Regulatory Update: 23/2010
Issued: 09 November 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 on 28 October 2010 to include the following active substances in Annex I of Directive 91/414/EEC:
- Fenbuconazole
- Haloxyfop-P
- Metosulam
- Napropamide
- Pyridaben
- Quinmerac
- Zinc phosphide
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.
Please note that for these recent inclusions and those that follow the date from vote to entry into force has been reduced - from 9 to 6 months, to ensure that all decisions will enter into force before the 31 December 2011 expiry date.
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.
Haloxyfop-P and Napropamide inclusions
The haloxyfop-P and napropamide inclusions do not have re-registration deadlines (none are specified in the Inclusion Directives).
There are currently no UK approved products containing haloxyfop-P. In order to gain approval for haloxyfop-P, 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.
There are existing approvals for napropamide. These were to be withdrawn following a non-inclusion decision published in 2008 (Commission Decision 2008/902/EC) however the decision on withdrawal of products was suspended and the EU General Court has extended the suspension of this decision until 30 November 2010. We are awaiting further clarification in relation to this deadline and its implications. CRD will be contacting approval holders directly in relation to the re-registration requirements for this substance.
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 inclusions:
| 2-phenylphenol | Amendment of this inclusion, to extend the uses that may be authorised, has been agreed following the submission and assessment of further information. The amendment allows authorisation as a post harvest fungicide for indoor use. The amendment will come into force in due course following its publication in the Official Journal. |
| tetraconazole | Extension of the uses that may be authorised has been agreed. The original inclusion restricted uses to field crops with a restricted rate and timing of application. The new information allows use to be widened and the restriction to be removed. The amended inclusion allows use as a fungicide. The amendment will come into force in due course following its publication in the Official Journal. |
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.
