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The Applicant Guide: Re-Registration For Extensions Of Use

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 (EAMU) 'Extension of authorisation for a minor 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 Extension of authorisation for a minor Use in the UK meet product data 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.

A table of all active substance inclusions/ approvals 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 authorisation for a minor use will be allowed to continue. Occasionally we may need to amend an extension of authorisation for a minor 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 must  submit a new application for consideration of the extension of authorisation for a minor use to meet the Step 2 deadline. This must demonstrate that all relevant product data requirements are met (with the exception of efficacy) for the requested uses and that they satisfy the Uniform Principles and Annex I/ approval 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 authorisation for a minor use. Ideally you should submit your application to re-register any existing extensions of authorisation for a minor 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 must submit the following:

  1. A covering letter;
  2. A signed, dated CRD3 application form;
  3. Previous relevant correspondence;
  4. 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:

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,

  1. 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);
  2. Data and/or reasoned scientific cases to address any outstanding data gaps.

Further guidance on making extension of authorisation for a minor use applications can be found in the guidance document for Extensions of Use.

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 product data requirements. It would be useful if you could re-submit these data or alternatively provide a clear reference to when they were previously submitted (eg 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 authorisation for a minor 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 authorisation for a minor use until a satisfactory assessment has been carried out.

Are there any differences between a SOLA authorised under National rules (previously COPR) and one authorised after re-registration?

The main difference is that under national rules (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 product 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 authorisation for a minor use. However, in accordance with the use-up period allowed for on-label uses, providing there are no safety concerns, the existing extension of authorisation for a minor 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 authorisation 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.

Further information

Updated 2016-08-03