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Maximum Residue Level (MRL) confirmatory data

Regulatory Update: 15/2016
Issued: 11th August 2016

Purpose

As a result of the ongoing review of Maximum Residue Levels (MRLs), authorisation holders may be required to submit, in accordance with set deadlines, confirmatory data to maintain MRLs. Outlined below are the procedures for submitting the confirmatory data to the UK.

Background

European Union (EU) MRLs are currently being reviewed under Article 12 of Regulation (EC) No 396/2005.  The review is a collaborative project between all Member States, EFSA and the European Commission, with the aim of establishing fully supported, harmonised MRLs throughout the EU. As a consequence, data gaps may be identified by EFSA in its assessments of the data submitted in support of the MRL which are published in Reasoned Opinions. These are then discussed within the EU Standing Committee on Plants, Animals, Food and Feed (residues section). If the Committee agrees that confirmatory data are required to address the data gaps identified, and to maintain existing MRLs, the submission of these data will be set as specific requirements in the implementing MRL Regulations.  Authorisation holders will be required to submit confirmatory data in accordance with data submission deadlines. 
This update explains how this process will be handled in the UK.

Summary of new procedures

A guidance document outlining the process within the EU is available on the EU Commission website: EU guidance on data submitted to confirm MRLs.
Where the UK is the Rapporteur Member State (RMS) for an active substance as part of the Article 12 Review, HSE will highlight any confirmatory data requirements that must be fulfilled in order to maintain MRLs for the active substance.  The data submission deadlines will also be published on the HSE website: The Applicant Guide: Maximum Residue Levels. However, authorisation holders are responsible for consulting the appropriate amending Regulation and the EFSA Reasoned Opinion for the full details of the confirmatory data required for any authorisations they hold.
Authorisation holders must determine how to address the data requirements, for example, by submission of additional residues trials data.  Because the nature of the data requirements relate to active substances rather than products, HSE strongly urges stakeholders to collaborate to address the requirements rather than submitting individual applications.  It is in the interest of authorisation holders to work together to ensure the MRL(s) are maintained.   
Data to maintain the MRLs may be submitted under various procedures:

In the first two cases applicants must highlight, preferably in their covering letter and application overview, that the submission includes data that address the MRL confirmatory data requirements. Submission of MRL confirmation data as part of the renewal of the active should also be discussed with HSE in the pre-submission meeting.  Where the data have been submitted to a different MS then HSE must be informed that a specific submission to the UK (as the RMS) to address the confirmatory data will not be submitted.
Where data are submitted as a standalone application to specifically address the MRL confirmatory data then this submission must be to the RMS. HSE will accept applications to evaluate the confirmatory data as Import Tolerance applications.
The confirmatory data, except in the cases of data evaluated as part of the active renewal, must be presented by the applicant in the ‘Template Evaluation Report’. In addition, the applicant, in all cases, must submit a signed MRL application form. The Evaluation report and MRL application form are available on the EU Commission website: Guidelines - Maximum Residue Levels - European Commission.
If the data requirements are not met, the MRL(s) will not be fully supported which could result in the MRL(s) concerned being reduced to the lowest limit of determination.  HSE will withdraw any uses that are not supported by the resultant MRLs.
Other Member States may implement different procedures for dealing with MRL confirmatory data where they are the RMS; authorisation holders are advised to contact them directly to confirm their approach.

Fees and charges

Information on the charging structure and processing fees for MRLs are available on the HSE website: The Applicant Guide: Maximum Residue Levels. Note that:
1.    Where there are multiple applications to address the same confirmatory data requirement, each application will be charged the full fee and all the data to maintain the MRLs will be considered together as part of the overall assessment.
2.    Where data are submitted as a standalone application to specifically address the MRL confirmatory data HSE will accept and charge such applications as Import Tolerance applications.

 

Updated 2016-11-21