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Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Luxembourg Industries (Pamol) Ltd submitted a request to the competent national authority in Spain to modify the existing maximum residue levels (MRLs) for fosetyl/phosphonic acid (fosetyl‐Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl)) in citrus fruits. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates according to the existing and proposed residue definitions for enforcement in the commodities under consideration. Since EFSA raised concerns regarding the independence of some of the residue trials submitted in support of the MRL application, EFSA presented three options of MRL proposals for further risk management consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of potassium phosphonates on citrus crops 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 spirodiclofen. Although this active substance is no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, as spirodiclofen is classified as carcinogenic 1B with threshold, all MRL proposals derived by EFSA still require further consideration by risk managers.

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 (France after Brexit), for the pesticide active substance asulam 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 asulam (variant evaluated asulam‐sodium) as a herbicide on spinach and tulip, hyacinth and lily for bulb production. MRLs were assessed in spinach. The conclusions were updated with regard to the endocrine‐disrupting properties following a mandate received from the European Commission in February 2019. In addition, the peer review also provided considerations on whether exposure to humans and the environment from the representative uses of asulam‐sodium can be considered negligible, taking into account the European Commission's draft guidance on this topic. 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. An evaluation of data concerning the necessity of asulam‐sodium as a herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods is also presented.

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 Netherlands to modify the existing maximum residue level (MRL) for the active substance ametoctradin in honey. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for honey. Adequate analytical methods for enforcement are available to control the residues of ametoctradin in the commodity under consideration at the validated screening detection limit (SDL) of 0.0025 mg/kg. Based on the risk assessment results, EFSA concluded that the dietary intake of residues in food of plant and animal origin (including honey) resulting from the use of ametoctradin according to the existing agricultural practices 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, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain ABTS‐351 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 Bacillus thuringiensis subsp. kurstaki strain ABTS‐351 as an insecticide on cabbage (field use) and tomato (permanent greenhouse and walk‐in tunnel 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. 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, Spain, for the pesticide active substance Spodoptera exigua multicapsid nucleopolyhedrovirus 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 Spodoptera exigua multicapsid nucleopolyhedrovirus as an insecticide on pepper and leafy vegetables (lettuce crops) (field, greenhouse and walk‐in tunnel uses). 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 compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for abamectin which might lead to consumers intake concerns on the basis of the lower toxicological reference values established during the peer review, the data currently available to EFSA and the outcome of the Member States’ consultation. To identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for abamectin considering the new toxicological reference values and an acute risk could not be excluded for 12 commodities. Fall‐back MRLs for nine commodities were proposed based on the data received under the present assessment. For apples, pears and escaroles, fall‐back MRLs could not be derived, and thus, a lowering of the MRLs for these crops to the limit of quantification (LOQ) is proposed.

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

Abstract 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 metobromuron. To assess the occurrence of metobromuron 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 and the United Kingdom (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 all MRL proposals derived by EFSA still require further consideration by risk managers.

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, Poland, and co‐rapporteur Member State, France, for the pesticide active substance benthiavalicarb (variant assessed benthiavalicarb‐isopropyl) 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 benthiavalicarb‐isopropyl as a fungicide on potato (field use). The peer review also provided considerations on whether exposure to humans and the environment from the representative uses of benthiavalicarb‐isopropyl can be considered negligible, taking into account the European Commission's draft guidance on this topic. 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. An evaluation of data concerning the necessity of benthiavalicarb‐isopropyl as a fungicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods, is also 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 penthiopyrad. To assess the occurrence of penthiopyrad 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 and European authorisations reported by Member States and the UK (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 substances Beta‐cyfluthrin and Cyfluthrin. Although these active substances are no longer authorised for use on edible crops within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits (CXLs)) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. All CXLs were found to be sufficiently supported by data, whereas some import tolerances were not supported by adequate data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed. Apart from a possible acute risk to consumers for a CXL higher than the existing MRL, no risk to consumers was identified

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Nisso Chemical Europe GmbH and Sipcam Italia S.p.A. submitted requests to the competent national authority in the Netherlands and in Italy, respectively, to modify the existing maximum residue levels (MRLs) for the active substance acetamiprid in various crops. The data submitted in support of these requests were found to be sufficient to derive MRL proposals for plums, aubergines, peppers, cucumbers, courgettes, other cucurbits with edible peel, poppy seeds, mustard seeds, pomegranates and honey. Adequate analytical methods for enforcement are available to control the residues of acetamiprid in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of acetamiprid 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 levels (MRLs) for the active substance benzovindiflupyr in fresh herbs and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under assessment. Adequate analytical methods for enforcement are available to control the residues of benzovindiflupyr on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of benzovindiflupyr 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 Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance proquinazid in blueberries and cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for blueberries and cranberries. Adequate analytical methods for enforcement are available to control the residues of proquinazid in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of proquinazid 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 Austria to set an import tolerance for the active substance azoxystrobin in mangoes and oil palm fruits imported from Brazil and Colombia, respectively. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for mangoes and oil palm fruits. Adequate analytical methods for enforcement are available to control the residues of azoxystrobin on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, noting that an acute risk assessment was not deemed necessary for azoxystrobin, EFSA concluded that the long‐term intake of residues resulting from the uses of azoxystrobin 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 Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance cyflufenamid in blackberries and raspberries (red and yellow). The data submitted in support of the request were found to be sufficient to derive MRL proposals for blackberries and raspberries (red and yellow). Adequate analytical methods are available to control the residues of cyflufenamid according to the enforcement residue definition on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of cyflufenamid according to the reported agricultural practices 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, Sweden, and co‐rapporteur Member State, Italy, for the pesticide active substance bifenazate 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 bifenazate as an acaricide on strawberry, fruiting vegetables (tomatoes, peppers, aubergines, cucumbers, courgettes, melons, watermelons), flowering and ornamental plants and nursery ornamentals and updated following the request to peer review the exposure and risk assessments for bifenazate. 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 Syngenta France S.A.S. submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for emamectin. The data submitted in support of the request were found to be sufficient to derive MRL proposals for apricots, cherries, spinaches and similar leaves and herbal infusions from leaves and herbs, whereas a change of the existing MRL is not necessary for pome fruits. Adequate analytical methods for enforcement are available to control the residues of emamectin B1a 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 uses of emamectin benzoate according to the intended agricultural practices are unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative since affected by uncertainty related to the data gaps identified in the MRL review.

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, Spain, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance clofentezine and the assessment of applications for maximum residue levels (MRLs) 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 clofentezine as an acaricide on citrus, pome fruits, strawberry, tomatoes and aubergine. The peer review also provided considerations on whether exposure to humans and the environment from the representative uses of clofentezine can be considered negligible, taking into account the European Commission's draft guidance on this topic. 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. An evaluation of data concerning the necessity of clofentezine as acaricide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods is also presented.

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

Abstract 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 cyflumetofen. To assess the occurrence of cyflumetofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 and the MRLs established by the Codex Alimentarius Commission as well as European authorisations reported by Member States and the UK. 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 EFSA received from the European Commission a mandate to provide its reasoned opinion on the joint review of maximum residue levels (MRLs) for fosetyl and phosphonates in or on food and feed according to Article 43 of Regulation (EC) No 396/2005. 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 substances potassium and disodium phosphonates. As fosetyl, potassium phosphonates and disodium phosphonates degrade to phosphonic acid, it was considered appropriate to jointly review the residues of these three active substances. To assess the occurrence of fosetyl, potassium phosphonates and disodium phosphonate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data) and the monitoring data from official control. 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 compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission a mandate to provide its reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate‐methyl. Specifically, EFSA was asked to assess whether thiophanate‐methyl or carbendazim have clastogenic potential and, in case clastogenic potential can be excluded, to derive toxicological reference values necessary for consumer risk assessment and assessment of maximum residue levels (MRLs). Although these active substances are no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), and import tolerances are in place. Based on the assessment of the available data, toxicological reference values and MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, all 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 applicant FMC International Switzerland Sarl (FISSarl) submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance cyantraniliprole in table olives and olives for oil production. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the intended uses of cyantraniliprole in olives. Adequate analytical methods for enforcement are available to control the residues of cyantraniliprole in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the uses of cyantraniliprole according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract 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, Austria, for the pesticide active substance pelargonic acid (nonanoic acid) 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 pelargonic acid as a herbicide on vineyards, potatoes, paths and places with woody plants, ornamental shrubs, ornamentals lawn, home gardens and allotments, paths and open areas with tree growth, woody ornamentals, decorative lawns, turf (field use). The reliable end points appropriate for use in regulatory risk assessment are presented. Assessments not finalised and missing information identified as being required by the regulatory framework are listed.

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 isopyrazam. To assess the occurrence of isopyrazam 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 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 one MRL proposal derived by EFSA still requires further consideration by risk managers.

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 levels (MRLs) for the active substance acrinathrin in peaches and sweet peppers. The data submitted in support of the request were found sufficient to derive MRL proposals for both crops. Adequate analytical methods for enforcement are available to control the residues of acrinathrin and its enantiomer in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.02 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐ and long‐term intake of residues resulting from the use of acrinathrin according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract 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 France to modify the existing maximum residue levels (MRLs) for the active substance benzovindiflupyr in leeks and spring onions, green onions and Welsh onions. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under assessment. Adequate analytical methods for enforcement are available to control the residues of benzovindiflupyr on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of benzovindiflupyr 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 applicants Lainco S.A., Exclusivas Sarabia S.A., Biovert S.L., Sipcam Inagra S.A. and Tilco‐Alginure GmbH submitted respectively two requests to the competent national authorities in Greece and Germany, to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in certain citrus fruits and in herbal infusions from leaves and herbs. The data submitted in support of both requests were found to be sufficient to derive MRL proposals for lemons, limes, mandarins, strawberries leaves and the remaining plants included in the group of herbal infusions from leaves and herbs. Adequate analytical methods for enforcement are available to control potassium phosphonates residues in the commodities under consideration. Based on the risk assessment results using the currently set acceptable daily intake (ADI) of 2.25 mg/kg body weight (bw) per day for phosphonic acid, EFSA concluded that the long‐term intake of residues resulting from the uses of potassium phosphonates according to the reported good agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative; a more realistic intake assessment will be performed in the framework of the joint review of MRLs for fosetyl and potassium phosphonates.

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 Italy and co‐rapporteur Member State France for the pesticide active substances that are Straight Chain Lepidopteran Pheromones (SCLPs) and the considerations as regards the inclusion of the substances 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 representative uses of some SCLPs as semiochemicals used to protect grapes, pome fruits, walnuts, rice and any other crop (where Chilo suppressalis may be a pest) (all 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. Concerns are identified.

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 Denmark to modify the existing maximum residue levels (MRL) for the active substance tau‐fluvalinate in tomatoes and watermelons. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for tomatoes. For watermelons, a change of the MRL recently set in the EU legislation is not required. Adequate analytical methods for enforcement are available to control the residues of tau‐fluvalinate in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the intended uses of tau‐fluvalinate according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative.

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

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta España S.A. submitted a request to the competent national authority in Spain to modify the existing maximum residue levels (MRLs) in citrus fruits, bananas and witloofs. Additionally, Syngenta Crop Protection AG submitted two applications to Spain to set import tolerances in mangoes and in sweet potatoes. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for the commodities under evaluation and for commodities of animal origin. Adequate analytical methods for enforcement are available to control the residues of thiabendazole in the commodities under consideration and in animal matrices 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 thiabendazole 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 Adama Agriculture B.V on behalf of Adama Makhteshim Ltd submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance folpet in barley, oat, rye and wheat. The data submitted in support of the request were found to be sufficient to derive MRL proposals for these commodities. Adequate analytical methods for enforcement are available to control the residues of folpet and phthalimide in dry commodities at the validated limit of quantification (LOQ) of 0.01 mg/kg per analyte. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of folpet 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, FPS Public Health, Food Chain Safety and Environment on behalf of Belgium (evaluating Member State, EMS) submitted an application to modify the existing maximum residue levels (MRLs) for the active substance flupyradifurone and its metabolite difluoroacetic acid (DFA) in okra/lady's finger. The data submitted in support of the request were found sufficient to derive MRL proposals for the crop under consideration. The potential contribution of DFA residues in okra/lady's finger from the soil uptake was also estimated. Adequate analytical methods for enforcement are available to control the relevant residues in the crop under consideration. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues of flupyradifurone and of its soil metabolite DFA resulting from the use of flupyradifurone is unlikely to present a risk to consumer health. Due to the lack of proper consumption data of okra/lady's finger, the acute exposure assessment could not be reliably undertaken but due to this crop being a minor commodity it is unlikely that acute consumer intake concerns will be associated with this crop.

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, France, for the pesticide active substance Bacillus amyloliquefaciens strain IT‐45 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 use of Bacillus amyloliquefaciens strain IT‐45 as a fungicide on citrus (field use, application to soil via drip irrigation systems). 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 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, Greece, for the pesticide active substance potassium hydrogen carbonate 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 potassium hydrogen carbonate as a fungicide on strawberry, wine and table grapes, pome fruits, stone fruits, ornamentals and cucurbits. 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 not 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 1,4‐dimethylnaphthalene. To assess the occurrence of 1,4‐dimethylnaphthalene 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 and the UK (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 all 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 valifenalate. To assess the occurrence of valifenalate 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 European authorisations reported by Member States and the UK (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 one MRL proposal 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 8‐hydroxyquinoline. To assess the occurrence of 8‐hydroxyquinoline 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. 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 all MRL proposals derived by EFSA still require further consideration by risk managers.

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, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain PB 54 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 Bacillus thuringiensis subsp. kurstaki strain PB 54 as an insecticide on stone fruit and ornamentals (field uses) and tomato (field, permanent greenhouse and walk‐in tunnel 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. 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 authorities of the rapporteur Member State, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain EG2348 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 Bacillus thuringiensis kurstaki strain EG2348 as an insecticide on pome fruits (field use), solanaceous fruiting vegetables (uses in permanent greenhouse and walk‐in tunnel) and ornamentals (field, permanent greenhouse and walk‐in tunnel 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. Concerns are identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant UPL Europe Ltd. submitted an application to the competent national authority in Germany (evaluating Member State, EMS) to raise the existing maximum residue level (MRL) to 0.15 mg/kg for the active substance phenmedipham in celeriac. The submitted residue trials are sufficient to derive a tentative MRL of 0.15 mg/kg, pending further investigation of nature of phenmedipham residues in root crops. For this assessment EFSA considered that the available sugar beet metabolism data can be extrapolated to celeriac on a tentative basis. The acceptability of such proposal shall be further considered by risk managers. Adequate analytical methods for enforcement are available to control the residues of phenmedipham in celeriac at the validated limit of quantification (LOQ) of 0.01 mg/kg. Since the current MRL application was submitted before the finalisation of the EU pesticides peer review of the renewal of the approval of phenmedipham, the consumer exposure assessment was performed according to the conclusions on the toxicity of phenmedipham from the first approval under Directive 91/414/EEC. Accordingly, the long‐term intake of residues of phenmedipham resulting from the existing and the intended uses does not indicate a risk to consumer health. The present assessment does not consider the data gaps identified in the context of the renewal of the approval of phenmedipham under Regulation (EC) No 1107/2009 which prevented experts to derive toxicological reference values (TRVs) for phenmedipham, to derive the risk assessment residue definition for root crops other than sugar beet and to conclude on the toxicity of relevant metabolites.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Exponent International Ltd. (on behalf of the U.S. Highbush Blueberry Council (USHBC)) submitted a request to the competent national authority in France to set an import tolerance for the active substance potassium phosphonates in blueberries. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for blueberries. Adequate analytical methods for enforcement are available to control the residues of phosphonic acid on the commodity under consideration at the validated limit of quantification (LOQ) of 0.1 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 potassium phosphonates according to the reported agricultural practice is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative and a refined intake assessment will be performed in the framework of the joint review of MRLs for fosetyl and phosphonates.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer S.A.S. ‐ Crop Science division submitted a request to the competent national authority in Austria to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in leeks, spring onions and in honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all these crops and honey. Adequate analytical methods for enforcement are available to control the residues of spirotetramat and its metabolites in plant matrices on the commodities under consideration and in honey at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of spirotetramat according to the reported agricultural 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 levels (MRL) for the active substance fludioxonil in blueberries, gooseberries, currants and cranberries. The data submitted in support of the intended northern Europe (NEU) outdoor and EU indoor use were found sufficient to derive MRL proposals of 4 mg/kg for cranberries, gooseberries, 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 use of fludioxonil 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 Germany to modify the existing maximum residue levels (MRL) for the active substance cyprodinil in blueberries, cranberries, currants and gooseberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for blueberries, cranberries, currants and gooseberries. Adequate analytical methods for enforcement are available to control the residues of cyprodinil on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the uses of cyprodinil on blueberries, cranberries, currants and gooseberries according to the reported agricultural practices will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to present a risk to consumer health.

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

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants BASF Agro B.V. (represented by OAT Agrio Co. Ltd.) and Certis Europe B.V. submitted separate requests to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance cyflumetofen in various crops. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for citrus fruits, apricots, peaches, tomatoes, aubergines, cucumbers and hops. Adequate analytical methods for enforcement are available to control the residues of cyflumetofen on the fruit commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and on hops at the LOQ of 0.1 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of cyflumetofen according to the reported agricultural practices is unlikely to present a risk to consumer health.