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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]

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. [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 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]

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to prepare a reasoned opinion on the toxicological properties and the existing maximum residue levels (MRLs) set for propoxur. EFSA was requested to assess the toxicological properties of propoxur and derive toxicological reference values, based on the toxicological assessment performed by Health Canada. EFSA was also requested to review the information provided by Member States and the UK on the metabolism of propoxur in plants and animals and on the current MRLs, as well as the limit of quantification (LOQ) that can be achieved with analytical methods used in MRL enforcement. Based on the information available to EFSA, toxicological reference values could not be derived for propoxur. No evidence was provided by Member States and UK that the existing EU MRLs need to be maintained as import tolerances. Information to support the current MRLs or alternative MRLs have not been provided by Member States and the UK. Codex MRLs are not in place. EFSA therefore recommended lowering of all existing EU MRLs for propoxur to the LOQ. According to the EU Reference Laboratories, sufficiently validated analytical methods are available to analyse for propoxur residues in all plant and animal commodities. Lacking toxicological reference values derived at EU level, a conclusion cannot be derived whether the setting of MRLs at the LOQs is sufficiently protective for the European consumers. [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 applicant FMC Agricultural Solutions A/S submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new storage stability study was submitted and information on an analytical method for determination of bifenthrin in eggs was made available. The data gaps were sufficiently addressed. The new information provided, did not require a revision of the existing MRLs. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to set import tolerances for bifenthrin in sweet corn and maize grain. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for maize grain only. For sweet corn, data gaps were identified which precluded the derivation of an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of bifenthrin (sum of isomers) in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices. EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of bifenthrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment is affected by additional non‐standard uncertainty related to the expiry of EU authorisation for a number of crops for which previously EU MRLs were established, and which are still included in the risk assessment. [ABSTRACT FROM AUTHOR]

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 methoxyfenozide which might lead to consumers intake concerns on the basis of the new toxicological reference values agreed upon by Member States (MSs) on 13 December 2018. In order to identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for methoxyfenozide, considering the new toxicological reference values and an acute risk could not be excluded for eight commodities. A fall‐back MRL was proposed for tomatoes and the MRL for citrus fruit could be confirmed considering the use of a peeling factor. No other fall‐back good agricultural practices (GAPs) were received, and thus, a lowering of the MRLs for peaches, apples, pears and broccoli is proposed. [ABSTRACT FROM AUTHOR]

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 quinoxyfen. 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 an import tolerance was reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerance requested, and a consumer risk assessment was carried out considering the toxicological reference value established for the first inclusion under Directive 91/414/EEC. All CXLs and import tolerance were found to be adequately supported by data and no risk to consumers was 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 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 applicant Cheminova A/S submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data for the active substance flutriafol that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005. The applicant provided residue trials on rice representative for an adjusted Good Agricultural Practice (GAP), metabolism studies in goats and storage stability data in tissues of animal origin addressing the data gaps identified in the MRL review. For the nature of residues in processed commodities, relevant to confirm the MRLs on pome fruits and wine grapes, the applicant referred to the information provided in a previous MRL application and already assessed by EFSA. The data gaps on the authorised uses on beetroots, melons and watermelons assessed in the MRL review were not addressed. At the same time, the applicant submitted a request to the United Kingdom to modify the existing maximum residue level (MRL) for flutriafol in cucurbits with inedible peel according to Article 6 of Regulation (EC) No 396/2005. The data submitted were found to be sufficient to derive an MRL proposal for these crops. EFSA concluded that the proposed use of flutriafol on the crops under assessment will not result in a consumer exposure exceeding the toxicological reference values for flutriafol and therefore is unlikely to pose a risk to consumers' health. Regarding the triazole derivative metabolites (TDMs), the conclusions reached in a previously issued assessment for another triazole fungicide are still valid. An update of the indicative consumer risk assessment for each individual metabolite is not necessary since the residues expected in the concerned commodities are covered. [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 Sweden and co-rapporteur Member State Hungary for the pesticide active substance Pythium oligandrum strain M1 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 Pythium oligandrum strain M1 as a fungicide on oil seed rape, wheat and spring barley (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]

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 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]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt für Landwirtschaftund Gartenbau (LLG) submitted two applications to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance fluroxypyr in chives, celery leaves, parsley, thyme and basil and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under consideration, except for thyme for which a tentative MRL proposal was derived for further risk management considerations. Adequate analytical methods for enforcement are available to control the residues of fluroxypyr 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 use of fluroxypyr according to the reported agricultural practices 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 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]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands, and co‐rapporteur Member State, France, for the pesticide active substance Metarhizium brunneumBIPESCO 5/F52 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 Metarhizium brunneumBIPESCO 5/F52 as an insecticide and acaricide on meadows, grassland, amenity turf, maize, wine and table grape, potato, allium vegetables (only field uses) and ornamentals (floriculture, tree nurseries and perennials), strawberry, currants and berries, solanaceae fruiting vegetables (field and greenhouse uses) and cucurbit fruiting vegetables (only 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 Bayer SAS – Crop Science Division submitted a request to the competent national authority in Spain to modify the existing maximum residue level (MRL) for the active substance deltamethrin in carobs/Saint John's breads. The data submitted in support of the request were found to suffice to derive an MRL proposal for carobs. An adequate analytical method for enforcement is available to control the residues of deltamethrin in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results using the PRIMo rev. 3.1 model, EFSA concluded that the short‐term consumer exposure for the intended post‐harvest use on carobs did not exceed the toxicological reference value. The long‐term intake of residues of deltamethrin indicated a consumer risk. Although residues in carobs are minor contributors to the overall chronic consumer exposure, a risk management consideration is required to decide whether the MRL proposal for carobs is acceptable. The risk assessment shall be regarded as indicative and affected by non‐standard uncertainties. [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]

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 oxyfluorfen. To assess the occurrence of oxyfluorfen 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 one existing European MRL still requires further consideration by risk managers. [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 SA‐12 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis subsp. kurstaki strain SA‐12 as an insecticide on pome fruits (field use), protected tomato (including permanent greenhouses and walk‐in tunnels) and ornamentals (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]

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 pyroxsulam. To assess the occurrence of pyroxsulam 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. Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified. [ABSTRACT 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]

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]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Tilco‐Alginure GmbH, ADAMA Agriculture BV, Lainco S.A., Exclusivas Sarabia S.A., Biovert S.L. and Landwirtschaftskammer Steiermark submitted requests to the competent national authorities in Germany, France, Greece and Austria to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in various crops. The data submitted in support of the different requests were found to be sufficient to derive MRL proposals for all crops under assessment. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates in the crops under assessment. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of potassium phosphonates according to the reported agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative and a more realistic intake assessment will be performed in the framework of the joint review of MRLs for fosetyl and phosphonates. The reliable end points, appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

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 Streptomyces lydicus strain WYEC 108. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for Streptomyces lydicus strain WYEC 108 within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active substance. Therefore, residues of Streptomyces lydicus strain WYEC 108 are not expected to occur in any plant or animal commodity and therefore a consumer risk assessment is not required. Nevertheless, the available information allowed EFSA to propose a marker residue definition noting that methods for identification and quantification of Streptomyces lydicus strain WYEC 108 are available; however, a method for enforcement fully validated at a specific limit of quantification (LOQ) was not provided. An inclusion of Streptomyces lydicus strain WYEC 108 in Annex IV of (EC) No 396/2005 is not recommended. [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]

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 EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Austria and co‐rapporteur Member State Italy for the pesticide active substance captan are reported and the confirmatory data following the Article 12 of Regulation (EC) No 396/2005 as well. 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 captan as a fungicide on pome fruit, peaches and nectarines, plums, cherry, tomato, strawberries (field use) and strawberries (greenhouse application). 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]

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 chlorantraniliprole. To assess the occurrence of chlorantraniliprole 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 some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

The applicants Syngenta Crop Protection, UPL Europe Ltd. and Oxon Italia S.p.A. submitted requests to the competent national authority in the Netherlands to evaluate the confirmatory data for chlorothalonil that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available; in addition, Syngenta and UPL submitted requests for modifications of existing MRLs. Considering the recent decision on the non‐approval of chlorothalonil, the requests for amending existing MRLs to reflect intended EU uses for chlorothalonil and confirmatory data for EU uses became obsolete. EFSA focused therefore its assessment on the import tolerances and on general information on the analytical method required to enforce legal limits for chlorothalonil and its metabolite SDS‐3701 (R182281). Analytical methods for enforcement are available to control the residues of chlorothalonil and SDS‐3701 in plant matrices at the validated LOQ of 0.01 mg/kg; data on the extraction efficiency for high oil content matrices as requested in the MRL review were not provided. This data gap is relevant for the import tolerance for peanuts. The data submitted in support of import tolerances were found to be sufficient to derive MRL proposals for chlorothalonil and SDS‐3701 for bagged bananas, papayas and peanuts. Studies investigating the effect of high temperature processing on the magnitude of SDS‐3701 in processed products are not available. Based on exposure calculations for chlorothalonil, EFSA concluded that the long‐term intake of residues resulting from the use of chlorothalonil according to the reported agricultural practices is unlikely to present a risk to consumers. For papaya, an acute intake concern was noted for chlorothalonil, while for banana and peanuts, the expected short‐term intake of chlorothalonil residues was below the toxicological reference value. For the metabolite SDS‐3701, the toxicological profile is not fully elucidated, and therefore, toxicological reference values could not be derived. Hence, for this metabolite, the consumer risk assessment cannot be finalised. [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 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]

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 Pseudomonas sp. strain DSMZ 13134. To assess the occurrence of Pseudomonas sp. strain DSMZ 13134 residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals cannot be derived and are deemed not to be necessary. A consumer risk assessment cannot be performed quantitatively. Although no apparent risk to consumers was identified, some information required by the regulatory framework would still be desirable. The outcome of the assessment was compared to the criteria defined by the European Commission for inclusion of pesticide active substances in Annex IV of the Regulation. A proposal for inclusion of Pseudomonas sp. strain DSMZ 13134 into Annex IV of Regulation (EC) No 396/2005 is derived by EFSA based on the authorised uses of this Art. 12 review. [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, Austria, and co-rapporteur Member State, Malta, for the pesticide active substance abamectin 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 abamectin as an insecticide and acaricide on tomato and strawberry. 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 Syngenta Crop Protection AG submitted a request to the competent national authority in Portugal to set import tolerances for the active substance lufenuron in grapefruits, oranges, limes, pome fruits, peppers, coffee, sugar canes, muscle, fat, liver and kidney on the basis of the authorised uses of lufenuron in Brazil, Chile and Morocco. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for all commodities under assessment. For oranges, limes, pome fruits, peppers and coffee beans and commodities of animal origin, the submitted data indicated no need to modify the existing EU MRLs. For grapefruits and sugar cane, the residue data indicated that higher MRLs would be needed. Adequate analytical methods for enforcement are available to control the residues of lufenuron in plant and animal matrices. Based on the risk assessment results, EFSA concluded that the existing EU uses and the authorised uses of lufenuron in Brazil, Chile and Morocco will not result in chronic consumer exposure exceeding the toxicological reference value. Considering, however, that the estimated exposure is close to the acceptable daily intake (ADI) and in the light of the expiry of the approval of the active substance, EFSA recommends the review of the existing MRLs taking into account that the MRLs based on the EU uses will become obsolete. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance aminopyralid. To assess the occurrence of aminopyralid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified. [ABSTRACT 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]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance 6‐benzyladenine. To assess the occurrence of 6‐benzyladenine residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified. [ABSTRACT 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 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]