origin. 15 March 27. EFSA (European Food Safety Authority), 28. Conclusion on the peer review of the pesticide risk assessment of the active substance fenpropimorph. EFSA Scientific Report (28) 144, EFSA (European Food Safety Authority), 213. Reasoned opinion on the modification of the existing MRLs for fenpropimorph in cereals and commodities of animal origin. EFSA Journal 213;11(9):3359, 41 pp. doi:1.293/j.efsa FAO (Food and Agriculture Organization of the United Nations), Fenpropimorph. In: Pesticide residues in food Evaluations. Part I. Residues. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 137. FAO (Food and Agriculture Organization of the United Nations), Fenpropimorph. In: Pesticide residues in food Evaluations. Part I. Residues. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 157. FAO (Food and Agriculture Organization of the United Nations), 29. Submission and evaluation of pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide Residues. 2nd Ed. FAO Plant Production and Protection Paper 197, 264 pp. France, 214. Evaluation report prepared under Article 12 of Regulation (EC) No 396/25. Authorised uses to be considered for the review of the existing MRLs for fenpropimorph, November 214. Germany, 25. Draft assessment report on the active substance fenpropimorph prepared by the rapporteur Member State Germany in the framework of Council Directive 91/414/EEC, February 25. Germany, 28. Final addendum to the draft assessment report on the active substance fenpropimorph prepared by the rapporteur Member State Germany in the framework of Council Directive 91/414/EEC, compiled by EFSA, January 28. EFSA Journal 215;13(3):45 4

41 Germany, 213. Evaluation report prepared under Article 12.1 of Regulation (EC) No 396/25. Review of the existing MRLs for fenpropimorph, December 213. Germany, 214a. Additional evaluation report prepared under Article 12 of Regulation (EC) No 396/25. Authorised uses to be considered for the review of the existing MRLs for fenpropimorph, November 214. Germany, 214b. Additional evaluation report prepared under Article 12 of Regulation (EC) No 396/25. Fenpropimorph, December 214. Netherlands, 214. Evaluation report prepared under Article 12 of Regulation (EC) No 396/25. Authorised uses to be considered for the review of the existing MRLs for fenpropimorph, November 214. United Kingdom, 214. Evaluation report prepared under Article 12 of Regulation (EC) No 396/25. Authorised uses to be considered for the review of the existing MRLs for fenpropimorph, November 214. EFSA Journal 215;13(3):45 41

42 APPENDIX A GOOD AGRICULTURAL PRACTICES (GAPS) Appendix A.1 Critical Good Agricultural Practices (GAPs) currently authorised within the EU Appendix A.2 Critical Good Agricultural Practices (GAPs) supporting the demonstrated safe EU MRL proposals EFSA Journal 215;13(3):45 42

43 APPENDIX A.1 CRITICAL GOOD AGRICULTURAL PRACTICES (GAPS) CURRENTLY AUTHORISED WITHIN THE EU Review of the existing MRLs for fenpropimorph Strawberries Fragaria x ananassa NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Blackberries Rubus fruticosus NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Dewberries Rubus ceasius NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Raspberries Rubus idaeus NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Blueberries Cranberries Currants (red, black and white) Crop Outdoor/ Member state or Region Pests controlled Common name Scientific name Indoor Country Type Vaccinium corymbosum Vaccinium macrocarpon Critical Outdoor GAPs for Northern Europe Formulation Application Application rate PHI or Content Growth stage Number Interval (days) wiaiting Method Min. rate Max. rate Rate Unit period Conc. Unit Min. Max. Min. Max. (days) NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Ribes nigrum, rubrum NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Gooseberries Ribes uva-crispa NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Carrots Daucus carota NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Horseradish Armoracia rusticana NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Parsnips Pastinaca sativa NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Parsley root Petroselinum crispum NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Salsify Tragopogon porrifolius NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Leek Allium porrum NEU Outdoor BE Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 21 Barley Hordeum spp. NEU Outdoor SE Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Oats Avena fatua NEU Outdoor SE Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 From BBCH Until BBCH Comments (max. 25 charachters) A more critical GAP is authorised in BE (2 x 75 g a.i./ha, 28d PHI) but the GAP is not supported by data. Rye Secale cereale NEU Outdoor SE Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Wheat Triticum aestivum NEU Outdoor SE Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Hops Humulus lupulus NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 1 Max.water volume: 2 L/ha; Sugar beet Beta vulgaris NEU Outdoor FR Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Fodder beet Beta vulgaris NEU Outdoor FR Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 28 n.a.: not applicable Conc. Unit From BBCH Until BBCH Min. Max. Min. Max. Barley Hordeum spp. SEU Outdoor IT Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Oats Avena fatua SEU Outdoor IT Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Rye Secale cereale SEU Outdoor IT Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Wheat Triticum aestivum SEU Outdoor IT Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Sugar beet Beta vulgaris SEU Outdoor GR Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 7 n.a.: not applicable Crop Outdoor/ Member state or Region Pests controlled Common name Scientific name Indoor Country Type Formulation Conc. Content Critical Outdoor GAPs for Southern Europe Unit Method Application Growth stage Number Interval (days) From BBCH Until BBCH Min. Max. Min. Max. Application rate Min. rate Max. rate Rate Unit Bananas Musa x paradisica non-eu Outdoor VE Fungal disease OL 88. g/l Foliar treatment - spraying g a.i./ha n.a.: not applicable Crop Outdoor/ Member state or Region Pests controlled Common name Scientific name Indoor Country Type Critical GAPs for Import Tolerances (non-european indoor, outdoor or post-harvest treatments) Formulation Content Method Application Growth stage Number Interval (days) Application rate Min. rate Max. rate Rate Unit PHI or wiaiting period (days) PHI or wiaiting period (days) Comments (max. 25 charachters) PHI proposed by the applicant: 21 days Comments (max. 25 charachters) EFSA Journal 215;13(3):45 43

44 APPENDIX A.2 CRITICAL GOOD AGRICULTURAL PRACTICES (GAPS) SUPPORTING THE DEMONSTRATED SAFE EU MRL PROPOSALS Dewberries Rubus ceasius NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Raspberries Rubus idaeus NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Blueberries Cranberries Currants (red, black and white) Crop Outdoor/ Member state or Region Pests controlled Common name Scientific name Indoor Country Type Vaccinium corymbosum Vaccinium macrocarpon Critical Outdoor GAPs for Northern Europe Formulation Application Application rate PHI or Content Growth stage Number Interval (days) wiaiting Method Min. rate Max. rate Rate Unit period Conc. Unit Min. Max. Min. Max. (days) NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Ribes nigrum, rubrum NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Gooseberries Ribes uva-crispa NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 14 Carrots Daucus carota NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Horseradish Armoracia rusticana NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Parsnips Pastinaca sativa NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Parsley root Petroselinum crispum NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Salsify Tragopogon porrifolius NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Barley Hordeum spp. NEU Outdoor SE Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Oats Avena fatua NEU Outdoor SE Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 From BBCH Until BBCH Comments (max. 25 charachters) A more critical GAP is authorised in BE (2 x 75 g a.i./ha, 28d PHI) but the GAP is not supported by data. Rye Secale cereale NEU Outdoor SE Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Wheat Triticum aestivum NEU Outdoor SE Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Hops Humulus lupulus NEU Outdoor UK Powdery mildew EC 75. g/l Foliar treatment - spraying g a.i./ha 1 Max.water volume: 2 L/ha; Sugar beet Beta vulgaris NEU Outdoor FR Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Fodder beet Beta vulgaris NEU Outdoor FR Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 28 Leaves should not be fed to livestock. Leaves should not be fed to livestock. Crop Outdoor/ Member state or Region Pests controlled Common name Scientific name Indoor Country Type Formulation Conc. Content Critical Outdoor GAPs for Southern Europe Unit From BBCH Until BBCH Min. Max. Min. Max. Application rate Barley Hordeum spp. SEU Outdoor IT Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Oats Avena fatua SEU Outdoor IT Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Rye Secale cereale SEU Outdoor IT Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Method Application Growth stage Number Interval (days) Min. rate Max. rate Rate Unit PHI or wiaiting period (days) Comments (max. 25 charachters) Wheat Triticum aestivum SEU Outdoor IT Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 35 Sugar beet Beta vulgaris SEU Outdoor GR Fungal disease EC 75. g/l Foliar treatment - spraying g a.i./ha 7 Leaves should not be fed to livestock. Common name Crop Scientific name Region Outdoor/ Indoor Member state or Country Pests controlled Critical GAPs for Import Tolerances (non-european indoor, outdoor or post-harvest treatments) Type Formulation Conc. Content Unit From BBCH Until BBCH Min. Max. Min. Max. Bananas Musa x paradisica non-eu Outdoor VE Fungal disease OL 88. g/l Foliar treatment - spraying g a.i./ha Method Application Growth stage Number Interval (days) Application rate Min. rate Max. rate Rate Unit PHI or wiaiting period (days) Comments (max. 25 charachters) Bananas are bagged prior to treatment. EFSA Journal 215;13(3):45 44

45 APPENDIX B PESTICIDE RESIDUES INTAKE MODEL (PRIMO) Appendix B.1 EU scenario 1 including all EU MRL proposals resulting from the GAPs reported by the RMS Appendix B.2 EU scenario 2 including demonstrated safe EU MRL proposals resulting from the GAPs reported by the RMS Appendix B.3 EU/Codex scenario 1 including demonstrated safe EU MRL proposals and all CXLs Appendix B.4 EU/Codex scenario 2 including demonstrated safe EU MRL proposals and demonstrated safe CXLs EFSA Journal 215;13(3):45 45

46 APPENDIX B.1 EU SCENARIO 1 INCLUDING ALL EU MRL PROPOSALS RESULTING FROM THE GAPS REPORTED BY THE RMS Review of the existing MRLs for fenpropimorph EFSA Journal 215;13(3):45 46

47 EFSA Journal 215;13(3):45 47

48 APPENDIX B.2 EU SCENARIO 2 INCLUDING DEMONSTRATED SAFE EU MRL PROPOSALS RESULTING FROM THE GAPS REPORTED BY THE RMS EFSA Journal 215;13(3):45 48

49 EFSA Journal 215;13(3):45 49

50 APPENDIX B.3 EU/CODEX SCENARIO 1 INCLUDING DEMONSTRATED SAFE EU MRL PROPOSALS AND ALL CXLS EFSA Journal 215;13(3):45 5

51 EFSA Journal 215;13(3):45 51

52 APPENDIX B.4 EU/CODEX SCENARIO 2 INCLUDING DEMONSTRATED SAFE EU MRL PROPOSALS AND DEMONSTRATED SAFE CXLS EFSA Journal 215;13(3):45 52

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