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The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance lavandulylsenecioateare reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council.The conclusions were reached on the basis of the evaluation of the representative uses evaluated as a pheromone comprising manual applications to control Planococcusficus (vine mealybug) populations by mating disruption in table grape, wine grape, raisins and any other crops where P. ficus may be a pest in Southern Europe. The reliable endpoints,appropriate for use in regulatory risk assessmentare presented. Missing information identified as being required by the regulatory framework is listed.Concerns are identified.

Abstract 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 modify the existing maximum residue level (MRL) for the active substance acibenzolar‐S‐methyl in hazelnuts. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for hazelnuts/cobnuts. Adequate analytical methods for enforcement are available to control residues of acibenzolar‐S‐methyl in the plant matrix 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 acibenzolar‐S‐methyl according to the reported agricultural practice is unlikely to present a risk to consumer health.

Abstract The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for bentazone 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 livestock feeding study and storage stability data for bentazone and 6‐hydroxy bentazone in animal matrices were submitted. To address the data gap for potatoes, adjusted less critical good agricultural practices (GAPs) were reported and supporting residue data were provided. The data gap related to analytical methods in fat and herbal infusions were addressed in the framework of the peer review. The data gap for residue trials on leek has not been addressed. Further confirmation from the applicant/Member States are needed for the clarification of the GAP for herbal infusions. Based on the information submitted in support of the confirmatory data request, the existing EU MRLs for bentazone need to be modified for potato and leek, for swine fat and kidney and for bovine, equine, goat and sheep fat, liver and milk. The consumer risk assessment performed in the MRL review was updated, using new toxicological reference values derived by the peer review. No consumer intake concerns were identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Belgium Federal Public Service for Health, Food chain safety and Environment (Belgium FPS Health) submitted a request to modify the existing maximum residue level (MRL) for the active substance fludioxonil in Florence fennels. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 1.5 mg/kg for Florence fennels. Adequate analytical methods for enforcement are available to control the residues of fludioxonil 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 the long‐term intake of residues resulting from the use of fludioxonil according to the reported agricultural practice is unlikely to present a risk to consumer health.

Abstract According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD, version 1) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. This document is a consolidated version of the past four years’ guidance defining the appropriate SSD codes to describe the samples and the analytical results and it gives directions for the reporting of the pesticide residues monitoring data starting with the data generated in 2018 onwards. These provisions take into account the experience of both the previous reporting seasons and the new legislation applicable in 2018. This EFSA Guidance will not be applicable for the 2019 data collection provided to EFSA in 2020. In 2020, all data on annual monitoring will be transmitted in SSD2 format only.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram 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 the short‐term and long‐term intake of residues resulting from the use of fluopyram according to the reported agricultural practice for broccoli will not result in consumer exposure exceeding the toxicological reference values and therefore are unlikely to present a risk to consumer health.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance thiacloprid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of thiacloprid as an insecticide on oilseed rape foliar use and maize seed treatment. The peer review also provided conclusions on whether exposure of humans to thiacoprid can be considered negligible, taking into account the European Commission's draft guidance on this topic. Confirmatory data following the review of existing maximum residue levels (MRLs) according to Article 12 of Regulation (EC) No 396/2005 were also assessed in this conclusion. The reliable end points, appropriate for use in regulatory risk assessment are presented. An evaluation of data concerning the necessity of thiacloprid as an insecticide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods is presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are available to control the residues of cyprodinil in the plant matrix under consideration 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 authorised uses of cyprodinil and the intended use on Florence fennel is unlikely to present a risk to consumer health. An indicative acute exposure assessment was performed, considering the acute reference dose (ARfD) proposed by the rapporteur Member State (RMS) in the framework of the currently ongoing renewal of the approval of cyprodinil; no acute health concerns were identified with regard to cyprodinil residues in Florence fennel. As the peer review on the renewal of the approval of cyprodinil in accordance with Regulation (EC) No 1107/2009 is currently ongoing, the conclusions reported in this reasoned opinion may need to be reconsidered in the light of the outcome of the peer review.

Abstract 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 modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical methods for enforcement are available to control the residues of pyridaben in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed use of pyridaben on tomatoes and aubergines will not result in a consumer exposure exceeding the toxicological reference values and therefore it is unlikely to pose a risk to consumers’ health.

Abstract The applicant Nihon Nohyaku Co. Ltd. submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flutolanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to new residue trials for globe artichokes and beans with pods and for storage stability data in products of animal origin were addressed. Further risk management consideration is required regarding the tentative MRL on peppers and on certain products of animal origin, since the data gaps identified in the MRL review were not addressed or only partially addressed. A new metabolism study on ruminants was provided which will be assessed in the framework of the renewal of the active substance flutolanil; formally, this data gap is considered to be addressed. EFSA updated the most recent consumer risk assessment for flutolanil and concluded that the long‐term dietary intake is unlikely to present a risk to consumer health. The conclusion reported in this reasoned opinion may need to be reconsidered in light of the outcome of the EU pesticides peer review.

Abstract The applicant BASF SE submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified for imazamox 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, the applicant submitted new residue trials on rice. Since the number of trials was not sufficient, the data gap was considered only partially addressed. The remaining data gaps related to metabolism studies and analytical enforcement methods have been addressed in the framework of the renewal of the approval for imazamox. New enforcement and risk assessment residue definitions for plant commodities were derived and the toxicological reference values for imazamox were revised. The previous consumer risk assessment was updated using the residue data submitted on rice and the new revised toxicological reference values. No consumer intake concerns were identified. The current reasoned opinion is intended to give risk managers the necessary information to take a decision on the amendment of the tentative MRLs established in the EU MRL legislation. Furthermore, EFSA recommends to review all existing EU MRLs for imazamox, considering the new residue definitions derived in the framework of the peer review.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL proposals for beetroots, radishes, cauliflowers, Brussels sprouts, witloofs/Belgian endives, peas (without pods) and globe artichokes. Adequate analytical methods for enforcement are available to control the residues of mandipropamid 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 intake of residues resulting from the use of mandipropamid according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract The applicant Dow AgroSciences Ltd submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for spinosad in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to residue trials on globe artichokes, flowering brassica and the nature of residues in processed commodities were satisfactorily addressed. A new feeding study on poultry has been submitted as requested, but the information is not sufficient to derive conversion factors (CF) for risk assessment for poultry liver and eggs to replace the tentative conversion factors obtained from the metabolism study. The new information provided justifies the lowering of the MRLs for flowering brassica and products of poultry origin. The consumer risk assessment performed for spinosad was updated taking into account the acute reference dose (ARfD) which was recently derived by EFSA. Since for spinach a potential consumer intake concern was identified, the lowering of the existing MRL is recommended. For the remaining commodities assessed under this application (globe artichokes, flowering brassica, products derived from poultry), a consumer intake concern was not identified. For a number of commodities for which MRLs have been established previously but which are not subject of the current assessment, EFSA recommends a review of the MRLs because of potential short‐term intake concerns.

Abstract 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 triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical methods for enforcement are available to control MRL compliance for parent compound tetraconazole on the commodities under consideration and in animal products. The proposed use of tetraconazole on crops under assessment will not result in a dietary exposure to residues of parent tetraconazole exceeding the toxicological reference values for tetraconazole. For triazole derivative metabolites (TDMs), only an indicative exposure assessment was performed considering only the crops under assessment; the results showed that the expected exposure to TDMs in the three assessed commodities is well below the toxicological reference values derived for the TDMs. The proposed use of tetraconazole on crops under assessment is therefore unlikely to pose a risk to consumers’ health. TDMs may be generated by several pesticides belonging to the group of triazole fungicides, a comprehensive risk assessment has thus to be performed that covers all existing EU uses and import tolerances for all pesticides belonging to the class of triazole fungicides. EFSA recommended to elaborate together with risk managers a strategy to ensure that the required data are made available to finalise the overall risk assessment for triazole fungicides.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Cyprus for the pesticide active substance fenamiphos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of fenamiphos as a nematicide in fruiting vegetables (i.e. tomato, aubergine, cucumber, pepper and courgette), herbaceous ornamentals and in nursery stock (both perennial and herbaceous species). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wheat has been considered unnecessary. Adequate analytical methods for enforcement are available to control the residues of aminopyralid and its conjugates in plant matrices and on the commodities under assessment 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 aminopyralid according to the intended agricultural practices is unlikely to present a risk to consumer health.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the competent national authority in Belgium prepared a request to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in Florence fennels and rhubarbs. Furthermore, 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 modify the existing MRLs for spirotetramat in the group of other small fruits and berries, kiwi fruits and garlic. The data submitted in support to both requests were found to be sufficient to derive MRL proposals for all the crops under consideration. Adequate analytical methods are available to enforce the proposed MRLs. 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 intended agricultural practices is unlikely to present a risk to consumer health.

Abstract 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 chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active substance. Therefore, residues of chromafenozide are not expected to occur in any plant or animal commodity and therefore a consumer risk assessment is not required. Nevertheless, the available information allowed EFSA to propose a marker residue definition and a limit of quantification (LOQ) for enforcement against potential illegal uses.

Abstract 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 sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the 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.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Sweden and co‐rapporteur Member State the Netherlands for the pesticide active substance Verticillium albo‐atrum strain WCS850 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of Verticillium albo‐atrum strain WCS850 as a fungicide on elm trees. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed.

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 Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the MRL review for further investigations of the toxicological properties of the compounds formed under sterilisation conditions has not yet been addressed. Adequate analytical enforcement methods are available to control the residues of lambda‐cyhalothrin 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 uses of lambda‐cyhalothrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment presented might need to be reconsidered in the light of the confirmatory data requested following the renewal of the approval and the review of the existing MRLs.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. EFSA performed a tentative risk assessment in which the calculated exposure to residues of trifloxystrobin and one of its metabolites CGA 321113 did not exceed the toxicological reference values derived for trifloxystrobin. The risk assessment is tentative since the toxicological properties of certain metabolites identified in some metabolism studies are not fully elucidated and data on the occurrence of metabolites CGA 357262, CGA 357261, CGA 331409 in crops for which MRLs were established in the past are not available.

Abstract 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 metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the 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. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Abstract 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 dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the 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. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesifen and spiromesifen‐enol (M01) on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each compound. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of spiromesifen according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract 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 hexythiazox. To assess the occurrence of hexythiazox residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, 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. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Abstract 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 fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, an MRL proposal was derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified. In addition, EFSA identified some data gaps which are not expected to impact on the validity of the MRL derived but which might have an impact on national authorisations.

Abstract 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 imidacloprid. To assess the occurrence of imidacloprid 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/or 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 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.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of aclonifen in high water 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 exposure to residues resulting from the use of aclonifen according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement are available to control the residues of captan in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte in the crops assessed. Based on the exposure calculation, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of captan according to the reported agricultural practice will not result in a consumer exposure exceeding the existing toxicological reference values.

Abstract 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 the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue trials is sufficient to derive a tentative maximum residue level (MRL) for hops according to the residue definitions derived for fruits and fruiting vegetables, EFSA did not recommend this MRL for being implemented in the MRL legislation because due to the lack of a reliable residue definition for risk assessment. Adequate analytical methods for enforcement are available to control the residues of captan in hops.

Abstract The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State France for the pesticide active substance bromoxynil are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to bromoxynil can be considered negligible, taking into account the European Commission's draft guidance on this topic. The conclusions were reached on the basis of the evaluation of the representative uses of bromoxynil as a herbicide on maize and straw cereals. The reliable endpoints, derived from the studies and the literature data presented in the dossier and considered appropriate for use in regulatory risk assessment, are presented.

Abstract 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 pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the 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 missing and a possible risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only and no MRL proposals were derived by EFSA. Further consideration by risk managers are needed and measures for reduction of the consumer exposure should also be considered.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of propanil as a herbicide on rice. MRLs were assessed in rice. The reliable endpoints, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in coffee beans were submitted. The data gap for coffee beans was considered satisfactorily addressed. The new residue trials in table grapes give an indication that the existing MRL for table grapes should be raised. However, since a potential acute consumer health risk for table grapes could not be excluded, EFSA recommend the lowering of the existing MRL.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamide‐M as a herbicide on winter oilseed rape and brassica vegetable crops. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of pyraclostrobin according to the reported agricultural practices is unlikely to present a risk to consumer health. Taking into account the proposed new MRL, a long‐term intake concern for consumers was not identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for mandarins, grapefruits, lemons, limes, passion fruits/maracujas, pineapples, flowering brassica, head cabbages, lamb's lettuce, cresses and other sprouts, land cresses, rucola, red mustards, baby leaf crops, globe artichokes and leeks. For oranges, American persimmons, spinaches and similar leaves and sugar canes, data gaps were identified which precluded the derivation of MRL proposals. The data submitted did not provide evidence that the existing MRLs for crops belonging to the group of lettuces and maize have to be modified to accommodate for the intended uses. For escaroles, no MRL was proposed as the intended use was found to lead to residues for which a potential consumer health risk cannot be excluded. EFSA concluded that the short‐term intake of residues resulting from the uses of pyraclostrobin according to the reported agricultural practices assessed is unlikely to present a risk to consumer health, except for escaroles, where the expected intake was found to exceed the toxicological reference value. Taking into account the existing and the proposed new MRLs, a long‐term intake concern for consumers was not identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg, which is a value lower than the one currently in use. Adequate analytical methods for enforcement in animal matrices at the validated LOQ of 0.01 mg/kg are available. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of pyraclostrobin according to the reported agricultural practice is unlikely to present a risk to consumer health.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. 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 the 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 consumer risk assessment is affected by non‐standard uncertainties related to the pending hazard characterisation for the metabolite SYN 500003, which is expected to occur in root crops.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical methods for enforcement are available to control the residues of haloxyfop‐P in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.05 mg/kg. EFSA reiterates the recommendation from the Article 12 MRL review that an independent laboratory validation (ILV) should be provided. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of haloxyfop‐P according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)‐1,3‐dichloropropene as a nematicide in fruiting vegetables (tomato, pepper, eggplant, cucumber, zucchini, melon and watermelon). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed. The new information provided does not require a revision of risk assessment performed for cyazofamid.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Germany for the pesticide active substance clodinafop‐propargyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of clodinafop‐propargyl as a herbicide on wheat, rye and triticale. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived for mandarins is not fully compliant with the EU guidance on extrapolation and the proposal requires further risk management consideration. Adequate analytical methods for enforcement are available to control the residues of teflubenzuron on the commodities under consideration. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of teflubenzuron according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the 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. An MRL application for modification of MRLs in products of animal origin was also considered in this review. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Abstract The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl 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 confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered satisfactorily addressed. The new information provided did not require a revision of the existing MRLs and of the risk assessment performed for kresoxim‐methyl.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of methiocarb as an insecticide and a bird repellent on maize. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron 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 metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated analytical method to determine residues of teflubenzuron in products of animal origin were submitted. The data gaps were considered satisfactorily addressed. The new information provided does not require a revision of risk assessment performed for teflubenzuron.