Regulatory Update 12/2012
Issued: 03 April 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
Active substance approvals
The amended approval of the following substance was finalised at the Standing Committee on the Food Chain and Animal Health (SCoFCAH) on 9 March 2012:
Note: For metam the step 1 re-registration deadline for compliance with the conditions of the approval is 31 December 2014. This is in line with the expiry date of essential uses previously allowed for metam under Council Decision 2009/562/EC. CRD’s administrative deadline for step 1 submissions in support of products containing metam is 6 months before the December deadline i.e. 30 June 2014.
Member States and the Commission also agreed the following time lines for the registration of napropamide products:
- Administrative deadline for step 1 submissions to be received by MS: 30th June 2012
- Step 1 compliance deadline: 31st December 2012
- Administrative deadline for step 2 submissions to be received by MS: 30th June 2014
- Step 2 compliance deadline: 30th June 2016
If you are a UK authorisation holder for an existing product(s) containing 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 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.
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:
chlormequat, dithianon, isoxaben
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 information on the specification of the active substance.
blood meal, calcium carbide, calcium carbonate, limestone, Pepper, quartz sand
Following the completion of the peer review and finalisation of the EFSA scientific conclusions on these substances, their approvals and review reports have been updated.
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,