Applicant Guide: Notification process for non-significant changes to formulations
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
This process is a quick service through which authorisation holders can make changes to the formulation of their product where that change does not require any consideration of its impact on the product's supporting risk assessment.
Notifications for non-significant formulation changes should be made via email to [email protected]. Your notification should include:
- A completed notification form. You will need to complete part A and part B fully. Part C will normally be required except where indicated below. The notification form template can be found in the "Further Information" section below.
- A brief explanation of the reason for the proposed non-significant formulation change and a justification for submitting via the notification process.
A complete notification form is required for each product. HSE will not accept any notification forms that include details for multiple products and we will not accept any notification forms that have not been fully completed or that refer to the notification forms for other products.
There will be no fee for the submission of these notifications. It is the responsibility of the authorisation holder, as the duty holder, to ensure that the change is compliant with the definition of a non-significant formulation change and that accurate details of this change have been notified to us. HSE will not consider the validity of any notified non-significant formulation change to your product.
If we reject your notification due to an incomplete or incorrect form we will let you know within 6 weeks. We will not enter into any further discussion once we have notified you of the rejection. You may choose to either resubmit a corrected notification or submit a standard application for the change (with all associated fees and timescales) or choose that you no longer wish to pursue the change.
If we accept your notification we will record this against the product in our database and we will provide you with a reference number within 6 weeks. As soon as we have provided you with this number you will be authorised to sell/market/use the new formulation.
We will not update notices of authorisation as part of the notification process. However, when you make your next non-administrative application for a product for which you have previously submitted a non-significant formulation change we will incorporate the change into any resulting authorisation at that stage. To ensure that this is done when submitting your next non-administrative application you should include the reference number of the decision in your covering letter.
An authorised product may not have more than one non-significant formulation change notification on file at any given time. If you wish to make additional non-significant changes to an authorised product for which we already hold an extant notification of a non-significant formulation change then a new application for an authorisation will be required.
There are three types of formulation change that can be considered non-significant and that are suitable for the notification process
Alternative sources of co-formulant.
If you wish to add an alternative source or trade name of the same co-formulant then this is suitable for the notification process so long as the alternative is equivalent to the currently authorised co-formulant. You will need to complete a part C for every alternative co-formulant you wish to add (part C of the form can be copy/pasted sufficient times to cover all the proposed alternate co-formulants). In part C you will need to provide a breakdown of the components of both the alternative co-formulant and the equivalent, currently authorised co-formulant.
Cation exchange in an anionic surfactant / dispersant
This change can be considered via the notification process and the requirements for submission are the same as for the normal notification of an alternative source of a co-formulant as detailed above. The implicit difference is that the cation component of the alternative co-formulant will not be replaced like for like. You will still need to fully complete Part C of the notification form.
Addition of a previously agreed marker substance
If you already hold an authorisation for a product that contains a marker substance that has been assessed by us then you can add the same marker substance to other products via the notification process. You will need to indicate the product in which the marker substance is already agreed in Part A of the notification form. Part C of the notification form is not required for the addition of a marker substance.