- Tools voor indiening van een dossier
- R4BP 3
- Amendment to the conditions of an approved active substance
Amendment to the conditions of an approved active substance
Any person wishing to apply for an amendment to the conditions of an approved active substance must submit an application to ECHA through the Register of Biocidal Products, R4BP 3.
Refer to ECHA's Biocidal Products Regulation pages and to the legislation for information on the decision-making process.
For more information concerning the process (in particular availability and data requirements), please contact the Member State who will act as the evaluating Competent Authority. This Member State will need to liaise with the relevant parties, including the European Commission and the Agency.
If the manufacturer of the active substance is an SME established in the EU you as the applicant will be entitled to a reduced fee. ECHA needs to recognise the manufacturer's SME status before you submit your application. Please refer to the SMEs section on the ECHA website. SME fee reductions shall only be granted when the active substance is not a candidate for substitution.
Preparing an application
- Prepare your dossier in IUCLID 5 format (.i5z). Refer to the Biocides Submission Manuals: BSM 1, ‘Using IUCLID for biocide applications'; BSM 3 ‘Active substances – Part A: Initial submissions'; ‘Guidance on information requirements' as well as the legislation and the video tutorials.
- A dossier creation wizard will assist you in creating your dossier.
- 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. 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. Click on ‘NEW APPLICATION and select ‘Approval of active substance'. The submission wizard will guide you through the submission process.
Follow-up in R4BP 3
Check your messages and tasks in R4BP 3 regularly. You will find various types of messages under the ‘MESSAGES' tab in R4BP 3, for example:
- Result of the format check.
- Notification for invoices with a 30-day deadline that needs to be met. See BSM 5 'Invoicing in R4BP 3.
- 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.