The Applicant Guide: Maximum Residue Levels and Import Tolerances
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What are Maximum Residue Levels and import tolerances?
Maximum Residue Levels (MRLs) are set to reflect the highest amount of pesticide residue expected in food when pesticides are applied correctly (in accordance with approved conditions of use).
They thus provide a mechanism to verify that produce has only been treated with pesticides according to authorised agricultural practices, both for produce treated within the EU and for imported produce.
MRLs are set using the residue trial data which support the approved conditions of use and the OECD MRL calculator. The OECD MRL calculator and further information about its use and derivation can be found on the EPA website.
A further explanation of MRLs and details of the legislation governing MRLs and how compliance is controlled can be found at the following link: General Guidance Concerning Maximum Residue Levels (MRLs).
Why might you need to apply to change an MRL or import tolerance?
CRD cannot authorise a pesticide use that is likely to lead to residue levels above the relevant EC MRL. Equally, the importation into the EU of treated commodities with residues levels above the relevant EC MRL would be illegal.
- If you wish CRD to authorise a pesticide use that may lead to residues higher than the EC MRL, due either to a change in agricultural practice or to the introduction of a new use, the MRL must be changed before the authorisation can be given.
- If you wish to import produce into the EU with residues that may be higher than the EC MRL, the MRL will need to be changed before such treated commodities can be legally imported.
- This may be for pesticides already authorised in the EU, but for which different agricultural practices apply to imported commodities. Alternatively, this may be for pesticides not authorised for use in the EU, but which nevertheless can be legitimately used to treat commodities that might be imported into the EU.
CRD is able to accept applications to change MRLs, where a UK authorisation is intended, or for import tolerances for pesticides for which the UK is the Rapporteur Member State (RMS). CRD can also evaluate applications where no RMS has been allocated, or where it is not practical for the designated RMS to evaluate an import tolerance application. In these circumstances, applicants must first discuss options with CRD and if relevant, the designated RMS.
CRD can also assess MRL changes as part of the approval or renewal of the active substance. This includes the assessment of MRLs for the representative GAP supported for the approval/renewal assessment as well as additional GAP required for product authorisation. Further information on this process is outlined below.
When should an MRL or import tolerance application be submitted to CRD?
An MRL application can be made as part of one of three different processes:
As part of the product authorisation
In many cases, the MRL application would be submitted and processed at the same time as the relevant application for authorisation. Information on the procedures for the assessment of MRLs within a product authorisation as outlined in Regulatory update 04/2015 and Regulatory update 20/2015. The MRL assessment will be prioritised ahead of the rest of the evaluation in order to maximise the time available for EFSA to confirm and publish the MRL required
MRL applications processed together with the application for authorisation are charged for the authorisation only and do not incur a separate evaluation fee for the MRL
As part of a separate application
Owing to the time taken to establish a new EC MRL (see below), an early MRL application might be desirable to ensure that the relevant authorisation is not delayed. Hence, provided that a UK authorisation is intended and that necessary supporting information is available, CRD will accept an MRL application in advance of the relevant application for authorisation.
MRL applications received in advance of the application for authorisation are charged separately under the modular fee structure outlined below. If appropriate, a reduction may apply to the evaluation fee for the subsequent application for authorisation, to account for the components already evaluated under the MRL application. Nevertheless, the total fee will be higher where MRL and authorisation applications are submitted separately, due to the additional administrative workload.
Import tolerance applications can be submitted as soon as all supporting information is available, although there should be an existing or intended authorisation in the exporting country.
As part of the approval or renewal of the active substance
The MRLs required for the representative GAP or additional GAP required for product authorisation can be considered as part of the evaluation process for the approval or renewal of an active substance. Information on the procedure is outlined in the guidance document MRL Application Management.
Prior to the submission of the application for the approval/renewal of an active substance, the applicant must discuss the MRL changes with CRD, including how many GAPs in addition to the representative GAP will be submitted for an MRL assessment.
The number of additional GAPs that can be considered may need to be limited as part of the approval/renewal assessment.
If CRD is undertaking the approval/renewal assessment then all the residues data and core data (eg plant metabolism data, animal metabolism data, nature of the residue on processing) should be outlined in the dossier supporting the approval/renewal. Additional residues data supporting additional GAP for product authorisations should be submitted in a separate dossier and summarised separately to the data supporting the representative GAP.
The applicant must clearly indicate in the submission that MRL changes are required as part of the approval/renewal assessment.
An MRL application form, covering all MRL changes required, available on the EU Commission website must be submitted with the application for the renewal/approval assessment Link to EU Commission guidelines for MRLs. A separate Evaluation report does not need to be prepared. However, appropriate Tier summaries of all the residues data, including the validation data of the supporting analytical methods, must be provided.
The EFSA conclusion on the peer review of the approval/renewal will also serve as the reasoned opinion on the MRLs taken forward for a vote within the EU.
What documentation is required for an application for MRLs or import tolerances?
You should submit a covering letter, briefly outlining the purpose of the application, so that it can be easily identified at the applications sift.
The standard application form for EC MRLs can be downloaded (Link to application form download page). This asks for relevant information such as applicant contact details, pesticide name, crops for which MRLs or import tolerances are required and a reference list of all supporting data.
The overview should include a detailed description of the GAP relevant to the application and summaries of all data listed in Regulation (EC) No 544/2011 or Regulation (EC) No 283/2013 that are relevant to the MRL application. In particular a summary table of all supporting residue trials should be included. The Overview Document should be submitted in Microsoft Word format.
Previous relevant correspondence
Copies of any previous relevant correspondence with CRD,or other relevant organisations, relating to your application should be submitted, so that all the information relating to your application is available for the Evaluating Officer.
Proof of authorisation and the MRL in place in the exporting country
As outlined in the Regulatory update 11 from August 2015, EFSA will only process Import Tolerance applications with proof of authorisation and the MRL in place in the exporting country. This documentation does not need to be provided in the initial application to CRD and CRD will assess the data to support the IT without this information. However, CRD will only forward our completed assessment to EFSA once the proof of authorisation and the MRL in place in the exporting country are provided.
The technical and procedural guidance documents covering Regulation (EC) No 396/2005 available on the EU Commission website (Guidelines - Maximum Residue levels - European Commission ) should be followed.
A dossier with the relevant data listed in Regulation (EC) No 544/2011 or Regulation (EC) 283/2013 needs to be submitted, with sufficient data to allow the level of residues in the relevant treated commodity to be determined, as well as the risk to consumers.
Copies of all original study reports
should also be submitted. In particular, the dossier needs to address the following areas, although all data may not be needed or relevant to every application:
- metabolism in treated crops
- metabolism in rotational crops
- metabolism in animal commodities
- nature of residues in processed commodities
- analytical methods supporting the submitted studies
- analytical methods for enforcement (plant and animal commodities)
- stability of residues in (frozen) stored commodities
- supervised field trials
- magnitude of residues in processed commodities
- magnitude of residues in rotational crops
- animal feeding studies
- toxicological data to establish an Acceptable daily Intake (ADI) and an Acute reference Dose (ARfD).
- product label or draft label detailing the intended use
If the relevant data have already been submitted and assessed in the framework of the Peer Review under Regulation (EC) No 1107/2009, a reference to the respective assessment reports is sufficient and the data do not need to be submitted again.
NB - The "old" data requirements are laid down in Commission Regulation (EC) No 544/2011 for active substances continued to apply till 31 December 2013. "New" data requirements have been adopted by the Commission (Regulation (EC) No 283/2013. However, transitional measures apply for the 'old data requirements. Further information is outlined in the guidance document SANTE/11509/2013-rev 5.2 October 2015.
In the case the substance was approved or the approval was renewed under Regulation (EC) No 1107/2009 the data requirements applicable to the application for import tolerance will be the same as the data requirements applicable to the application for the approval or the renewal of the approval of the active substance whatever is the latest.
In the case the substance is not approved in the EU or the approval was not renewed under Regulation (EC) No 1107/2009 the old data requirements apply for applications for import tolerances submitted by 31 December 2013 and the new data requirements apply to applications for import tolerance submitted as from 1 January 2014.
Evaluation Report (ER)
The EFSA ER available from the Commission website (Guidelines - Maximum Residue levels - European Commission) should be completed and submitted with the applications. This is not required for MRLs considered as part of the assessment of the approval/renewal of the active substance.
What are the processing targets for MRL and import tolerance applications?
The target for the evaluation of standalone MRL applications is 12 months from the acceptance at the applications sift. However, CRD endeavour to complete simpler applications more quickly. If additional information is requested, the evaluation will be stopped until the requested information is submitted.
On completion of the evaluation, the applicant will be notified of the outcome and the evaluation report and supporting documentation will then be sent to the Commission and the European Food Safety Authority (EFSA). However, please note that the timetables for establishing EC MRLs are outside of CRD 's control.
How are MRL and import tolerance applications progressed under Regulation 396/2005?
Current estimates are that it will take about 12 months once the ER is sent to EFSA until the new MRL or import tolerance is established in the relevant Annex to Regulation 396/2005.
The assessment of applications for MRLs and import tolerances in Regulation 396/2005 involves three distinct stages:
- The application and supporting data are evaluated by the Evaluating Member State (EMS) according to EU guidelines. The EMS may request further information from the applicant if required. On completion of the evaluation, the EMS will submit an 'evaluation report' to EFSA for peer review. Current estimates are that the EMS will take about 12 months to complete the MRL assessment. HSE will prioritise MRL assessments with the aim of reducing the overall processing time for this stage in the process.
- For routine MRL requests (usually an evaluation of residues data only), EFSA are obliged to provide an opinion on the risk to consumers and the availability of a suitable monitoring method within three months of receipt of the Evaluation Report. In exceptional circumstances (usually where an evaluation of the residue definition and/or toxicological endpoints is required) EFSA have six months to issue an opinion. This additional time is to allow consultation with Member States (MSs). For all MRL applications, EFSA also have the right to request further information and in such circumstances, this will delay the opinion. EFSA and HSE will inform you if additional information is required at this stage of the process. HSE will set the standard deadline of 13 weeks to respond to this request.
- When EFSA's opinion has been issued, the proposed MRL will be discussed by all MSs at the next available Commission working group (WG) on pesticide residues. MSs will then decide on the acceptability of the proposed MRL by qualified majority voting, taking account of EFSA's opinion and other relevant factors. The decision of the MSs is subject to scrutiny by the European Parliament to ensure compliance with procedures before final publication in the Official Journal. At this stage, the MRL becomes law and is applicable to all MSs.
The Process is summarised in the diagram below:
How is the fee for MRL and import tolerance applications calculated?
All applications will be charged a sift fee. Additionally, there are three evaluation charging categories, depending on the amount of information to be evaluated:
Full human health evaluation
This category is mainly for pesticides not currently authorised in the EU. In certain cases, it may also include pesticides still being reviewed, if toxicological endpoints have not yet been agreed at a European level.
These applications require a full evaluation of oral toxicity data in order to establish Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) values.
Metabolism and residues evaluations as detailed in Categories 2 and 3 are also required.
Metabolism and residues evaluation
This category is for pesticides where toxicological endpoints have already been agreed by the EU, but the residue definition has only been established for crop groups unrelated to the intended use or imported produce. These applications require an evaluation of additional plant or animal metabolism data in order to establish or confirm the residue definition.
A residue evaluation as detailed in Category 3 is also required.
This category is for pesticides where relevant toxicological endpoints and residue definitions have already been agreed by the EU .
These applications only require an evaluation of residues data and consumer exposure for the proposed crops.
Applications can be accepted for multiple MRLs or import tolerances for the same active substance. Here, the fee will be calculated on a modular basis, with a charge for each crop as follows:
Application for use on apples and wheat, for an active substance not authorised in the EU:
- Category 1 (evaluation of toxicology, fruit metabolism and apple residues data)
- Category 2 (evaluation of additional cereals metabolism and wheat residues data)
- Total fee = Category 1 fee + Category 2 fee.
Application for use on oranges, apples and bananas for an active substance currently authorised in the EU for use only on cereals.
- Category 2 (additional fruit metabolism and orange residues data)
- Category 3 (additional apple and banana residues data)
- Total fee = Category 2 fee + 2 x Category 3 fee.
For applications involving a large number of crops, some reduction in fee compared to the above calculation method may be appropriate. This can be discussed with CRD, or will be decided on receipt of the application.
Details of the current processing fees for MRL and import tolerance applications can be found at the following link: Application Fees
MRL confirmatory data submissions
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.
A guidance document outlining the process within the EU is available on the EU Commission website: EU guidance on data submitted to confirm MRLs.
Information on MRL confirmatory data and the date submission deadlines are outlined in the following document for actives where the UK is the RMS:
However, authorisation holders should consult the appropriate amending Regulation and the EFSA Reasoned Opinion for the 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:
- As part of a product submission – as the data are essential to support a GAP
- As part of the renewal assessment of the active
- Specifically to address the MRL confirmatory data requirement
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.
Information on the charging structure and processing fees for MRLs are outlined above. Note that:
- 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.
- 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.
Who should I contact for further information?
If you have questions regarding MRL or import tolerances not answered by the above guidance, please contact us.