Registration process & instructions for submission
The applicant submits an MRL application in the Member State in which an authorisation is requested. For the Netherlands, the Ctgb is the authority to which MRL applications are submitted.
The following procedure applies to setting a new EU-MRL:
- The applicant submits an MRL application in the Member State in which an authorisation is requested. For the Netherlands, the Ctgb is the authority to which MRL applications are submitted. The MRL application form is used for this purpose. The application must be accompanied by a complete dossier (prepared according to the requirements in Article 7 of Regulation 396/2005/EC). Import tolerances are requested from the Rapporteur Member State (RMS) for the active substance concerned. In the EU Pesticides database you can see which Member State is the RMS (look in the active substance details). Application fees are charged.
- The applicant is charged a fee by the Ctgb (based on the Ctgb Tariffs Decree) for summarising and evaluating studies and for preparing the assessment. As soon as the application is complete and the applicant has paid the required assessment costs, the Ctgb begins the assessment and notifies the European Commission (COM) and the European Food Safety Authority (EFSA) about the application.
- Based on the dossier, the Ctgb prepares an Evaluation Report as soon as possible, using the templates developed by EFSA, according to the new data requirements or the old data requirements which can be found under MRL procedural guidance. No legal deadline has been set for this step, and its duration depends on the size and complexity of the dossier.
- When the Evaluation Report is ready, the Ctgb gives the applicant an opportunity –briefly- to comment on the Report. After processing the comments, the Evaluation Report is uploaded to the Pesticides MRL Workspace of EFSA. The Ctgb notifies the COM and EFSA that the Evaluation Report is finished.
- The COM then requests EFSA to prepare a Reasoned Opinion based on the Evaluation Report. For routine MRL applications, only three months are allowed for completing the EFSA Reasoned Opinion. In principle, no consultation takes place with the Member States. For complex applications, the term can be extended to six months, and the Member States are given an opportunity to comment. It is also possible for the EFSA to “stop the clock” to give the applicant time to answer additional questions. The final Reasoned Opinion and the Evaluation Report are published on the EFSA website.
- Based on the Reasoned Opinion of EFSA, the COM prepares a draft regulation with the new EU-MRLs. A draft regulation can be a combination of multiple MRL applications submitted in various Member States. This draft regulation is submitted for discussion and voting to the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF), Section "Phytopharmaceuticals-Pesticide residues". Following SCoPAFF approval, the future MRLs from the draft regulation are published in the EU Pesticides database. At that point, these MRLs are not yet in force.
- Finally, the draft regulation is submitted to the European Parliament and the Council of the European Union. If there is no objection from these two bodies, the regulation with the new European MRLs is translated into several languages and is published in the Official Journal of the European Union. The period between the SCoPAFF vote and the publication is at least five months. New MRLs enter into force 20 days after publication of the regulation.
Applicants should account for a total term of two years between submission of the application for an EU-MRL and its official publication. See also the Guidance Document on the MRL Setting Procedure 2016.
See also what happens in a product authorisation process when a MRL has not been set yet.
After the renewal of an active substance has taken place, the existing MRL’s have to be reviewed, conform article 12 (Reg. (EU) 396/2005). During this review, additional data can be required from the applicant, if an existing MRL isn’t fully supported by data. The MRL will have a footnote, stating the missing information and a deadline for submission of these “confirmatory data”. The EU commission has put in place a working document for the evaluation of ‘confirmatory data’ following a MRL-review.