Classification of a change to a product authorisation

If an intended change is not listed in one of the tables in the Annex to the Changes Regulation (Regulation (EU) No 354/2013), the authorisation holder may request an opinion from ECHA on the classification of that change in accordance with the criteria laid down in the Annex to the Changes Regulation.
One separate application must be submitted for each change sought. ECHA shall deliver its opinion within 45 days following receipt of the corresponding fee (in accordance with Article 2 of the Changes Regulation).

Preparing a notification

  • Refer to the Biocides Submission Manual (BSM) 4, ‘Biocidal products – Part B: National authorisation changes on request'.
  • 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'. Log into R4BP 3 with your User ID and password defined in REACH-IT. Refer to BSM 4 ‘Biocidal products – Part B: National authorisation changes on request' for instructions. Under the ‘NEW APPLICATION' tab, select ‘Classification of a change to a product authorisation‘. 

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, e.g.:

  • Result of the format check.
  • Result of the acceptance step.
  • Notification of invoices with a 30-day deadline that needs to be met. See BSM 5 'Invoicing in R4BP 3'.

You may also receive authority requests for more information through R4BP 3, with a deadline. The requests will appear under TASKS.

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