In line with the ruling of the European Court of Justice (C-309/22 and C-310/22 [4]), the potential endocrine disrupting characteristics for humans of the active substance(s) in the plant protection product must be considered based on relevant and credible scientific and technical knowledge available at the time of assessment.

Pending an EU harmonised implementation of the ECJ ruling, Ctgb decided to implement the following interim measures in our processes for all applications under evaluation on or after 01-11-2024, summarised in figure 1. There are three scenario's for the active substance:  

  1. Either the assessment based on the scientific ED criteria has been finalised, and a formal European decision has been taken on the active substance in question.   
    For applications for products based on these substances, we follow the usual EU processes.   

  1. Or the ED assessment has been finalised, however no formal decision has yet been taken on the substance.   
    The renewal assessment report (RAR) is in any case available, including a conclusion on ED in accordance with the scientific criteria from 2018. When peer review has not yet taken place, the competent authority that evaluates the product application (hereafter: the zRMS) checks whether they reach the same conclusion based on the human ED data as the RMS. When peer review has been finalised, the zRMS adopts the outcome of the expert meeting, as noted in the minutes or the outcome reported in the EFSA conclusion, if available.   

  1. Or no conclusion based on the scientific ED criteria is yet available.   
    Then the zRMS itself needs to assess whether such knowledge is available elsewhere, and if so, which conclusion can be drawn. First, the following reliable and relevant sources are consulted, in line with the sources for biocidal co-formulants:  

  • If available, check the BPR opinion (by ECHA's Biocidal Product Committee) of the same substance on ED properties in accordance with the scientific criteria.  

  • Check whether the substance is included on the REACh list of substances of very high concern (SVHC) due to ED properties.   

  • Check whether there are relevant ED assessments ongoing or planned under the REACh framework via the Activity Coordination Tool (ACT).  

In case the substance is not identified as having ED properties in the mentioned sources, the zRMS examines whether a conclusion can be drawn on ED based on the available toxicity data in the active substance dossier. In addition to ED yes/no there is a third option, namely that the knowledge is insufficient to conclude whether the substance is ED in accordance with the scientific criteria, or that it does not meet the conditions set by the ECJ ruling. In that case, there is no knowledge available on the basis of which the substance is considered to have adverse ED properties, and authorisation can be granted.

Figure 1. Flowchart method for taking into account knowledge about ED effects on humans that is available at the time of evaluation.  

Up to and including ‘BPR ED’ = adopt existing conclusion in accordance with the scientific ED criteria agreed.  

* For simplicity, only the option ‘yes’ is shown, namely that the conclusion is that the substance has adverse ED effects on humans. However, when the substance does not cause adverse ED effects on humans, approval is possible.  

From ‘SVHC’ = search for existing knowledge of adverse ED effects of the active substance on humans in designated reliable sources. Need to reassess this knowledge based on the scientific ED criteria – as far as possible.

For new and ongoing applications with the NL as the zRMS and for which no additional questions have yet been asked, the applicant will provide the analysis of the available knowledge about ED effects on humans, which the Ctgb will check.  

For ongoing applications with the NL as the zRMS and where additional questions have already been asked, the Ctgb will analyse this itself at some point during the assessment phase.   

If another zRMS has not applied the method described here - and in many cases that will be until the European method has been amended - Ctgb will still do so in the national addendum. The conclusion of the reporting Member State on the ED component will be complemented, which may also result in the decision of the RMS being changed by the Ctgb for its national authorisation.  

This applies to all current applications except NLKUG, NLWG and applications based on a low-risk substance.  

The ruling does not foresee the generation of new data, therefore, the applicant will not be requested to generate data on ED for a product application.

Please refer our Evaluation Manual.