Active substances

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

  • The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for Active Substance'.
  • The Biocides Submission Manual (BSM) 'Technical Guide: How to prepare a biocides dossier'.
  • The Biocides Submission Manual (BSM) ‘Technical Guide: How to use R4BP 3'.
  • The ‘Guidance on information requirements for Biocides'.
  • The Practical Guides.

 

Approval of an active substance
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘AS-APP – Approval of active substance' to launch the application ‘wizard' which will guide you through the various steps of the submission process.

 

Approval of an active substance in an additional product type
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION’ tab, select ‘AS-APP - Approval of active substance’ to launch the application ‘wizard’ which will guide you through the various steps of the submission process.

 

Amendment to conditions of an approved active substance
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘AS-APP – Approval of active substance' to launch the application ‘wizard' which will guide you through the various steps of the submission process.

 

Scientific data update of active substance
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘AS-UPD – Scientific data update of active substance’ to launch the application ‘wizard which will guide you through the various steps of the submission process.

 

Renewal of an active substance approval
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘AS-RNL – Renewal of active substance' and enter the reference number (the asset number of the reference active substance you want to renew) to launch the application ‘wizard' which will guide you through the various steps of the submission process.

 

Amendment of Annex I to the BPR (first inclusion of an active substance)
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘AN-APP – Inclusion of active substance in Annex I' to launch the application ‘wizard' which will guide you through the various steps of the submission process.

 

Amendment of active substance in Annex I (amendment of restrictions)
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘AN-CHG – Amendment of active substance in Annex I' to launch the application ‘wizard' which will guide you through the various steps of the submission process.
  • AN-CHG application wizard requires a reference asset of AN-APP. Please note that the information related to the selection of category is extracted directly from the reference asset case.

 

Scientific data update of active substance in Annex I
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘AN-UPD – Scientific data update of active substance in Annex I’ to launch the application ‘wizard which will guide you through the various steps of the submission process.

 

Inclusion on list of active substances and suppliers (Art. 95)
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘AS-ACC – Inclusion in the Article 95 (active substance suppliers) list' to launch the application ‘wizard' which will guide you through the various steps of the submission process.

 

Inclusion on list of active substance suppliers (Article 95) administrative change on request
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search with ‘AA-Access to active substance dossier’ as asset type. After launching the search, click on the relevant asset number. From the details page launch your application by clicking ‘Create new case’ for ‘AA-ADC –Inclusion on the list of active substance suppliers (Article 95) administrative change on request’, the application ‘wizard’ will guide you through the various steps of the submission process.

 

Inclusion on list of active substance suppliers (Article95) cancellation on request
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search with ‘AA-Access to active substance dossier’ as asset type. After launching the search, click on the relevant asset number. From the details page launch your application by clicking ‘Create new case’ for ‘AA-CCL – Inclusion on the list of active substance suppliers (Article 95) cancellation on request’, the application ‘wizard’ will guide you through the various steps of the submission process.

 

Scientific data update of inclusion in Article 95 (active substance suppliers) list
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search with ‘AA-Access to active substance dossier’ as asset type. After launching the search, click on the relevant asset number. From the details page launch your application by clicking ‘Create new case’ for ‘AA-UPD – Scientific data update of inclusion in Article 95 (active substance suppliers) list’, the application ‘wizard’ will guide you through the various steps of the submission process.

 

Renewal of inclusion in Article 95 (active substance suppliers) list
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search with ‘AA-Access to active substance dossier’ as asset type. After launching the search, click on the relevant asset number. From the details page launch your application by clicking ‘Create new case’ for ‘AA-RNL –Scientific data renewal of inclusion in Article 95 (active substance suppliers) list’, the application ‘wizard’ will guide you through the various steps of the submission process.

 

 

Transfer of Article 95 asset (access to active substance dossier)
  • The owner of an ‘AA-Access to active substance dossier’ asset must first initiate a transfer process in R4BP 3, this is done in the ‘Delegation/ Nomination’ tab of the asset. Once the owner has delegated the asset, you can start the acceptance.
  • Log into R4BP 3.
  • From the ‘ASSETS’ tab, search for the relevant ‘AA - Access to active substance dossier’ as an asset that is to be transferred to you. Locate the specific asset labelled with a ‘T’ (for ‘transfer’) and click on the asset number and from the details page click ‘Accept Asset Transfer’. The application ‘wizard’ will guide you through the various steps of the submission process.

 

 

Submission of declarations of interest to notify an active substance / product type combination
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘DI-SUB – Declaration of interest to notify'.
  • The application ‘wizard' will guide you through the various steps of the submission process.

Notifications for inclusion in Review Programme
  • Prepare your IUCLID dossier.

    The information requirements for notifications are listed in Annex I to the Review Programme Regulation and include information on the substance identity and intended uses and exposure

    Please note that in situ systems need to describe the active substance and the precursor(s). The procedure to report in situ active substance precursor systems in IUCLID files is described in Annex 2 in the Biocides Submission Manual (BSM) 'Technical Guide: How to prepare a biocides dossier’.
     
  • From the ‘NEW APPLICATION' tab, select ‘‘RP-NOT – submission of notifications for inclusion in the Review Programme" to launch the application ‘wizard which will guide you through the various steps of the submission process.

 

Active substance evaluation under Regulation (EU) No 1062/2014 (Participant)
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘AS-EVA – Active substance evaluation under Regulation (EU) No 1062/2014 (Participant)'.
  • The application ‘wizard' will guide you through the various steps of the submission process.

 

Addition, replacement or withdrawal of a participant from Review Programme
  • Log into R4BP 3.
  • From the ‘CASES' tab, search with ‘AS-EVA – Active substance evaluation under Regulation (EU) No 1062/2014 (Participant)' as case type. After making the search click on the relevant case number. From the details page launch your application by clicking ‘Create new case' for ‘PA-CHG – Change of participants'.
  • The application ‘wizard' will guide you through the various steps of the submission process.

 

Inquire to share data for active substances
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘IN-REA – Inquire to share data (for active substance)' to launch the application ‘wizard' which will guide you through the various steps of the submission process.

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