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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]

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 Czech Republic (CZ) and co‐rapporteur Member State France (FR) for the pesticide active substance sheep fat 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 sheep fat 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. [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 Czech Republic and co‐rapporteur Member State France for the pesticide active substance fish oil 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 fish oil as a game 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. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the original rapporteur Member State United Kingdom supported by the new rapporteur Member State Sweden, for the pesticide active substance penthiopyrad 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 area of mammalian toxicology. The European Commission mandated EFSA to arrange a further peer review of the confirmatory data. The conclusions were reached on the basis of the evaluation of the representative uses of penthiopyrad as a fungicide on pome fruit, tomato, aubergines, cucurbits, cucumbers, courgettes and cereals. 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 EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the United Kingdom (France after Brexit), for the pesticide active substance asulam and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of asulam (variant evaluated asulam-sodium) as a herbicide on spinach and tulip, hyacinth and lily for bulb production. MRLs were assessed in spinach. The conclusions were updated with regard to the endocrine-disrupting properties following a mandate received from the European Commission in February 2019. In addition, the peer review also provided considerations on whether exposure to humans and the environment from the representative uses of asulam-sodium can be considered negligible, taking into account the European Commission’s draft guidance on this topic. The reliable endpoints, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. An evaluation of data concerning the necessity of asulam-sodium as a herbicide to control a serious danger to plant health which cannot be contained by other available means, including non-chemical methods is also presented. [ABSTRACT 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 spirodiclofen. Although this active substance is no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, as spirodiclofen is classified as carcinogenic 1B with threshold, all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT 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, Denmark, and co-rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain ABTS-351 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis subsp. kurstaki strain ABTS-351 as an insecticide on cabbage (field use) and tomato (permanent greenhouse and walk-in tunnel uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT 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, Spain, for the pesticide active substance Spodoptera exigua multicapsid nucleopolyhedrovirus and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Spodoptera exigua multicapsid nucleopolyhedrovirus as an insecticide on pepper and leafy vegetables (lettuce crops) (field, greenhouse and walk-in tunnel uses). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT 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 metobromuron. To assess the occurrence of metobromuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the European authorisations reported by Member States and the United Kingdom (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT 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 substances Beta-cyfluthrin and Cyfluthrin. Although these active substances are no longer authorised for use on edible crops within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits (CXLs)) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. All CXLs were found to be sufficiently supported by data, whereas some import tolerances were not supported by adequate data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed. Apart from a possible acute risk to consumers for a CXL higher than the existing MRL, no risk to consumers was identified. [ABSTRACT 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, Poland, and co-rapporteur Member State, France, for the pesticide active substance benthiavalicarb (variant assessed benthiavalicarb-isopropyl) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/ 1659. The conclusions were reached on the basis of the evaluation of the representative use of benthiavalicarb-isopropyl as a fungicide on potato (field use). The peer review also provided considerations on whether exposure to humans and the environment from the representative uses of benthiavalicarb-isopropyl can be considered negligible, taking into account the European Commission’s draft guidance on this topic. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. An evaluation of data concerning the necessity of benthiavalicarb-isopropyl as a fungicide to control a serious danger to plant health which cannot be contained by other available means, including non-chemical methods, is also presented. [ABSTRACT 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 penthiopyrad. To assess the occurrence of penthiopyrad residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT 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 isopyrazam. To assess the occurrence of isopyrazam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and one MRL proposal derived by EFSA still requires further consideration by risk managers. [ABSTRACT 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, France, and corapporteur Member State, Austria, for the pesticide active substance carbon dioxide 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 carbon dioxide as an insecticide and acaricide on stored cereal grains, oilseeds, medicinal plants, cereal products, spices, tobacco, tea, dried fruits and other stored plant products (except semolina and oilseed meal) (all indoor uses). 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 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]

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]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pinoxaden. To assess the occurrence of pinoxaden residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [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 cyproconazole. Considering that no application was received to support the renewal of the approval of cyproconazole and considering the expiry date for its approval on 31 May 2021, and that the import tolerances identified were not supported by sufficient data, and are not forming the basis of any existing EU MRLs, but correspond to existing MRLs established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), the current assessment is limited to CXLs. To assess the occurrence of cyproconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the MRLs established by the Codex Alimentarius Commission. Based on the assessment of the available data, EFSA assessed the CXLs and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. [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]

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 thiram. Although this active substance is no longer authorised within the European Union, MRLs based on the use of thiram were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the existing import tolerances, and a consumer risk assessment was carried out for thiram only. Although no apparent risk to consumers was identified, the import tolerances were not fully supported by data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed. [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]

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, Spain, for the pesticide active substances Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 and the considerations as regards the inclusion of the substances in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by 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 Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 as an elicitor on tomato (permanent greenhouse production systems). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. [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 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]

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]

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]

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]

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‐11 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‐11 as an insecticide on pome fruits (field use), protected tomato (including permanent greenhouses and walk‐in tunnels) and turf (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]

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 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 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]

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 propineb. Although this active substance is no longer authorised within the EU, due to insufficient information in order to conclude on the consumer risk assessment for the active substance, the toxicity of the metabolite propane-1,2-diamine (PDA) the impact on non-target organisms and the risk to honeybees, MRLs based on the use of propineb were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and are still in place. Additionally, propineb has potential endocrine-disrupting properties related to the hazards of its major metabolite 4-methylimidazolidine-2-thione (PTU). Lacking a full toxicological characterisation for the compound PDA, exposure data for metabolites propineb-DIDT in plants and PDA in processed commodities and considering that propineb-MRLs correlated to CXLs were based on EU uses that were withdrawn following the non-renewal and are no longer in place, it was not possible for EFSA to perform an assessment of these MRLs and their incorporation in European legislation cannot be recommended. Nevertheless, available data allowed EFSA to propose a marker residue and a limit of quantification (LOQ) for enforcement against potential illegal uses. [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]

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]

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, the Netherlands, for the pesticide active substance aqueous extract from the germinated seeds of sweet Lupinus albus 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 the aqueous extract from the germinated seeds of sweet Lupinus albus as a fungicide on strawberry and tomatoes (field use and greenhouse application). 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 were 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, France, for the pesticide active substance prosulfuron 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 prosulfuron as a herbicide on maize and sweet corn. Following the renewal of approval, prosulfuron has been renewed with the restriction that the use shall be limited to one application every 3 years. This assessment follows the request of the applicant to lift the restriction of the approval conditions. 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, Estonia, and co‐rapporteur Member State, France, for the pesticide active substance Streptomyces strain K61 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 Streptomyces strain K61 as a fungicide on fruiting vegetables, leafy vegetables, bulb vegetables, pulses, ornamentals, aromatic herbs and root crops, onions and seedlings, in permanent greenhouses and walk‐in tunnels. 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 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]

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 amisulbrom. To assess the occurrence of amisulbrom 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 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 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]