Product Renewals (NL zRMS and NL=CMS)
After their first approval in the EU, active substances for plant protection products (PPPs) are subject to a re-evaluation after 7, 10 or 15 years depending on their EU classification. To plan the next round of re-evaluations, the European Commission divided active substances into 5 groups based on their subsequently scheduled expiration dates; AIR-1 to AIR-5. Re-evaluation of the active substance approvals often leads to changes in the List of Endpoints.
Following the active substance renewal, the authorizations of PPPs containing the active substance are up for re-evaluation according to article 43 of PPPR (EC) 1107/2009. Renewals for PPPs based on AIR-1 substances are executed under the transitional conditions of article 80 of PPPR (EC) 1107/2009. PPP renewals for active substances from AIR-2 and higher AIR groups should be fully executed under PPPR (EC) 1107/2009, following a zonal procedure.
Authorization holders that want to maintain their current authorization and uses (as based on old Endpoints) in The Netherlands after the active substance renewal have to fulfil the requirements as set out in article 43 of PPPR (EC) 1107/2009. This applies to all authorizations based on old Endpoints irrespective of their history, whether originally authorized under 91/414 or PPPR (EC) 1107/2009, through a national procedure, zonal procedure, mutual recognition, extension, or minor use extension. In the PPP renewal assessment the authorization will be re-assessed based on the new List of Endpoints for the active substance and the Guidance in place at the time of submitting the product renewal application.
Within 3 months after the Date of Application (DoA) set in the EU renewal regulation of the approval of the active substance, the authorization holder should submit an application for renewal of the product to Ctgb. Note that for products based on more than one active substance, each active substance renewal triggers its own subsequent PPP renewal process (consequences are further explained in these pages).
Ctgb can act as zRMS or CMS for PPP renewal applications. In terms of the dossier and main procedures, renewals follow the guidelines set out for zonal applications for art 33 of PPPR (EC) 1107/2009. However, time lines and procedures are adapted to fit the nature of a reassessment, and will therefore be set out in the following pages as based on art 43 of PPPR (EU) 1107/2009 and the EU GD art. 43 PPP renewals (SANCO/2010 13170).
As the EU Guidance Document on art 43 PPP renewal will receive regular updates, these Ctgb pages on art 43 PPP renewals will be adjusted accordingly. Major changes will be actively communicated to stakeholders.
Comparative assessment for renewal application
Comparative assessment for renewal applications is triggered as soon as the product contains an active substance labelled as Candidate for Substitution. Meaning that in case the product contains 2 or more active substances, a comparative assessment should be executed for every renewal application, whether triggered by renewal of active substance labelled as Candidate for Substitution or one of the other active substances. An application for renewal of a PPP containing a Candidate for Substitution will include an evaluation of available alternatives (PPPR (EU 1107/2009, art. 50). Therefore, in these cases applicants should submit the application form for a Comparative Assessment together with the renewal application.
Refer to the EU Pesticide database to check the status of an active substances.
Impact of active substance renewals on ongoing applications
From the Date of Application set in the active substance renewal regulation, Ctgb can no longer issue new authorizations based on the old List of Endpoints – ref. section 3.2 of EU GD art. 43 PPP renewals (SANCO/2010 13170 rev. 14, 7 October 2016). This means that the renewal of the active substance may also have significant consequences for ongoing (and planned) applications based on old Endpoints. In extremis, applications based on old Endpoints cannot be decided on, or have to be denied for procedural reasons.