The CTGB adapts its working methods to a recent European Court of Justice ruling
In light of two rulings by the European Court of Justice (ECJ), the Ctgb is implementing changes to its operational method. These changes involve the scope and interpretation of some provisions of the European Plant Protection Products Regulation. The ECJ ruling is the result of a request from a Dutch court in various appeal procedures. In the interest of society, the Ctgb wants to adapt its current operational methods as soon as possible to the possibilities offered by the ECJ ruling. These adaptations are aligned with the anticipated EU working agreements and the pending appeals before the national court. The new methods will apply to applications for authorisation of plant protection products that are pending on 1 November 2024 or are submitted after that date.
Using the latest knowledge
The ECJ stated that the Ctgb may always rely on the latest relevant and credible scientific and technical knowledge when it assesses a product. Even if another Member State (in a zonal assessment) previously concluded that the product is acceptable without taking account of that knowledge, the Ctgb may deviate from this conclusion if the latest knowledge indicates unacceptable risks. Indeed, if the latest knowledge points specifically to endocrine-disrupting effects in humans, this deviation is mandatory.
This means that from now on, when assessing a product the Ctgb will look at whether new and credible scientific/technical knowledge on endocrine disruption in humans has recently been developed. If so, the Ctgb will take this into account. Furthermore, the Ctgb will use new guidelines and methodologies as soon as they are published by EFSA or a similar body, even if they have not yet been finalised. Key conditions for this are that the new guidelines and methodologies must be 'stricter' than those used previously AND that the existing data package can be used. If essential data are still missing, this may mean that the new guideline cannot yet be implemented. It its authorisation decision, the Ctgb will explain which guideline/methodology was used and why.
It is not entirely new for the Ctgb to consider additional or new knowledge when assessing a product. For instance, it already takes nationally-specific elements into account if environmental or use conditions in the Netherlands differ from those in the international assessment. In addition, the Ctgb can intervene in an existing authorisation when harmful or unacceptable effects are observed or reported.