From water to land-Usage of Generalized Unified Threshold models of Survival (GUTS) in an above-ground terrestrial context exemplified by honeybee survival data.

In regulatory aquatic risk assessment, toxicokinetic-toxicodynamic (TKTD) methods, such as the generalized unified threshold model of survival (GUTS), are already established and considered ready for use, whereas TKTD methods for aboveground terrestrial species, like arthropods, are less developed and currently not intended for risk assessment. This could be due to the fact that exposure in aboveground terrestrial systems is more event-based (feeding, contact, overspray, etc.), whereas exposure in aquatic systems is simply related to substance concentrations in the surrounding water.

Integrating Time-Resolved Gene-Expression Data into a Full GUTS Model as a Proxy for Toxicodynamic Damage in Zebrafish Embryo.

The immense production of the chemical industry requires an improved predictive risk assessment that can handle constantly evolving challenges while reducing the dependency of risk assessment on animal testing. Integrating omics data into mechanistic models offers a promising solution by linking cellular processes triggered after chemical exposure with observed effects in the organism. With the emerging availability of time-resolved RNA data, the goal of integrating gene expression data into mechanistic models can be approached.

A conceptual framework for landscape-based environmental risk assessment (ERA) of pesticides.

While pesticide use is subject to strict regulatory oversight worldwide, it remains a main concern for environmental protection, including biodiversity conservation. This is partly due to the current regulatory approach that relies on separate assessments for each single pesticide, crop use, and non-target organism group at local scales. Such assessments tend to overlook the combined effects of overall pesticide usage at larger spatial scales.

A systems-based analysis to rethink the European environmental risk assessment of regulated chemicals using pesticides as a pilot case.

A growing body of scientific literature stresses the need to advance current environmental risk assessment (ERA) methodologies and associated regulatory frameworks to better address the landscape-scale and long-term impact of pesticide use on biodiversity and the ecosystem. Moreover, more collaborative and integrative approaches are needed to meet sustainability goals. The One Health approach is increasingly applied by the European Food Safety Authority (EFSA) to support the transition towards safer, healthier and more sustainable food.

Toxicokinetic-Toxicodynamic Model to Assess Thermal Stress.

Temperature is a crucial environmental factor affecting the distribution and performance of ectothermic organisms. This study introduces a new temperature damage model to interpret their thermal stress. Inspired by the ecotoxicological damage model in the General Unified Threshold model for Survival (GUTS) framework, the temperature damage model assumes that damage depends on the balance between temperature-dependent accumulation and constant repair.

Statement of the Scientific Panel on Plant Protection Products and their Residues (PPR Panel) on the design and conduct of groundwater monitoring studies supporting groundwater exposure assessments of pesticides.

Groundwater monitoring is the highest tier in the leaching assessment of plant protection products in the EU. The European Commission requested EFSA for a review by the PPR Panel of the scientific paper of Gimsing et al. (2019) on the design and conduct of groundwater monitoring studies.

Revised guidance on the risk assessment of plant protection products on bees (, spp. and solitary bees).

The European Commission asked EFSA to revise the risk assessment for honey bees, bumble bees and solitary bees. This guidance document describes how to perform risk assessment for bees from plant protection products, in accordance with Regulation (EU) 1107/2009. It is a review of EFSA's existing guidance document, which was published in 2013.

Development of adverse outcome pathways relevant for the identification of substances having endocrine disruption properties Uterine adenocarcinoma as adverse outcome.

Development of adverse outcome pathways (AOPs) for uterine adenocarcinoma can provide a practical tool to implement the EFSA-ECHA Guidance (2018) for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. AOPs can give indications about the strength of the relationship between an adverse outcome (intended as a human health outcome) and chemicals (pesticides but not only) affecting the pathways. In this scientific opinion, the PPR Panel explored the development of AOPs for uterine adenocarcinoma.

Explicit Consideration of Temperature Improves Predictions of Toxicokinetic-Toxicodynamic Models for Flupyradifurone and Imidacloprid in .

In the face of global climate change, where temperature fluctuations and the frequency of extreme weather events are increasing, it is needed to evaluate the impact of temperature on the ecological risk assessment of chemicals. Current state-of-the-art mechanistic effect models, such as toxicokinetic-toxicodynamic (TK-TD) models, often do not explicitly consider temperature as a modulating factor. This study implemented the effect of temperature in a widely used modeling framework, the General Unified Threshold model for Survival (GUTS).

The effect of temperature on toxicokinetics and the chronic toxicity of insecticides towards Gammarus pulex.

A comprehensive understanding of chemical toxicity and temperature interaction is essential to improve ecological risk assessment under climate change. However, there is only limited knowledge about the effect of temperature on the toxicity of chemicals. To fill this knowledge gap and to improve our mechanistic understanding of the influence of temperature, the current study explored toxicokinetics and the chronic toxicity effects of two insecticides, imidacloprid (IMI) and flupyradifurone (FPF), on Gammarus pulex at different temperatures (7-24 °C).

Comparing the acute and chronic toxicity of flupyradifurone and imidacloprid to non-target aquatic arthropod species.

Flupyradifurone (FPF) is a new type of butenolide insecticide. It was launched on the market in 2015 and is considered an alternative to the widely used neonicotinoids, like imidacloprid (IMI), some of which are banned from outdoor use in the European Union. FPF is claimed to be safe for bees, but its safety for aquatic organisms is unknown.

Evaluation of the risks for animal health related to the presence of hydroxymethylfurfural (HMF) in feed for honey bees.

The European Commission has asked the EFSA to evaluate the risk for animal health related to the presence of hydroxymethylfurfural (HMF) in honey bee feed. HMF is a degradation product of particular sugars and can be present in bee feed. HMF is of low acute toxicity in bees but causes increased mortality upon chronic exposure.

Scientific Opinion of the Scientific Panel on Plant Protection Products and their Residues (PPR Panel) on testing and interpretation of comparative metabolism studies.

EFSA asked the Panel on Plant Protection Products and their residues to deliver a Scientific Opinion on testing and interpretation of comparative metabolism studies for both new active substances and existing ones. The main aim of comparative metabolism studies of pesticide active substances is to evaluate whether all significant metabolites formed in the human test system, as a surrogate of the situation, are also present at comparable level in animal species tested in toxicological studies and, therefore, if their potential toxicity has been appropriately covered by animal studies. The studies may also help to decide which animal model, with regard to a particular compound, is the most relevant for humans.

Safety for the environment of a feed additive consisting of nicarbazin (Coxar) for use in turkeys for fattening (Huvepharma N.V.).

Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety for the environment of the coccidiostat Coxar (nicarbazin) when used in feed for turkeys for fattening. In previous assessments, the FEEDAP Panel could not conclude on the safety of Coxar for the environment due to concerns on 4,40-dinitrocarbanilide (DNC, one of the moieties of nicarbazin). On the basis of the new data provided, the FEEDAP Panel updates its previous conclusions on the safety of Coxar for the environment as follows: The use of nicarbazin from Coxar in complete feed for turkeys does not pose a risk for the terrestrial and aquatic compartment and in sediment.

Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelate of ethylenediamine (Copper-EDA-Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) identified several issues related to the data provided concerning the chemical characteristics of the additive and, based on the information provided from an dissociation study, considered it unlikely that the additive consists only of copper mono-chelate of EDA but of several coexisting (copper) species. Therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation of the additive.

Safety and efficacy of a feed additive consisting of iron chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of iron chelate of ethylenediamine (Iron-EDA-Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of iron monochelate of EDA, but of several coexisting (iron) species; therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation.

Statement of the PPR Panel on a framework for conducting the environmental exposure and risk assessment for transition metals when used as active substances in plant protection products (PPP).

The European Commission asked the European Food Safety Authority (EFSA) to prepare a statement on a framework for the environmental risk assessment (ERA) of transition metals (e.g. iron and copper) used as active substances in plant protection products (PPPs).

Safety and efficacy of a feed additive consisting of manganese chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese chelate of ethylenediamine (Manganese-EDA-Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of manganese mono-chelate of EDA, but of several coexisting (manganese) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive.

Safety and efficacy of a feed additive consisting of zinc chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of zinc chelate of ethylenediamine (Zinc-EDA-Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of zinc mono-chelate of EDA, but of several coexisting (zinc) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive.

Soil Biodiversity: State-of-the-Art and Possible Implementation in Chemical Risk Assessment.

Protecting the structure and functioning of soil ecosystems is one of the central aims of current regulations of chemicals. This is, for instance, shown by the emphasis on the protection of key drivers and ecosystem services as proposed in the protection goal options for soil organisms by the European Food Safety Authority (EFSA). Such targets require insight into soil biodiversity, its role in the functioning of ecosystems, and the way it responds to stress.