Arianna Chiusolo

Guidance on dermal absorption

Abstract This guidance on the assessment of dermal absorption has been developed to assist notifiers, users of test facilities and Member State authorities on critical aspects related to the setting of dermal absorption values to be used in risk assessments of active substances in Plant Protection Products (PPPs). It is based on the ‘scientific opinion on the science behind the revision of the guidance document on dermal absorption’ issued in 2011 by the EFSA Panel on Plant Protection Products and their Residues (PPR). The guidance refers to the EFSA PPR opinion in many instances. In addition, the first version of this guidance, issued in 2012 by the EFSA PPR Panel, has been revised in 2017 on the basis of new available data on human in vitro dermal absorption for PPPs and wherever clarifications were needed. Basic details of experimental design, available in the respective test guidelines and accompanying guidance for the conduct of studies, have not been addressed but recommendations specific to performing and interpreting dermal absorption studies with PPPs are given. Issues discussed include a brief description of the skin and its properties affecting dermal absorption. To facilitate use of the guidance, flow charts are included. Guidance is also provided, for example, when there are no data on dermal absorption for the product under evaluation. Elements for a tiered approach are presented including use of default values, data on closely related products, in vitro studies with human skin (regarded to provide the best estimate), data from experimental animals (rats) in vitro and in vivo, and the so called ‘triple pack’ approach. Various elements of study design and reporting that reduce experimental variation and aid consistent interpretation are presented. A proposal for reporting data for assessment reports is also provided. The issue of nanoparticles in PPPs is not addressed. Data from volunteer studies have not been discussed since their use is not allowed in EU for risk assessment of PPPs.

Peer review of the pesticide risk assessment of the active substance pethoxamid

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, Austria, and co‐rapporteur Member State, the Czech Republic, for the pesticide active substance pethoxamid 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 pethoxamid as a herbicide on maize and soya bean. 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 mepanipyrim

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, Belgium, and co‐rapporteur Member State, Greece, for the pesticide active substance mepanipyrim 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 mepanipyrim as a fungicide on table and wine grapes, and in field and protected strawberries 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 for the active substance terbuthylazine in light of confirmatory data submitted

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 metazachlor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data regarding the groundwater exposure of metabolites and their toxicological relevance triggering an assessment. The conclusions were reached on the basis of the evaluation of the representative uses of metazachlor as a herbicide on winter and spring rapeseed and on ornamental trees and shrubs. 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 pesticide risk assessment of the active substance chlorpropham

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, the Netherlands, and co‐rapporteur Member State, Spain, for the pesticide active substance chlorpropham 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 chlorpropham as a plant growth regulator on potatoes and as a herbicide on glasshouse and field lettuce, field onion and field flower bulbs. MRLs were assessed in potato and animal commodities. 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.

Peer review of the pesticide risk assessment of the active substance Clonostachys rosea strain J1446 (approved in Regulation (EU) No 540/2011 as Gliocladium catenulatum strain J1446)

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, Hungary, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Clonostachys rosea strain J1446, currently approved as Gliocladium catenulatum strain J1446, 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 Clonostachys rosea strain J1446 as a fungicide in agriculture and horticulture. 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 Metschnikowia fructicola NRRL Y‐27328

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 Metschnikowia fructicola NRRL Y‐27328 and the assessment of the application for inclusion in Annex IV of Regulation (EU) 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 Metschnikowia fructicola NRRL Y‐27328 as a fungicide on stone fruits, strawberries and 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.

Peer review of the pesticide risk assessment of the active substance laminarin

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, the Netherlands, and co‐rapporteur Member State, France, for the pesticide active substance laminarin 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 laminarin as elicitor on apple, pear, vine, kiwi, green bean, lettuce, strawberry, tomato, cucurbits, aubergine and pepper. 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 forchlorfenuron

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, Spain, and co‐rapporteur Member State, Greece, for the pesticide active substance forchlorfenuron 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 forchlorfenuron as a plant growth regulator on kiwifruit and grapes. 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. Concern is identified.

Peer review of the pesticide risk assessment of the active substance Ampelomyces quisqualis strain AQ10

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, France, and the co‐rapporteur Member State, Germany, for the pesticide active substance Ampelomyces quisqualis strain AQ10 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 Ampelomyces quisqualis strain AQ10 as a fungicide by spraying against powdery mildew in grapes and spray applications in tomato, pepper and aubergine grown under protection or in the open field. 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.