Conclusion on the peer review of the pesticide risk assessment of the active substance metobromuron

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 France, for the pesticide active substance metobromuron are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative use of metobromuron as a herbicide on potatoes. 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. The consumer risk assessment should be considered provisional pending the outcome of the requested toxicological information on the metabolites included in the plant residue definitions. A high long-term risk to birds could not be excluded with the available data

Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance dimethoate

The conclusions of the European Food Safety Authority (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 dimethoate are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory mammalian toxicology, residues and ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of dimethoate as an insecticide on sugar beet and protected lettuce. Concerns are identified

Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment

Upon request of the European Commission, the Scientific Committee (SC) of the European Food Safety Authority reviewed existing information related to the testing and assessment of endocrine active substances (EASs) and endocrine disruptors (EDs). This work was conducted by a working group of experts in endocrinology, risk assessment and toxicology, together with observers from other EU agencies, namely EMA, ECHA and EEA. To distinguish between EDs and other groups of substances with different modes of action, it was concluded that an ED is defined by three criteria: the presence of i) an adverse effect in an intact organism or a (sub)population; ii) an endocrine activity; and iii) a plausible causal relationship between the two. As scientific criteria for adversity have not been generally defined, specific criteria for endocrine disrupting effects could not be identified. Hence, expert judgement is required to assess on a case-by-case basis the (eco)toxicological relevance of changes at the molecular to individual and/or (sub)population level following exposure to an EAS. The SC concluded that a reasonably complete suite of standardised assays for testing the effects of EASs is (or will soon be) available for the oestrogenic, androgenic, thyroid and steroidogenic modalities in mammals and fish, with fewer tests for birds and amphibians. Shortcomings in current tests and for other endocrine modalities and species were reviewed. Critical effect, severity, (ir)reversibility and potency aspects are part of the hazard characterisation of EDs. To inform on risk and level of concern for the purpose of risk management decisions, risk assessment (taking into account hazard and exposure data/predictions) makes best use of available information. Levels of concern are not determined exclusively by risk assessment but also by protection goals set by the risk management

Conclusion on the peer review of the pesticide risk assessment of the active substance thiencarbazone-methyl

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 United Kingdom, for the pesticide active substance thiencarbazone-methyl are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative use of thiencarbazone-methyl as a herbicide on maize. 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. Missing information identified as being required by the regulatory framework is listed. Concerns are identified

Scientific Opinion on good modelling practice in the context of mechanistic effect models for risk assessment of plant protection products

The Panel has interpreted the Terms of Reference as a stepwise analysis of issues relevant to both the development and the evaluation of models to assess ecological effects of pesticides. The regulatory model should be selected or developed to address the relevant specific protection goal. The basis of good modelling practice must be the knowledge of relevant processes and the availability of data of sufficient quality. The opinion identifies several critical steps in order to set models within risk assessment, namely: problem formulation, considering the specific protection goals for the taxa or functional groups of concern; model domain of applicability, which drives the species and scenarios to model; species (and life stage) selection, considering relevant life history traits and toxicological/toxicokinetics characteristics of the pesticide; selection of the environmental scenario, which is defined by a combination of abiotic, biotic and agronomic parameters to provide a realistic worst-case situation. Model development should follow the modelling cycle, in which every step has to be fully documented: (i) problem definition; (ii) model formulation, i.e. design of a conceptual model; (iii) model formalisation, in which variables and parameters are linked together into mathematical equations or algorithms; (iv) model implementation, in which a computer code is produced and verified; (v) model setup, including sensitivity analysis, uncertainty analysis and comparison with observed data, that delivers the regulatory model; (vi) prior to actual use in risk assessment, the regulatory model should be evaluated for relevance to the specific protection goals; (vii) feedback from risk assessor with possible recommendations for model improvement. Model evaluation by regulatory authorities should consider each step of the modelling cycle: the opinion identifies points of particular attention for the use of mechanistic effect models in pesticide risk assessment. It is recommended that models be documented in a complete and transparent way, that a feedback platform be established involving risk assessors and model developers, and that a set of agreed models be made available

Scientific Opinion on the relevance of dissimilar mode of action and its appropriate application for cumulative risk assessment of pesticides residues in food

Abstract The European Food Safety Authority (EFSA) asked the Panel on Plant Protection Products and their Residues (PPR Panel) to develop a Scientific Opinion on the relevance of dissimilar mode of action and its appropriate application for cumulative risk assessment of pesticides residues in food. The present opinion was preceded by three previous opinions of the PPR Panel (EFSA, 2008, 2009, 2013). The purpose of the present opinion was to assess the relevance of dissimilar modes of action (MoA) for cumulative risk assessment, to evaluate the existing methods for assessing chemicals acting by dissimilar MoA and to identify which methods need to be considered. The PPR Panel restricted its considerations of pesticide combinations with dissimilar modes of action to substances that produce a common adverse effect on the same organ/system. The PPR Panel noted that there is no case documented in the scientific literature where independent action provided more conservative predictions of combination effects than dose addition, and where at the same time independent action also produced accurate predictions. The use of independent action as an assessment concept for combination effects requires demonstration that modes of action of individual substances in a mixture are strictly independent, a condition that can rarely be met in practice. The PPR Panel also noted that there is no cumulative risk assessment method derived from independent action. The PPR Panel therefore recommends using cumulative risk assessment methods derived from dose addition also for the assessment of mixtures of pesticides with dissimilar modes of action, provided they produce a common adverse outcome. Pesticides that produce common adverse outcomes on the same target organ/system should be grouped together in CAGs, and their combined effects assessed by using the concept of dose addition as a pragmatic and conservative default approach for the purpose of assessing cumulative risk in relation to MRL setting or risk assessment of chemical mixtures in practice