ECP guidance on emergency authorisations

Reviewed: 25 September 2020

The Expert Committee on Pesticides (ECP) agreed a framework for the consideration of applications for Article 53 emergency use. This framework includes the criteria laid down by Regulation 1107/2009 as it has effect in Great Britain/ Northern Ireland. It requires that:

Emergency authorisations are to deal with emergency situations and will be temporary, limited in scale and controlled. On this basis, it may be possible to allow some flexibility in the safety assessment, with each case considered on its merits. An assessment will need to rely on existing information that is both relevant to the proposed emergency use and of adequate quality. As emergency applications need to be considered within a short period, the ECP also agreed that consultation via email to seek advice could be appropriate in exceptional circumstances.

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 November the year before use is required to allow consideration at the Spring ECP meeting of that year. Ministerial agreement can then be obtained before the season of use.

It would not generally be expected that there will be requests for emergency authorisations that have been previously granted to be renewed.

In all cases of a potential application for emergency authorisation, applicants are encouraged to contact HSE at the earliest possible stage to seek advice.

Article 53 emergency authorisations are driven by an immediate need and therefore, applications are usually submitted by users (farmer and grower organisations) and not companies. In many cases the applicant is unlikely to be able to generate and/or provide data to support the 'safety case'. A decision, therefore, has to be made on the information available.

Outline for an application for emergency use

This information on the emergency situation is essential to enable confirmation of emergency status.

Information to help assess the likely scale of the problem and hence the likely scale of use of the emergency authorisation:

A map of the emergency area showing the locations of any protected areas (for example, sites of special scientific interest (SSSIs), nature reserves) is very helpful.

Information about the product proposed for emergency authorisation:

If it is authorised in a member state of the EU or Organisation for Economic Co-operation and Development (OECD), for example, USA, Canada, Australia or it has been considered by Joint Meeting on Pesticide Residues (JMPR), provide any relevant information about the authorisation.

This may include evidence of:

This will include a consideration of the likely environmental fate and behaviour and the risks to groups of organisms likely to be exposed. It will also consider the likelihood of contamination of water, including groundwater.

Information about the work being done to develop a permanent solution. This can be any of the following:

Authorisation considerations

It is highly likely with Article 53 emergency applications that the evidence base on human and environmental safety will be weaker than that required for a normal commercial authorisation.

Article 53 emergency authorisations allow in some circumstances for special conditions (which might be inappropriate for a standard authorisation) to be applied. For instance, limiting treatment to a particular site(s) (such as might be the case under a Plant Health Order) might allow environmental impacts or uncertainties to be tolerated.

Compliance with some or all of the general conditions applied to permits for trials purposes, where data are still being gathered about the safety of the product, may apply to the Article 53 emergency authorisation. Where this is the case, the applicant for an Article 53 emergency authorisation could use these controls as a reason for considering the risks acceptable. The controls that apply to permits for trials purposes are set out in the Applicant Guide Overview.

 
Updated 2021-08-09