New notification process for non-significant formulation changes to Plant Protection Products
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Regulatory Update: 08/2016
Issued: 24 March 2016
To announce a new process for authorisation holders to notify HSE of non-significant changes to the formulation of their plant protection products.
Guidance document SANCO/12638/2011 issued under EU Regulation 1107/2009 sets out the harmonised process for handling formulation changes considered to have a negligible effect on the risk assessment supporting an authorised plant protection product. These are classed as 'non-significant changes'. The guidance document states that notification of such changes to the regulatory authority is sufficient and that a new assessment (and authorisation) is not required.
To implement this guidance, HSE will now allow plant protection product authorisation holders to make non-significant formulation changes to their products via a new notification process.
When does this apply?
HSE will apply these arrangements to all notifications received from 01 April 2016.
What is a non-significant formulation change?
Non-significant formulation changes are those where there is no chemical change to the manufactured product. The following formulation changes are considered to be non-significant:
- Where a co-formulant is from an alternative source or has a new trade name. The co-formulant must be chemically equivalent and present in the same quantity as the co-formulant that it is replacing.
- For anionic surfactants/dispersants the cation may be exchanged.
- The addition of a marker substance to a plant protection product where it is less than 0.1% of the formulation and presents no toxicological or ecotoxicological concern. This must have been determined by HSE under a previous assessment. The marker must already be included in the authorised formulation of another plant protection product.
How will you notify HSE of a non-significant formulation change to your authorised product?
Notifications for non-significant formulation changes can be made to HSE by emailing a completed copy of the notification form to [email protected].
(see our website for a blank notification form - note this should be available on the site shortly after the issue of this update. If you need a copy before then, please email: pesticides&[email protected])
All notifications must explain the reason for the change and include a justification for consideration via the notification process. Further guidance on submissions can be found in the Applicant Guide page of our website.
Where the formulation change affects several products, applicants should complete a separate notification form for each product. Notifications for multiple products will not be accepted. A notification that refers to a previously (or concurrently) submitted notification rather than fully reproducing the required parts of the form will not be accepted.
An authorised product should not have more than one notified non-significant formulation change. If you wish to make further changes, then an application for a new authorisation should be made. At HSE's discretion, a single notification for more than one change may be acceptable if supported with a suitably argued case.
There will be no charge for the submission and consideration of a notification for a non-significant formulation change.
How will we consider your notification of a non-significant formulation change?
HSE will record your notification against the relevant product and will confirm when our records have been updated. You will then be authorised to manufacture and market your product with the notified changes as soon as you receive this confirmation. However, HSE will not update your notice of authorisation as part of the notification process. Instead, HSE will issue a reference number with which you will be able to refer to the accepted notification.
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.
Non-significant formulation changes notified to HSE will be incorporated into the product authorisation whenever the next non-administrative application is authorised. To ensure that the changes are accommodated, you should include the reference number of the notification decision in your covering letter when submitting your next non-administrative application.