- Wie wird eine Zulassung beantragt?
- Submit a review report if you still need to use the substance
Submit a review report if you still need to use the substance
All authorisation decisions have a time-limited review period. During this period, authorisation holders have to continue looking for a suitable alternative substance or technology that would make the use of the substance of very high concern (SVHC) unnecessary.
If the authorisation holders do not succeed in this, they can submit a review report. This report must be submitted at least 18 months before the end of the review period.
As part of the review reports, the authorisation holders should update all documents submitted in the original application that have changed and submit any other elements required by the conditions or monitoring arrangements of the authorisation decision.
- Analysis of alternatives (AoA) - Authorisation holders must submit an update of the AoA, including information about any relevant research and development activity, possible new alternatives and progress made towards substitution with safer alternatives. If the update of the AoA shows that there is a suitable alternative, authorisation holders have to submit a substitution plan. If the authorisation holder submitted a substitution plan as part of its original application, an update of it as part of the review report also has to be given.
- Chemical safety report (CSR) – If the authorisation decision included conditions or monitoring arrangements related to the management, the authorisation holder must submit an update of the exposure scenarios in the CSR. The exposure scenarios should also be updated if there are changes affecting them (e.g. because of new risk management measures or improved knowledge of exposure levels). The succinct summary should also be re-submitted.
- Socio-economic analysis (SEA) – If the benefits of a granted authorisation have changed (e.g. due to the updated AoA or employment changes), the SEA should be updated accordingly. Furthermore, to the extent the exposure scenarios are updated, the health or environmental impacts of the granted authorisation may also change. Similarly, the applicant’s reasoning for the duration of the review period may need to be updated.
- Explanatory note - The authorisation holder should also submit a brief note explaining what has changed since the original application was made and since the authorisation was granted. The purpose of this note is to ease the reading of the reports.
The process for submitting and handling a review report is the same as for the initial application for authorisation. The authorisation holder can request a pre-submission information session before submitting the review report.
The review report is also submitted within one of the “submission windows” established for applications for authorisation. This will ensure that the review report will be processed within the shortest time possible. The fees for review reports are the same as for applications for authorisation.