Annex I amendment
Amendment of Annex I to the BPR (first inclusion of an active substance or amendment of restrictions)
You can submit an application for the first inclusion of an active substance in Annex I to the Biocidal Products Regulation (EU) 528/2012 (BPR), or an application for the amendment of the relevant restrictions on that inclusion, through the Register for Biocidal Products, R4BP 3.
The application must include sufficient data to demonstrate that the substance does not give rise to concern within the meaning of Article 28(2) of the BPR.
Refer to ECHA's Biocidal Products Regulation pages and to the Commission Implementing Regulation (EU) 88/2014 specifying a procedure for the amendment of Annex I for information on the decision-making process.
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
For application requirements and information on how to prepare your dossier in the IUCLID 5 format (.i5z), consult the ‘Guidance on information requirements', the Biocides Submission Manuals (BSM 1: ‘Using IUCLID for biocide applications' and BSM 3a: ‘Active substances: Initial submissions') and the video tutorials available on the ECHA website.
- The dossier creation wizard, in IUCLID 5, will assist you in creating your dossier.
- Ensure you include the additional supporting document for this process. Supporting document templates are available on the ECHA website.
- In case you would like to apply for the inclusion of your active substance in Annex I category 7 please contact the ECHA Helpdesk.
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 amendment of Annex I does not have a specific application ‘wizard' in R4BP 3. Therefore, under the ‘NEW APPLICATION' tab on the R4BP 3 taskbar, select ‘Approval of active substance' 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 3A: ‘Active Substances: Initial submissions'.
Follow-up in R4BP 3
Regularly check your message list and task items in R4BP 3, to monitor the status of your submission and receive/react to requests from the Authorities.
You will find various types of messages under the ‘MESSAGES' tab in R4BP 3, for example:
- the result of the format check,
- notification for invoices with a 30-day payment deadline (see BSM 5 'Invoicing in R4BP 3'), and
- the result of the ECHA acceptance step.