13 November 2002
Back-Stop Expiry Dates for COPR Approvals and Sell-Out Periods
The purpose of this letter is to advise approval holders and interested parties of extensions to expiry dates for approvals issued under national rules, i.e. the Control of Pesticides Regulations 1986 (as amended) (COPR). Inform of the planned introduction of shorter wind-down periods for revoked approvals (phased revocations).
COPR Back-stop expiry Dates
Under the transitional period provided for in Article 8(2) of Council Directive 91/414/EEC, we currently have a backstop expiry date for COPR approvals of 25 July 2003 (based on the date of implementation of the Directive). Debbie Hussey’s all approval holders letter of 12 August 2002 (AAH ref 18/2002), explained that a new Commission regulation had been drawn up to allow the time period referred to in Article 8(2) to be extended to:
- 31 December 2005 - for products containing active substances being considered under the first and second stages of the EC review programme.
- 31 December 2008 - for products containing those active substances being considered under the third and fourth stages of the programme.
For products containing existing actives already included in Annex I
The Directive allows for relevant authorisations to be granted, withdrawn or varied, as appropriate within a prescribed period (as specified in the inclusion Directives).
- This period is usually four years although may be shorter (if a product contains an existing and and new active substance) or longer (for a mixed active product also containing an unlisted existing active substance).
- For products containing existing actives listed in Annex I after December 2004, the period would start to extend beyond December 2008.
Given the endless possibilities arising from these different scenarios, there would be practical difficulties in determining the specific expiry dates for each and every COPR approval.
PSD will therefore be extending the backstop expiry date for all COPR approvals to 31 December 2008, unless earlier decisions are made or further prescribed extensions are granted by inclusion Directives.
The imposition of this backstop date is purely an administrative one. PSD fully understands its obligations under the Directive, and will complete all necessary actions with respect to active substances included in the first and second lists of the EC review programme within the timeframes specified by the Commission.
A blanket amendment Notice extending extant COPR approvals in line with the above is enclosed. An expiry date is specified for both provisional and full approvals, with the latter no longer being granted for an unstipulated period, as has previously been the case. Off-label approvals will be subject to the same expiry date.
For some time now, in revoking COPR approvals, PSD has been restricting approval for advertisement, sale and supply to 25 July 2003. Where revocation Notices have already been issued, PSD is not planning to automatically amend wind-down periods. However, where a longer period is required for advertisement, sale and supply, in accordance with the maximum wind-down period that would have been granted without the 25 July 2003 expiry date, approval holders may submit an application to extend these periods. Such requests will be dealt with via the Administrative Fast stream. For details on how to make such an application, please refer to Section E10 of the Application Handbook.
Sell-out or wind-down periods
There are currently three main approaches adopted by PSD in respect of wind-down periods for revoked approvals (phased revocations):
- Complete (immediate) revocation.
- 0+2 year phased revocation (where the approval holder and agents immediately lose the benefit of the approval but others may have a period not exceeding two years to continue to market and use existing stocks in the supply chain).
- 1+2 year phased revocation (as previously but with an additional one-year sell-out period for the approval holder and agents, providing others with a maximum of three years in total).
As has been demonstrated with non-inclusion decisions and in the recent Commission Regulation, it is now apparent that the Commission considers that periods of grace, in accordance with the provisions of Article 4(6) of the Directive, should be as short as possible and commensurate with the reason for withdrawal.
For recent non-inclusion decisions, 18 months has been considered to be a reasonable period for disposal, storage, placing on the market and use of existing stocks i.e. with a 6 month sell-out period for the approval holder and agents, and a further 12 months for approval for others to allow existing stocks to pass through the supply chain or be disposed of.
The periods of grace currently allowed by PSD are therefore out of line with latest Commission thinking on what constitutes a reasonable period for withdrawal of stocks from the supply chain. PSD is therefore planning to reduce the standard wind-down period for all phased revocations, as follows:
- The current one year period for the advertisement, sale, supply and use of superseded stock by the approval holders and their agents will be reduced to a maximum of six months.
- The further two year period for persons other than the approval holder and agents for advertisement, sale, supply and use of superseded stock will be reduced to a maximum of 12 months (i.e. allowing 18 months in total from the date of the Notice being issued for stocks to pass through the supply chain). Storage by any person will be permitted for the entire duration of the wind-down period.
- Shorter periods will still be applied if necessary.
These new wind-down periods will be introduced for all phased revocation actions initiated from 1 April 2003.
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