Compendio degli studi più significativi con riferimento a proprietà, assunzione, effetti.

Dobe C, Bonifay S, Fliege R, Krass J, Mostert V, Vosswinkel R, Wormuth M. Development of REACH Generic Exposure Scenarios for Substances Used as Coformulants in Plant Protection Products. Risk Anal. 2017 May;37(5):930-942. doi: 10.1111/risa.12666.

Abstract. This article reviews the interactions between the REACH (Registration, Evaluation, Authorization and restriction of Chemicals) regulation and the plant protection product regulation for substances used as coformulants in the European Union, and describes generic exposure scenarios developed for their exposure and risk assessment. The REACH exposure scenarios describe the operational conditions and risk management measures used in the risk assessment of a coformulant, and as such these translate as the boundaries of safe use. 

Guidance on Information Requirements and Chemical Safety Assessment - ECHA (europa.eu) 

Abstract. This guidance describes the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, in the context of the chemical safety assessment. It is part of a series of guidance documents that are aim to help all stakeholders with their preparation for fulfilling their obligations under the REACH Regulation.

Straw EA. A Brief Note on Pollinator Exposure to Co-Formulants and Adjuvants. Environ Toxicol Chem. 2022 Jul;41(7):1584-1585. doi: 10.1002/etc.5344. 

Abstract. Bees and other pollinators are exposed to co-formulants and adjuvants at very high levels in agriculture. Thorough, targeted, assessment of the toxicity of co-formulants and adjuvants is urgently required. 

Karaca M, Fischer BC, Willenbockel CT, Tralau T, Marx-Stoelting P, Bloch D. Effects of co-formulants on the absorption and secretion of active substances in plant protection products in vitro. Arch Toxicol. 2021 Oct;95(10):3205-3221. doi: 10.1007/s00204-021-03140-x. 

Abstract. Currently, the authorisation process for plant protection products (PPPs) relies on the testing of acute and topological toxicity only. Contrastingly, the evaluation of active substances includes a more comprehensive set of toxicity studies. Nevertheless, mixture effects of active ingredients and co-formulants may result in increased toxicity. Therefore, we investigated effects of surface active co-formulants on the toxicity of two PPPs focussing on qualitative and quantitative toxicokinetic effects on absorption and secretion....

Balmer ME, Janser D, Schaller U, Krauss J, Geiser HC, Poiger T. Magnitude and decline of pesticide co-formulant residues in vegetables and fruits: results from field trials compared to estimated values. Pest Manag Sci. 2021 Mar;77(3):1187-1196. doi: 10.1002/ps.6128. 

Abstract. The application of plant protection products (PPPs) leads to the formation of residues in treated crops. Even though PPPs contain considerable amounts of co-formulants, regulation and monitoring of residues normally focus on the active substances (a.s.) only. For our study we selected four commonly used co-formulants (three anionic surfactants and one organic solvent) and investigated the formation and decline of residues in vegetables and apples under field conditions. The aims were to characterize the behavior of co-formulant residues on crops and to provide a basis for future investigations on consumer exposure....

Mostert V, Bonifay S, Dobe C, Fliege R, Krass J, Vosswinkel R, Wormuth M. REACH Worker Exposure Model for Co-formulants Used in Plant Protection Products. Ann Work Expo Health. 2019 Jan 7;63(1):54-67. doi: 10.1093/annweh/wxy088.

Abstract. ...This work reports a customized screening level model developed to support human health risk assessment of operators, workers, and bystanders (OWB) for co-formulants used in PPP....

Matthies M, Berding V, Beyer A. Probabilistic uncertainty analysis of the European Union system for the evaluation of substances multimedia regional distribution model. Environ Toxicol Chem. 2004 Oct;23(10):2494-502. doi: 10.1897/03-529. 

Abstract. The European Union System for the Evaluation of Substances (EUSES) is a computerized model system to facilitate and harmonize health and environmental risk assessment of previously notified and new substances. For calculation of regional background exposure, a multimedia distribution model is used. In the present study, the uncertainty of this regional model is analyzed. Environmental parameters were collected for North Rhine Westphalia (Germany), which resembles the standard region of EUSES. Probability distribution functions of various types (uniform, triangular, normal, log normal) depending on data availability were derived for environmental input parameters, including geometric parameters. Generic log-normal distribution functions with fixed standard deviations were chosen for solubility in air, water, and n-octanol as well as for degradation half-lives. Monte Carlo simulations were carried out for 10 reference substances having different properties. Contribution of environmental parameter uncertainty to total output uncertainties is higher than that of substance parameters. Range of output uncertainty, defined as the ratio of the logarithms of the 90th and 10th percentiles of the cumulative probability distribution function, shows an increase from air and water to soil. The highest-occurring range is 1.4 orders of magnitude, which means that total uncertainty of the regional model is relatively low and, usually, is lower than the range of measured values. The median of output probability distributions lies above the point estimate. Influence of input parameters was estimated as their rank correlation coefficients to output uncertainty. Substance and environmental parameters contribute differently to output variance depending on individual substance properties and environmental compartment. Hence, the present study underlines the need to perform uncertainty analyses instead of either using a set of simple rules or just looking at certain parameters.

Reihlen A, Bahr T, Bögi C, Dobe C, May T, Verdonck F, Wind T, Zullo L, Tolls J. SPERCS-A tool for environmental emission estimation. Integr Environ Assess Manag. 2016 Oct;12(4):772-81. doi: 10.1002/ieam.1745.

Abstract. The European Union (EU) chemicals regulation Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires a hazardous substance registration to identify the uses of a substance and the corresponding conditions of safe use. This requirement includes a human and an environmental safety assessment. Exposure scenarios are developed and employed for estimating emissions resulting from the uses of hazardous substances.