Endocrine disruption assessment for humans for the active substance(s) in a product
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.
From 1 November 2024, the Ctgb will implement the judgment of the European Court of Justice. Therefore, the following procedure will be used:
At the time of a product evaluation, there are three possible scenarios regarding the active substance in the product in question:
(a) the evaluation based on the three ED scientific criteria has been completed, and a formal European decision has been taken on the active substance in question;
(b) an ED assessment has been carried out but no formal decision has yet been taken on the substance;
(c) no conclusion based on the scientific ED criteria is yet available.
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.