Guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water.

This guidance document provides a tiered framework for risk assessors and facilitates risk managers in making decisions concerning the approval of active substances (AS) that are chemicals in plant protection products (PPPs) and biocidal products, and authorisation of the products. Based on the approaches presented in this document, a conclusion can be drawn on the impact of water treatment processes on residues of the AS or its metabolites in surface water and/or groundwater abstracted for the production of drinking water, i.e. the formation of transformation products (TPs). This guidance enables the identification of actual public health concerns from exposure to harmful compounds generated during the processing of water for the production of drinking water, and it focuses on water treatment methods commonly used in the European Union (EU). The tiered framework determines whether residues from PPP use or residues from biocidal product use can be present in water at water abstraction locations. Approaches, including experimental methods, are described that can be used to assess whether harmful TPs may form during water treatment and, if so, how to assess the impact of exposure to these water treatment TPs (tTPs) and other residues including environmental TPs (eTPs) on human and domesticated animal health through the consumption of TPs via drinking water. The types of studies or information that would be required are described while avoiding vertebrate testing as much as possible. The framework integrates the use of weight-of-evidence and, when possible alternative (new approach) methods to avoid as far as possible the need for additional testing.

Peer review of the pesticide risk assessment of the active substance mancozeb.

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.

Peer review of the pesticide risk assessment of the active substance blood meal.

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.

Peer review of the pesticide risk assessment of the active substance chloropicrin.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the initial rapporteur Member State the United Kingdom and the new rapporteur Member State Italy for the pesticide active substance chloropicrin 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 chloropicrin as a soil fumigant on strawberries, tomatoes, peppers, cucurbits (field and greenhouse applications) and tree crops: pome fruit, stone fruit, citrus, olives (field 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. Concerns are identified.

Peer review of the pesticide risk assessment for the active substance sulfoxaflor in light of confirmatory data submitted.

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.

Peer review of the pesticide risk assessment of the active substance beta-cyfluthrin.

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, Hungary, for the pesticide active substance beta-cyfluthrin 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 beta-cyfluthrin as an insecticide on beet, potato, wheat and greenhouse tomato. In addition, this conclusion also addresses the request received from the European Commission during the decision-making phase following completion of the peer review with regard to the risk to non-target arthropods. 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.

Peer review of the pesticide risk assessment of the active substance Akanthomyces muscarius strain Ve6, formerly Lecanicillium muscarium strain Ve6.

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 Akanthomyces muscarius strain Ve6 formerly Lecanicillium muscarium strain Ve6 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 Akanthomyces muscarius strain Ve6 as an insecticide on fruiting vegetables of cucurbitaceae with edible and inedible peel, fruiting vegetables of solanaceae, strawberries, floriculture crops (except roses), cut roses and tree nursery. 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.

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop-propargyl).

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.

Peer review of the pesticide risk assessment of the active substance fenamiphos.

The conclusions of 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 Cyprus for the pesticide active substance fenamiphos 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 fenamiphos as a nematicide in fruiting vegetables (i.e. tomato, aubergine, cucumber, pepper and courgette), herbaceous ornamentals and in nursery stock (both perennial and herbaceous species). 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.

Peer review of the pesticide risk assessment of the active substance Verticillium albo-atrum strain WCS850.

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 the Netherlands for the pesticide active substance Verticillium albo-atrum strain WCS850 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 use of Verticillium albo-atrum strain WCS850 as a fungicide on elm trees. 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.

Peer review of the pesticide risk assessment of the active substance Phlebiopsis gigantea strains VRA 1835, VRA 1984 and FOC PG 410.3.

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.

Peer review of the pesticide risk assessment of the active substance pydiflumetofen.

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 and co-rapporteur Member State Austria for the pesticide active substance pydiflumetofen 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 uses of pydiflumetofen as a fungicide field application on pome fruits, grapes, potato, fruiting vegetables, cucurbits and Brassica vegetables. 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.

Peer review of the pesticide risk assessment of the active substance benfluralin.

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.

Peer review of the pesticide risk assessment of the active substance dimethyl disulfide.

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.

Peer review of the pesticide risk assessment of the active substance thiacloprid.

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 Germany for the pesticide active substance thiacloprid 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 thiacloprid as an insecticide on oilseed rape foliar use and maize seed treatment. The peer review also provided conclusions on whether exposure of humans to thiacoprid can be considered negligible, taking into account the European Commission's draft guidance on this topic. Confirmatory data following the review of existing maximum residue levels (MRLs) according to Article 12 of Regulation (EC) No 396/2005 were also assessed in this conclusion. The reliable end points, appropriate for use in regulatory risk assessment are presented. An evaluation of data concerning the necessity of thiacloprid as an insecticide to control a serious danger to plant health which cannot be contained by other available means, including non-chemical methods is presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance pyriproxyfen.

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 Spain for the pesticide active substance pyriproxyfen 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. The conclusions were reached on the basis of the evaluation of the representative uses of pyriproxyfen as an insecticide on citrus fruit, pome fruit (apple, pears), tomatoes, ornamentals (field use) and tomatoes, ornamentals (greenhouse application). MRLs were assessed in citrus fruits. The reliable end points, 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.

Updated peer review of the pesticide risk assessment for the active substance terbuthylazine in light of confirmatory data submitted.

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.

Peer review of the targeted hazard assessment of the pesticide active substance quinoxyfen.

The conclusions of EFSA following the peer review of the initial assessments carried out by the competent authorities of the rapporteur Member State, the United Kingdom, and co-rapporteur Member State, Austria, for the pesticide active substance quinoxyfen 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 information targeted at the assessment of the potential persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB) and persistent organic pollutant (POP) properties of quinoxyfen according to Article 11(2) of Regulation (EC) No 1107/2009. The reliable end points, appropriate for use in these regulatory hazard cut off assessments are presented. Missing information identified as being required by the regulatory framework is listed. The concern is identified that quinoxyfen may be considered to exhibit the hazard properties of both a PBT and vPvB substance considering the triggers specified in Annex II of Regulation (EC) No 1107/2009.

Peer review of the pesticide risk assessment of the active substance chlorothalonil.

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, Belgium, for the pesticide active substance chlorothalonil 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 chlorothalonil as a fungicide on wheat, barley, tomato and potato. 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.

Peer review of the pesticide risk assessment of the active substance tolclofos-methyl.

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, Sweden, and co-rapporteur Member State, Denmark, for the pesticide active substance tolclofos-methyl 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 tolclofos-methyl as a fungicide on potatoes, lettuce and ornamentals. 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.