Regulatory Update: 22/2012
Issued: 2 July 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 1 June 2012 to approve under Regulation (EC) 1107/2009:
If you are a UK authorisation holder for an existing product(s) containing fluxapyroxad 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 authorisation 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 authorisations following active substance approval.
Failure to take appropriate action will result in revocation of your relevant national authorisation.
Note: This is also relevant for permit holders for parallel imported products and holders of extensions of authorisation for minor uses of existing products (off-labels). 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 authorisations following active substance approval.
Bifenthrin and fenpyrazamine approvals
The bifenthrin approval does not have re-registration deadlines (none are specified in the Approval Regulation).
There are currently no UK authorised products containing bifenthrin. In order to gain authorisation for bifenthrin 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.
Fenpyrazamine was approved as a new active substance, and products containing this substance have not been authorised previously in the UK. In order to gain authorisation for fenpyrazamine 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 approval conditions and review reports for a number of substances:
1,4-diaminobutane (putrescine), aluminium ammonium sulphate, aluminium silicate, denathonium benzoate, fat distillation residues, fish oil, hydrolysed proteins, iron sulphate, methyl nonyl ketone, plant oils/spearmint oil, tall oil crude, tall oil pitch
Following the completion of the peer review and finalisation of the EFSA scientific conclusions on these substances, approval regulations and review reports have been updated.For some of these substances confirmatory data requirements have been identified to maintain their approval.
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