Review of existing MRLs
In the context of the European residue regulation (396/2005), a review programme was foreseen to have existing MRLs assessed by the EFSA (European Food Safety Authority). The functioning of this programme was laid down in article 12 of the European residue regulation.
Ideally within 12 months of the approval or non-approval of an active substance, the EFSA must draft and submit an opinion to the European Commission and the Member States. In this opinion, it is examined whether sufficient studies are available which support the existing MRLs for the active substance; whether it is necessary to establish new MRLs; which processing factors are required; which MRLs can be deleted.
In drafting this opinion, the EFSA uses, in the first instance, the DAR (Draft Assessment Report) and the EFSA conclusions for the active substance as the basis. However, these do not contain all the necessary information to review existing MRLs. As such, for this review, the EFSA works closely together with the RMS (Rapporteur Member State) of the active substance.
Since 2017, the review of EU MRLs follows a step-wise ‘new’ procedure, as outlined further below. The EFSA coordinates the process at all steps, but MSs (particularly the RMS) are involved from the early stage and are responsible for the evaluation of the data provided by the authorization holders. The RMS may contact and involve the main authorisation holders at specific steps in the procedure if needed, but consultation is exclusively open to MSs. For all scientific matters regarding the assessment, the contact point for EFSA is the RMS. For the sake of efficiency, GAPs and supporting data are collected in 2 different steps and no additional GAPs or residue data are accepted at a later stage in the process. The workflow foresees that EFSA drafts its reasoned opinion right after the evaluation by the RMS, in order to reduce occurrence of GAP changes during the procedure. A flowchart with indicative timelines for each step is available on the EFSA website.
1. Collection of GAPs (1 month)
- Notification of initiation of MRL review (to all EU Member States and other stakeholders)
The EFSA is not actively contacting each individual authorisation holder, but they can keep themselves informed of the upcoming (and ongoing) MRL reviews via the “Overview of the MRL review progress under Article 12 of Regulation (EC) No 396/2005”, available on the EFSA website.
Moreover, the EFSA sends a notification e-mail to the RMS and to the stakeholders (industry and trade associations; e.g. ECPA) to inform them whenever a new MRL review is initiated. EFSA expects that through these channels authorisation holders are reached. All authorisation holders (including non-EU ones) are advised to liaise with the RMS in case they want to support the EU MRL review of an active substance.
- EFSA invites MSs to upload their national (authorized) GAPs on the EFSA Document Management System (DMS) by using the harmonized GAP form. It is the unique opportunity for MSs to submit GAPs.
- GAPs authorised in third (non-EU) countries should be reported by the RMS, preferably after having consulted the main authorisation holders.
2. Collection of supporting data
- Within 6 weeks, the RMS identifies the most critical GAPs (cGAP’s) for each crop in each zone, using the EFSA tool developed for the compilation of GAPs (GAP overview file). The availability of data is also indicated at this stage (if necessary after consultation with the main authorisation holders).
- After file validation by EFSA (2 weeks), MSs have 1 month to provide residue data supporting the critical GAPs to the RMS. The data must be reported by means of a detailed evaluation report; only data that have been independently evaluated by MSs can be taken into consideration.
3. RMS submission (2 months)
Based on the dossier of the notifier and the information from the other Member States, the RMS draws up a PROFile (Pesticide Residues Overview File), which is an electronic inventory of all residue data relevant for the risk assessment and for establishing the MRLs for a given active substance. The RMS also draws up a detailed Evaluation Report (ER) in which the most critical (European) uses (cGAPs) are assessed.
The RMS may contact the main authorisation holder(s) at this stage, but it is not foreseen or allowed to share the ER or PROFile with authorization holders at this stage.
4. EFSA completeness check
Within 1 month, EFSA conducts a completeness check of the documents provided by the RMS. In case further clarifications are needed, the (R)MS have 3 weeks to submit them and the EFSA has another 1 month.
5. Member State Consultation (MSC)
Based on the information in the Evaluation Report(s) and the PROFile, EFSA produces a draft Reasoned Opinion (dRO). In this opinion, the EFSA makes recommendations as regards the revision of the existing MRLs. All MSs then have 3 weeks to provide comments to this dRO. This is referred to as the Member State Consultation (MSC) period. The deadline for this MSC is really short, because only technical comments can be made on the content of the dRO (notification of additional national GAPs is not allowed). EFSA compiles comments (in a draft MSC report) within 2 weeks and decides whether further discussion via experts’ consultation is required (max. 6 weeks additional time).
6. EFSA Reasoned Opinion
Within 2 weeks following the compilation of comments (or following experts’ consultation), EFSA finalises its Reasoned Opinion and the MSC report. The final EFSA Reasoned Opinion, as well as all supporting documents (ER, PRIMo, PROFile, MSC report) are eventually published on the EFSA website.
The final decision (whether the new MRLs proposed by the EFSA have to be included in the annexes to the European residue regulation) is not taken by the EFSA, but by the Commission, in consultation with the Member States. There is a vote on the new MRLs in the SCPAFF (Standing Committee on Plants, Animals, Food and Feed). A qualified majority is required for the new MRLs to be included in the annexes to the European residue regulation.
Information for industry regarding the contents and format of the dossier
If Belgium is appointed as RMS, the Belgian authority will contact the main EU notifier(s) once the MRL review process for the particular active substance has been launched and will invite him/them to submit a complete residue dossier which contains an inventory of all residue data of all existing uses that were not assessed in the DAR. This dossier must contain the following information:
- an overview of all supported GAPs (Good Agricultural Practice)
- residue studies (in accordance with the supported GAPs) that have not yet been assessed in the DAR
- analytical methods for monitoring
- studies investigating the stability of residues during storage
- metabolism studies (for plants; for processed products; for succeeding crops) if there are additional uses which are not covered by the metabolism studies which are available in the DAR
In accordance with the OECD format, this corresponds with the following documents:
- document D
- document L – sections 2 and 4
- document M – sections 2 and 4
- document K (studies which have not yet been assessed in the DAR).
The notifier should provide a draft Evaluation Report conforming to the template available on https://ec.europa.eu/food/plant/pesticides/max_residue_levels/guidelines_en (Implementation of Regulation EC 396/2005). The data requirements applicable for the MRL review are those that were applicable for the approval of the active substance or its renewal/amendment (cf. SANTE/11509/2013 rev. 5.2 – Guidance document on the interpretation of the transitional measures for the data requirements).