Applicant Guide: Notification process for non-significant formulation changes
The ability for authorisation holders to make changes to the formulation of their product is derived from Article 45(2) of Regulation (GB) 1107/2009 and supplemented by the SANCO guidance document SANCO/12638/2011. The notification process for non-significant formulation changes provides a quick service through which authorisation holders can make changes to the formulation where that change does not require any consideration of its impact on the product's supporting risk assessment.
Formulation change types
There are 3 types of formulation change that can be considered non-significant and suitable for the notification process.
1. 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 Part C of the CRD-N form for every alternative co-formulant you wish to add (Part C of the form can be copied pasted sufficient times to cover all the proposed alternate co-formulants).
If the proposed co-formulant is a mixture, you will need to provide a breakdown of the components of both the alternative co-formulant and the equivalent, currently authorised co-formulant in Part D of the CRD-N form. If this is not your first non-significant notification since the last technical assessment of your product, you should provide a statement confirming that the notification has no bearing on the data and risk assessment supporting the current authorisation of the product (Part E).
2. 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 CRD-N form.
3. 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 HSE previously, 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 CRD-N form. Part C of the CRD-N form is not required for the addition of a marker substance.
Notifications for non-significant formulation changes should be made via email to [email protected].
Your notification should include:
- a completed CRD-N form for each product
- Part A and Part B must be completed for all notifications Part C will normally need to be completed except where indicated below
- Part D will need to be completed if the authorised and proposed co-formulants are mixtures
- Part E will need to be completed if this is not your first non-significant notification since the last technical assessment of your product
- a brief explanation of the reason for the proposed non-significant formulation change and a justification for submitting via the notification process
HSE will not accept any CRD-N forms that include details for multiple products and we will not accept any that are incomplete or that refer to the CRD-N 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 determine, based on the information provided, if the non-significant formulation change is acceptable.
If we reject your notification due to an incomplete or incorrect form, or if we deem the notification unacceptable or insufficient, 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 revised CRD-N form or submit a standard application under Article 33 (Amendment) of Regulation 1107/2009 for the change (with all associated fees and timescales) or choose to no longer pursue the change.
If we accept your notification, we will record this against the product in our database and we will provide you with an internal 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.
We will now accept multiple non-significant formulation change notifications on a case-by-case basis, providing Part E of the CRD-N is completed.