Union authorisation

A Union authorisation is valid throughout the Union unless otherwise specified and grants the same rights and obligations in each Member State as a national authorisation.

You can apply for the Union authorisation for a product that has similar conditions of use throughout the Union. Refer to ECHA's Biocidal Products Regulation pages and to the legislation for the conditions, exceptions and the decision-making procedure.

For a biocidal product containing a new active substance that has not yet been approved, a provisional Union authorisation can be granted for a maximum period of three years with a possible one year extension, provided that certain conditions are fulfilled (a dossier for the new active substance has been evaluated and the evaluating competent authority has submitted a recommendation to ECHA for approval and the biocidal product has to comply with points b), c) and d) of Article 19(1) taking into account the factors set out in Article 19(2)). The provisional Union authorisation can be requested for both a single Biocidal Product and a Biocidal Product family. For further information, please consult Article 55(2) of the BPR.

Submit your application through the Register for Biocidal Products, R4BP 3. 

  • Preliminary information should be submitted to ECHA before submission of the application for Union authorisation. Refer to the Biocides Submission Manual (BSM) 4 'Biocidal products: Part A. Initial submissions' for details. Contact ECHA Helpdesk if you would like to submit.
  • If the authorisation holder is an SME established in the EU you as the applicant will be entitled to a reduced fee.  ECHA needs to recognise the authorisation's holder 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 product does not contain a substance which is candidate for substitution.

Preparing an application

  • Prepare your dossier in IUCLID 5 format (.i5z). Refer to the Biocide Submission Manuals: BSM 1 'Using IUCLID for biocide applications'; BSM 2 'Using R4BP 3 for biocide applications'; BSM 4 'Biocidal products: Part A. Initial submissions'; the '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. Refer to BSM 4 'Biocidal products: Part A. Initial submissions' for instructions. Under the 'NEW APPLICATION' tab, select 'Union authorisation'. 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.
  • Notifications 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 depending on the processing step.

Categories Display

Tagged as:

(click the tag to search for relevant content)