Change to HSE procedure for processing plant protection product applications dependent upon the setting of a Maximum Residue Level
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Regulatory Update: 04/2015
Issued: 31st March 2015
This Regulatory Update sets out the new arrangements for processing plant protection product applications where the authorisation is dependent on the establishment of a Maximum Residue Level (MRL) for that product and use combination.
What the changes mean for applicants
These changes require applicants to submit a new ‘administrative’ application to HSE once an MRL is published in a Commission Regulation. HSE will charge the appropriate fee (a sift fee and an administrative fee), as published on the HSE website. In processing the application, HSE will check the authorisation, to ensure the assessment of the original application remains valid. HSE will then issue the authorisation.
These changes aim to streamline the processing of such applications, ensure HSE recovers the full processing costs and also assist applicants by providing advice on the detail of the proposed authorisation in advance of the MRL being published.
A maximum residue level (MRL ) is the highest level of a pesticide residue that is legally tolerated in or on food or feed when pesticides are applied to plant products correctly, ie in accordance with Good Agricultural Practice. Sometimes it is necessary to establish a new MRL or to amend an existing MRL before HSE can issue an authorisation for a pesticide product.
When HSE receives an application for a plant protection product where authorisation is dependent upon the evaluation of an MRL , HSE submits an ‘evaluation report’ to EFSA for peer review, requesting either a new MRL or a change to an existing MRL. Once the application is made to EFSA, HSE suspends the application pending determination of the MRL. HSE then resumes processing of the application once notification is received that the MRL has been published.
This is an inefficient process and does not allow HSE to recover the full cost of processing the whole application.
Under the new arrangements, where an authorisation requires the establishment of a new or amended MRL , HSE will complete the assessment of the application as far as possible and make the MRL application to EFSA . At that point, the application will be refused. The applicant will be advised that an application for an MRL has been submitted, and will also be provided with the details of the authorisation that could be issued once the new/revised MRL comes into force.
The applicant will also be advised that it is their responsibility to check for the publication of the implementing Regulation establishing the new MRL and then submit a new ‘administrative application’ once the MRL comes into force, to trigger the issue of the authorisation. The further application would be charged the appropriate fee (a sift fee and an administrative fee), as published on the HSE website, and as part of this process the authorisation will be checked to ensure the assessment of the original application remains valid.
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 these new arrangements to applications received after 1 April 2015.
If you have any questions relating to this Regulatory Update, please contact us: Link to Contact details page
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