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:
How to submit notifications
Notifications for non-significant formulation changes can be made to HSE by emailing a completed copy of the notification form.
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 the HSE/CRD 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. To make further changes, 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.
For advice on risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, firstname.lastname@example.org
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