The Applicant Guide: Maximum Residue Levels and Import Tolerances
What are Maximum Residue Levels and import tolerances?
Maximum Residue Levels (MRL s, including import tolerances) 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.
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.
Hence, if you wish CRD to authorise a pesticide use that may lead to residues higher than the EC MRL, the MRL must be changed before the authorisation can be given .
This may be for a new use or for a change to the agricultural practice for an existing use. Equally, 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 CRDand if relevant, the designated RMS.
When should an MRL or import tolerance application be submitted to CRD?
In many cases, the MRL application would be submitted and processed at the same time as the relevant application for authorisation. However, because of 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 processed together with the application for authorisation are charged for the authorisation only and do not incur a separate evaluation fee for the MRL. However, 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.
What documentation is required for an application for MRLs or import tolerances?
Covering Letter
You should submit a covering letter, briefly outlining the purpose of the application, so that it can be easily identified at the Approvals Secretariat applications sift.
Application Form
The standard application form for EC MRLs can be downloaded (Link to application form). 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.
Overview Document
The overview should include a detailed description of the GAP relevant to the application and summaries of all data listed in Annexes II and III to Directive 91/414/EEC 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.
Supporting data/information
A dossier with the relevant data listed in the data requirements handbook 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 Directive 91/414/EEC, a reference to the respective assessment reports is sufficient and the data do not need to be submitted again.
What are the processing targets for MRL and import tolerance applications?
The evaluation of all applications will be completed within 14 weeks of acceptance at the Approvals Secretariat applications sift. However, 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 from submission a routine application 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.
- 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.
- 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:
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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:
|
Category |
Description |
|---|---|
|
1 |
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. |
|
2 |
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. |
|
3 |
Residues evaluation. 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:
Example 1:
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.
Example 2:
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
Who should I contact for further information?
If you have questions regarding MRL or import tolerances not answered by the above guidance, please contact Donal Griffin by telephone on 01904 455788, or by e-mail to donal.griffin@hse.gsi.gov.uk or by writing to Donal Griffin at CRD, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK.