Simplified authorisation of biocidal products
Biocidal products and product families can be authorised in a simplified procedure under certain conditions. A holder of a simplified authorisation can make the biocidal product available on the market in other EU Member States without mutual recognition but needs to notify the Member State in question at least 30 days before placing the product on its territory.
Refer to ECHA's Biocidal Products Regulation pages and to the legislation for the conditions of simplified national authorisation and the decision-making process. Submit your application through the Register for Biocidal Products, R4BP 3.
Preparing an application
- Prepare your dossier in IUCLID 5 format (.i5z). Follow the instructions in the Biocides Submission Manual (BSM) 1, ‘Using IUCLID for biocide applications'; BSM 2 ‘Using R4BP 3 for biocide applications'; ‘Guidance on information requirements'; 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. Refer to BSM 4, ‘Biocidal Products – Part A: Initial submissions'.
- Under the ‘NEW APPLICATION' tab, select ‘National authorisation – simplified procedure'. The submission wizard will guide you through the submission process
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.