The Applicant Guide: Commercial withdrawals

How do I commercially withdraw a product?

If you wish to withdraw your plant protection product (PPP) from the market for a commercial reason you should contact us so that your authorisation can be formally withdrawn. We do not charge a fee for carrying out this procedure.

You should email the Applications Sift at [email protected] confirming:

• details of the product you wish to withdraw
• reasons for withdrawal. If the reasons are due to adverse effects then a submission in line with the adverse data procedure must be submitted
• the withdrawal period you require.

Further information on withdrawal periods can be found in the guidance on withdrawal of authorisations and permits.

How do I commercially withdraw an authorised use?

If you wish to withdraw a use from the label of your authorised PPP you will need to submit an application for the commercial withdrawal of this use and a new authorisation will need to be issued for the product. In your application you must state why you wish the use to be withdrawn. You must submit an Admin application to the Applications Sift confirming:

• details of the use you wish to withdraw
• reasons for withdrawal. If the reasons are due to adverse effects then a submission in line with the adverse data procedure must be submitted
• the withdrawal period you require. Further information on withdrawal periods can be found in the guidance on withdrawal of authorisations and permits

However, note below about major amendments.

Minor amendments

Where the amendment to the authorisation is considered to be of a minor nature and no technical consideration is required, then your application can be processed via the Admin' Stream (go to the guidance on application streams and targets for further information). The use will be deleted from your new authorisation and a label amendment will be issued to delete all references to the withdrawn use.

Major amendments

If your request for withdrawal is more complex and may potentially involve the checking of your product label, we will conduct a more detailed evaluation which may be considered via the 52-week stream. The types of withdrawal that may be given for your product's authorised use are detailed above.

Authorisation holders are not required to make an application to HSE to remove an authorised use from the product label but have the option of doing so.

Authorisation holders should note that the position regarding liability for the consequences of product failure set out in the Consumer Protection Act 1987 continue to apply.

Unless a use is formally withdrawn by means of an application to alter the statutory conditions in the notice of authorisation, the authorisation holder remains liable for any crop damage which may arise so long as the PPP has been used in accordance with the authorised conditions of use (including during the period of any phased withdrawal).

This applies regardless of whether or not the use appears on the label.

Authorisation holders may wish to consider this when removing a use permanently from the product label placed on the market.