Active substances

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: Active Substances'
  • 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

 

Approval of an active substance
  • Prepare your IUCLID dossier. Refer to the instructions in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.
  • 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 ‘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. Refer to the instructions in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.
  • 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 ‘AS-NPT – Approval of an active substance in an additional product type’ to launch the application ‘wizard’ which will guide you through the various steps of the submission process.

 

Amendment to the conditions of an approved active substance
  • Prepare your IUCLID dossier. Refer to the instructions in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.
  • 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 ‘AS-APP – Approval 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. Refer to the instructions in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.
  • 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 ‘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 or amendment of restrictions)
  • Prepare your IUCLID dossier. Refer to the instructions in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.
  • 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 ‘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
  • Prepare your IUCLID dossier. Refer to the instructions in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Active substances’.
  • 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. When creating the reference asset of AN-APP, you are required to select the category of Annex I in which you intend the active substance to be included or amended. The information related to the selection of category is extracted directly from the reference asset case.

 

 

Inclusion on the list of active substances and suppliers (Art. 95)
  • Prepare your IUCLID dossier. Refer to the instructions in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.
  • 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 ‘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.

 

Submission of declarations of interest to notify an active substance / product type combination
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Technical Guide: Using 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 different submission processes.

Notifications for inclusion in the Review Programme
  • Prepare your IUCLID dossier. Refer to the instructions in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.

    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 II in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.

  • 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. The instructions are in the Biocides Submission Manual (BSM) ‘Technical Guide: Using 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 different submission processes.

 

Addition, replacement or withdrawal of a participant from the Review Programme
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Technical Guide: Using 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 different submission processes.

 

Inquire to share data for active substances
  • 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 ‘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