Regulatory Update: 16/2010
Issued: 27July 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) a positive opinion was given to include the following active substances in Annex I of Directive 91/414/EEC:
- FEN 560 (fenugreek seed powder) – SCoFCAH vote 11/05/2010
- Sulfuryl fluoride – SCoFCAH vote 11/05/2010
- Azimsulfuron – SCoFCAH vote 09/07/2010
- Azoxystrobin – SCoFCAH vote 09/07/2010
- Imazalil – SCoFCAH vote 09/07/2010
- Prohexadione – SCoFCAH vote 09/07/2010
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.
Other updates
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 recently been made:
| Penconazole | This substance was originally included with the specific provision that Member States may only authorise uses in greenhouses and that the notifier should submit further information on the fate and behaviour of the soil metabolite U1 by 31 December 2011. Following the consideration of additional information the restriction to greenhouse use has been removed and the inclusion amended to state that ‘Only uses as fungicides may be authorised’. In addition the confirmatory requirement for further information on the metabolite U1 has been removed and replaced by a confirmatory requirement for the notifier to submit further information to address the fate and behaviour of the soil metabolite CGA179944 in acidic soils. The amendment was published in June 2010. |
| Iprodione | At the Standing Committee in July a positive opinion was delivered on an amendment to the inclusion to extend the uses that may be authorised to include use as a nematicide. The amendment will come into force in due course following its publication in the Official Journal. Document not available in the table – it will be made available on the Commission database |
| Dimethachlor | Minor amendments to the Review Reports were made for these substances to reflect finalisation of the reference specifications. |
| Quizalofop-P |
| Zeta-cypermethrin |
| Cyprodinil | The Review Report was amended to reflect agreement that the confirmatory data submission had addressed the requirements in relation to birds, mammals and residues in food of animal origin. Document not available in the table – it will be made available on the Commission database |
Contact Details
If you have any queries please contact Lesley McCartney, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX. Telephone: 01904 455760 or email applicant-enquiries@hse.gsi.gov.uk.
