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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 Greece for the pesticide active substance mancozeb 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 mancozeb as a fungicide on wheat (winter/spring), grapevine, potatoes and tomatoes. 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 conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Greece, for the pesticide active substance dithianon are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory mammalian toxicology and residues data. The conclusions were reached on the basis of the evaluation of the representative uses of dithianon as a fungicide on table and wine grapes and on pome fruit. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified.

Abstract 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 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 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 Portugal to set import tolerances for the active substance lufenuron in grapefruits, oranges, limes, pome fruits, peppers, coffee, sugar canes, muscle, fat, liver and kidney on the basis of the authorised uses of lufenuron in Brazil, Chile and Morocco. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for all commodities under assessment. For oranges, limes, pome fruits, peppers and coffee beans and commodities of animal origin, the submitted data indicated no need to modify the existing EU MRLs. For grapefruits and sugar cane, the residue data indicated that higher MRLs would be needed. Adequate analytical methods for enforcement are available to control the residues of lufenuron in plant and animal matrices. Based on the risk assessment results, EFSA concluded that the existing EU uses and the authorised uses of lufenuron in Brazil, Chile and Morocco will not result in chronic consumer exposure exceeding the toxicological reference value. Considering, however, that the estimated exposure is close to the acceptable daily intake (ADI) and in the light of the expiry of the approval of the active substance, EFSA recommends the review of the existing MRLs taking into account that the MRLs based on the EU uses will become obsolete.

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 aminopyralid. To assess the occurrence of aminopyralid 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. 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 BASF Agro BV Arnhem submitted a request to the competent national authority in Austria to set and modify the maximum residue levels (MRLs) for the active substance mefentrifluconazole in various products of plant and animal origin. The data submitted in support of the request were found to be sufficient to derive MRL proposals for pome fruits, apricots, cherries, peaches, plums, grapes, potatoes, sweet corns, maize, sunflower seeds, rapeseeds, sugar beet roots, swine liver, bovine kidney and ruminant milk. Adequate analytical methods for enforcement are available to control the residues of mefentrifluconazole in plant and animal matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. A consumer risk assessment was performed for mefentrifluconazole. The short‐term and the long‐term intake of parent mefentrifluconazole resulting from the intended uses is unlikely to present a risk to consumer health. EFSA also performed an indicative risk assessment for the following four metabolites of mefentrifluconazole, which are called triazole derivative metabolites (TDMs): triazole alanine (TA), triazole lactic acid (TLA), triazole acetic acid (TAA) and 1,2,4‐triazole (1,2,4‐T). These metabolites are common metabolites for a number of triazole fungicides. For the TDM risk assessment, EFSA took into account not only data from the intended uses of mefentrifluconazole but also the information available from various triazole pesticides previously assessed. Overall, the estimated exposure for TDMs did not exceed the toxicological reference values, noting that the consumer exposure assessments for the TDMs are affected by uncertainties related to the data gaps identified in the EU peer review of confirmatory data for TDMs.

Abstract 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 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, the Netherlands, for the pesticide active substance aqueous extract from the germinated seeds of sweet Lupinus albus and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 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 the aqueous extract from the germinated seeds of sweet Lupinus albus as a fungicide on strawberry and tomatoes (field use and greenhouse application). 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 were not identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Estonia, and co‐rapporteur Member State, France, for the pesticide active substance Streptomyces strain K61 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative use of Streptomyces strain K61 as a fungicide on fruiting vegetables, leafy vegetables, bulb vegetables, pulses, ornamentals, aromatic herbs and root crops, onions and seedlings, in permanent greenhouses and walk‐in tunnels. 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 LLG Sachsen‐Anhalt, Dez. Pflanzenschutz submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for copper compounds in herbs and edible flowers. The data submitted in support of the request were found sufficient to derive an MRL proposal of 150 mg/kg, confirming the MRL proposal of the MRL review, for copper compounds in herbs and edible flowers in support of the intended indoor use. Based on the 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 herbs and edible flowers are minor contributors to the overall consumer exposure, a risk management decision has to be taken whether it is appropriate to increase the existing MRLs for these crops, given that a potential consumer intake concern could not be excluded.

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 6‐benzyladenine. To assess the occurrence of 6‐benzyladenine 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. All information required by the regulatory framework was present and a risk to consumers was not identified.

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 Netherlands for the pesticide active substance Bacillus amyloliquefaciens strain AH2 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 Bacillus amyloliquefaciens AH2 as a fungicide on grapes. 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 conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance prosulfuron 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 prosulfuron as a herbicide on maize and sweet corn. Following the renewal of approval, prosulfuron has been renewed with the restriction that the use shall be limited to one application every 3 years. This assessment follows the request of the applicant to lift the restriction of the approval conditions. 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 SIPCAM Italia S.p.A. submitted a request to the competent national authority in Italy to modify the existing maximum residue level (MRL) for the active substance etofenprox in plums. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for plums. Adequate analytical methods for enforcement are available to control the residues of etofenprox in plums 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 existing and intended uses of etofenprox 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 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 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 Germany to modify the existing maximum residue level (MRL) for the active substance fludioxonil in elderberries in support of the intended NEU use. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 4 mg/kg for elderberries, as an extrapolation from red and black currants and blueberries. Adequate analytical methods for enforcement are available to control the residues of fludioxonil 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 intended use of fludioxonil according to the reported agricultural practice and from the existing authorised uses is unlikely to present a risk to consumer health.

Abstract The conclusions of the 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. The European Commission mandated EFSA to reconsider the acceptable operator exposure level (AOEL) setting and to update the non‐dietary exposure assessment if needed.

Abstract 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 level (MRL) for the active substance acrinathrin in lettuce. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for lettuce. Adequate analytical methods for enforcement are available to control the residues of acrinathrin 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 acrinathrin according to the reported agricultural practice and the current approval restrictions of acrinathrin is unlikely to present a risk to consumer health. However, uncertainties remain, particularly on the toxicological profile of the different isomers. Hence, the consumer risk assessment is considered tentative.

Abstract 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 EFSA received from the European Commission a mandate to deliver a reasoned opinion according to Article 43 of Regulation (EC) No 396/2005 on the safety of a proposed temporary maximum residue level (tMRL) for chlorpropham in potatoes to consumers. Sprout inhibitors based on the active substance chlorpropham have been widely used in commercial storage facilities in Europe over multiple seasons. Following the non‐renewal of approval of chlorpropham, representatives of potato trade organisations and manufacturers of chlorpropham reported an issue of cross‐contamination above the limit of quantification (LOQ) of untreated potatoes stored in facilities with a history of applications of chlorpropham as a post‐harvest treatment. The evaluating Member State (EMS) the Netherlands, in accordance with Articles 6(2) and 16 (1)(a) of Regulation (EC) No 396/2005, submitted an application for the setting of a tMRL for chlorpropham in potatoes in order to address the cross‐contamination in commercial storages. The EMS proposed to set a tMRL for the active substance at a level ranging between 0.3 and 0.5 mg/kg. Based on the assessment of the available data and information with different methodologies, optional tMRL proposals of 0.3, 0.4 and 0.5 mg/kg were derived, and an indicative consumer risk assessment was carried out. The tMRL proposals require further consideration by risk managers, mainly with regard to identified uncertainties, and measures for further reduction of occurrence of chlorpropham residues will also need to be considered. With this prospect, EFSA concluded that the short‐term and long‐term intake of residues of chlorpropham and 3‐chloroaniline resulting from cross‐contamination in potatoes 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 Germany to modify the existing maximum residue level (MRL) for the active substance lambda‐cyhalothrin in seed and fruit spices. The data submitted in support of the request were found to be sufficient to derive MRL proposals in seed spices and in fruit spices. Since the general data gap related to toxicity of degradation products formed under sterilisation conditions and identified in the framework of the MRL review has not yet been addressed, a risk management decision is required whether it is appropriate to take over the proposed MRLs in the MRL legislation. 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 use of lambda‐cyhalothrin on spices according to the reported agricultural practice is unlikely to present a risk to consumer health. However, the consumer exposure calculation shall be considered provisional, pending the toxicological assessment of the compounds formed under sterilisation conditions.

Abstract 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 Finland to set an import tolerance for the active substance flonicamid in various crops and products of animal origin on the basis of the authorised use of flonicamid in the USA. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for all crops under assessment. Based on the results of the feeding studies and the updated animal burden calculations, no need for new MRL proposals on products of animal origin was identified. Adequate analytical methods for enforcement are available to control the residues of flonicamid in plant and animal matrices. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that the authorised USA uses of flonicamid will not result in acute or chronic consumer exposure exceeding the toxicological reference values and, therefore, is unlikely to pose a risk to consumers’ health.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Du Pont (UK) submitted a request to the competent national authority in the United Kingdom to set an import tolerance for the active substance oxathiapiprolin in various crops in support of authorised uses in the United States. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for citrus fruits, blackberries, raspberries, Chinese cabbage, basil and edible flowers and asparagus. For dewberries, potatoes and sweet potatoes, data gaps were identified which precluded the derivation of MRL proposals. 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 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 meptyldinocap (DE‐126). To assess the occurrence of meptyldinocap residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, Commission Regulation (EU) No 188/2011 and 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. 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 requires 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 metaflumizone. To assess the occurrence of metaflumizone 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 and 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 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 Bayer CropScience AG and Bayer SAS submitted two requests to the competent national authority in the Netherlands to set import tolerances and to modify existing EU maximum residue levels (MRLs) for the active substance flupyradifurone and its metabolite difluoroacetic acid (DFA) in various crops. The application also included the request to evaluate the confirmatory data related to residues that were identified in the framework of the peer review of flupyradifurone under Regulation (EC) No 1107/2009 as not available. The data submitted in support of intended and authorised uses were found to be sufficient to derive MRL proposals for flupyradifurone and DFA in all crops under consideration except for prickly pear and hops; for grapefruit, pome fruits, grape leaves and witloof, further risk management discussion is recommended to decide on the appropriate MRL. Furthermore, EFSA recommended risk management discussion to examine different options to deal with DFA residues in crops that can be grown in crop rotation. The calculated livestock dietary burdens indicated that existing EU MRLs for flupyradifurone and DFA in animal commodities need to be modified. Adequate analytical methods for enforcement are available to control the residues of flupyradifurone and the DFA in plant and animal matrices. The submitted data are considered sufficient to address the data gaps related to residues which were identified in the framework of the EU pesticides peer review, and thus, the footnotes set for DFA and flupyradifurone MRLs in the Commission Regulation (EU) 2016/1902 can be deleted. Based on the consumer exposure assessment, acute consumer exposure concerns could not be excluded for tomatoes, melons, celery and processed escaroles. Hence, the raising of the existing MRLs for flupyradifurone in these crops is not recommended. For these four crops, MRL proposals for DFA were derived, which reflect the uptake of residues via soil resulting from previous use of flupyradifurone. For the remaining commodities of plant and animal origin, EFSA concludes that the intended EU uses and authorised US and Canadian uses of flupyradifurone and resulting residues of DFA will not result in chronic or acute consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Ireland, and co‐rapporteur Member State, Denmark, for the pesticide active substance garlic extract and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative use of garlic extract as a repellent, insecticide and nematicide on a wide range of crops in agriculture, horticulture, amenity. 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 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 flubendiamide. To assess the occurrence of flubendiamide 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 import tolerances (including the supporting residues data). No European authorisation was reported by Member States. 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 acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still requires further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands, and co‐rapporteur Member State, France, for the pesticide active substance Akanthomyces muscarius strain Ve6 formerly Lecanicillium muscarium strain Ve6 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012 as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Akanthomyces muscarius strain Ve6 as an insecticide on fruiting vegetables of cucurbitaceae with edible and inedible peel, fruiting vegetables of solanaceae, strawberries, floriculture crops (except roses), cut roses and tree nursery. 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 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, Austria, for the pesticide active substance 24‐epibrassinolide and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 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 24‐epibrassinolide as an elicitor on grapes, leafy vegetables, sugar beet and as plant activator on grapes and cucurbits. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. No concerns are identified.

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 Bacillus pumilus QST 2808. To assess the occurrence of Bacillus pumilus QST 2808 residues in primary crops, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, 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 cannot be derived and are deemed not to be necessary. A consumer risk assessment cannot be performed quantitatively. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. The outcome of the assessment was compared to the criteria defined by the European Commission for inclusion of pesticide active substances in Annex IV of the Regulation. A proposal for inclusion of Bacillus pumilus QST 2808 into Annex IV of Regulation (EC) No 396/2005 is derived by EFSA.

Abstract The applicant Bayer Crop Science submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for aclonifen 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, an analytical method for enforcement in complex/no group matrices (spices) and additional four residue trials supporting SEU authorisation on peppers were submitted. The data gaps were considered satisfactorily addressed and the tentative MRLs can be confirmed in peppers, in seed and fruit spices and in flowers and leaves and herbs of herbal infusions. The previous consumer intake assessment remains valid.

Abstract The applicant ISK Biosciences Europe N.V, submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flonicamid in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. In order to address the data gaps, the applicant provided method validation data for hops, residue trials on cherries, plums, tomatoes and melons and referred to results from trials in cucumbers and storage stability and hydrolysis studies which have been assessed in previous EFSA outputs. The provided information was considered sufficient to address the confirmatory data gaps for hops, cherries, plums, tomatoes and aubergines, courgettes and cucurbits with inedible peel. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that for the crops under assessment, the long‐term and short‐term dietary intake is unlikely to present a risk to consumer health.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Tilco‐Alginure GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance potassium phosphonates in flowering brassica, Chinese cabbages, kales and spinaches. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all the crops under assessment. Adequate analytical methods for enforcement are available to control residues of potassium phosphonates in the crops under assessment. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of potassium phosphonates according to the reported agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative and a more realistic intake assessment will be performed in the framework of the MRL review for potassium phosphonates. The reliable end points, appropriate for use in regulatory risk assessment are presented.

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Germany, and co‐rapporteur Member State, Hungary, for the pesticide active substance beta‐cyfluthrin 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 beta‐cyfluthrin as an insecticide on beet, potato, wheat and greenhouse tomato. In addition, this conclusion also addresses the request received from the European Commission during the decision‐making phase following completion of the peer review with regard to the risk to non‐target arthropods. 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 conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the co‐rapporteur Member State, the Czech Republic, for the pesticide active substance sulfoxaflor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of sulfoxaflor as an insecticide on fruiting vegetables (field and greenhouse application), cucurbits (field and greenhouse application), spring and winter cereals (field application) and cotton (field application). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. For the field and non‐permanent structure greenhouses, a high risk to honeybees and bumble bees was identified related to some pertinent scenarios (treated crop scenario except after flowering period, weed scenario, field margin scenario). A low risk was concluded for honeybees, bumble bees and solitary bees in case of permanent structure greenhouse provided the low exposure in such scenarios. The European Commission mandated EFSA to complete the assessment of the spray drift reducing measures necessary to protect bumblebees and solitary bees in field margins from exposure to sulfoxaflor and to complete the assessment of the risk to bees from puddle water.

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 Austria and co‐rapporteur Member State Greece for the pesticide active substance kieselgur (diatomaceous earth) and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of kieselgur (diatomaceous earth) as an insecticide and acaricide on stored cereals, empty storage rooms and storage rooms, mills and warehouses (with stored goods). 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 The applicant Asahi Chemical Europe s.r.o. submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for the pesticide active substances sodium 5‐nitroguaiacolate, sodium o‐nitrophenolate and sodium p‐nitrophenolate (sodium nitrocompounds) 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 gap related to validated analytical enforcement method, the validation data of a method for the determination of sodium nitrocompounds in high acid content commodities, dry commodities and hops (dried) was submitted. The data gap was considered satisfactorily addressed. The risk assessment performed for the three active substances sodium 5‐nitroguaiacolate, sodium o‐nitrophenolate and sodium p‐nitrophenolate in the framework of the MRL review remains valid.

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 Nissan Chemical Europe S.A.S. submitted two requests to the competent national authority in the Netherlands, respectively to modify the existing maximum residue level (MRL) in sweet pepper/bell pepper and to set an import tolerance in tree nuts for the active substance pyridaben. The data submitted in support of the requests were found to be sufficient to derive the MRL proposals of 0.3 mg/kg for sweet peppers/bell peppers and of 0.05* mg/kg for tree nuts. Adequate analytical methods for enforcement are available to control the residues of pyridaben in the commodities under consideration, at or above the validated limits of quantification (LOQs) 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 pyridaben on imported tree nuts from United States and from the indoor use on sweet peppers/bell peppers 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 The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Austria and co‐rapporteur Member State Lithuania for the pesticide active substance blood meal and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of blood meal as a game repellent on deciduous and coniferous trees in forestry, orchard trees and ornamental plants and as a vole repellent on deciduous and coniferous trees in forestry (field uses). 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. No concerns are identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer SAS Crop Science and the Agriculture and Horticulture Development Board submitted two requests to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for prothioconazole in rapeseeds and celeriacs, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for these crops. The applicant Bayer SAS Crop Science additionally submitted a request to the competent national authority in the United Kingdom 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, residue trials on carrots, onions, rapeseeds and wheat, and storage stability studies were submitted. The data gaps are considered fully addressed for the root and tuber vegetables, the oilseeds concerned and wheat. The data gaps have been partially addressed for onions, shallots, flowering brassica, Brussels sprouts, head cabbages, leeks, rye, barely and oat. The data gaps were not addressed for pulses and grass. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the existing and intended uses of prothioconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. For the triazole derivative metabolites (TDMs), only an indicative exposure assessment was performed considering celeriacs and rapeseeds; the results showed that the expected exposure to TDMs in these commodities is well below the toxicological reference values derived for the TDMs.

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 the United Kingdom to set import tolerances for the active substance fluxapyroxad for certain root crops and for coffee beans produced in the US and Brazil. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops assessed. Adequate analytical methods for enforcement are available to control the residues of fluxapyroxad in the products concerned 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 fluxapyroxad 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 thiencarbazone‐methyl. To assess the occurrence of thiencarbazone‐methyl residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 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. All information required by the regulatory framework was present and a risk to consumers was not identified.

Abstract The applicant AgroFresh Holding France S.A.S. submitted a request to the competent national authority in the United Kingdom 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 metabolism study representative for apples was submitted. In addition, residue trials in apples and bananas were provided. For apples, residues were below the limit of quantification (LOQ), and for bananas, EFSA concluded that there is sufficient evidence to assume that quantifiable residues of 1‐methylcyclopropene (1‐MCP) are unlikely to occur, if bananas are treated according to the Good Agricultural Practice (GAP) reported. The new information provided did not require a revision of the existing MRLs for apples and bananas.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Agan Ltd submitted a request to the competent national authority in Italy to modify the existing maximum residue level (MRL) for the active substance imazamox in soyabeans to support the intended use in Europe. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for imazamox in soyabeans according to the existing and the revised enforcement residue definition. Adequate analytical methods for enforcement are available to control the residues of imazamox and CL 263284 in plant matrices at the individual validated limit of quantification (LOQ) of 0.01 mg/kg. The calculated livestock dietary burdens indicate no need to modify the existing EU MRLs in commodities of animal origin. EFSA proposes that the risk managers consider the modification of the existing enforcement and risk assessment residue definitions according to the conclusions of the EU pesticides peer review. Based on the risk assessment results, EFSA concluded that the proposed use of imazamox on soyabeans and the imazamox residues from the authorised uses will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a risk to consumers’ health.

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 fludioxonil in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals of 0.3 mg/kg for linseeds, sesame seeds, rapeseeds, mustard seeds, borage seeds, gold of pleasure seeds, hemp seeds and 0.02 mg/kg for cattle milk. Adequate analytical methods for enforcement are available to control the residues of fludioxonil in the plant matrix under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. From the chronic risk assessment performed by EFSA, it is concluded that the intake of residues resulting from the use of fludioxonil according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment is affected by additional, non‐standard uncertainties because experimental data on the magnitude of certain metabolites included in the risk assessment residue definition are not available for the oilseeds under assessment.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted two individual requests to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in kohlrabies and in the crop group of herbs and edible flowers, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for kohlrabies and for the group of herbs and edible flowers. Adequate analytical methods for enforcement are available to control the residues of mandipropamid in the crops under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the indicative risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of mandipropamid according to the intended 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 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 proquinazid. To assess the occurrence of proquinazid 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 requires further consideration by risk managers.