Active substances voluntarily withdrawn from the EU re-evaluation
A series of active substances have been non-included in Annex I of the Pesticides Directive (directive 91/414) in accordance with Commission decisions (2008/934/EF) of 5. December 2008 and (2008/941/EF) of 8. December 2008.
The non-inclusion of these active substances in Annex I is not based on any clear evidence of harmful effects but that the applications have been voluntarily withdrawn and an extended deadline has been granted. Approvals for products containing active substances covered by the Commission decisions must hereafter be withdrawn by 31. December 2010 at the latest.
The special agreement on extended withdrawal deadline may, however, raise doubts as to what is the current procedure. For products containing active substances which are voluntarily withdrawn, see the following ;
Renewal of approvals in Denmark
If a national approval for a product containing one of the withdrawn active substances runs out before the date of withdrawal, or the non-inclusion decision, a renewed national approval can not be granted. The reason for this is that a non-inclusion decision is valid from the date of its issue. The consequence is that when an approval expires, it will only be possible to apply for a new one if and when the active substance is included in Annex I. In this case, a new application must be submitted with a complete annex III data package. An application for approval of a product containing the withdrawn active substances can be submitted at the earliest when the substances are included in Annex I and after the inclusion directive is made public.
Example: If a national approval is due to expire in April 2010, but the date for withdrawal after non-inclusion is, at the latest, 31. December 2010, the approval must be seen as expired. A new application can be made if and when the active substance is included in Annex I .
As the Commission decisions come into force immediately, it will no longer be possible to get an extended use approval as the conditions for authorisation after the publishing of the non-inclusion list are no longer applicable .
Parallel approval and ‘me too’
A parallel approval or a ‘me too’ approval can not be granted after the Commission decision on non-inclusion are published, as the conditions for approval of this type do not fulfil the conditions of the Plant Protection Directive.
Applications submitted before publication of non-inclusion
Applications submitted prior to the publication of non-inclusion decisions can not be authorised and must be withdrawn.
Withdrawal dates and ban on sale and use
The member states can set dates for withdrawal earlier than 31. December 2010, which is the latest date set by the Commission decision. Such shorter deadlines have been set in connection with the non-inclusion of the active substance terbuthylazin.
Deadlines for the ban on sale and use are dealt with in Annex 9 of the Executive Order on pesticides with later changes.
Link to Executive Order on pesticides: