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Modification of the existing maximum residue levels for difenoconazole in leafy brassica

2021; Wiley; Volume: 19; Issue: 2 Linguagem: Inglês

10.2903/j.efsa.2021.6407

1831-4732

Maria Anastassiadou, Giovanni Bernasconi, Alba Brancato, Luis Carrasco Cabrera, Lucien Ferreira, Luna Greco, Samira Jarrah, Aija Kazocina, Renata Leuschner, José Oriol Magrans, Ileana Miron, Stéfanie Nave, Ragnor Pedersen, Hermine Reich, Alejandro Rojas, Angela Sacchi, Miguel Santos, Alessia Pia Scarlato, Anne Theobald, Bénédicte Vagenende, Alessia Verani,

Pesticide Residue Analysis and Safety

EFSA JournalVolume 19, Issue 2 e06407 Reasoned OpinionOpen Access Modification of the existing maximum residue levels for difenoconazole in leafy brassica European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) pesticides.mrl@efsa.europa.eu Correspondence:pesticides.mrl@efsa.europa.euSearch for more papers by this authorMaria Anastassiadou, Maria AnastassiadouSearch for more papers by this authorGiovanni Bernasconi, Giovanni BernasconiSearch for more papers by this authorAlba Brancato, Alba BrancatoSearch for more papers by this authorLuis Carrasco Cabrera, Luis Carrasco CabreraSearch for more papers by this authorLucien Ferreira, Lucien FerreiraSearch for more papers by this authorLuna Greco, Luna GrecoSearch for more papers by this authorSamira Jarrah, Samira JarrahSearch for more papers by this authorAija Kazocina, Aija KazocinaSearch for more papers by this authorRenata Leuschner, Renata LeuschnerSearch for more papers by this authorJose Oriol Magrans, Jose Oriol MagransSearch for more papers by this authorIleana Miron, Ileana MironSearch for more papers by this authorStefanie Nave, Stefanie NaveSearch for more papers by this authorRagnor Pedersen, Ragnor PedersenSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorAlejandro Rojas, Alejandro RojasSearch for more papers by this authorAngela Sacchi, Angela SacchiSearch for more papers by this authorMiguel Santos, Miguel SantosSearch for more papers by this authorAlessia Pia Scarlato, Alessia Pia ScarlatoSearch for more papers by this authorAnne Theobald, Anne TheobaldSearch for more papers by this authorBenedicte Vagenende, Benedicte VagenendeSearch for more papers by this authorAlessia Verani, Alessia VeraniSearch for more papers by this author European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) pesticides.mrl@efsa.europa.eu Correspondence:pesticides.mrl@efsa.europa.euSearch for more papers by this authorMaria Anastassiadou, Maria AnastassiadouSearch for more papers by this authorGiovanni Bernasconi, Giovanni BernasconiSearch for more papers by this authorAlba Brancato, Alba BrancatoSearch for more papers by this authorLuis Carrasco Cabrera, Luis Carrasco CabreraSearch for more papers by this authorLucien Ferreira, Lucien FerreiraSearch for more papers by this authorLuna Greco, Luna GrecoSearch for more papers by this authorSamira Jarrah, Samira JarrahSearch for more papers by this authorAija Kazocina, Aija KazocinaSearch for more papers by this authorRenata Leuschner, Renata LeuschnerSearch for more papers by this authorJose Oriol Magrans, Jose Oriol MagransSearch for more papers by this authorIleana Miron, Ileana MironSearch for more papers by this authorStefanie Nave, Stefanie NaveSearch for more papers by this authorRagnor Pedersen, Ragnor PedersenSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorAlejandro Rojas, Alejandro RojasSearch for more papers by this authorAngela Sacchi, Angela SacchiSearch for more papers by this authorMiguel Santos, Miguel SantosSearch for more papers by this authorAlessia Pia Scarlato, Alessia Pia ScarlatoSearch for more papers by this authorAnne Theobald, Anne TheobaldSearch for more papers by this authorBenedicte Vagenende, Benedicte VagenendeSearch for more papers by this authorAlessia Verani, Alessia VeraniSearch for more papers by this author First published: 09 February 2021 https://doi.org/10.2903/j.efsa.2021.6407 Requestor: European Commission Question number: EFSA-Q-2020-00522 Acknowledgements: EFSA wishes to thank Stathis Anagnos, Laszlo Bura, Viktorija Krivova, Silvia Ruocco and Viktor Toth for the support provided to this scientific output. Adopted: 20 January 2021 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to the group of leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for leafy brassica. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated LOQ of 0.01 mg/kg and for difenoconazole and metabolite CGA205375 in animal matrices at the validated LOQ of 0.01 mg/kg for meat muscle, fat, liver, kidney and eggs and at the validated LOQ of 0.005 mg/kg for milk. Based on the risk assessment results, EFSA concluded that for the crops assessed in this application the short-term intake of residues resulting from the use of difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. Long-term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. Overall, this risk assessment is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and has to be re-considered when the missing data become available. Additionally, this assessment does not take into consideration triazole derivative metabolites (TDMs) which may be generated by several pesticides belonging to the group of triazole fungicides as this application was submitted before September 2019 which is the date of application of the new strategy endorsed by the risk managers for the assessment of TDMs. Summary In accordance with Article 6 of Regulation (EC) No 396/2005, Syngenta Crop Protection AG submitted an application to the competent national authority in the Netherlands (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to the group of leafy brassica. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 19 July 2020. To accommodate for the intended uses of difenoconazole, the EMS proposed to raise the existing MRLs in leafy brassica (Chinese cabbage and kale) from 2 to 6 mg/kg. EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification, which were requested from the EMS. On 28 October 2020, the EMS submitted the requested information in a revised evaluation report, which replaced the previously submitted evaluation report. EFSA emphasises that the present assessment does not take into consideration triazole derivative metabolites (TDMs), which are generated by difenoconazole and by several other pesticides belonging to the group of triazole fungicides. It is noted that in June 2019, the Standing Committee on Plants, Animals, Food and Feed (Pesticide residues) endorsed the EFSA recommendation to perform a separate risk assessment for TDMs and to apply the clock-stop mechanism in case data are missing that are needed in order to perform a comprehensive assessment for the TDMs. Risk managers agreed that such comprehensive risk assessment should be conducted for applications submitted from September 2019 onwards. As the present application was submitted before September 2019 (21 August 2019), the risk assessment for TDMs was not performed. Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the data evaluated under previous MRL assessment and the additional data provided by the EMS in the framework of this application, the following conclusions are derived. The metabolism of difenoconazole following foliar applications was investigated in crops belonging to the groups of fruit crops (tomatoes and grapes), cereals (wheat), root crops (potatoes) and pulses/oilseed crops (rapeseed). Difenoconazole and triazole derivative metabolites (TDMs) were main metabolites in all plants. In rotational crops, the major residues identified in cereal/grasses, leafy and root crops were the parent compound, difenoconazole alcohol (CGA205375) and triazole metabolites. It was noted that CGA205375 was also minor metabolite in primary crops (< 5% total radioactive residue (TRR)). Studies investigating the effect of processing on the nature of difenoconazole (hydrolysis studies) demonstrated that difenoconazole is hydrolytically stable. Based on the metabolic pattern identified in metabolism studies and considering the results of hydrolysis studies, the residue definitions for plant products were proposed as difenoconazole for enforcement and risk assessment and, additionally, triazole derivative metabolites (TDMs) for the risk assessment. These residue definitions are applicable to primary crops, rotational crops and processed products. EFSA concluded that for the crops assessed in this application, metabolism of difenoconazole in primary and in rotational crops, and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definitions are applicable. During the peer review, a data gap on information investigating the possible preferential metabolism/degradation of the four stereoisomers of difenoconazole in plants was identified and it is still open. Once the confirmatory data are available, the residue definitions may have to be revised. Sufficiently validated analytical methods based on high-performance liquid chromatography with tandem mass spectroscopy (HPLC-MS/MS) are available to quantify residues in the crops assessed in this application according to the residue definition for enforcement. The methods enable quantification of residues at or above the LOQ of 0.01 mg/kg in the crops under assessment. In support of the NEU authorisations of difenoconazole in leafy brassica, the applicant submitted six residue trials on kale which were performed in various northern EU member states during the growing seasons of 2002, 2003 and 2018. The available residue trials are sufficient to derive an MRL proposal of 6 mg/kg for all commodities belonging to the group of leafy brassica. The occurrence of difenoconazole residues in rotational crops was investigated in the framework of the EU pesticides peer review, which noted some limitations of the available studies regarding magnitude of TDMs in rotational crops. Regarding the magnitude of residues of the parent difenoconazole and metabolite CGA205375 in rotational crops EFSA concluded that since the maximum annual application rate on the crops under consideration is lower (i.e. 375 g a.s./ha) than the application rate tested in the limited rotational crop field trials and the more recent confined rotational crop study, significant levels of difenoconazole and CGA205375 in rotational crops are not expected, provided that the active substance is applied according to the proposed good agricultural practice (GAP). Specific studies investigating the magnitude of difenoconazole residues in processed commodities have not been submitted. According to previously assessed studies on the magnitude of difenoconazole residues in cooked carrots, a reduction of difenoconazole residues is expected under cooking of vegetables, including processed (cooked/boiled) leafy brassica. It was noted that processing studies might become relevant once the data gap related to the isomeric composition of difenoconazole in crops and the relative toxicity of different isomers is addressed. Kale is fed to livestock and is the main contributor to the estimated livestock dietary burdens which exceeded the trigger value of 0.1 mg/kg DM for all relevant animal species. Therefore, the possible occurrence of difenoconazole residues in commodities of animal origin was further investigated. Studies on the nature of residues in lactating goats and laying hens showed that difenoconazole was extensively metabolised to difenoconazole alcohol CGA205375 which was found to be the major metabolite in goat and hen liver, kidney, fat, muscle, milk and eggs whereas the 1,2,4-triazole was transported preferentially to eggs and milk. Two separate residue definitions for risk assessment were proposed in products of animal origin: (1) Difenoconazole alcohol (CGA205375) expressed as difenoconazole, (2) Triazole derivative metabolites. In the peer review, the residue definition for enforcement was proposed as difenoconazole alcohol (CGA205375) expressed as difenoconazole. The currently in place residue definition for enforcement in Regulation (EC) No 396/2005 is difenoconazole alone. A revision of the residue definition for enforcement might be considered by the risk managers in order to reflect the proposal of the EU pesticides peer review. Sufficiently validated analytical methods based on HPLC-MS/MS are available to quantify residues of difenoconazole and metabolite CGA205375 in the products of animal origin. The methods enable quantification of residues at or above the LOQ of 0.01 mg/kg per substance in fat, muscle, eggs, kidney and liver and an LOQ of 0.005 mg/kg per substance in milk. It is noted that the currently applicable MRLs for animal products are based on the Codex Maximum Limits (CXLs) derived by the JMPR in 2010, reflecting the residues of difenoconazole and its alcohol metabolite CGA205375. Based on the newly calculated livestock dietary burdens, the existing EU MRLs would need to be raised in mammalian fat, milk and liver. However, EFSA is of the opinion that the modification of the existing MRLs in products of animal origin at this stage is not required as long as metabolite CGA205375 is not included in the residue definition for enforcement according to Regulation (EC) No 396/2005. The toxicological profile of difenoconazole was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.1 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.16 mg/kg bw. For the metabolite CGA205375, which is the risk assessment residue definition for commodities of animal origin, no toxicological reference values were derived in the peer review from 2011 and no conclusions on its toxicity was derived. The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo) The short-term exposure did not exceed the ARfD for any of the crops assessed in this application and accounted for kale (84% of ARfD) and Chinese cabbage (62% of ARfD). The long-term exposure assessment which was performed in the most recent EFSA reasoned opinion on difenoconazole was updated using the supervised trial median residue (STMR) values for leafy brassica, as derived from the residue trials submitted in this application. For the remaining plant commodities, the input values were the STMRs as available from previous EFSA assessments or the MRLs as set in the Commission Regulation (EU) No 2019/552. For animal commodities (except poultry), the STMR values as derived for the calculated dietary burdens were used; these STMRs correspond to residues of metabolite CGA205375 expressed as difenoconazole assuming that parent and metabolite have a similar toxicological profile. Based on this assumption, the calculated long-term exposure accounted for a maximum of 102% of the ADI (NL toddler). The contribution from commodities with MRLs at the LOQ is 5% of the ADI, from which 3.5% accounts for consumption of maize (NL toddler). It was noted that Dutch toddlers consume at least 5.5 times more maize-based products than all other European populations for which no ADI exceedance was observed. Considering that most of these commodities are consumed processed, the availability of processing factors would allow to refine the long-term assessment but these are not currently available. Regarding the commodities evaluated in this application, the contribution of residues to the long-term exposure is lower than 2% of the ADI per commodity. EFSA concludes that for the crops assessed in this application, the short-term intake of residues resulting from the use of difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. Long-term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. Overall, the present risk assessment is considered provisional pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereoisomers of difenoconazole in plants. Additionally, it does not take into consideration triazole derivative metabolites (TDMs). EFSA proposes to refine the consumer exposure assessment in the framework of the ongoing renewal of the approval of the active substance and subsequent comprehensive review of all existing uses under the MRL review. The renewal of approval of the active substance in accordance with Regulation (EC) No 1107/2009 is ongoing, and therefore, the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the renewal. EFSA proposes to amend the existing MRL as reported in the summary table below. Full details of all endpoints and the consumer risk assessment can be found in Appendices B, B–D. Codeaa Commodity code number according to Annex I of Regulation (EC) No 396/2005. Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/justification Enforcement residue definition: Difenoconazole 0243010 0243010 0243090 – Chinese cabbages/pe-tsai – Kales – Others 2 Further risk management considerations are required The submitted data are sufficient to derive an MRL proposal of 6 mg/kg for the NEU use. Risk for consumers from short-term intake of residues of difenoconazole from leafy brassica is unlikely. Long-term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. a Commodity code number according to Annex I of Regulation (EC) No 396/2005. Assessment The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for difenoconazole in commodities belonging to the group of leafy brassica. The detailed description of the intended NEU outdoor uses of difenoconazole in leafy brassica, which are the basis for the current MRL application, is reported in Appendix A. Difenoconazole is the ISO common name for 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E. Difenoconazole was evaluated in the framework of Directive 91/414/EEC11 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, 19.8.1991, p. 1–32. with Sweden designated as rapporteur Member State (RMS) for the representative uses as foliar applications on pome fruits and carrots and as seed treatment on cereals. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2011a). Difenoconazole was approved22 Commission Directive 2008/69/EC of 1 July 2008 amending Council Directive 91/414/EEC to include clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen as active substances OJ L 172, 2.7.2008, p. 9–14. for the use as fungicide on 1 January 2009. The process of renewal of the first approval is currently ongoing. The EU MRLs for difenoconazole are established in Annex III of Regulation (EC) No 396/2005.33 Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 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 70, 16.3.2005, p. 1–16. To date, EFSA has issued several reasoned opinions on the modification of MRLs for difenoconazole. The proposals from these reasoned opinions have been considered in recent MRL regulations.44 For an overview of all MRL Regulations on this active substance, please consult: http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=pesticide.residue.selection&language=EN Certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation.55 Commission Regulation (EU) No 441/2012 of 24 May 2012 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bifenazate, bifenthrin, boscalid, cadusafos, chlorantraniliprole, chlorothalonil, clothianidin, cyproconazole, deltamethrin, dicamba, difenoconazole, dinocap, etoxazole, fenpyroximate, flubendiamide, fludioxonil, glyphosate, metalaxyl-M, meptyldinocap, novaluron, thiamethoxam and triazophos in or on certain products. OJ L 135, 25.5.2012, p. 4–56. ,66 Commission Regulation (EU) 2015/845 of 27 May 2015 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, chlorantraniliprole, cyantraniliprole, dicamba, difenoconazole, fenpyroximate, fludioxonil, glufosinate-ammonium, imazapic, imazapyr, indoxacarb, isoxaflutole, mandipropamid, penthiopyrad, propiconazole, pyrimethanil, spirotetramat and trinexapac in or on certain products. OJ L 138, 4.6.2015, p. 1–69. ,77 Commission Regulation (EU) 2017/626 of 31 March 2017 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid, cyantraniliprole, cypermethrin, cyprodinil, difenoconazole, ethephon, fluopyram, flutriafol, fluxapyroxad, imazapic, imazapyr, lambda-cyhalothrin, mesotrione, profenofos, propiconazole, pyrimethanil, spirotetramat, tebuconazole, triazophos and trifloxystrobin in or on certain products C/2017/2035. OJ L 96, 7.4.2017, p. 1–43. ,88 Commission Regulation (EU) 2019/552 of 4 April 2019 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, bicyclopyrone, chlormequat, cyprodinil, difenoconazole, fenpropimorph, fenpyroximate, fluopyram, fosetyl, isoprothiolane, isopyrazam, oxamyl, prothioconazole, spinetoram, trifloxystrobin and triflumezopyrim in or on certain products C/2019/2496. OJ L 96, 5.4.2019, p. 6–49. In accordance with Article 6 of Regulation (EC) No 396/2005, Syngenta Crop Protection AG submitted an application to the competent national authority in the Netherlands (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in leafy brassica. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 19 July 2020. To accommodate for the intended uses of difenoconazole, the EMS proposed to raise the existing MRLs from 2 mg/kg to 6 mg/kg for the whole group of leafy brassicas (kale, Chinese cabbage/pe-tsai and others). EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification, which were requested from the EMS. On 28 October 2020, the EMS submitted the requested information in a revised evaluation report (Netherlands, 2020), which replaced the previously submitted evaluation report. EFSA based its assessment on the evaluation report submitted by the EMS (Netherlands, 2020), the draft assessment report (DAR) (Sweden, 2006) prepared under Council Directive 91/414/EEC, the Commission review report on difenoconazole (European Commission, 2008, 2020), the conclusion on the peer review of the pesticide risk assessment of the active substance difenoconazole (EFSA, 2011a), as well as the conclusions from previous EFSA opinions on difenoconazole (EFSA, 2009, 2010, 2011b, 2012, 2013, 2014a,b, 2017, 2018a). For this application, the data requirements established in Regulation (EU) No 544/201199 Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances. OJ L 155, 11.6.2011, p. 1–66. and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a,b,c,d,e,f,g, 2000, 2010a,b, 2017a,b; OECD, 2011, 2013). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011.1010 Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, 11.6.2011, p. 127–175. Since the review of the existing MRLs under Article 12 of Regulation 396/2005 is not yet initiated and the renewal of the first approval has not yet been finalised, the conclusions reported in this reasoned opinion are provisional and may need to be reconsidered in the light of the outcome of the renewal of the approval of difenoconazole and the future MRL review. A selected list of end points of the studies assessed by EFSA in the framework of this MRL application including the end points of relevant studies assessed previously are presented in Appendix B. The evaluation report submitted by the EMS (Netherlands, 2020) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion. 1 Residues in plants 1.1 Nature of residues and methods of analysis in plants 1.1.1 Nature of residues in primary crops The metabolism of difenoconazole in primary crops has been investigated in the framework of the EU pesticides peer review following foliar applications in fruit crops (tomatoes and grapes), cereals/grass crops (wheat), root crops (potatoes) and pulses/oilseed crops (rapeseed). Studies in cereals following seed application were also considered (Sweden, 2006; EFSA, 2011a). The metabolism was found comparable in the four crop groups. Difenoconazole was the major component of the residues in the major plant parts, except for cereal grains, potato tubers and rape seeds, where the major components of the residues were the triazole derivative metabolites (TDMs) triazole alanine, triazole acetic acid and 1,2,4-triazole. Metabolites CGA205374 (ketone), CGA205375 (alcohol) and CGA189138 (benzoic acid) were also identified in low proportions (below 5% TRR). The data gap on the investigation of the possible preferential metabolism/degradation of the four stereoisomers of difenoconazole in plants that was identified in the framework of the peer review (EFSA, 2011a) has not yet been addressed. It was concluded that for the intended use, the metabolic behaviour of difenoconazole in primary crops is sufficiently addressed. 1.1.2 Nature of residues in rotational crops Difenoconazole is proposed to be used on kale and other leafy brassica which can be grown in rotation with other crops. According to the soil degradation studies evaluated in the framework of the peer review, the DT90 value of difenoconazole is 879 days (EFSA, 2011a) which exceeds the value of 100 days triggering the need for studies investigating the nature and magnitude of residues in rotational crops. Metabolism of difenoconazole in rotational crops has been investigated in the framework of the peer review in two studies with 14C-labelled difenoconazole (Sweden, 2006; EFSA, 2011a).