Environment

Environmental behaviour: models regarding the entry of plant protection products into non-target areas

EVA3 (rev2h)

Estimation of deposition caused by drift and volatilisation of active substances contained in plant protection products in non-target areas (Exposure Via Air).

The program EVA3 calculates PEC and TER values for adjacent surface waters (water bodies, sediment) and terrestrial ecotones on the basis of current basic drift values and empirical models for deposition after volatilisation as introduced by the programs EVA 2.0 and EVA 2.1. Volatilisation is examined for treated crops outdoors and in greenhouses. To support FOCUS step 4 calculations, time-resolved values for deposition after volatilisation on a 1-h time scale from 0-24 h are provided on a separate worksheet.

Application patterns can be entered for up to 12 single applications and variable application rates, intervals and drift scenarios. The user is free to choose the units for the application rate and PEC. Corresponding entry fields are provided for the exposure-decisive substance properties. Either PECact or PECtwa can be selected for deposition in water bodies. The PECtwa calculation is based on a flexible time frame. The twa interval is calculated automatically with the maximum resulting PECtwa. For substances with very short half-lives in the target compartment (< 24 h), a reduced effective volatilisation within 24 h compared to the standard value is automatically taken into account.

In line with the convention that was introduced with the first version of EVA, deposition after volatilisation is considered only for the final spraying event within a multiple-application scheme. However, for multiple-application schemes with varying application rates or intervals, which can now be modelled with EVA3, this convention does not necessarily represent the "realistic worst case". Therefore, two additional options were implemented in EVA3 to identify this "realistic worst case" (consideration of deposition after volatilisation either for the single spraying event with the highest application rate or the single spraying event that leads to the highest concentration in the target compartment due to spray drift).

Based on the calculated PEC values and the data entered by the user regarding ecotoxicity and the necessary safety factor, the TER values are calculated for aquatic or terrestrial organisms depending on what was selected previously. Furthermore, the conditions of application required to achieve an acceptable risk level are displayed. These should always be checked by the user.

The basic principles for exposure estimation and useful information are provided as spreadsheets in the program's xlsm file. These can be displayed via the page "Start". In a similar manner, the worksheet with the time-resolved results for deposition after volatilisation can be made visible via a toggle button on the worksheet "vd". To be able to do so, macros have to be activated. All other program functions are executed via Excel functions only and do not require the activation of macros. The program was written and tested with Excel versions 2007 to 2013. The operability of the program with older Excel versions cannot be guaranteed.

In the current version (rev2h), an error has been corrected, which occurred in the calculation of entries via volatilisation and deposition and was related to the limiting impact of the water solubility of a compound on surface water entries via this pathway. The error resulted in wrong PEC values for water and sediment. Therefore, only the version rev2h should be used for calculations, in particular for (semi-)volatile compounds, and the previous version rev2e should no longer be applied.

The current version further contains the option, as already included in version rev2e, for assessing the consequences of multiple application of a plant protection product by applying the concept of effect cumulation (see EFSA Journal 2014;12(7):3800; Appendix E). This option has been implemented for information purposes, but it is not yet applied for regulation in Germany.

EVA offers the possibility to enter experimentally determined deposition data as a refinement option of the exposure estimation for the volatilisation/deposition pathway. Such data can be determined in volatilisation experiments in the wind tunnel. A method description for conducting such investigations is available below.

EXPOSIT 3.02

Calculation of the entry of plant protection products into surface and groundwater, particularly taking into consideration surface run-off and drainage

The currently valid version of the model EXPOSIT 3 (version 3.02) is referred to for the evaluation in the national authorisation procedure of plant protection products (download link at the end of this page).

In version 3.02 of the model the differentiation between KocRunoffaustrag and KocGefährdungsklasse made in version 3.01 has been cancelled. The single Koc value to be selected for total discharge as well as for selection of the hazard class is now derived from the results of the EU evaluation of the active substance. As a further simplification for the user additional sheets “Report” and “90. Perz.” have been inserted.

Active substances for which lower elimination factors are used for bank infiltration due to experimental data can be selected in the spreadsheet with their individual elimination factors.

Comments and documentation on the basic approach for exposure estimation and the use of PEC values for the aquatic risk assessment are included in the model file on separate sheets.

As of now the new version EXPOSIT 3.02 may be used for the preparation of dossiers for the procedure of plant protection product authorisation. For applications submitted as of 1st August 2018 the use of EXPOSIT 3.02 is mandatory.

If a security warning appears when the model file is opened, macros may have to be activated.

Interim refinement option for the discharge pathway run-off:

Owing to the modifications in the assumed reduction capacity of vegetated filter strips with the changes in the model (from EXPOSIT 2.0 to EXPOSIT 3.01), products or intended uses may turn out to as to no longer fulfil the authorisation criteria. Where it is possible to prove a safe use by considering the reduction capacity of vegetated filter strips according to the parameterisation in the model EXPOSIT 2.0 (taking into account, where relevant, reduced bank infiltration capacity), an interim refinement option for the discharge pathway run-off is, in principle, available (see pdf document linked to in the right column). This refinement option is maintained regardless of the version upgrade from EXPOSIT 3.01 to EXPOSIT 3.02.

PELMO

The possible entry of plant protection products into groundwater is assessed on the basis of results from simulation calculations, and experimental studies if appropriate (lysimeter studies, field leaching studies). The FOCUS-PELMO model is used for modelling the leaching behaviour of active substances contained in plant protection products for the authorisation procedure. The new FOCUS-PELMO version 6.6.4 is available since June 2021 and is applicable from 1st January 2022 for all active substance evaluations on EU-level as well as all authorisation procedures for plant protection products. Until then FOCUS-PELMO version 5.5.3 is applicable. All versions of the model can be accessed here.

The programme AppDate is for choosing the application date and interceptions in different crops. The new version 3.0 is to be used only in combination with FOCUS-PELMO 6.6.4 since changes have been made in both components. AppDate can be accessed here.

As of May 2015 the European assessment guideline „EFSA Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil“; EFSA Journal 2014; 12(5);3662, is implemented. It is applicable to applications for approval of active substances on EU-level (AIR 3 procedure) as well as to applications for product authorisation submitted after this date. Further information on the implementation of this Guidance Document in the authorisation procedure in Germany can be found here. In principle, aggregate endpoints for degradation (DT50) and adsorption (Kfoc, 1/n) from the evaluation on EU-level (List of Endpoints) can be used as input parameter for modelling of predicted groundwater concentrations with FOCUS-PELMO.

ESCAPE 2

The ESCAPE model in version 2 is available for calculating the anticipated concentration of active substances contained in plant protection products and of metabolites in soil. This model developed by the Fraunhofer Institute for Molecular Biology and Applied Ecology ("Fraunhofer IME") also enables higher tier simulations of PECsoil values in addition to standard calculations, including the calculation of plateau concentrations. The link to the program can be found at the end of this page.

Ecotoxicology

Submission of all relevant data and information for ecotoxicological assessment

For an application for the approval of an active substance or for the authorisation of a plant protection product, a complete dossier must be submitted containing all biological data and information significant for assessing the ecotoxicological profile of the active substances and products, including all the potentially harmful effects observed during ecotoxicological studies. The data must suffice to be able to judge the impact on non-target species and to determine risk mitigation measures. These requirements originate from the data requirements for active substances and plant protection products (Regulation (EU) No 283/2013, Regulation (EU) No 284/2013) as well as the uniform principles (Regulation (EU) 546/2011).

Therefore, existing studies on salt and brackish water species must be submitted with the dossiers, e.g. Americamysis bahia and Crassostrea virginica. These studies which were generated for the North American authorisation procedure represent relevant information for assessing the ecotoxicological profile of a substance, especially if these studies provide the endpoint which is relevant for assessment, it being the most sensitive.

Evaluations by the Federal Environment Agency (UBA) and also a corresponding expert opinion for EFSA (Klok et al. 2012): Literature review on the sensitivity and exposure of marine and estuarine organisms to pesticides in comparison to corresponding fresh water species. Supporting Publications: EN-357) do not show a systematic difference in ecotoxicological sensitivity between fresh water species and salt or brackish water species so that in certain individual cases the applicant could only be understood for not considering this when a comprehensible and active substance-related justification is provided.

Risk assessment for birds and mammals

The assessment of the risk for birds and mammals in the authorisation procedure has been based on the EFSA-Guidance Document on risk assessment for birds and mammals since 1 July 2010. The BVL has updated the standard values to be used in model calculations for refined risk assessments through a notification concerning the implementation of this Guidance Document.

This notification will be repealed as of 31 December 2022. For marketing authorisation applications submitted on or after 1 January 2023, the risk assessment with regard to effects on wild birds and mammals will be carried out without generic national refinement (see technical information of 1 July 2022, only in German).

Data requirements for chronic toxicity to honeybees

Transitional provisions are laid down for applications which have been submitted to the BVL before 30 June 2020:

On the page "Bee protection in the authorisation of plant protection products” you will find general information on the protection of bees in the authorisation process and on appropriate risk-management measures.

Links and documents

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