Dossier submission for the amendment of Annex I
Companies will submit applications through R4BP 3. A IUCLID file is required.
This graph shows an overview of dossier submission for the amendment of Annex I.
Dossier submission proceeds in several steps. Each step needs to be completed before the application can move to the next step. It is important that the applicant makes sure that all applicable deadlines are met, otherwise the application will be rejected during the course of the process.
ECHA checks that the application and data have been submitted in the correct format and sends the fees invoice through R4BP 3.
The applicant pays the related fees to ECHA within 30 days from the invoice date.
ECHA accepts the application and informs the evaluating competent authority. If the application concerns category 6 the evaluating competent authority has 30 days to validate the application (completeness check).
The applicant pays the related fees to the evaluating competent authority within 30 days.
If case the applications concerns category 6 and the dossier is deemed to be incomplete, the evaluating competent authority will ask for the missing information and the applicant will have 90 days to provide it. The evaluating competent authority has 30 days to validate the application based on the new information provided.
Evaluation of the dossier starts.
The main actors in the dossier submission process are:
Applicants have the responsibility to provide dossiers with all relevant information on their active substances and to provide additional information if requested by the evaluating competent authority. Applicants are responsible for the quality of the data in their dossiers.
ECHA is responsible for making sure that the information in the dossiers is in the correct format. ECHA also makes sure that the submission process proceeds within the set timelines.
Evaluating competent authority
The evaluating competent authority is responsible for carrying out the validation of the application dossiers and subsequently for the evaluation of the dossiers submitted by the applicants. Applicants can choose which Member State they would like to have evaluating their dossiers. This is finally decided in agreement with the Member State.