What happens at re-registration?
After an active substance has been included in Annex I of Council Directive 91/414/EEC or approved under Regulation (EC) 1107/2009, if you are a grower or grower group responsible for an ‘Extension of Use’ (formerly known as Specific Off-Label Approval (SOLA)) for a product containing that active substance, we will inform you explaining the impact of the decision and the action you will need to take to support these uses in the future.
At re-registration, we need to confirm that any extensions of use in the UK meet Annex III requirements and satisfy the Uniform Principles.
Details of deadlines and actions required can be found on our website under Re-registration requirements for existing UK authorisation holders.
Deadlines and detailed supporting information for all active substances with an Inclusion Date of 1 January 2009 or later are provided on this website as a pdf file, either alphabetically by a.s. or by date of decision.
A table of all active substance inclusions and their associated deadlines is also provided either alphabetically or in date order.
What do I need to do at Step 1?
You will not need to take any action at Step 1. Providing the product authorisation is maintained, any existing extensions of use will be allowed to continue. Occasionally we may need to amend an extension of use to comply with the terms of the Annex I inclusion or approval.
If the product does not successfully meet Step 1, its authorisation will be revoked at the compliance deadline. Action will also be taken against any extensions of use. In accordance with the use-up period allowed for on-label uses, the extension of use will continue for a further year after the compliance deadline (or to its current expiry date if this is sooner).
What do I need to do at Step 2?
You will need to submit a new application for consideration for the extension of use to meet the Step 2 deadline. This will need to demonstrate that all relevant Annex III requirements are met (with the exception of efficacy) for the requested uses and that they satisfy the Uniform Principles and Annex I agreed endpoints.
You should liaise with the product authorisation holder to establish the uses that they will be supporting. If they are making changes, these may have an impact on the extension of use. Ideally you should submit your application to re-register any existing extensions of use at the same time as the re-registration application for the on-label uses. This will enable us to consider all uses being supported for a product at the same time.
What do I need to submit?
You will need to submit the following:
- A covering letter; and,
- A signed, dated CRD3 application form; and,
- Previous relevant correspondence; and,
- A safety assessment for the proposed extension of use, supported by data and/or reasoned cases. These must satisfy conditions referred to in regulation 6(3)(c),(d) and (f) of PPPR and demonstrate that the product, when used in accordance with the proposed conditions for the extension of use:
- Does not cause unnecessary suffering and pain to vertebrates to be controlled.
- Has no harmful effect on human or animal health, directly or indirectly (for example, through drinking water, food or feed) or on groundwater.
- Has no unacceptable influence on the environment, with particular regard to its fate and distribution in the environment and its impact on non-target species.
Reasoned cases may include extrapolation of relevant recommendations from the product label (providing these are being re-registered) in support of the proposed use. Where read-across is proposed, it is useful to provide a table comparing the following parameters for the proposed use to the on-label use:
- The application rate(s).
- The maximum in-use concentration.
- The exact timing of any application(s) (including time of year).
- The stage of crop and canopy development at each application.
- The number of applications possible per calendar year (number of crops per year and treatments).
- Situation of use (indoor or outdoor).
- Method of application.
You should make a case addressing why the differences do not affect risks to humans or the environment if any of these parameters differ.
You must address any areas highlighted in the Review Report as requiring particular attention (we will identify these in our letter issued following the Annex I Inclusion/approval); and,
- Relevant individual test and study reports specific to the use (or uses) in question, in accordance with the requirements specified in Annex III, (see below); and,
- Data and/or reasoned scientific cases to address any outstanding data gaps.
Further guidance on making extension of use applications can be found in the guidance document for Extensions of Use and the Post inclusion document for UK Extensions of use authorisation holders (pdf)
Can I refer to data and/or information previously considered by CRD?
Yes, providing these data and/or information are scientifically valid and address the Annex III requirements. It would be useful if you could re-submit these data or alternatively provide a clear reference to when they were previously submitted (e.g. COP number, date submitted). New data and/or information will be required where there are outstanding data gaps that need to be addressed.
What happens if my application is successful?
Where requirements are met, a new extension of use will be issued. This will be subject to the same period of authorisation as for the on-label uses of the product.
Can I submit a re-registration application after your Step 2 deadline?
Yes, but we will not issue a new extension of use until a satisfactory assessment has been carried out.
Are there any differences between a SOLA authorised under COPR and one authorised after re-registration?
The main difference is that under COPR, we will allow a provisional authorisation, with a data submission deadline set for further confirmatory data to address requirements for full authorisation. With the exception of some minor and non-safety related data gaps, we will not be able to issue an authorisation following reregistration unless all Annex III requirements have been addressed.
What happens if I do not submit a re-registration application or my application is unsuccessful?
We will not be able to issue a new extension of use. However, in accordance with the use-up period allowed for on-label uses, providing there are no safety concerns, the existing extension of use will be allowed to continue for a further year after the final deadline for re‑registration (or to the expiry date specified on the extension of use approval if this is sooner).
What happens if the product is not re-registered?
Arrangements will be as detailed in the section above.
What about Maximum Residue Levels?
Further information is provided on our website.
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