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:
- Before submitting an MRL application, the potential applicant should register in EFSA’s portal (Connect EFSA). Through this portal, the applicant should do the mandatory notification of studies (NoS) commissioned or carried out in view of the MRL application. Via this online platform, the applicant may also, optionally, request general pre-submission advice (GPSA) from EFSA. Those pre-submission activities and contacts with EFSA will be linked to a unique pre-application identification number (PA-ID) allocated by EFSA.
A potential applicant should in any case contact Ctgb about his intention to submit an MRL application to the Netherlands for evaluation.
- The MRL application form is used to request the setting or amendment of MRLs. The application must be accompanied by a complete dossier (according to the requirements in Article 7 of Regulation 396/2005/EC) prepared by the applicant using the IUCLID (International Uniform Chemical Information Database) software. Once prepared, the dossier must be uploaded through a central EU submission system (ECHA Cloud Services) and the Evaluating Member State (EMS) as agreed (see above) should be indicated. EFSA, the European Commission and the competent authorities of the EU Member States have access to this secure online platform.
A summary of the tools that applicants are expected to use in the preparation of the application and subsequent phases (e.g. EFSA’s portal supporting pre-submission activities, database of study notifications, IUCLID software) is available in the toolkit on the EFSA website.
Once a valid submission is received, EFSA, the European Commission (EC), the EMS and all other EU MSs are informed via an automatic e-mail.
- The applicant is charged a fee by the Ctgb (based on the Ctgb Tariffs Decree). The fee includes an advance payment and subsequent costing of the actual costs incurred. If the actual costs incurred are less than the advance payment, the difference is refunded.
- After receipt of the MRL application, Ctgb will assess the admissibility of the application in line with the procedure described in EFSA’s administrative guidance (EFSA, 2021) , particularly chapter 4.4. Besides a completeness check against the data requirements, this includes a verification of compliance with the legal obligations of notification of new studies (prior to submission of the MRL application). Non-compliance with those obligations may result in non-admissibility of the MRL application.
Once the application is found admissible, Ctgb will notify the applicant, the other EU MSs, the EC and also EFSA, who will subsequently publish the non-confidential version of the dossier on its website (OpenEFSA portal). Following the implementation of the confidentiality decision, EFSA will launch a public consultation on its website.
- 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. In an annex to the ER, the EMS will report how the comments received during the public consultation of the dossier have been taken into account in the assessment. 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 2021.
See also what happens in a product authorisation process when a MRL has not been set yet.
MRL article 12 review process
According to Art. 12 of Regulation (EC) No. 396/2005, existing MRLs need to be reviewed by the European Food Safety Authority (EFSA) after the approval or renewal of an active substance. This document describes the steps of the future procedure and elucidates the responsibilities and tasks of the Commission, EFSA, Member States, as well as applicants.
- EFSA will initiate the new process by collecting all national GAPs of authorized uses in the Member States. It is the responsibility of each Member State to report the national GAPs to EFSA. In The Netherlands, data will be collected in close collaboration between the Food and Consumer Product Safety Authority (NVWA) and the Board for the Authorisation of Plant Protection Products and Biocides (Ctgb). Applicants are informed by EFSA about the initiation of an Art. 12 review.
- After all national GAPs have been collected, the Rapporteur Member State (RMS) of the active substance will select the critical GAPs (cGAP) for each zone (Northern and Southern Europe), as well as the cGAPs for indoor uses. At this stage, the RMS may contact the authorisation holders or other Member States if further clarifications are necessary.
- If additional data are required to support a certain use, the RMS asks the other Member States to submit these data. If a Member State needs some clarifications, they may contact the authorisation holders at this stage.
- With the available data, the RMS drafts an Evaluation Report, as well as a PROFile (Pesticide Residues Overview File), and uploads these documents to the Pesticide MRL Workspace of EFSA.
- EFSA will perform a completeness check and, if required, asks the RMS for clarifications. Afterwards, EFSA confirms the completeness check and drafts a Reasoned Opinion.
- When the draft Reasoned Opinion is finalised, all Member States have the opportunity to comment on it (however, no additional GAPs or residue data can be taken into account anymore). EFSA will prepare a Member State Commenting Report in which all comments will be addressed.
- If further discussions are needed, an expert meeting can be planned by EFSA. Otherwise, the received comments are considered and the Reasoned Opinion is finalised and published.
Timelines within the new process are linked to tight deadlines (see the figure below), however, it might still be possible that new national uses are authorised between the collection of national GAPs and the publication of a Reasoned Opinion with recommended MRLs. These uses are consequently not reported to EFSA and the RMS. Nonetheless, this should not pose any problem since an adequate MRL should already be applicable before authorising a new use.
Setting MRL scheme
In its Reasoned Opinion, EFSA recommends maintaining, amending or deleting MRLs. In addition, tentative MRLs might be proposed that are not fully supported by data but for which no risk to consumers could be identified. Subsequently, discussion takes place in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF). There will be a voting session on the MRLs and the need for potential confirmatory data. In the case of confirmatory data, tentative MRLs are included in Annex II of Regulation (EC) 396/2005 and a footnote is added to the MRLs. The availability of confirmatory data, or the absence thereof, as reported by the footnote in Annex II will be reviewed in the future. The need for confirmatory data is also indicated in the EU Pesticide Database. Within the period foreseen, typically two years after the implementing regulation entered into force, authorisation holders have the possibility to conduct studies and submit these confirmatory data to support the tentative MRLs.
Confirmatory data are submitted by the applicant under an Art. 10 application of Reg. (EC) 396/2005 and the Rapporteur Member State (RMS)/Evaluating Member State (EMS) prepares an Evaluation Report. Additionally, the RMS/EMS will inform EFSA about the receipt of confirmatory data since EFSA is involved in the assessment of confirmatory data in all cases. If the applicant intends to amend MRLs in addition to the submission of confirmatory data, one Evaluation Report will be prepared by the RMS/EMS (combined submission of MRL-application and confirmatory data, according to Art. 10 and Art. 12, respectively). The data requirements that were applicable at the time point of the MRL review will also apply for the evaluation of the confirmatory data of that review.
After the Evaluation Report has been drafted and submitted on the Pesticide MRL Workspace of EFSA, EFSA will prepare a Reasoned Opinion in which it recommends to maintain or amend the MRL. Subsequently, the SCoPAFF will vote about the MRLs.
For further information about the Art. 12 MRL review process, interested parties may consult the following documents: