Application and assessment procedure
Companies will apply for inclusion on the list of active substance suppliers through R4BP 3.
This graph shows an overview of the application procedure for inclusion on the list of active substance suppliers.
The application process has 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. The application is inserted in the list of pending Article 95 applications.
ECHA accepts the application and starts the compliance check. Any information gaps or inconsistencies identified in the compliance check are described and compiled in a draft decision. The draft decision is sent to the submitter with a request to respond within a one- month commenting period. This commenting period can be extended by an additional two months upon request.
The applicant submits any comments as well as any additional information within the commenting period.
ECHA will take the final decision on the inclusion of the company in the list of active substance suppliers based on the information available at the end of the commenting period.
The main actors in the dossier submission process are:
Applicants have the responsibility to provide all relevant information related to the active substance suppliers assessment. Applicants are responsible for the quality and format of the data in their applications.
ECHA is responsible for checking that the information in the dossiers is in a correct format. ECHA also carries out the assessment of applications and makes sure that the submission process proceeds within the set timelines.