- Dossier Submission Tools
- R4BP 3
- Inclusion on the list of active substances and suppliers
Inclusion on the list of active substances and suppliers
Article 95 of the BPR has been amended by Regulation (EU) 334/2014 of the European Parliament and of the Council of 11 March 2014.
All active substance manufacturers and importers (the 'substance supplier') placing active substances on the EU market, either on their own or in a biocidal product, that have not already submitted their own dossier on the active substance under the Biocidal Products Directive (BPD) or the Biocidal Products Regulation (BPR) must apply to be included on the 'active substances and suppliers (Article 95) list'. In addition to this, the amendment of the BPR also allows for 'product suppliers' (e.g. formulators) to apply to be included in this list.
For further information, refer to ECHA's Biocidal Products Regulation pages. Please note that the 'Guidance on active substance suppliers' is currently under revision.
Preparing an application
- An application needs to be submitted to ECHA through the Register for Biocidal Products, R4BP 3.
- A dossier in IUCLID 5 format (.i5z-file) is always required for an application. Use the relevant IUCLID template. Refer to Biocides Submission Manual (BSM) 1 ‘Using IUCLID for biocide applications'; the guidance and the legislation.
- Refer also to the supporting documents table for submission requirements. Use the available document templates where appropriate.
Submission through R4BP 3
- Before accessing R4BP 3, an account in REACH-IT needs to be generated. 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 3 ‘Active substances - Part A: Initial submissions'. Under the ‘NEW APPLICATION' tab, select 'Access to active substance dossiers‘. 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 requests from ECHA to provide further information or clarification through R4BP 3, with a deadline indicated. Check your messages and tasks in R4BP 3 regularly. You will find messages related to your application under the ‘Events history' in R4BP 3.
- Biocides Submission Manuals
- Guidance on biocides legislation
- Guidance on data sharing
- Supporting documents table
- Biocidal Products Regulation explained
- Commission Implementing Regulation (EU) No 564/2013 (Fee Regulation)
- Regulation (EU) 334/2014 of the European Parliament and of the Council amending Regulation (EU) No 528/2012