EAMUs and Emergency Authorisations
The HCP Extension of Authorisation for Minor Use (EAMU) programme ensures commercial UK growers have the essential plant protection products needed for sustainable and efficient production of home-grown horticultural crops.
“Major UK crops are: grassland, barley, forage maize, oats, wheat, dry harvested field beans, oilseed rape, sugar beet and potatoes (other than seed). Major crops are generally not eligible for Extensions of Authorisation for Minor Use (EAMU) in accordance with Article 51 of Regulation 1107/2009 (GB/NI).
All other basic crops are considered minor and may be considered for an EAMU (subject to demonstration of need and an acceptable risk assessment).” hse.gov.uk
What are EAMUs and Emergency Authorisations?
EAMUs give the UK horticulture industry access to fungicides, herbicides, insecticides, acaricides, plant growth regulators and seed treatments. Authorisations are necessary for both chemical and biological plant protection products (PPPs).
HCP acts on behalf of the commercial horticulture industry to seek minor use authorisations from the Chemicals Regulation Division (CRD) of the Health and Safety Executive (HSE). These EAMUs are for uses that plant protection companies would not otherwise pursue, due to the cost and resources needed and the small market size of horticulture crops.
The authorisation process is costly, time-consuming, and often complex, so it is difficult for individual growing businesses to apply themselves. An EAMU or Emergency Authorisation is available to any grower of the named crop on the authorisation and cannot be limited to particular users.
In addition to EAMUs, HCP presents data and information to CRD to secure 120-day Emergency Authorisations when there is a critical pest or disease pressure that cannot be controlled with existing authorised products.
HCP also works with CRD and the wider industry to seek novel plant protection product options, including biocontrol options.
How do we secure EAMUs for the horticulture industry?
We work with CRD, plant protection product companies, Crop Associations and counterparts in the EU to identify products that will be valuable for the industry and are likely to be authorised.
The role of crop associations is crucial. At our regular meetings with each group, we work with the technical committee to review their risk registers in order to understand their priority crop protection targets for which EAMUs and Emergency Authorisations are needed. This information feeds into discussions with plant protection product companies, who work to identify if they have any available or pipeline products that could help to tackle the issues.
For all applications, data is crucial to enable CRD to carry out risk assessments.
In some cases, all data may be available, and an EAMU submission can be made to CRD, with the support of the relevant crop association and product authorisation holder.
In other cases, an application might first require the generation of residue data or the undertaking of a non-dietary exposure evaluation. There may also be the need for trials to determine product efficacy and crop safety on specific minor crops.
When a submission for an EAMU application is made to CRD, if successful we hope to get an authorisation 12 months later. There are however, numerous reasons why an application might not be authorised including a lack of data, concerns over product safety, or due to sufficient other products being available to tackle the issue.
How do we secure Emergency Authorisations for the horticulture industry?
Emergency Authorisations allow a plant protection product (PPP) to be placed on the market with limited and controlled use. They may be granted in special circumstances where the PPP is necessary because a pest, disease or weed cannot be contained by any other means.
Under an Emergency Authorisation, the PPP can only be available for sale for a period not exceeding 120 days. Emergency Authorisation is sometimes referred to as an Article 53 authorisation.
Examples where Emergency Authorisations might be required include when a new pest or disease has no existing control options, when there is resistance to existing products, or when no remaining control options are available due to loss of products and legislative changes.
Emergency Authorisations are highly specific in terms of crop, pest or disease target and cropping situation, and are always time- and use-limited. When preparing and gathering the information to submit to CRD, significantly more information is required for an Emergency Authorisation compared to an EAMU application. They are therefore very time consuming for all parties involved.
HCP works closely with growers and manufacturers to identify how use of a product can be limited and controlled. Limited use might include a maximum geographical area over which the product may be used, or restricting use to circumstances when a certain threshold is reached (e.g. pest pressure).
For controlled use, we have to demonstrate as a minimum what stewardship measures are to be implemented during the period of the Emergency Authorisation and what data collection will be required. It is also vital that clear exit strategies are outlined to demonstrate how the Emergency Authorisation can be avoided in the future.
Assessing Emergency Authorisation applications
HSE is responsible for assessing Emergency Authorisation applications across the UK and Ministers are responsible for deciding whether an application should be granted in their respective countries.
In practice, ministers delegate this responsibility to HSE. HSE makes decisions on applications on behalf of all four countries of the UK, although ministers may choose to take a decision themselves on a case-by-case basis for use in their country.
HSE may also request independent advice from the UK Expert Committee on Pesticides (ECP) on specific scientific issues.