Article 53 of Regulation (EC) 1107/2009: Emergency authorisations
Reviewed: 25 September 2020
Purpose
To announce the updated arrangements for considering Article 53 emergency authorisations under Regulation 1107/2009 as it has effect in Great Britain/ Northern Ireland and associated charging.
The changes outlined here, including the introduction of a new application form (CRD9), will take effect from 10th January 2017.
Background
Under certain circumstances it is possible to grant an emergency use of a plant protection product to place on the market for a period not exceeding 120 days, for a limited and controlled use where such a measure is necessary because of a danger which cannot be contained by any other reasonable means, as set out in Article 53 of Regulation (EC) 1107/2009.
HSE has reviewed its procedures to improve the handling and efficiency of Article 53 applications and ensure that we cover our costs in full.
Changes in the process
New application form
HSE has produced a new application form for Article 53 applications (form CRD9). Applicants should no longer use the CRD3 application form to request emergency authorisation. The CRD3 application form will now only be accepted for Article 51 Extensions of Authorisation for Minor Use (EAMU) applications.
The CRD9 form clearly outlines the information required to support an application for Article 53 emergency authorisation of a product.
The role of the Expert Committee on Pesticides (ECP) in considering applications for emergency authorisations
All Article 53 applications HSE accepts will be considered by the ECP. The ECP will advise the Minister of their recommendation. The final decision on whether authorisation can be issued can be made by the Minister for each of the four Devolved Administrations. GOV.UK has more advice on the role of the ECP and dates of their meetings .
Processing applications: Timing
On receipt of the application, HSE will first consider the case for need and the degree of urgency. Once an application is accepted, HSE will advise applicants of the likely timescale for reaching an authorisation decision.
Additional time may be required for the ECP consultations. It is not possible to specify precisely how long the decision-making process will take. However, the ECP meets regularly (6 to 7 times a year). Consultation will be via a paper to the next scheduled ECP meeting.
In exceptional circumstances, HSE may consult the ECP via correspondence if the nature of the emergency means that consideration cannot be delayed until the next scheduled meeting. Applicants must provide evidence of the extreme urgency to support the need for the application to be considered outside a scheduled ECP meeting. When submitting applications, applicants should note the dates of the ECP meetings and submit their application to allow for ECP consultation.
Responsibilities of the applicant
It is the responsibility of the applicant to provide all relevant information to justify the need for an emergency authorisation (describing the emergency circumstances and the proposed use). This will assist HSE in making a prompt decision on the emergency need.
It is particularly important for the applicant to demonstrate how the emergency use will be limited in scale and to provide details of on going and future work towards a permanent solution to eliminate the need for repeat applications for an emergency authorisation in the future.
Applicants must use the CRD9 application form.
Applicants should provide as much information as possible to address the risk assessment. This will enable HSE to progress the risk assessment efficiently and reach a risk management decision as quickly as possible.
Where there is no existing information on the active substance, for example, where an active substance is new, then HSE will not progress an emergency application because of the volume of evaluation work required to meet the requirements of Article 53.
HSE recognises that many applicants do not always have access to the information and data supporting the authorised product being cited in the emergency application. Applicants should always seek advice and assistance from the authorisation holder and data owner in order to complete the section in the CRD9 form relating to the risk assessment. Note: in rare circumstances, HSE may complete the risk assessment at the request of the applicant. HSE will charge accordingly for this extra work. HSE will not do this routinely but only in exceptional circumstances. These will be considered on a case by case basis.
Charging
HSE must charge fees to recover the full cost of processing emergency applications. HSE will use the modular fee charging system as used for other types of applications.
| Description of fee | Relevant applications | Comments |
|---|---|---|
| Sift fee | All Article 53 applications | Covers the cost of a validation check. Fee charged even where an application is then rejected. |
| Reasoned case fee | All Article 53 applications |
Covers the cost of a validation check. Fee charged even where an application is then rejected. |
| When an application is accepted | ||
| Coordination fee | All Article 53 applications accepted by HSE | |
| Modular (data or case) fee | Where required (likely to include consumer risk, non-dietary human exposure, environmental fate and behaviour and ecotoxicology) | Dependent on specialist input required. This is a separate modular fee for each specialist input required. |
The fees in Table 1 reflect the new procedures, where HSE will complete a validation check to ensure that the application is complete before acceptance. At this stage we will also consider the case for need and urgency.
Limit on number of repeat applications
Many applications recently received have been repeats of previous emergency authorisations. The regulation makes it clear that an Article 53 authorisation is a temporary derogation. Applicants must be working towards a permanent solution such as an extension of authorisation for minor use under Article 51, or a product authorisation under Article 33.
HSE recognises that when a pest is new, then there will not be the regulatory data to support an authorisation under Article 51 or 33. However, where the emergency authorisation is for UK authorised product, it is expected that applicants will generate supporting data during the period of the emergency authorisations, and then apply for an authorisation under Article 51 or 33. For this reason, HSE will not consider more than three repeats of an emergency authorisation; this gives four years to generate the data and obtain a full authorisation. Only in exceptional circumstances will we allow more than three repeat emergency authorisations. What to do when you receive your Article 53 Notice gives further information.
Timing of submission of repeat applications
When submitting an application requesting the repeat of an emergency authorisation, applicants know when the use is required. To allow sufficient time for HSE to consider the application and consult with the ECP and Ministers, repeat applications must be submitted by the end of January in the year of use to allow consideration at the Spring ECP meeting of that year. Ministerial agreement can then be obtained before the season of use.
If you have any queries concerning the contents of this Regulatory Update, contact HSE.