Renewal of active substance approval
Approved active substances are re-evaluated before their expiry date under the renewal programme (“AIR”). A Member State is appointed as a “rapporteur” (RMS) to carry out an initial risk assessment and to prepare a renewal assessment report (RAR) with the contribution of a Member State appointed as Co-rapporteur (Co-RMS), which is then peer reviewed by EFSA together with the Member States.
The process of active substance renewal is described in Regulation EU 2020/1740 (repealing Regulation EU 844/2012). The process has a lot of similarities with the process for active substance approval. Therefore, only the most important differences are stated here, for each subject.
The renewal assessments of the active substances are distributed at different RMS’s, by EU commission in the ScoPAFF meetings. For renewal assessments a co-RMS is designated.
Confidentiality claims for dossiers for renewals will be handled and processed by EFSA.
Duration period active substance renewal
An active substance will be renewed for a period of 15 years. Except for substances approved under the conditions referred to in art 4(7) of Reg. (EC) no 1107/2009.
Before submitting an application, the applicant has to request renewal pre-submission advice from EFSA. This is obligatory.
Applicant may also request General Pre-Submission Advice from EFSA (GPSA) or advice from the RMS (Pre-Submission Advice – PSM). For a PSM (with RMS NL), please contact email@example.com.
The RMS will evaluate the confidentiality claims that are requested by the applicant. After the application is declared admissible the applicant’s dossier excluding confidential information as defined in the Regulation, is made publicly available by EFSA.
The admissibility check should be carried out within 30 day after receipt of dossier. If the RMS concludes that the dossier is not complete, the applicant is allowed 14 days to provide the missing elements. If the applicant cannot do this within 14 days, the application is declared inadmissible and rejected
EFSA will evaluate the confidentiality claims that are requested by the applicant. After the application is declared admissible the applicant’s dossier excluding confidential information as defined in the Regulation, is made publicly available by EFSA.
Submission of additional information
During the renewal assessment process there is a limited opportunity to submit additional data. Jut during the EFSA Peer review there is a period of 1 month foreseen to submit additional information.
Instructions for submission
No deviations from the approval process
Additional to the documentation for the active substance approval: EU regulation on renewal of active substances