Regulatory Update: 13/2012
Issued: 10 April 2012
Regulatory Update 32/2011 announced changes to CRD ’s withdrawal procedures which we considered necessary in order to comply with Regulation (EC) No 1107/2009. However, since then, we have received clarification from the European Commission on Articles 45 and 46 of the Regulation and have reviewed our approach in light of apparent difficulties these withdrawal periods are causing within the supply chain. We have concluded that in some circumstances we can be more flexible in our approach to periods of grace following a withdrawal than set out in Regulatory Update 32/2011.
Extended Periods of Grace for Superseded Authorisations
Following a withdrawal or amendment, Article 46 of Regulation (EC) No 1107/2009 allows a maximum 6 months for the sale and distribution and an additional maximum of 1 year for the disposal, storage and use of existing stocks. However, Article 45 states that where a withdrawal is made at the request of the authorisation holder, then Article 46 should be applied to the withdrawal of an authorisation where appropriate.
We have concluded that it is not appropriate to apply the periods set out in Update 32/2011 where the withdrawal of an authorisation follows an applicant’s request to change that authorisation and any resulting withdrawal of a notice is only for housekeeping or other non-safety related reasons.
Where a notice is withdrawn following an application for a new authorisation, and there are no safety concerns regarding the old authorisation, we will now apply longer periods of grace to allow for safe use up and disposal of existing stocks. In these cases, the new grace period will be up to a maximum of 24 months for sale and distribution plus a further 24 months for use, storage and disposal of the existing stocks.
Where granting a withdrawal period of 24 months for sale and distribution plus a further 24 months for use, storage and disposal would result in a date which exceeds expiry dates required to meet EU decisions, then the EU deadline dates will take precedence over any CRD withdrawal periods.
What will happen to existing grace periods?
CRD will not automatically extend authorisations which are already the subject of a phased withdrawal. However, if authorisation holders wish to extend the grace period of a product which has already been withdrawn, they may apply to do so via an Administrative Application. Any notices which have been withdrawn since 14 June 2011, and meet the above criteria, may be eligible for extension up to a maximum of 24 months for sale and distribution plus a further 24 months for use, storage and disposal from the original date of withdrawal.
Other Periods of Grace remain unchanged
The periods of grace allowed for notices which are withdrawn for other reasons, such as safety concerns or EU decisions, will remain unchanged.
As already mentioned above, any EU decisions and deadline dates will continue to take precedence over any CRD withdrawal periods.
Details of all withdrawal periods can be found in the Applicant Guide and the attached table.
If you have any questions relating to this Regulatory Update, please contact CRD Pesticides Branch and your enquiry will be sent to the appropriate person to respond:
Postal address: Pesticides Branch, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK.