- Dossier Submission Tools
- R4BP 3
- Renewal of authorisations subject to mutual recognition
Renewal of authorisations subject to mutual recognition
Article 31 of the BPR has been supplemented by Commission Delegated Regulation (EU) No 492/2014.
Applicants who wish to have renewed national authorisations for one or more product-types that were subject to, or granted through, mutual recognition, must submit an application at least 550 days before the earliest expiry date of the concerned national authorisation.
The application shall be submitted to the reference Member State (the Member State which evaluated the initial application or the Member State chose by the applicant, with written confirmation that the Member State agrees to be responsible for the evaluation). At the same time, the application needs to be submitted to all other Member States where the renewal is sought. A separate application is needed for each concerned Member State.
The renewal of applications for authorisation is made through the Register for Biocidal Products, R4BP 3. Refer to the legislation, in particular Article 31 of the BPR and Commission Delegated Regulation (EU) 492/2014, for more information on the renewal and the decision-making process.
N.B. This is only possible for authorisations having the same terms and conditions at the time of the application for renewal in all the Member States where the renewal is sought, unless one of the exceptions under Article 1(3) of Commission Delegated Regulation (EU) 492/2014 applies.
Preparing an application
Your application to the reference Member State must always include an IUCLID dossier with at minimum the information on the product composition; in addition, any new data that has been generated since the initial authorisation (or previous renewal), must also be included in the IUCLID 5 file.
Where the renewal is sought for authorisations granted under the BDP, the inclusion of the previously submitted technical and scientific data in IUCLID 5 format is optional.
For all of the subsequent applications to concerned Member States, an IUCLID 5 dossier is not required.
- Prepare your dossier in IUCLID 5 format (.i5z). Refer to the instructions in the Biocides Submission Manuals: BSM 1, 'Using IUCLID for biocide applications', and BSM 2 'Using R4BP 3 for biocide applications'; also consult the Guidance on information requirements, as well as the legislation and video tutorials. A dossier creation wizard will assist you in creating your dossier.
- Refer to the supporting documents table for submission requirements. Use the available document templates, where appropriate.
Submission through R4BP 3
- Login to R4BP 3 with your ‘User ID' and password that was defined during account creation in REACH-IT. Refer to BSM 2: ‘Using R4BP 3 for biocide applications' for detailed instructions on account creation.
- The Renewal of national authorisation subject to, or granted through, mutual recognition does not have a specific new application ‘wizard' in R4BP 3. Therefore, under the ‘NEW APPLICATION' tab on the R4BP 3 taskbar, select ‘''Renewal of national authorisation' from the list of processes. The application ‘wizard' will guide you through the submission process.
- For more information, refer to the Biocides Submission Manuals: BSM2: 'Using R4BP 3 for biocides applications' and BSM 4 'Biocidal products - Part A. Initial submissions'.
If your asset is not visible in R4BP 3 it may be that the relevant national authorisation has not yet been migrated from R4BP 2 to R4BP 3. In this case, please refer to the ‘Migration' Q&A section on the ECHA website or contact the ECHA helpdesk for further advice on how to proceed with your application.
Follow-up in R4BP 3
Check your messages and tasks in R4BP 3 regularly. The various types of messages under the 'MESSAGES' tab in R4BP 3 may include e.g.:
- Result of the format check (including a possible resubmission request).
- Result of the acceptance step.
You may also receive authority requests for more information through R4BP 3 with a deadline. The requests will appear under TASKS. If you fail to meet the deadline, your application may be rejected or the evaluation may be completed disregarding the information that has been provided too late, depending on the processing step.