Applications
The following information concerns applications intended to be submitted on or after 27 March 2021. For applications submitted before that date, rules concerning the format for the submission of applications and the rules concerning notification of studies do not apply.
The EU country performing the initial scientific and technical evaluation of an active substance dossier is called a "Rapporteur Member State" (RMS). The producer of an active substance applying for first EU approval can choose the RMS and should contact the national competent authority well before submitting an application.
An alternative is the co-rapporteur (co-RMS) system where 2 or more EU countries collaborate. For renewal of approval, a RMS and a co-RMS are assigned by the Commission as set out in Regulation EU 686/2012.
In accordance with the provision set out in the General Food Law, applicants may request general and non-committing pre-submission advice from EFSA for applications for first approval, for renewal of approvals, MRL settings and basic substance approvals.
EFSA recommends submitting the request at least six months before the envisaged submission date of the application. Applicants (and laboratories) must notify information on studies commissioned or carried out to support a future application.
The RMS checks if the applicant has fulfilled all required pre-submission requirements, and has provided all required tests and study reports before confirming that the application is admissible.
Member States may recover the costs associated with any work they carry out, by means of fees or charges.
Applications (dossiers) submitted for the approval, the amendment of approval or the renewal of an approval of an active substance have to be submitted via IUCLID format, which allows to share them with Member States, EFSA and the Commission.
Dossiers must comply with the data requirements set out in Regulation EU 283/2013 and its associated Communication and Regulation 284/2013 and its associated Communication, as last amended.
Draft Assessment Report or draft Renewal Assessment Report
Based on the applicant's dossier, the rapporteur Member State (RMS) and where relevant the co-rapporteur Member State (co-RMS), prepares a Draft Assessment Report (DAR) for first approval or a draft Renewal Assessment Report (RAR) for renewal of approval.
According to the legislation, the RMS has to submit its assessment to the Commission and to EFSA 1-1.5 years after the admissibility of the application for a first approval or 13 months for a renewal of approval. EFSA then launches the peer-review process starting with a public consultation on the assessment prepared by the RMS (and co-RMS).
There is a common structure for the DAR/RAR agreed by the EU and OECD. The template can be found on the guidelines webpage.
A specific procedure is set out for the approval of so-called basic substances.