Prioritisation of Maximum Residue Level (MRL) assessments in applications for the authorisation of Plant Protection Products
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Regulatory Update: 20/2015
Issued: 18 December 2015
This Regulatory Update announces the introduction of a change to HSE's processing of MRL assessments in applications for the authorisation of Plant Protection Products, to allow early submission to the European Food Standards Authority (EFSA). The aim is to reduce the overall processing time for such applications.
Standalone MRL applications can still be submitted to HSE prior to the submission of an application for a product authorisation. Such applications are charged in accordance with applications for import tolerances (Link to information on import tolerances)
What the change means for applicants
Applications for the authorisation of Plant Protection Products under Regulation (EC) No 1107/2009 may require a new MRL or an amendment to an existing MRL before HSE can issue an authorisation. The MRL is confirmed and published by the European Food Standards Authority (EFSA) based on HSE's assessment.
HSE will now complete the MRL assessment ahead of other areas of the risk assessment and then submit this immediately to EFSA. We will apply this approach to all relevant applications to maximise the time available for EFSA to confirm and publish the MRL required, and avoid a delay to the PPP authorisation process.
In order for this priority to operate, the need for an MRL must be clearly outlined in the covering letter and application overview. The applicant must:
- Follow the EU guidance documents on MRL assessments Link to EU Commission guidelines for MRLs
- Complete the MRL application form and the 'Template Evaluation Report'
- Provide a summary of the crops
- Clearly indicate existing and proposed MRLs
Prioritising the MRL assessment in product applications aims to reduce the interval from completion of the product application to the date of entry into force of the new or amended MRL. However, the arrangements for product applications announced in Regulatory update 04/2015 will be applied if a final conclusion on the product authorisation is reached prior to the date of entry into force of the new or amended MRL.
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC.
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of Plant Protection Products on the market.
When does this apply?
HSE will apply this approach from the date of this Regulatory update. However, accepting an application to prioritise the MRL assessment will be at HSE's discretion, and in some circumstances we may be unable to prioritise the MRL. Applicants will be notified of HSE's decision to accept or reject the prioritisation of the MRL assessment.
The procedure will be operated for a trial period of one year from the date of publication of this Regulatory update. HSE will then review the benefit of this approach and decide about its continued operation.