Simplifying the national addendum for environmental aspects involving spray drift exposure for applications for mutual recognition and zonal authorisation where the Netherlands is a concerned Member State

When assessing an application for the authorisation of a plant protection product, the risks to non-target organisms in the environment are determined. 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.

European 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. 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. This analysis and its results apply only to the use of plant protection products for intended uses that fall under the Environmental Activities Decree.

The analysis was based on the current national and European spray drift data and methodologies.

For 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. The zonal assessment is described in the ‘core dossier’, while the national assessment is described in the ‘NL addendum’.

Type of use

Field crops

(downward spraying)

Fruit crops

(upwards and sideways spraying)

Avenue trees

(upwards and sideways spraying)  

Assessment aspect

Aquatic organisms PECsw * - steps 1, 2 and 3 ** (no drift mitigation required in core dossier)

Core dossier sufficient

Core dossier sufficient

NL addendum required

Aquatic organisms PECsw - step 4 (drift mitigation)

NL addendum required

NL addendum required

Non-target plants (no drift mitigation required in core dossier)

Core dossier sufficient

Core dossier sufficient

Non-target plants (no drift mitigation required in core dossier)

NL addendum required

NL addendum required

Non-target arthropods (no drift mitigation required in core dossier)

NL addendum required

Core dossier sufficient

Non-target arthropods (drift mitigation is required in core dossier)

NL addendum required

NL addendum required

*              if PECsediment calculations are necessary, the TOXSWA-NL scenario must still be followed

**            the highest calculated concentration of all scenarios relevant to the central zone

For 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. 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. when drift reduction measures are needed that exceed the requirements of the Environmental Activities Decree), a national assessment is still required.

How will this amended approach affect you?

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). 

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:

  1. the input parameters for the model used;
  2. information about the model used and the version number;
  3. an overview of the chemical input parameters for the active substance and metabolites;
  4. the highest initial PECsw value, the scenario in which this highest value is calculated and the scope of permitted use.

In the NL addendum B9 – ecotoxicology – only a reference to the core dossier needs to be included in the following sections:

  • Section 9.7 (effects on arthropods other than bees)
  • Section 9.10 (effects on non-target terrestrial plants)

Please refer to the templates for the relevant aspects:

For which dossiers does this simplification of the national assessment apply to environmental aspects where exposure via spray drift is relevant?

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). For dossiers where the Netherlands is the zonal rapporteur, the full NL addendum must be submitted, including TOXSWA-NL calculations.

The Ctgb is currently discussing whether this method can also be extended to the national addendum for applications for which the Netherlands carries out the zonal assessment as a zonal rapporteur. You will be informed as soon as a decision has been taken.

No changes in the Ctgb Tariffs Decree 2019 for these applications

The Ctgb sets its fees and charges annually. The fees and charges for the assessments of the types of applications to which the simplified method applies are therefore fixed in advance and are based on an average assessment time. The Ctgb can only change the fees and charges in the interim in very exceptional cases. Due to the simplification of the assessment, the average assessment time is expected to be reduced somewhat, but how much that is will only become clear in the course of 2019. When amending the fees and charges for 2020, any time savings will be taken into account if possible.