Regulatory Update 01/2012
Issued: 12thJanuary 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
The review report on the following substance was finalised at the Standing Committee on the Food Chain and Animal Health (SCoFCAH) on 11 October 2011 and after further deliberation at the Appeals Committee, a decision taken to approve under Regulation (EC) 1107/2009:
There are currently no UK authorised products containing this active substance. In order to gain authorisation 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.
Other information
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 review reports:
| fenpropimorph, fluazinam, lufenuron, metribuzin | The review reports for these active substances have been revised to indicate the submission of acceptable Annex II confirmatory data required to maintain their approval.This consisted of further data on soil mobility of a metabolite for fenpropimorph, further information on the specification of fluazinam and lufenuron, and for metribuzin, further data on risk to groundwater by metabolites at higher application rates. |
Contact Details
If you have any queries please contact Matthew Burns, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX. Telephone: 01904 455836 or email applicant-enquiries@hse.gsi.gov.uk.
