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In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Certis Europe B.V. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance imazalil in cucumbers, courgettes and gherkins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.08 mg/kg for the whole group of cucurbits with edible peel. It is noted that the derived MRL is proposed to replace the existing tentative MRL of 0.1 mg/kg for courgettes, thus also addressing the data gap identified in the context of the MRL review. As regards to cucumbers and gherkins, it is noted that the MRL proposal derived in the current application is covered by the MRL of 0.5 mg/kg currently in place for these commodities. Nevertheless, it is also noted that the aforementioned MRLs are based on Codex maximum residue limits (CXLs) which were revoked in 2019 following the JMPR proposal. Should this proposal be implemented in the EU regulation in the future, the proposed MRL of 0.08 mg/kg as derived in the current application would be considered an appropriate fall‐back option for the whole group of cucurbits with edible peel. Further risk management considerations are therefore required. Adequate analytical methods for enforcement are available to control the residues of imazalil on the commodities under consideration at the validated limit of quantification (LOQ) of 0.005 mg/kg (QuEChERS method based on LC–MS/MS) and 0.01 mg/kg (HPLC–MS/MS method). Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of imazalil according to the reported agricultural practices is unlikely to present a risk to consumer health. However, it should be noted that a high degree of uncertainty on the overall long‐term exposure calculation remains due to the data gaps identified in the context of the MRL review on full toxicological assessment of the metabolite R014821, which is expected to occur following post‐harvest uses of imazalil, and animal metabolites FK‐772 and FK‐284. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe SAS submitted a request to the competent national authority in the Czech Republic to modify the existing maximum residue levels (MRLs) in pome fruits and to evaluate the confirmatory data identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps on residue trials, new trials according to the Good Agricultural Practices (GAPs) on apples, pears, medlars, quinces, loquats/Japanese medlars, apricots, peaches and beans with pods evaluated during the MRL review were not provided. These data gaps are not addressed. However, residue trials on apples and pears for an alternative GAP were provided and resulted by extrapolation in an MRL proposal for pome fruits lower than the current (tentative) MRL in EU legislation. The provided information may require a revision of the existing MRLs for pome fruits, apricots, peaches and beans with pods. Information on storage temperature of samples from the feeding study and a validated analytical method for animal commodities were submitted. The two data gaps on animal commodities were satisfactorily addressed. Adequate analytical methods for enforcement are available to control the residues of pyridaben in plant matrices under consideration and in all animal matrices, where currently an limit of quantification (LOQ) of 0.02 mg/kg is considered at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of pyridaben according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Austria to set an import tolerance for the active substance fipronil in potatoes, maize, rice, sugar canes and to modify the existing EU MRLs (maximum residue levels) for fipronil in commodities of animal origin. During the assessment, the applicant withdrew the import tolerance requests on maize and rice. The data submitted in support of the present assessment were found to be sufficient to derive MRL proposal for sugar canes. For potatoes, data gaps were identified which precluded the derivation of MRL proposal. The livestock exposure to fipronil residues from the intake of sugar canes molasses required the setting of MRL in fat of bovine, sheep and goat. Adequate analytical methods for enforcement are available to control the total residues of fipronil in plant and animal matrices at the validated limit of quantification (LOQ) 0.005 mg/kg. Based on the risk assessment results, EFSA concluded that consumer intake concerns are not associated with fipronil residues in food commodities under consideration: sugar canes and fat of bovine, sheep and goat. There are no EU authorisations of fipronil as well as no Codex maximum residue limits (CXLs) or import tolerances are set for fipronil in the EU MRL legislation; therefore, other plant and animal commodities were not considered in the consumer exposure assessment. [ABSTRACT FROM AUTHOR]

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for penconazole in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Moreover, in the application submitted to Germany, the applicant also included a request to raise the existing MRLs in pome fruits, raspberries and blackberries. To address the data gaps, detailed results on the metabolism substudy in tomato, a new storage stability on metabolites CGA127841, CGA132465 and CGA190503 and new residue trials were submitted. The data gap on metabolism was considered satisfactorily addressed. The data gap on complete sets of residue trials analysing simultaneously for monitoring and risk assessment residue definitions was considered addressed for raspberries, blackberries, pumpkins and watermelons; not addressed for pome fruits, stone fruits, grapes, gooseberries, tomatoes and aubergines. The new information provided justified an increase of the existing MRLs for pome fruits, plums, blackberries and raspberries and a revision of the risk assessment performed for penconazole. Adequate analytical methods for enforcement are available to control the residues of penconazole on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of penconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Glanzit Pfeiffer Gmbh & Co. KG submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance metaldehyde in flowering brassica and leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for both brassica crop groups. Adequate analytical methods for enforcement are available to control the residues of metaldehyde on the commodities under consideration at the validated limit of quantification (LOQ) of 0.05 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the intended uses of metaldehyde according to the reported agricultural practices is unlikely to present a risk to consumer health. The long‐term consumer risk assessment shall be regarded as indicative only due to the data gaps identified for certain existing MRLs in the framework of the MRL review of metaldehyde according to Article 12 of Regulation (EC) No 396/2005. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro B.V. submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance pendimethalin in peas (with pods), beans (with pods) and leeks. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under assessment. Adequate analytical methods for enforcement are available to control the residues of pendimethalin on the commodities under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of pendimethalin according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicant Belchim Crop Protection submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for tebufenpyrad in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, new residue trials on peaches, apricots and raspberries (extrapolated to blackberries and dewberries) as well as a new analytical method for enforcement in animal commodities and its independent laboratory validation were submitted. The data gaps were considered satisfactorily addressed. The new information provided required a revision of the existing MRLs for peaches and apricots while the existing MRLs for blackberries and dewberries could be confirmed. An update of the consumer risk assessment for tebufenpyrad was performed in light of the new data submitted and it did not indicate any consumer intake concerns in relation to the chronic exposure and the acute exposure of the crops under consideration in the present assessment. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva Agriscience submitted a request to the competent national authority in Italy to set an import tolerance for the active substance tricyclazole in rice. The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal for rice. Adequate analytical methods for enforcement are available to control the residues of tricyclazole in rice at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of tricyclazole according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 Austria to set an import tolerance for the active substance mandipropamid in papayas. The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal of 0.8 mg/kg for papayas. Adequate analytical methods for enforcement are available to control the residues of mandipropamid on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that long‐term intake of residues resulting from the use of mandipropamid according to the reported agricultural practice is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt für Landwirtschaft und Gartenbau (LLG) submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in herbs and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the group of herbs and edible flowers. Adequate analytical methods for enforcement are available to control the residues of spirotetramat and its metabolite spirotetramat‐enol on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of spirotetramat according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicant Proplan Plant Protection Company submitted a request to the competent national authority in Austria (originally the United Kingdom) to evaluate the confirmatory data that were identified for paclobutrazol in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, two new metabolism studies performed on apples were submitted. In addition, two studies on the magnitude of residues in apples and pears providing data for triazole derivative metabolites were also submitted. The data gaps were considered satisfactorily addressed. The new information provided did not require a revision of the existing MRLs for pome fruits, apricots and peaches. An update of the risk assessment was performed for paclobutrazol and for the triazole derivative metabolites in light of the new data submitted and did not indicate any consumer intake concerns. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to set an import tolerance for the active substance pyridaben in grapefruits imported from the United States of America. The data submitted in support of the requests were found to be sufficient to derive an MRL proposal of 0.5 mg/kg for grapefruits. Adequate analytical methods for enforcement are available to control the residues of pyridaben on the commodity under consideration, at or above the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of pyridaben on imported grapefruits from United States according to the reported agricultural practices, is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriphar SA submitted a request to the competent national authority in Ireland to modify the existing maximum residue levels (MRLs) for the active substance triclopyr in oranges, lemons and mandarins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for these commodities. Adequate analytical methods for enforcement are available to control the residues of triclopyr in the plant matrices under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of triclopyr according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Spain to evaluate the confirmatory data that were identified for in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new storage stability study, new residues trials and a validated analytical enforcement method for the determination of the relevant residues in animal products were submitted. The data gaps were considered satisfactorily addressed for the plant commodities. The new information provided required a revision of the existing MRL for avocados. As regards the commodities of animal origin, the data gaps were only partially addressed and therefore further risk management considerations are required regarding the revision of the existing MRLs which were derived from Codex MRLs. The risk assessment performed for thiabendazole was also updated. No risk was identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nufarm Europe Gmbh submitted a request to the competent national authority in Austria to modify the existing maximum residue levels (MRLs) for the active substance acetamiprid in honey, linseeds, poppy seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for linseeds, poppy seeds, mustard seeds and gold of pleasure seeds. For honey, however, data gaps were identified by EFSA and were not fully addressed by the justification provided by the applicant. Considering the remaining uncertainties, risk managers are given the option to either accept the justification provided and the related uncertainties or to merge the provided data with a data set from a previous application to derive an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of acetamiprid in plant matrices and in honey at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of acetamiprid according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance pyridate in chives. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for chives. Adequate analytical methods for enforcement are available to control the residues of pyridate on the commodity under consideration at the validated limit of quantification (LOQ) of 0.05 mg/kg pyridate equivalent. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of pyridate according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Spiess‐Urania Chemicals GmbH submitted a request to the competent national authority in Austria to modify the existing maximum residue levels (MRLs) for the active substance copper compounds in the whole group of other small fruits and berries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the whole subgroup of other small fruits and berries. Adequate analytical methods for enforcement of mineral copper independently from its chemical form are available for matrices under consideration at the validated limit of quantification (LOQ) of 5 mg/kg. Based on indicative risk assessment results, EFSA concluded that the long‐term intake of copper residues resulting from the intended and existing uses, natural background levels and monitoring levels might present a risk to consumer health. Although residues in other small fruits and berries are minor contributors to the overall consumer exposure, a risk management decision has to be taken on whether it is appropriate to increase the existing MRLs for these crops, given that a potential consumer intake concern could not be excluded. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant DuPont submitted a request to the competent national authority in Ireland to set an import tolerance for the active substance oxathiapiprolin in blueberries in support of an authorised use in the United States. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for highbush blueberries by noting that lowbush blueberries (Vaccinium angustifolium) are excluded from the authorised use in the United States. Adequate analytical methods for enforcement are available to control the residues of oxathiapiprolin in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of oxathiapiprolin according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants FMC International and Syngenta Crop Protection submitted two requests to the competent national authority in France, respectively, to set import tolerances for the active substance cyantraniliprole in various crops and to modify the existing maximum residue levels (MRLs) in apricots. The data submitted in support of the requests were found sufficient to derive MRL proposals for apricots, potatoes, tropical root and tuber vegetables, cucurbits (inedible peel), lettuces and salad plants, Chinese cabbage and other leafy brassica (except kale), spinaches and similar leaves (except spinach), parsley and minor oilseeds. Based on the risk assessment results, EFSA concluded that the dietary intake of residues resulting from the uses of cyantraniliprole according to the reported agricultural practices is unlikely to present a risk to consumer health for the parent compound. A definitive conclusion on the risk for consumers cannot be derived for the degradation products IN‐N5M09 and IN‐F6L99 which are formed during cooking/boiling. For both compounds, the concerns on genotoxicity have been ruled out, but the general toxicity has not been addressed. The indicative exposure calculated by the EMS and EFSA for these compounds is affected by non‐standard uncertainties but can support risk managers to take an informed decision on the requested modification of the existing MRLs for the crops under assessment. [ABSTRACT FROM AUTHOR]

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Sweden to evaluate the confirmatory data that were identified for diquat in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The applicant provided sufficient data to address the data gaps related to plant metabolism studies and analytical methods for plant and animal products. The data gap requesting further studies to investigate the nature of residues of diquat and its metabolite TOPPS in processed products was not sufficiently addressed. Considering the new studies submitted under the current application and considering that the EU uses for diquat had to be withdrawn following a decision on non‐approval, EFSA proposed the lowering of the existing MRLs to the appropriate limit of quantifications for the commodities under assessment. In addition, EFSA proposed to perform a more comprehensive review of the existing MRLs that were not subject to the current assessment, taking into account the findings and conclusions of the peer review, the consequences of the non‐approval decision and the revisions of Codex MRLs. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to set import tolerances for the active substance deltamethrin in mangoes and papayas. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for mangoes and papayas. Adequate analytical methods for enforcement are available to control the residues of deltamethrin (cis‐deltamethrin) in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of deltamethrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative and affected by non‐standard uncertainties. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agro‐Kanesho submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance acequinocyl in sweet peppers/bell peppers. The data submitted in support of the request were found to be sufficient to derive MRL proposal for peppers. Adequate analytical methods for enforcement are available to control the residues of acequinocyl in peppers at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of acequinocyl according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicants Bayer SAS – Crop Science Division, Diachem S.p.A. and Isagro S.p.A., submitted two requests to the competent national authority in Austria to evaluate the confirmatory data identified for deltamethrin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The application from Bayer SAS – Crop Science Division also included a proposal for the modification of the MRL for deltamethrin in tomatoes in accordance with Article 6 of Regulation (EC) No 396/2005. A third application was submitted by the Federal Public Service (FPS) Health, Food chain safety and Environment on behalf of Belgium, to modify the existing maximum residue level for the active substance in okra/lady's fingers. The three applications were combined by EFSA under the current assessment. The data gaps based on monitoring analytical methods were addressed; the data gaps on storage stability studies, processing trials in potatoes, metabolism studies of deltamethrin isomers in livestock and livestock feeding studies were not addressed by providing the requested experimental data; data gap on residue trials analysing simultaneously for monitoring and risk assessment residue definitions was not addressed for most of the concerned crops and requires risk managers' decisions in numerous cases. The new information provided requires a revision of certain existing MRLs. Adequate analytical methods for enforcement are available to control the residues of deltamethrin in plant and animal matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the results of the refined risk assessment following evaluation of the confirmatory data, EFSA concluded that the short‐term and long‐term intake of residues resulting from the proposed uses of deltamethrin according to the reported agricultural practices are unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative and affected by non‐standard uncertainties. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant DLR‐Rheinpfalz submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance oxathiapiprolin in kales, with the specific intention to derive an MRL in radish leaves (classified under the subgroup of kales), based on an intended NEU use on radishes. The residue data in radish leaves submitted in support of the request were found to be sufficient to derive MRL proposal for this commodity which could be applicable also for kales. Adequate analytical methods for enforcement are available to control the residues of oxathiapiprolin in radishes at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of oxathiapiprolin on radishes according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant OAT Agrio Co. Ltd submitted a request to the competent national authority in Belgium (originally the United Kingdom) to set import tolerances for the active substance flutianil in various crops. The data submitted in support of the request were found to be sufficient to derive MRL proposals for apples, cherries, strawberries, cucumbers and courgettes. For melons, data gaps were identified which precluded the derivation of MRL proposals. Adequate analytical methods for enforcement are available to control the residues of flutianil in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of flutianil according to the reported agricultural practices is unlikely to present a risk to consumer health. It is to be noted that the consumer risk assessment could not be finalised with regard to the potential presence of soil metabolite OC 56635 in rotational crops. The reliable end points appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant FMC International Switzerland Sarl (FISSarl) submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance cyantraniliprole in table olives and olives for oil production. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the intended uses of cyantraniliprole in olives. Adequate analytical methods for enforcement are available to control the residues of cyantraniliprole in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the uses of cyantraniliprole according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nichino America Inc submitted a request to the competent national authority in the Netherlands to set an import tolerance for the active substance flutolanil in peanuts. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposal for peanuts. Adequate analytical methods for enforcement are available to control the residues of flutolanil in plant matrices at the validated limited of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of flutolanil according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Cheminova A/S submitted a request to the competent national authority in Spain to modify the existing maximum residue levels (MRLs) for the active substance acrinathrin in peaches and sweet peppers. The data submitted in support of the request were found sufficient to derive MRL proposals for both crops. Adequate analytical methods for enforcement are available to control the residues of acrinathrin and its enantiomer in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.02 mg/kg. Based on the risk assessment results, EFSA concluded that the short- and long-term intake of residues resulting from the use of acrinathrin according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in Belgium to modify the existing maximum residue levels (MRLs) for the active substance isofetamid in raspberries, blackberries and dewberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for blackberries, dewberries and raspberries. Adequate analytical methods for enforcement are available to control the residues of isofetamid in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of isofetamid according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd submitted a request to the competent national authority in Denmark to modify the existing maximum residue levels (MRL) for the active substance tau-fluvalinate in tomatoes and watermelons. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for tomatoes. For watermelons, a change of the MRL recently set in the EU legislation is not required. Adequate analytical methods for enforcement are available to control the residues of tau-fluvalinate in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the intended uses of tau-fluvalinate according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nisso Chemical Europe GmbH submitted a request to the competent national authority in Greece to set an import tolerance for the active substance cyflufenamid in hops. The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal for hops; however, further risk management considerations are required to decide on the appropriate MRL values considering that the MRL in the country of origin is lower than the MRL proposal derived from the residue trials. Adequate analytical methods for enforcement are available to control the residues of cyflufenamid in the crop under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the consumer risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of cyflufenamid according to the reported agricultural practice in the country of origin is unlikely to present a risk to consumer health. This conclusion shall be regarded as indicative considering that some MRL proposals derived by EFSA during the MRL review require further confirmatory data. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to amend the residue definition for risk assessment and to modify the existing maximum residue levels (MRLs) for the active substance acibenzolar‐S‐methyl in beans (with pods) and peas (with pods). The toxicological data submitted in support of this MRL application were found to be sufficient to conclude that the plant metabolite 4‐OH acibenzolar acid is not genotoxic in vitro, however lacking investigation of the general toxicity, a definitive conclusion cannot be derived whether 4‐OH acibenzolar acid (free and conjugated) should be included or excluded from the residue definition for risk assessment for all commodities belonging to the groups of leafy crops and pulses/oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals on the basis of the current residue definition (sum of acibenzolar‐S‐methyl and acibenzolar acid (free and conjugated), expressed as acibenzolar‐S‐methyl) for the intended uses on lettuces and salad plants, beans (with pods) and peas (with pods). The available residue trials are sufficient to derive MRL proposals of 1 mg/kg for beans with pods and peas with pods. The submitted information did not provide evidence that the existing MRL has to be changed for the intended uses on lettuces and other salad plants. For herbs and edible flowers, data gaps were identified which precluded the derivation of MRL proposals. The consumer risk assessment for the current residue definition did not identify an unacceptable risk for consumers. The indicative exposure calculations performed for the metabolite 4‐OH acibenzolar indicate that exposure to this metabolite is lower than the exposure to acibenzolar‐S‐methyl and acibenzolar acid (free and conjugated). However, considering the data gaps identified, a definitive conclusion cannot be derived by EFSA on the risk for consumers related to the intake of residues of 4‐OH acibenzolar acid. The reliable end points appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to prepare a reasoned opinion on the toxicological properties and the existing maximum residue levels (MRLs) set for propoxur. EFSA was requested to assess the toxicological properties of propoxur and derive toxicological reference values, based on the toxicological assessment performed by Health Canada. EFSA was also requested to review the information provided by Member States and the UK on the metabolism of propoxur in plants and animals and on the current MRLs, as well as the limit of quantification (LOQ) that can be achieved with analytical methods used in MRL enforcement. Based on the information available to EFSA, toxicological reference values could not be derived for propoxur. No evidence was provided by Member States and UK that the existing EU MRLs need to be maintained as import tolerances. Information to support the current MRLs or alternative MRLs have not been provided by Member States and the UK. Codex MRLs are not in place. EFSA therefore recommended lowering of all existing EU MRLs for propoxur to the LOQ. According to the EU Reference Laboratories, sufficiently validated analytical methods are available to analyse for propoxur residues in all plant and animal commodities. Lacking toxicological reference values derived at EU level, a conclusion cannot be derived whether the setting of MRLs at the LOQs is sufficiently protective for the European consumers. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Italia Srl submitted a request to the competent national authority in Italy to set import tolerances for the active substance metiram in passion fruits/maracujas, bananas, pineapples and to modify the existing maximum residue level (MRL) in celeriacs on the basis of intended northern Europe (NEU) use. The data submitted in support of the request were found sufficient to derive MRL proposals for pineapples and passion fruits/maracujas; according to the data provided, the existing EU MRL in bananas did not require modification and the data were not sufficient to derive an MRL proposal for celeriacs. A consumer exposure calculation, which considered only metiram uses, indicated no long-term consumer intake concerns, but is affected by several uncertainties related to the lack of residue data reflecting the existing uses of metiram. A second exposure scenario in which the lack of information was overcome by conservative assumptions indicated potential chronic exposure concerns for a number of diets. The contribution of residues in the crops under consideration to the long-term consumer exposure is low. The consumer exposure to ethylenethiourea (ETU) residues from the existing and intended metiram uses indicated no consumer intake concerns. However, the risk assessment is affected by a number of uncertainties that could not be addressed with the currently available data. EFSA therefore proposed that a comprehensive consumer exposure to ETU residues is performed in the framework of Article 12 MRL review, considering the existing uses of dithiocarbamates that are known to degrade to ETU in processed products. Considering the inconclusive results and overall uncertainties in the risk assessment, EFSA is of the opinion that further risk management discussions are required whether a modification of existing dithiocarbamate MRLs is justified prior to the finalisation of the MRL review on metiram and other dithiocarbamates. [ABSTRACT FROM AUTHOR]

The applicant FMC Agricultural Solutions A/S submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new storage stability study was submitted and information on an analytical method for determination of bifenthrin in eggs was made available. The data gaps were sufficiently addressed. The new information provided, did not require a revision of the existing MRLs. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to set import tolerances for bifenthrin in sweet corn and maize grain. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for maize grain only. For sweet corn, data gaps were identified which precluded the derivation of an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of bifenthrin (sum of isomers) in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices. EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of bifenthrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment is affected by additional non‐standard uncertainty related to the expiry of EU authorisation for a number of crops for which previously EU MRLs were established, and which are still included in the risk assessment. [ABSTRACT FROM AUTHOR]

The applicant Cheminova A/S submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data for the active substance flutriafol that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005. The applicant provided residue trials on rice representative for an adjusted Good Agricultural Practice (GAP), metabolism studies in goats and storage stability data in tissues of animal origin addressing the data gaps identified in the MRL review. For the nature of residues in processed commodities, relevant to confirm the MRLs on pome fruits and wine grapes, the applicant referred to the information provided in a previous MRL application and already assessed by EFSA. The data gaps on the authorised uses on beetroots, melons and watermelons assessed in the MRL review were not addressed. At the same time, the applicant submitted a request to the United Kingdom to modify the existing maximum residue level (MRL) for flutriafol in cucurbits with inedible peel according to Article 6 of Regulation (EC) No 396/2005. The data submitted were found to be sufficient to derive an MRL proposal for these crops. EFSA concluded that the proposed use of flutriafol on the crops under assessment will not result in a consumer exposure exceeding the toxicological reference values for flutriafol and therefore is unlikely to pose a risk to consumers' health. Regarding the triazole derivative metabolites (TDMs), the conclusions reached in a previously issued assessment for another triazole fungicide are still valid. An update of the indicative consumer risk assessment for each individual metabolite is not necessary since the residues expected in the concerned commodities are covered. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt für Landwirtschaftund Gartenbau (LLG) submitted two applications to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance fluroxypyr in chives, celery leaves, parsley, thyme and basil and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under consideration, except for thyme for which a tentative MRL proposal was derived for further risk management considerations. Adequate analytical methods for enforcement are available to control the residues of fluroxypyr in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the use of fluroxypyr according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, Dienstleistungszentrum Ländlicher Raum Rheinpfalz, submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance picloram in flowering brassica. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli, cauliflowers and other flowering brassica. Adequate analytical methods for enforcement are available to control the residues of picloram and its conjugates in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of picloram according to the reported agricultural practices is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment, are presented. [ABSTRACT FROM AUTHOR]

The applicants Syngenta Crop Protection, UPL Europe Ltd. and Oxon Italia S.p.A. submitted requests to the competent national authority in the Netherlands to evaluate the confirmatory data for chlorothalonil that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available; in addition, Syngenta and UPL submitted requests for modifications of existing MRLs. Considering the recent decision on the non‐approval of chlorothalonil, the requests for amending existing MRLs to reflect intended EU uses for chlorothalonil and confirmatory data for EU uses became obsolete. EFSA focused therefore its assessment on the import tolerances and on general information on the analytical method required to enforce legal limits for chlorothalonil and its metabolite SDS‐3701 (R182281). Analytical methods for enforcement are available to control the residues of chlorothalonil and SDS‐3701 in plant matrices at the validated LOQ of 0.01 mg/kg; data on the extraction efficiency for high oil content matrices as requested in the MRL review were not provided. This data gap is relevant for the import tolerance for peanuts. The data submitted in support of import tolerances were found to be sufficient to derive MRL proposals for chlorothalonil and SDS‐3701 for bagged bananas, papayas and peanuts. Studies investigating the effect of high temperature processing on the magnitude of SDS‐3701 in processed products are not available. Based on exposure calculations for chlorothalonil, EFSA concluded that the long‐term intake of residues resulting from the use of chlorothalonil according to the reported agricultural practices is unlikely to present a risk to consumers. For papaya, an acute intake concern was noted for chlorothalonil, while for banana and peanuts, the expected short‐term intake of chlorothalonil residues was below the toxicological reference value. For the metabolite SDS‐3701, the toxicological profile is not fully elucidated, and therefore, toxicological reference values could not be derived. Hence, for this metabolite, the consumer risk assessment cannot be finalised. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance propineb. Although this active substance is no longer authorised within the EU, due to insufficient information in order to conclude on the consumer risk assessment for the active substance, the toxicity of the metabolite propane-1,2-diamine (PDA) the impact on non-target organisms and the risk to honeybees, MRLs based on the use of propineb were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and are still in place. Additionally, propineb has potential endocrine-disrupting properties related to the hazards of its major metabolite 4-methylimidazolidine-2-thione (PTU). Lacking a full toxicological characterisation for the compound PDA, exposure data for metabolites propineb-DIDT in plants and PDA in processed commodities and considering that propineb-MRLs correlated to CXLs were based on EU uses that were withdrawn following the non-renewal and are no longer in place, it was not possible for EFSA to perform an assessment of these MRLs and their incorporation in European legislation cannot be recommended. Nevertheless, available data allowed EFSA to propose a marker residue and a limit of quantification (LOQ) for enforcement against potential illegal uses. [ABSTRACT FROM AUTHOR]

The applicant Syngenta submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data that were identified for azoxystrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available, and to consider new good agricultural practices (GAPs) for lettuces and other salad plants. To address the data gaps, new residue trials performed on open leaf varieties of lettuce supporting adjusted indoor, northern and southern GAPs, an assessment of the genotoxicity of the livestock metabolites L1, L4 and L9 and an assessment of the human dietary exposure to the livestock metabolites L1, L4 and L9 were submitted. The data gaps were considered partially addressed. The new information provided may require a revision (lowering) of the existing MRLs for lettuce and other salad plants and further risk management consideration for MRLs in animal commodities. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Indofil Industries Limited submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance mancozeb in garlic, broccoli, cauliflowers and leeks. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under consideration. Based on the risk assessment results, EFSA derived recommendations for further consideration by the risk managers. Adequate analytical methods for enforcement are available to control the residues of mancozeb in the crops under consideration. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt für Landwirtschaft und Gartenbau (LLG) submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance aclonifen in fennel seed and caraway fruit. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under consideration. Adequate analytical methods for enforcement are available to control the residues of aclonifen in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of aclonifen according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeScience Benelux submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substance triclopyr in kiwi fruits. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for kiwi fruits. Adequate analytical methods for enforcement are available to control the residues of triclopyr in the plant matrix under consideration (i.e. high acid content commodity) at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of triclopyr according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 set an import tolerance for the active substance abamectin in various commodities imported from the United States of America. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tree nuts, peaches, avocados, lettuces and salad plants, spinaches and similar leaves, Florence fennels and cotton seed. Adequate analytical methods for enforcement are available to control the residues of abamectin on the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of abamectin according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]