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Article 53 of Regulation 1107/2009 – Emergency Authorisations

Regulatory Update: 01/2017
Issued: 5th January 2017

Purpose

To announce the updated UK arrangements for considering Article 53 emergency authorisations under Regulation (EC) 1107/2009 (the Regulation) and associated charging.

The changes outlined here, including the introduction of a new application form (CRD9), will take effect from 10th January 2017.

Background

Article 53 of Regulation (EC) 1107/2009 allows Member States, under certain circumstances, to authorise the use of a plant protection product 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 means.

The Commission has published a working document for implementing these provisions (SANCO/10087/2013 Commission Working document on Article 53 Emergency authorisations).

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 will be made by the Minister. Further advice on the role of the ECP and dates of their meetings can be found at the link below.

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 as detailed in the link below 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 new application form CRD9 from 10th January 2017. After this date, HSE will not accept Article 53 applications without a CRD9 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 e.g. where an active substance is new to the EU, 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.

Processing applications – notification of emergency authorisation to the European Commission

HSE must inform the Commission and other Members States of the details of all Article 53 authorisations granted. The Commission has released a database, PPPAMS (Plant Protection Products Application Management System), and has asked Member States to notify Article 53 authorisations via this system. The new Article 53 application form provides HSE with the information required to consider the case for emergency use, and also provide the details required by the Commission.

Charging

HSE must charge fees to recover the full cost of processing emergency applications. For all applications received after 10th January 2017, HSE will use the modular fee charging system as used for other types of applications.

Table 1: Summary of fees for Article 53 Emergency Authorisations
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 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, introduced on 29th June 2016, 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.

For details of the current fees check the fees page at the link below.

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 a 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.

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, please contact HSE: Link to Contact Details Page.

Links to relevant guidance on HSE website

Note that all guidance given in this bulletin is also included on the main website pages.

UK Guidance on Article 53 applications: The Applicant Guide: Emergency (120 day) Authorisation

ECP guidance on emergency authorisations

CRD 9 Application Form – see The Applicant Guide: What Should I Include In An Application(scroll down table to CRD9 form)

CRD Fees Charged for Individual Application Types

Procedures for handling applications

ECP website

Updated 2017-02-21