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Expiration of the PPP authorization in case no application for renewal was or can be submitted

Timely application for renewal of PPP authorizations is the responsibility of the authorization holder, and although Ctgb will try to contact authorization holders in case their intentions are not clear, Ctgb does not accept responsibility in case authorizations expire because authorization holders miss deadlines for renewal applications in the Netherlands. Authorization holders are referred to the EU Pesticide database and the official publications website (EUR-lex) for reference on active substance expiration dates and the Date of Application (DoA) of Active substance renewals.

The following general rules apply for expiration of PPP authorizations around renewal or expiration of the active substance. In case a product contains more than 1 active substance, the first active substance to expire or (to be) renewed is triggering the expiration date for the PPP authorization.

  In case of The PPP autorisation will
1. Active substance has been renewed but no subsequent zRMS or CMS application for PPP renewal was received by Ctgb before DoA + 3 months.
  • expire on the national expiration date of the PPP authorization if this date is set on (or before *) DoA + 12 months (as based on articles 32 and 46.5 of PPPR (EC) 1107/2009)**.
  • be revoked by Ctgb on DoA + 1 year in case the national expiration date of the PPP authorization is set after DoA + 12 months**.
2.

It is confirmed that no application for renewal of the active substance approval is submitted or it was aborted.
•    No renewal applied for – original AS date of expiry stands
•    Renewal aborted – original date of AS expiry stands or in case it was already postponed, the EC may set a new AS date of expiry.
  • expire on (or before *) the national expiration date of the PPP authorization if this date is set on the confirmed date of expiry set for the active substance**.
  • be revoked by Ctgb on the date of expiry confirmed for the active substance, in case the national expiration date of the PPP authorization is set after this date**.

    Article 32 of PPPR (EC) 1107/2009 does not apply in these cases. As the approval of the active substance is terminated, the conditions set in article 29 sub 1a are no longer fulfilled, and according to article 44 sub 3 product applications should expire on the same date as the active substance approval.
3.

Non-renewal of active substance approval
- the renewal evaluation failed to pass the criteria and non-renewal was decided on -
  • expire on (or before *) the national expiration date of the PPP authorization if this date is set on the confirmed date of expiry set for the active substance**
  • Be revoked by Ctgb on the deadline set in the EC non-renewal regulation**. 

    Article 32 of PPPR (EC) 1107/2009 does not apply in these cases. As the approval of the active substance is terminated, the conditions set in article 29 sub 1a are no longer fulfilled.  the EC non-renewal regulation usually specifies an expiry date and grace periods for PPP authorizations deviating from the standard rules laid down in article 32 and article 46.

* In case a PPP authorization cannot be renewed (active substance approval expires) or no application for renewal was received before DoA + 3 months and the authorization expires between DoA + 3 months and  DoA + 12 months, authorization holder may request an administrative extension for the period remaining until DoA +12 months.

** In all cases that the authorization expires or has to be withdrawn by Ctgb, authorization holders have the option to apply for voluntary withdrawal of the authorization on or before the scheduled expiration date. Authorization holders can at the same time apply and build a case for grace periods to phase out the product.

Expiration of individual uses not applied for

In section 3.6 of EU GD art. 43 PPP renewals (SANCO/2010 13170 rev. 14, 7 October 2016) it is stated that also individual uses (crops) not being defended for renewal, should expire in line with article 32 of PPPR (EC) 1107/2009; i.e. on the DoA of the active substance renewal + 1 year. For the time being, the Board of Ctgb has decided not to follow the EU Guidance in this point. Dutch authorizations for which a partial renewal is applied for, will be left untouched until the decision on the product renewal.  Applicants are requested to submit a statement that the uses in question are in compliance with the conditions and restrictions set in the active substance renewal regulation. Uses that do not comply with the conditions and restrictions of the active substance renewal regulation cannot be maintained.