What to do when you receive your emergency authorisation (Article 53) notice
What to do when you receive your Article 53 Notice
This guide applies to all returning Article 53 applications. Having received your Article 53 Notice, it details what you need to do during the treatment season, at the end of the season and in preparation for submission of a repeat Article 53 application. The points and principles outlined here can also be applied to new requests for uses under Article 53, including those that are planned and expected.
Remember: An Article 53 Notice is a derogation to permit use or placing on the market for use of a (usually) unauthorised product for a limited period; even when agreed in previous years, they are in no sense 'automatic'. It is not an EAMU (Extension of Authorisation for Minor Use); you must be able to demonstrate that use is limited and controlled. It is necessary to comply with all the additional restrictions and collate information as requested to demonstrate that the product has only been used when essential, in other words, that thresholds have been met, that use has been limited and controlled and all stewardship requirements, where set, have been met. Where a further emergency derogation is required, it is the responsibility of the applicant, not the authorisation holder, to assemble this information and present it with their submission for renewal of the Article 53 use, along with thorough and well explained cases for need, fully addressing all alternatives.
When you receive your Article 53 Notice:
- Read the restrictions carefully and all the data requirements as set out after the advisory information section on the Notice and in the covering letter. Sometimes there are additional notes and advice in the covering letter; these must be noted and acted on where relevant. If you are unclear about any of the requirements then ask the HSE officer responsible for the application. It is important you understand the purpose of any requirement so that you can establish how the data collected satisfies it. If you wish to discuss the requirements and obtain advice about how to address them, the information required or to check your proposals, then this is the time to have that discussion with HSE. If a stewardship programme has been specified but not agreed prior to issue you must propose it now and agree it with HSE.
- Before the Notice is distributed determine how you will collect the information required. Will you request the grower group for that crop to collect information on when their members spray and how they have made the decision to spray? For example, has the level of pest reached the threshold, or were they advised that the conditions were such that the pest would become a danger, and so on? This information needs to be collated to show the level of usage in each area of the country. Where there are export restrictions you need to determine how the evidence will be recorded and collated to demonstrate that none of the treated crop and produce derived from it have been exported. Records will need to be submitted to HSE. Decide how the requirements not to export and to record information in line with the restrictions will be communicated to users and downstream. Keep the evidence of those communications. They will be required to support your returning application and may be requested by HSE at the end of the season even if a returning application is not submitted.
- Only provide the Notice to those users who need to control the pest. The Notice will only permit use of the product to control the specific pest that has been identified as a danger in your application.
- Throughout the treatment season ensure that the necessary information and data have been/are being collated or where data requirements have been set that the data are generated or obtained (for example, the effectiveness of netting in preventing infection by Spotted Wing Drosophila).
- At the end of the treatment season collate all the information and data. Write up any overview or summary of the information in line with the purpose. It is necessary for returning applications, and indeed for any Article 53 applications, to present evidence to show that the use is limited and controlled which means records will need to be kept, collated, summarised and submitted.
- Only when you have all the required information, complete your CRD9 form (using the latest version as available on the HSE website) detailing the usage, areas treated and not treated, and other information as required by the form, for example, amount of crop saved due to the usage of the product, threshold criteria, and so on. Ensure areas of cropping and treatment are consistent throughout the CRD9 form. Ensure that the form has the correct up-to-date information; to avoid copying over out of date or superseded information it is recommended that you complete the form afresh each year. For example, including reference to meetings with HSE staff three or four years ago is not relevant. Only recent meetings or discussions, in the last 12 months, should be included. Ensure when you discuss alternative products that you include any that have been recently authorised. Always update your justification for need and include information on non-chemical methods of control. Ensure the information on work/research for a permanent solution or alternative means of control is current. Include the outcomes of that research in your submission, even if interim, and also engagement with companies towards a permanent solution.
- For returning applications, once the CRD9 form, supporting evidence, data/information as set out in the requirement detailed in the Notice and covering letter are summarised, compiled and collated then the application can be submitted. It is the applicant's responsibility to ensure that all the requirements have been addressed and to provide the necessary data and information (to a good standard) with their submission, together with appropriate Letters of Access. It is not for HSE to chase such information post-acceptance as it diverts resources from the assessment; it can also delay the evaluation.
- The application needs to be submitted as soon as possible after the season end ideally in the autumn (Sept/Oct) 2020 for the 2021 season and at the very latest in November 2020. Always submit the autumn before the following treatment season. You are advised not to await real-time pest pressure data for the year in which the new application is requested, or there will not be adequate time to process the application. Ensure you update the HSE officer allocated to your application as pest pressure builds and specifically flag up any build-up which might mean the period of use may need to be brought forward. (This will have implications for the risk assessment done, so needs to be identified as soon as possible).
- It is critical that submissions for planned or expected new Article 53 and returning Article 53 requests are timely, especially when HSE can be evaluating, preparing ECP papers and discussing with Defra and the Devolved Administrations in the region of 30 applications at the same time. It is a huge amount of work for all concerned: Product Delivery Team, Risk assessment evaluators, senior managers within HSE and the ECP Secretariat.
- See below for example timelines for papers for an Article 53 ECP meeting. Slippage in any of these deadlines causes difficulties and extra work for those involved later in the process.
|Action or event
|Deadline or date
|21 April 2020
|Deadline for papers to the Secretariat
|Deadline for papers to Head of Unit for Clearance
|Deadline for papers to Product Delivery Team manager for review
|Deadline for assessments by Risk Assessors
|Deadline to commission assessments
|14 January [note two weeks lost over Christmas]
|Deadline to accept applications
|30 November 2019*
*Applications submitted around this date and later which are accepted allow less time to allocate and commission. Note there are no application sifts for two weeks over Christmas so applications submitted in late December will not be considered at the application sift until January. Incomplete applications make it even harder to meet these timelines and risk being rejected.
Additionally, applications for products containing the same active will be grouped for evaluation purposes and so need to be submitted together. Submitting some later will delay the whole group of applications and compromise the ability to meet the required timelines.
Note: Dates may have to be brought forward. HSE is reviewing the overall Article 53 process now we are dealing with higher numbers of applications, and because demands on the ECP are expected to increase when HSE is operating as an independent regulator completely outside the EU. Please submit as many applications as possible ahead of these deadlines so assessment work is not restricted to this intense and concentrated period.