National authorisation - major change on request
A major change of a product is a change that can be expected to affect the conclusion with regard to the fulfilment of the conditions of Articles 19 or 25 of the Biocidal Products Regulation (BPR).
The Changes Regulation (Regulation (EU) No 354/2013) sets out the procedure to apply for a major change to a product authorisation. The grouping of changes is also possible in certain circumstances.
If an intended change is not listed in one of the tables in the Annex to the Changes Regulation, or if the authorisation holder is unable to determine the category to which their intended change belongs, they may request ECHA to issue an opinion on the classification of the change. A separate application for an opinion must be submitted for each change sought.
Preparing an application
- Prepare your dossier in IUCLID 5 format (.i5z). Use the relevant IUCLID template. Follow the instructions in the Biocides Submission Manuals: BSM 1 ‘Using IUCLID for biocide applications'; BSM 2 'Using R4BP 3 for biocide applications‘; the Guidance on information requirements as well as the legislation and the video tutorials.
- Refer also to the supporting documents table for submission requirements. Use the available document templates where appropriate.
Submission through R4BP 3
- Sign up for REACH-IT. Import your IUCLID dossier. Refer to BSM 2 ‘Using R4BP 3 for biocide applications' for instructions.
- Log into R4BP 3 with your User ID and password defined in REACH-IT. Refer to BSM 4 ‘Biocidal Products - Part B: National authorisation changes on request'. Access your asset for national authorisation in R4BP 3and create a new case for ‘National authorisation major change on request'. The submission wizard will guide you through the submission process.
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
Regularly check your messages and tasks in R4BP 3. You will find various types of messages under the ‘MESSAGES' tab in R4BP 3, for example:
- Result of the format check
- 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.