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Abstract 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 Greece for the pesticide active substance kieselgur (diatomaceous earth) 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 kieselgur (diatomaceous earth) as an insecticide and acaricide on stored cereals, empty storage rooms and storage rooms, mills and warehouses (with stored goods). 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 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the co‐rapporteur Member State, the Czech Republic, for the pesticide active substance sulfoxaflor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of sulfoxaflor as an insecticide on fruiting vegetables (field and greenhouse application), cucurbits (field and greenhouse application), spring and winter cereals (field application) and cotton (field application). 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. For the field and non‐permanent structure greenhouses, a high risk to honeybees and bumble bees was identified related to some pertinent scenarios (treated crop scenario except after flowering period, weed scenario, field margin scenario). A low risk was concluded for honeybees, bumble bees and solitary bees in case of permanent structure greenhouse provided the low exposure in such scenarios. The European Commission mandated EFSA to complete the assessment of the spray drift reducing measures necessary to protect bumblebees and solitary bees in field margins from exposure to sulfoxaflor and to complete the assessment of the risk to bees from puddle water.

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 Italy for the pesticide active substance lavandulylsenecioateare 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 evaluated as a pheromone comprising manual applications to control Planococcusficus (vine mealybug) populations by mating disruption in table grape, wine grape, raisins and any other crops where P. ficus may be a pest in Southern Europe. The reliable endpoints,appropriate for use in regulatory risk assessmentare presented. Missing information identified as being required by the regulatory framework is listed.Concerns are identified.

Abstract 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 Lithuania for the pesticide active substance blood meal 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 blood meal as a game repellent on deciduous and coniferous trees in forestry, orchard trees and ornamental plants and as a vole repellent on deciduous and coniferous trees in forestry (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. No concerns are identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Poland for the pesticide active substance ferric pyrophosphate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of ferric pyrophosphate as a molluscicide on all edible and inedible crops. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract The conclusions of 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 dimethyl disulfide 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 dimethyl disulfide as a nematicide, fungicide and herbicide on carrot (field use) and on tomato (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 are identified.

Abstract 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, Norway, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance benfluralin 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 benfluralin as a herbicide on chicory and lettuce. 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 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 Estonia and co‐rapporteur Member State, France, for the pesticide active substance Phlebiopsis gigantea strains VRA 1835, VRA 1984 and FOC PG 410.3 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 Phlebiopsis gigantea strains VRA 1835, VRA 1984 and FOC PG 410.3 as a fungicide (field use) on conifer forests: pine, spruce, larch. 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 The conclusions of 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 terbuthylazine are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data on groundwater metabolites. The conclusions were reached on the basis of the evaluation of the representative uses of terbuthylazine as a herbicide on maize and sorghum and taking into account the scientific opinion of the EFSA Panel on Plant Protection Products and their Residues (PPR) on the setting of health‐based reference values for metabolites of the active substance terbuthylazine. 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 In response to the request of the European Commission to EFSA, this document provides guidance on the information necessary to perform the risk assessment of plant protection active substances that contain stereoisomers in their composition as active components or impurities. The guidance should also be used for active substances that without containing any stereogenic element may generate transformation products or metabolites that do contain them. As a general principle, stereoisomers need to be treated as different chemical components for the risk assessment. Current data requirements in the EU regulatory framework (Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005) already establish that the substance tested should match the technical specifications (including its isomeric composition) and that formation and effects of metabolites, degradation and transformation products should be investigated (which certainly includes the case when transformation products are stereoisomers). Experience gained during the application of EU pesticides regulation has shown that guidance may be needed to provide applicants and evaluators advice on how to generate and assess the required data. Also, guidance is needed on how to make the best use of the available information to perform the risk assessment of these substances, particularly in situations when the information on individual isomers is not available or difficult to obtain, with a primary objective being to reduce the need for repeating vertebrate animal testing. This guidance does not aim to provide specific technical advice on analytical methods. In this guidance, the Regulation (EU) 283/2013 on the data requirements for the plant protection active substances is analysed and recommendations are given on how to best address and assess data requirements for active substances containing stereoisomers.