Union authorisations

Make sure that you have everything you need before making your application.

You will see what you need in these places:

  • The Biocides Submission Manual (BSM) ‘Application instructions: Union authorisations'
  • The "Supporting Documents" table from ECHA's website. Make sure that you use the latest document template.
  • The ‘Guidance on information requirements for Biocides'
  • The Practical Guides

Submit your application

 

Getting started – pre-submission
  • Contact the ECHA Helpdesk which will provide you with the application requirements necessary for each step of the submission.
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Technical Guide: Using R4BP 3' and in the ‘ECHA Accounts Manual for industry users'.
  • From the ‘NEW APPLICATION' tab, select ‘UP-APP – Pre-submission for union authorisation' to launch the application ‘wizard', which will guide you through the submission process.

 

Union authorisation
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Technical Guide: Using R4BP 3' and in the ‘ECHA Accounts Manual for industry users'.
  • From the ‘ASSETS' tab, search for your pre-submission asset. Click on the asset number and, from the details page, launch your application by clicking ‘Create new case' for ‘UA-APP - Union authorisation'. The application ‘wizard' will guide you.
  • If you don't have a pre-submission asset, you can start your application from the ‘NEW APPLICATION' tab and select ‘UA-APP – Application for union authorisation' to launch the application ‘wizard' which will guide you through the various steps of the submission process. Important note: although the pre-submission is optional, you are strongly encouraged to apply for it before submitting your Union authorisation application.

 

Authorisation of the same biocidal product (pending)
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Technical Guide: Using R4BP 3' and in the ‘ECHA Accounts Manual for industry users'.
  • From the ‘NEW APPLICATION' tab, select ‘UA-BBP – Union authorisation of the same biocidal product (pending)' and enter the reference number (the union authorisation case number of the reference biocidal product) to launch the application ‘wizard', which will guide you through the various steps of the submission process.

 

Union authorisation major change on request
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Union authorisations’.
  • From the ‘ASSETS’ tab, search for the specific asset number by filling in some search criterion. Clicking on the asset number hyperlink in the ‘Assets list’ will open a details page for that specific asset. On this page, click ‘Create new case’ and a list of application types available for that asset will appear. From this list, you can launch the wizard by selecting ‘UA-MAC – Union authorisation major change on request’.
  • The application ‘wizard’ will guide you through the various steps of the different submission processes.

 

Notification of product in product family for Union authorisation
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Union authorisations’.
  • From the ‘ASSETS’ tab, search for the specific asset number by filling in some search criterion. Clicking on the asset number hyperlink in the ‘Assets list’ will open a details page for that specific asset. On this page, click ‘Create new case’ and a list of application types available for that asset will appear. From this list, you can launch the wizard by selecting ‘UA-NPF – Notification of product in product family for Union authorisation’.
  • The application ‘wizard’ will guide you through the various steps of the different submission processes.

 

Notification of unexpected or adverse effect for Union authorisation
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Union authorisations’.
  • From the ‘ASSETS’ tab, search for the relevant Union authorisation asset by filling in some search criterion. Clicking on the asset number hyperlink in the ‘Assets list’ will open a details page for that specific asset. On this page, click ‘Create new case’ and a list of application types available for that asset will appear. From this list, you can launch the wizard by selecting ‘UE-NOT – Notification of unexpected or adverse effect for Union authorisation’.
  • The application ‘wizard’ will guide you through the various steps of the different submission processes.

 

Union authorisation administrative change on request
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Union authorisations’.
  • From the ‘ASSETS’ tab, search for the specific asset number by filling in some search criterion. Clicking on the asset number hyperlink in the ‘Assets list’ will open a details page for that specific asset. On this page, click ‘Create new case’ and a list of application types available for that asset will appear. From this list, you can launch the wizard by selecting ‘UA-ADC – Union authorisation administrative change on request’.
  • The application ‘wizard’ will guide you through the various steps of the different submission processes.
  • If you want to submit a batch of administrative change(s) (i.e: UA-ADC), click on the ‘NEW APPLICATION’ tab on the R4BP 3 toolbar, and select ‘Administrative changes’ at the bottom of the page to launch the application wizard.

 

Transfer of a Union authorisation
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Union authorisations’.
  • From the ‘ASSETS’ tab, search for the specific asset number by filling in some search criterion. Locate the specific asset labelled with a ‘T’ (for ‘transfer’) and click on the asset number hyperlink to open a details page for that specific asset. Clicking on ‘Accept Asset Transfer’ will launch the wizard for Transfer of a Union authorisation.
  • The application ‘wizard’ will guide you through the various steps of the different submission processes.

 

Union authorisation minor change on request
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Union authorisations’.
  • From the ‘ASSETS’ tab, search for the specific asset number by filling in some search criterion. Clicking on the asset number hyperlink in the ‘Assets list’ will open a details page for that specific asset. On this page, click ‘Create new case’ and a list of application types available for that asset will appear. From this list, you can launch the wizard by selecting ‘UA-MIC – Union authorisation minor change on request’.
  • The application ‘wizard’ will guide you through the various steps of the different submission processes.

 

Union authorisation of the same biocidal product (authorised)
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Union authorisations’.
  • From the ‘NEW APPLICATION’ tab, select ‘UA-BBS – Union authorisation of the same biocidal product (authorised)’ to launch the application ‘wizard’. You will be prompted to provide a reference ‘asset number’. It is important to note that when you are creating a UA-BBS single product starting from a family, it is mandatory to insert the asset of the member of the family as reference asset in the submission wizard.
  • The application ‘wizard’ will guide you through the various steps of the different submission processes.

Follow up your applications

  • Important – make a note of your submission number. You will need it for further reference.
  • Important - check your tasks and messages in R4BP 3 regularly. They can include:
    • Requests for more information. These are important because if you fail to complete the task by the deadline, your application may be rejected.
    • Invoices, which have a 30-day deadline for payment. If you fail to pay the fee within the deadline, you application will be rejected.
    • Results of the ECHA format check.
    • Results of the acceptance step.

Withdraw your application

If you don’t want to proceed with one of your application, you are allowed to withdraw it from the system:

  • Search for your case
  • In the case details page, click on ‘withdraw case’
  • Confirm the case withdrawal

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