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The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance Purpureocillium lilacinum strain PL11 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 Purpureocillium lilacinum strain PL11 as nematicide on tomato, pepper, aubergine, cucumber, courgette, melon, watermelon, pumpkin (field and greenhouse applications). The reliable endpoints appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. [ABSTRACT FROM AUTHOR]

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

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

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 FROM AUTHOR]

The conclusions of 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 Hungary for the pesticide active substance calcium carbonate 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 calcium carbonate as a repellent on deciduous and coniferous trees in forestry. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. No concerns were identified. [ABSTRACT FROM AUTHOR]

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

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant 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 FROM AUTHOR]

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 FROM AUTHOR]

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, Greece, for the pesticide active substance phosmet 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 uses of phosmet as an insecticide on citrus fruits, pome fruits, peaches/nectarines and potatoes (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 FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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

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. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Austria to set an import tolerance for the active substance 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nisso Chemical Europe GmbH submitted a request to the competent national authority in 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. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in 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. [ABSTRACT FROM AUTHOR]

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Germany, and co-rapporteur Member State, Denmark, for the pesticide active substance Bacillus amyloliquefaciens strain QST 713, formerly Bacillus subtilis strain QST 713, 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 amyloliquefaciens strain QST 713 as a fungicide on strawberry (field and greenhouse uses) and grapes (field use). 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 FROM AUTHOR]

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

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Sweden and co‐rapporteur Member State Spain for the pesticide active substance Bacillus thuringiensis ssp. israelensis (serotype H‐14) strain AM65‐52 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 Bacillus thuringiensis ssp. israelensis (serotype H‐14) strain AM65‐52 as an insecticide on ornamental plants (permanent greenhouse production). 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 FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Greece for the pesticide active substance mancozeb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of mancozeb as a fungicide on wheat (winter/spring), grapevine, potatoes and tomatoes. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Asahi Chemical Europe s.r.o. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substances sodium 5-nitroguaiacolate (Na 5-NG), sodium o-nitrophenolate (Na o-NP) and sodium p-nitrophenolate (Na p-NP) in table olives and olives for oil production in support of the intended SEU use. The data submitted in support of this MRL application were sufficient to derive an MRL of 0.12 mg/kg (at the combined limit of quantification (LOQ) of the three sodium nitrocompounds as validated in the framework of the residue trials). This higher MRL does not reflect residues in olives from the intended use but refers to occurrence of p-nitrophenolate (p-NP) from unidentified source. As p-NP was present in all untreated olive samples regardless of the country of origin and the year of the treatment, in some cases at levels above the enforcement LOQ of 0.01 mg/kg, the applicant analysed residue trial samples using a method with a higher validated LOQ of 0.1 mg/kg for Na p-NP. The competent authorities shall be aware that residues of p-NP at levels < 0.1 mg/kg in olives are not related to the use of sodium nitrocompounds on the crop but to other sources of unknown origin. The current analytical methods for enforcement control residues of sodium nitrocompounds in high oil content matrices at the validated LOQ of 0.01 mg/kg per substance (combined LOQ of 0.03 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 sodium nitrocompounds according to the reported agricultural practice and occurrence of p-NP from unidentified source is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant FMC Agro Limited submitted a request to the competent national authority in the UK to set import tolerances for the active substance chlorantraniliprole in strawberries and the whole category pulses (beans, lentils, peas and lupins/lupini beans). The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal for the whole category pulses. The available data are not sufficient to derive an import tolerance for strawberries and no modification of the current EU MRL is required. Adequate analytical methods for enforcement are available to control the residues of chlorantraniliprole 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 long-term intake of residues resulting from the use of chlorantraniliprole according to the reported agricultural practice is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS - Crop Science Division submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRL) for the active substance flupyradifurone and its metabolite DFA in rapeseeds/canola seeds and mustard seeds. The data submitted in support of the request were found sufficient to derive MRL proposals for both compounds in rapeseeds and mustard seeds. Adequate analytical methods for enforcement are available to control the relevant residues in plant matrices under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues of flupyradifurone and of its metabolite DFA resulting from the use of flupyradifurone is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State The Netherlands and co-rapporteur Member State Germany for the pesticide active substance Bacillus thuringiensis ssp. aizawai strain GC-91 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 ssp. aizawai strain GC-91 as an insecticide on pome fruits (apple, pear), grapes and sports turf (field uses) and tomato (greenhouse 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 FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance Beauveria bassiana strain 203 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 Beauveria bassiana strain 203 as an insecticide on Phoenix canariensis (field use, indoor and greenhouse applications) and Phoenix dactylifera (field use) in southern Europe. 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 FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State The Netherlands and co‐rapporteur Member State Germany for the pesticide active substance Bacillus thuringiensis ssp. aizawai strain ABTS‐1857 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 ssp. aizawai strain ABTS‐1857 as an insecticide on fruiting vegetables (pepper, field and greenhouse 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 FROM AUTHOR]

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

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance penthiopyrad in Florence fennels and celeries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for Florence fennels and celeries. Adequate analytical methods for enforcement are available to control the residues of penthiopyrad 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 penthiopyrad residues and of its metabolite PAM, resulting from the use of penthiopyrad according to the reported agricultural practice is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment, are presented. [ABSTRACT FROM AUTHOR]

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the Czech Republic, for the pesticide active substance flumioxazin are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of flumioxazin as a herbicide on winter wheat and sunflower (pre‐ and post‐emergence). The conclusions were updated with regard to the endocrine‐disrupting properties. The reliable end points concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance tri‐allate are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data. The conclusions were reached on the basis of the evaluation of the representative uses of tri‐allate as a herbicide on cereals (barley and wheat). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified. [ABSTRACT FROM AUTHOR]

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, Hungary, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Purpureocillium lilacinum strain 251, formerly called Paecilomyces lilacinus strain 251, 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 Purpureocillium lilacinum strain 251 as a biological nematicide on tomato and cucumber (uses in the field and permanent greenhouses). 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 FROM AUTHOR]

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

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance boscalid in granate apples/pomegranates. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for pomegranates. Adequate analytical methods for enforcement are available to control the residues of boscalid in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of boscalid according to the reported agricultural practice is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

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, France, and co‐rapporteur Member State, Latvia, for the pesticide active substance cyazofamid 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 cyazofamid as a fungicide on potato, tomato and cucurbits and were updated for non‐target organisms. 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 FROM AUTHOR]

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

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

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

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Cheminova A/S submitted a request to the competent national authority in Spain to modify the existing maximum residue level (MRL) for the active substance acrinathrin in lettuce. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for lettuce. Adequate analytical methods for enforcement are available to control the residues of acrinathrin on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of acrinathrin according to the reported agricultural practice and the current approval restrictions of acrinathrin is unlikely to present a risk to consumer health. However, uncertainties remain, particularly on the toxicological profile of the different isomers. Hence, the consumer risk assessment is considered tentative. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance fludioxonil in elderberries in support of the intended NEU use. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 4 mg/kg for elderberries, as an extrapolation from red and black currants and blueberries. Adequate analytical methods for enforcement are available to control the residues of fludioxonil in the plant matrix under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the intended use of fludioxonil according to the reported agricultural practice and from the existing authorised uses is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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

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

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LLG Sachsen‐Anhalt, Dez. Pflanzenschutz submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for copper compounds in herbs and edible flowers. The data submitted in support of the request were found sufficient to derive an MRL proposal of 150 mg/kg, confirming the MRL proposal of the MRL review, for copper compounds in herbs and edible flowers in support of the intended indoor use. Based on the risk assessment results, EFSA concluded that the long‐term intake of copper residues resulting from the intended and existing uses, natural background levels and monitoring levels might present a risk to consumer health. Although residues in herbs and edible flowers are minor contributors to the overall consumer exposure, a risk management decision has to be taken whether it is appropriate to increase the existing MRLs for these crops, given that a potential consumer intake concern could not be excluded. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance Bacillus amyloliquefaciens strain AH2 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of Bacillus amyloliquefaciens AH2 as a fungicide on grapes. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Greece, and co‐rapporteur Member State, Germany, for the pesticide active substance clodinafop‐propargyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of clodinafop‐propargyl as a herbicide on wheat, rye and triticale. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. The European Commission mandated EFSA to reconsider the acceptable operator exposure level (AOEL) setting and to update the non‐dietary exposure assessment if needed. [ABSTRACT FROM AUTHOR]

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

The applicant Bayer Crop Science submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for aclonifen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, an analytical method for enforcement in complex/no group matrices (spices) and additional four residue trials supporting SEU authorisation on peppers were submitted. The data gaps were considered satisfactorily addressed and the tentative MRLs can be confirmed in peppers, in seed and fruit spices and in flowers and leaves and herbs of herbal infusions. The previous consumer intake assessment remains valid. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted two individual requests to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in kohlrabies and in the crop group of herbs and edible flowers, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for kohlrabies and for the group of herbs and edible flowers. Adequate analytical methods for enforcement are available to control the residues of mandipropamid in the crops under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the indicative risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of mandipropamid according to the intended agricultural practices is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

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 Poland for the pesticide active substance ferric pyrophosphate 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 ferric pyrophosphate as a molluscicide on all edible and inedible crops. 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 FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants BASF SE, Landwirtschaftliches Technologiezentrum Augustenberg and Tilco Biochemie GmbH submitted a request to the competent national authorities in Greece and Germany to modify the existing maximum residue levels (MRLs) for fosetyl/phosphonic acid in various crops related to the use of potassium phosphonates. The data submitted in support of the request were found to be sufficient to derive MRL proposals for several tree nuts, pomegranates, fresh herbs and edible flowers, currants, gooseberries and blueberries. Adequate analytical methods for enforcement are available to control the residues of phosphonic acid in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.1 mg/kg in high acid content matrices and at 0.01 mg/kg in high water and high oil content matrices. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the use of potassium phosphonates is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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