Directions for application under BPR
Procedure Biocidal Products Regulation
The procedures for each type of application are described in brief below. For more information, please refer to the Biocidal Products Regulation. The role of the Board is also described in brief. Our tool 'How to apply?' leads you through a series of questions to the relevant application type.
Before submission of your application, you must approach the evaluating competent authority you wish to evaluate your application, and ask them for a written agreement. The agreement needs to be included in your application.
If you wish The Netherlands (Ctgb) to act as eCA, please contact Cindy van der Meer.
Pre-submission meeting (PSM)
Under the BPR, a pre-submission meeting is mandatory as soon as the eCA agreement has been signed. In addition, it is possible to request an extra PSM during the further preparation of the application file to discuss bottlenecks in this application file or questions about the application procedure. For details, see our information on Pre Application Support.
Submission must be done via R4BP. Instructions are given in ECHA’s Manual on using R4BP. The application must refer to the active substance dossier in IUCLID and must include a draft Assessment Report in Word format. Instructions can be found on the ECHA website. All documents should be in English.
The intake process for biocidal product applications uses a priority list to assess whether each aspect of the application meets the required quality and whether the dossier contains all the elements needed to be able to assess the application.
Biocides applications under the Regulation must be made through R4BP, while applications for biocides under transitional legislation and plant protection products and substances should be submitted online to the Ctgb.
Please note that the priority list is not exhaustive; applications that comply with all the points on the priority list may still require additional information before the dossier contains all the elements needed to start the assessment.
First the Ctgb starts with the intake phase to conduct a critical assessment about whether all the studies provided by the applicant meet the criteria. The actual assessment begins only after the application dossier is complete. During the assessment, the possible exposures to substances for humans, animals and the environment are calculated. These calculated exposures are then compared with the safe values. In this way, the risks of using the product are specified. If the assessment indicates that the product can be used safely and that it is effective, then the Board will decide to authorise the product.
The Ctgb assesses the risks and how these should be assessed and reviewed according to the prevailing regulations and directives. We refer to this as the the assessment framework. The framework applies to all EU Member States. However, country-specific rules and requirements may also apply. The adoption of these laws and regulations is a political process.
After the Ctgb secretariat has prepared a decision, a draft decision is submitted to the Board of the Ctgb. The Board checks the draft decision to make sure it is correct and then makes a decision on the application (whether or not to authorise the product). All decisions concerning an authorisation can be appealed. See also Public disclosure of studies.