For dossiers where the Netherlands is the zonal rapporteur, the full NL addendum must be submitted, including TOXSWA-NL calculations. This amendment takes effect on 1 September 2019 only for applications for mutual recognition (NLWERG) and applications for zonal admission for which the Netherlands is a concerned Member State (NLTG and NLRG). Part B Section 9 Ecotoxicology to be used from April 1, 2022įor which dossiers does this simplification of the national assessment apply to environmental aspects where exposure via spray drift is relevant?.Part B Section 8 Environmental Fate to be used from April 1, 2022.Please refer to the templates for the relevant aspects: Section 9.10 (effects on non-target terrestrial plants).Section 9.7 (effects on arthropods other than bees).In the NL addendum B9 – ecotoxicology – only a reference to the core dossier needs to be included in the following sections: the highest initial PECsw value, the scenario in which this highest value is calculated and the scope of permitted use.an overview of the chemical input parameters for the active substance and metabolites.information about the model used and the version number.the input parameters for the model used.In NL-addendum B8 - fate: in Section 8.7 – (Predicted Environmental Concentrations in Surface Water (PECsw)) – only the following information (copied from the core dossier) needs to be reported: When preparing an application dossier, you are required to fill in the NL addendum as follows – for the cases in which it is concluded that no national assessment is required- with regard to the downward spraying of field crops and/or the upwards or sideways spraying of fruit crops (in accordance with the previous table). How will this amended approach affect you? when drift reduction measures are needed that exceed the requirements of the Environmental Activities Decree), a national assessment is still required. For situations in which the zonal assessment is not sufficient (e.g., does not cover the risk for non-target arthropods in the case of downward spraying) and/or does not correspond to Dutch agricultural practices and conditions (e.g. From November 1, 2019, this also applies on applications for which the Netherlands is a zonal RMS. ** the highest calculated concentration of all scenarios relevant to the central zoneįor situations in which the zonal core dossier is sufficient, as of 1 September 2019 the Ctgb will no longer perform a national assessment for applications for mutual recognition and zonal authorisations for which the Netherlands is a concerned Member State. * if PECsediment calculations are necessary, the TOXSWA-NL scenario must still be followed Non-target arthropods (drift mitigation is required in core dossier) Non-target arthropods (no drift mitigation required in core dossier) Non-target plants (drift mitigation required in core dossier) Non-target plants (no drift mitigation required in core dossier) Type of useĪquatic organisms PECsw * - steps 1, 2 and 3 ** (no drift mitigation required in core dossier)Īquatic organisms PECsw - step 4 (drift mitigation) The zonal assessment is described in the ‘core dossier’, while the national assessment is described in the ‘NL addendum’. The analysis was based on the current national and European spray drift data and methodologies.įor each use type, the table below shows for which assessment aspects a zonal assessment is sufficient and in which specific situations a national assessment is still required. This analysis and its results apply only to the use of plant protection products for intended uses that fall under the Environmental Activities Decree. Based on an analysis, the Ctgb has established that in a number of cases the outcome of the zonal assessment, which uses European spray drift data and methodologies, sufficiently covers the risk for the situation in the Netherlands. When calculating the exposure of those organisms to a product, the degree of spray drift of the product to off-field sites, among other aspects, is taken into account.Įuropean spray drift data and methodologies are used for the core section of zonal assessments, while Dutch spray drift data and methodologies are used for the national part of zonal assessments. When assessing an application for the authorisation of a plant protection product, the risks to non-target organisms in the environment are determined.
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