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.

The effect of coconut coir substrate on the yield and nutritional quality of sweet peppers (Capsicum annuum) varieties.

The industry standard for estimating the quantity of horticultural produce harvested is crop yield. Producing sufficient amounts of high-quality biochemical ingredients crops can therefore aid in resolving concerns with food security and nutrition. Most producers prefer the use of organic substrate over natural soils when growing crops such as peppers in greenhouses, to ensure that there is a sufficient supply of food all year round.

Field test of the TOXSWA pesticide fate model: Comparison of simulated and observed chlorpyrifos in water, sediment and macrophytes in four stagnant ditches.

TOXSWA is a numerical model describing pesticide behavior in an edge-of-field waterbody. It is widely used to predict exposure in regulatory risk assessment for aquatic ecosystems. Exposure concentrations are predicted based upon pesticide process parameters obtained in standardized laboratory experiments.

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.

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).

Scientific report of EFSA on the 'repair action' of the FOCUS surface water scenarios.

The European Commission asked EFSA to undertake a 'repair action' of the FOCUS surface water report after the EFSA Pesticide Steering Network had been consulted. The main request was to introduce into all FOCUS surface water scenarios (both run-off and drainage) a 20-year assessment period instead of the current 12- or 16-month assessment period. Because of the 20-year assessment period, the way application dates are defined needed to be reviewed, reconsidering the functionality of the pesticide application timing currently used.

Scientific Opinion of the Scientific Panel on Plant Protection Products and their Residues (PPR Panel) on the genotoxic potential of triazine amine (metabolite common to several sulfonylurea active substances).

The Panel received a mandate from the European Commission to assess the genotoxic potential of triazine amine based on available information submitted by the applicants. Available information includes experimental genotoxicity data on triazine amine, Quantitative Structure-Activity Relationship (QSAR) analysis and read across with structurally similar compounds. Based on the overall weight of evidence, the Panel, in agreement with the cross-cutting Working Group Genotoxicity, concluded that there is no concern for the potential of triazine amine to induce gene mutations and clastogenicity; however, the potential to induce aneugenicity was not adequately investigated.

Scientific statement on the coverage of bats by the current pesticide risk assessment for birds and mammals.

Bats are an important group of mammals, frequently foraging in farmland and potentially exposed to pesticides. This statement considers whether the current risk assessment performed for birds and ground dwelling mammals exposed to pesticides is also protective of bats. Three main issues were addressed.

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms.

Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species- and compound-specific and can be used to predict (sub)lethal effects of pesticides under untested (time-variable) exposure conditions. Three different types of TKTD models are described, viz.

Scientific opinion on pesticides in foods for infants and young children.

Following a request from the European Commission, the EFSA Panel on Plant Protection Products and their Residues (PPR Panel) prepared a scientific opinion to provide a comprehensive evaluation of pesticide residues in foods for infants and young children. In its approach to develop this scientific opinion, the EFSA PPR Panel took into account, among the others, (i) the relevant opinions of the Scientific Committee for Food setting a default maximum residue level (MRL) of 0.01 mg/kg for pesticide residues in foods for infants and young children; (ii) the recommendations provided by EFSA Scientific Committee in a guidance on risk assessment of substances present in food intended for infants below 16 weeks of age; (iii) the knowledge on organ/system development in infants and young children.

Scientific Opinion on the state of the science on pesticide risk assessment for amphibians and reptiles.

Following a request from EFSA, the Panel on Plant Protection Products and their Residues developed an opinion on the science to support the potential development of a risk assessment scheme of plant protection products for amphibians and reptiles. The coverage of the risk to amphibians and reptiles by current risk assessments for other vertebrate groups was investigated. Available test methods and exposure models were reviewed with regard to their applicability to amphibians and reptiles.

Scientific Opinion of the PPR Panel on the follow-up of the findings of the External Scientific Report 'Literature review of epidemiological studies linking exposure to pesticides and health effects'.

In 2013, EFSA published a comprehensive systematic review of epidemiological studies published from 2006 to 2012 investigating the association between pesticide exposure and many health outcomes. Despite the considerable amount of epidemiological information available, the quality of much of this evidence was rather low and many limitations likely affect the results so firm conclusions cannot be drawn. Studies that do not meet the 'recognised standards' mentioned in the Regulation (EU) No 1107/2009 are thus not suited for risk assessment.

Investigation into experimental toxicological properties of plant protection products having a potential link to Parkinson's disease and childhood leukaemia.

In 2013, EFSA published a literature review on epidemiological studies linking exposure to pesticides and human health outcome. As a follow up, the EFSA Panel on Plant Protection Products and their residues (PPR Panel) was requested to investigate the plausible involvement of pesticide exposure as a risk factor for Parkinson's disease (PD) and childhood leukaemia (CHL). A systematic literature review on PD and CHL and mode of actions for pesticides was published by EFSA in 2016 and used as background documentation.

Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in-soil organisms.

Following a request from EFSA, the Panel on Plant Protection Products and their Residues developed an opinion on the science behind the risk assessment of plant protection products for in-soil organisms. The current risk assessment scheme is reviewed, taking into account new regulatory frameworks and scientific developments. Proposals are made for specific protection goals for in-soil organisms being key drivers for relevant ecosystem services in agricultural landscapes such as nutrient cycling, soil structure, pest control and biodiversity.

The effect of the runoff size on the pesticide concentration in runoff water and in FOCUS streams simulated by PRZM and TOXSWA.

Within the European Union the exposure of aquatic organisms to pesticides is assessed by simulations with the so-called FOCUS Surface Water Scenarios. Runoff plays an important role in these scenarios. As little is known about the effect of runoff size on the exposure, we investigated the effect of runoff size on the concentration in the runoff water and in streams simulated with the PRZM and TOXSWA models for two FOCUS runoff scenarios.

Monitoring and risk assessment of pesticides in irrigation systems in Debra Zeit, Ethiopia.

Since Ethiopia is going through a rapid transformation of its agricultural sector, we assessed the human health and environmental risks due to the past use of organochlorine pesticides (OCPs) as well as the risks of the current pesticide use by farmers. A monitoring programme and risk assessment was carried out for the Wedecha-Belbela irrigation system in the Debra Zeit area. The Wedecha and Belbela rivers and adjacent temporary ponds were sampled and examined for the presence of OCPs between August and October 2014, while data on the current pesticide use by small- and large-scale farmers was collected by interviews.

Surface water risk assessment of pesticides in Ethiopia.

Scenarios for future use in the pesticide registration procedure in Ethiopia were designed for 3 separate Ethiopian locations, which are aimed to be protective for the whole of Ethiopia. The scenarios estimate concentrations in surface water resulting from agricultural use of pesticides for a small stream and for two types of small ponds. Seven selected pesticides were selected since they were estimated to bear the highest risk to humans on the basis of volume of use, application rate and acute and chronic human toxicity, assuming exposure as a result of the consumption of surface water.

Effects of linuron on a rooted aquatic macrophyte in sediment-dosed test systems.

Effects of linuron on the sediment-rooted aquatic macrophyte Myriophyllum spicatum L. were studied in sediment-dosed test systems following a proposed guideline with extended test duration. Sediment, pore water, overlying water and macrophyte shoots were sampled weekly for chemical analyses.