Acceptance of national and Union authorisation applications
The Ctgb receives many requests (notifications) to act as evaluating Competent Authority (eCA) for EU national applications and Union authorisations under the BPR. In recent years, the Ctgb has therefore extended its evaluation capacity. The objective was to accept all requests to act as eCA and to finalise the applications within the BPR timelines. However, the BPR applications take more time than expected, especially due to the extra hours needed to ‘defend’ the authorisations in the EU. This has consequences for the processing times: the timelines will therefore not be met for many of these applications. There are also possible consequences for the number of applications that the Ctgb can accept in the next few years.
Many Member States are currently facing the same types of problems. We therefore recommend contacting Member States that could potentially act as eCAs at an early stage, at least 1.5 to 2 years before the planned date of submission of the application dossier.
The Ctgb is currently making an inventory of the exact amount of work required for the applications that have already been submitted in relation to the available assessment capacity for biocides. Therefore, the Ctgb is not yet able to provide any commitment about acceptance for new BPR applications for national and Union authorisation that have to be submitted in 2018 and 2019 and have not been notified previously. For the time being, the Ctgb can accept notifications for applications with a submission date in 2020 and later. You can address your notification or requests for further information to the Ctgb biocides account manager.