Changing a pesticide product application mid-evaluation

A request to make a minor change to an application once it has been accepted is only acceptable if it falls within the criteria below, and the overall scope of the original application cannot be changed.

We consider such changes on a case-by-case basis; and the decision will depend on the stage we have reached with the evaluation of your application.

You may also be asked to submit additional data mid-evaluation or as the second part of a 'two-stage' procedure to allow us to complete the evaluation of your application.

We will consider changes in the following cases:

• where it is a simple administrative change which would normally qualify as an admin application (see the guidance document on submitting applications)
• when additional data/information/labels are submitted to support your original application. We only guarantee to accept this type of add-to if the evaluation of the application has not started

Examples of acceptable changes are:

• changes in product name, authorisation holder and marketing company. If access to third party data is required, new letters of access that reflect the proposed change must be submitted. This change can be made up to the issue of an authorisation
• a two-year storage stability study that supersedes a previously submitted accelerated or one-year study (only accepted prior to the start of the evaluation of the application by the chemistry specialist assessor)
• revised labels that do not extend the scope (meaning what the application is for) of the application. These must be submitted before the start of the evaluation of the application
• additional convenience tank-mix recommendations supported by a Compatibility Assurance Statement (CAS). These may be accepted at any time as the CAS refers to an attached list of tank-mixes and no new label is submitted (see the guidance document on tank-mixes)
• additional tank mix recommendations supported by data - only accepted before the start of the of the application by specialist assessors
• minor formulation changes where new data are not required to support the change. Health and safety data sheets and a reasoned scientific case to support the change must be submitted (only accepted before the start of the evaluation of the application by specialist assessors)
• revised efficacy or residues overviews as long as they do not extend the scope of the application (only accepted before the start of the evaluation of the application by specialist assessors)

We will not consider the following changes:

• any changes that would extend the scope of the application or alter it beyond what was requested when the application was submitted. Examples of altering the scope include requesting authorisation for additional crops; requesting an increase in the application rate, the number of treatments, or shortening the harvest interval; amending the classification of a proposed formulation
• if the evaluation of the application is nearing completion so that it is no longer possible to consider your add-to request without a new evaluation, for example we will not accept a revised efficacy overview if the efficacy evaluation for your application has been completed