The Applicant Guide: Zonal authorisations – following zonal procedures under Regulation (EC) 1107/2009
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
What do I need to submit for a Following Zonal application?
- A cover letter and detailed application overview, including detailed evidence that the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product in the zonal Member State are comparable with those in the UK;
- A signed and completed application form (CRD1);
- A copy of the draft UK label for your product;
- A draft Registration Report Part A/B0, detailing the risk management pertinent to the UK, a draft Registration Report part C, and the draft Registration Report Part B UK addenda in all relevant areas detailing the risk assessment to address UK specific issues;
- A complete and summary dossier for the product and each active substance, safener and synergist.
- A declaration that the active substance technical specification, the formulation recipe of your product and classification labelling are all the same as those assessed and accepted by the zRMS, and that the assessment is to Uniform Principles using EU agreed endpoints;
- A declaration that the GAP and packaging type is within that assessed and accepted by the zRMS;
- If the product contains a candidate for substitution, a comparative assessment is required.
Your application will need to contain appropriate information so that we can determine whether the use of the product in the reference Member State is comparable with the proposed use of the product in the UK. These applications should not involve data evaluation (except where data are required to address the national specific requirements or demonstrate comparability of environmental / agricultural conditions).
UK procedures for sifting and processing of following zonal applications in accordance with Articles 33–39 of
All following zonal applications will be processed in line with the normal procedures for consideration of applications for authorisation of new Plant Protection Products, or applications for changes to the authorisations of Plant Protection Products. The exceptions to this are detailed below.
How will my application be sifted?
Following the Review of the Regulatory Process and Procedures for Plant Protection Products in 2016 (see guidance document: ‘Overview of the Processes and Procedures for the Authorisation of Plant Protection Products’), it was deemed appropriate for HSE to continue operating the existing procedures for sifting following zonals and commenting on the core assessment. The procedures are summarised in brief as follows:
- Commenting upon a zonal Rapporteur Member State draft assessment will be conducted in tandem with the detailed sifting of a following zonal application (for which comments are requested where the UK are a concerned Member State).
- Once a draft assessment is circulated for commenting by the zonal Rapporteur Member State, a following zonal application is considered for the first time since submission. This process is carried out over the 4 week sift period, after which the result of the detailed sift are finalised. Once the content of both the UK commenting table and the detailed sift feedback have been finalised, the comments are then sent to the zonal Rapporteur Member State.
The non-confidential comments and the detailed sift feedback will be sent to the applicant
No charging or invoicing is carried out at this point. This is the first contact an applicant will receive to confirm that HSE is considering their following zonal application.
- A sift fee will be charged for consideration of the application. Should the initial sift result in a rejection and subsequent re-submission, two sift fees will be charged. For more information on fees and charging, please see the fees page.
How will my application be processed?
Once the final Registration Report is received from the zonal Rapporteur Member State, with any provisions made following consideration of Member State comments, the following zonal application will be accepted, charged, and the 120 day statutory processing time will begin. Under exceptional circumstances, the UK may allow an applicant additional time to address any detailed sift feedback requirements before beginning processing of the following zonal under 120 day timelines, even if this information is received after the zonal Rapporteur Member State's final report. This is granted because an application is not 'complete' until the dossier fully addresses UK requirements, and is amended in accordance with the results of a zonal Rapporteur Member State assessment.
Where additional time is allowed, the sifter for the following zonal application will be available to negotiate a suitable submission date for the revised following zonal dossier if necessary.
Please note, no requests for further information can be issued once the 120 day processing time has commenced, in line with procedures for Mutual Recognitions.