Regulatory Update: 08/2010
Issued: 23 March 2010
Annex I inclusions and re-registration requirements
All approval holders should note that following inclusion of an active substance on Annex I of Directive 91/414, they have specific obligations relating to re-registration. Details of the requirements and timelines can be found via the post-inclusion deadline and re-registration page of our website. Please note that since July 2008, we have not sent individual post-inclusion letters to approval holders (see Regulatory Update 17/2008 for details)
Recent Annex I inclusions
Following consideration at the Standing Committee on the Food Chain and Animal Health (SCoFCAH) and (for active substances with a no-opinion decision at Standing Commitee) by the Environment Council or the Agriculture and Fisheries Council, a positive opinion was given to include the following active substances in Annex I of Directive 91/414/EEC:
- Cyflufenamid - 02/10/2009
- Fluopicolide - 27/11/2009
- Heptamaloxyloglucan - 27/11/2009
- Malathion - 22/01/2010
- Penoxulam - 22/01/2010
- Proquinazid - 22/01/2010
- Spirodiclofen - 22/01/2010
- Flonicamid - 12/03/2010
- Metalaxyl - 12/03/2010
- Triflumizole -12/03/2010
If you are a UK approval holder for an existing product(s) containing any of the above active substances you will be affected by this decision and the following information is relevant to you.
The decision triggers the start of the product re-registration process and you should take action if you wish to ensure continued approval for your product(s). You should consult the post-inclusion deadline and re-registration page on our website. The page sets out information about your obligations and the deadlines that you must meet to maintain your existing product approvals following Annex I inclusion.
Failure to take appropriate action will result in revocation of your relevant national approvals if they contain an active substance listed above.
Note: This is also relevant for approval holders for parallel imported products and off-label approvals. The post inclusion deadline and re-registration page on our website also sets out information about your obligations with respect to maintaining your existing product approvals following Annex I inclusion.
Malathion and Triflumizole inclusions
As resubmissions, the malathion and triflumizole inclusions do not have re-registration deadlines (none are specified in the Inclusion Directives). Please note that there are currently no UK approved products containing either malathion or triflumizole. In order to gain approval for either substance, a complete Annex II and III submission would be required. You should also take account of the specific provisions in the inclusion directive. You should follow the guidance for re-registration to help you complete your submission.
Since previous Regulatory updates were issued, various draft documents have been published (data lists and Inclusion Directives) so we have updated the ‘table of recent deadlines’ to reflect this. Each time we alert you to new inclusions, and the resultant re-registration requirements, we will update the links to the documentation in this table. You should check this table on a regular basis to determine if e.g. lists of protected studies are now available. At this time you may wish to note the following amendments that have been made to inclusions:
These inclusions have been amended to correct terminology used to identify the range of uses that may be authorised. The amendment was published in November 2009.
This inclusion has been amended to refer to the common name and purity specifications set out in the Review Report. The amendment was published in December 2009.
This inclusion has been amended to extend the uses that may be authorised to include non-edible crops. The amendment was published in January 2010.
These inclusions have been amended with respect to the specific provisions imposed to protect non-target organisms in particular honey bees. The amendment was published in March 2010.
If you have any queries concerning this update, please contact us: Link to Contact details page