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The applicant Corteva Agriscience submitted a request to the competent national authority in Austria to evaluate the confirmatory data that were identified for myclobutanil in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gap related to the lack of information on the triazole derivative metabolites (TDMs), new residue trials analysing for TDMs were submitted on apples, grapes, strawberries, tomatoes and melons. Following the assessment of the submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for pome fruits, grapes, cucurbits with inedible peel, strawberries and tomatoes. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No information was provided to address the Article 12 confirmatory data referred to in Regulation (EU) 2020/770 for blackberries, gooseberries, bananas, aubergines/eggplants, lamb's lettuces/corn salads, beans (with pods), globe artichokes, hops, sugar beet roots and products of animal origin. For these commodities, the existing EU MRL could be lowered to the enforcement limit of quantification (LOQ). For kaki/Japanese persimmon and azararoles/mediterranean medlars, the existing EU MRL is set on the basis of Codex MRL in pome fruits. The applicant did not request maintaining a Codex MRL in these commodities, but should risk managers decide otherwise, the Article 12 data gap is considered addressed for kaki/Japanese persimmon while for azaroles/Mediterranean medlars, a risk management decision might be required. No consumer intake concerns were identified. [ABSTRACT FROM AUTHOR]

The applicant Arysta Life Science Great Britain Limited submitted a request to the competent national authority in Croatia to evaluate the confirmatory data that were identified for quizalofop‐P‐tefuryl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Since Article 12 data gaps were also set for the two other quizalofop‐P variants sharing the same residue definitions for risk assessment and monitoring, EFSA included in the present assessment all quizalofop‐P variants: quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop. Moreover, in the application submitted to Croatia, the applicant also included a request to modify the existing MRLs for quizalofop‐P‐tefuryl in grapes, sunflower seeds and soyabeans in accordance with Article 6 of Regulation (EC) No 396/2005. To address the data gaps, new data on hydrolysis efficiency of quizalofop‐P‐tefuryl, quizalofop acid, quizalofop‐pentanoic acid and quizalofop‐P‐glycerate in different matrices of animal origin in accordance with the guidance document SANTE/2020/12830 Rev.1 were submitted, along with a validated analytical method for animal commodities. EFSA concluded that the data gap on validation of the efficiency of the extraction and hydrolysis included in the enforcement method of residues in livestock animal commodities was only fully addressed for muscle, poultry liver and eggs. Regarding plant commodities, the remaining data gaps were not addressed. EFSA also considered data gaps for quizalofop‐p‐ethyl in caraway as sufficiently addressed in the context of a previous MRL application. In general, the new information provided required a revision of the existing MRLs for several commodities of plant and animal origin. Further risk management considerations are required. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of quizalofop‐P‐tefuryl according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicant Detia Freyberg GmbH submitted to the competent national authority in Germany two requests to evaluate the confirmatory data that were identified for tree nuts, oilseeds, cereals and commodities of animal origin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available and two requests in accordance with Article 6 of Regulation (EC) No 396/2005 to increase the existing MRL for the active substance aluminium phosphide in peanuts, barley, oat, rye, rice and wheat, roots of herbal infusions, cocoa beans and seed spices and for the active substance magnesium phosphide in oilseeds (except peanuts) and pistachios. The four applications were combined by EFSA under the current assessment. To address the data gaps, validation data for the method of analysis for enforcement of phosphide in high‐oil content commodities and new residue trials were submitted. The data gaps on additional residue trials supporting authorisations on oilseeds and cereal grains, on clarifications regarding the discrepancies observed in the residue trial results for pistachios, and on data confirming the negligible occurrence of phosphane and its oxidation products in livestock products were considered addressed. The data gap on independent laboratory validation (ILV) and a confirmatory method for monitoring of phosphide in high‐oil content commodities was considered not fully addressed. The information provided justified a lowering of the current tentative MRLs for the whole group of cereals (except rice and 'others'), an increase of the current tentative MRLs for pistachios, the whole group of oilseeds, rice and 'other' cereals, herbal infusions from roots, cocoa beans and seed spices, and a revision of the risk assessment performed for phosphane and its phosphide salts. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of AlP and Mg3P2 according to the reported agricultural practices is unlikely to present a risk to consumer health. Further risk management considerations are required. [ABSTRACT FROM AUTHOR]

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for S‐metolachlor in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new freezer storage stability study for S‐metolachlor in commodities with high acid content was submitted. However, the data gap on storage stability was considered only partially addressed for strawberries because, in the absence of information on the storage time interval of the samples of the residue trials performed on strawberries, no conclusion on the validity of these trials could be drawn. The data gap on the lack of trials to support the good agricultural practice (GAP) on pineapples was not addressed. Consequently, the existing tentative MRLs for strawberries and pineapple cannot be confirmed and EFSA recommends lowering these MRLs to the enforcement limit of quantification (LOQ). Since a new lower LOQ for enforcement in high acid content commodities of 0.01 mg/kg has been validated, it is proposed to change the existing MRL value from 0.05* to 0.01* mg/kg for these two commodities. [ABSTRACT FROM AUTHOR]

The applicant Corteva Agrosciences submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for fenbuconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the Article 12 confirmatory data gaps, new residue trials analysing triazole derivative metabolites (TDMs) were submitted on grapefruits, lemons, apples, pears, peaches, cherries and blueberries. Following the assessment of submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for grapefruits, oranges, lemons, limes, pome fruits, peaches, cherries and blueberries. The calculated livestock dietary burdens indicated that for the individual TDMs, the trigger value of 0.004 mg/kg bw day is not exceed from the intake of apple pomace and citrus dried pulp. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No data were submitted to address the Article 12 confirmatory data gaps for tree nuts, apricots, plums, table grapes, wine grapes, cranberries, bananas, sweet peppers/bell peppers, cucurbits with edible/inedible peel, peanuts/groundnuts, sunflower seeds and rapeseeds/canola seeds, barley, rye and wheat. For these commodities, the existing EU MRL could be lowered to the enforcement LOQ. [ABSTRACT FROM AUTHOR]

The applicant UPL Europe Ltd submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for napropamide in the framework of the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new storage stability study on grapes (high acid content commodity) was submitted while a metabolism study in fruit crops following foliar treatment, residue trials on fresh herbs and edible flowers and an analytical method for matrices difficult to analyse were not submitted. Therefore, only the data gap for storage stability was satisfactorily addressed. The new information provided required a revision of the tentative MRLs for commodities where confirmatory data were indicated. An update of the consumer risk assessment for napropamide was performed considering the new data submitted and it did not indicate any consumer intake concerns in relation to the chronic exposure. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Belgium, for the pesticide active substance flutianil, are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information with regard to the endocrine disruption potential of the substance. The conclusions were reached on the basis of the evaluation of the representative uses of flutianil as a fungicide on grapevine and ornamental crops. Assessments not finalised, together with the missing information identified as being required by the regulatory framework, are listed. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Sweden, for the pesticide active substance propyzamide are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information in the areas of mammalian toxicology and residues. The conclusions were reached on the basis of the evaluation of the representative uses of propyzamide as an herbicide on lettuce and winter oilseed rape. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and/or 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 assessment carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance spiroxamine are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of spiroxamine as a fungicide on grapes, wheat, triticale, rye, barley and oats. 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. [ABSTRACT FROM AUTHOR]