Regulatory Update: 26/2012
Issued: 1 August 2012
All authorisation holders should note that following approval of an active substance under Regulation (EC) 1107/2009 (formerly inclusion in Annex I of Directive 91/414 EC) 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 authorisation holders (see Regulatory Update 17/2008 for details).
Active substance approvals
Following consideration at the Standing Committee on the Food Chain and Animal Health (SCoFCAH) a positive opinion was given on 13 July 2012 to approve under Regulation (EC) 1107/2009:
- Adoxophyes orana granulovirus
There are currently no UK approved products containing this active substance. In order to gain approval a complete Annex II and III submission would be required. You should also take account of the specific provisions in the approval regulation. You should follow the guidance for re-registration to help you complete your submission.
Since the 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, for example, lists of protected studies are now available. At this time you may wish to note the following amendments that have been made to the approval conditions and review report for the following substance:
|Potassium hydrogen carbonate ||Following the completion of the peer review and finalisation of the EFSA scientific conclusion on this substance, the approval has been revised to specify max limits for two impurities.|
If you have any questions relating to this Regulatory Update, please contact CRD Pesticides Branch.
Postal address: Pesticides Branch, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK