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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.

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.

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 set import tolerances for the active substance fludioxonil in sugar beet roots and bananas. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for sugar beet roots and bananas. Adequate analytical methods for enforcement are available to control the residues of fludioxonil in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices at the validated LOQ of 0.01 mg/kg in milk and muscle and 0.05 mg/kg in liver, kidney, fat tissues and eggs. 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 practices is unlikely to present a risk to consumer health.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeScience (ALS) Benelux SPRL submitted a request to the competent national authority in Spain to modify the existing maximum residue level (MRL) for the active substance dodine in citrus fruits. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the group of citrus fruits. Adequate analytical methods for enforcement are available to control the residues of dodine in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. In animal matrices, no enforcement method is available for fat, muscle and milk whereby in liver and kidney dodine can be enforced at the LOQ of 0.01 mg/kg however an interlaboratory validation (ILV) is still required. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of dodine according to the reported agricultural practices is unlikely to present a risk to consumer health.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 cyproconazole. Considering that no application was received to support the renewal of the approval of cyproconazole and considering the expiry date for its approval on 31 May 2021, and that the import tolerances identified were not supported by sufficient data, and are not forming the basis of any existing EU MRLs, but correspond to existing MRLs established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), the current assessment is limited to CXLs. To assess the occurrence of cyproconazole 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 MRLs established by the Codex Alimentarius Commission. Based on the assessment of the available data, EFSA assessed the CXLs 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.

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 sugar beet roots. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for sugar beet roots. However, robust processing factors for Annex VI in view of monitoring of residues in processed commodities could not be derived. Adequate analytical methods for enforcement are available to control the residues of azoxystrobin in plant and 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 azoxystrobin according to the reported agricultural practice is unlikely to present a risk to consumer health.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landwirtschaftliches Technologiezentrum Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance phenmedipham in strawberries. Noting that at least one additional trial is missing, an MRL of 0.7 mg/kg was derived for the intended NEU use of phenmedipham on strawberries. Adequate analytical methods for enforcement are available to control the residues of phenmedipham in strawberries 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 is unlikely to present a risk to consumer health. EFSA notes that the present assessment does not take into account 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 fruit crops and to conclude on the toxicity of relevant metabolites.

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.

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.

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.

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.

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.

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 pinoxaden. To assess the occurrence of pinoxaden 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 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.

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 sulfuryl fluoride. To assess the occurrence of sulfuryl fluoride and fluoride ion residues in plants, processed commodities and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRLs were calculated, but a consumer risk assessment could be carried out for sulfuryl fluoride only. Although no apparent risk to consumers was identified for sulfuryl fluoride, a standard consumer risk assessment to fluoride ion could not be performed, lacking information on the toxicological reference values for fluoride. Hence, an ‘overall’ consumer risk assessment could not be performed, only tentative MRLs proposal could be derived and measures for reduction of the consumer exposure should also be considered. Nevertheless, considering that fluoride ion is naturally occurring in food of plant and animal origin, EFSA performed an indicative calculation of the consumer exposure to estimate whether the uses currently authorised will contribute significantly to the overall consumer exposure to fluoride.

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for propiconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. Following the decision on the non‐renewal of the approval of propiconazole and the decision to lower the maximum residue levels (MRLs) for propiconazole to the limit of quantification (LOQ) for all commodities, the data gaps identified in the MRL review are no longer relevant. EFSA summarised some new studies on the toxicological profile of propiconazole metabolites CGA91305, SYN547889 and NOA436613, which were assessed by the rapporteur Member State. Overall, the available information is not sufficient to characterise the toxicological profile of metabolites convertible to 2,4‐dichlorobenzoic acid as data gaps still exist for SYN547889, NOA436613, CGA118244, CGA118245, CGA91304 and CGA91305.

In compliance with Article 43 of Regulation (EC) No 396/2005, the EFSA received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for spinosad which might lead to consumers intake concerns on the basis of a new toxicological reference value established during the peer review and of the data currently available to EFSA. In order to identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for spinosad considering the new toxicological reference values and an acute risk could not be excluded for six commodities. Fall‐back MRLs for all six commodities were proposed on the basis of the data received under the present assessment.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva submitted a request to the competent national authority in Finland to modify the existing maximum residue levels (MRLs) for the active substance clopyralid in various commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for wheat, oat and for animal commodities. An adequate analytical method for enforcement is available to control the residues of clopyralid in the plant commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. The analytical methods for animal commodities are validated at LOQ of 0.01 mg/kg, but demonstration of extraction efficiency is lacking. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of clopyralid according to the reported agricultural practices is unlikely to present a risk to consumer health provided that risk mitigation measures are in place to avoid clopyralid residues in rotational and/or succeeding crops.

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.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to the group of leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for leafy brassica. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated LOQ of 0.01 mg/kg and for difenoconazole and metabolite CGA205375 in animal matrices at the validated LOQ of 0.01 mg/kg for meat muscle, fat, liver, kidney and eggs and at the validated LOQ of 0.005 mg/kg for milk. Based on the risk assessment results, EFSA concluded that for the crops assessed in this application the short‐term intake of residues resulting from the use of difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. Long‐term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. Overall, this risk assessment is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and has to be re‐considered when the missing data become available. Additionally, this assessment does not take into consideration triazole derivative metabolites (TDMs) which may be generated by several pesticides belonging to the group of triazole fungicides as this application was submitted before September 2019 which is the date of application of the new strategy endorsed by the risk managers for the assessment of TDMs.

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

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 Italy to modify the existing maximum residue levels (MRLs) for the active substance tebufenozide in apricots and peaches. The data submitted in support of the request were found to be sufficient to derive MRL proposals for apricots and peaches. Adequate analytical methods for enforcement are available to control the residues of tebufenozide 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 tebufenozide according to the reported agricultural practice is unlikely to present a risk to consumer health.

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

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 levels (MRLs) for bentazone in beans and peas with and without pods. The data submitted in support of the request were found to be sufficient to derive MRL proposals for peas with pods. Results from the residue trials indicated that there is no need to modify the existing MRLs for beans with pods, beans without pods and peas without pods. Adequate analytical methods for enforcement are available to control the residues of bentazone and its metabolites in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. EFSA concluded that the proposed use of bentazone on peas with pods will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health for parent bentazone. The risk assessment however is indicative and affected by additional, non‐standard uncertainties resulting from the insufficient information related to the toxicological properties for 6‐hydroxy‐bentazone in the wheat metabolism study.