Temporary restriction on influx of applications
The Ctgb has ascertained an increase in the demand for assessment capacity in European Union and in the number of requests for the Ctgb to act as reporting Member State. In recent years, the Ctgb has responded to this increased demand through controlled growth as an organisation. As a result, the Ctgb has accepted more than its fair share of applications for products and substances for biocides and plant protection. Overall, however, there is still a shortage of EU assessment capacity among the competent authorities in the Member States, and that shortage has been exacerbated by brexit. The Ctgb is prioritising this issue in various EU consultations because the Member States have to solve this problem together.
Applications for authorisation have become more extensive and more complex. This is because many uses are being requested, products are being grouped into biocidal product families, the quality of biocidal product dossiers is occasionally poor and often there is no harmonised assessment framework. In application dossiers for plant protection products, especially for ecotoxicology, more and more changes or refinements are required to ensure safe use. EU procedures are also becoming increasingly intensive and challenging. Notable examples of this are the assessments of endocrine-disrupting properties and neurotoxicity. Currently, the workload at the Ctgb is higher than the available capacity, resulting in problems with predictability and turnaround time. This has compelled us to take measures. One of these measures is that the influx of applications will be temporarily restricted. In addition, if possible, work will be outsourced to evaluating bodies. Every year it will be assessed whether continued restriction of the influx will be necessary, and whether outsourcing to evaluating bodies and continuing the controlled growth of the organisation are necessary and feasible to stabilise and reduce the backlog.
For plant protection products, the influx (acceptance) of zonal applications (for new products and changes to and extensions of existing product authorisations) with the Ctgb as zonal rapporteur Member State (zRMS) and active substance applications with Ctgb as reporting Member State (RMS) will be limited. For new active substances for which Ctgb was the RMS, in principle Ctgb will take the role as zRMS for the zonal application for authorization of the representative formulation (first authorization).
For biocidal products, the influx of applications for National and Union authorisations (and renewal or amendment of such authorisations) with the Ctgb as evaluating Competent Authority (eCA) will be restricted, as will the influx of applications for approval of new active substances.
These measures will not affect previous commitments. As usual, you can submit a request for the Ctgb to accept your application as reporting Member State to the Account Manager for Biocidal Products or Plant Protection Products.