New MRLs

• When to apply for a new MRL
• What to include in your application
• How long an application takes to process
• Fees
• Search for evaluation reports, reasoned opinions and decision documents

When to apply for a new maximum residue level (MRL)

You may have to apply for a new MRL:

• when you apply for a plant protection product (PPP) authorisation
• before you import produce with residues that may exceed the GB MRL (import tolerances)
• as part of an active substance approval

There are separate rules for Northern Ireland.

PPP authorisation

If the proposed use of a PPP may lead to residues exceeding the GB MRL,you must apply to change the MRL before the use of the PPP can be authorised. This may be due to:

• a change in agricultural practice
• the introduction of a new use

If the proposed use in Northern Ireland may lead to residues exceeding the EU MRL, you must apply to change the EU MRL.

You can apply for a GB MRL at the same time as applying for a PPP authorisation. HSE will evaluate the MRL assessment at the same time as the product evaluation. The MRL will be amended in the GB MRL Statutory Register when the PPP use is authorised. HSE will not charge a separate evaluation fee for the MRL assessment.

You can apply for an MRL before you apply for the PPP authorisation if the supporting information is available. HSE will charge separately for MRL applications made before the application for PPP authorisation. HSE may reduce the PPP evaluation fee if components were already evaluated under the MRL application. The total fee will be higher due to the additional administration required.

Import tolerances

You must apply for an import tolerance before importing produce into Great Britain with residues that may exceed the GB MRL. Import tolerances may be required for:

• pesticides not used in Great Britain
• commodities not treated in Great Britain  
• different agricultural practice in the exporting country

To import produce into Northern Ireland with residues exceeding the EU MRL, you must apply for new EU MRLs. There is separate guidance on the rules for Northern Ireland.

You can apply for a GB import tolerance when the supporting information is available. There should be an existing or intended authorisation in the exporting country.

Active substance approval

You can apply to change MRLs as part of the approval of the active substance. The MRLs may be for:

• the representative good agricultural practice (GAP)
• additional GAPs required for product authorisation

You should discuss the number of additional crops being supported for MRL assessments at the pre-submission meeting. HSE may need to limit the number of additional GAPs to ensure the assessment is not unduly delayed.

What to include in your application

You must submit:

• covering letter
• CRDMRL application form
• an application overview with a table summarising the residue trials
• previous relevant correspondence
• product label or draft label detailing the intended use
• data 
• evaluation report (not required for the representative uses for the approval of an active substance or for Emergency authorisation (Article 53) or extension of authorisation for minor use (Article 51))
• evidence for import tolerances  

More detail about what you must submit is available in the applicant guide.

Data you must submit

The data that you submit should address the:

• residues data requirements
• toxicological data relevant to the consumer exposure including the data required to establish an acceptable daily intake (ADI) and an acute reference dose (ARfD)

The data requirements are the same as those applied at the latest approval or renewal of the active substance. Regulation (EC) No 283/2013 applies to active substances which are not approved in Great Britain.

You must submit copies of all original study reports unless the data were assessed at the approval or renewal of an active substance. In this case, make a clear reference to the assessment report. The EFSA conclusions on the peer review and Reasoned Opinions for MRL assessments can be referenced if they relate to decisions that were implemented in the UK.

If you submit new metabolism studies, you should summarise the residue levels and toxicity information for metabolites in the Plant_and_livestock_metabolism spreadsheet.

For the approval of the active substance, you can outline data supporting the MRLs for the representative uses in the main dossier. You should submit data for additional GAPs in a separate dossier.

Evaluation report

Use the correct report template for the applicable data requirements:

• Regulation (EC) No 544/2011 - MRL_ER_old_data_requirements
• Regulation (EC) No 283/2013 - MRL_ER_new_data_requirements

The template contains additional information to consider when preparing the submission to HSE.

The template does not need to be completed for applications under article 51 and 53 of Regulation (EC) No 1107/2009.

Evidence for import tolerances

Evidence of the following for the exporting country:

• PPP authorisation – labels, authorisation documents, relevant legislation
• MRLs in force and relevant legislation
• residue definitions in force (enforcement and risk assessment)

Provide links to the national websites where this information is available and provide English translations if necessary.

HSE can start the assessment without this evidence. For example, if the authorisations is under evaluation by the competent authority of the exporting country. However, HSE will be unable to implement the MRL if the evidence is not provided by the assessment completion deadline, and you will need to make a new application with the evidence. In this case, HSE will check the evaluation report to ensure the assessment remains valid and charge a sift fee and an administrative fee.

For active substances not approved in GB, you should submit a summary of relevant data from scientific peer reviewed open literature. The data should relate to the toxicological and residues/dietary exposure assessment and cover:

• the active substance
• metabolites
• breakdown or reaction products
• PPPs containing the active substance

Temporary MRLs

Temporary MRLs (tMRLs) may be set:

• to support emergency authorisations under Article 53 of Regulation (EC) No 1107/2009
• for residues arising as a result of contamination
• where the products form a minor component of the diet of consumers or, where relevant, of animals
• for honey
• for herbal infusions
• for essential uses of PPPs following non-approval of an active substance
• for  food or feed products newly included in Part 1 of the GB MRL Statutory Register to allow studies to support an MRL to be performed

Further details on temporary MRLs can be found in Article 16 of Regulation (EC) No 396/2005.

You may be able to provide monitoring data to apply for temporary MRLs. Various approaches can be taken to establish a tMRL using monitoring data and the approach taken will be dependent on the specific situation. Further details on using monitoring data are outlined in the FAO Manual (2016). HSE will take into account the approaches outlined in the FAO Manual when relevant.

How long an application takes and processing targets

HSE processes MRL applications made at the same time as PPP authorisation or active substance approval to the timescales for the PPP or active substance.

The target for standalone MRL applications, including import tolerances, is 12 months from acceptance at the applications sift. Large data packages may require longer processing times. HSE recommends that the submission of large data packages is discussed beforehand.

If HSE requests additional information, the evaluation will be put on hold until you submit the requested information. Applications can be put on hold for up to 6 months.

Fees

The following guidance outlines what fee categories apply to potential applications. There is a separate page where you can find out what the current fees for applications are.

MRLs as part of a PPP Authorisation

No additional fees, on top of those charged for the product authorisation assessment, are charged for the assessment of the MRL.

Standalone MRL and Import Tolerance Applications

you will be charged:

• a sift fee
• a coordination fee
• an additional fee for each category of information to be evaluated

Full human health description

• active substances not approved in GB
• may include active substances still under review, if the ADI and ARfD are not agreed in GB
• full evaluation of oral toxicity data to establish the ADI and ARfD
• metabolism and residues evaluation also performed

Metabolism and residues evaluation

• ADI and ARfD agreed in GB
• residue definition only established for crop groups unrelated to the MRL commodity
• evaluation of plant and/or animal metabolism data to establish or confirm residue definition
• residues evaluation also performed

Residues evaluation

• ADI and ARfD and residue definitions agreed in GB
• evaluation of residues data and assessment of consumer exposure

You can apply for several MRLs or import tolerances for an active substance. HSE calculates the fee on a modular basis, with a charge for each crop.

Examples

Uses on apples and wheat, for an active substance not approved in GB:

• sift fee
• coordination fee
• apples - full human health description fee (toxicology, fruit metabolism and apple residues data)
• wheat - metabolism and residues evaluation fee (cereal metabolism and wheat residues data)


• total fee = sift fee + coordination fee + full human health description fee + metabolism and residues evaluation fee

Uses on oranges, apples and bananas for an active substance currently approved in GB on cereals:

• sift fee
• coordination fee
• orange - metabolism and residues evaluation fee (fruit metabolism and orange residues data)
• apple - residues evaluation fee (apple residues data)
• banana - residues evaluation fee (banana residues data)
  
  
• total fee = sift fee + coordination fee + metabolism and residues evaluation fee+ 2 × residues evaluation fee

The fee may be reduced for applications with many crops. You can discuss this with HSE or HSE will decide when receiving the application

Search for evaluation reports, reasoned opinions and decision documents

New and raised MRLs

Search for evaluation reports, reasoned opinions and decision documents for new and raised MRLs by downloading the Published new and raised GB MRLs list.