Regulatory Update: 31/2008
Issued: 18 September 2008
Microbial inclusions
At the Standing Committee on the Food Chain and Animal Health, 10-11 July 2008, a positive opinion was given to include various microbial active substances (including Bacillus thuringiensis, Beauvaria bassiana, Cydia pomonella granulovirus, Lecanicillium muscarium, Metarhizum anisopliae, Phlebiopsis gigantea, Pythium oligandrum, Streptomyces K61, Trichoderma atroviridae, Trichoderma polysporum, Trichoderma harzianum, Trichoderma asperellum, Trichoderma gamsii and Verticillium albo-atrum) in Annex I of Directive 91/414/EEC.
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.
Diuron inclusion - correction
Regulatory Update 21/2008 highlighted that following re-submission, diuron had been included on Annex I. The complete list of deadlines included dates for re-registration in error, since none were specified in the Inclusion Directive (which enters into force on 1 October 2008).
It is not possible to re-instate Control of Pesticides Regulations (COPR) approvals for products containing diuron which are currently in the final phases of wind-down following the earlier non-inclusion. In order to 're-instate' these approvals, you are required to submit full Annex III packages (refering to assessments conducted under COPR if they are to modern standards), as well as access to all protected Annex II data. You should also take account of the specific provisions in the inclusion directive (noting the rate restriction). You should follow the guidance for re-registration to help you complete your submission.
Other amendments to the table of recent deadlines
Since Regulatory updates 17/2008 and 21/2008 were issued, various documents were made available so we have updated the table of information 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.
We expect to update this information shortly after the next meeting of the Standing Committee on the Food Chain and Animal Health, to be held in Brussels next week, 25 & 26 September 2008.
Contact
If you have any queries contact Tracy Roberts, Pesticides Safety Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX. Telephone: 01904 455818 or email applicant-enquiries@hse.gsi.gov.uk
