Regulatory Update No: 04/2009
Issued: 29 January 2009
Introduction
Further to Regulatory Update 1/2008, this update advises of the completion of the 1st phase of the exercise to replace the Long Term Arrangements for Extension to Use (LTAEU) with Specific Off-Label Approvals (SOLAs) for use on non-edible crops.
Information for Growers and Crop Protection Industry
The 1st stage of the replacement exercise for the LTAEU on non-edible crops has now been completed. Of the 401 products requested by users, the first stage has dealt with the 131 products which contain active substances that have already been fully reviewed in the EU review programme, and included on Annex I of Council Directive 91/414/EEC (see list of active substances at Appendix 1). 29 of these products were either already approved for the requested use or had been revoked, so no approval has been given. The remaining 102 products have been given new replacement (SOLAs) and these are listed in Appendix 2. The remainder of the 401 requests will be dealt with over the next 5 or so years. This will be undertaken during re-registration of the product approvals when the active substances they contain are included on Annex I of 91/414/EEC. Full details of these products can be found at Appendix 3.
A new restriction has now been added to the LTAEU prohibiting the use of any product containing the active substances listed in Appendix 1. Any products containing these substances (either singly or in mixture with other substances on the list) must not be used under the LTAEU from the 1st June 2009. In many cases these former LTAEU uses now have replacement SOLAs and the active substances that have SOLAs are highlighted in Appendix 1. Copies of the SOLA notices are available for viewing on the PSD Off-label home page.
Not all active substances listed in Appendix 1 have replacement SOLAs as either they were not requested under this exercise or the uses no longer meet the appropriate regulatory requirements. Approval for a previously approved LTAEU use of any product containing these excluded active substances can be requested for re-consideration. This will be undertaken via the normal off-label application route and they will be evaluated on a case by case basis. It is recommended that applicants contact PSD for advice at the address detailed below before submitting an application.
Any products containing an active substance on this list plus an additional active substance(s) not listed can continue to be used until all the component substances appear on the list (sometime over the next 5 years). It is the user’s responsibility to check this list before using such products. The list contains many active substances which are not approved in the UK. These have been included for completeness and in case products containing these substances gain UK approval in the future.
The remaining 270 products will be considered on an ad-hoc basis as the component actives are included on Annex I of 91/414/EEC, and the products containing them are re-registered. Additions to this list can be requested by submitting to PSD, at the address below, details of the product (name and Ministerially Approved Pesticide Product (MAPP) number), LTAEU crop(s) required and the on-label crop the use is to be based on. The prohibited active substance list as detailed in Appendix 1 will be expanded as these SOLAs are issued until all UK products have been re-registered. Thus the number of products available for use under the LTAEU will decrease until the Arrangements are no longer valid. At this point they will be withdrawn.
Please note that the restriction of use of these active substances/products only relates to use under the LTAEU and does not impact on any other uses or approvals. Therefore, if these actives/products currently hold approval (on-label or SOLA) for use on LTAEU crops, these uses will remain approved.
Contact Information
Enquiries concerning this Update should be made to Francis Daly either by telephone to 01904 455824, by email to: francis.daly@hse.gsi.gov.uk, or in writing.
